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. 2017 Sep 27;28(3):1118–1131. doi: 10.1007/s00330-017-4972-z

Table 3.

Recommendations for dealing with Incidental Findings

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