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Fall 2008, Issue 9

Certificates of Confidentiality Provide Legal Protection

A certificate of confidentiality (CoC) may be required if, in the process of conducting human subjects research, sensitive information is collected that, if disclosed, could have adverse consequences for the human subjects. Adverse effects include damage to subjects’ financial standing, employability, insurability, or reputation. Sensitive information can include information relating to sexual attitudes, use of addictive products, illegal conduct, mental health, and genetic data. CoCs are issued by the National Institutes of Health (NIH) and allow researchers “to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding” (NIH CoC Kiosk). CoCs provide legal protection to human subjects, researchers, and institutions.

The principal investigator (PI), with input from the sponsor and the institutional review board (IRB), is responsible for determining if a CoC is required. Information can be found on the NIH CoC Kiosk. CoC applications must be submitted to the NIH institute or center funding the research. If the research is not funded by NIH, the application should be submitted to the institute or center that supports similar work. After reviewing the Kiosk information, if the PI believes a CoC is required, s/he should contact the appropriate CoC Contact for specific instructions (because some institutes and centers require information in addition to what is found on the Kiosk and summarized below). According to the NIH CoC Kiosk, applications for CoCs should be submitted at least three months prior to the proposed research start date.

Basic Steps for Requesting a Certificate of Confidentiality

  1. Incorporate required CoC language in the research protocol and the informed consent form, and submit these documents to the IRB. The informed consent form must include a description of the protections and limitations of the CoC, including the circumstances in which the investigators plan to voluntarily disclose identifying information about research participants (eg, child abuse, harm to self or others, etc). Sample language is provided at CoC Application Instructions. Check with the appropriate CoC Contact for specific required language.
  2. Obtain a conditional IRB approval letter (pending the issuance of a CoC).
  3. Download and complete a memorandum confirming Tufts Federalwide Assurance (FWA) numbers. For Tufts University Health Sciences (Boston campus) and Tufts Medical Center, download the memo from http://tnemcirb.tufts.edu/?pid=25. For Social, Behavioral & Educational Sciences (Medford/Somerville campus), click here for the memo.
  4. Create a CoC application on the letterhead of the research applicant institution following the guidelines provided below (excerpted from CoC Application Instructions).
  5. Obtain the signature of the institutional official on the CoC application (Margaret E. Newell, vice provost, for Tufts University Boston Health Sciences campus and Medford/Somerville campus; Elayn Byron, vice president of research administration, for Tufts Medical Center).
  6. Submit the CoC application with all required attachments to the appropriate NIH Institute or Center.
  7. After receiving the CoC, submit a copy to your IRB office along with any necessary changes to the research protocol and/or the informed consent form. After reviewing all material the IRB will acknowledge receipt of the CoC or issue an approval of any revised documents for you to begin the research study.

Basic Guidelines for Creating a CoC Application
(check with the appropriate NIH Institute or Center for additional requirements)

  1. Name and address of applicant research institution on institution letterhead.
  2. Sites where the research will be conducted and a brief description of the facilities available for the conduct of the research.
  3. Title of the research project.
  4. Source and number of the supporting grant, if applicable. If there is no support, type “None.”
  5. Name, title, mailing and email addresses, telephone and fax numbers of the applicant as well as name and title of other key personnel. Also include a brief summary of the scientific training of the applicant and key personnel.
  6. Beginning date and expected end date of the project.
  7. Concise description of project aims and research methods.
  8. A description of means used to protect subjects’ identities.
  9. Reasons for requesting a CoC (include brief description of sensitive and identifying information to be collected).
  10. Insert the following five sentences verbatim:
    1. This institution agrees to use the Certificate of Confidentiality to protect against the compelled disclosure of personally identifiable information and to support and defend the authority of the Certificate against legal challenges.
    2. The institution and personnel involved in the conduct of the research will comply with the applicable Federal regulation for the protection of human subjects or, if no such Federal regulation is otherwise applicable, they will comply with 45 CFR Part 46.
    3. This Certificate of Confidentiality will not be represented as an endorsement of the project by the DHHS or NIH or used to coerce individuals to participate in the research project.
    4. All subjects will be informed that a Certificate has been issued, and they will be given a description of the protection provided by the Certificate.
    5. Any research participant entering the project after expiration or termination of the Certificate will be informed that the protection afforded by the Certificate does not apply to them.
  11. Both the PI and the institutional official must sign this letter. The name and title of the institutional official should be typed below the signature.
  12. Attachments:
    1. IRB conditional approval letter signed by authorized IRB representative.
    2. Memorandum confirming FWA number.
    3. Informed consent form for human subjects, as approved by the IRB.
    4. For research not funded by NIH in which drugs will be administered to human subjects, documentation is required that identifies drugs, dosages, and methods of administration, as is evidence that individuals who will receive the drugs are authorized to do so under applicable federal and state law.
    5. For all research in which a controlled drug or drugs will be administered, the applicant must submit a copy of the Drug Enforcement Administration Certificate of Registration (BND Form 223) under which the research project will be conducted.
    6. If the research project is testing for reportable communicable diseases, the applicant must submit information relating to its compliance with state reporting laws as specified in http://grants.nih.gov/grants/policy/coc/cd_policy.htm.

Certificates protect against involuntary disclosure; however, research subjects may voluntarily disclose their research data or information. They may also authorize the investigator (in writing) to release the information to insurers, employers, or other third parties.

For more information, please contact your IRB office.



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