1 Nimh Duc (ncrd)

OMB# 0925-0667

EXP: 01/31/2016

Burden Disclosure Statement

Public reporting burden for this collection of information is estimated to vary from 15 min to 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0667). Do not return the completed form to this address.

NIMH Data Access Request/Use Certification

Date: _____________________

Data Requested: ___NIMH Clinical Research Datasets

Specify dataset: ______________________________________

First Name:  ____________________________    Last Name:  __________________________

Degree: _______________ Academic Position (or Title):  ______________________________

Institution: _______________________________ Department:  _________________________

Street Address: ________________________________________________________________

City: ________________________  State/Province: ___________________________

Zip/Postal Code: __________________ Country: ____________________________

Telephone:  ____________________________ FAX: ________________________

E-mail Address: ___________________________________

Research Project (title):

______________________________________________________________________________

By signing and dating this DUC as part of requesting access to NIMH Clinical Research Datasets, my Institutional Officials and I certify that we will abide by the DUC and the NIH principles, policies and procedures for the use of NIMH Clinical Research Datasets. I further acknowledge that I have shared this document and the NIH policies and procedures with any research staff who will participate in the use of NIMH Clinical Research Datasets. My Institutional Business Official(s) also acknowledges that they have shared this document and the relevant NIH policies and procedures with appropriate institutional organizations.

Signature: ____________________________  Date: ____________

Authorized Institutional Business Official (as registered in the NIH eRA Commons: https://commons.era.nih.gov/commons/)

Name: _______________________________________________             

Title: ________________________________________________

FWA#:_____________________

Signature: _____________________________Date: ____________

Inquiries about NIMH Clinical Research Datasets should be sent to:

Clinical Trials Operations and Biostatistics

National Institute of Mental Health, National Institutes of Health

6001 Executive Boulevard, Room 7154, MSC 9649

Rockville, MD 20892-9649 (if overnight delivery): Rockville, Maryland 20852

Email: nimhdatasets@mail.nih.gov

Project Director/Principal Investigator Contact Information (if different from above)

First Name:  ____________________________    Last Name:  __________________________

Degree: _______________ Academic Position (or Title):  ______________________________

Institution: _______________________________ Department:  _________________________

Street Address: ________________________________________________________________

City:                 ________________________  State/Province: ___________________________

Zip/Postal Code: __________________ Country: ____________________________

Telephone:  ____________________________ FAX: ________________________

E-mail Address: ___________________________________

Authorized Representative (Institutional Official)

First Name:  ____________________________    Last Name:  __________________________

Degree: _______________ Academic Position (or Title):  ______________________________

Institution: _______________________________ Department:  _________________________

Street Address: ________________________________________________________________

City:  ________________________  State/Province: ___________________________

Zip/Postal Code: __________________ Country: ____________________________

Telephone:  ____________________________ FAX: ________________________

E-mail Address: ___________________________________

Other Project Information:

1. Are Human Subjects involved? __ Yes __ No

If YES to Human Subjects

Is the Project Exempt from Federal regulations? __ Yes __ No

If yes, check appropriate exemption number. __1 __2 __3 __4 __5 __6

If no, is the IRB review pending? __ Yes __ No

IRB Approval Date: _______________

2. Research Use Statement/Project Summary:

Insert here.

Senior/Key Person Profile (Collaborating Investigator at Same Institution)

First Name:  ____________________________    Last Name:  __________________________

Degree: _______________ Academic Position (or Title):  ______________________________

Institution: _______________________________ Department:  _________________________

Street Address: ________________________________________________________________

City: ________________________  State/Province: ___________________________

Zip/Postal Code: __________________ Country: ____________________________

Telephone:  ____________________________ FAX: ________________________

E-mail Address: ___________________________________

Project Role: ____________________________ Other Project Role Category: _____________________

Senior/Key Person Profile (Collaborating Investigator at Same Institution)

First Name:  ____________________________    Last Name:  __________________________

Degree: _______________ Academic Position (or Title):  ______________________________

Institution: _______________________________ Department:  _________________________

Street Address: ________________________________________________________________

City: ________________________  State/Province: ___________________________

Zip/Postal Code: __________________ Country: ____________________________

Telephone:  ____________________________ FAX: ________________________

E-mail Address: ___________________________________

Project Role: ____________________________ Other Project Role Category: _____________________

Senior/Key Person Profile (Collaborating Investigator at Same Institution)

First Name:  ____________________________    Last Name:  __________________________

Degree: _______________ Academic Position (or Title):  ______________________________

Institution: _______________________________ Department:  _________________________

Street Address: ________________________________________________________________

City: ________________________  State/Province: ___________________________

Zip/Postal Code: __________________ Country: ____________________________

Telephone:  ____________________________ FAX: ________________________

E-mail Address: ___________________________________

Project Role: ____________________________ Other Project Role Category: _____________________

Use additional sheets for additional profiles as needed.