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Argosy University Institutional Review Board Handbook – January 2014

Institutional Review Board

Handbook

Guidelines and Information Related to the Certification of Research Projects Connected in Any Manner to Argosy University Revised January 2014

Argosy University Institutional Review Board Handbook – January 2014

Table of Contents

Preface ............................................................................................................................... vi The Compliance Review Procedure in Brief ............................................................... viii Substantive Changes Made to This Edition of the Handbook ........................................ x

SECTION 1: ADMINISTRATIVE DOCUMENTS ..................................................... 10 Responsibilities of National and Local Campus Institutional Review Boards .......... 10

Mission and Guiding Principles ..................................................................................... 3 Mission....................................................................................................................... 3

IRB Certification of Compliance .................................................................................... 3 Review of Applications for Certification ....................................................................... 3 Appeal of IRB Decision ................................................................................................. 5 Definitions ...................................................................................................................... 5 Guiding Principles .......................................................................................................... 6 Code of Federal Regulations .......................................................................................... 7 Ethical Principles ............................................................................................................ 8 A Cautious Stance .......................................................................................................... 8

Membership and Governance of the IRB ....................................................................... 8 Membership .................................................................................................................... 8 IRB Governance ............................................................................................................. 9

Self- governing .......................................................................................................... 9 Role of IRB Chairperson ......................................................................................... 10

Authority ............................................................................................................. 10 Meetings of the Institutional Review Board ................................................................. 10

Meeting schedule ..................................................................................................... 10 Yearly organizational meeting ................................................................................. 10

Letter of Assurance ............................................................................................. 11 Regular meetings of the full Institutional Review Board ........................................ 11

Quorum ............................................................................................................... 12 Consultation .................................................................................................................. 12 Conflict of Interest ........................................................................................................ 13 Record of IRB Actions and Activities .......................................................................... 13

Required records ...................................................................................................... 13 Tracking procedures and submission procedures .................................................... 13

IRB Compliance Audits................................................................................................ 14 Investigating noncompliance ................................................................................... 14 Reporting an issue of noncompliance to the IRB .................................................... 14

SECTION 2: PREPARATION OF APPLICATIONS FOR IRB REVIEW AND CERTIFICATION OF COMPLIANCE ....................................................................... 16 Purpose of Review ........................................................................................................... 16 Criteria for IRB Certification of Research Projects .................................................... 16

Risks to participants are Minimized ............................................................................. 16 Risks to Participants are Reasonable ............................................................................ 16

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Argosy University Institutional Review Board Handbook – January 2014

Selection of Participants is Equitable ........................................................................... 17 Benefits of Review ....................................................................................................... 17 Definition of Human Research ..................................................................................... 18 Studies Requiring Review ............................................................................................ 18 Categories of Certification ............................................................................................ 18 Studies Qualifying for Exempt Review (Level 1) ........................................................ 19 Studies Subject to Expedited Review (Level 2) ........................................................... 19 Studies Subject to Full IRB Review (Level 3) ............................................................. 20

Procedures for Applying for Certification of Compliance .......................................... 20 STEP 1: Initial Review ................................................................................................. 21 STEP 2: Logging the Application ................................................................................ 21 STEP 3: Review by Designated IRB Member ............................................................. 21 STEP 4: Certification or Resubmission ........................................................................ 22 STEP 5: Filing of Application ...................................................................................... 22 STEP 6: Project Completion Report ............................................................................. 22

Informed Consent ............................................................................................................ 23 Consent Process ............................................................................................................ 23 Consent form ................................................................................................................ 23 Elements of Informed Consent ..................................................................................... 24 Special Consent Procedures.......................................................................................... 24

Oral Consent ............................................................................................................ 24 Internet Consent ....................................................................................................... 25 Waiver of Informed Consent ................................................................................... 25 Documentation of Informed Consent ...................................................................... 25

Conflict of Interest ........................................................................................................ 26 Collaborative Institutional Training Initiative (CITI) .................................................. 26 Research Conducted at the Place of Employment ........................................................ 27 Class Research Projects ................................................................................................ 27 Research projects Lacking Definite Plans for Human Participant Involvement .......... 29 Cooperative Research Activities .................................................................................. 30

Cross-Campus Cooperative Research ...................................................................... 30 Argosy University Research at the National Level ................................................. 31

Permissions Required .......................................................................................... 31 Argosy University Research at the Campus Level ............................................. 32

Changing Research Direction ....................................................................................... 33 Action Research ............................................................................................................ 33 Notification of IRB Decisions ...................................................................................... 33 Interim Certification of Compliance ............................................................................. 33 Continuing Review ....................................................................................................... 34

All Certifications are Subject to Continuing Review .............................................. 34 Completing the Continuing Review Form ............................................................... 35 Submission of Continuing Review Form................................................................. 35 Continuing Review More Often than Annually ....................................................... 36

Research Project Amendments or Modifications ......................................................... 36 Adverse Events ............................................................................................................. 37

Argosy University Institutional Review Board Handbook – January 2014

Procedures to Ameliorate an Untoward Incident ......................................................... 37 Suspension of Certification .......................................................................................... 37 Preparation of Application Materials ........................................................................... 38 Filing and Record Retention ......................................................................................... 38

SECTION 3: IRB APPLICATIONS FORMS AND REPORTS ................................ 39 General Guidelines .......................................................................................................... 39

Submitting an Application for IRB Review and Certification of Compliance: ........... 39 Copies of all informed consent and assent documents that will be used in the research .................................................................................................. 40 Permission letters ..................................................................................................... 40 Certification from other institutions ........................................................................ 40 Study materials ........................................................................................................ 41 Permission for usage of previously collected data................................................... 41

Responding to a Request for Revisions ........................................................................ 41 Request to Continue IRB Certification ......................................................................... 42 Research Project Amendments and Changes ............................................................... 42 Reporting Adverse Events ............................................................................................ 42 Elements of an Informed Consent Document ............................................................... 43

Designing a Consent Form ...................................................................................... 43 Additional Notes ........................................................................................................... 46

SECTION 4: APPENDIXES ......................................................................................... 48 Appendix A ...................................................................................................................... 49

Exempt Application Form Checklist ............................................................................ 49 Exempt Cover Sheet ..................................................................................................... 50 Exempt Application ...................................................................................................... 52

Appendix B ....................................................................................................................... 54 Expedited Application Form Checklist ........................................................................ 54 Expedited Cover Sheet ................................................................................................. 55 Expedited Application .................................................................................................. 57

Appendix C ...................................................................................................................... 60 Full Application Form Checklist .................................................................................. 60 Full Cover Letter .......................................................................................................... 61 Full Application ............................................................................................................ 63

Appendix D ...................................................................................................................... 66 Sample Basic Consent Form......................................................................................... 66 Alternative Consent Form ............................................................................................ 68

Sample Oral Consent Form……………………………………………………………70

Appendix E ....................................................................................................................... 72 Letter to Correct IRB Application Deficiencies ........................................................... 72

Appendix F ....................................................................................................................... 73 Letter to Other Institutions Which Have Requested Argosy University Certification First .......................................................................................................... 73

Argosy University Institutional Review Board Handbook – January 2014

Appendix G ...................................................................................................................... 74 Continuing Certification of Compliance ...................................................................... 74

Appendix H ...................................................................................................................... 76 Project Completion Report (use for notification of completion for research projects certified by an Argosy University IRB) .......................................................... 76

Appendix I ........................................................................................................................ 77 Amendment to Original IRB Certification ................................................................... 77

Appendix J ....................................................................................................................... 78 Unanticipated Report .................................................................................................... 78

Appendix K ...................................................................................................................... 79 Change in Procedure Application (Use for Minor Change) ......................................... 79

Appendix L ....................................................................................................................... 81 Application for IRB Certification of Faculty Research and Assigned Course Research Projects ......................................................................................................................... 81

Appendix M ...................................................................................................................... 83 Assigned Course Research Progress Report ................................................................. 83

Appendix N ...................................................................................................................... 85 IRB Organizing Letter: IRB Letter of Assurance ......................................................... 85

Appendix O ...................................................................................................................... 86 IRB Procedural Forms (Examples)............................................................................... 86

Appendix P ....................................................................................................................... 87 EDMC Code of Business Ethics and Conduct ............................................................. 87 Example Conflict of Interest (Disclosure) Statement ................................................... 88

Appendix Q ...................................................................................................................... 90 Additional Resources .................................................................................................... 90

The American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct ........................................................................ 90 CITI Training ........................................................................................................... 90 Code of Federal Regulations.................................................................................... 90 The Belmont Report................................................................................................. 90

Argosy University Institutional Review Board Handbook – January 2014

Preface

This Handbook contains descriptions of procedures and forms required by Argosy University

for any research project conducted by employees or students of Argosy University, and for the

conduct of research by outside organizations or institutions seeking the involvement of any

Argosy University employee or student. This includes research performed for dissertations,

Clincal Research Projects (CRPs), Applied Clinical Research Projects (ACPs) and other

significant research, but it also includes research conducted for student posters, PowerPoint

presentations, and class assignments where research is being done. If a faculty or staff member

is conducting research that has no relation to his or her Argosy duties or affiliation, the research

is not subject to Argosy IRB review. To ensure consistency, this handbook uses the terms

principal investigator to indicate the person performing the research and faculty research

supervisor to indicate the principal investigator’s dissertation chairperson, CRP chairperson,

ACP chairperson, classroom instructor or any other person who is responsible for supervising

the research described in the principal investigator’s application.

Contents of student / researcher IRB applications are not guaranteed to be treated

confidentially. In a limited number of situations applications are subject to public disclosure and

researchers should be aware of this potential outcome.

The Institutional Review Board Handbook is organized into four sections.

Section 1: Administrative Documents presents the purpose of an IRB, an explanation of its role

as the certifier of compliance for the protection of research participants, and the guidelines for

operation of an Argosy University IRB.

Section 2: Preparation of Applications for IRB Review and Certification of Compliance

provides a detailed explanation of the procedures used to prepare and submit an application for

certification of compliance.

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Argosy University Institutional Review Board Handbook – January 2014

Section 3: IRB Application Forms and Reports describes the various documents used in IRB

certification.

Section 4: Appendixes contains instructions, forms, and links to additional resources.

Applicants should expect to complete an exempt (Appendix A), expedited (Appendix B), or full

application (Appendix C), including the appropriate consent form (Appendix D). The Principal

Investigator must also include a completed Conflict of Interest Statement (Appendix P), and

CITI completion forms for both applicant and applicant’s research chairperson. The IRB will

respond with a Certification Statement or a Letter To Correct IRB Application Deficiencies

(Appendix E).

For some research, two or more institutions may be involved. If so, the IRB will send a letter to

any other institution which requests Argosy University Certification first (Appendix F). If

research extends for more than one year, the Principal Investigator will complete a Continuing

Certification of Compliance form (Appendix G). When research is completed, the Principal

Investigator files a Project Completion form (Appendix H) and receives an acknowledgement of

filing from the IRB.

Research protocols may change, requiring an Amendment to Original IRB Certification form

(Appendix I), an Unanticipated Problem Report form (Appendix J), or a Change in Procedure

Application form (Appendix K). When a course includes research, faculty must submit an

Application for IRB Certification of Faculty Research and Assigned Course Research Projects

form (Appendix L), and Assigned Course Research Progress Report (Appendix M).

Annually, each IRB files a Letter of Assurance (Appendix N). Principal Investigators, faculty

research supervisors, and IRB Board members must adhere to The American Psychological

Association's (APA) Ethical Principles of Psychologists and Code of Conduct; the Code of

Federal Regulations, Title 45, Part 46; and, the Belmont Report (Resource Links can be found

in Appendix Q).

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Argosy University Institutional Review Board Handbook – January 2014

The Compliance Review Procedure in Brief

The Application for Review and Certification of Compliance enables a review of a

proposed research study for the purpose of certification of compliance with various

governmental and organizational rules and guidelines for the protection of human participants.

A critical aspect of compliance is the principal investigator’s described understanding of the

present and potential feelings of the proposed research participants and the principal

investigator’s plan to ameliorate any possible adverse reaction to participation. Simply, there are

inherent risks associated with any research involving interaction with human participants. It is

the principal investigator’s responsibility to control to a reasonable extent any potential harm

and to have a plan ready to correct any potential harm.

1. The Argosy University Institutional Review Board does not approve research studies,

but certifies the principal investigator’s compliance with guidelines for the ethical

treatment of human research participants. The IRB considers the design and data-

gathering procedures of the study in its review.

2. Prior to determining level of application and filing the appropriate forms, the principal

investigator completes Collaborative Institutional Training Initiative (CITI) training.

