Milestone 7

Institutional Review Board (IRB)

Policy and Procedures Manual

Version 2.1

Modified July 1, 2015

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Table of Contents A. Mission Statement……………………………………………………………..………... 5 B. Abbreviations and Definitions……………………………….………………….……... 5

1. Definitions used by HHS…………………………………………………….…... 5 2. Definitions used by South University………………………………………..…... 7

C. Codes of Regulations……………………………………………………………….…... 8 1. HHS Protection of Human Subjects, 45 CFR Part 46…………………………… 8 2. The Belmont Report………………………………………………………………8 3. HIPAA…………………………………………………………………………… 9 4. Application State and Local Laws…………………………………….………… 10

i. State laws………………………………………………………...……… 10 ii. Local laws……………………………………………………..………… 10

D. Training and Education………………………………………………………..……… 10 1. Public Responsibility in Medicine and Research (PRIM&R)…………...……… 10 2. The Collaborative Institutional Training Initiative (CITI)……………….……... 11 3. Health Insurance Portability and Accountability Act (HIPAA)………………… 11

E. Categories of Review…………………………………………………………..………. 11 1. Exempt Review…………………………………………………………………. 11 2. Expedited Review……………………………………………………………….. 12 3. Full Review……………………………………………………………………... 12

F. Authority/Purpose of the IRB…………………………………………………..…….. 12 1. IRB Oversight…………………………………………………………………… 12 2. IRB Staff Members’ Roles and Responsibilities……………………..…………. 13

i. IRB Staff………………………………………………………………… 13 1. IRB Director of Training and Compliance……………...………. 13 2. IRB HIPAA Compliance Officer………………………..……… 13

ii. IRB Members…………………………………………………….……... 14 1. Overview of the Committee……………………………...……... 14 2. IRB Committee Chair…………………………………………… 14 3. IRB Liaisons (IRBL)……………………………………..……... 15

a. IRBL selection process…………………………….……. 15 b. IRBL terms of appointment……………………...……… 15

4. IRB Community Representative………………………………... 16 5. Nonscientist……………………………………………………... 16 6. Alternate Members……………………………………………… 16

iii. Orientation of IRB Staff and Members……………………………..…... 17 3. IRB Committee Meetings………………………………………..……………… 17

i. Frequency……………………………………………………………….. 17 ii. Committee Review Composition……………………………………….. 17

1. Exempt review………………………………………...………… 17 2. Expedited review…………………………………………...…… 18

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3. Full board review………………………………………...……… 18 iii. Quorum……………………………………………………………..…… 18

4. Storage and Transmission of IRB Documents……………………………...…... 18 5. Institutional Review Board Authority…………………………………………... 18

i. Decision-Making………………………………………………………... 18 ii. Authority………………………………………………………………... 19

iii. Conflict of Interest…………………………………………………….... 19 6. Research Review Materials…………………………………………………...… 19

i. Initial Review Materials………………………………………………… 19 ii. Continuing Review Materials…………………………………………… 20

iii. Guidance Relevant to IRB Records and Documentation……………….. 20 1. IRB Protocol Records……………………………………...……. 20 2. Minutes of IRB Meeting………………………………………… 21

iv. Documentation of Findings………………………………………...…… 21 v. Retention of IRB Records………………………………………………. 21

G. IRB Review Process…………………………………………………………….……… 22 1. Principal Investigator Responsibilities…………………………………..……… 22

i. Education requirements……………………………………….………… 22 ii. Training and documentation of training requirements………………..… 22

iii. Responsibilities when leaving the university………………….………... 22 iv. Documentation………………………………………………..………… 23

2. Changes to protocol……………………………………………………...……… 24 3. Continuing Review of Active Protocols………………………………………… 24

v. Continuance Request………………………………………….………… 24 4. Completion of Study…………………………………………………..………... 25 5. Adverse Events/Unanticipated Problems………………………………...……... 25

vi. Definitions………………………………………………………..……... 25 vii. Reportable Problems and Events………………………………...……… 25

viii. Reporting Requirements………………………………………………… 26 ix. IRB Review of Adverse Events/Unanticipated Problems………………. 27 x. Notification of Investigator(s)……………………………………..……. 27

6. Appeals of IRB Decisions…………………………………………….………… 27 H. Informed Consent and Assent………………………………………………………… 27

1. Requirements for Informed Consent……………………………………..……... 28 2. Assent…………………………………………………………………………… 29 3. Circumstances in Which Written Consent May Not Be Required……………… 29

i. Internet research………………………………………………….……... 29 ii. Waiving one or more requirements of informed consent……..………… 29

4. Documentation of Consent……………………………………………………… 30 I. Participants…………………………………………………………………..………… 30

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1. Risks……………………………………………………………………...……... 30 i. Types of Risk to Research Subjects……………………………..……… 31

1. Physical harm…………………………………………………… 31 2. Psychological harm……………………………………………... 32

ii. Ways to Minimize Risk………………………………………….……… 32 2. Benefits……………………………………………………………..…………… 32 3. Risk/Benefit Assessment………………………………………………...……… 32 4. Selection of Subjects……………………………………………………..……... 33 5. Vulnerable Populations…………………………………………………..……... 34

iii. Resident of any facility………………………………………………….. 34 1. Prisoners………………………………………………………… 34

iv. Women and minorities……………………………………………….…. 34 1. Pregnant women…………………………………………….…... 34

v. Children and minors…………………………………………………...... 35 1. Consent procedures………………………………………...…… 35

vi. Wards of the state…………………………………………………...…... 35 vii. Mentally and emotionally disabled……………………………………... 35

viii. Subordinates and colleagues of the researcher……………………..…… 36 ix. Students of the researcher…………………………………………..…… 36 x. Individuals are not fluent in English………………………………..…... 37

xi. Individuals who are in crisis……………………………………….……. 37 xii. Economically disadvantaged individuals………………………….……. 37

xiii. Elderly subjects……………………………………………………..…... 38 J. Students Involved in Research………………………………………………………... 38

1. Students as Researchers……………………………………………………...….. 38 i. Students conducting class projects, dissertations, and theses…………... 38

2. Students as Research Subjects……………………………………...………….... 38 3. Investigator and IRB member conflicts of interest…………..…………………. 39

K. Noncompliance with IRB Policies……………………………………………………...39 1. Notification to Cease Research Activities………………………….…………… 39

L. Internet Research…………………………………………………………….………... 39 M. Cooperative Research…………………………………………………………..……... 40

1. Research sites with an IRB……………………………………………...………. 40 2. Research sites without an IRB…………………………………………...……… 41

N. International Research………………………………………………………...………. 41 1. Specific information to be included in the IRB proposal……………….………. 42 2. Risk assessment…………………………………………………...…………….. 43 3. Special considerations for Informed Consent……………………...…………… 43 4. Communication with the IRB and Local Authorities…………………...……… 44

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A. Mission Statement The mission of South University’s Institutional Review Board is to protect the rights and welfare of human participants in research by reviewing all proposed research to be conducted by or with faculty, staff, and/or students of South University to ensure that participants are treated in an ethical manner that is also in compliance with federal regulations and the principles outlined in the Belmont Report.

B. Abbreviations and Definitions

Federal regulations and University policy use the following abbreviations:

IRB Institutional Review Board HHS Department of Health and Human Services CFR Code of Federal Regulations OHRP Office for Human Research Protection PI Principal Investigator FDA Food and Drug Administration

Federal regulations and University policy define various terms in regard to protection of human research participants. 45 CFR 46, also known as the Common Rule, is the body of regulations promulgated by HHS. Most projects at the University fall under these regulations. 45 CFR 46 includes the following definitions:

1. Definitions used by the Department of Health and Human Services

i. Research means a systematic investigation—including research development, testing, and evaluation—designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purpose of the policy and procedures, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

ii. Department or Agency means the head of any federal department or agency and any

other officer or employee of any department or agency to whom authority has been delegated.

iii. Human subject means a living individual about whom an investigator (whether

professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.

iv. Intervention includes both physical procedures by which data are gathered (e.g.,

venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (e.g., cognitive experiment).

v. Interaction includes communication or interpersonal contact between investigator and

human subject (e.g., a telephone interview).

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vi. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which he or she can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human participants.

vii. Minimal risk means that 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.

viii. IRB means an institutional review board established in accord with and for the

purposes expressed in this policy. ix. IRB approval means the determination of the IRB that the research has been reviewed

and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

x. Vulnerable population means children, prisoners, pregnant women, mentally disabled

persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them especially vulnerable to coercion (e.g., probationers).

xi. Prisoner means any individual involuntarily confined or detained in a penal

institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Prisoners receive additional protections under 45 CFR 46, Subpart C.

xii. Child means a person who has not yet attained the age of consent to treatments or

procedures involved in the research, under the applicable laws of the jurisdiction in which the research will be conducted. Children receive additional protections under 45 CFR 46, Subpart D.

xiii. Parent means a child’s biological or adoptive parent. xiv. Guardian means an individual who is authorized under applicable state or local law

to consent on behalf of a child to general medical care.

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xv. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

xvi. Permission means the voluntary agreement of parent(s) or guardian to the

participation of their child or ward in research.

xvii. Adverse effect means an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., subject becomes upset following completion of a depression questionnaire or subject experiences intestinal bleeding associated with aspirin therapy) that is directly or indirectly due to participation in a research study.

2. Definitions used by South University

i. IRB Liaison (or IRBL) is the member of a particular college who is a current or alternate member of the IRB and serves as a reviewer on proposals submitted by the University. Each campus’ IRBL also serves as a reference on IRB matters (e.g. proposals, submission) for faculty and students on his/her campus (or division) and throughout the South University system as needed.

ii. Principal Investigator is the person who leads the project and is ultimately

responsible for all aspects of it. On most projects, the term has the same meaning as “primary researcher.”

iii. Student project means a study in which a student investigator (individually or as part

of a group) gathers or analyzes information in a systematic manner, primarily for pedagogical purposes. It is not intended to contribute to generalizable knowledge and is not to be presented outside the class in which the research is being done or published/disseminated (including publication on the Internet) in any way, presented, archived, or compiled with similar research for later publishing or presentation. Research conducted for a senior project, master’s thesis or seminar project does not fall under this definition.

iv. Institutional research (or quality improvement research) is a study that is designed to

obtain information to assist in the administration of the University. Institutional research provides information for administrative planning, policy making, decision making, and includes examinations of institutional effectiveness. Institutional research is specifically defined as those data collection and interpretation efforts that: (a) will not be shared outside of the University environment; (b) will not be disseminated to other professionals or the public in any forum; (c) presents no more than “minimal risk” (as defined by Federal regulation); (d) is not intended to produce “generalizable knowledge”; and (e) contains no identifiers in the data that might compromise an individual’s confidentiality. Institutional efforts meeting this definition are not subject to the IRB policy and procedures.

