The Right to Know: A Revised Standard for Reporting Incidental Findings

Abstract

During the course of biomedical research, researchers sometimes obtain information on participants that is outside the aim of the study but may nonetheless be relevant to the participants. These incidental findings, as they are known, have been the focus of a substantial amount of discussion in the bioethics literature, and a consensus has begun to emerge about what researchers should do in light of the possibility of incidental findings. A consensus, however, is not necessarily correct. In this article, we address the common view that reporting of incidental findings should be based primarily on the possibility of medical benefit, factoring in the findings' validity, clinical actionability, and significance to health or reproduction. While such medical beneficence should not be discarded, the need to give proper attention to participants' autonomy, privacy, and interests (especially considering discussion of participants' right not to know) suggests an alternative standard for when to report incidental findings: even if they are of no direct medical benefit, incidental findings should be reported based on the extent to which the participant can be expected to comprehend the information. We will offer a preliminary defense of this alternative as best respecting participants' autonomy and privacy and promoting their interests. However, we acknowledge that the standard would face significant practical barriers, and these barriers lead us to propose a metaconsent addendum that would allow subjects to essentially waive the comprehension standard when resource or other constraints make meeting it impracticable.

Ethical values supporting the disclosure of incidental and secondary findings in clinical genomic testing: a qualitative study

“…Incidental and secondary findings are the subject of various reporting guidelines and policy documents, for instance in Europe, the US and Canada [1][2][3][4][5][6][7]. Ethical arguments, especially concerning autonomy, non-maleficence and beneficence, have been frequently cited for reporting these results or not doing so [8,9]. The study presented in this article set out to investigate empirically how professionals consider these and potentially other values in actual practice regarding IFs and SFs in clinical ES.…”

Improving Translation and Cultural Appropriateness of Spanish‐Language Consent Materials for Biobanks

“…Although improvements to our translations of the consent forms may help correct some of these misunderstandings, participants’ expectation that they will be notified if researchers find something serious about their health has also been noted in studies conducted with English‐language speakers 25 . Evidence suggests that, even when consent materials use very conservative language to caution participants not to expect results, a fair number still believe that researchers will find a way to communicate the information to them 26 . This belief is particularly problematic if participants misinterpret the lack of results as meaning they have no serious health problems (“no news is good news”) 27 .…”

“…25 Evidence suggests that, even when consent materials use very conservative language to caution participants not to expect results, a fair number still believe that researchers will find a way to communicate the information to them. 26 This belief is particularly problematic if participants misinterpret the lack of results as meaning they have no serious health problems ("no news is good news"). 27 Our findings suggest that attention is needed to ensure that consent materials emphasize the research purpose of biobanks and clearly distinguish between the roles of researchers and physicians.…”

Ethical questions concerning newborn genetic screening

“…This question is additionally complicated in the case of the appearance of information of uncertain interpretation or meaning. [32][33][34][35] In our opinion, the criteria used to manage such information should be the same as those applied in the management of information for which a direct search was made in the screening process.…”