Returning Individual Research Results to Participants Guidance for a New Research Paradigm (2018) / Chapter Skim
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Appendix D: The Return of Individual-Specific Research Results from Laboratories: Perspectives and Ethical Underpinnings
Appendix D: The Return of Individual-Specific Research Results from Laboratories: Perspectives and Ethical Underpinnings
Pages 339-358
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From page 339... ...
If so, should this occur pre- or post-publication? Should they share incidental findings that, while not part of the study's objectives, could carry important health implications for an individual subject?
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From page 340... ...
Third, although this paper refers to research subjects and questions about whether and when their individual research results or incidental findings should be returned to them, technically such persons may not be research subjects at all. Once one's information -- e.g., genetic information stored in a biobank -- has been de-identified, the use to which that information is put is no longer defined as research, and the person who contributed it is no longer deemed by the Common Rule to be a research subject (Richardson and Cho, 2012; Wolf, 2013; Wolf et al., 2012)
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From page 341... ...
Thus, a non-CLIA lab existing within a HIPAA-covered entity is in an impossible predicament: it both must return, and must not return, individual results. Thus noting this potential regulatory snag, we turn to various proposed ethical underpinnings that would require RoR.
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From page 342... ...
"[I] n selecting a minimal list that is weighted toward conditions where prevalence may be high and intervention may be possible, we felt that clinicians and laboratory personnel have a fiduciary duty to prevent harm by warning patients and their families about certain incidental findings and that this principle supersedes concerns about autonomy" (Green et al., 2013, p.
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From page 343... ...
. Their principles included • research differs significantly from clinical care, hence standards of dis closure differ; • researchers have no duty to use limited funds affirmatively to hunt for actionable genomic findings; • analytically and clinically valid information should, if actionable and important, be returned to research participants; and • participants have a right to refuse such information.
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From page 344... ...
, proposes that "participants permit researchers access to their private data, specimens, and bodies, access that researchers otherwise would not have. This grant of access represents an act of partial entrustment (‘partial' because participants are not fully entrusting their medical welfare to the researcher, as they would to a clinician)
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From page 345... ...
also offer a relationship-based rationale for investigators' obligations to return findings, but with broader roots and narrower obligations than the partial entrustment model. Rather than focusing only on the investigator–participant relationship, they reflect on professional relationships generally.
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From page 346... ...
Although their writing does not specifically address IRRs, it is reasonable to suppose the same rationale would warrant returning IRRs, or at least those are valid, important, and 3 "We argue that if (but not only if) A is in a professional relationship with B, such that A has consensual access to private information bearing on the welfare of B, then A has a limited obligation to intervene to help B based on incidental findings outside the scope of the contractual professional relationship.
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From page 347... ...
t would be disrespectful to treat research volunteers as conduits for generating scientific data without giving due consideration to their interest in receiving information about themselves derived from their participation in research" (Shalowitz and Miller, 2005, p.
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From page 348... ...
. In the research setting no "seizing" is contemplated, but only a duty to inform someone of a serious, validated, actionable hazard.4 Indeed, as noted above, the ACMG concluded that investigators need not even obtain subjects' prior consent to be warned about serious incidental findings.
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From page 349... ...
CRITICAL ANALYSIS If we are to conclude that investigators are morally required to return IFs or IRRs under certain circumstances, then we should be able to adduce fairly forceful reasoning to support that supposed obligation. "Well, isn't it just obvious?
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From page 350... ...
. Although research participants do waive certain rights and grant certain permissions as specified in the consent form, by no means does this grant researchers vast discretion over their health.
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From page 351... ...
Many people share remarkable amounts of highly private information to friends and to "friends" on social media or even to a stranger-seatmate on a subway. Such waivers of privacy convey no discretion to the other person, other than presumably the right to tell my friends all about "that crazy person I sat next to on the subway this morning." Moreover, my sharing intimate, excruciating details of my noxious, oozing skin disease hardly makes you responsible to care for my health.
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From page 352... ...
We argue that if (but not only if) A is in a professional relationship with B, such that A has consensual access to private information bearing on the welfare of B, then A has a limited obligation to intervene to help B based on incidental find ings outside the scope of the contractual professional relationship.
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From page 353... ...
We need not strain to posit a "professional relationship" -- an oil change guy, a bra-fitter, or even a plumber -- and we need not insist on "privileged access" to recognize that any of these people might be in a situation where (1) they happen to recognize something serious and (2)
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From page 354... ...
In sum, in the research setting the main reason the investigator may have a specific, personal duty to return an IF or IRR need not rely on any sort of professional relationship or privileged access. It is enough that (1)
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From page 355... ...
And even if the person is making a significant sacrifice, there are other ways to recognize it, from paying money, to returning aggregate results, to exercising the utmost good stewardship. To assert that the reason we must return IRRs and IFs is because we must exhibit gratitude, and then to define gratitude exclusively as requiring return of IRRs and IFs begs the question.
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From page 356... ...
; burdening researchers with heavy costs (Illes et al., 2006; Ossorio, 2012; Partridge and Winer, 2002; Shalowitz and Miller, 2005; Wolf et al., 2006) , potentially in the form of asking researchers to make up for lack of access to health care elsewhere in the system; and potentially diverting legitimate research into some sort of chimeric entity that does not distinguish well between research and clinical care (Clayton and McGuire, 2012; Miller et al., 2008)
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From page 357... ...
2008. Incidental findings in human subjects research: What do investigators owe research participants?
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From page 358... ...
2012. Managing incidental findings and research results in genomic research involving biobanks and archived datasets.
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