THE UNIVERSITY OF NORTH CAROLINA AT ASHEVILLE

FACULTY SENATE

Senate Document Number 3110S

Date of Senate Approval 03/18/10

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Statement of Faculty Senate Action:

FWDC 5: Revision to Institutional Review Board (SD0393F, Faculty Handbook 10.4.20)

Effective date: Fall 2010

Rationale:

UNC Asheville’s Institutional Review Board (IRB) was constituted in 1993, and in the intervening 18 years has not been reviewed. With an increase in research projects involving human subjects, it has been difficult to promptly complete the review of proposals. In addition, there have been changes to the Federal guidelines governing Institutional Review Boards (most recent revision July 2009), which alter the requirements for a board to meet and vote on proposals.

This document will reform the Human Subjects Policy to become in line with Federal Regulation Title 45, Part 46, and expand the membership to eight, representing four affiliations.

Revised Faculty Handbook 10.4.20

10.4.20 Institutional Review Board (formerly Human Subjects, 10.5.6) (SD0393F)

Purpose

The UNCA [UNC Asheville] Institutional Review Board (IRB) is charged with the responsibility of reviewing all research proposals involving human subjects, according to the Code of Federal Regulations (45 CFR 46, June 18, 1991. [July 14, 2009]). These regulations require IRB approval for federally-funded research on human subjects and also require that the Institution have a policy on such studies "regardless of whether the research is subject to federal regulation." (#46.103 (b)(1).) This policy allows departments to adopt their own, more restrictive review procedures. The UNCA [UNC Asheville] policy on human subjects applies not only to the research of individual faculty and staff members but also to the research projects assigned to students. Since most of UNCA's [UNC Asheville’s] research has in the past involved minimal risk to human subjects, the review procedure for most projects is also minimal.

Membership

Membership of the IRB conforms to federal guidelines (46.107). [The eight members will include]

· Five [Six] members, approved by the Chancellor, serving staggered three year [three-year] terms with at least one appointed each year. Faculty members as well as administrative staff are eligible for appointment to the IRB.  Reappointment to a second term of three years is allowable for the sake of continuity.  Members shall not be all male or all female and there must be representation [of two members] from [each of] the natural science, social science, and humanities areas of the university.

· One member [Two members, approved by the Chancellor, who are] not be otherwise affiliated with UNCA[UNC Asheville, nor part of the immediate family of a person who is affiliated with UNC Asheville].

[Procedures

1. Before beginning any study involving human subjects, a brief proposal must be submitted to the Chair of the IRB.

2. If the Chair or a delegated member of the IRB determines that the study involves only "minimal risk", approval may be given. "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." (46.102 (i).)

3. If it is decided that more than "minimal risk" to human subjects may be involved, the full IRB will consider the proposal. The research (or faculty member assigning student projects) will be invited to explain the project to the IRB.

4. According to Federal Regulations (46.109), the IRB shall "have the authority to approve, require modifications in (to secure approval) or disapprove all research activity covered by this policy." The Regulations further state that the Institution (UNC Asheville) may reverse an approval given by the IRB, but it cannot overrule a negative decision by the IRB.

5. Independent research projects which individual students design and carry out under faculty supervision must be reviewed and approved by the IRB.

6. All other student research assignments, such as those in research methods courses, etc., will be reviewed by the course instructor, who will be acting as the delegate of the IRB. The instructor will report to the IRB through means of a check list.

7. IRB approval of a project is limited to one calendar year.

8. A quorum shall be a majority of the eight members of the IRB, one of whom must have primary concerns in nonscientific areas. Approval of a project requires the approving vote of the majority of those present.]

Recommendations and reports to:   the VCAA [Provost]