Certificate of Confidentiality
A Certificate of Confidentiality is issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by allowing investigators and institutions to avoid compulsory release of information that could be used to identify subjects with a research project (i.e., any information that could lead directly or indirectly to identification of a research subject).
Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator 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. A project may receive protection under a certificate of confidentiality even if the project is not sponsored or funded by NIH.
A Certificate may be used for biomedical, behavioral, clinical or other types of research that is sensitive. Research is considered sensitive if disclosing the information could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. Examples of studies that may be considered sensitive include those collecting genetic information, information on subjects’ psychological well being, information on sexually transmitted diseases or on subjects’ sexual attitudes, preferences or practices, data on substance abuse or other illegal conduct, and studies where subjects may be involved in litigation related to exposures under study (i.e., breast implants, environmental or occupational exposures).
Usually, a certificate is issued for a single, well-defined research project following IRB approval. It may, however, be issued for a cooperative multi-site project under limited circumstances. A Certificate is issued with an expiration date, but it may be extended if the research continues past the expiration date. The protection afforded by a Certificate is in any event permanent; all personally identifiable information maintained about subjects in the study while the Certificate is in effect is protected forever.
Applying for a Certificate of Confidentiality:
A). For online Certificate of Confidentiality applications, complete the NIH requirements found at the NIH Certificate of Confidentiality Kiosk. Please note that the online applications require an additional letter of assurances to be submitted to the Institutional Official (IO) for signature. The content requirements for this letter are found at the end of the online application. For instructions on how to submit this letter to the IO for signature, please skip to steps 3 thru 5 below. If you are applying for a Certificate of Confidentiality from the CDC, please skip to step 5 below and refer to CDC Certificate of Confidentiality for FAQs and application instructions.
B). For Institutes that do not provide an option for an online Certificate of Confidentiality application, a paper application must be used. To apply for a Certificate of Confidentiality using a paper application, follow steps 1-4 below.
- Complete the Application Letter per the instructions found at the Application Instructions for Certificate of Confidentiality
The Application Letter must:
- be printed on letterhead
- include the University of Michigan FWA #00004969
- list James A. Ashton-Miller, Ph.D. as the Institutional Official, with his title, Associate Vice President for Research
- Compile the complete application, to include:
- The Application Letter (see above)
- A copy of the IRB Approval notice indicating that there are no contingencies, EXCEPT the requirement to obtain a Certificate of Confidentiality
- A copy of the informed consent document
James A. Ashton-Miller, Ph.D., Associate Vice President for Research, MUST SIGN the application for a Certificate of Confidentiality before it can be submitted to the NIH.
Hard copy submissions can be sent to:
- Karin Teske
Regulatory Compliance Specialist
Office of the Vice President for Research
4080 Fleming Bldg.
503 Thompson St.
Ann Arbor, MI 48109-1340
Please contact Karin Teske at (734) 763-1289 or email@example.com with any questions.