3. The principal investigator, with his or her faculty research supervisor, determines the

level of risk to the proposed research study’s participants, completes the appropriate

Application for IRB Review and Certification of Compliance, and, where needed,

provides the appropriate approval documents as attachments. All questions must be

answered fully. The faculty research supervisor signs the Application indicating

approval that the study has academic merit and meets the requirements for IRB

certification.

4. The principal investigator attaches a Conflict of Interest Disclosure Statement

(Appendix P) and documentation of principal investigator and faculty research

supervisor’s CITI completion.

Argosy University Institutional Review Board Handbook – January 2014

5. The Application is forwarded to the appropriate person (IRB Chairperson, designated

person, or clerk) for logging and forwarding to the assigned IRB Member.

6. The IRB Member determines if the level of the application is correct, reviews it if it is

an Exempt or Expedited application, and forwards Full IRB Review applications to the

IRB Chairperson for review at the IRB monthly meeting.

7. The cover to the Application for Certification contains certification conditions. A copy

of the cover of the application with signatures is returned to the principal investigator, a

copy is sent to the faculty research supervisor, and the original application with the

original attachments (with original signatures) and original IRB signatures is placed in

an appropriate secure file in campus administrative offices.

8. Upon completion of the study, the principal investigator completes a Project Completion

Report form (Appendix H), which is submitted to the college administrative assistant

(IRB Chairperson, designated person or clerk) for filing with the principal investigator’s

original Application for Certification. The principal investigator will receive an

acknowledgement of filing from the IRB Chairperson.

Argosy University Institutional Review Board Handbook – January 2014

Substantive Changes Made to This Edition of the Handbook

This section provides a quick list of substantive changes to the IRB handbook, including updates from the previous edition. This handbook supersedes previous handbooks, and principal investigators and research supervisors are responsible for understanding and applying the rules in this edition. 1. New Conflict of Interest form has been created in Appendix P. The new form addresses

specific conflicts of interest that primary researchers must answer.

2. The National IRB Letter of Assurance now designates the Chancellor of Argosy University as the Chief Academic Officer.

3. The construct adverse event has been changed to unanticipated problem throughout the

manual as advised by the Office of Human Research.

4. A model Oral Consent Form is now included in the appendices – see Appendix D.

5. All references to two or more AU campuses has been changed to more than two campuses.

6. Waiver of Informed Consent section now includes language regarding the waiver of assent.

7. Language regarding the use of AU faculty, staff and students has changed to strongly

discourage the practice of using any AU members in clinical or dissertation research.

8. Additional guidelines for students who want to use AU members in clinical or dissertation

research are now included.

9. Language clarifying confidentiality has been added to page 46 of the manuscript.

SECTION 1: ADMINISTRATIVE DOCUMENTS

Responsibilities of National and Local Campus Institutional Review Boards

Argosy University’s Institutional Review Boards certify compliance with research

guidelines that provide for the ethical treatment of human research participants. The Institutional

Review Board carries out its primary responsibility by reviewing applications for certification of

compliance submitted by principal investigators.

Argosy University Institutional Review Board Handbook – January 2014

Argosy University has two types of Institutional Review Boards (IRBs): the National

Review Board, which reviews proposals of research projects to be conducted at the national level

or where more than two Argosy University campus sites are involved, and Campus review

boards, which review proposals of research projects to be conducted at the single campus level.

The National IRB is comprised of the chairpersons of the campus IRBs. The National IRB

is tasked with reviewing national research projects, ensuring consistent application of the

guidelines contained in this Handbook, reviewing and updating the IRB Handbook, assisting

campus IRBs in implementing the IRB Handbook guidelines, providing guidance to local IRBs,

when asked, filing an annual Letter of Assurance with Argosy’s VCAA, and facilitating the

interaction of the various local IRBs via a listserve, teleconferences, and other methods.

Campus IRBs review all research conducted by anyone affiliated with the campus. To

implement their responsibilities, the campus IRBs establish their own calendar and procedures

for the review of applications for certification of compliance as described in this handbook. The

campus IRB announces its responsibilities and holds meetings to train principal investigators and

their supervisors in the processes and procedures for review of campus research projects.

In addition to reviewing all research by anyone affiliated with the campus, a campus IRB

may also review research from another Argosy campus when it possesses either expertise not

available on the originating campus or assurances such as a Federalwide Assurance (FWA) or

Department of Defense Addendum that would significantly facilitate the timely review of

research from the originating campus. In such instances, the reviewing IRB shall maintain

oversight over the reviewed research until after the submission of a project completion report and

accompanying IRB acknowledgement.

While the operation of a local IRB is subject to monitoring by the national IRB, for

application review decisions an IRB is autonomous, and the decisions of the local IRB and the

National IRB are not subject to review or appeal.

Annually, each IRB files a Letter of Assurance with the unit’s chief academic officer,

indicating that the IRB is duly constituted according to the following guidelines and that it will

conduct its reviews in accordance with the guidelines. For local IRB’s, a copy of the campus

Letter of Assurance is also sent to the chairperson of the National IRB.

The following describes the mission, guiding principles, and procedures for both boards.

Argosy University Institutional Review Board Handbook – January 2014

Mission and Guiding Principles

Mission. The mission of the Argosy University IRB at each campus, and at the national

level, is to ensure the ethical treatment of human participants in the conduct of any research by

any individual affiliated with Argosy University, in accordance with the guidelines set forth in

the Code of Federal Regulations and the Belmont Report. The IRB does not approve research

projects, but certifies that the protection of research participants has been adequately provided

for, as described in an Application for IRB Review and Certification of Compliance. The

principal investigator and the investigator’s faculty research supervisor are responsible for

implementing the procedures for the protection of human participants, as described in the

application for certification.

IRB Certification of Compliance

Each principal investigator proposing a research project, large or small, must request IRB

review and Certification that the proposed research project complies with the guidelines set forth

below for the protection of human participants. This policy applies, regardless of source of

funding and location of study, to all research studies or pilot studies conducted by, or on, faculty,

staff, students, or employees of Argosy University, or by, or on, Argosy University as an

institution. Faculty and staff engaged in research that is not related to their affiliation with

Argosy are not required to seek Argosy certification. This policy applies to research performed

for conference presentations or poster sessions, as well.

A review of a research project by the IRB is initiated with an Application for

Certification (Appendixes A, B, or C) and is concluded by a Completion of Research Form

(Appendix H).

Review of Applications for Certification

Applications for certification involving university-wide research originating from non-

Argosy University investigators are reviewed by the National IRB. Research involving studies

that originate with an investigator on an Argosy University campus and concern a single campus

are reviewed and certified by the campus IRB. Campus IRBs also review research involving

non-Argosy University investigations that will be conducted locally. At the national level, or

Argosy University Institutional Review Board Handbook – January 2014

when more than two campus sites are involved, the National IRB Chairperson will form an ad

hoc IRB subcommittee consisting of 2-3 campus IRB chairpersons to review the certification

request. In most cases, the subcommittee will include the IRB chairpersons from the sites where

the proposed research will take place. The review procedure is the same as for campus IRBs.

Records of the action of the university-wide IRB will be kept on the IRB SharePoint and

reported in the minutes of the IRB chairpersons’ meetings.

The principal investigator, after completing CITI training and in consultation with his or

her faculty research supervisor, submits an appropriate level of certification of an Application for

Certification of Compliance: Exempt (Level 1), Expedited (Level 2) or Full IRB Review (Level

3), based on an assessed risk-to-benefit ratio.

In brief, Exempt is generally reserved for research that uses archived data or literature

reviews, and for which there is no principal investigator-participant interaction. The Expedited

application is used for research with low-to-moderate risk to the participants, which can be

reduced through the protection-of-participants’ procedures planned by the principal investigator.

The Full IRB Review application is used in those instances where the principal investigator is

working with a protected class of participants or the risk-to-benefit ratio is high.

The review of an Application for IRB Review and Certification of Compliance may result

in one of these three outcomes:

1. “Certified” – Certified as written with no conditions (signed cover);

2. “Contingently Certified” – The research application or the procedures for the

protection of the research participants described in the application are deficient in one

or more minor areas. A memorandum (Appendix E) is attached to the application that

specifies deficiencies or changes that must be completed and documented prior to

beginning the research (For these deficiencies, the IRB chairperson or designated

reviewer can, upon reviewing the Principal Investigator’s response(s) to the required

changes, certify the research proposal on behalf of the IRB.

3. “Not Certified” – The research application or the procedures for the protection of the

research participants described in the application are significantly deficient in one or

more areas (unsigned). A memorandum (Appendix E) is attached to the application

that specifies deficiencies or changes that must be completed and documented prior to

beginning the research (For these deficiencies, the IRB chairperson or designated

Argosy University Institutional Review Board Handbook – January 2014

reviewer can, upon reviewing the Principal Investigator’s response(s) to the required

changes, certify the research proposal on behalf of the IRB.

Each Argosy University campus will decide whether the Application for Certification of

Compliance is submitted before or after a dissertation proposal defense. No research (including

data collection, interviewing, field observations, etc.) may be conducted for any Argosy

University-related research project without prior certification by the appropriate IRB.

Appeal of IRB Decision

If a principal investigator wishes to contest an IRB decision, he or she may request in

writing to the IRB chairperson to reconsider. No further appeal is possible. No faculty member

or administrator may conduct or approve a research project involving human participants that has

not been certified by the IRB to be in conformance with applicable ethical and legal standards.

Definitions

Argosy University uses the following definitions of terms as adapted from the Code of

Federal Regulations (CFR Title 45, Part 46, 1991, and the Belmont Report.

Human Participant means a living individual about whom an investigator (whether

professional or student) conducting research obtains data through intervention or interaction with

the individual. (Following the position of the American Psychological Association, Argosy

University uses the term participant in place of the term subject.)

Intervention includes both physical procedures by which data are gathered and

manipulations of the participant or the participant’s environment that are performed for research

purposes.

IRB Certification means the determination of the IRB that the research (project or

activity involving human participants) has been reviewed and may be conducted at an institution

within the constraints (guidelines) set forth by the IRB and by other institutional (including

employer) and federal regulations.

Argosy University Institutional Review Board Handbook – January 2014

Minimal Risk means the probability and magnitude of harm or discomfort anticipated in

the research are not greater in and of themselves than those ordinarily encountered in daily life or

during the performance of routine physical or psychological examinations or tests.

This definition sets the baseline used to establish the three levels of risk used by Argosy

University IRBs to establish IRB review guidelines for the certification of compliance, where

exempt is reserved for archival research and full is reserved for research carrying more than

moderate risk or involving vulnerable populations. All other research is reviewed at the

expedited level.

Research (project, study, protocol, etc.) means a systematic investigation, including

research development, testing, and evaluation designed to develop or contribute to knowledge.

Guiding Principles

The purpose of an IRB review is to determine whether participants in a research study

will be placed at physical or mental risk and, if risk is involved, to certify that the following

conditions have been met:

1. Risks to participants are minimized. This is an essential condition for certification. The

determination of when a research participant is at risk is a matter of the application of

common sense and sound professional judgment as it relates to the circumstances of the

research activity in question. The IRB will carefully weigh the relative risks and benefits of

the research procedures as they relate to the participants.

2. Participants in the study (and their guardians) are fully aware of the risks and that individuals

may withdraw from the study at any time without any form of penalty.

3. Research activities, designed to yield fruitful results for the benefit of individual participants

or society in general, may incur risks to the participants provided such risks are outweighed

by the benefit to be derived from those activities.

4. Risks to the participants are so outweighed by the sum of the benefits to the participants, and

the importance of the knowledge to be gained, as to warrant a decision to allow the

participants to voluntarily accept these risks.

Argosy University Institutional Review Board Handbook – January 2014

5. The degree of risk involved in any activity should never exceed the humanitarian importance

of the problems to be solved by that activity. Likewise, compensation to volunteers should

never be such as to constitute an undue inducement to the participants.

6. Rights and welfare of any such participants will be adequately protected. There is a wide

range of medical, social, and behavioral research projects and activities in which no

immediate physical or mental risk to the participant is involved; for example, those utilizing

personality inventories, interviews, questionnaires, or the use of observation, photographs,

taped records, or stored data. However, some of these procedures may involve varying

degrees of discomfort, harassment, or invasion of privacy, which may constitute a risk.

Some studies depend upon stored data or other information that may have been obtained

for quite different purposes. Here, the IRB will determine whether the use of these materials is

within the scope of the original consent, whether new consent should be obtained, or whether

consent is waived. The IRB may ask to see the original consent to make this determination.

Legally effective informed consent will be obtained by adequate and appropriate methods

in accordance with the provisions of this document.

Conduct of the research activities may be reviewed at intervals determined by the IRB,

but not less than annually.

