Drew University

Institutional Review Board

Guidelines for the IRB and IRB Chair

 1)  According to 45 CFR, Subtitle A, Part 46.108.b, "except when an expedited review procedure is used, review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting".

2) The IRB shall maintain a list of IRB members in the same detail as described in 45 CFR, Subtitle A, Part 46.103(b)(3)) and written procedures for the IRB in the same detail as described in 45 CRF, Subtitle A, Part 46.103(b)(4)-(5).

3)  The IRB will maintain the following records and the records in (2) above for a period of three years, and if research is conducted, for a period of three years after research completion, in accordance with 45 CFR, Subtitle A, Part 46.115:.

i) 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.

ii) 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 the discussion of controverted issues and their resolution.

iii) Records of continuing review activities.

iv) Copies of all correspondence between the IRB and the investigators.

v) Statements of significant new findings provided to subjects, as required by 45 CFR, Subtitle A, Part 46.116(b)(5).

4)  Every three years the Human Protections Administrator must renew the Federalwide Assurances and the IRB registration in order to maintain active registration of the IRB. (See (3) and (4) at the following link.)

5)  All ongoing research must have its procedures reviewed annually.  An application for continuation of the research should be filed with the chair of the IRB.  The Human Protections Administrator will send a reminder to all researchers who have ongoing research.

6) In the event of any change in IRB procedures or membership, the following must be updated:

i) If the change involves an alteration of the information on record in the Federalwide Assurances or the IRB registration, then the Human Protections Administrator must file an update of those documents. (See (3) and (4) at the following link.) In particular, this update must be filed for any change in committee membership.

ii) The personnel and procedures listed on the Drew University IRB web page must be updated as necessary. 

7)  Additional Resources:

i) Health and Human Services Human Subjects Decisions Charts

ii) Course Content of National Cancer Institute's Human Participant Protections Education for Research Teams

iii) American Anthropological Association Statement on Ethnography and IRBS