Managing Incidental Findings in Human Subjects Research
By S. Wolf, F. Lawrenz, Charles A. Nelson, J. Kahn, M. Cho, E. Clayton, J. Fletcher, Michael Georgieff, D. Hammerschmidt, K. Hudson and 11 more. Journal of Law, Medicine & Ethics, 2008
656 citations recorded by the source corpus.
No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.
Subfields: Oncology, Public Health, Environmental and Occupational Health, Statistics and Probability
View Paper: https://www.semanticscholar.org/paper/575af9e0c96bac9a44f9990fb880bfecf9e70434
How researchers see this paper
The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.
In Oncology
In Public Health, Environmental and Occupational Health
In Statistics and Probability
Citations in the corpus
- Exome sequencing as a tool for Mendelian disease gene discovery (2011, neutral): “69) .”
- Incidental findings on brain magnetic resonance imaging: systematic review and meta-analysis (2009, background): “However, a systematic review and meta-analysis of the published literature has been recommended”
- Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (2018, background): “…May or may not be clinically actionable, but the information is of significance to the individual, for example, with regards to reproductive decision making (Wolf et al., 2008, 2012, 2015) • IRB approved for return with an appropriate disclosure plan, and the benefits outweigh the risks (Fabsitz…”
- Using electronic health records to drive discovery in disease genomics (2011, background): “One of the thorniest questions remains whether unanticipated incidental findings should be communicated back to the patient and provider, particularly if the link to the EHR is maintaine”