IRB Certification is for one year and is terminated by a Report of Completion of a

Research Project. Certification is automatically terminated at the end of one year and may be

extended by a Request to Extend Certification signed by the principal investigator and the faculty

research supervisor.

Code of Federal Regulations

Argosy University IRBs adopt, as part of their guiding principles, the Code of Federal

Regulations. These regulations are adopted in their most current version. If disagreements arise

between the Argosy University IRB policies and procedures and the Title 45 of the Code of

Federal Regulations, the latter has preeminence.

Argosy University Institutional Review Board Handbook – January 2014

Ethical Principles

Argosy University IRBs adopt, as part of their guiding principles, the Ethical Principles

for the protection of human research participants as published in the Belmont Report and other

documents.

A Cautious Stance

Argosy University IRBs will err on the side of caution to ensure the protection of

research participants.

Membership and Governance of the IRB

Membership

Each campus IRB shall have at least five members, with varying backgrounds, who will

review research activities commonly conducted by the institution. The IRB shall be sufficiently

qualified, through the experience, expertise, and diversity of its members, to promote respect for

its advice and counsel in safeguarding the rights and welfare of human participants. The

composition of the IRB should reflect the university’s commitment to diversity.

Campuses may use a variety of procedures to identify members of the campus IRB. The

IRB is responsible for perpetuating itself within the guidelines of the Handbook. The board may

invite new members, and colleges or departments may designate a representative (as a designee

of the chairperson), who will review the applications of that college. The chairperson may solicit

participation with an eye to the guidelines in the paragraph above. New campuses may initiate an

IRB by appointing a temporary IRB Chairperson.

In addition to possessing the professional competence necessary to review specific

research activities, the IRB shall be able to certify the acceptability of proposed research in terms

of institutional commitments and regulations, applicable law, and standards of professional

conduct and practice.

At least one of the members present must have no affiliation with Argosy University

other than serving on the IRB. An employee or agent of any EDMC entity (or a member of that

person’s immediate family) is considered affiliated. Affiliated members include, but are not

Argosy University Institutional Review Board Handbook – January 2014

limited to individuals who are: part-time employees; current students; members of any governing

panel or board of the institution; paid or unpaid consultants; and volunteers working at the

institution on business unrelated to the IRB. Unaffiliated members may include, but are not

limited to, people whose only association with EDMC is that of a patient, subject, or former

student at that institution.

The IRB shall include at least one member whose primary concerns are in scientific areas

and one whose interests are in non-scientific issues. Meetings cannot be held unless there is at

least one member present whose main interest is in non-scientific issues. Any local Argosy IRB

may have a student for a member, but no IRB is required to have a student member. A student

member cannot be also counted as a representative of his or her current department or field of

study. Students cannot be counted as outside members.

Every effort will be made to ensure that no IRB consists entirely of men or entirely of

women, including the institution's consideration of qualified persons of both sexes, so long as no

selection is made to the IRB based on gender.

No IRB may consist entirely of members of one profession. All colleges and schools in

the university campus should be represented on each IRB.

The National IRB is composed of chairpersons of campus IRBs, reflecting the diversity

described above.

Exceptions to these rules must be requested by the campus IRB chairperson, approved by

the Argosy University Vice Chancellor of Academic Affairs (VCAA), and noted in written

correspondence to be maintained by the campus IRB.

IRB Governance

Links to pertinent federal law related to Governance are found in Appendix Q

“Governance Guidelines.”

Self-governing. Each IRB is self-governing. No other group or individual may interfere

with its decision-making process or overrule its decisions. Policies and procedures governing

Argosy University IRBs may be changed only by the university-wide National IRB, except for

procedural details unique to each campus, which may be changed by the IRB of that campus at a

regular meeting and approved by the national Vice President of Academic Affairs.

Argosy University Institutional Review Board Handbook – January 2014

Role of IRB Chairperson. Each IRB shall designate a chairperson using a process to be

determined by each campus. Each IRB is encouraged to appoint a Vice Chairperson, responsible

for carrying out the chairperson’s duties when the chairperson cannot do so. With the approval of

the full IRB, the chairperson shall:

1. Conduct the meetings of the IRB;

2. Assign certification authority to the members;

3. Maintain a record of the proceedings of the IRB meetings, including agendas,

actions of the IRB and the certification logs of the members;

4. Respond to all project completion filings with an acknowledgement of filing

5. Maintain a record of all IRB members for that campus, including current

curriculum vitae for each member; and,

6. Invite new board members.

Authority

Unless otherwise agreed upon, the full IRB retains authority over all matters related to its

responsibility to assure the protection of research participants.

Meetings of the Institutional Review Board

Meeting schedule. The IRB shall establish a calendar of full Board meetings appropriate

to the campus and university calendar. The IRB must schedule sufficient meetings to conduct

business in a timely manner.

Yearly Organizational Meeting. Each IRB must conduct an annual organizational

meeting at which time the members of the IRB agree to comply with the guidelines and

procedures established for the IRB and sign a Letter of Assurance to be submitted to the unit’s

chief academic officer.

At its annual organizational meeting, each campus IRB shall constitute itself for the

current academic year. At its constitutional meeting, the IRB will:

1. Admit new members and dismiss members who wish to terminate their service on the

IRB;

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2. Select a chairperson when needed from among its membership as per campus

protocols;

3. Review applicable parts of Title 45 of the Code of Federal Regulations, ethical

guidelines published in the Belmont Report, and other applicable state and federal

laws, rules, and regulations to determine what, if any, changes have been made in

these rules and regulations;

4. Direct all new members to complete the training program for new IRB members (The

Argosy University IRB SharePoint has information about available training

opportunities); and,

5. Establish a schedule of meetings for the current academic term to be made available to

the campus (If the schedule changes from term to term at a campus, the schedule for

each term shall be made available to the campus at the beginning of each term).

In addition, the chairperson authorizes specific members to review assigned Applications

for Certification, further authorizes the members to determine and Certify Exempt and Expedited

Applications, and to prepare and place on the full IRB agenda requested Full IRB Review (Level

3) Applications and other applications the member determines might require full Board review.

Letter of Assurance. At the conclusion of the annual organizational meeting, each IRB

shall prepare and file with the chief academic officer for that unit a Letter of Assurance that

states the composition of the IRB (the names, positions and affiliations of it members), its

proposed meeting schedule, and its agreement it abide by the guidelines set forth in this

document. Changes to any of the elements of the Letter of Assurance shall be reported in a

subsequent letter. Local IRB’s should also send a copy of the letter to the National IRB chair.

In situations when the chief academic officer of a unit is a member of the National IRB,

the Letter of Assurance should be filed with the Chancellor, Argosy University System.

Regular Meetings of the Full Institutional Review Board. While a fixed monthly

meeting date is desirable, the IRB shall establish a calendar of full Board meetings appropriate to

the campus and university calendar. The IRB must schedule sufficient meetings to conduct

business in a timely manner. The IRB follows Robert's Rules of Order (Robert et al., 1984) in all

procedures and meetings.

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The primary purpose of these monthly meetings is to review Full IRB Review (Level 3)

Applications for Certification. While Exempt and Expedited applications may be reviewed by

the IRB Chairperson, or the Chairperson’s designee on a continuous basis, Full IRB Review

applications must be reviewed by the IRB Committee, at scheduled monthly meetings.

Designated reviewers present logging reports of Exempt and Expedited Applications to

the IRB Committee at scheduled monthly meetings. The board also conducts any other business

of the IRB.

Quorum. A majority of members of record shall constitute a quorum for the purposes of

conducting the business of the full IRB. A quorum of members (>50 %) is required at full Board

meetings, and lack of a quorum prohibits taking official action at its meeting.

At the beginning of each IRB Board meeting, members should certify for the record that

they have no conflicts of interest in any research project currently under consideration. If any

member who is a co-investigator, or otherwise has a conflict of interest with a research project,

he or she must be excused from voting.

Special attention must be paid to ensure that a quorum is not lost during a meeting. If a

member abstains from voting, or is excused due to a conflict of interest, a quorum of total

members must remain for certification of full reviews. If not, the research project in question

cannot be certified. In addition, if during the meeting, the number of members present falls to a

level below that required for a quorum, the meeting must be adjourned as no official action can

be taken.

Consultation

If the IRB determines it may lack expertise in an area of research that is the subject of a

research project submitted for IRB certification, at its discretion either during a scheduled IRB

meeting or ”specially called” meetings, the IRB may include outside consultants in its

deliberations. Consultants may not vote on the submission under consideration.

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Conflict of Interest

A member of the IRB may not certify compliance of a research proposal for which the

IRB member has a direct interest either as an investigator or as a dissertation, ACP or CRP

committee member or faculty sponsor of a student's project. (Appendix P)

Record of IRB Actions and Activities

Required records. Records of all business conducted at monthly meetings of the IRB

shall be kept in a safe location by the chairperson. Records shall include agendas and minutes of

the business meetings. Records of IRB applications shall be managed through the logging

procedure described below. In addition, copies of the IRB applications shall be kept in the

investigator’s academic file or, for principal investigators who are not students, in a separate file

controlled by the IRB Chairperson. Annual reports from the campus IRBs will be submitted to

the campus president or designee and the National IRB. Annual reports from the National IRB

will be submitted to the school’s VCAA.

Tracking procedures and submission procedures. Each IRB shall develop a logging-

tracking procedure (Appendix O) which accounts for each application from the beginning to the

end of the review process.

The principal investigator, in consultation with his or her faculty research supervisor,

prepares and signs an application for certification of compliance appropriate for the procedures

of the study.

The faculty research supervisor reviews the principal investigator’s application and, if

appropriate signs his or her approval and forwards the application to the designated clerk who

records (logs) the receipt of the application and records the forwarding of the application to the

IRB Chairperson or his or her designee.

The IRB member reviews the application and determines whether the correct level of

application has been presented. If the application level is correct, the IRB member reviews and

certifies Exempt and Expedited applications. If the application is a Full IRB Review (Level 3),

the member requests in writing that the IRB Chairperson place the Level 3 Application on the

agenda of the next available monthly meeting. The member also duplicates and distributes copies

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of the Level 3 application to all IRB members before the meeting with a transmittal memo

requesting their review.

If the IRB member determines that the level of application is completed incorrectly, the

member returns the application with a Letter to Correct IRB Application Deficiencies (Appendix

E) requesting the application be completed correctly to the IRB Chairperson or his or her

designee for logging and subsequent return to the principal investigator and faculty research

supervisor. The faculty research supervisor may forward the application to the principal

investigator for correction or retain the application and request that the investigator supply

missing components.

Once an application has been certified, the IRB Chairperson or his or her designee copies

the application cover page and makes a copy of the complete application to return to the faculty

research supervisor with the original copy returned to the principal investigator. The copy of the

cover with signatures is filed in the principal investigator’s permanent file, if the principal

investigator is a student, or into a designated, secure file if the principal investigator is not a

student.

A copy of each month’s application transactions, copied from the log/tracking system, is

submitted to the IRB Chairperson as part of the monthly IRB meeting. If the logging procedure

is electronic, appropriate conveyance procedures are developed by the IRB.

IRB Compliance Audits

Investigating noncompliance. Any reported significant deviation in activities previously

certified by the IRB must be investigated by the IRB as an issue of noncompliance with

certification requirements. An ad hoc subcommittee of the IRB, composed of the chairperson

and any other IRB member whose presence is deemed as essential, will be appointed by the

chairperson.

Reporting an issue of noncompliance to the IRB. The chairperson shall brief the IRB,

at the next scheduled meeting or at a specially convened meeting, on the details of an allegation

of noncompliance by a principal investigator. Then, the IRB will determine whether there was, in

fact, a violation of regulatory or institutional policies. If a violation occurred, then the IRB will

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determine those restrictions, conditions, or other actions that are necessary to resolve the non-

compliance, and what procedures will be required to prevent future occurrences.

The principal investigator and the investigator’s research supervisor will then be notified

in writing of the requirements or conditions necessary to ensure compliance with the restrictions,

conditions, or decisions of the IRB. Every effort will be taken to ensure the confidentiality of all

aspects of the investigation and any subsequent IRB actions relating to the incident(s). In the

case of student investigators, a referral to the Ethics and Evaluation (Student Conduct)

Committee may be made.

When appropriate, University administrators (deans and department heads) will be

informed. If the research involved external funding or if the campus currently holds an

institutional Federal wide Assurance (FWA), the Office for Human Research Protections

(OHRP) and any granting agency (e.g., APA Minority Fellowship Program) receiving the

assurance should also be informed when appropriate.

In instances when the IRB has reason to suspect that there may be noncompliance not

reported by the investigators (e.g., participant complaints made directly to the IRB, past

instances of noncompliance), an ad hoc subcommittee of the IRB, composed of the chairperson

and any other IRB member whose presence is deemed as essential, will be appointed by the

chairperson to investigate the suspicion and report to the IRB as above.

