Policy identification number: To come...
File: Academic Policies > Research Policies
Institutional Review Board
Governing the requirements of and procedures for the Institutional Review Board.
Provost and Vice President for Academic Affairs
March 28, 2018
July 1, 2018
Scheduled for Review
In accordance with its Federal-wide Assurance on file with the Department of Health and Human Services, Fort Lewis College has an Institutional Review Board (IRB) for review of the use of human participants in research. The IRB is a standing committee of the University Faculty. Its activities are overseen by the Provost and Vice President for Academic Affairs or designee (hereafter referred to as Provost).
1 Material for this policy has been used with permission from Cornell University.
The IRB shall ensure the protection of human participants as subjects of research at Fort Lewis College. The IRB shall:
5 45 CFR 46.116
III. Composition of the IRB7
7 45 CFR §46.107
IV. IRB Member Responsibility
V. Researcher Responsibility
VI. Determining Whether Research Activity Needs IRB Review and Approval
VII. Requests for Exemptions from IRB
VIII. Review and Decisions made by IRB
IX. Quorum Requirements for Votes on Convened IRB Decisions
X. Minimal Criteria for Approval of Research
XI. Procedures for Prompt Reporting and Review of Unanticipated Problems within FLC:
XII. Defining and Managing Noncompliance with Approved Research Protocols (see Appendix 5: Timeline)
XIII. Suspensions and Terminations of IRB Approved Research Proposals
XIV. Reporting Unanticipated Problems, Noncompliance, Suspensions, and Terminations
8 In the regulations (21 CFR 312.3(b)), a sponsor is defined as “a person who takes responsibility for and initiates a clinical investigation. A sponsor may be an individual or a pharmaceutical company...” For example, a sponsor may the pharmaceutical or device company that initiates a clinical trial for one of its products.
For following policy: Faculty, Staff and Students
For enforcement of policy: Provost and Vice President for Academic Affairs
For oversight of policy: Provost and Vice President for Academic Affairs
For notification of policy: Policy Librarian
For procedures implementing the policy: Faculty Chair(s) and IRB Members