**[REQUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN
SUBJECTS]{.underline}**

INSTRUCTIONS: Please type directly on this form. You can expand the
document if you need more space. If your research involves a survey or
questionnaire, please attach it to this completed form.

Completed forms (with all required signatures) may be sent to OHSR by
FAX (301-402-3443) or by mail (2C146). If you have any questions, call
OHSR at (301) 3444.

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

To: OFFICE OF HUMAN SUBJECTS RESEARCH, Building 10, Room 2C-146

From:
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(Signature)

Through:
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(Signature of appropriate Official for IC, e.g., Lab/Branch Chief)

**Name of NIH Principal
Investigator(s)**:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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IC \_\_\_\_\_\_\_\_\_\_\_\_\_ Laboratory/Branch
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Building & Room No. \_\_\_\_\_\_\_\_\_ Tel. No. \_\_\_\_\_\_\_\_\_\_ FAX
No. \_\_\_\_\_\_\_\_\_\_\_

**Is the Principal investigator an NIH employee? \_\_\_\_\_Yes
\_\_\_\_\_\_\_No**

**If no, please
explain:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

> **1. What is the proposed research activity that you intend to perform
> at NIH (please use lay terms):
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

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**2. If applicable, list your non-NIH Collaborating
Investigator(**s**).**

Name Institution Address Tel. \# FAX \#

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**3. Proposed start date of your research** \_\_\_\_\_\_\_

**Proposed completion date** \_\_\_\_\_\_\_\_\_\_\_\_

**4.** **Will you be \_\_\_\_\_\_\_\_\_these samples or data?**

Collecting Yes/No

Receiving Yes/No

Sending Yes/No

5\. Do the samples or data:

> \(a\) Already exist? \_\_\_Yes \_\_\_\_No
>
> \(b\) Or are they being collected for the express purpose of this
> study? \_\_\_Yes \_\_\_\_No
>
> If "yes," please
> describe:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \(c\) Or a combination of (a) and (b)? \_\_\_\_Yes \_\_\_\_\_No

6\. What role will you have in this research project? (Check all that
apply)

\_\_\_ Analyze samples/data only.

\_\_\_ Consultant/advisor to collaborator(s) listed above.

\_\_\_ Author of the protocol that is being implemented by your
collaborating investigator (identified in question #2).

\_\_\_ Co-authorship on publication(s)/manuscript(s) pertaining to this
research.

\_\_\_ You or NIH hold an IND for this research.

\_\_\_ Decisional authority over the design or implementation of the
research at the IRB approved site? If so, please explain.
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\_\_\_\_\_Other (If necessary, use this space to describe your role in
this research).
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7\. Where are the subjects of this research activity located?

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**8. If human subjects are located elsewhere (not at NIH), will you have
direct contact or intervention with them?** (Examples: as subject\'s
physician; in obtaining samples directly from the subject; by
interviewing the subject?) \_\_\_\_ Yes \_\_\_\_No

**9. What kind of human samples (e.g., tissue, blood) or data (e.g.,
private information, responses to questionnaires) will be involved in
your research?**

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10\. If the samples, data do not come from an IRB approved protocol, do
they come from:

> \(a\) Repository \_\_\_\_Yes \_\_\_ No
>
> \(b\) Pathological waste \_\_\_ Yes \_\_\_\_\_No
>
> \(c\) Autopsy material \_\_\_ Yes \_\_\_ No
>
> \(d\) Publicly available source \_\_\_Yes \_\_\_ No
>
> \(e\)
> Other\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**11. Please check the box(es) that apply(ies) to the samples/data that
you will receive.**

\(a\) \_\_\_\_ Samples and/or data will be anonymized/unlinked. (The
samples/data cannot be linked to individual subjects by you or your
collaborators at other sites.)

\(b\) \_\_\_ Samples and/or data will be coded, however that code cannot
be used by either the sender or the receiver to identify specific
individuals.

\(c\) \_\_\_ Samples and/or data will be coded so that the provider of
the samples/data can link them to specific individuals but the receiver
will not be able to do so.

**12. Will you send results back to the provider(s) (listed in question
2 of this form)?**

(a) \_\_\_ No, I will not send results back to the provider(s).

(b) \_\_\_ Yes, I will send aggregate results to the provider(s).

(c) \_\_\_ Yes, I will send results to the provider(s) that are linked
    to identifiable individuals.

If yes, does the provider intend to link your data to identifiable
individuals?

\_\_\_\_\_Yes \_\_\_\_\_\_\_No

**13. Has the research activity [that you are proposing in this
form]{.underline} been approved by an Institutional Review Board (IRB)
elsewhere?**

\_\_\_\_\_\_\_\_\_ Yes, the NIH research activity has been reviewed by
the following IRB (s) (Please provide the following information for
**each** IRB):

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Name of institution
that provided the review

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Address of reviewing
institution

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Name of PI for the
IRB approved protocol

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Title of IRB
approved protocol and protocol \#

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Federal Wide
Assurance (FWA) number**\*\***

\_\_\_\_\_\_\_\_\_No IRB review of the research activity described in
question #1 above has taken place

(**\*\***An FWA is a contract between the U.S. Department of Health and
Human Services (DHHS) and an entity receiving DHHS funds to conduct
clinical research that the latter will follow ethical guidelines and
federal regulations for the protection of human subjects. For a list of
domestic and international institutions go to
<http://ohrp.cit.nih.gov/search/asearch.asp#ASUR>

**14. Per NIH guidance\*\*\*, have conflicts of interest by NIH
employees, if any, been resolved?**

**\_\_\_\_\_Yes \_\_\_\_\_No**

**If your answer is no, please see your Clinical Director about this
matter before proceeding with this research.**

\*\*\*The January 5, 2005 NIH Guide to Preventing Conflict of Interest
applies to all research conducted at NIH,
<http://ohsr.od.nih.gov/New/mpafwa_docs.html>