Returning Individual Research Results to Participants Guidance for a New Research Paradigm (2018) / Chapter Skim
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2 Principles for the Return of Individual Research Results: Ethical and Societal Considerations
2 Principles for the Return of Individual Research Results: Ethical and Societal Considerations
Pages 59-92
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From page 59... ...
Resources for biomedical research, therefore, are precious and require careful and responsible stewardship. The return of individual research results necessarily requires the diversion of some research resources from the primary goal of the research, which is to contribute to generalizable knowledge (Williams et al., 2012)
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From page 60... ...
The recognition is growing that, for many clinical studies, aggregate study results should be shared with the research participants and presented in such a way that the results can be understood by members of the general public. This is consistent with the ethical principles widely used to guide clinical research, which hold that study participants should be treated with respect, acknowledged for the important role they play in advancing science, protected from harm to the extent possible, and receive the maximum possible benefit from their participation (CIOMS, 2016; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979)
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From page 61... ...
. Published commentaries on the return of individual research results commonly refer to a number of different ethical principles that the authors suggest support an argument for or against returning individual research results to participants.
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From page 62... ...
Beneficence/Non-Maleficence According to the ethical principle of beneficence, investigators have an obligation to promote and safeguard the well-being of research participants (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979)
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From page 63... ...
. Role of the Investigator–Participant Relationship in Obligations to Return Individual Results Although some ethical arguments for returning results, such as the duty to warn, are largely independent of any relationship between the investigator and the participant, from both a legal (discussed in Chapter 5)
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From page 64... ...
. In contrast to Richardson and colleagues, who base the obligation to return individual results on the specific relationship between the physician investigator and participant, Miller, Mello, and Joffe offer an alternative relationship-based rationale in which the ethical obligations for returning secondary findings stem from the principle of beneficence applied in the context of a professional relationship more generally4 -- one that does not necessarily have to be a physician– patient relationship (2008b)
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From page 65... ...
. 6 Testimony of Ellen Wagner of Parent Project Muscular Dystrophy at the public meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017.
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From page 66... ...
But what about research participants who do not have decision-making capacity or lose that capacity during the research roject? This includes younger children, adults and older children who have never p had decision-making capacity, and those who lose capacity through disease progression, injury, or death during the conduct of the research.
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From page 67... ...
Participants may benefit from the return of individual research results that inform clinical decision making, life planning, and other actions that may affect health and the quality of life. 7 Testimony of John Molina of Native Health at the public meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories on December 11, 2017.
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From page 68... ...
Some results may have implications for family members, partners, or even whole communities. For example, the genetic results for hereditable conditions, if shared, may lead to cascade testing for family members,9 and individual biomonitoring results may foster activism aimed at 8 Testimony of Ellen Wagner of Parent Project Muscular Dystrophy at the public meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017.
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From page 69... ...
Because I've had so much trauma around hospitals, I feel like I don't have a voice." Returning individual research results in a way that makes them meaningful, this participant said, is a way to create a more level playing field and to help participants feel appreciated for their contribution to the research study.11 Potential Risks to Participants from Receiving Individual Research Results The potential benefits discussed above suggest that there are many reasons to consider expanding the return of individual research results beyond the current practice. However, it is also important to consider the potential risks to participants who choose to receive results.
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From page 70... ...
and is another potential adverse outcome of receiving research results that indicate an increased risk for some health conditions. Although similar types of concerns have been raised about the psychological effects of disclosing potentially worrying or disturbing test results in both clinical and research contexts (e.g., when such results are not clinically actionable)
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From page 71... ...
risks associated with returning individual research results, but the committee emphasizes that the current state of knowledge reflects a lack of evidence, not conclusive evidence of a lack of effect. Clearly, more research is necessary to better understand the risks associated with results disclosure, including whether certain subsets of individuals are more vulnerable to adverse impacts.
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From page 72... ...
. Despite the increased interest from investigators in returning individual results to research participants, countervailing concerns have been raised about the risks to participants, the legal liabilities, and the burdens placed on the research enterprise (Bredenoord et al., 2011; Klitzman et al., 2013; Ohayon et al., 2017)
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From page 73... ...