Argosy University Institutional Review Board Handbook – January 2014

SECTION 2: PREPARATION OF APPLICATIONS FOR IRB REVIEW AND

CERTIFICATION OF COMPLIANCE

Purpose of Review

The purpose of IRB review of a proposed research project is to certify compliance with

Argosy University research standards for the protection of the rights and welfare of participants

in research projects. To this end, the background, purpose, and methodology of proposed

research projects are reviewed to determine any potential physical, psychological, social, and

legal risks to the proposed research participants, the protection of their confidentiality and the

adequacy of their informed consent. All principal investigators must follow the guidelines for

collaboration with participants and other stakeholders as noted in the Publication Manual of the

American Psychological Association (6th ed.), the Belmont Report, and APA Code of Conduct

(Appendix Q). The Board does not ordinarily review scientific design, but may do so if the

design of the study could affect the risk-benefit ratio.

Criteria for IRB Certification of Research Projects

To certify compliance with Argosy University research standards for the protection of

participants, the appropriate IRB shall determine that all the following requirements are satisfied.

Risks to Participants are Minimized

Adequate provisions are described to protect the privacy of participants and to maintain

the confidentiality of data; procedures are used which are consistent with sound research design

and which do not unnecessarily expose participants to risk; and, whenever appropriate,

procedures are already being performed on the participants for diagnostic or treatment purposes.

Risks to Participants are Reasonable

Risks to participants are reasonable in relation to anticipated benefits, if any, to

participants, and to the importance of the knowledge that may reasonably be expected to result.

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In evaluating risks and benefits, the IRB considers only those risks and benefits that may

result from the research (as distinguished from risks and benefits of therapies participants would

receive even if not participating in the research). The IRB does not consider possible long-range

effects of applying knowledge gained in the research (for example, the possible effects of the

research on public policy) as among those research risks that fall within the purview of its

responsibility.

Selection of Participants is Equitable

In making this assessment, the IRB takes into account the purposes of the research and

the setting in which the research will be conducted, and is particularly cognizant of the special

problems of research involving vulnerable populations when some or all of the participants are

likely to be vulnerable to coercion or undue influence. Vulnerable populations include children,

prisoners, pregnant women, mentally disabled persons, or economically or educationally

disadvantaged persons. Additional safeguards are required in the study to protect the rights and

welfare of these participants.

Informed consent will be sought from each prospective participant, or the participant's

legally authorized representative, in accordance with, and to the extent required by, federal

guidelines. Informed consent will be appropriately documented, in accordance with, and to the

extent required by, federal guidelines.

When appropriate, the research plan makes adequate provision for monitoring the data

collected to ensure the safety of participants.

Participant selection must be appropriately reviewed by the principal investigator and the

faculty research supervisor, as well as the principal investigator’s institutional review board or

designated authorizer prior to submission for Argosy University IRB review.

Benefits of Review

IRB review offers the following benefits to investigators and the institution:

1. It certifies that the investigator's research project is in compliance with ethical guidelines and with state and federal rules and regulations;

Argosy University Institutional Review Board Handbook – January 2014

2. It may bring to the attention of an investigator ethical factors which may not have been considered; and,

3. It demonstrates and documents the institution's commitment to the protection and

ethical treatment of human participants.

Definition of Human Research

For purposes of defining the purview of campus IRBs, human research is any activity

with the primary intent of securing information from or about human participants for advancing

basic, clinical, or psychosocial understanding of humans. Such activity may or may not differ

significantly from psychological or other professional practice. Such research includes, but is not

limited to, the following: group design studies, classroom projects, single participant design

studies, case reports and analyses, chart review, observational studies, paper and pencil based

studies, qualitative studies, research in preparation for a conference presentation or poster, or

comparison of interventions. This includes pilot studies with small samples. Internal research

conducted at Argosy University for purposes such as program review, departmental assessment

and university accreditation do not require IRB review.

Studies Requiring Review

To ensure the protection and ethical treatment of human participants, and to comply with

federal and state laws, Argosy University requires that, prior to their initiation, all research

projects, except for those conducted internally by Argosy University for self review or those

conducted by faculty or staff members where research has no relation to his or her Argosy duties

or affiliation, be reviewed and a determination of compliance be made by the Argosy University

IRB.

Categories of Certification

There are three levels of Certification: Exempt (Level 1), Expedited (Level 2), and Full

IRB Review (Level 3), based on risk/benefit ratio to the participants. The investigator must assess

the level of risk, or exposure to sensitive or harmful experiences, due to participation in the study

and assign a level of certification to the application (see Section 3).

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The IRB determines the certification level of a research project.

Studies Qualifying for Exempt Review (Level 1)

Argosy University reserves the Exempt (Level 1) application for research projects using

archived data and research projects for which there is no human participant interaction, such as a

meta analysis or literature review. Thirty days may be required for processing after receipt of a

complete application. One IRB member’s (the Argosy University campus representative or the

IRB Chairperson) signature is required.

For archival studies, any previously obtained consent document is not a required part of

the researcher’s application packet; still, each IRB is within its rights to ask about the provenance

of any given data set when there are concerns and to request a copy of the consent when it seems

to be relevant to a given application’s determination.

Sensitive topics and vulnerable participants, such as children or minors, pregnant women,

patients, physically or mentally challenged individuals, and prisoners, do not qualify for exempt

research. International studies also do not qualify for exempt IRB review.

The IRB makes the final determination about whether a proposal is Exempt.

Studies Subject to Expedited Review (Level 2)

The Expedited review process is used to review certain categories of research involving

no more than moderate risk to human participants. Any research in which human participant

interaction is anticipated falls under this level unless risk to participants is more than moderate.

Most studies will fall into this level. Thirty days may be required for processing after receipt of a

complete application. One IRB member’s (the designated IRB member or the IRB Chairperson)

signature is required.

In addition to meeting the general eligibility criteria described previously, the research

must also meet the Certification criteria as follows:

1. The risks to participants for participating in the research must be reasonable in relation

to the anticipated benefits, if any, and the importance of the knowledge that may be

gained.

2. Participant selection must be fair.

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3. Informed consent will be sought and documented unless a waiver of consent or

documentation of consent has met the waiver criteria.

4. The plan to collect and monitor data assures participant safety.

5. Procedures provide for the privacy of participants and for maintenance and disposal of

confidential data.

6. Where necessary, additional safeguards are included to protect vulnerable participants.

Studies Subject to Full IRB Review (Level 3)

Research projects that entail sensitive or risky research topics or methodologies or

vulnerable participants (including children and minors, pregnant women, patients, physically or

mentally challenged individuals, prisoners and those under court supervision) require Full IRB

review in a full Board meeting. These applications must contain extensive detail describing

procedures designed to protect vulnerable participants. A majority of IRB members must certify

the proposal, verified by the minutes of the monthly IRB meeting, and the IRB Chairperson signs

the cover page. Sixty days may be required for processing after receipt of a complete application.

Procedures for Applying for Certification of Compliance

BEFORE ANY DATA ARE GATHERED, THE INVESTIGATOR MUST OBTAIN A

CERTIFICATION OF COMPLIANCE. FAILURE TO FOLLOW THIS GUIDANCE IS A

VIOLATION OF FEDERAL LAW AND ARGOSY UNIVERSITY POLICY. IT MAY

RESULT IN THE INVESTIGATOR’S RESEARCH BEING DISQUALIFIED, AND IT MAY

RESULT IN OTHER DISCIPLINARY CONSEQUENCES, UP TO AND INCLUDING

DISMISSAL FROM THE UNIVERSITY.

In brief, after completing CITI training, the principal investigator, in consultation with his

or her faculty research supervisor, prepares and signs an application for certification of

compliance appropriate for the procedures of the study. Attached to the application are: (a)

proposed Letters of Consent; (b) interview and survey questions to be used in the study; (c)

appropriate institutional approval letters from both data holders and proposed research sites; (d) a

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conflict of interest form; and, (e) both principal investigator and faculty research supervisor’s

CITI completion forms as noted in the application.

STEP 1: Initial Review

For a research project conducted as part of a student’s academic work, the following

applies: At least one member of the Argosy University faculty, core faculty where required1,

(serving as faculty research supervisor or dissertation chairperson) will evaluate whether the

project has scientific merit and whether the research project conforms to IRB submission

guidelines. Upon determining that the project has both merit and has been prepared according to

guidelines, the faculty member will sign the cover sheet that is part of each set of forms.

For other research projects, the principal investigator’s faculty research supervisor

conducts a similar review and signs the cover sheet.

STEP 2: Logging the Application

The faculty research supervisor forwards the application to the IRB Chairperson (or

person designated for this procedure) who logs the application and forwards the application to

the designated IRB member. Faculty research supervisors are encouraged to use the IRB

application checklist as a cover to the application as a device for assuring the completeness of

the application.

STEP 3: Review by Designated IRB Member

The designated IRB member reviews the application and determines if the level of the

presented application is correct. If the application level is correct, the IRB member reviews and

certifies Exempt (Level 1) and Expedited (Level 2) applications. If the application is a Full IRB

Review (Level 3), the member requests in writing that the IRB Chairperson place the Level 3

application on the agenda of the next available monthly meeting. The member also duplicates

and distributes copies of the Level 3 application to all IRB members.

1 Core faculty for programs with accreditation requirements.

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STEP 4: Certification or Resubmission

If the IRB member determines that the information on the application is not correct or it

is incomplete, the member returns the application with a note requesting correction of

deficiencies to the IRB Chairperson or his or her designee for logging and subsequent return to

the principal investigator and faculty research supervisor for the principal investigator to fix. The

faculty research supervisor returns the corrected application to the clerk for logging and

forwarding to the IRB member with the original note describing any deficiencies.

STEP 5: Filing of Application

The cover to the Application for Certification (Appendix A, B, or C) contains certification

conditions. A copy of the cover of the application with signatures is returned to the principal

investigator, a copy is sent to the faculty research supervisor, and the original Application

(Appendix A, B, or C) with the original attachments (with original signatures) and original IRB

signatures is placed in an appropriate and secure file in campus administrative offices.

STEP 6: Project Completion Report

The last step in the IRB review process is completion of the IRB Project Completion

Report (Appendix H) which is submitted by the investigator at the conclusion of the research

project as part of the final research requirements in accordance with Federal Regulations. The

form is completed after the final defense and is submitted as part of the final defense paperwork.

For other research activities, it is submitted at the conclusion of the research project. Submission

is the responsibility of the principal investigator and faculty research supervisor. The Project

Completion Report is filed with the principal investigator’s original application. (Note: it is

required to be submitted upon completion of the dissertation process - see the Guide to the

Dissertation Research Process, Spring 2012, p. 18). Once a Project Completion Report is filed,

the IRB Chairperson will reply with an acknowledgement of filing.

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Informed Consent

Consent Process

Ethical practice and law require that a participant’s consent be intelligent, knowing, and

voluntary. It is essential that consent to participate in a research project be obtained under

circumstances where a participant has (a) reasonable time to listen to investigators' explanations;

and, (b) the participant’s physical, mental, or psychological state does not impede

comprehension of information or the ability to make rational and non-coerced choices. To ensure

the validity of consent where other than minimal risks are involved, the initial presentation to the

participant should precede execution of the consent form by several hours or days. In addition,

investigators should make every effort to avoid using participants whose capacity for

competence to give consent is limited because of mental infirmity, medication, severe

debilitation, pain, etc. Such participants should be thought of as non-consenting.

Most persons under the age of 18, or persons judged legally incompetent due to mental

disability, are legally incapable of consent and their legal guardians must be petitioned for

permission or consent on their behalf.

In addition, investigators must allow a minor or legally incompetent participant the right

to refuse to participate in the study even when guardian approval has been secured. In studies

involving minors, children must be permitted to agree or refuse to participate in the research

project. Investigators must obtain and document the assent of minors and legally incompetent

persons to participate in the research project. Adults cannot sign away the rights of children to

choose their participation in research projects.

Consent Form

The documented consent form is a statement that gives potential participants sufficient

detailed information about the study, and sufficient opportunity to read and review the consent

form, to allow meaningful decisions about participation. A model consent form and an alternate

consent form can be reviewed in Appendix D.

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Elements of Informed Consent

Except as described herein, investigators may not enroll human participants in research

unless they have obtained the legally effective, written, informed consent of the participant or the

participant’s legally authorized representative prior to enrollment of the participant in the

research.

This holds true for research using internet surveys and other electronic data-gathering

technology. The approval of the principal investigator’s committee is required for procedures

used to gain participant approval. For example, for research using “the web,” a letter of consent,

which has an embedded link to a survey, may contain a statement that, by completing the self-

administered survey, the invited participant agrees to the conditions described in the letter of

consent, including voluntariness and use of the data.