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v. Training refers to a process approved by the University, and required by federal regulations, to instruct investigators in the conduct of research involving human participants.

Some studies may fall under the regulations promulgated by the FDA (21 CFR 50). These will generally be studies that involve the testing of an investigational medication or a medical device. Refer to 21 CFR 50 for specific definitions regarding these studies. Some FDA definitions differ from the above HHS definitions.

C. Codes of Regulation

1. HHS Protection of Human Subjects, 45 CFR Part 46 In 1974 The United States Department of Health and Human Services delineated a set of uniform specific regulations (i.e., Code of Federal Regulations, Title 45, Part 46) to provide protection to human subjects rights and welfare when engaging in research. All research that includes the use of human subjects and/or private information about humans must comply with all of the regulations in 45 CFR 46. These regulations are most commonly referred to as 45 CFR 46, are based in part on the ethical guidelines proposed in the Belmont Report, and the regulations provide the basics for the protection of human subjects, guidance for protecting vulnerable populations, and delineate the requirement for registering Institutional Review Boards. Hence, the document is divided into with five subparts: (Subpart A) basics on the protection of human subjects; (Subpart B) protection of pregnant women, fetuses, and neonates; (Subpart C) protection of prisoners; (Subpart D) protection of children; and, (Subpart E) requirement of IRB which conduct review of human research proposed, conducted, and supported by HHS. Please see Appendix A and the links below for the full text of 45 CFR 46.

i. Link to full text of 45 CFR 46 Subpart A: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subparta

ii. Link to full text of 45 CFR 46 Subpart B: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartb

iii. Link to full text of 45 CFR 46 Subpart C: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartc

iv. Link to full text of 45 CFR 46 Subpart D: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd

2. The Belmont Report

In September of 1978, after a four day extensive conference, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted The Belmont Report, which encompasses the basic ethical principles that govern acceptable conduct in any research that involves human subjects. In essence, the contents of The Belmont Report are designed to aid researchers in resolving ethical dilemmas that arise when conducting research with human subjects. The three essential requirements for conducting research ethically are as follows:

• Respect for persons encompasses a recognition of a person’s autonomy and personal dignity, and a person’s right to be protected should he or she have a diminished autonomy

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• Beneficence necessitates that researchers protect human subjects from harm by clearly outlining any expected benefit to the participant and taking action to minimize possible risks of harm to the participant.

• Justice requires the promotion of equity in human subjects research

The Belmont Report also delineates how researchers are to apply these principles when conducting research. Specifically, the principle of respect for persons underlies the need to obtain informed consent; the principle of beneficence underlies the need to engage in a risk/benefit analysis and to minimize risks; and the principle of justice requires that subjects be fairly selected. In addition, because the Commission required a distinction be made between “practice” and “research” the text of the Belmont Report is divided into two sections: (a) boundaries between practice and research; and (b) basic ethical principle. The principles in the Belmont Report became the basis for the regulations in Title 45 Code of Federal Regulations Part 46 (45 CFR 46). Please see Appendix B and the following link for the full text version of the Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

3. HIPAA

All personal health information of participants collected by researchers must be protected by the Health Insurance Portability and Accountability Act (HIPAA). The Department of Health and Human Services’ Office for Civil Rights is responsible for enforcing the Privacy and Security Rules outlined by HIPAA. The HIPAA Privacy Rule provides federal protection for personal health information held by covered entities and gives patients rights with respect to that information. At the same time, the Privacy Rule is balanced so that it allows the disclosure of personal health information needed for patient care and other important purposes, including research. The HIPAA Security Rule specifies a series of administrative, physical, and technical safeguards for covered entities to use to assure the confidentiality, integrity, and availability of electronic protected health information. HIPAA is relevant for researchers when working with participants involved in clinical (i.e., physical or mental health) research or services. HIPAA requires that informed consent forms for research studies include extensive detail on how the participant’s protected health information will be kept private and that specific guidelines are followed for the storage and transmission of personal health information. Researchers conducting clinical research must provide mandated information to research subjects about their privacy rights and how personal health information can be used, inform subjects about the right to access and amend their personal health information, adopt clear and systematic privacy and database security procedures, designate an individual to be responsible for seeing that the privacy procedures are adopted and followed, and secure records containing individually identifiable health information in a private, locked location. According to HIPAA’s privacy rule, the information in the following list is considered director identifiers. In order for data to be de-identified, none of this information can be collected:

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i. Names ii. Geographic area (including

city, state, and zip) iii. Elements of dates iv. Telephone numbers v. Fax numbers

vi. Email addresses vii. Social security numbers

viii. Medical records ix. Prescription numbers x. Health plan beneficiary

numbers xi. Account numbers

xii. Certificate/license numbers xiii. Automobile VIN and serial

numbers xiv. License plate numbers xv. Device identifiers/serial

numbers xvi. Web URLs

xvii. Computer IP address numbers

xviii. Biometric identifiers (e.g., fingerprints)

xix. Full face photo images xx. Unique identifying numbers

4. Applicable State and Local Laws

The HHS regulations do not affect any applicable State or local laws or regulations which provide additional protections for human subjects [see 45 CFR 46.101(f)].

i. State Laws Because South University’s campuses and students are located in various states throughout the United States, it is the responsibility of the principal investigator to be familiar with and adhere to all state laws within the research jurisdiction. It is the principal investigator’s responsibility to provide the IRB with information about application state regulations. For example, Georgia state law requires that each subject participating in a research study be informed of his or her rights and that an individual attest to the fact that informed consent was given in the proper manner. When state law is silent regarding particular research activities, the institution will provide guidance to investigators basing such guidance from 45 CFR 46 and guidance and other currently recognized ethical standards for human subjects’ research. The South University IRB relies on the counsel of the General Counsel of the institution for the interpretation and application of state law and the laws of any other state or other jurisdiction where research is conducted as they apply to human subjects’ research.

ii. Local Laws

Researchers are expected to know and abide by any local or municipal laws when conducting research. Researchers working in jurisdictions off campus are responsible for obtaining this information. This is also true for research conducted in other countries. It is the principal investigator’s responsibility to provide the IRB with information about local regulations.

D. Training and Continuing Education

1. Public Responsibility in Medicine and Research (PRIM&R) The purpose of PRIM&R is to help professionals improve human subjects safeguards and is one of the premier organizations that the government calls upon to give advice that is impartial that guides the government in making the right rules and regulations for research; both in humans and animals. It is required that the IRB Director of Training and

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Compliance attend a PRIM&R workshop at least once per fiscal year in order to remain up-to-date on current trends in the research community. The Collaborative Institutional Training Initiative (CITI) or the National Institute of Health’s training on Protecting Human Research Participants All IRB committee members must maintain CITI and/or NIH certification. Before submitting an IRB application, all research personnel are required to take the appropriate CITI/ NIH training modules and attach complete certificates for all study personnel to their IRB application. Training expires after a three year period. It is the principal investigator’s responsibility to ensure that all research personnel have updated certifications filed with the IRB. Failure to maintain certification is treated as an adverse event (see section G.5. below).

2. Health Insurance Portability and Accountability Act (HIPAA) HIPAA is a federal law enacted in 1996 to reform the healthcare industry by improving the privacy and security of patients’ information. HIPAA training is required for all principal investigators who plan to assess participants’ protected health information. When completion of this module is required in order to conduct a proposed research study, the investigator (and all participating researchers) must submit documentation of their training with the IRB application.

E. Categories of Review In its review of research projects, the IRB must be assured that risks to subjects are minimal, any risks to subjects are reasonable relative to any benefits that might be expected from taking part in a research study and to the importance of the knowledge obtained from the research, participation is voluntary and informed consent is obtained from each prospective participant (or legal guardian), and there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data. All research projects submitted to the IRB fall into one of three categories of review:. 1. Exempt Review

The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. At South University, determinations of exemption are made by the IRB (not by the principal investigator). In order to make this determination, the IRB uses 45 CFR 46.101(b) and must include documentation regarding the specific category justifying the exemption in its notification to the principal investigator. When the IRB notifies a principal investigator that a research project is exempt, it also notifies the principal investigator that the research is approved for initiation or continuation. In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption outlined by HHS and it cannot place subjects at greater than minimal risk. Exemption means that a research protocol is exempt from the requirements set forth in 45 CFR 46.101b. Exemption does not mean that the protocol is exempt from local and/or state laws.

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Publicly available unidentified data (such as CDC data) is considered exempt from IRB under 45 CFR 46.101(b).

2. Expedited Review Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the full IRB. A list of categories of research has been established by HHS that may be reviewed by the IRB through an expedited review procedure. In order to qualify for expedited status, reviewer(s) must find the protocol to involve no more than minimal risk. For ongoing projects, minor changes in previously approved research during the period (of one year or less) for which approval is authorized may qualify for expedited status. At South University, determinations of exemption are made by the IRB (not by the principal investigator). Examples of minimal risk procedures include EKGs, moderate exercise testing, and administration of psychological tests involving a minor level of stress. Archived data from a previous research study may require expedited review.

3. Full Review If the study does not meet the criteria for exempt or expedited review, then it must undergo full IRB review. Activities that require full review are those that require more advanced medical procedures, such as blood draws, and those that involve specific populations of protected individuals, such as children, pregnant women, prisoners, or current students/ subordinates of the researcher.

