In the consent forms, is it made clear that eventually the de-identified data will go to the NIH in terms of transparency with the participant? This program is a federal database and I don’t know if ethically we have to enter that in the consent form or not – is that customary?

It is customary to let the prospective participants know what data are being collected, how and whether data will be either anonymized or handled in terms of confidentiality – all of this is very much a part of any normal consent. How we convey this information needs to be accurate, accessible, and transparent so that potential volunteers can decide on their own whether to participate in the program.