Certificate of Confidentiality From NIH

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Background

Procedures

Consent Form Wording

 

Background

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to safeguard the privacy of research study participants by protecting identifiable research information from forced disclosure. A Certificate of Confidentiality allows 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 FAQs are available on the NIH website.

UCSF Contact Information: If you have any questions, contact Karen Simpkins at 415-476-9134.

Procedures

The NIH Certificate of Confidentiality Kiosk explains the submission process to NIH, so please use the kiosk info and follow the steps below. 

NIH has a online application system for all Certificate of Confidentiality requests. You will fill out the Certificate of Confidentiality application and attach the required documents in the online system. Certificates of Confidentiality are issued by the individual NIH Institutes/Centers (ICs), and you will need to know to which NIH IC you are applying.

Note: When seeking to amend or extend an existing certificate, please contact the issuing IC staff to determine if the online system can be used for this purpose.

1. The PI obtains IRB approval of a consent form that includes the Certificate of Confidentiality wording (see sample wording below). The links below describe how/when to submit the consent form to the IRB based on the status of your study.

If you are submitting a new study to the IRB and know you are going to apply for a Certificate of Confidentiality

Incorporate the Certificate wording into the consent form accompanying your IRB Application. Bear in mind 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 need to start enrolling subjects on a new study before a Certificate of Confidentiality will be granted by NIH

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 IRB approval, submit a consent form without the Certificate wording in your IRB Application and tell the IRB in section 1.8 of the Initial Review Submission Packet that you plan to apply for a Certificate.

After you get IRB approval to begin your study, you can submit a modified consent form with the Certificate wording. When the modification is approved, you can apply to the NIH.

The consent form initially approved by the IRB 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 the IRB suggests you consider obtaining a Certificate of Confidentiality for your new study

Address the suggestion in your submission response. After you obtain IRB approval, you can submit a modification adding the Certificate wording to your consent form and use the modified consent form in your Certificate application.

If you already have IRB approval and decide you want to apply for a Certificate of Confidentiality

Submit a modified consent form that includes the Certificate wording to the IRB first. Apply for the Certificate after the modification is approved.

2. The PI uploads the following documents in the online application system.

a. Current IRB approval letter.

b. IRB-approved consent form.

c. A signed assurance document. Click here for the assurance template. Include the study title and IRB number on this document.

The Institutional Official signature block should read:

_____________________________

Theresa O’Lonergan, PhD, MA
Associate Vice Chancellor
Chief Ethics and Compliance Officer
Institutional Official
University of California, San Francisco
3333 California St.
San Francisco, CA 94118

3. The PI will:

a. Keep current records of correspondence with agency and IRB.

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.

4. The IRB office will:

a. Have the Institutional Official or designated official sign the Certificate Confidentiality.

b. File the signed copy.

c. Mail the original to the PI.

5. 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.

Consent Form Wording

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 IRB-approved consent form should include appropriate wording from the Certificate of Confidentiality Application OR from the IRB 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.

Step 1 in the Procedures section describes how/when to add this wording to your study, based on the study status.