F. Authority/Purpose of the IRB The IRB at South University was established in accordance with federal, state, and University regulations to review all research involving human subjects and as such is guided by the highest ethical standards in the industry. The IRB is charged with the task of ethically protecting the rights and welfare of all human subjects in any research conducted under the aegis of South University. The three basic ethical Principles that serve as the guidelines for South University’s IRB are derived from the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1978) and include: (a) respect for persons, (b) beneficence, and (c) justice, which are described in section C.2. above. It is the policy of South University that all research involving human subjects be reviewed by the IRB. Researchers are not permitted to conduct research with human subjects until the IRB has reviewed and approved the research protocol. This means that the researcher(s) cannot have any contact with potential subjects (including recruiting participants and obtaining consent) and researcher(s) cannot begin the research process until the proposal has been approved, although researchers do have permission to contact organizations from which subjects will be recruited. Furthermore, unless the IRB specifically waives the need for informed consent, the principal investigator must attain the informed consent of all subjects or the subjects’ legal guardians. Finally, the IRB approves all projects for one calendar year and reviews all ongoing projects annually.

1. IRB Oversight

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The oversight of the IRB will be maintained by the Vice Chancellor for Academic Affairs (VCAA). This role will include coordination and consultation with the College and School Deans. The direct oversight, including daily operations will include specific roles for:

• The IRB Director of Training and Compliance • The IRB HIPAA Compliance Officer • The IRB Liaisons

These roles are defined in the following section.

2. IRB Staff and Members’ Roles and Responsibilities

Membership of the IRB for South University shall include representatives from all campuses and divisions as well as diverse cultural and professional groups within the university. Members shall have diverse backgrounds and areas of expertise that allow for competence in reviewing applications from a variety of disciplines. Membership shall also include a community representative who is not otherwise affiliated with the university. i. IRB Staff

1. South University IRB Director of Training and Compliance The South University IRB Director of Training and Compliance position will be filled by an SU faculty member who will serve as an ex-officio member of the IRB committee. This position will provide administrative support for the committee by maintaining responsibility for training new and existing committee members, university liaisons, and compliance with IRB policies and procedures. The South University IRB Director of Training and Compliance is responsible for:

i. Advising IRB staff and principal investigators; ii. Managing protocol review;

iii. Providing/overseeing education; iv. Recordkeeping; v. Reporting;

vi. Handling allegations and complaints; vii. Conducting quality improvement or assurance reviews;

viii. Managing IRB staff; ix. Coordinating cooperative research agreements; x. Overseeing special initiatives.

2. Assistant IRB Director/ HIPAA Compliance Officer

This position will be filled by an SU faculty member who will serve as an ex- officio member of the IRB committee. This position will provide consultation to the committee by ensuring that research studies requiring adherence to HIPAA laws meet and maintain compliance. This position will also serve as back up to the Director of Training, as necessary. This position will also serve as a system- wide resource on IRB matters for all interested students, staff, and faculty. The South University IRB HIPAA compliance officer is responsible for providing

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training to all health care providers who transmit health information in electronic transactions, including researchers who provide treatment to research participants.

i. IRB Members 1. Overview of the Committee

The IRB Committee is composed of representatives from various areas of South University. The composition of the IRB meets the requirements of the Department of Health and Human Services and the Food and Drug Administration. A sufficient number of members are selected to assure complete and adequate review of research related matters at South University. The membership will represent varying backgrounds to promote complete review of research at South University. The committee is sufficiently qualified through the maturity, experience, and expertise of their members and diversity of membership to insure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable laws, standards of professional conduct and practice, and community attitudes and are constituted to meet those requirements. According to HHS guidelines, an IRB should contain at least five members of both genders and varied professions who are sensitive to community attitudes, knowledgeable about institutional commitments and regulations, as well as applicable laws and standards of professional conduct and about vulnerable subjects. There should be at least one member with a nonscientific concern, at least one member with a scientific concern, and at least one member who is not otherwise affiliated with the institutions (such as a retired professional from the community or a former research subject). When no member of the South University IRB has expertise in a subject, a consultant may be added to the committee to provide professional opinion. As a group, the IRB committee is responsible for:

i. Ensuring rights, safety, and welfare of human research subjects; ii. Ensuring compliance with all application federal and state laws/regulations;

iii. Conducting ethical review of human subject research activities including initial, continuation, medication, unanticipated problems, and alleged noncompliance;

iv. Applying disciplinary and regulatory knowledge; v. Disclose conflicts of interest;

vi. Complete mandatory education requirements; vii. Maintain confidentiality.

2. IRB Committee Chair Each fiscal year, a new campus or division (i.e., online) IRBL will be selected to serve as Chair of the IRB committee for a period of one year. The chair will serve as the liaison between faculty/students regarding proposal submission and the

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committee to ensure adherence to IRB policies and procedures and will be responsible for organizing and executing all review meetings and proceedings during his/her service time. The chair will also provide assistance to the new chair during the period of transition. The IRB Committee Chair is responsible for:

i. ensuring that the IRB carries out its regulatory responsibility (i.e., that each approved protocol meets all requirements of 45 CFR 46 and any other applicable guidelines);

ii. conducting exempt reviews; iii. Delegating expedited reviews; iv. Maintaining communication with investigators and IRB staff; v. Providing oversight and leadership in review of alleged noncompliance;

vi. Chairing convened committee meetings; vii. Assisting in educating IRB staff and researchers.

3. IRB Liaisons (IRBL) IRB liaisons are IRB committee members and alternates that will serve as a reference on IRB matters (e.g., proposals, submission) for faculty and students on his/her campus (or division) and throughout the South University system as needed. IRBL (IRB Liaisons) will be selected from each academic campus and the online division within the South University system. The identified positions will be filled by an SU Program Director or Chair (on ground) or Director of Training Effectiveness (online division). Each campus and online division will have an individual appointed to the IRB. This role is designed to not only serve as a member of the committee in the role of reviewing proposals, but will also serve as a reference on IRB matters (e.g. proposals, submission) for faculty and students on his/her campus (or division) and throughout the South University system as needed. a. IRBL selection process

In order to be considered as an IRBL, nominations must be provided by self- nomination to the IRB Director. Nominees must then submit the following materials to the IRB Director of Training and Compliance and the IRB HIPAA Compliance Officer for consideration: 1) a one-page statement outlining the reasons why the applicant believes s/he should be selected as an IRBL; 2) a current CV; and 3) a letter of support from a supervisor. Nominees will be selected based on previous experience, research background, and academic field, as every effort will be made to include representatives from all areas of the University on the committee. Notification will be provided to the Campus DOAAO, the selected IRBL, and additional applicants from the campus (and online).

b. IRBL terms of appointment

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Terms will be limited to a period of three years. Initially, the following process will be established in order to achieve an optimal schedule of rotation. The identified structure includes a minimum of:

• Two, three year IRBL positions • Two, two-year IRBL positions • One, one-year IRBL position

This structure allows for rotation and consistency in the work of the group. Once this first rotation is completed, the IRBL positions will all turnover within three years and will still allow for adequate training/ transitioning. Approximately 2 months before an IRBL’s term is up, the IRB Director will solicit interest from the University community and begin accepting/ reviewing applications.

4. IRB Community Representative

Two community representatives will be selected to serve as IRB members for a term of three years with one serving as the identified IRB Community Member and the second as the IRB Alternate Community Member, in the event the IRB Community Member is unable to serve due to schedule or conflict of interest. Eligibility to serve will be defined as: i. Not having a formal affiliation with South University through employment

(e.g., adjunct faculty, consultant). 1. Affiliation is defined as an employee or agent of the organization

registering the IRB (or a member of that person’s immediate family) is considered affiliated. Affiliated members include, but are not limited to, individuals who are: part-time employees; current students; members of any governing panel or board of the institution; paid or unpaid consultants; healthcare providers holding credentials to practice at the institution; and volunteers working at the institution on business unrelated to the IRB. An individual that has no affiliation with the organization registering the IRB, other than as an IRB member, is considered unaffiliated with the entity operating the IRB. Unaffiliated members may include people whose only association with the institution is that of a patient, subject, or former student at that institution. Paying unaffiliated members for their services would not make the member “otherwise affiliated” as stated in the regulations, or cause the member to have a conflicting interest.

ii. Not presently serving on a South University Program Advisory Committee. iii. Having a background in the scientific community from disciplines/industry

including Behavioral Sciences (e.g., Psychology, Psychiatry, Social Work), Health Professions (Physicians, Nursing, Pharmacy, Physical Therapy, Medical Assisting), Business, and Engineering.

5. Nonscientist

Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research

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activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews. A community representative may also serve the role of nonscientist.

6. Alternate Members The HHS regulations at 45 CFR part 46 do not address the designation of alternate IRB members. However, for many years, the OHRP has permitted organizations submitting IRB registrations to OHRP to identify alternate members for primary members. When reviewing rosters that include alternate members OHRP assumes that, in general, with respect to the capacity in which the primary IRB member was intended to serve, each alternate IRB member has experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate would replace. The minutes of an IRB meeting should document the attendance of all primary and alternate IRB members who attended any part of the IRB meeting. If both a primary IRB member and his or her alternate(s) attend the same IRB meeting, OHRP assumes that the primary member is acting as the official voting member of the IRB for review of research protocols, unless the minutes clearly indicate otherwise. A designated alternate IRB member for a primary IRB member may substitute for the primary IRB member for an entire meeting or at any time during a meeting. Substitution during a meeting commonly occurs when the primary member is (a) absent from the room for part of the meeting, or (b) recused from review of certain research protocols because the primary IRB member has a conflicting interest with respect to a specific research protocol. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member. OHRP recommends that the reason for the substitution of the alternate IRB member also should be documented in the minutes. South University’s IRB committee structure includes an IRBL on each campus; therefore, any of the IRBLs could be called into a committee meeting to serve as an alternate.

iii. Orientation of IRB staff and members New IRB members and IRB staff are required to attend an orientation session and complete training either through CITI or the NIH.

