Provost

IX. Record keeping

The IRB shall maintain the following records (in electronic or hard copy form):

1. Copies of all research proposals (including supporting documentation such as sample consent forms) reviewed; progress reports and renewals submitted by researchers; and reports of injuries to subjects.

2. Minutes of IRB meetings which should be in sufficient detail to show attendance at the meetings, actions taken; the vote on these actions including the number voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a summary of the discussion of controverted issues and their resolution.

3. Copies of all correspondence between the IRB and researchers.

4. Copies of all correspondence between the IRB and Departmental Coordinators.

5. A list of the IRB members detailing their name, earned degree, representative capacity, indications of experience sufficient to describe each member's chief anticipated contribution to the IRB, and any employment or other relationship between the member and Muhlenberg College (e.g. full-time employee).

6. Written procedures for review of research.

 

The records required by this policy shall be retained for at least 3 years; records relating to research conducted shall be retained for 3 years after completion of the research.  All records shall be accessible for inspection and copying by the Institutional Officer and if applicable, the appropriate granting agency official, at reasonable times and in a reasonable manner.