If you have an IRB-related question, others probably do too! This column is an opportunity to answer your questions. Check in each month to see the answers to some of the most common questions asked by the research community. To find more questions from previous months, click here to search the archive.
Please send your questions to crtimes@bu.edu.
Q. I’m currently drafting a study protocol and have a question regarding the inclusion of NIH Certificate of Confidentiality (CoC) language. The study is NIH-funded and involves recruitment sites across multiple countries, each of which will follow its respective national privacy and confidentiality regulations. The U.S. institutions involved serve as home institutions for the study investigators and are not recruitment sites. However, one of the U.S. institutions will host and manage the central study database.
Given this context, are we still required to include CoC language in the protocol? Does the NIH CoC apply to the U.S. institutions involved given the lack of direct involvement in participant recruitment and management?
Thank you in advance for your guidance.
A: NIH does not have a formal exception to the inclusion of CoC language in the consent form for studies conducted outside of the United States. We recommend you reach out to your NIH Program Officer to ascertain whether they require the inclusion of CoC language in the consent form (which is not particularly meaningful for international subjects). If they are ok with omitting it from the consent form, then it is fine with us as well. If NIH does require CoC language, or declines to provide an official response, then the CoC language does need to be included.