Institutional Review Board

Certifications and Records

Certification of IRB Review (for Funded Projects only)

Certification of IRB review refers to the official notification by the university to the DHHS) that the research activity or project involving human subjects has been reviewed by the IRB. Certification of initial IRB review is incorporated into the text of each Single Project Assurance (SPA) which is then forwarded to the Office for Protection from Research Risks (OPRR).

Suspension or Termination of Research

The IRB shall have authority to suspend or terminate research that is not being conducted in accordance with the IRB's requirements, other institutional and federal requirements, or has been associated with any serious harm to subjects. Concerns regarding the conduct of research must be reported immediately to the Chair of the IRB by any individual having such knowledge. Any suspension or termination of research must include a statement of the IRB's action and the Chair must report its decision promptly to the principal investigator, the Office of Grants and Contracts, and the funding agency, in the case of a sponsored project.

Cooperative Research

Cooperative research projects are those that involve more than one institution and can be designed to be both multi-site and multi-protocol in nature. In the conduct of such projects, each participating institution is responsible for safeguarding the rights and welfare of human subjects and for complying with all regulations.

Institutional Approval: In cases where the research project will be housed and conducted at another institution with participation by Wofford College faculty, staff, or research participants, it is required that documentation of the primary institution's IRB approval and a copy of the research protocol and consent forms be obtained and made part of the official IRB records. The proposed research project must then go through an additional review by and receive approval from Wofford's IRB. All cooperative research projects involving Wofford faculty, staff, or research participants, whether conducted at Wofford or off-site, must have Wofford IRB approval.
Assurances: It is the responsibility of the lead institution to file the required assurances and certifications with the Office for Protection from Research Risk (OPRR).

Records
It will be the responsibility of the Chair or the Chair's designee to prepare and/or maintain adequate documentation of IRB activities regarding research involving human subjects, including the following:
- Copies of all research proposals reviewed and actions taken, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects
- 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 issues of dispute and their resolution
- Records of continuing review of research activities
- Copies of all correspondence between the IRB and investigators
- A list of all IRB members, including their name, race, ethnicity, and gender; earned degrees; affiliation (i.e., Center for Psychological Studies, Health Professions Division-College of Osteopathic Medicine, etc.); indications of experience, such as board certifications, licenses, etc.
- Written procedures governing the IRB.
Copies of all documentation regarding research reviewed by the IRB also will be maintained in the University Office of Grants and Contracts. All records shall be retained for at least three (3) years. Records relating to funded research conducted shall be retained for at least three years after completion.

Return to IRB Manual