. Author manuscript; available in PMC: 2018 May 21.

Published in final edited form as: Mol Psychiatry. 2017 Nov 21;23(1):15–23. doi: 10.1038/mp.2017.228

Table 2.

Arguments for and against the return of genomic results to individual research participants

RoR	Arguments	Description of Arguments
Arguments Against	Goal of research	to generate generalizable knowledge, not provide individual care; there is no duty to return individual results^27,29
	Cost	deviating from the goal of research to return individual results drains already limited research resources
	Minimize therapeutic misconception	by returning clinically relevant findings researchers may promote the misconception that the research is being conducted for the therapeutic benefit of the participant^30,31
	Respect for Autonomy	denying RoR is respectful of participants’ autonomy if researchers make it clear during the informed consent process that there will not be RoR and participants agree to these terms³²
	Difficult to obtain meaningful informed consent	Genome-wide testing could generate a plethora of clinically relevant findings and it would be impractical to describe potential findings to obtain meaningful informed consent for RoR³³
	Difficult to determine the pathogenicity of variants	it may be difficult for researchers to identify clinically relevant findings, particularly when they are not clinicians³⁴ or if annotations are ambiguous
	Non-maleficence	given the complexity of genomic information, participants may overestimate their risk, suffer needless emotional distress, and seek unnecessary treatments; this may be exacerbated in people with severe psychiatric disorders
	Lack of genetics training among clinicians	Most internists³⁵ and psychiatrists^36–38 report inadequate understanding of genetics and the interpretation and management of genomic tests; this could lead to unnecessary tests and procedures that will increase health care costs, and could potentially harm patients
	Unknown impact of RoR on participants	there is lack of research about the impact of RoR on individuals with a history of, currently suffering from, or at risk of developing a psychiatric disorder; it is conceivable that this could exacerbate suicidality or become part of a delusional scheme
Arguments in Favor	Beneficence	genomics research can generate clinically relevant findings that, if known, could improve health outcomes;^11,39,40 denying participants access to these findings is inconsistent with beneficence, a basic principle of ethical research advocated by the Belmont Report and others.^39,41–44
	Respect for Persons	implies not using participants as just means to an end, thus, using participants to generate data but not offer certain clinically relevant findings generated in the course of research may be considered unethical.^{28, 45}
	Respect for Autonomy	if researchers are in possession of clinically relevant findings—and it is feasible to make these available to participants—researchers should not decide for participants whether they should know this information, but allow participants or their legally authorized representative to make this determination^39,45,46
	Justice	although this may change in the future, given the cost of genetic testing and usual lack of insurance coverage for these tests, participants may not be able to access this genomic information through other means
	Reciprocity	should not withhold clinically relevant findings from participants who contributed and made study possible^30,47–49
	Participants want findings	a large majority of individuals would like to know their genomic research results^50–52
	Many researchers and other stakeholders support return of certain clinically relevant findings	in 2013, 95% of 234 genomic researchers surveyed in the US believed that highly penetrant and medically actionable findings should be offered;^34,53 funding agencies, professional groups, and other stakeholders support the return of certain findings^54–60