#1_Attach2_OHSRP Review_CRNurse

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

301 480-3441

To:

Gradv. Meredith

Exempt:#:

11635

NCI
6116 Executive Blvd.
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The NCI in collaboration with the NIH Clinical Center, The Johns Hopkins University School of Nursing, and
the Georgetown University Medical Center conducted formative research to gain a better understanding of
the current environment around clinical research from the diverse perspective of schools of nursing faculty,
nurse employers, and practicing nurses. Results indicated that clinical research is considered to be an
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Original Request Received in OHSR on:

10/12/2012

Responsible NIH Research lnvestigator(s):

Meredith Grady, MPH NCI

OHSR review of your request dated Wed. Oct 10, 2012 has determined that:

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

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Reliance

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Amendment

D

Other
Office Person H B

Admin Assist. CB

Note:

Signature

Director. OHSRP

10/23/2012

Title

Date

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

No

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