Is there a requirement to include language explaining the Open Data Policy (de-identified data will be shared publicly) in the informed consent document if the data is being collected as part of human subjects research and will be uploaded to the DDL?
I've heard reports that this is a USAID requirement but I've not seen any documents or publications stating this requirement.
According to 45 CFR part 46, when data set is rid of identifiers, it no longer considers the dataset to contain human subjects and consent for use of that data is not required.
We have been including this language because other recipient organizations have told me it is required but I'd like confirmation.
