Introduction and Methodology - Use the appropriate template and only submit the portion of the template that services the assignment.

Wilmington University

Human Subjects Review Committee (HSRC)

Forms Check List

Dissertation

Master’s

Undergraduate

Faculty

Other

Assemble materials in the order shown below.

· 1. Human Subjects Protocol

· 2. Human Subjects Certificate

· 3. Consent Forms

· 4. Instruments

WILMINGTON UNIVERSITY

HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)

RECORD AND REVIEW OF RESEARCH PROTOCOL

Contact Information

Principal Investigator:

(Last) (First) (Middle)

Address:

City State Zip

Phone: Day Evening Cell

E-Mail: FAX:

Project status

This research is for (check one):

Dissertation Practicum Master’s Undergraduate

Other (specify)

This research proposal is (check one):

New Renewal Re-evaluation

Instructor or assigned faculty sponsor:

Project Information

Title of study:

Research purpose or issue:

Population to be studied: Gender Age Race/ethnicity

Number of groups and number of participants in each group:

Inclusion and exclusion criteria:

How Subjects will be recruited:

Describe the procedures that the participants will undergo in the proposed research project

to include the physical location and duration of subject participation (attach a copy of all research instruments e.g., surveys, questionnaires, interview questions etc.):

Describe procedures that will be used to maintain confidentiality, including plans for storing/disposing of tapes and other data records at the conclusion of the research:

Research Protocol Please answer yes or no to all questions below.

Does this research involve:

YES NO

prisoners, probationers, pregnant women, fetuses, the seriously ill or mentally

or cognitively compromised adults, or minors (under 18 yrs) as participants

the collection of information regarding sensitive aspects of the participants

behavior (e.g., drug, or alcohol use, illegal conduct, sexual behavior

the collection or recording of behavior which, if known outside the research,

could place the participants at risk of criminal or civil liability or could be damaging to the participant’s financial standing, employability, insurability,

or reputation

procedures to be employed that present more than minimal risk* to

participants

deception or coercion

benefits or compensation to participants

a conflict of interest (e.g., teacher/student, employer/employee:

is there any financial interest in this research)

If you answered NO to all of the questions please proceed to the next page.

If you answered YES to any of the questions your proposal must clearly indicate why the use of participants in any of these categories is scientifically necessary and what safeguards will be employed to preserve the participants anonymity/confidentiality. The proposal must identify all risks (physical, psychological, financial, social, other) connected to the proposed procedures, indicate clearly how such risks to participants are reasonable in relation to anticipated benefits, describe methods to protect or minimize such risks, and access their likely effectiveness. Consent/assent forms must be included for research involving minors.

Consent Forms

YES NO Is a consent form included with this study? If so, attach a copy.

YES NO Are child assent forms included with this study? If so, attach a copy.

Minors must provide an affirmative consent to participate by signing a simplified form,

unless the principal investigator can provide evidence that the minors are not capable

of assenting because of age, maturity, psychological state, or other factors.

Who is obtaining consent? Check all that apply:

Principal Investigator Research Assistant Other (specify)

How is consent being obtained?

What steps are being taken to determine that potential subjects are competent to participate in the decision-making process?

Obligations of Principal Investigator:

HSRC meets on the second Thursday of each month September to May and twice during the summer months. Protocol must be received two weeks before that date.

Any changes made to the research protocol must be reported to division representatives of the HSRC for review prior to implementation of such change. Any complications, adverse reactions, or changes in the original estimates of risks must be reported at once to the HRSC chairperson before continuing the project.

Any data collection that extends beyond one year must be resubmitted before the anniversary for continuing review by the HSRC.

According to federal regulation all data, including signed consent form documents must be retained for a minimum of three years past the completion of the research.

I have read and understand my obligations as an investigator. I certify that the research proposal is accurate and complete.

Print name:

Signature: Date:

Instructor or Assigned Faculty Sponsor:

Print name:

Signature: Date:

WILMINGTON UNIVERSITY

HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)

PROTOCOL REVIEW

This section is to be completed by the HSR Committee Person.

Principal Investigator:

Date submitted:

The protocol and attachments were reviewed:

The proposed research is approved as:

Exempt Expedited Full Committee

The proposed research was approved pending the following changes:

See attached letter

Resubmit changes to the HSRC chairperson

The proposed research was disapproved:

See attached letter for more information.

HSRC Chair

or Representative

Print name

Signature Date:

HSRC Chair

Or Representative

Print name

Signature Date:

minimal risk means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in everyday life or during the performance of routine physical or psychological examinations or tests.