3. IRB Committee Meetings i. Frequency

Full board meetings will occur monthly via teleconferencing. A reduced IRB committee will meet biweekly for expedited reviews.

ii. Committee Review Composition Research proposals will be identified according to one of the following categories: 1) Exempt, 2) Expedited Review, and 3) Full Board Review. Although formal approval of research proposals will occur according the process as listed below, the IRB Director of

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Training and Compliance along with the IRB HIPAA Compliance Officer will also serve in an ex-officio capacity on all research proposals. 1. Exempt Review

Research proposals in this category require a quorum of one member of the IRB identified as the IRB Chair (or designee).

2. Expedited Review Research proposals in this category require a quorum of three IRB committee members. The composition of the review team for this category must include the IRB Chair and at least one university IRBL.

3. Full Board Review Research proposals in this category require a quorum of four IRB committee members. The composition of the review team for this category must include the IRB Chair and at least two university IRBLs.

iii. Quorum In accordance with HHS regulations at 45 CFR 46.108(b), initial and continuing reviews of research must be conducted by the IRB at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concern is nonscientific (i.e., a quorum), except where expedited review is appropriate under HSS regulations at 45 CFR 46.110. Approval of research is by a majority vote of this quorum. Should the quorum fail during a meeting (e.g., loss of majority through recusal of members with conflicting interests or early departures, or absence of a nonscientific member), the IRB may not take further actions or votes unless the quorum can be restored.

4. Storage and Transmission of IRB Documents The IRB shall maintain records documenting their activities. These will include a listing of members of the IRB, minutes of all meetings (including attendance, agenda, discussions, actions taken, and votes), copies of applications and research proposals, copies of approved documents for informed consent, progress reports from investigators, adverse action reports, records of continuing research review, copies of correspondence between the IRB and investigators, and any other documents relevant to the process of the IRB. These documents shall be maintained for a period of at least three years after the completion of reviewed research. Electronic documents may be destroyed and all paper documents may be shredded after this three year period. Given the identified structure in which IRB committee members are located throughout the South University system (on ground campuses and online), ImageNow and/ or email will serve as the platform for review of all proposals irrespective of review status. All research proposals submitted will be permanently archived. Note: Given the established electronic security standards for South University, the community IRBL will conduct his/her review via email. Comments from the community IRBL will be uploaded into the ImageNow system by the IRB Director of Training and Compliance.

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5. Institutional Review Board Authority

i. Decision- Making Decisions are made by a majority vote of the IRB membership. No other entity in the university can make decisions concerning scientific review.

ii. Authority The IRB has the authority to: a. approve, require modifications to secure an approval, or disapprove research

activities overseen and conducted at South University and involving human subjects, based on its consideration of the risks and potential benefits of the research and whether the rights and welfare of the subjects are adequately protected;

b. require reports for protocol continuing approval; c. continuously monitor the conduct of studies; d. suspend or terminate a study not being conducted in accordance with the

IRB’s requirements or that has been associated with unexpected serious harm to subjects;

e. place restrictions on a study; f. observe, or have a third party observe, the consent process; g. observe, or have a third party observe, the conduct of the research.

iii. Conflict of Interest

The IRB is charged with protecting research subjects from risks in experimental studies. Principles codified in the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, and existing federal regulations are employed to provide a framework for ethical considerations and assessment of risk and benefit in individual studies. The decisions made by the IRB are guided by these principles, but the IRB can only be successful if members are free of conflicts of interest.

6. Research Review Materials

i. Initial Review Materials for New Submissions HHS regulations at 45 CFR 46.111 set forth the criteria that must be satisfied in order for the IRB to approve research. These criteria include, among other things, determinations by the IRB regarding risks, potential benefits, informed consent, and safeguards for human subjects. In conducting the initial review of proposed research, IRBs must obtain information in sufficient detail to make the determinations required under HHS regulations at 45 CFR 46.111. Materials should include (forms can be found on the Inside South IRB Webpage or via the IRB Director):

• the completed research application with protocol, • a proposed informed consent document, • any relevant grant application(s), • confidentiality agreements from all research personnel,

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• any recruitment materials, including advertisements intended to be seen or heard by potential subjects.

Furthermore, for HHS-supported multicenter clinical trials, the IRB should receive and review a copy of the HHS-approved sample informed consent document(s) and the complete HHS-approved protocol, if they exist. Unless a primary reviewer system is used, all members should receive a copy of the complete documentation. These materials should be received by members sufficiently in advance of the meeting date to allow review of this material. The IRB Director of Training and Compliance will review submitted materials to ensure that all materials are obtained before IRB meetings. If these materials have not been provided by the researcher(s) before 24 hours before a scheduled meeting, the proposal will not be reviewed until the following schedule meeting. All other IRB members should at least receive and review a protocol summary (of sufficient detail to make the determinations required under HHS regulations at 45 CFR 46.111), the proposed informed consent document, and any recruitment materials, including advertisements intended to be seen or heard by potential subjects. In addition, the complete documentation should be available to all members for review.

ii. Continuing Review Materials Investigators are responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out continuing review prior to the expiration date of the current IRB approval. In particular, investigators are responsible for submitting sufficient materials and information for the IRB to meet its regulatory obligations, and should follow the institutional policies and procedures for continuing IRB review of research that are required by 45 CFR 46.103.

iii. Guidance Relevant to IRB Records and Documentation

1. IRB Protocol Records IRB protocol records must include all the information stipulated by HHS regulations at 45 CFR 46.115(a) which state that an institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: i. Copies of all research proposals reviewed, scientific evaluations, if any, that

accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.

ii. Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.

iii. Records of continuing review activities. iv. Copies of all correspondence between the IRB and the investigators.

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v. A list of IRB members in the same detail as described in 45 CFR 46.103(b)(3).

vi. Written procedures for the IRB in the same detail as described in 45 CFR 46.103(b)(4) and 45 CFR 46.103(b)(5).

vii. Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).

2. Minutes of IRB Meetings The minutes of IRB meetings must include all the information stipulated by HHS regulations at 45 CFR 46.115(a)(2). The minutes of IRB meetings should document, among other things: i. Separate deliberations, actions, and votes for each protocol undergoing

initial or continuing review by the convened IRB. ii. The vote on all IRB actions including the number of members voting for,

against, and abstaining; the basis for requiring changes in or disapproving the research; and a summary of the discussion of controverted issues and their resolution. OHRP recommends that the recusal of IRB members because of a conflicting interest also be documented when recording votes on IRB actions. In order to document the continued existence of a quorum, the following examples demonstrate one acceptable format for documenting in the minutes the votes on actions taken by the IRB on research projects undergoing initial or continuing review: Total = 15; Vote: For-14, Opposed-0, Abstained-1. Total = 14 (1 member recused and did not vote); Vote: For-12, Opposed-2, Abstained-0.

iv. Documentation of Findings

HHS regulations at 45 CFR 46.116(d) require that the IRB make and document four findings when approving a consent procedure which does not include, or which alters, some or all of the required elements of informed consent or when waiving the requirement to obtain informed consent. OHRP recommends that when approving such a waiver for research reviewed by the convened IRB, these findings be documented in the minutes of the IRB meeting, including protocol- specific information justifying each IRB finding. Similarly, where HHS regulations require specific findings on the part of the IRB, such as: (a) approving a procedure which waives the requirement for obtaining a signed consent form [see 45 CFR 46.117(c)]; (b) approving research involving pregnant women, human fetuses, or neonates (see 45 CFR 46.204-207); 8 (c) approving research involving prisoners (see 45 CFR 46.305-306); or (d) approving research involving children (see 45 CFR 46.404-407), the IRB should document such findings. OHRP recommends that for research approved by the convened IRB, all required findings be fully documented in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding.

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For research reviewed under an expedited review procedure, these findings should be documented by the IRB Chairperson or other designated reviewer elsewhere in the IRB record.

v. Retention of IRB Records HHS regulations at 45 CFR 46.115(b) require that IRB records be retained for at least three years, and records relating to research that is conducted be retained for at least three years after completion of the research. All records must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner. All IRB Records will be stored by the IRB Director as well as within the WebNow system for a minimum of three years. The following records must be kept by the IRB for a minimum of three years according to HHS guidelines:

1. IRB registration records; 2. Reliance agreements with other institutions; 3. IRB rosters/member curriculum vitas; 4. Meeting minutes (including date/time/location, members present/absent,

actions taken, voting, and quorum); 5. Protocol files (including proposals, applications, correspondence with

principal investigators, approvals, consent documents, subject complaints, etc.)

G. IRB Review Process

1. Principal Investigator Responsibilities The principal investigator must request IRB approval for any research project involving human participants regardless of sample size. The principal investigator is responsible for designing and implementing his/her research in such a way as to minimize the risk of potential harm to participants and to have a plan in place to ameliorate any adverse consequences that participants may experience. The principal investigator will not collect any data until an approval by the IRB of their project is received. The principal investigator will ensure that procedures for the protection of human subjects are followed as described in their approved application and required by policy and federal law.

i. Education requirements In order to ensure an adequate understanding of the research process, the principal investigator must hold at least a master’s degree. In the case where the principal investigator does not meet this educational requirement, then s/he must have a co-investigator that meets this requirement. For students who are conducting research as part of their program requirements, this co-investigator will be the faculty member charged with overseeing their project.

ii. Training requirements The principal investigator (and all other signatories on the application [faculty sponsor, co-investigators, and students research assistants, etc]) must complete CITI/ NIH and HIPAA (when necessary) training and submit copies of

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certification of these trainings with their IRB application. The principal investigator is also responsible for ensuring that any other researchers working on the research project have completed CITI/NIH and HIPAA training and that certification of their training is on file with the IRB. CITI/NIH and HIPAA training certification is valid for a period of three years and must be renewed prior to expiration while research is continuing or if significant policy changes occur. See section D above regarding details about training.

iii. Responsibilities when leaving the university When principal investigators leaves the institution, it is the investigators’ responsibility to contact the IRB to discuss their institutional status in regards to ongoing research activities and to close or appropriately transfer protocols before their departure. If this is not accomplished prior to leaving the institution, all protocols may be administratively closed by the IRB.

iv. Documentation

Principal investigators will be responsible for submitting all required documents prior to review. Detailed information on the required documents can be found on the InsideSouth IRB Webpage or via the IRB Director. The required documentation includes:

1. The completed application 2. The entire research proposal 3. Instrumentation (e.g., surveys, participant recruitment information) 4. Informed consent and assent forms 5. Cover letter to participants 6. External letters of approval from partnering institutions (e.g., IRBs) 7. Additional materials (as required)

In addition to the responsibilities outlined above, the principal investigator is also responsible for:

1. Ethically conducting research with each human subject; 2. Designing and implementing ethical research without sound study

designs according to The Belmont Report; 3. Involving research personnel qualified by training and experience for

their research responsibilities; 4. Obtaining IRB approval prior to initiating human research activity; 5. Complying with federal and state regulations, institutional and IRB

requirements, and requirements of HIPAA; 6. Implementing research as approved and in compliance with all IRB

decisions, conditions, and requirements; 7. Maintaining appropriate project and personnel oversight and

appropriately delegating research responsibilities; 8. Conducting recruitments of subjects fairly and equitably while assessing

risks/benefits to research subjects; 9. Obtaining and documenting informed consent/assent/authorization when

applicable;

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10. Providing a mechanism for receiving and responding to subjects’ complaints or requires for information;

11. Monitoring data integrity as well as the rights, safety, and welfare of human subjects;

12. Submitting progress reports; 13. Reporting unanticipated problems/adverse events; 14. Obtaining prior approval for modifications, exceptions, or deviation to

research protocols, including promotional materials; 15. Maintaining written documentation of activities for three years after

completion of a research project.

