Tips for Certificate of Confidentiality Applicants
What is this privacy protection?
Under Section 301(d) of the Public Health Service Act (42 U.S.C. 241 (d)) the Secretary of Health and Human Services may authorize persons engaged in biomedical, behavioral, clinical, or other research to protect the privacy of individuals who are the subjects of that research by refusing to disclose individually identifiable research information in any Federal, State or local civil, criminal, administrative, legislative or other proceedings.
The National Institutes of Health (NIH) extends this privacy protection in the form of Certificates of Confidentiality (CoC) to qualified applicants conducting research within its mission areas. While the researchers need not have federal support to qualify for a Certificate, their issuance is discretionary.
Where can I find information about eligibility and application instructions?
Detailed information about this privacy protection is available on the Office of Extramural Research (OER) Certificates of Confidentiality Kiosk. This site contains information about the scope of protection against compelled disclosure of individually identifiable information about research subjects, eligibility requirements, and application instructions.
When should the Principal Investigator (PI) begin the application process? It is best to apply before the study begins enrollment. An application can be submitted once the Institutional Review Board (IRB) has approved the study. This application must be submitted by the PI who is a faculty member or official of the research institution. See below for steps that should be taken if the Certificate of Confidentiality is obtained after enrollment and data collection has begun.
What should the PI do if the IRB will not issue its final approval until the project has been issued a Certificate of Confidentiality?
The PI may submit an IRB approval conditioned only upon the issuance of the Certificate of Confidentiality.
What if the research includes multiple protocols and/or sites?
The National Heart, Lung, and Blood Institute (NHLBI) supports many multi-site and networked clinical studies and trials. A single Certificate of Confidentiality can be issued where the same or overlapping subjects will be enrolled, and/or where one or more protocols will be carried out at more than one site. The lead site (or another site agreeing to accept the lead site responsibilities i.e. data management concerns, etc.) applies for all sites and affiliated groups. That site must promise to ensure that the consent forms at all sites are revised to appropriately describe the Certificate and its protections, and to remove language that is inconsistent with those protections. The lead site also agrees to ensure that all sites have copies of the Certificate and agree to the assurances. It is recommended that you contact your specific Division Coordinator or Program Director (the scientist administering your grant) for guidance if you are uncertain about whether a single application should be submitted.
What should the consent form submitted with the application include?
The application should include a consent form or a draft consent form that reads as it would if a Certificate of Confidentiality is obtained - explaining the Certificate, its protections and the circumstances in which disclosure might be made, i.e. to protect the subject or others from serious harm. This may mean making changes to the consent form that you would use if there were no Certificate of Confidentiality. Since the Certificate changes the legal ground rules, you should eliminate provisions that are confusing in light of the Certificate protections (such as references to disclosures required by law - the Certificate enables researchers to resist disclosures that would otherwise be compelled by law). It permits voluntary disclosures, such as to protect the subject or another person from harm, and these should be described.
What are the PI's responsibilities with respect to informing subjects about the Certificate of Confidentiality?
Once a Certificate has been obtained, it is the responsibility of the Principal Investigator (PI) to amend the consent forms to reflect receipt of the Certificate to inform participants, and to ensure that all sites (current and future) are in compliance and are using the amended consent form. For additional information, refer to the OER Certificates of Confidentiality Kiosk.
What should the PI do if the research takes longer than originally planned?
The PI should apply for an extension of the end date of the Certificate of Confidentiality. If this is a simple extension - with no major changes to the study (significant protocol changes, different PI, change of location) then a letter should be submitted from the PI on letterhead requesting the extension for the follow-up data collection providing the new end date. Included with the letter should be a currently effective IRB approval and a copy of the consent form(s) being used which should describe the Certificate protections and the circumstances in which disclosure might be made. The request for extension should be submitted at least three (3) months prior to the end date of the Certificate of Confidentiality.
What should the PI do if there are significant changes to the research?
If a component is to be added, then the PI should submit an amendment request using the NIH application format (extramural) on the website.
What should the PI do if new sites are added? If the research plan indicates that there will be more than one site, the PI should obtain signed copies of the assurances from each new site, and maintain them in its files along with a copy of the current IRB approval. When a new site is being added, the PI should submit a written request for an amendment of the original Certificate to add the new site(s), to the NHLBI Certificate of Confidentiality Coordinator.
Should the application be submitted to NHLBI, or to another NIH Institute?
The NHLBI reviews Certificate of Confidentiality requests from its own grantees and for projects related to heart, lung, blood and sleep disorders research as well as acts as a service center for the following other NIH Institutes and Centers: NINDS, NINR, NCCAM, and NCRR. These requests include applications from non-federal institutions and organizations that involve research within the mission of these Institutes and Centers. How should the application be submitted?
Send the application letter and attachments (electronically or via email) to the NHLBI Coordinator at jonesd@nhlbi.nih.gov or croomm@nhlbi.nih.gov. An original hard copy with the appropriate signatures must also be submitted to the NHLBI Certificate of Confidentiality Coordinator, Building 31, Room 5A-16, 31 Center Drive , MSC 2490, Bethesda , MD , 20892-2490.
What is the review process and how long will it take?
The NHLBI Certificate of Confidentiality Coordinator coordinates the review process. The CoC coordinator will assist the applicant and certificate reviewer and serve as a liaison and point of contact between the applicant and the certificate reviewer. The CoC coordinator ensures that the application package is complete and once the certificate is approved, the CoC coordinator will issue the Certificate to the applicant. Ordinarily applications are acted upon within 30 days of receipt. NHLBI will make every effort to expedite the review of your request. However, an incomplete application package, or documents lacking the appropriate signatures will delay the review process. An application is first reviewed for technical completeness by the NHLBI Coordinator, then by one or more Federal scientific program officials with the appropriate expertise. Attention is paid to the consent form language, the security measures planned for data and samples, and the appropriateness of the request in terms of meeting the statutory requirements for issuance of a CoC.
Where can I go for additional help and information?
You may obtain additional assistance from:
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