Paine College has submitted to the U. S. Department of Health and Human Services (DHHS) written assurances that it will comply with that agency’s policy for human protection in research as required by their compliance regulations. The assurance statement provides for the protection of human subjects participating in activities supported directly or indirectly by grants or contracts from the Department of Health and Human Services. By extension, the assurance from Paine College is that such protection will be provided in any research conducted by faculty or students of the College and involving facilities of the College. The assurance statement also stipulates the mechanisms by which such protection shall be guaranteed with regard to the tights and welfare of subjects, the risks vs. benefits to subjects, and the right and necessity of properly informed consent. Questionnaires and survey-type instruments come within the purview of human subject research.
a. The Institutional Review Board (IRB) is made up of five members, with four members from the faculty of Paine College and one representative preferably with a background in ethics on human subjects from the surrounding community and not employed by the College. This member from the community is as required under Federal guidelines for the IRB. The four faculty members shall include at least one member from the Division of Natural Sciences and Mathematics (DNSM) and one member from the Division of Social Sciences (DSS), each of whom must be familiar with research methodologies involving human subjects. The other two faculty members academic affiliation is intentionally unspecified as to division or department.
- Selection of Members: Selection of the four (4) faculty members of the Committee shall be annually as nominated by the Nominating Committee and voted by the Faculty. The one (1) community representative is by annual appointment by the President.
- Terms of Service: Terms of the members of the Committee shall be for one (1) year, with members to serve not more than three (3) consecutive years without at least one (1) year rotated off.
- Organization: At its initial meeting each academic year, the Committee shall elect a chairperson and a recorder, and shall inform the Provost and Vice President of Academic Affairs as to those elected. The Chairperson shall call and conduct meetings of the Committee, and arrange for a substitute in the case of the Chairperson’s absence. The Recorder shall keep minutes of all meetings and transmit copies appropriately for the record.
- Definition of Quorum: A quorum shall consist of at least three (3) members of the Committee.
- Meeting Schedule: The Committee shall normally meet at least once a month during the academic year; more often, when needed.
- Responsibilities and Functions: As a College-wide committee on human research, IRB has the responsibility of policy interpretation, review surveillance, and monitoring of all human subjects research at the College. This Committee is advisory to and reports to the Provost and Vice President of Academic Affairs, ex officio, through the Office of Sponsored Programs (OSP).
The specific responsibilities and procedures of the IRB governing human research are to conform to the Code of Federal Regulations (45 CFR 46), revised as of March 8, 1983 and any subsequent revisions. It is important for researchers (faculty or student) to understand that the IRB has authority to determine whether any research involving human subjects or human tissues is exempt from IRB review. It is also important to know that prior approval from the IRB is required before any research involving human subjects can begin. There is no appeal from decisions of this committee.
The IRB is also the group responsible for review of any research proposed that would involve animal research that uses as its subjects live vertebrate animals. Paine College should and must submit to the Office of Protection from Research Risks (OPRR) an assurance that spells out the College’s compliance with Public Health Service (PHS) guidelines for all PHS-supported research activities involving live vertebrate animal subjects. The College has voluntarily committed itself to upholding the PHS standards in all animal research conducted at Paine College, whether funded by PHS or not. It is suggested that a veterinarian be appointed when animal research is being conducted.
- Guidelines: IRB has produced, as guidelines for those planning research with human subjects, a
Booklet on Research Involving Human Subjects in Appendix 18.104.22.168.15 (latest revision January
1999). With this publication are provided a sample consent form and a standardized form for
making application to the Committee. These are available from the Office of Sponsored
Programs as well as from members of the Committee, and have been shared with the faculty.
Last updated Paine College Policy Manual: Volume I – Page 32 March 2010