Investigators are responsible for ensuring that participants, or their representatives, are

given sufficient opportunity to consider whether to participate and must seek to avoid coercion,

implied, overt, or covert, or undue influence. Information given to potential participants or their

representatives must be in language that is understandable to the participant or participant’s

representative. No process of obtaining consent may include exculpatory language through

which the participant waives any of his or her legal rights or releases, or appears to release, the

investigator, sponsor, or institution or its agents from liability for negligence. The IRB, at its

discretion to comply with changing requirements, has the authority to alter these requirements or

waive the informed consent process.

Appendix D contains a detailed explanation of factors, including formatting of the

consent form, which must be considered in the creation of an appropriate consent form. The

principal investigator should review these statements, albeit the principal investigator chooses to

use the model consent paragraphs.

Special Consent Procedures

Oral Consent. In most cases, a written consent is required. However, on rare occasions

oral consent may be considered more appropriate. For such research, the investigator must

submit in writing to the IRB Chairperson the information that is to be presented to participants

orally, an explanation of why oral consent is considered more appropriate, and a request for a

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waiver of the requirement for written consent (See Appendix D for Model Oral Consent Form ).

Internet Consent. Web-based surveys require participant consent (see elements of consent),

which may be gained with a descriptive paragraph that contains words to the effect that by self-

administering the online survey the participant is giving approval. The survey transmittal letter

should contain all elements of a formal informed consent document, and should conclude with

wording such as, “I have read the transmittal email/letter detailing the purpose and procedures

for this research, and I am completing this survey as evidence of my consent to be a voluntary

participant in this research project.”

Waiver of Informed Consent and Assent. The IRB may waive the requirements for

obtaining informed consent, or certify a consent procedure which does not include, or which

alters, some or all of the elements of informed consent listed previously, provided that:

1. The research involves no more than minimal risk to the participants;

2. The waiver or alteration will not adversely affect the rights and welfare of the

participants;

3. The research could not practicably be performed without the waiver or alteration, and,

whenever appropriate, the participants will be provided with additional pertinent

information after participation so as to prevent deception; and,

4. If the informed consent is waived, the conditions of the waiver must appear in the

minutes of the IRB meeting in which the waiver is approved.

Assent may be waived if;

1. The minor or children involved in the study are so limited in capability that they

cannot be reasonably consulted

2. The prospect of direct benefit to the health or well being of a minoris available

only through the context of the research

3. The waiver meets the same criteria for the waiver or alteration of consent for

adults

Documentation of Informed Consent

Proposed Informed Consent documents are reviewed as part of the IRB certification

process. Signed consent forms are maintained by the principal investigator and disposed three

years after the conclusion of the research project, unless a greater time is specified by the grant

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or foundation funding agreement for the research, as part of the maintenance of confidentiality of

the research participants.

The participant or the participant’s guardian must provide consent before the research is

conducted. In the case of children and minors, both the parent/guardian and child/minor must

sign, or, where age or developmentally appropriate, give oral consent. It is assumed that the

consent form is only part of the total consent process in which the investigator, perhaps using the

written consent form as an outline, describes all facets of the research and addresses the

participant’s questions. The investigator is responsible for ensuring that research participants

understand the research procedures and risks. Failure of the participants to ask questions should

not be construed as understanding on the part of the participant or be seen as voluntary

agreement to participate.

Conflict of Interest

An investigator may have a conflict of interest when other interests, such as financial or

other personal gain or personal relationships, bias his or her judgment regarding the welfare of

study participants or the integrity of the research. Investigators must disclose any conflicts of

interest to the IRB, study participants, and in any publications resulting from such research. The

IRB will review the potential conflict and determine whether the investigator has minimized the

risks involved and provided for the disclosure of such information to the participants. Conflicts

of interest can be reviewed as a research risk.

A Conflict of Interest statement (Appendix P) must be submitted with all IRB

applications. Annually, this disclosure must be updated, as the IRB research project is renewed

or amended. It is required that all investigators comply with the conditions or restrictions

imposed by the University to manage, reduce, or eliminate actual or potential conflicts of

interest, or the principal investigator is in jeopardy of forfeiting IRB Certification. Principal

investigators may use the model statement in Appendix P.

Collaborative Institutional Training Initiative (CITI)

The Collaborative Institutional Training Initiative (CITI) Program is a subscription

service that supports research ethics education. Argosy University subscribes to CITI to promote

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the highest ethical standards for research reviewed by its Institutional Review Boards. Prior to

applying for IRB certification, each principal investigator must complete the required CITI

modules and document completion as part of his or her application. Additionally, each IRB

application must contain documentation of completion by the principal investigator’s faculty

research supervisor. The training must be renewed at 5-year intervals (see link in Appendix Q).

Argosy University faculty are required to complete the CITI modules necessary for their

status as a chairperson for a dissertation, CRP, or for seeking IRB certification of the faculty

member’s research project.

IRB committee members are required to successfully complete all CITI modules

necessary for their service as a committee member.

Research Conducted at the Place of Employment

Proposals to conduct research at the principal investigator’s place of employment are

carefully reviewed because of the risk of a dual relationship that the principal investigator may

have with the research participants; that is, there may be perceived bias against, or perceived

coercion of, participants during the research process. In writing their proposals, principal

investigators must clearly address any conflict of interest that such studies can present, including

their relationship to participants. Investigators are strongly urged to avoid the use of participant

pools of convenience (See section entitled “Conflict of Interest”). ”). Argosy University strongly

discourages the use of other Argosy University students or employees for clinical or dissertation

research. Internal research conducted at Argosy University for purposes such as program

review, departmental or institutional assessment, and university accreditation do not require IRB

review.

Class Research Projects

Research conducted by students, as part of their class assignments, and class research

conducted by professors, as they work with students, is subject to IRB Certification. (Appendix

L).

To judge whether any particular classroom assignment needs IRB certification, faculty

must consider the nature of the assignment. In-class or out-of-class informal interviews, used for

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class purposes, typically do not need IRB review. These assignments are not research per se,

because their focus is on informational interviewing rather than collecting data for a research

project that may lead to publication or to a public presentation. However, if these out-of-class

assignments involve sensitive topics, proprietary information, vulnerable or special populations,

include videotaping or audiotaping, or participant identification is possible, then IRB

certification is needed.

Research at Argosy University must meet the highest professional and ethical standards.

Activities designed to train students in research methods in the normal classroom setting usually

do not fall within the federal definition of research. However, any research conducted with the

intent to either contribute to generalizable knowledge or to construct knowledge related to a

specific situation that will be published or presented within an academic discipline, even that

originating from the classroom activity, falls within the requirement for IRB review and

certification.

Undergraduate or graduate student research activities that reach outside of the classroom

may fall under the federal definition of research depending upon the type of interaction with the

research participant(s) and the risk involved. Research (see below) completed in preparation for a

conference presentation or poster session requires IRB review. Graduate theses, CRPs, ACPs,

and dissertations are clearly understood as research, and fall within the IRB purview when

human participants are involved. When in doubt, faculty research supervisors should consult

with their local IRB board to ensure compliance.

The Argosy University instructor has the responsibility for ensuring that the student is

educated on the general principles of research ethics, human participant protection, and

investigator training. To provide guidance to faculty members, the IRB has developed the

following criteria to determine whether classroom assignments require IRB Certification:

1. Are the participants from a special population such as minors (under 18 years old),

prisoners, patients, physically or mentally challenged individuals, or pregnant women?

1. Does the assignment require using a setting such as a prison, nursing home, hospital, or

school?

2. Does the assignment focus on topics such as alcohol or drugs, depression or suicide,

learning disabilities, abortion, AIDS or HIV or sex, sexually transmitted diseases, eating

disorders, or psychological inventories?

Argosy University Institutional Review Board Handbook – January 2014

3. Does the assignment include audiotaping or videotaping?

4. Will participants be directly identified through the assignment?

5. Will the data be formally presented to any audience outside of the class?

6. Will the research extend beyond the realm of the classroom environment?

7. Does the assignment require the use of proprietary or privileged information that is not

publicly available?

If the answer to any of the above questions is “Yes,” the project must be reviewed by the

IRB. Faculty and students may contact the IRB to discuss the assignment and obtain assistance in

determining if review is needed.

Research projects Lacking Definite Plans for Human Participant Involvement

Certain types of activities are planned and initiated with the knowledge that human

participants will be involved, without definite plans for their involvement. Examples of such

proposed activities are:

1. Training programs in which individual training projects remain to be selected and

designed;

2. Research, pilot, or developmental studies in which the involvement of human participants

depends on such things as the completion of survey instruments or prior studies that have

already been certified to conform; and,

3. General support programs where selection of the project is the responsibility of the

institution or program administrator. In consultation with the investigator’s supervisor,

the appropriate anticipated level of review application is to be submitted to the IRB with

as much information as is available. The application must include assurances that

additional information will be submitted when developed, and in the case of training

grants, that all trainees will submit individual applications if human participants are to be

used.

Argosy University Institutional Review Board Handbook – January 2014

Cooperative Research Activities

The Institutional Review Board has special requirements for the review and Certification

of proposals involving cooperative activities. Cooperative activities are those in which Argosy

University faculty, staff, employees or students, seek access to human participants at one or more

cooperating institutions, or when investigators from cooperating institutions seek access to

human participants at Argosy University.

For the cooperative activity, if an investigator from a cooperating institution desires to

obtain direct access to any person at AU, the cooperative activity must be reviewed jointly, and

an AU faculty member must be listed on the research project request. Any restrictions imposed

by the Argosy University IRB are binding on the outside investigator.

For the cooperative activity, if an Argosy University faculty, staff member, employee, or

student wishes to collect data from an outside agency, the principal investigator is responsible for

submitting a letter indicating Certification to do such from an authorized member of the

cooperative institution.

If the cooperating agency has its own IRB, Argosy University faculty, staff, employees,

and students may be required to apply for Certification from, and accommodate requests made

by, an outside IRB. That is, applicants for Argosy University IRB certification must have

received approval from their institutions or superiors even if the research is outside their

institutions.

Cross-Campus Cooperative Research. In cases where cross-campus research is

requested (more than two campuses), the application must be filed with the chairperson of

Argosy University’s National IRB. The National Chairperson will then convene a subcommittee

of the National IRB for review of the application. For most national requests, the convened

subcommittee will include the chairpersons of the campus sites where the proposed research will

take place. For national requests at the Full Board level of certification, a quorum of the

members of the National IRB will review the application at their next regularly scheduled

meeting. Once certification has been obtained at the national level, local campus VPAAs will be

notified and research may commence. Local permission is not required for protocols certified at

the national level.

When there are only two campuses involved, the following procedure should be employed:

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The IRB application and certification is conducted by the originating campus;

The VPAA and, if required, the regional director of HR of the host campus provides a permission letter for the research;

The VPAA and, if required, the director of HR from the second campus provides a permission letter allowing the research to take place on their campus. The VPAA sends this letter to the applicant’s home campus IRB Chairperson plus the principal investigator and his or her advisor; and,

The principal investigator includes VPAA’s permission as an appendix in the original application or as an amendment if the principal investigator is seeking to expand the participant pool from the original campus.

Argosy University Research at the National Level. In cases where research is

requested at the National level, the principal investigator files an application with the chairperson

of Argosy University’s National IRB and the National IRB will review the materials, certifying

when possible.

Permissions Required. At the National level, if a principal investigator seeks to use

Argosy University students, class practices, or related educational materials, the permission

process involves three steps:

1) The study must be approved by National College Dean. If more than one college is

involved, both deans must provide approval,

2) The study must be approved by University’s Vice Chancellor of Academic Affairs (VCAA).

If a principal investigator seeks to use Argosy University employees or business practices at the

national level as part of a study, permission must be obtained from the university’s National Vice

President for Human Resources, in consultation with the VCAA. In the principal investigator’s

request for permission, the principal investigator must explain in detail the purpose and

procedures of the study and what is being requested from the campuses or university. The VCAA

or VP of Human Resources will then either approve or deny the request in writing.

Argosy University Institutional Review Board Handbook – January 2014

3) With the National College Dean and University VCAA approvals of the study, the researcher

will send the IRB application to the National IRB. The National IRB will convene a committee

with representatives from each campus that is a part of the proposed study. On behalf of the

National IRB, this committee will either certify protocol or returns to researcher and chair for

revision and reapplication.

