Certificate of Confidentiality From NIH

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What is a Certificate of Confidentiality?

Procedures

Consent Form Wording

 

What is a Certificate of Confidentiality?

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

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. Learn more about the new policy and read the NIH blog on these changes

How does this new policy affect already approved/ongoing studies?

All partly or wholly funded NIH research ongoing on or after December 12, 2016, will also be covered by a CoC and by this new policy. For research funded by one of NIH's sister HHS agencies that issue CoCs to their awardees (HRSA, CDC, SAMHSA), the investigator should contact the agency about obtaining this protection through the agency.

Note: Investigators are required to ensure that other investigators or collaborating institutions whom they share identifiable sensitive information with are notified that they are also subject to the disclosure restrictions even if they are not funded by NIH.

Is re-consent required?

Re-consent is not required for participants currently enrolled in ongoing studies. For ongoing studies that did not have a CoC and now receive one as part of the new policy, please turn in a revised consent form at the time of your next modification or continuing review. Include the wording described below.

In the interim, provide enrolled participants with this IRB-provided handout that describes the protections afforded by the certificate and any exceptions to those protections.

CoC not automatically granted for non-federally funded research; continue to submit CoC applications to NIH

NIH will continue to consider requests for Certificates for non-federally funded research in which identifiable, sensitive information is collected or used. Follow the procedures below to apply for a CoC.

NIH definition of sensitive information

Sensitive information includes (but is not limited to) information relating to sexual attitudes, preferences, or practices; information relating to the use of alcohol, drugs, or other addictive products; information pertaining to illegal conduct; information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination; information pertaining to an individual's psychological well-being or mental health; and genetic information or tissue samples.

CoC Application Procedures for Non-Federally Funded Research: NIH will continue to consider requests for Certificates for non-federally funded research in which identifiable, sensitive information is collected or used.

1. The PI obtains IRB approval of a consent form that includes the CoC wording. 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 CoC

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 CoC 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 CoC 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 CoC

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

2.  To obtain a Certificate of Confidentiality (Updated April 2020): 

Step 1: Go to this link: https://grants.nih.gov/policy/humansubjects/coc/how-to-apply.htm and click on “Get your CoC”  

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

  • [UCSF IRB #(XX-XXXXX)] + Research Project Title
  • Project Start Date
  • Project End Date
  • Project Description
  • Name of Instition
  • Institution Address
  • 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

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.