TEMPLATE: Gatekeeping Form

Repository Use Only

Number ______

Date Received ______

Request for Research Use of Data and/or Specimens

[INSERT TITLE OF DATABASE, REPOSITORY, OR REGISTRY]

[INSERT NAME AND CONTACT INFORMATION FOR DATABASE, REPOSITORY, OR REGISTRY DIRECTOR]

Requestor Information:
Principal Investigator / Title / Department:
Box / Telephone / Pager: / Fax
If non-UW, mailing address:
Study Coordinator (if not PI): / Title
Telephone / E-mail: / Fax:
Date Requested: / Date Needed:
If you are requesting data or specimens from specific individuals, what kind of consent do you have?
IRB approved waiver of individual consent
IRB approved consent forms
Signed record release form
Specify location of Research:
Internal (UW only) research (attach UW Confidentiality Agreement or signed consent or record release forms)
External collaborative research (attach Material Transfer Agreement (MTA))
External non-collaborative research (attach School of Medicine approval) / Level of Data-Specific Information Requested: (if more than one, complete separate request forms for each)
Aggregate data only
Anonymous (identifiers removed, no link between data and subject identities)
Coded data (requestor does not have link to subjects’ identities)
Coded data (requestor has link to subjects’ identities)
Identifiers provided by requestor
Other, explain:
Requestor’s Institutional Review Board(IRB) approval number:
Date of current approval: Title of study:
Description of purpose of project and data requested: (Summarize how you plan to use the data or specimens. Specify data fields, tissue types, numbers of samples, etc. Add additional pages as necessary.)
Confidentiality Agreement

If data or specimens I receive are linked to individual identifiers, I agree that only the parties signing this agreement will have access to this information.
If data or specimens I receive are identified with a code, I agree that I will not request access to the master list linking the code with the identifier.
I agree that the identity of individual subjects will not be disclosed when the data are presented or published.
I acknowledge that the quality and completeness of data cannot be guaranteed, and that I will use these data or specimens at my own risk.

Signature of Requestor (P.I.): ______Date ______

Approval of Request

Signature of Repository Director or designee: ______Date ______

Attach as appropriate:

Confidentiality Agreement for waiver of consent/authorization

Signed and dated consent or record release forms

Material Transfer Agreement (MTA)

School of Medicine approval for non-collaborative use

Budget number:

Budget Coordinator: Phone no.: email: Mail stop:

Q-464Sample Gatekeeping Form (rev. 3-06)Version 1.0