048.1 Institutional Review Board for Proposed Research Involving Human Subjects

Created by: Pat Teague on 2/5/1999

Category: 0 - General Administration; 40 - Planning/Research

Originator: Vice President for Academic Affairs and Dean

Current File: 048.1

Adoption Date: 1/15/1999

Reviewed for Currency: 1/15/1999

Replaces File: 048.1

Date of Origin: 7/16/1982

Classification: Faculty

In Archive? No

048.1 Institutional Review Board for Proposed Research Involving Human Subjects

A. Background

Furman University desires to comply with federal regulations regarding the protection of human subjects used in research projects conducted at the university or by university personnel and students. Compliance with the regulations of the Department of Health and Human Services (HHS) is required for research funded directly by HHS and some other federal funding agencies. The regulations have served as a model for protection of human subjects in general.

B. Policy

An Institutional Review Board (IRB) shall be established for the purpose of evaluating potential risks to human subjects involved in university-related activities. This board's functions will be to conduct initial and continuing review of human research projects according to the guidelines specified in the Federal Register (Vol. 46, No. 16; 45 CFR Part 46; Jan. 26, 1981) and to make recommendations to the investigator(s) and to the institution concerning the research procedures.

C. Guidelines

A. Membership of the IRB:

1. At least five persons of diverse backgrounds (race, sex, culture, professional interest, and sensitivity to issues) appointed by the Vice President for Academic Affairs and Dean.

2. At least one member from a nonscientific professional area.

3. At least one member not affiliated with the University.

4. Membership shall include some persons whose primary concern is the protection of "vulnerable" subjects (e.g., children or institutionalized persons).

5. Any member who has a conflict of interest in a particular research project shall be excluded from the decisionmaking in that instance (except to provide information).

B. Procedures of the IRB:

1. The IRB shall hold convened meetings with a majority of members present (except under the HHS guidelines for expedited procedures and exemptions for low risk research).

2. A majority vote shall be required for specific decisions.

3. Records of all proposals, committee action, correspondence, membership and operating procedures shall be kept for a minimum of three years after the completion of the research.

...........................