National applications that do not contain the required written permissions will be denied. Please

note that OHRP cautions against research using “participant pools of convenience,” and the IRB

strongly discourages researchers from using Argosy students unless the student population is

relevant and appropriate for the research question proposed and that Argosy students received

direct benefit for participating in the study.. Internal research conducted by Argosy University at

the national or local levels for purposes of program review, departmental or university

assessment and academic program or university accreditation do not require IRB review, as these

practices do not fall under the definition of research, as per the Argosy University Institutional

Review Board Handbook.

Argosy University Research at the Campus Level. When research is conducted at the

campus level no national review is required. The process is similar as mentioned in the previous

section but applies to research conducted at the campus level. However, the principal

investigator must secure written permission from the VPAA, and for the Clinical Psychology

programs the local Dean of the campus, and when required the director of HR to conduct the

study. Again, requests to use Argosy University’s students, staff, educational or business

practices, or faculty as research participants are only approved when the research provides a

specific benefit to those being studied.

Argosy University Institutional Review Board Handbook – January 2014

Changing Research Direction

On occasion, the principal investigator may foresee the possibility of changing directions

in a study from archived data to gathering data from research participants. This kind of change

requires the submission of a new Application for Certification of Compliance. To accommodate

accelerated data gathering procedures, the principal investigator, through his or her faculty

research supervisor may submit the new Application to the IRB Chairperson and request interim

certification to gather data under the strict supervision of the faculty research supervisor.

Action Research

Action Researcher(s), and all principal investigators, must follow the guidelines for

collaboration with participants and other stakeholders as noted in the Publication Manual of the

American Psychological Association (Sixth Edition), the Belmont Report and APA Code of

Conduct (Appendix Q of this Handbook).

Notification of IRB Decisions

Generally, the principal investigator and faculty research supervisor are notified of IRB

decisions with the receipt of a signed copy of the Application. Requests for revisions will be sent

to both the principal investigator and research chairperson. The Certification of Compliance is

logged by the clerk and serves as official documentation that the research project has been

certified. This documentation can be used for the dissertation proposal defense depending on

campus procedures.

Interim Certification of Compliance

Interim Certification is reserved for research projects that may have immediacy for data

collection.

If beginning a Full IRB Review (Level 3) study prior to the next scheduled monthly

meeting of the IRB becomes essential--for example, when a patient with an unusual disorder

suddenly becomes available for study and might suffer adversely by delay--the investigator may

request interim certification. In such an instance, the investigator, through his or her faculty

Argosy University Institutional Review Board Handbook – January 2014

research supervisor, presents to the IRB Chairperson a complete, signed application and a written

request for interim certification, including the appropriate reasons for beginning the study before

the next scheduled IRB meeting. The IRB Chairperson (or the chairperson’s designee) in

consultation with at least one other IRB member will decide on the emergency interim

compliance application. The interim certification is limited to the time until the next IRB

meeting when the application will receive full Board review.

Interim conformance certification is neither appropriate nor will it be granted for

purposes of meeting a grant or academic deadline or for the convenience of the applicant.

Continuing Review

All Certifications are Subject to Continuing Review. Any research activity involving

the use of human participants that has received initial review and Certification by the Argosy

University IRB is subject to continuing review and Certification. Time intervals for such reviews

shall be made at the discretion of the Argosy University IRB, based on the risk to the

participants, but shall occur no less than annually. It is the responsibility of the principal

investigator to request an extension of Certification in a timely manner. Failure to adhere to these

guidelines will be considered an act of non-compliance and the principal investigator could have

research and/or funding suspended.

No human participant research may take place after the Certification expiration date

without re-Certification. Failure to request re-Certification may result in disciplinary action.

A request for continuing certification (Appendix G) will normally occur during the

eleventh month of a yearlong certification period and the subsequent Certification period will

begin during that month. Continuing review for subsequent years will normally occur every 12

months, with the Certification period always beginning on the last day of the month in which the

Argosy University Institutional Review Board Handbook – January 2014

research project is reviewed. This procedure will ensure compliance with federal requirements

and will ensure that research projects are reviewed “at least annually.”

Completing the Continuing Review Form. In completing the Argosy University IRB

Continuing Review Form, the principal investigator will report the condition of the research

project, including the following:

1. Whether the study was initiated, and if not, indicate if the research project should be

terminated;

2. If the conditions of certification or the project changed, including, for example,

changes in the informed consent form or any other modifications to the study (any

changes to the research project must be reviewed and Certified by the Argosy

University IRB); and,

3. If there have been any adverse events regarding human participants in the

investigation (adverse events should be reported as required).

Submission of Continuing Review Form. The completed Argosy University IRB

Continuing Review Form is submitted by the principal investigator through his or her faculty

research supervisor to the IRB with a copy of the original application. The Argosy University

IRB Chairperson or his or her designee will review the Argosy University IRB Continuing

Review Form and any other documentation submitted by the principal investigator as part of the

continuing review report. One member may certify those who qualify under the Exempt or

Expedited categories. No research may continue until Certification for continuation is granted. If

full Board review is required, the original Argosy University IRB application and a written status

report of the research project and other supporting documents are copied and distributed to

Argosy University IRB members, and placed the next available meeting agenda. After the full

Board meeting, the Certification for Continuation is signed by the IRB Chairperson and returned

Argosy University Institutional Review Board Handbook – January 2014

to the principal investigator and faculty research supervisor. Those research projects qualifying

for and receiving continuing Certification are reported to the IRB in a separate section of the

agenda.

Continuing Review More Often than Annually. There are situations when the risks

associated with a particular research project are such that continuing review should take place

more frequently than annually. These risks include the possibility of death, severe injury, major

damage or loss, or outcomes that may result in negative publicity for the participants involved. In

these cases, the Argosy University IRB may specify that the principal investigator report to the

IRB either at a shorter time interval or after a specified number of participants are enrolled. The

Argosy University IRB may request the principal investigator to report the observed effects of

the research activities and how the participant(s) responded to the research interventions. The

Argosy University IRB will determine whether continued and active monitoring of the research

project is warranted and, if so, it will specify the period for monitoring.

Research Project Amendments or Modifications

Requests to modify or amend an Argosy University IRB Certified research project,

consent form, or any other document related to an Argosy University IRB Certified research

project must be made in writing by the principal investigator using an Argosy University IRB

Amendment Form (Appendix I). If revisions to the consent form are required, the principal

investigator must submit two copies of the revised consent form with one copy noting where the

changes were made using bolding, strike-through, or highlighting. These requests must come

through the faculty research supervisor. The designated Argosy University IRB member

processes these requests and determines whether or not the amendment or modification changes

the direction of the research. If not, the research may proceed as amended. However, if the

amendment and or modification significantly alters the direction of the research, the primary

investigator will have to submit a new IRB Certification Application. The designated IRB

Argosy University Institutional Review Board Handbook – January 2014

member then notifies the faculty research supervisor and principal investigator in writing of the

determination regarding the changes. The forms are attached to the principal investigator’s

original Argosy University IRB documents and appropriately filed.

Adverse Events

Argosy University policy requires principal investigators to report promptly any “adverse

event” related to the conduct of research, regardless of the severity. An unanticipated problem is

defined as any potential for harm or any unanticipated problem(s) involving risks to participants

or others. Such reports should be submitted to the principal investigator’s faculty research

supervisor immediately. The written report using an Unanticipated Problem Report form

(Appendix J) must be submitted to the designated Argosy University IRB member within 10

days of the event.

All reports of adverse events are reported for review by the full Board at the next

convened meeting. The designated reviewer or Argosy University IRB Chairperson should

specifically present especially serious events to the IRB at the next convened meeting.

Procedures to Ameliorate an Untoward Incident

Argosy University takes the position that any activity involving humans has the potential

for an untoward incident. The risk of such incidents is controlled for in the principal

investigator’s procedures, but may still occur. The principal investigator is responsible for

planning for a possible incident and for describing appropriate procedures in case an incident

should occur. Being prepared to follow an employer’s institutional procedures or school district

procedures already in place constitutes appropriate planning.

Suspension of Certification

The Argosy University IRB has the authority to suspend a project at any time for

justifiable reasons, such as failure to comply with applicable state or federal regulations, adverse

reactions to a study procedure or activity, or the inability to complete the study within the

Certification period. If the research involved external funding or if the campus currently holds an

institutional FWA, OHRP and any granting agency receiving the assurance must be informed of

any suspension of certification.

Argosy University Institutional Review Board Handbook – January 2014

Preparation of Application Materials

All documents must be typed. All formatting and spacing should conform to the current

edition of the APA Publication Manual, unless as specified in this Handbook. Applications and

all materials submitted to the Argosy University IRB should be carefully prepared and

completely filled out. These materials become part of permanent student and faculty records and

are subject to inspection and review by various accrediting, granting, and government agencies.

Filing and Record Retention

All related continuation documentation, including new Argosy University IRB Forms,

copies of the new consent form, memoranda, and other correspondence associated with

continuing review will be appropriately filed with other documents submitted by the principal

investigator. Argosy University IRB records are maintained according to the records

management system currently used by the University. According to OHRP (45.46.115), each

IRB must retain a copy of the application and updates for a minimum of three (3) years after the

completion of the research. Data retention practices for each protocol should be governed by the

guidelines of the protocol’s appropriate discipline, funding source or governmental regulation.

Section 4 contains various applications and documents presented as templates. Investigators are encouraged to select the appropriate application and other materials in

consultation with their faculty research supervisors.

Argosy University Institutional Review Board Handbook – January 2014

SECTION 3: IRB APPLICATIONS FORMS AND REPORTS

Application Forms for IRB Review of Research Projects Involving the Use of Human

Participants

General Guidelines

The Argosy University IRB’s primary mission is to ensure the protection and ethical

treatment of human participants in research conducted under the auspices of Argosy University.

All students, faculty, staff, and administrators conducting research at Argosy University must

first receive Certification of Compliance from the Argosy University IRB before collecting data.

Note to investigators:

1. These forms have been formatted for completing and mailing in hard copy and electronically. Your campus location may require hard copy and/or electronic filing. Check with your local IRB for campus requirements.

2. Select the appropriate form and save it to a file on your computer or other storage

device. 3. You may use text from your research proposal to answer questions. DO NOT reference

or attach your proposal to an application. 4. Future tense is appropriate. Correct all spelling, grammar and style. 5. Please answer every question on an application. N/A is not an appropriate answer for

any question. 6. Incomplete forms will be returned and will extend the timeline for Certification. 7. Principal Investigators may communicate with the IRB through their faculty research

supervisors.

Submitting an Application for IRB Review and Certification of Compliance:

CITI training must be completed prior to submitting the Argosy University IRB

application. The training will facilitate the applicant’s determination of the appropriate level of

certification. Determine the level of certification appropriate to the content and procedures of the

proposed research project: Exempt, Expedited, or Full IRB Review. Note that the entire

application must be completed, including signatures and attachments. Please consult this

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Handbook for definitions of research that qualifies for an Exempt (Appendix A), Expedited

(Appendix B), or Full IRB Review (Appendix C).

The procedures for submitting completed applications may vary from Argosy University

campus to campus (e.g., some may require the submission of multiple copies of the application;

some may require the submission of an electronic application). Nonetheless, all Argosy

University campuses require the principal investigator to submit a completed application with

faculty research supervisor’s signature and current date, a conflict of interest form,

documentation of CITI completion, the consent form to be used, and the necessary supporting

documentation. If applicable to the research, the following information must be submitted with

an Argosy University IRB application:

Copies of all informed consent and assent documents that will be used in the

research. Depending on the type of consent/assent being used, this might take the form of a

formal informed consent document, an information sheet containing the elements of consent, a

letter to accompany online surveys or email surveys, or a copy of a script used to obtain verbal

consent. Guidelines for creating a consent document can be found in this IRB Handbook and a

sample consent form can be found in Appendix D. In addition to consent or assent documents,

any agreement documents used with minors must be attached to the application.

Permission letters. If data are being collected from another institution (e.g., hospital,

school, clinic, etc.), the investigator is required to submit a signed letter from the appropriate

official at that institution granting permission to do so.

Permission letters or emails must be attached from the owner/developer of any survey or

other instrument granting the applicant permission to use and/or amend it as part of the research.

Certification from other institutions. In the case that the institution has its own IRB

and requires Certification from that IRB, the investigator must submit a Certification letter from

that institution’s IRB. Rarely, another institution may require local certification before granting

their certification (Appendix F). Most often, other institutions request a letter stating that the

applicant is affiliated with Argosy University, the name of the research study and the

circumstance for which it is being conducted (e.g., the completion of doctoral requirements—

dissertation) and the name and contact information of the faculty research supervisor.

In the instance that the other institution requires the Certification of Argosy University’s

IRB before considering requests, Contingent Certification may be requested, pending

Argosy University Institutional Review Board Handbook – January 2014

Certification from the other institution. In such a case, a final Certification letter from the other

institution must be received before the research may proceed.