2. Changes to Protocol 1. The IRB must be informed of any changes which might influence the

completion of an approved research study. A Notification Form (NF) must be submitted to the IRB when there is a change to the original proposal which can influence the collection of data and treatment of subjects. The NF must be submitted to the IRB prior to implementation of the changes. Events that require IRB notification and approval include (yet are not limited to):

• An unexpected interruption of the research study process • Research protocol changes/adjustments (e.g., methodology,

recruitment, etc.) • Instrumentation changes/adjustments (e.g., existing or new) • A change in the demographics of research participants recruited • Inclusion of additional research participants

Events impacting the research study which do not require approval, yet do require notification include (yet are not limited to):

• An unexpected interruption of the research study process • The departure of an investigator • The addition of an investigator • The departure of a research assistant • The addition of a research assistant

Submission of an NF does not automatically constitute approval or review by the board. In the event full board review is required, the investigator(s) will be notified. Approval must be granted on all NFs prior to the implementation of any adjustments/changes to the research study.

2. If an investigator is unsure of whether or not an NF is required, please contact the IRB office.

3. Amendment approvals do not change the approval period of the protocol. Therefore, the expiration date will remain the same as was determined for the protocol at the time of initial or continuing review

3. Continuing Review of Active Protocols All active research must be reviewed for compliance by the IRB at least annually. The IRB may request more frequent continuation reviews of research on an individual application basis based on the risk to participants.

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i. Continuance Request Approximately one to two months prior to the end of the approval period, the principal investigator will be contacted by the IRB Director of Training and Compliance indicating the expiration date of the approval period. In the event additional time is needed beyond the approval, a Continuance Request (CR) form, which can be found on the Inside South IRB Webpage or via the IRB Director, must be submitted by the principal investigator prior to expiration of the current approval period in order to request approval for additional time. The principal investigator should include a copy of current informed consent documents and instruments being used along with the Continuation Request form. Research requiring IRB approval may not continue after the expiration of the most recent approval period. The extension requested can be for a maximum of one year from the current date of expiration of the approval.

4. Completion of Study

Approximately one to two months prior to the end of the approval period, the principal investigators will be contacted by the IRB Director of Training and Compliance reminding the investigators of the expiration date of the approval period. Upon completion of the study, the principal investigators are responsible for submitting a Research Study Final Report (RSFR) to the IRB signifying the completion of the study. The RSFR form may be obtained from the Inside South Webpage and or via the IRB Director. Completion of this form signifies that the study has been completed and no further action will be taken on the approved protocol. Once submitted, no additional subjects can be recruited into the study.

5. Adverse Events/Unanticipated Problems When a subject who is participating in a research study experiences an unanticipated problem involving risks to themselves or others which may or may not be an adverse event, the principal investigator is required to report the incident to the (IRB). The form to be used for reporting internal and external unanticipated problems is the Adverse Event and Unanticipated Problem Report Form.

i. Definitions An adverse event is any untoward or unfavorable occurrence. An unanticipated problem involving risks to the subject or others is defined as an incident, experience or outcome that is unanticipated and indicates that subjects or others are at increased risk of harm. For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events. In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm has occurred.

ii. Reportable Problems and Events

Prompt reporting of any unanticipated problem or events to the IRB is expected. Examples of such events include:

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a. Any event (including on-site and off-site adverse event reports, injuries, breaches of confidentiality, or other problems) that occurs at any time during or after the research study, which in the opinion of the principal investigator involved harm to one or more subjects or others, or places one or more subjects or others at increased risk of harm

b. An event that is unexpected (an event is “unexpected” when it is not described with specificity in the protocol and informed consent document or, if described with specificity, it occurs beyond the expected frequency and/or severity identified);

c. An event which is related to the research procedure (an event is “related to the research procedure” if, in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures).

d. Information that indicates a change to the risk-benefit ratio of the research. For example: an interim analysis indicates that subjects have a lower rate of response to treatment than initially expected;

e. Changes to the protocol made without prior IRB review to eliminate an apparent immediate hazard to a research subject.

f. Incarceration of a subject. g. An event that requires prompt reporting to the sponsor. h. A sponsor-imposed suspension of a protocol due to possible increased risk. i. A complaint from a subject when the complaint indicates unexpected risks

or the complaint cannot be resolved by the research team. j. Protocol violations (a term often used by NIH or commercial sponsors

meaning an accidental or unintentional change to the IRB approved protocol) that place one or more subjects at increased risk or have the potential to occur again.

iii. Reporting Requirements Prompt reporting of unanticipated problems/events should occur as soon as possible after the principal investigator learns of the event. All unanticipated problems/events must be reported within 10 days of the investigator (s) becoming aware of the unanticipated problem/event. If the research project is being supported with funds from outside the institution, the investigator is also responsible for notifying the sponsor of the unanticipated problem/event.

iv. IRB Review of Adverse Events/Unanticipated Problems The IRB will review the unanticipated problem/event report(s) and determine whether the report represents an unanticipated problem/event involving risks to subjects or others based on whether the problem is unanticipated and indicates that subjects or others are at increased risk. If not, or if the problem is determined by the reviewer to involve minimal risk to subjects or others, no further action is taken under this policy. If it does represent an unanticipated problem/event involving more than minimal risks to subjects or others, the IRB will implement a corrective action. These actions include, but are not limited to:

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a. changes to the protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects may need to be made a permanent part of the protocol

b. modification of inclusion/exclusion criteria to mitigate the newly identified risks

c. implementation of additional procedures for monitoring subjects, the consent process and/or the research

d. suspension of enrollment of new subjects e. suspension of research procedures on currently-enrolled subjects f. modification of the protocol g. modification of the continuing review schedule h. modification of informed consent documents to include a description of

newly recognized risks or any other information that should be disclosed during the consent process

i. notification of current subjects when such information may relate to subjects’ willingness to continue

j. provision of additional information about newly recognized risks to previously enrolled subjects

k. termination of the protocol with consideration for treatment of currently enrolled subjects

l. reporting the adverse problem to HHS/FDA if necessary

v. Notification of Investigator(s) After review by the IRB, the investigator will be notified by letter regarding the necessary recourse or solution. If the problem/event does not meet the criteria of unanticipated and indicates that subjects or others are at increased risk, the letter will acknowledge the report. If the problem/event meets the criteria of being unanticipated and indicates that subjects or others are at increased risk, the letter will inform the investigator that the IRB determined the problem/event to be an unanticipated problem involving risks to subjects or others, that the problem/event will be reported to the appropriate agency and provide a list of required actions and/or changes to the protocol or consent form.

6. Appeals of IRB Decision The IRB will deny any research applications for which it is not demonstrated that benefits outweigh any foreseeable risk of harm to participants and/or for which adequate protections for participants are not in place. A principal investigator may appeal the IRB decision within 90 days of receipt of the decision by submitting a written request for appeal to the IRB Chairperson. The written request should include documentation of why they believe the denial was in error. The Chairperson will review the request and notify the principal investigator if any additional documentation is needed and schedule the appeal for review at the next scheduled meeting of the full IRB. The Chairperson may invite the principal investigator to be present at the next full IRB meeting to answer any questions. The decision of the full IRB at the appeal is final. However, the principal investigator may submit a new application if substantial modifications have been

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made to the original submitted protocol. It is at the discretion of the Chairperson to determine if the modifications are substantial.

H. Informed Consent and Assent All research requires informed consent. Voluntary participation and informed consent is at the very core of the need for IRB oversight. How that consent is achieved varies based on the research design and the level of review. Informed consent is a process, not just a form. Information must be presented to enable people to voluntarily decide whether or not to participate as research subjects. It ensures respect for people by providing the opportunity for thoughtful consent to ensure that participation is voluntary. The procedures used to obtain informed consent should be designed to educate the subject population in terms that they can understand to ensure that research participants understand the consent they have provided. As a result, the IRB will seek to ensure that the following general requirements of informed consent are satisfied in all studies: a. Informed consent must be prospectively obtained from the participants or their legally

authorized representatives; b. Information must be conveyed in understandable language, which may necessitate

that the form be translated (and reverse translated as a check for accuracy); c. Subjects must be given sufficient opportunity to consider whether they want to

participate; d. Consent must be given without coercion or undue influence; and e. Subjects must not be made to give up legal rights or be given the impression that they

are being asked to do so. Subjects must have sufficient information to make an informed decision to participate in the research study. If subjects cannot give informed consent, it must be obtained from their legal representatives. When subjects are minors (under eighteen) or when they are mentally incapacitated, legal representatives are required to provide consent (and assent must be obtained from the research subject when possible). Consent and assent requests should be either clearly written and/or orally conveyed in a manner understandable to subjects, using language that is non-technical. Scientific, technical, or medical terms should be plainly defined. Sample consent forms can be found on the Inside South page.

