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Resources :: Guide :: Certificate of confidentiality :: Applying for a certificate of confidentiality

Applying for a Certificate of Confidentiality

Do I need a Certificate of Confidentiality?
Studies that need a Certificate of Confidentiality include but are not limited to:
  • Using a legally at-risk population, such as abusers of illegal substances, prisoners, victims of crime, persons with conditions that might affect custody cases, etc., where the data collected from these individuals describes their illegal or sensitive behaviors.  Although using these participants may make it more likely for a researcher to learn information about sensitive or illegal behaviors, it is not the participant that determines the need for a Certificate of Confidentiality, but the data collected about the participant.
  • Asking questions about illegal or sensitive behavior. If the participants are minors, this may include asking questions about tobacco and alcohol use. For more information, see How Do I Include a Risk Sensitive Population?

Where can I apply for a Certificate of Confidentiality?
Most social and behavioral science research can obtain a Certificate of Confidentiality through the National Institutes of Health (NIH).  For more information, please see their website: http://grants.nih.gov/grants/policy/coc/

IRB Approval and a Certificate of Confidentiality
In order to obtain a Certificate of Confidentiality, you must have IRB approval.  However, in order to obtain IRB approval, the Board will want to know in your protocol that your intention is to obtain a Certificate of Confidentiality.  Your IRB approval will be provisional and you will not be able to conduct your study until you have submitted a copy of your Certificate of Confidentiality to the Board.  Please note that the NIH will require that you put specific template language in your consent form.  When you submit your Certificate of Confidentiality to the IRB, please submit a final copy of your consent form(s); the SBS staff will send you a stamped copy to use as your master copy.

A word of caution: if your protocol needs a Certificate of Confidentiality, it is likely that it is a riskier study, which will require at least one review by the full board, if not more.  You should plan for at least six weeks for review by the IRB-SBS; the NIH recommends planning for at least three months for their approval.  For tips on how to include a certificate of confidentiality in your protocol and consent forms, please see Protocol and consent form additions. For more information about the NIH review process, please see their website: http://grants.nih.gov/grants/policy/coc/

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