Study materials. Copies of all advertisements, announcements, flyers, scripts, etc., used

to recruit participants, must be submitted with the application. These recruitment materials must

contain the name, phone, address of the investigator, and the purpose of the study, eligibility

requirements for participant, description of benefits, compensation, and location of the study.

Copies of all material provided to participants must be submitted with the application.

This includes instruction forms, copies of all surveys or questionnaires that will be used,

debriefing information, and planned questions for interviews. In the case of observational

research, a copy of whatever coding form is used should be attached.

Permission for usage of previously collected data. If using archival data, the

investigator must submit a letter from the owner of the data granting the investigator permission

to use it. The letter must include an assurance that the data were initially collected in an ethical

manner and that participants gave their consent for their information to be used for research

purposes. The Argosy University IRB may request a copy of the original consent form. If

requesting an exempt review, the permission letter must also state that the data will be stripped

of all identifying information before it is provided to the investigator.

Responding to a Request for Revisions

Following an Argosy University IRB review, the investigator may be asked to edit and

revise the application or include additional information. Response to such requests should be

made in a timely manner (30 days). When submitting revisions, the investigator should include a

letter of transmittal that includes listing or highlighting where in the documents the requested

changes were made. To facilitate a timely response, the principal investigator should also return

the memorandum requesting changes. The revision should be returned to the investigator’s

faculty research supervisor. If approved, the faculty research supervisor returns the application to

the Argosy University IRB Chairperson of his or her designee for logging and forwarding to the

appropriate IRB member.

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Request to Continue IRB Certification

When a research project is certified, the investigator will receive notification from the

Argosy University IRB. This notice will specify the period of time for which the research has

been certified. Typically, research projects are certified for one year, though sometimes the

period of certification can be shorter. Whenever the study is completed, the principal investigator

is required to submit a completed copy of the Project Completion Form (Appendix H) stating

that the research was completed as planned and the IRB Chairperson will respond with an

acknowledgement of the filing (Note: the student is required by the 2012 Dissertation Guide to

submit the Project Completion Form to her of his CRP or dissertation chairperson). If the

research is not completed before the period of Certification expires, the investigator is required

to submit a Continuing Review Form requesting an extension. The investigator may not continue

to collect data after the period of Certification ends unless he or she receives a Continuance.

Research Project Amendments and Changes

All changes or amendments to a research project must be certified by the Argosy

University IRB before they can be implemented. To make a change, the investigator must

complete the Argosy University IRB Amendment Form (Appendix I or K) and submit it with

any necessary supporting material. If making changes to existing documents (e.g., instructions,

consent forms, etc.), the investigator should submit the new forms with the changes highlighted

and explain what changes were made on the Argosy University IRB Amendment Form.

Amendments are submitted through the Faculty research supervisor.

Reporting Adverse Events

In the case of any significant deviation (accidental or otherwise) from the Certified

research project, investigators are required, within 10 days of the incident, to submit an

Unanticipated Problem Report Form (Appendix J) to the Argosy University IRB, including any

necessary supporting information. Any incidences in which participants are harmed, or have

otherwise adverse reactions to the research proceedings, must be immediately reported to the

Argosy University IRB.

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Elements of an Informed Consent Document

Every investigator at Argosy University must obtain the informed consent of any

potential human participant of research before that person participates in research. Investigators

must provide participants with informed consent documents written in simple, first person, lay

language and in the native language understandable to the participant (or the participant's legally

authorized representative). If participants do not read the native language in which the form is

written, or if there is no written native language, then terms must be written either in a translated

informed consent document in their native language or explained verbally in detail in their native

language. Verbal consent must be documented and witnessed by another party who can speak the

native language.

Parental consent is required of minors who have not attained 18 years of age. Parents

cannot sign away a minor’s right to choose to participate, and minors must give their assent

(even if parental consent is obtained). The investigator must provide minor participants with a

separate form—called an agreement (or assent) form—written to the minors' level of

understanding in simple language.

An example of a Consent/Assent Form is found in Appendix D. The investigator may

create a consent form following the guidelines below or modify one of the sample forms. The

consent form should be created in consultation with the faculty research supervisor and

personalized to match the needs of the study.

Designing a Consent Form. The following elements must be included in the consent

form(s), where appropriate.

1. Generally, the informed consent must be written in the first person (“I” of the

participant) for example, “I understand that I will participate in a research study....”

The informed consent must be written in simple, lay language. Word processing

programs such as Microsoft Word can provide an estimate of the reading-level of

documents.

The opening paragraph should state that it is a research study conducted by

(researcher or student’s name and affiliation such as a doctoral student in Business at

Argosy University-Seattle) and provide sufficient details for participants to be

informed as to the purpose and objectives of the study (if the study is part of degree

Argosy University Institutional Review Board Handbook – January 2014

requirements this must be clearly stated); that their participation is voluntary; where

the study will be conducted; and, the duration, dates, and nature of participants'

participation. Do not include a statement such as "I agree to what has been verbally

described." The investigator must describe the study and its procedures on the

informed consent document.

2. Description of the procedures to be followed, including any that are experimental;

describe discomforts and risks. Specify the amount of time participation will take in

terms of hours, days, weeks, etc.

3. Description of any risks (psychological, emotional, physical, etc.), however slight,

and how those risks will be mitigated.

4. Description of any benefits to the person participating and available alternative

procedures. If there are not any benefits for participation, indicate this also. Do not

claim benefits to society or benefits to the investigator.

5. Description of compensation (monetary or psychotherapy benefits), schedule of

payments, and compensation in the event of withdrawal from the study.

6. A statement informing participants if their medical records, grades, exam scores, or

other personal documents will be examined or used.

7. Contact information for principal investigator, faculty research supervisor, and IRB.

8. For survey, questionnaire, or other similar measurements, a statement informing

participant(s) that they may refuse to answer (without loss of benefits to the

participant) any questions that make them feel uncomfortable. If not answering

questions would cause the principal investigator to have to withdraw the participant

from the study, note this and any resulting consequences of being withdrawn, in the

consent form.

9. For sensitive topics (e.g., depression, sex, AIDS/HIV, drug or alcohol abuse, suicide,

abusive behavior, minorabuse, etc.) the investigator must include sources where the

participant can obtain assistance, such as counselors, treatment centers, or hospitals.

Emphasize the plan of action for identified behaviors involving the risk of injury to

self or others and for compliance with State and Federal reporting laws.

10. If appropriate, a statement that detected minor abuse will be reported to the proper

authorities.

Argosy University Institutional Review Board Handbook – January 2014

11. A statement that the participant can withdraw from the study at any time, or have the

audiotaping or videotaping discontinued at any time, and that such withdrawal will

not affect any treatment, employment, benefits, etc., if applicable. Specify the

consequences or lack of consequences for withdrawing, (i.e., there will not be loss of

benefits, grades, payment, treatment, course credit, employment, etc.).

12. A description of anticipated circumstances under which the participant's participation

may be terminated by the investigator without regard to the participant's consent, and

what effect this termination would have on any benefits, payment, treatment, course

credit, etc.

13. A statement that the study is confidential or anonymous--it cannot be both; explain

how the investigator will maintain confidentiality of records and data (e.g., coded

responses or secure storage). Confidential means that the information provided by the

participant may be connected to the participant, whereas anonymous means that the

information provided cannot be connected to the participant. Confidentiality cannot

be guaranteed; some situations such as a subpoena will over ride a promise of

confidentiality made by a researcher.

14. Permission for audiotaping and/or videotaping, specifying how and by whom the

tapes will be used, must appear in the consent form if taping will be part of the

protocol. The investigator must let the participants know how long the tapes will be

kept and how the tapes will be destroyed or erased. If a participant refuses to be

taped, but still may participate in the study, a separate form must be developed stating

the options with a signature line for each option. If the study includes the videotaping

of classrooms, the investigator must provide options to people who do not wish to

participate or be videotaped, such as allowing them to sit out of the videotape range,

at the back of the classroom, or permitting them to leave the room. (NOTE: A

separate Audio-Videotape release form should only be used in cases of deception

studies in which participants are not informed that they have been audiotaped or

videotaped until after their participation, or if the participant can still participate

without being audiotaped or videotaped.)

15. A statement, if appropriate, that the particular treatment or procedure may involve

risks to the participant that are currently unforeseeable.

Argosy University Institutional Review Board Handbook – January 2014

16. A listing of any additional costs the participant may incur while participating in the

research, (e.g., parking fees, travel costs, medical costs, and loss of work time).

Oral informed consent may be Certified by the Argosy University IRB in some cases if

all elements of consent are given and the consent is witnessed or, in certain cases, audio or video

taped. A transcript of the oral consent process must be provided to the Argosy University IRB

and must be given to the participant if they request a copy.

If the statement is longer than one page, each page must contain specific identifying

details so that, in effect, the participant’s signature is immediately below the statement of

understanding. Consent forms with more than one (1) page should be initialed and dated by the

participant (initial____ date______on each page) and pages should be numbered (page x of y #

of pages).

Additional Notes

The final statements should be similar to the following: I have read and understand the

explanation provided to me. I have had all my questions answered to my satisfaction, and I

voluntarily agree to participate in this study. I have been given a copy of this consent form.

The informed consent must be dated and have appropriate signatures. For parent’s

informed consent, include a line for the printed name of the child.

Give a signed copy of the informed consent document to the participant. Collected

consent forms must be kept in a locked, secure place.

Provide the investigator’s name, address, and telephone number, as well as those of

another contact person. This means the graduate advisor, if the investigator is a graduate student;

otherwise, provide the information for another responsible individual at Argosy University

(insert campus name). Name, address, and phone number must be listed on the bottom of the

form, so that participants know whom to contact for information on the study or in the event of a

research-related injury to the participant. For safety, where possible, avoid using a principal

investigator’s home phone or address, instead providing a mailing address at the campus (such as

c/o the faculty research chairperson’s work address).

Argosy University Institutional Review Board Handbook – January 2014

Please note that the name of the study and the principal investigator’s name should be in

a header on each page of these forms. Also, at the top of each page should be a page identifier as

in “Page 1 of 2.”

Argosy University Institutional Review Board Handbook – January 2014

SECTION 4: APPENDIXES

Argosy University Institutional Review Board Handbook – January 2014

Appendix A

Application for IRB Review and Certification of Compliance:

Exempt Application Form Checklist

Exempt Review (Level 1) Application

No or Minimal Risk (This level of application is reserved for research projects using archived data where there is no principal investigator-participant interaction.) To the Principal Investigator of a research project: 1. Please review the documents listed below that pertain to your research project. In the event that your project

does require the use of any of the listed documents, attach a copy of that document to the application submitted for IRB review.

2. If you are conducting a research project in another institution (e.g., a hospital or school), you must attach a

signed permission letter from a supervisor/administrator who is in a position to grant you permission to conduct the research at that site. The letter must be on institutional letterhead and must have an original signature.

3. If that institution also has a Human Subjects Review Committee--often referred to as the Institutional Review

Board (IRB)--, then written permission from the participating institution’s IRB must be attached to your IRB application.

4. If you are conducting research outside of the United States, you may not file at the Exempt level. Please check: The attached Application for Certification of Compliance contains

Institutional Permission Letter (where data are held) or documentation of ability to use data

Letter(s) of Informed Consent (may be needed if there is a question about use of data)

Conflict of Interest Disclosure Statement

CITI completion documentation for both Principal investigator and Faculty research supervisor

Principal Investigator and Faculty Research Supervisor’s signatures

Argosy University Institutional Review Board Handbook – January 2014

Application for IRB Review and Certification of Compliance

Exempt Cover Sheet

IRB# ________ Date Logged: _______

Use this form for research involving Archival Data or Literature Review No or Minimal Risk

(Review by one or more IRB Members — May lead to Expedited or Full review) Principal Investigator/Researcher’s Name: ______ Student ID Number: ______ Type of Research Project (CRP, Dissertation, ACP, describe other) ______ Title of Research Project: ______ Principal Investigator/Researcher’s Address: ______ Telephone Number: ______ Email: ______ Faculty Research Supervisor/CRP/Dissertation Committee Chairperson’s Name: ______ College: Business Psychological and Behavioral Sciences Education Health Sciences OTHER

Program of Study: ______ Degree ______ Project Proposed Start Date: ______ Project Proposed Completion Date: ______ As the principal investigator, I attest that all of the information on this form is accurate, and that every effort has been made to provide the reviewers with complete information related to the nature and procedures to be followed in the research project. Additional forms will be immediately filed with the IRB to report any change in participant(s), selection process, change of principal investigator, change in faculty research supervisor, adverse incidents, or completion date of project. I also attest that I will treat human participants’ data ethically and in compliance with all applicable state and federal rules and regulations that apply to this study, particularly as they apply to research work conducted in countries other than the United States. Signature of Principal Investigator/Researcher __________________________/_______ Date Approval Signature – Faculty Research Supervisor/CRP/Dissertation Committee Chairperson: ____________________________________________________/_____________ Date IRB Certification Signature___________________________________________________/____________

Argosy University Institutional Review Board Handbook – January 2014

The above named research project is certified for compliance with Argosy University’s requirements for the protection of human research participants with the following conditions:

1. Research must be conducted according to the research project that was certified by the IRB;

2. Any changes to the research project, such as procedures, consent or assent forms,

addition of participants, or study design must be reported to and certified by the IRB;

3. Any adverse events or reactions must be reported to the IRB immediately;

4. The research project is certified for the specific period noted in this application; any collection of data from human participants after this period is in violation of IRB policy.

