Contact Information

Organization

THE COMMITTEE ON HUMAN RESEARCH

CONSENT PROCESS - CERTIFICATE OF CONFIDENTIALITY

• UCSF Contact Information
• Background
• Procedures

UCSF Contact Information

If you have any questions please contact Terry Colbert weekdays 8:00 a.m. to 4:30 p.m. Pacific Time at 415-502-5816 (on campus extension 2-5816).

Background

The Certificate of Confidentiality is an agreement between the PI and the respective institute of the National Institutes of Health (NIH). It is issued by the NIH to protect the privacy of research subjects by allowing investigators and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

More Background Information and Frequently Asked Questions can be obtained on the NIH website.

When a researcher obtains a Certificate of Confidentiality, the research subjects must be told about the protections afforded by the certificate and any exceptions to those protections. The CHR-approved consent form should include appropriate wording from the Certificate of Confidentiality Application OR from the CHR Guidelines:

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.

Exceptions: A Certificate of Confidentiality does not prevent researchers from voluntarily disclosing information about you, without your consent. For example, we will voluntarily disclose information about incidents such as child abuse, and intent to hurt yourself or others. In addition, a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. Finally, the Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

Procedures

First: The PI must obtain CHR approval of a consent form that includes the Certificate of Confidentiality wording.

If you are submitting a new CHR application and know you are going to apply for a Certificate of Confidentiality, you may incorporate the Certificate wording into the consent form accompanying your CHR application.  Bear in mind, however, that applications for Certificates must be submitted to the NIH at least three months prior to the date on which enrollment is expected to begin.  If you will not have that much time following CHR approval, you may submit a consent form without the Certificate wording in your CHR application and tell the CHR in your cover letter that you plan to apply for a Certificate.  After you get CHR approval to begin your study, you can submit a modified consent form with the Certificate wording, and when the modification is approved you can apply to the NIH.  The consent form initially approved by the CHR can be used until you obtain the Certificate.  Subjects who enroll before the Certificate is issued will still be protected by it if they participate in the study during any time the Certificate is in effect.

If you have submitted a new CHR application without plans to apply for a Certificate and the CHR suggests in a conditional or contingent approval that you should consider obtaining one, you should address the suggestion in your response letter.  After you obtain CHR approval, you can submit a modification adding the wording to your consent form and use the modified consent form in your Certificate application.

If you already have CHR approval and are using a consent form without the Certificate wording but decide that you want to apply for a Certificate, you should submit a modified consent form to the CHR first and apply for the Certificate after the modification is approved.

Second: The PI submits the following documents to the CHR, not Contracts and Grants.

a.	Current CHR approval letter.
b.	CHR-approved consent form.
c.	The Certificate of Confidentiality application addressed to the NIH Certificate of Confidentiality Contact or Coordinator at the NIH Institute or Center. The Institutional Official signature block should read: _____________________________ John Heldens, CIP Director, HRPP University of California, San Francisco, CA 3333 California St., Suite 315 San Francisco, CA 94118

Third: The PI will:

a.	Keep current records of correspondence with agency and CHR .
b.	Inform the NIH of any modifications or changes to the IRB protocol or consent form.
c.	Submit these changes to the NIH
d.	Be responsible for submitting these changes and maintaining the expiration date

Fourth: The CHR office will:

a.	Have the Institutional Official or designated official sign the Certificate Confidentiality
b.	File the signed copy in the CHR protocol.
c.	Mail the original to the PI

Fifth: NIH will:

a.	Review the Certificate of Confidentiality and provide correspondence of approval or disapproval to both the PI and Institutional official.
b.	The IRB will then file this information with the original application.