Institutional Review Board (IRB) Records
Records that document the review of research proposals that involve any type of use of human subjects. Records may include applications for approval by the review board; Protection of Human Subjects records (OMB-0531-0009); Protection of Human Subject C Assurance/ Certification/Declaration records (OMB-0925-0637); descriptions of protocol; signed consent records; sample questionnaires or surveys; copies of grant proposals; review summaries; and minutes of IRB meetings.
The following records must be retained: 1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings 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; documentation of specific findings required by the regulations, and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described above under assurances. (6) Written procedures for the IRB in the same detail as described above in assurances. (7) Statements of significant new findings provided to subjects. The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department at reasonable times and in a reasonable manner.
21 CFR 56.115; 45 CFR 46.115(b)
Confidential destruction is required. Paper must be shredded, pulped, or incinerated; electronic records must be overwritten or the storage media physically destroyed. Deletion of information in computer files or on electronic storage media is not sufficient.
Last Updated: December 31, 2008