Duty to disclose what? Querying the putative obligation to return research results to participants

Abstract

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of "research results," specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action.

International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

“…10 The rise of data-intensive science stemming from the use of high-throughput technology has led to a debate on the pertinence of returning IRRs and IFs in genomic biobanks. [11][12][13] Although most of these debates are jurisdictionspecific, how is the issue of the return of IRRs and IFs reflected in international norms? What trends, if any, are discernable?…”

Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results

“…Various guidelines have emerged during the past decade implying an obligation for researchers to return results. 11,12 As Miller et al 13 have pointed out, a considerable amount of confusion exists concerning the extent and character of this putative duty.…”

What is a meaningful result? Disclosing the results of genomic research in autism to research participants

“…[11][12][13] Critics have questioned the coherence of the obligation, and the implications of a uniform duty for the research enterprise as a whole. [14][15][16] The obligation to report individually relevant research results to research participants is advanced as a general requirement of research ethics, 10,17 without regard for the specific issues arising in different disease contexts. Yet this omission is substantial, as it is not clear that standards that are sensible in one domain (eg, cancer genetics) make full sense in others (eg, psychiatric genetics).…”