Certificates of Confidentiality

Certificates of Confidentiality are 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.

Certificates 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, certificates are issued for single, well-defined research projects following IRB approval.  They may, however, be issued for cooperative multi-site projects under limited circumstances.  Certificates are issued with expiration dates, but may be extended if the research continues past those dates.  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.

The NIH Certificate of Confidentiality Kiosk provides detailed information about obtaining a Certificate of Confidentiality. The application is a letter created by the Investigator on Letterhead, providing the information identifed at http://grants2.nih.gov/grants/policy/coc/appl_extramural.htm.

Associate Vice President for Research, Judith A. Nowack, must sign all certificate of confidentiality applications before submission to NIH.

To Obtain a Certificate of Confidentiality:

1. Complete the Application Letter per the instructions on the NIH Certificate of Confidentiality Kiosk. Please note that the Application Letter must be on Letterhead and the University of Michigan FWA #00004969 must be included in the letter.
   
   
2. Compile the complete application:
   1. The Application Letter
   2. A copy of the IRB Approval notice indicating that there are no approval contingencies, except the requirement to obtain a Certificate of Confidentiality
   3. A copy of the informed consent document.
      
      
3. The preferred method of submission to OVPR is hard-copy original. Send the complete application for signature to:

   Gale Nicolai, Assistant to Judith Nowack
   Office of the Vice President for Research
   4080 Fleming, Box 1340

   Electronic submissions to OVPR will be also be accepted. Contact Gale Nicolai (gnicolai@umich.edu) for additional information.

4. The signed originals will either:
   1. Be returned to the origniator for mailing, or
   2. Be mailed to the NIH by the OVPR office. Please include an addressed, postage-paid envelope. A copy will then be returned to the origniator.

A back-up copy of the complete application will be maintained in OVPR.

For additional information, please contact Gale Nicolai at (734) 763-1289 or gnicolai@umich.edu