1. Requirements for Informed Consent Federal regulations require that consent forms include specific information, including: a. A statement that the study involves research, an explanation of the purposes of

the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

b. A description of any reasonably foreseeable risks or discomforts to the subject;

c. A description of any benefits to the subject or to others which may reasonably be expected from the research;

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d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

e. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

f. For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

g. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

h. A statement that participation is voluntary, refusal to participate will involve no penalty or decrease in benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Where appropriate, regulations further provide that the following additional information be provided: a. A statement that the particular treatment or procedure may involve risks to the

subject (or to an embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

b. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

c. Any additional costs to the subject that may result from participation in the research;

d. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

e. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

2. Assent

Minor children (under age 18) should be given an explanation - at a level appropriate to the child's age, maturity, experience, and condition - of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. Children should be asked if they wish to participate in the research or not. Mere failure to object on the part of the child should not, in the absence of affirmative agreement, be construed as assent. In cases where verbal assent is necessary, this active agreement should be documented by having a witness sign the assent form. When proposing research with minors, the proposal should indicate:

• how assent will be obtained (what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present),

• how assent will be documented. The child may either sign a very brief assent form or verbally indicate a willingness to participate.

3. Circumstances in Which a Written Consent Form May Not Be Required

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i. Internet research Some research requires the use of mailed or emailed questionnaires. In such cases, a mailed or emailed response will itself be regarded as evidence of informed consent, provided that the questionnaire clearly explains the purpose and nature of the research.

ii. Waiving one or more requirements of informed consent

Based on CFR 46.116, the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and documents that: a. The research or demonstration project is to be conducted by or subject to

the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: public benefit or service programs; 1. Procedures for obtaining benefits or services under those programs; 2. Possible changes in or alternatives to those programs or procedures; 3. or possible changes in methods or levels of payment for benefits or

services under those programs; and 4. The research could not practicably be carried out without the waiver or

alteration, as in prospective emergency research conducted under 21 CFR 50.24, when time may not permit informed consent.

b. The research involves no more than minimal risk to the subjects; c. The waiver or alteration will not adversely affect the rights and welfare of

the subjects; d. The research could not practicably be carried out without the waiver or

alteration; and e. Whenever appropriate, the subjects will be provided with additional

pertinent information after participation. f. The research is not FDA regulated.

It is the IRB’s discretion whether a waiver of one or more requirements of consent may be allowed. If consent documentation is waived, the principal investigator will be notified in writing and the reason for allowing the waiver will be expressly stated.

4. Documentation of Consent

All consent documents must be submitted for IRB review and must be approved before use. Based on OHRP’s recommendation, South University requires that all approved consent documents be stamped with approval and expiration dates and stipulates that copies of these dated documents must be used in obtaining consent. This procedure helps ensure that only the current, IRB-approved informed consent documents are presented to subjects and serves as a reminder to the investigators of the need for continuing review.

I. Participants 1. Risks

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The IRB identifies and analyzes potential sources of risk and measures to minimize risk, including physical, psychological, social, legal, or economic risks. The IRB will evaluate the principle investigator’s submission to determine the following: • Risks to participants are minimized by using procedures that are consistent with

sound research design and that do not unnecessarily expose participants to risk. • Risks to participants are minimized, when appropriate, by using procedures

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

• Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that may be expected to result from the research.

• The IRB should consider risks and benefits that may result directly from the research.

• The IRB also considers a wide range of benefits, including therapeutic, educational, informational, or broad empowerment benefits using the appropriate review guide checklists applicable to the type of research (DHHS, FDA, VA). Benefits may accrue to the participants or their community.

i. Types of Risk to Research Subjects The risks to which research subjects may be exposed have been classified as physical, psychological, social, and economic. 1. Physical Harm

Medical research often involves exposure to minor pain, discomfort, or injury from invasive medical procedures, or harm from possible side effects of drugs. All of these should be considered "risks" for purposes of IRB review. Some of the adverse effects that result from medical procedures or drugs can be permanent, but most are transient. Procedures commonly used in medical research usually result in no more than minor discomfort (e.g., temporary dizziness, the pain associated with venipuncture). Some medical research is designed only to measure more carefully the effects of therapeutic or diagnostic procedures applied in the course of caring for an illness. Such research may not entail any significant risks beyond those presented by medically indicated interventions. On the other hand, research designed to evaluate new drugs or procedures may present more than minimal risk, and, on occasion, can cause serious or disabling injuries.

2. Psychological Harm Participation in research may result in undesired changes in thought processes and emotion (e.g., episodes of depression, confusion, or hallucination resulting from drugs, feelings of stress, guilt, and loss of self-esteem). These changes may be transitory, recurrent, or permanent.

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Most psychological risks are minimal or transitory, but some research has the potential for causing serious psychological harm. Stress and feelings of guilt or embarrassment may arise simply from thinking or talking about one's own behavior or attitudes on sensitive topics such as drug use, sexual preferences, selfishness, and violence. These feelings may be aroused when the subject is being interviewed or filling out a questionnaire. Stress may also be induced when the researchers manipulate the subjects' environment - as when "emergencies" or fake "assaults" are staged to observe how passersby respond. More frequently, however, is the possibility of psychological harm when behavioral research involves an element of deception.

ii. Ways to Minimize Risk Principal investigators should:

• Provide complete information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, including the results of previous animal and human studies.

• Ensure that the projected sample size is sufficient to yield useful results. • Incorporate adequate safeguards into the research design such as an

appropriate data safety monitoring plan, the presence of trained personnel who can respond to emergencies, and procedures to protect the confidentiality of the data (e.g., encryption, codes, and passwords).

2. Benefits Study participants may (but not necessarily) be compensated monetarily or provided other incentives or inducements as symbolic recognition for their enrollment and/or continuing contributions to research. When given, such compensation, incentives or other inducements must be limited in extent and manner so they are not perceived to be coercive or providing undue influence or duress; and they should be provided without regard to a subject’s economic status. Incentives, compensation and/or other inducements to subjects should reflect the risk, discomfort or inconvenience associated with study participation; and they should not be so large as to result in any one group of individuals (such as the economically disadvantaged) bearing an unduly large share of the risks and burdens of research participation. Incentives, compensation or inducements must not be such that a subject’s participation in research is other than voluntary. IRB study approval requires that the promise or expectation of a reward for study participation should not influence a subject’s willingness to participate in the research. Nor should rewards influence a subject’s decision-making process such that the subject acts without due consideration of the risks of participation.

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In IRB deliberations, incentives/compensation or other inducements must not be considered a “benefit” off-setting (in whole or part) “risk” to subjects. Rather, the IRB must be assured that these are not influencing subjects to participate in research that they would not otherwise choose to participate in.

3. Risk/Benefit Assessment

Risks to subjects who participate in research should be justified by the anticipated benefits to the subject or society. This requirement is found in all codes of research ethics, and is a central requirement in the Federal regulations (45 CFR 46.111 and 21 CFR 56.111). Two of the required criteria for granting IRB approval of the research are: a. Risks to subjects are minimized by using procedures which are consistent with

sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

b. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB Committee will consider only those risks and benefits that may result from the research, as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research.

The IRB is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies inviting any person to undertake the risks. The IRB cannot approve research in which the risks are judged unreasonable in relation to the anticipated benefits. The IRB must: a. Identify the risks associated with the research, as distinguished from the risks

of therapies the subjects would receive even if not participating in research; b. Determine that the risks will be minimized to the extent possible; c. Identify the probable benefits to be derived from the research; d. Determine that the risks are reasonable in relation to be benefits to subjects, if

any, and the importance of the knowledge to be gained; and e. Assure that potential subjects will be provided with an accurate and fair

description (during consent) of the risks or discomforts and the anticipated benefits.

The benefits of a study do not alter the risk classification. The risk/benefit assessment only refers to the acceptability of the risk, not the level of the risk. A study deemed greater than minimal risk cannot be classified as minimal risk because the potential benefits are great, but it could be approved for this reason. Whereas, the same greater than minimal risk study may not be approvable if the benefits are lacking. An IRB reviewer should disapprove research in which the risks are judged to be unreasonable in relation to the anticipated benefits.

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4. Selection of Subjects IRBs are required to make a specific determination that the selection of subjects is equitable. As a matter of social justice, there should be an order of preference in the selection of classes of subjects: adults before children, competent individuals before incompetent individuals, and noninstitutionalized persons before institutionalized persons. In addition, those who are already burdened (e.g., by disabilities or institutionalization) should not be asked to accept the burdens of research unless other appropriate subjects cannot be found (i.e., if the research concerns their particular disability or circumstance). IRBs should consider the extent to which a proposed subject population is already burdened by poverty, illness, poor education, or chronic disabilities in deciding whether they are a suitable subject population.

