- What is a Certificate of Confidentiality?
- Procedures/FAQs
- CoC Application Procedures for Non-Federally Funded Research
- CoC IRB Submission Procedures
- Consent Form Wording
- Resources
What is a Certificate of Confidentiality?
A Certificate of Confidentiality (CoC) is 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 CoC 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.
Procedures/FAQs
Policy Change Effective October 1, 2017: Under the updated policy, NIH-funded researchers will no longer have to request a CoC, nor will they receive an actual certificate. The CoC will be issued automatically to NIH-funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that collects or uses identifiable, sensitive information.
CoC Application Procedures for Non-Federally Funded Research
As noted above, the NIH CoC application system for non-NIH funded research is currently unavailable. In the event that this system becomes available again, the following procedures should be followed:
- Only apply for the certificate for an already approved study. The NIH is not able to make certifications when there is not yet an actual study.
- Be sure to include the IRB number in the same field as the title for the study
- Be sure to use the main UCSF address (505 Parnassus Ave., SF, CA 94143) as the institutional address - they want this to be uniform. Any other UCSF address would be included under "performance site" addresses
CoC IRB Submission Procedures
The instructions below describe how/when to submit the consent form to the IRB based on the status of your study.
1. The PI obtains IRB approval of a consent form that includes the CoC wording.
If your study is funded by NIH so that you will automatically receive a CoC:
Incorporate the Certificate wording into the consent form accompanying your initial IRB Application.
If NIH funding is anticipated but has not been awarded, or new NIH funding is obtained during the course of the study:
Do not add the language. Instead, submit a modification form to provide final details of funding when received. This modification should also include a revised consent form incorporating the Certificate wording. For studies with new NIH funding, the Certificate of Confidentiality question in the study application should also be changed to “yes.”
If your study is not funded by the NIH, and you will be applying to the NIH for a certificate after initial IRB approval:
Answer the “Certificate of Confidentiality” question in the Study Application “yes,” but do not incorporate the Certificate wording into the consent form.
Include a note in the “Extra Confidentiality Measures” section of the application or another appropriate place that you plan to apply for a CoC from NIH after initial IRB approval.
After you receive confirmation from the NIH that you have an approved CoC, submit a modification including a modified consent form that includes the Certificate wording, and documentation from the NIH that the CoC has been obtained.
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.
2. To obtain a Certificate of Confidentiality (Updated April 2020):
Step 1: Go to this link: https://grants.nih.gov/policy/humansubjects/coc/request-certificate.htm and click on “Access NIH Certificate of Confidentiality System”
Step 2: Fill out these 6 questions and click "Next"
Step 3: Fill out the next application questions that comes up. [please note: you will be asked to provide the following information, including the Institutional Official’s contact info. It is: Brian Smith, [email protected], 415.514.2080
Do not submit until your study is approved.
- [UCSF IRB #(XX-XXXXX)] + Research Project Title
- Project Start Date
- Project End Date [must be a date a few weeks ahead of application date- NIH won't approve if they receive a date prior to their review]
- Project Description
- Name of Institution
- Institution Address [505 Parnassus Ave., San Francisco, CA 94143]
- Name of Institutional Official (Brian Smith)
- Email Address of Institutional Official ([email protected])
- Phone Number of Institutional Official (415.514.2080)
- Performance Site Name
- Performance Site Address
- Name of PI
- Other Key Personnel
- List any drugs that will be administered in this study, including method of administration and dosage (e.g. Phenobarbital 50 mg 2 times daily)
Add Drug name [if applicable, upload proof of DEA controlled substance registration in field provided]
Step 4: Click “Submit for Verification”
Step 5: Wait to hear back from NIH.
Once submitted, the NIH will send an e-mail to the Institutional Official, Brian Smith, for verification. Please do not contact Brian Smith with questions about your application. The information will be verified and confirmed to NIH, and NIH will contact you. We anticipate providing an update on the status within a week.
NIH contact info: [email protected]
Consent Form Wording
When a researcher obtains a CoC, 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 the Suggested Consent Language Describing the CoC Protections from NIH.
Step 1 in the Procedures section describes how/when to add this wording to your study, based on the study status.
Resources
- Guidance on Certificate of Confidentiality: This memo provides information about CoCs, which federal agencies may issue to researchers to protect subjects' privacy, and highlights good data management practices in cases where identifiable research information is commingled with other data.