Table 3.
Questions arising from research scan | NIH recommendation (reproduced from Wolf [88]) |
---|---|
Do researchers have an obligation to examine their data for IFs? | ‘It is unrealistic to place on researchers an affirmative duty to search for IFs’ |
What should be done if an IF is detected - should it prompt specialist referral for definitive diagnosis? | ‘Obligation to establish a pathway for handling IFs and communicate that to the Independent ethics committee/review board and research participants’ |
What should the research participant be told? | ‘In many, but not all circumstances, researchers have an obligation to offer to report IFs to participants’ |
What should research protocols and consent forms include relating to IFs, should the right to refuse knowledge of IF be addressed? | ‘Researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, also in consent forms and communications with research participants’ |
Key NIH recommendations for addressing IFs: • Plan for the discovery of IFs in study protocol and IRB communication • Plan to verify and evaluate a suspected IF with expert review if necessary • Researchers and IRBs should create and monitor pathways for IFs • Address IFs in the consent process • Plan to determine whether to report IFs, based on likely health importance: a. Strong net benefit to health from reporting IF b. Possible net benefit c. Unlikely net benefit • Address the potential for IFs in future analyses of archived data |