5. Vulnerable populations i. Residents of any facility

Prisoners and patients in mental institutions are confined under the strict control of people whom they must please and to whom they must appear cooperative and rational if they are to earn their release. These potential subjects may believe, probably as a result of their dependent situation, which agreeing to participate in research will be viewed positively by their wardens, psychiatrists, or social workers. They are also readily available in large numbers, and, therefore, have historically been involved as subjects of drug research that is totally unrelated to the basis of their confinement. Mental patients and prisoners have accepted the risks of research in disproportionate numbers, while the benefits of the research in which they participated went to all segments of the population. Investigators are required to justify any proposed involvement of hospital patients, other institutionalized persons, disproportionate numbers of racial or ethnic minorities, or persons at the lower end of the socioeconomic scale. 1. Prisoners

In addition to the requirements of subparts A and C of 45 CFR 46, additional requirements pertain to research involving prisoners. In summary, the major additional considerations are: the exemptions that generally apply to certain types of research involving human subjects do not apply to research involving prisoners (45 CFR 46.101, footnote 1); in order to approve research involving prisoners, the IRB must find that the proposed research falls into one of the permissible categories of research; the institution must certify to OHRP that an IRB has reviewed the proposal and made seven required findings, and receive OHRP authorization prior to initiating any research involving prisoners (45 CFR 46.305c); the IRB must include a prisoner or prisoner representative (or approval from their system IRB) (45 CFR 46.304b) and meet a membership requirement concerning the number of IRB members not associated with a prison involved in the research(45 CFR 46.304a); and

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waiver of informed consent in emergency research is not applicable to research involving prisoners (61 FR 51531).

ii. Women and minorities

The research should include minorities and women in study populations so that the research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. If a proposed project includes a study population in which women and minorities are not appropriately represented, the investigator must provide a clear compelling rationale for their exclusion or inadequate representation.” 1. Pregnant women

Pregnant women may be involved in several categories of research. The primary objectives are assessing: (1) whether the research is directed toward the mother's health or toward the fetus; and (2) the risks to the woman and to the fetus or infant. Subsequent actions depend on those assessments. For research activities directed toward pregnant women as subjects, the federal regulations provide that no pregnant woman may be involved as a subject unless either: (1) the purpose of the activity is to meet the health needs of the mother, and the fetus will be placed at risk only to the minimum extent necessary to meet such needs; or (2) the risk to the fetus is minimal [45 CFR 46.207].

iii. Children and minors

The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. Title 45 CFR Part 46, Subpart D provides for "Additional Protections for Children Involved as Subjects of Research." Research that is contrary to the rights and welfare of child-subjects is prohibited. IRBs reviewing research involving children as subjects must consider the benefits, risks, and discomforts inherent in the proposed research and assess their justification in light of the expected benefits to the child-subject or to society as a whole. In all cases, the IRB must determine that adequate provisions have been made for soliciting the assent of children and the permission of their parents or guardians [45 CFR 46.408]. 1. Consent procedures

When children or minors are involved in research, the regulations require the assent of the child or minor and the permission of the parent(s), in place of the consent of the subjects.

iv. Wards of the state

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The special protections for children set forth in Subpart D include additional limitations on some research involving children who are wards of the state or any other agency, institution, or entity. Where the research involves greater than minimal risk to the subjects with no prospect of direct benefit to individual subjects (45 CFR 46.406), or requires Health and Human Services (HHS) Secretarial approval (45 CFR 46.407), the research must either be related to their status as wards, or else be conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards [45 CFR 46.409]. The IRB must require, for each child who is a ward, appointment of an advocate in addition to any other individual acting on behalf of the child as a guardian or in loco parentis.

v. Mentally and emotionally disabled

Persons who are institutionalized, particularly if disabled, should not be chosen for studies that bear no relation to their situation, just because it would be convenient for the researcher. An institutional setting can be advantageous to the conduct of research - the population is easily accessible, close supervision to prevent extraneous influences is possible, and medical monitoring and emergency services are available. Some not uncommon characteristics of the institutional setting, however, create circumstances that may compromise the voluntary nature of participation in research. For example, institutionalized individuals may have become emotionally dependent on their caretakers and may acquiesce too readily to requests for their "cooperation." Persons who are totally dependent on an institution may be vulnerable to perceived or actual pressures to conform to institutional wishes for fear of being denied services or privileges. If medical care, staff attention, or living conditions are inadequate, an invitation to move into a special unit or research ward may be appealing. Finally, with little or no opportunity to make decisions regarding their daily living, the ability of institutionalized subjects to make choices may be further diminished. Subjects should be recruited from among noninstitutionalized populations whenever possible.

vi. Subordinates and colleagues of the researcher

Researchers who include colleagues or subordinates as research subjects must be able to provide a rationale other than convenience for selecting them and must show that the recruitment method does not lead colleagues to think they will be compromised by not participating. The compromised circumstances and fear of retribution, even subtle cues of compromise, can place colleagues or subordinates in a position of involuntary participation in a research project. Whenever possible, researchers should avoid using their subordinates and colleagues if another population of subjects is equally suited to the research question. In the event that the IRB approves research with subordinates or colleagues of the researcher, it is unacceptable to use the faculty or staff directory (i.e., emails to all faculty or staff) to recruit subjects. The principle investigator

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should instead discuss with the IRB and their college dean the best method for subject recruitment.

vii. Students of the researcher Researchers who include students as research subjects must be able to provide a rationale other than convenience for selecting them and must show that the recruitment method does not lead students to think they will be compromised by not participating. The compromised circumstances and fear of retribution, even subtle cues of compromise, can place students in a position of involuntary participation in a research project. Whenever possible, researchers should avoid using their own students if another population of subjects is equally suited to the research question (e.g., another class section not taught by the researcher, recruitment by another instructor, or blinded/coded data collected by an associate) so that subjects are not identified to the instructor.

viii. Individuals who are not fluent in English All translations of documents must be certified by a qualified translator who is acceptable to the IRB (an “Acceptable Translator”). The IRB will use its discretion in determining whether the credentials of the translator are acceptable, based on the nature and level of risk involved in the research study. For each translation described in items 1 and 2 below, the IRB must receive a letter or other written documentation certifying that the translation is consistent in content, style, and level of readability with the IRB-approved document and, for non-commercial translators, an explanation of the translator’s qualifications. The letter or other documentation should reference the IRB approval and expiration dates of the study, as well as a document identifier (i.e., consent form number, document title) that is unique to each IRB-approved item that is being translated. Acceptable translators include the following, although all may not be appropriate for all types of research:

• A commercial entity that provides translations as a service to the public. • An individual who is bilingual and fluent in both English and the language

of the Non-English Speaking Subject, for minimal risk studies.

For research that is greater than minimal risk, the translated document must be back-translated into English by another individual who is also bilingual and fluent in both languages; for Spanish translations, item 5 below may be utilized in lieu of the back translation. If the research is a minor increment over minimal risk, the IRB may waive the requirement of the back translation into English.

ix. Individuals who are in crisis

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A humanitarian crisis does not allow for the suspension of the ethical foundations governing human subject’s research. A disaster such as an earthquake has the potential to leave overwhelming numbers of people homeless and financially devastated—the very definition of a vulnerable group. Federal regulations outline more—not fewer—research protections for such vulnerable populations (45 CFR sec 46. 2009 ed.). The vulnerable status of the proposed subjects makes IRB review even more critical.

x. Economically disadvantaged individuals Economically disadvantaged individuals may be particularly vulnerable to the risks of research. They may be easily persuaded to participate in research if the economic compensation is so great that it would result in the subject ignoring or disregarding the research risks because of the income generated by the study. In such cases investigators should be careful to set economic compensation at a meaningful level that compensates the subject for her/his time, but it not so great that it becomes coercive. It is also important in such cases that the risks to the subjects be made clear to the subjects.

xi. Elderly subjects Elderly subjects are persons over the age of 65. Advancing age may place them at increased physical, cognitive, or financial risks. However, there is no specific age at which persons become high risk subjects and thereby ineligible for research. Researchers have the responsibility to determine the level of risk that research poses on an individual basis and to minimize risks accordingly. The use of age per se to define the ability to consent and therefore to participate in research is not valid, and the inclusion of older persons in the research enterprise is important. When older persons are cognitively impaired or institutionalized, the same protections apply to them that apply to persons with cognitive or emotional impairments and to children. They should not be used as subjects merely because they provide a convenient sample, but research involving elderly institutionalized persons should bear some direct relationship to their condition or circumstances. Furthermore, they should be informed and given the opportunity to assent to research, to the extent they are able, even if a guardian must provide informed consent for them to be subjects. Researchers should be aware that merely because an elderly individual agrees to participate in research, that this does not necessarily guarantee that the decision was truly voluntary. A debilitating illness associated with aging can make a potential subject susceptible to being manipulated. Further, a potential subject might enroll in a protocol out of desperation because he or she may believe that no other treatment option is available. Researchers must be cautious not to take advantage of this desperation in order to promote their own agenda, and they must inform potential participants regarding existing treatment options for their condition.

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J. Students Involved in Research

1. Students as Researchers i. Students conducting class projects, dissertations, and theses.

Research conducted by students of South University as part of their academic requirements is subject to review by the IRB. Research in this case is defined as any interaction to collect data that is not part of an informal interview (up to 3 of these are allowable) on a non-sensitive subject with someone who is not part of a vulnerable population and for which the data will not be used outside of the current class and no- personally identifying information is recorded. Students should consult with the assigned faculty member for the class and/or the chair of their thesis/dissertation committee for guidance on what activities are exempt from IRB review.

2. Students as research subjects

Principal investigators who wish to recruit students from South University as participants in their research must receive approval from the South University IRB, regardless of the affiliation of the principal investigator with South University or lack thereof. It is the principal investigator’s responsibility to recruit subjects as the South University IRB will not provide student directory contact information to principal investigators. Principal investigators must incorporate compliance with applicable FERPA guidelines in their research design and IRB application.

3. Investigator and IRB member conflicts 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 a principal investigator or co-investigator OR as a committee member or a faculty sponsor of a student's research project. When an IRB committee member has provided scientific guidance on a project or has some other relationship with the investigator (i.e. supervisee), he/she may still review the application as long as the extent of said guidance is minimal (for instance, helping someone identify an appropriate statistical measure is “minimal,” while helping someone submit a grant is not).

K. Noncompliance with IRB Policies The South University IRB serves the role of ensuring all research studies meet the necessary policies and procedures of the University and those of the Department of Health and Human Services, regarding the Protection of Human Participants. The IRB remains committed to assisting the research endeavors of investigators involved with South University. As such, all policies and procedures associated with conducting and reporting research require strict adherence, with no exceptions. All investigators and research personnel must ensure awareness and understanding of the explicit and implicit rules and policies. 1. Notification to Cease Research Activities (NCRA)

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In the event that an investigator(s) or associated research personnel fail to comply with the rules and policies, a formal Notification to Cease Research Activities (NCRA) may be issues by the IRB Chair. In such event, all research activities (e.g. participant recruitment/advertisement, research procedures including instrumentation and methodology, etc.) must cease. Once an NCRA has been issued, a meeting between the investigator(s) and representatives from the IRB committee will be scheduled to discuss the issues and needed course of action. Once an NCRA has been issued, activities for the project can be resumed upon receipt of a formal Notification to Resume Research Activities (NRRA). Failure to follow the guidelines of the NCRA will result in withdrawal of the approval for the project and the investigators will need to resubmit the entire application. Additional sanctions and/or disciplinary action may also result (see chart).

