Deadlines Approaching for Feb. 25 and May 6 IRB Meetings

Posted January 27th, 2011 at 3:38 pm.

From Institutional Review Board Chair Leslie B. Alexander:

Dear faculty, students, and staff:

Above please find the dates of the IRB meetings for the spring, where all proposals requiring a full review must be reviewed. Your Departmental Reviewer and if you are a student, your adviser for the research, must sign off on the proposal. Then you need to send ten collated copies to the IRB chair who must receive them no later than 8 days before the stated IRB meeting. This means that proposals should be received by the IRB Chair no later than Thursday, February 17, 2011 for consideration at the IRB meeting of February 25, and by Thursday, April 28, 2011 for consideration at the IRB Meeting on May 6, 2011.

Proposals requiring an expedited review or are exempt from further review can be received by the chair at any point in time. We respond to these proposals within two weeks of the IRB Chair’s receiving them. Only one copy of the proposal is needed for expedited and exempt reviews.

The direct link to the IRB website is: http://www.brynmawr.edu/grants/irb/
The direct link to all necessary IRB forms is: http://www.brynmawr.edu/grants/irb/appendix.html
The direct link to the IRB policy and consent statement on web surveys is: http://www.brynmawr.edu/grants/irb/survey_consent.html

All proposals must have a completed Form B-1. If a full review is needed, Form B-4 should also be included; if an expedited review is needed, Form B-3 should also be included; and if an exemption is being sought, Form B-2 should also be included.

Four updates to our procedures
Exempt proposals

All proposals deemed exempt from further review need to come to the IRB chair, after review by your Departmental Reviewer. The chair will write a letter to you, confirming the exemption classification. These are found in Part B of Form B-1. Please be sure to check off as many of the criteria on Form B-2, Part B, as apply.

Assent and consent form guidance

Because the IRB often finds information missing from the assent and consent forms, which can delay proposal approval, we have developed some guidance for each, found on the IRB website under Forms. Please be sure to consult these guidance documents when you develop your consent and/or assent forms.

Reminder about web policy and consent statement

Be sure to check our web policy BEFORE sending in proposals that include web-based research
not all survey software provides encryption free of charge, but our IRB requires it. Also, you must have a consent statement at the beginning of the web survey, providing all of the necessary components of informed consent, including the blurb about limits to confidentiality on the BMC IRB website.

Responding to requested changes from the IRB

If changes are requested after IRB review, please use the tracking option in Word to provide these changes in any of your original documents where change was requested. Please include in your return email a brief documentation of the changes made and where to find them.

Two important reminders

Continuing Review, Termination

Please remember that all research approved by the IRB, except for research which is approved as exempt from further review, must have a continuing review on an annual basis, provided in one of the four annual meetings of the IRB. Nona Smith will notify you if your research needs a continuing review in an upcoming IRB meeting. She will inform you using your BMC email address, so if you don’t use that address on a regular basis, be sure to have Bryn Mawr email forwarded to your primary email account Please complete either the continuation or termination form and any associated documents requested, in a timely fashion. These should be sent directly to the IRB Chair so that they can be reviewed in the appropriate IRB meeting (the one closest to the initial approval date). They do need a signature. A facsimile signature is now acceptable.

Changes to approved protocol

If you make any changes to the protocol, these changes must be approved by the IRB BEFORE the changes can be instituted. If the changes do not raise the level of risk to study participants, the IRB chair will approve the changes and send you a letter to that effect. If the Chair has any concerns about the levels of risk involved, then the full IRB will need to be consulted. The chair will let you know in a timely fashion if the latter applies to your modifications to the approved protocol.

Your IRB colleagues thank you for your continued patience and good humor. A hard copy of this email is also provided as an attachment. Please print it out for later consultation.

Sincerely,

Leslie Alexander, Chair
Juan Arbona
Jim Baumohl
Phil Kilbride
David Consiglio
Lauren Myers
Judy Porter
Bethany Schneider
Morgan Wallhagen
Glenn Wilson, Community Member
Nona Smith, Ex Officio
Sam Magdovitz, Ex Officio

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