. Risks and Burdens for the Research Enterprise from Returning Individual Research Results To mitigate the risks of returning research results, investigators will need to provide participants with sufficient information and deliver results in ways that enable participants to make informed decisions.
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From page 74... ...
. While there is broad agreement that the return of research results should not be a substitute for clinical care and cannot compensate for inadequate health care access, participants sometimes enroll in studies with the intent of accessing testing or care that they cannot otherwise obtain.18 Some argue that the return of individual research results may promote therapeutic misconception, leading participants to mistakenly assume that a research study will yield reliable results with clinical value when, in reality, the clinical implications of research results will only rarely be clear (Clayton and McGuire, 2012)
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From page 75... ...
Benefits to the Research Enterprise from Returning Individual Research Results Although commentaries on the return of individual research results often focus on the expected burdens to investigators, there could be benefits to investigators as well. In particular, if the return of results leads to increased trust and public engagement in the research enterprise, it could have multiple positive effects, including possible improvements in the efficiency, generalizability, and participant-centeredness of research.
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From page 76... ...
21 Testimony of Febe Wallace of Cherokee Health Systems at the public meeting of the Commit tee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017. 22 Testimony of Ellen Wagner of Parent Project Muscular Dystrophy at the public meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017.
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From page 77... ...
24 Testimony of Jessica Langbaum of Banner Alzheimer's Institute at the public meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017. 25 Testimony of Wendy Chung of Columbia University at the public meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017.
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30 Testimony of Febe Wallace of Cherokee Health Systems at the public meeting of the Commit tee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017.
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From page 79... ...
Considerations for Society The benefits and risks to participants, the research enterprise, and the health care system from the return of individual research results can in many cases be seen as benefits and risks to society. However, some implications of the issues 31 Testimony of Febe Wallace of Cherokee Health Systems at the public meeting of the Commit tee on the Return of Individual-Specific Research Results Generated in Research Laboratories on September 6, 2017.
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From page 80... ...
The effects of returning individual research results will need to be continuously evaluated to build a stronger empirical evidence base. CONCLUSION: Considering the full spectrum of ethical and societal considerations for the return of individual research results, it is clear that there are certain circumstances when there are compelling reasons to return individual results to participants and others in which it is appropriate to limit and constrain the return of results.
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From page 81... ...
Investigators, with oversight from their IRBs and institutions, will ultimately be responsible for making decisions on a case-by-case basis regarding whether and how to return individual research results, as the decisions require careful consideration of many factors, which are described below. However, as discussed in Chapter 4, research sponsors and funding agencies also have an important role in reviewing return-of-results plans in funding applications in order to support reasonable consistency across research studies and institutions.
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From page 82... ...
The potential value of returning individual research results must be carefully considered along with the trade-offs for research participants, investigators, research institutions, and society. The purpose of biomedical research is to expand generalizable knowledge in order to advance our understanding of pathophysiology and medicine, with the ultimate goal of improving health outcomes for patients and the public.
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From page 83... ...
By offering research results to participants, investigators are respecting participant needs and preferences in the research process; however, participants retain their choice about whether to receive results. As a matter of respect for participant autonomy, investigators may offer the results of their study to its participants; however, what a participant ultimately decides to receive will be contingent on his or her perspective at the time of offer, even if the participant had previously consented to receiving research results.
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From page 84... ...
Consistent with the principle of justice, investigators must strive for equity in participation, access to research, and value for the participant. Investigators cannot fail to include certain groups in research simply because they are perceived as more difficult to engage or because of other social characteristics, such as insurance status (relevant because many clinical research studies bill research participants or their insurers for standard-of-care services not related to the study)
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From page 85... ...
2015. The CLIA/HIPAA conundrum of returning test results to research participants.
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From page 86... ...
2011. Feedback of individual genetic results to research participants: In favor of a qualified disclosure policy.
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2006. Implications of disclosing individual results of clinical research.
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2004. Considerations and costs of disclosing study findings to research participants.
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2016. Health research participants' preferences for receiving research results.
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From page 90... ...
2008b. Incidental findings in human subjects research: What do investigators owe research participants?
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2006. Disclosing individual genetic results to research participants.
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From page 92... ...
2013. Return of individual research results and incidental findings: Facing the challenges of translational science.
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