L. Internet Research Internet research involves the transmission of participant information and response via online sources, such as Survey Monkey. All research conducted through the internet rather than face to face formats must adhere to all policies of the IRB, including informed consent and proposal review. See Section H.3. above regarding informed consent procedures for online research. See the Inside South IRB Webpage or contact the IRB Director for sample informed consent guidelines.

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M. Cooperative Research Cooperative research is any research that is conducted at a site not covered by the South University IRB’s authority. There will be times when South University faculty will collaborate or work with individuals from other universities, which may require submission to other IRBs. Any faculty participating in research must have the project reviewed by the South University IRB. Research sites may require their own IRB review or may wish to create a relationship with South University to accept the IRB review, without further review or action. In the event of cooperative research, authorization agreements are necessary from both sites and must be submitted to the acting IRB. 1. Research Sites with an IRB

If the other institution has an IRB and wishes to provide the review, South University can accept their review under the following circumstances:

a. The Reviewing IRB shall ensure that South University’s IRB’s organization has agreed to rely on the Reviewing IRB for the specific study. The IRB at any institution has the right to decline, on a case by case basis, to be the Reviewing IRB for research being conducted at other institutions.

b. The Reviewing IRB will consider conflicts of interest using its local Conflict of Interest policy. The Reviewing IRB will include the Conflict of Interest management plan applicable to investigators from relying organizations in the study approval.

c. The Reviewing IRB will notify the South University IRB of any unanticipated problems involving risks, serious or continuing non-compliance with regulations or requirements or determinations of the Reviewing IRB, and termination or suspension of IRB approval of research. The Reviewing IRB will collaborate with Relying IRBs in drafting joint notification on such subjects to any required reporting agencies.

d. The Reviewing IRB will make its records, including any relevant communications with investigators, available upon request to the South University IRB and to regulatory and accrediting organizations.

e. The Reviewing IRB will communicate to the South University IRB, all approvals, disapprovals and/or closures of the proposed research.

f. The Reviewing IRB may require the South University IRB to conduct a monitoring visit of the study and/or observe the consent process at the relying institution.

g. The Reviewing IRB has the right to terminate serving as the IRB of record, after initial approval of a study. The Reviewing IRB may terminate serving as the IRB of record with at least six months advance written notice to the Principal Investigator and the South University IRB, in order to provide time for the protocol to be transferred to another IRB.

h. The principal investigator, not the South University IRB, is responsible for subject recruitment. It is unacceptable to use the faculty or staff directory to send emails to faculty members or staff for subject recruitments purposes.

The South University IRB will accept or decline, on a case by case basis, in its sole discretion, to rely on the Reviewing IRB. The South University IRB shall notify the Reviewing IRB of its decision.

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If the South University IRB disapproves the request to rely, the local principal investigator must submit an application to the South University IRB in order to participate in the research project. If the South University IRB approves the request to rely, the site’s principal investigator will submit information required by the Reviewing IRB according to the Reviewing IRB’s policies and procedures. The South University IRB grants the Reviewing IRB the authority to:

a. Approve, require modifications to secure approval, disapprove; and to suspend, or terminate the research when not being conducted in accordance to the Reviewing IRB’s requirements or has been associated with unexpected serious harm to subjects.

b. Observe, or have a third party observe, the consent process and the conduct of research.

The South University IRB will notify the Reviewing IRB of any significant or serious issues relating to the conduct of the study at its site. Examples of such issues include, but are not limited to, noncompliance by an investigator on another study or a serious adverse event. The IRB Director, or that of his designee, will review all correspondence and protocol specific communications received by the Reviewing IRB or site’s principal investigator pertaining to all research being conducted at South University, under the approval of another IRB. The South University Institutional Officer may suspend or terminate the conduct of research at any of its components. In the case of such an occurrence, the South University IRB will promptly notify the Reviewing IRB in writing. The South University IRB may terminate, on a case by case basis, its reliance on the Reviewing IRB. The South University IRB will notify the site’s principal investigator and the Reviewing IRB and ensure that the research has been reviewed and approved by another IRB prior to termination of reliance.

2. Research Sites without an IRB

In the event that a cooperative research site does not have an IRB, the South University IRB will serve as acting IRB. Any site utilized for research for South University must be included in the IRB proposal reviewed by South University. All research conducted by South University faculty must have IRB review and approval. Note that while research conducted at a South University site (whether physical or electronic) does not need site approval (for instance from campus administration), investigators should notify supervisors or an administrator before commencing data collection.

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N. International Research When performing human subject research in foreign countries, South University expects that the research activities are consistent with the ethical principles set forth in the IRB Policy and Procedure manual and provide levels of subject protection equivalent to those provided when performing human subject research in the United States. Researchers are also expected to comply with local laws and take into account the cultural context of the country in which the research is taking place. When performing human subject research in other countries, researchers are expected to comply with U.S. regulations and guidelines and any applicable regulations of the country in which the research is performed. Specifically, the investigator(s) agree to:

i. Provide the same or equivalent protections to human subjects in research conducted in other countries,

ii. Respect subject autonomy and dignity, iii. All protections should encompass the ethical principles of respect for person,

beneficence, and justice. Researchers agree to be aware of and abide by local laws, regulations, political and socio- economic factors, and cultural context in all locations where the research is conducted. In addition, the researcher is expected to:

i. have sufficient knowledge of the local context to enable carrying out of the research in ways that protect the rights and welfare of subjects,

ii. Have knowledge of the local context may influence all aspects of the research design,

iii. Comply with local laws and adhere to cultural norms.

Requirements and expectations for reviewing proposed international research includes specific guidelines. Generally:

i. The IRB must ensure that equivalent protections are provided to research subjects enrolled in research in another country

ii. The IRB will make determinations and decisions based on laws and knowledge of the country in which the research will be conducted, including if there are laws or guidance related to human research subject protections if there are other laws that will need to be factored into the research, and if the local or government has their own required approvals.

Reviewers should review the HHS International Compilation of Human Subject Protections found at http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html for more information on making these determinations.

1. Specific information to be included in the IRB proposal

i. The IRB will require certain information be addressed in the submitted protocol. For example, the information provided should include but not be limited to:

ii. Whether the researcher speaks the language of the country in which participants will be enrolled and the research will be conducted. If the researcher does not

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speak the local language, describe how communication with the research subjects will be accomplished.

iii. Whether the researcher is familiar with the local customs and culture or whether a local collaborator will be used and the involvement of the local collaborator will have in the conduct of the research.

iv. Whether the subjects will be reimbursed and, if reimbursed, the amount and how it relates to the local economy and subject income.

v. If consent will be obtained, how or from whom will consent be obtained along with the following information, if applicable: a. Describe local customs/culture in which the subject might not have the

autonomy to provide consent and a family member or other person will be providing consent to participate.

b. How the researcher will assure that there is no coercion for participation if a person other than the subject will be providing consent.

c. If written documentation of consent will be obtained, and If so, a description of how or from whom the consent will be translated.

d. If not, a description of how consent will be documented or if there are cultural/other prohibitions regarding use of consent forms.

vi. Describe how the privacy for the subjects and confidentiality of their research data will be assured and if there is a local custom that research data be revealed to someone other than the subject.

vii. Describe how the communications with the South University IRB/local authorities will be achieved for requesting amendments or reporting unanticipated problems.

viii. For student researchers, a description how the academic faculty sponsor(s) will oversee conduct of the research.

ix. The investigator (s) will provide the South University IRB requires the applicable local laws and regulations for the country where the proposed study will occur. The principal investigator shall provide the IRB with any necessary certifications or permissions and evidence of local ethics review when appropriate. To help ensure compliance with this requirement the IRB committee will utilize the U.S. Department of Health & Human Services International Compilation of Human Subject Protections found at http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html and may utilize a consultant with knowledge of the laws and practices of the country.

2. Risk Assessment

The South University IRB must assure that the risk assessment is accurate for the foreign site. Research methods that have minimal risk in the U.S. might have greater than minimal risk when conducted at certain foreign sites. The following must be given consideration: i. Questions that might be innocuous in the U.S. could be offensive at certain

foreign sites. ii. Assuring and maintaining confidentiality may be difficult in other countries.

iii. Breach of confidentiality in the research locale could have dangerous consequences.

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3. Special Considerations for the Informed Consent

i. The informed consent process must honor local custom. Some cultures may have a different authority structure for consent.

ii. The local consent structure may seem coercive and clash with the researcher's, reviewer's, or IRB’s views on autonomy.

iii. Surrogate consent/permission should not substitute for a subject's informed consent unless the IRB has approved an alteration or waiver to the consent process.

iv. The consent process/form should, unless waived by the IRB, contain all required elements of informed consent.

v. Consent is best obtained using the language that is most familiar to the subjects taking into account:

a. Some languages/dialects are not written. b. Subjects may be illiterate/unable to read. c. There may be words in the foreign language that do not translate to/from

English. d. If researchers are not fluent in the local language, interpreters/translators

who are fluent should be used. vi. Documentation of consent may be difficult because:

a. In some cultures, it may be inappropriate to ask for a signature b. There may be legal implications when signing documents. c. Subjects may be suspicious, distrustful, or fearful they are giving up their

rights when asked to sign documents. vii. Alternate consent procedures may have to be considered such as:

a. Use of pictures, video, or computers. b. Alternate forms of documentation such as thumbprints

4. Communication with the IRB and Local Authorities

With the research occurring outside of the country there should be consideration on how the communication between the researcher and South University will take place. The protocol should describe the following:

i. How communication will occur with the IRB and the local Ethics Committee ii. How ongoing review, amendments, or reporting of unanticipated problems or

complaints will be handled and by whom. iii. If it is a student researcher abroad, the student's knowledge of the country and

how the student will communicate with their faculty advisor. iv. List a local contact in case principal investigator or faculty sponsor cannot be

reached.

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