Question

Research the interpretive problems surrounding incidental findings in medicine. How do you think this difficult issue can be addressed?

Answer 1

Ans) As genetic, genomic, and imaging research technologies become more powerful, the IFs problem will grow.

- Genetic and genomic research will predictably include larger populations. Genomic research will cover larger stretches of the genome, up to the entire genome. Imaging research will increasingly incorporate functional (non-structural) information and quantification of imaging data will lead to additional information provided by even structural (i.e., anatomic) images.

- Data produced in all of these research domains will increasingly be archived and reanalyzed, thanks in part to federal data-sharing policies and the growing capabilities of computers and bioinformatics.

- This suggests that we are early in the development of the problem of how to handle IFs in research. Research would be helpful to clarify the types of IFs generated by different kinds of research, the statistical prevalence of these IFs, the costs of evaluating them and clinical following-up, and the positive and negative impacts on research participants.

- Meanwhile, we need to assure that IFs are handled responsibly and research participants understand what information they may be offered. These recommendations, generated by considering IFs in genetic, genomic, and imaging research, suggest the importance of looking at this problem comparatively across research domains and grounding ethics recommendations in the critical study of approaches currently in use.

- Our recommendations are limited by considering only genetic, genomic, MRI neuroimaging, and CT colonography research. Further, we informed our recommendations by considering research consent forms, university model consent forms, statements by professional societies, and federal guidance documents publicly available on the Internet.

- We reasoned that these forms and documents are likely to exert the most influence on researchers and IRBs because these are the materials that they will most readily find when researching guidance and models. We refrained from seeking forms and university documents that were not posted on the Internet and we did not perform observational research to find out whether researchers are deviating from consent forms or supplementing those forms by discussing IFs with research participants.

- The problem of IFs is important and deserves broad discussion among researchers, research participants, IRBs, funders, and oversight bodies. Handling IFs responsibly requires clarity about the difference between research and clinical care, coupled with attention to the ethical duties of researchers when faced unexpectedly with information that could save a life, significantly alter clinical care, or prove important to the research participant.