Guide :: Certificate of Confidentiality :: Procedure
What is the procedure for obtaining 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 write 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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Guide :: Certificate of Confidentiality :: Procedure |
