IRB 041332 Approval Healthy Weight

Date:
To:

June 21, 2013
Susan Wood, PhD

From:

The George Washington University Committee on Human Research,
Institutional Review Board (IRB), FWA00005945

Re:
Subject:
Sponsor:
Risk Level:

Correspondence dated 04/17/2013
IRB#041332 -- Healthy Weight in Lesbian and Bisexual Women
Office of Women’s Health, DHHS
Minimal
Status: Active
Expiration date: 6/19/2014

This is to certify that the Institutional Review Board has fully approved the above referenced
protocol via expedited review procedure under categories # 4 & 7 of 45 CFR 46.110.
The IRB has also determined that this study meets the criteria for a waiver of the subjects’ signature
as documentation of consent under 45 CFR 46.117 (c).
The expiration date of this project is 6/19/2014. HHS regulations at 45 CFR 46.109(e) require that
continuing review of research be conducted by the IRB at intervals appropriate to the degree of risk
and not less than once per year. The regulations make no provision for any grace period extending
the conduct of the research beyond the expiration date of IRB approval. When your protocol
expires all research activities must stop. Please mark your calendar now to insure that the IRB
receives a renewal request 30 days before the anniversary date of the project, if this study is expected
to extend beyond one year.
This protocol has been approved for a maximum number of 190 subjects to be enrolled under the
auspices of George Washington University. If you wish to increase enrollment beyond this number,
you must submit a modification request to the IRB and obtain approval before exceeding this
number.
Please note that the IRB must be notified if the project is altered in any way (change in location,
personnel, number of subjects, age of subjects, or any change in research protocol). If you have any
questions, please do not hesitate to contact the Office of Human Research either by email
at [email protected] or via phone at 202-994-2715.

MPB/dba

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