Attachment 3 IRB OHSR Response to Review

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVING HUMAN SUBJECTS
FAX:

Exempt:#:

To:

12843

Easter, Carla
NHGRI
BG 31 RM B1 B55
Office of Human Subjects Research (OHSR)

From:

Nature of Research Activity:
NHGRI is conducting a two-phase outcome evaluation of the NHGRI Summer Workshop in Genomics, Short
Course, an intensive, four-day course is designed to update biology instructors, as well as other instructors
and researchers in related disciplines, on genomic science. During the first phase, NHGRI will administer an
online survey to all past participants (approximately 350 from 2004-2014) to explore three main outcomes:
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Original Request Received in OHSR on:

3/12/2015

Responsible NIH Research lnvestigator(s):

Carla Easter, PhD NHGRI

OHSR review of your request dated Tue, Mar 10, 2015 has determined that:

[g) Federal regulations for the protection of human subjects do not apply to above named activity. The OHSR

0

determination of Not Human Subjects Research is based on the interpretation of 45 CFR 46 under "Research
Involving Coded Private Information or Biological Specimens" (OHRP, Revised October 16, 2008) and Guidance
on Engagement of Institutions in Human Subjects Research (October 16, 2008). NOTIFY OHSR VIA AN E-MAIL
AMENDMENT OF ANY CHANGES THAT MAY ALTER THIS RESEARCH ACTIVITY.
The activity is designated EXEMPT, and has been entered in the OHSR database. PLEASE NOTIFY OHSR
OF ANY SIGNIFICANT CHANGES THAT MAY ALTER THE EXEMPT STATUS OF THIS RESEARCH
ACTIVITY.

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NOT EXEMPT. OHSR recommends IRB review. Please forward your request to the Chair of your IRB, who
may ask you to provide additional information in order to determine whether expedited or full review is
aoorooriate.

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Confidentiality Agreement

0

Reliance

0

Amendment

0

Other
Office Person JE

Admin Assist. CB

Note:
3/23/2015: Program evaluation

Julie M. Eiserman

Policy Analyst, OHSRP

3/23/2015

Signature

Title

Date

Domestic/International:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

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