IRB Review Process

Initial approval for faculty, students, and staff at Bryn Mawr College

For faculty and students, the review process is initiated by submitting research proposals to your IRB Departmental Reviewer. Policies and necessary forms for each level of review are available on the web (see below). It is expected that most research projects will fall in either the exempt or expedited category. Exempt projects require no further review beyond the departmental level. Note, however, that this is not the decision of an individual investigator. Exempt status must be approved by your IRB Departmental Reviewer and requires that the researcher complete the relevant forms (B-1, B-2). Your Departmental Reviewer then forwards the proposal and Forms B-1 and B-2 to the Grants Office for filing.

Projects requiring expedited review are forwarded by your IRB Departmental Reviewer to the IRB chair, who designates a member of the IRB to conduct the review. Expedited reviews should be completed within two weeks of the receipt of the proposal by the IRB Chair.

Proposals requiring full IRB review must be received by the IRB chair two weeks before the IRB meeting date (held four times a year, in October, December, February, and May) , and include 10 collated copies of the entire proposal. Please remember that your Departmental Reviewer must sign off on all proposals before they come to the IRB

Chair for distribution for review.

Administrators and staff planning to do research using human subjects should consult the IRB Chair directly.

Initial approval for faculty, students, and staff from outside of the Bryn Mawr College Community

Any research involving Bryn Mawr College students, faculty, or staff, performed by a researcher outside of the Bryn Mawr Community, must first send the research proposal, if it involves Bryn Mawr College undergraduates, to the Dean of the Undergraduate College. If it involves graduate students, it should go to either the Dean of the Graduate School of Arts and Sciences or the Graduate School of Social Work and Social Research. If the relevant Dean feels the research is of interest then the proposal is forwarded to the Bryn Mawr College IRB. At that point, the IRB Chair confirms the level of IRB review required and reviews the appropriate IRB forms, described above. If the research requires an Expedited Review, the Chair forwards it to a member of the IRB for review. If the research requires a Full Review, then the proposal and appropriate IRB forms will be reviewed in one of the four standing meetings of the IRB.

Protocol changes, reporting of adverse effects

IRB approval only applies to the protocol as described in the approved proposal. Changes of any kind made to the protocol after initial or continuing review must be reported to the IRB Chair immediately and cannot be instituted until IRB approval is given. In addition, any and all adverse effects on participants (including complaints) must be reported to the IRB Chair immediately.

Continuing Research

All research originally approved through either expedited or full IRB review must be reviewed annually. This requires submission of a continuation (or if completed, a termination) form. Continuation requests must be received prior to the annual approval anniversary date. The Grants Office will remind researchers of their deadline for continuing review. The Continuing Review Form and any associated materials must then be received by the IRB Chair prior to that deadline, for review at the nearest full meeting of the IRB.

Continuing research for which IRB approval has not been obtained must cease as of the annual review date. Please note also that at the time of continuing review, protocol changes (even though already approved by the IRB) and adverse effects (even though already reported to the IRB) must be summarized. Please also note that even if data collection has been completed, continuing approval is required for data analysis.

Policies and Forms

General Policies: http://www.brynmawr.edu/grants/IRBPol.html

Main Forms: http://www.brynmawr.edu/grants/APPEND.html

Continuation/Termination request: (http://www.brynmawr.edu/grants/Review.pdf).

On behalf of your colleagues on the IRB, I would like to thank you for your continued cooperation and assistance in what, we know, can sometimes feel like a burdensome procedure.

If you have any questions, please don’t hesitate to be in touch with me.

IRB Members, Spring, 2008

Leslie Alexander, Chair

Jim Baumohl

Rick Davis (sub this semester for Phil Kilbride)

Ignacio Gallup-Diaz

Judy Porter

Bethany Schneider

Marc Schulz

Sandra Kenton, Community Representative

Sam Magdovitz, Ex Officio

Nona Smith, Ex Officio

Kim Cassidy, Ex Officio

January 22, 2008