Form 16 Landing Page

PHS Human Subjects and Clinical Trials Information
0MB Number: 0925-0001 and 0925-0002

I View Burden Statement ]

Expiration Date: 03/31/2020

Use of Human Specimens and/or Data
* Does any of the proposed research in the application involve human specimens and/or data?

0 Yes

0 No

Provide an explanation for any use of human specimens and/or data not considered to be human
subjects research.
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Please complete the human subjects section of the Research & Related Other Project Information form prior to completing this form.
The following items are taken from the Research and Related Other Project Information form and displayed here for your reference. Any changes
to these fields must be made on the Research & Related Other Project Information form and may impact the data items you are required to
complete on this form.
Are Human Subjects Involved?
Is the Project Exempt from Federal regulations?
Exemption Number:

0 Yes

0 No

O Yes
01

0 No
02

03

04

05

06

07

08

If No to Human Subjects
Skip the rest of the PHS Human Subjects and Clinical Trials Information Form
If Yes to Human Subjects
Add a record for each proposed Human Subject Study by selecting "Add New Study" or "Add New Delayed Onset Study" as appropriate. Delayed
onset studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on
Delayed Onset Studies. For delayed onset studies, you will provide the study name and a justification for omission of human subject study
information.
Other Requested Information
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Click here to extract the Human Subject Study Record Attachment
Study Record(s)
Attach human subject study records using unique filenames.

0 1) Please attach Human Subject Study 1

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Add New Study

Delayed Onset Study(ies)

Study Title

[Kl

Add New Delayed Onset

Anticipated
Clinical Trial?

0

J

Justification

I

J [

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