5. When the study is complete, the investigator must complete a Completion of Research form.

6. Any future correspondence should be through the principal investigator’s faculty research supervisor and include the assigned IRB research project number and the project title.

******************************************************************************

NOTES: • Please complete this cover and the Application in detail. Every question must be

answered. Please type your answers. • Attach the appropriate documents and submit the entire application materials under the

cover of a completed Application Checklist to the CRP or Dissertation Chairperson. • Do not proceed with any research work with participants until IRB certification is

obtained. • If any change occurs in the procedure, sample size, research focus, or other element of

the project impacts participants, the IRB must be notified in writing with the appropriate form (see ancillary forms).

• Please allow 30 days after receipt of a complete application for processing. • DO NOT COLLECT DATA PRIOR TO RECEIVING IRB

CERTIFICATION

Argosy University Institutional Review Board Handbook – January 2014

Application for IRB Review and Certification of Compliance

Exempt Application

Exempt Review Application, No or Minimal Risk

(This level of application is generally reserved for research projects using archived data or literature reviews, where there is no principal investigator-participant interaction.) In addition, the following conditions apply. Read and complete the following statements: If you answer “no” to both of the statements, your research does NOT qualify for Exempt status. (If your project does NOT qualify for Exempt status, complete an Expedited or Full application, based on risk/benefit ratio to participants).

a. Any research that involves only archival data. Y N b. A literature review. Y N

Please completely answer the requested information (NA is not acceptable for any question). DO NOT attach your research proposal – answer the questions as stated.

Begin typing in the gray boxes.

1. Identify Study Site: ______ 2. Brief but detailed summary of the project, including methodology: ______ 3. Describe the nature of the involvement of human participants in the project. ______ 4. Describe the nature of required institutional approvals or other approvals (parental

approval as necessary according to institutional policy). ______ 5. Describe how confidentiality will be maintained: Be specific, including the use of

secondary documents, audio/video tapes, etc. Describe procedures for the safekeeping and disposal of information stored electronically.

______ 6. Describe why this project fits the Exempt level of risk. ______ 7. Describe review by institutions outside of Argosy University. (Attach copies of

permission letters, IRB certifications, and any other relevant documents). ______

Argosy University Institutional Review Board Handbook – January 2014

Attach any other required forms, including the principal investigator and faculty research supervisors’ CITI completion forms, the principal investigator’s Conflict of Interest form, tests, institutional permission slips, etc., related to this study. Failure to do so will result in delayed processing of the application.

Argosy University Institutional Review Board Handbook – January 2014

Appendix B

Application for IRB Review and Certification of Compliance:

Expedited Application Form Checklist

Expedited Review (Level 2) Application, Moderate Risk

(Review by the designated IRB member or the IRB Chairperson). Application Form Checklist To the Principal Investigator of a research project:

1. Please review the documents listed below that pertain to your research project. In the event that your project does require the use of any of the listed documents, attach a copy of that document to the application submitted for IRB review.

2. Please be advised that research projects involving interaction with human participants must have an

Informed Consent Form(s) attached. If a minor or incapacitated individual of any age is involved, parent/guardian permission must be included.

3. Parental permission does not negate the child’s right to chose not to participate.

4. If you are conducting a research project in another institution (e.g., a hospital or school), you must attach

a signed permission letter from a supervisor/administrator who is in a position to grant you permission to conduct the research at that site. The letter must be on institutional letterhead and must have an original signature.

5. If that institution also has a Human Subjects Review Committee--often referred to as the Institutional

Review Board (IRB) -- then written permission from the participating institution’s IRB must be attached to your IRB application.

6. If you are conducting the research outside of the United States, attach a letter of assurance that where the

research is being conducted. Please check: The attached Application for Certification of Compliance contains

Institutional Permission Letter (where research is taking place) Assurance of Adherence to Governmental Regulations concerning Human Subjects (if research

project is conducted outside the US) Letter(s) of Informed Consent

Data gathering instruments: Observation, Interview, Survey, other

CITI completion documentation for both Principal investigator and Faculty research supervisor

Conflict of Interest Disclosure Statement

Principal Investigator and Faculty Research Supervisor’s signatures.

Argosy University Institutional Review Board Handbook – January 2014

Application for IRB Review and Certification of Compliance

Expedited Cover Sheet

IRB# ________ Date Logged: _______

Expedited Review (Level 2) Application, Moderate Risk

(Review by one or more IRB Members—May lead to Full IRB Review) Principal Investigator/Researcher’s Name: ______ Student ID Number: ______ Type of Research Project (CRP, Dissertation, ACP, describe other) ______ Title of Research Project: ______ Principal Investigator/Researcher’s Address: ______ Telephone Number: ______ Email: ______ Faculty Research Supervisor’s Name: ______ College: Business Psychological and Behavioral Sciences Education Health Sciences OTHER

Program of Study: ______ Degree ______ Project Proposed Start Date: Project Proposed Completion Date: As the principal investigator, I attest that all of the information on this form is accurate, and that every effort has been made to provide the reviewers with complete information related to the nature and procedures to be followed in the research project. Additional forms will be immediately filed with the IRB to report any change in participant(s), selection process, change of principal investigator, change in faculty research supervisor, adverse incidents, or completion date of project. I also attest that I will treat human participants ethically and in compliance with all applicable state and federal rules and regulations that apply to this study, particularly as they apply to research work conducted in countries other than the United States. Signature of Principal Investigator/Researcher __________________________/_______ Date Approval Signature – Faculty Research Supervisor/CRP/Dissertation Committee Chairperson: ____________________________________________________/_____________ Date IRB Certification Signature___________________________________________________/____________

Argosy University Institutional Review Board Handbook – January 2014

The above named research project is certified for compliance with Argosy University’s requirements for the protection of human research participants with the following conditions:

1. Research must be conducted according to the research project that was certified by the IRB.

2. Any changes to the research project, such as procedures, consent or assent forms,

addition of participants, or study design must be reported to and certified by the IRB.

3. Any adverse events or reactions must be reported to the IRB immediately.

4. The research project is certified for the specific period noted in this application; any collection of data from human participants after this period is in violation of IRB policy.

5. When the study is complete, the investigator must complete a Completion of Research form.

6. Any future correspondence should be through the principal investigator’s faculty research supervisor and include the assigned IRB research project number and the project title.

******************************************************************************

NOTES: • Please complete this cover and the Petition in detail. Every question must be answered.

Please type your answers. • Attach the appropriate documents and submit the entire application materials under the

cover of a completed Application Checklist to the CRP or Dissertation Chairperson. • Do not proceed with any research work with participants until IRB Certification is

obtained. • If any change occurs in the procedure, sample size, research focus, or other element of

the project impacts participants, the IRB must be notified in writing with the appropriate form (see ancillary forms).

• Please allow 30 days after receipt of a complete application for processing. • DO NOT COLLECT DATA PRIOR TO RECEIVING IRB

CERTIFICATION

Argosy University Institutional Review Board Handbook – January 2014

Application for IRB Certification of Compliance

Expedited Application

Expedited Review (Level 2) Application, Moderate Risk

(Review by one or more IRB Members— May lead to Full Review) Research with minors, prisoners, mentally/emotionally/physically challenged persons, pregnant women, fetuses, in vitro fertilization, and/or individual or group studies where the investigator manipulates the participants/ behavior or the participant is exposed to stressful or invasive experiences do(es) not qualify for Expedited status. Please completely answer the requested information (NA is not acceptable for any question). DO NOT attach your research proposal – answer each specific question in the area provided. Begin typing in the gray boxes. 1. Purpose of the Study: ______ 2. Summary of the Study. Methodology (Be Specific). ______ 3. Participant Demographics:

a. Anticipated Sample Size: b. Special Ethnic Groups (describe): c. Institutionalized Y N Protected Group (describe):

d. Age group:

e. General State of Health:

f. Other details to describe sample group. ____________ 4. Will deception be used in the study? Y N (please describe) ______ 5. Will audio or videotapes be used in the study? Y N (please explain) ______ 6. Confidentiality protection issues (pertains to audio and video as well as written

documents.)

Argosy University Institutional Review Board Handbook – January 2014

a. What precautions will be taken to insure the privacy and anonymity of the

participants? (i.e. closed doors, private rooms, handling of materials where participants' identify could be discovered, etc.). ______

b. What specific precautions will be taken to safeguard and protect participant’s

confidentiality while handling the data (audio/video/paper) both in principal investigator’s possession and in reporting the findings? (i.e., coding, removal of identifying data). ______

c. Describe procedures where confidentiality may be broken by law (e.g.,

minorabuse, suicidal intent). ______

7. Review by institutions outside of Argosy University/XX Y N (Attach copies of

permission letters, IRB certifications, and any other relevant documents). ______ 8. Informed Consent and Assent (Attach copies of all relevant forms). If consent is not

necessary (e.g., anonymous interview), describe how you will inform all participants of the elements of consent (see instructions). ______

9. If written or oral informed consent is required, describe the manner in which consent

and/or assent was obtained ).

(a) Adult Participants (18 years and older – written consent required). ______

10. Describe any possible physical, psychological, social, legal, economic, or other risks to participants. ______

a. Describe the precautions taken to minimize risk to participants. ______

b. Describe procedures implemented for correcting harm caused by participating in the study (e.g., follow up calls, referral to appropriate agencies). ______

11. Potential benefit of the study:

a. Assess the potential benefit(s) of the study for the participants: ______ b. Assess the potential benefits(s) to the professional community: ______

Attach any other required forms, including the principal investigator and faculty research supervisors’ CITI completion forms, the principal investigator’s Conflict of Interest form, tests,

Argosy University Institutional Review Board Handbook – January 2014

institutional permission slips, etc., related to this study. Failure to do so will result in delayed processing of the application.

Argosy University Institutional Review Board Handbook – January 2014

Appendix C

Application for IRB Review and Certification of Compliance

Full Application Form Checklist

Full IRB Review (Level 3) Application, High Risk

(Full Board Review) Application Form Checklist

To the Principal Investigator of a research project:

2. Please be advised that research projects involving interaction with human participants must have an

Informed Consent Form(s) attached. If a minor or incapacitated individual of any age is involved, parent/guardian permission must be noted and included.

3. Parental permission does not negate the child’s right to chose not to participate.

4. If you are conducting a research project in another institution (e.g., a hospital or school), you must attach

5. If that institution also has a Human Subjects Review Committee--often referred to as the Institutional

Review Board (IRB) --, then written permission from the participating institution’s IRB must be attached to your IRB application.

6. If you are conducting the research outside of the United States, attach a letter of assurance that you will

abide by the laws and regulations of the governing bodies that preside over the location where the research is being conducted.

Please check: The attached Application for Certification of Compliance contains

Institutional Permission Letter (where research is taking place)

Assurance of Adherence to Governmental Regulations concerning Human Subjects/Participants (if research project is conducted outside the US)

Letter(s) of Informed Consent

Parent/guardian Permission Letter (must have provision for written signature)

Oral statement of Assurance (used with minors)

Data gathering instruments: Observation, Interview, Survey

Conflict of Interest Disclosure Statement

CITI completion documentation for both Principal investigator and Faculty Research Supervisor

Principal Investigator and Faculty Research Supervisor’s signatures.

Argosy University Institutional Review Board Handbook – January 2014

Application for IRB Review and Certification of Compliance:

Full Cover Letter

Full IRB Review (Level 3) Application, High Risk (Full Board Review) IRB# ________

Date Logged: _______ Principal Investigator/Researcher’s Name: ______ Student ID Number: ______ Type of Research Project (CRP, Dissertation, ACP, describe other) ______ Title of Research Project: ______ Principal Investigator/Researcher’s Address: ______ Telephone Number: ______ Email: ______ Faculty research supervisor/CRP/Dissertation Committee Chairperson’s Name: ______ College: Business Psychological and Behavioral Sciences Education Health Sciences OTHER