The following email was sent to faculty, students, and staff on behalf of the Institutional Review Board on Sunday, September 27.
Dear faculty, students, and staff:
We ask that you carefully review the procedures below so that IRB reviews can be done as expeditiously as possible. PLEASE NOTE THAT ANY CHANGES TO FORMS, POLICIES AND PROCEDURES WILL BE POSTED ON THE IRB WEBSITE. NOTE THAT WE HAVE REVISED FORMS AND WILL BE ADDING NEW GUIDANCE DOCUMENTS OVER THE COURSE OF THIS YEAR.
We finally have fillable forms. Please note that the letters of the forms have changed. Form B-1 is now Form A; Form B-2 for exempt proposals is now Form B; Form B-3 for expedited reviews in now Form C; and Form B-4 is now Form D. THE IRB ACCEPTS MANUAL OR FACSIMILE SIGNATURES. NO TYPED SIGNATURES WILL BE ACCEPTED.
No new proposals will be reviewed without a screenshot of the NIH Protecting Human Research Participants certificate. The directions for obtaining this certificate are on the IRB website. All students, faculty and staff who are developing IRB proposals must complete this or comparable training, such as CITI, and provide documentation of the completed training.
I. Process for Initial Review of proposals dealing with human subjects, no matter what the level of review required.
a) The BMC IRB has four stated meetings during the academic year, two in the fall (end of October or early November and in December) and two in the spring (late February and early May). The actual dates are announced at the beginning of each semester. All proposals requiring a full review must be reviewed in one of the four scheduled meetings of the IRB. ALL FULL REVIEWS MUST BE RECEIVED BY THE IRB CHAIR ONE WEEK BEFORE THE SCHEDULED IRB MEETING. This means by Thursday, October 15 for theOctober 22, 2015 meeting and by Monday, December 7 for the December 14 IRB meeting. A full review is reserved for any proposal posing more than minimal risk to research respondents.
b) Proposals that have been confirmed by the Departmental Reviewer (DP), the researcher, and the researcher’s supervisor as exempt or expedited may be received by the IRB Chair at any time, not just at the time of one of the four annually scheduled IRB meetings.
c) No proposal can be reviewed without the signature of the Departmental Reviewer. The DP’s signature represents agreement with the proposed level of review and confirmation that the relevant supportive documentation is provided. Forms B, C, and D indicate the types of supportive documentation required. When signatures are required, please do not use typed signatures. Use either a manual or a facsimile signature.
d) If the IRB Chair agrees with the Departmental Reviewer’s assessment that the level of review is exempt, the IRB Chair confirms this with a short letter to the investigator. Unless changes are made in the protocol, this is the last contact that the IRB has with the investigator.
e) If the proposal requires an expedited review, the IRB Chair forwards the proposal to an anonymous member of the IRB for review. We hope to get a response back to the investigator within two weeks of the chair’s receipt of the proposal. The investigator may or may not be asked to make some further revisions. This decision will be relayed to the investigator by e-mail from the IRB Chair.
f) All IRB proposals, regardless of the level of review required, must be sent to the IRB Chair electronically as one continuous document.
II. What does a complete IRB application contain?
All proposals require a completed and signed Form A (signed by researcher, researcher’s supervisor (if a student) and the DP. For exempt proposals, Form B should also be completed.
For expedited proposals, Form C should also be completed.
For full reviews, Form D should also be completed
For all proposals (exempt, expedited, full) recruitment procedures and scripts, consent and assent forms, and all instrumentation (recruitment scripts, interview guides, questionnaires, experimental procedures and debriefing scripts, if appropriate), should be included with the proposal. Otherwise, the proposal is incomplete and cannot be reviewed until all documents are received.
Screen shot of NIH Protecting Human Research Participants certificate or comparable training, such as CITI.
IRB WEBSITE
The direct link to the IRB website and all necessary forms is: http://www.brynmawr.edu/grants/irb/
The direct link to all necessary IRB forms, including consent, assent, and web survey guidance is: http://www.brynmawr.edu/grants/irb/appendix.html
III. What happens after the initial IRB review is completed and approved by the IRB?
a) If the investigator wants to make any changes to the approved protocol, s/he must send a request for administrative approval to the IRB Chair. NO PROPOSED CHANGES CAN BE MADE UNTIL THE IRB CHAIR PROVIDES APPROVAL. The turnaround on amendments should be no longer than two weeks, depending on the changes requested and whether or not the level of risk for participants is raised.
b) All protocols, except for those which were approved by investigator, the departmental reviewer, and the IRB Chair as exempt, require an annual review (Continuing Review). These reviews are conducted in one of the four standing meetings of the IRB. You will receive an email reminder that your continuing review is upcoming in the next IRB meeting from Nona Smith, Director of Sponsored Research at the College. The relevant materials should then be sent directly to the IRB Chair (lalexand@brynmawr.edu).
YOUR REMINDER ABOUT CONTINUING REVIEWS WILL BE SENT TO YOUR BRYN MAWR COLLEGE EMAIL ADDRESS ONLY.
c) Termination Forms
All research approved by the IRB, except for research which is approved as exempt from further review, must be terminated when the research is completed. Research where data collection is completed, but data analysis is not completed, must receive a continuing review.
We thank you for your attention to these points and look forward to working with you. We will be working on the IRB website this year to make it more use-friendly. If you have suggestions, please send them to any of the individuals listed below.
Sincerely,
Leslie Alexander – Chair – Social Work
Jim Baumohl – Social Work
David Consiglio – Head of Research Support and Educational Technology
Gary McDonogh – Growth and Structure of Cities
Judy Porter – Sociology (Emerita)
Bethany Schneider – English
Jennifer Spohrer – Coordinator of Academic Technology Initiatives
Anjali Thapar (Semester I), Rob Wozniak (Semester II) – Psychology
Nona Smith – Director of Sponsored Research, Ex Officio
Billie Jo Ember – Grants Associate, Ex Officio
Sam Magdovitz – College Counsel, Ex Officio