Returning Individual Research Results to Participants Guidance for a New Research Paradigm (2018) / Chapter Skim
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4 Processes to Enable Appropriate Decision Making Regarding the Return of Individual Research Results
4 Processes to Enable Appropriate Decision Making Regarding the Return of Individual Research Results
Pages 147-188
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From page 147... ...
Given the numerous technical and operational considerations associated with the return of individual research results, investigators conducting research on human biospecimens need to consider early in their study design process whether individual results may be returned to participants. Research sponsors and institutions can ensure that such assessments are performed routinely by requiring eturn-of-results plans in their funding applications and institutional review r board (IRB)
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From page 148... ...
Defining Value in the Context of Returning Individual Research Results Decision-making approaches regarding the return of individual research results have traditionally focused on several specific criteria for evaluating the expected value or usefulness of the results to participants. The factors that contribute to value include the analytic and clinical validity, clinical utility, and personal utility1 of the results (Bookman et al., 2006; Ravitsky and Wilfond, 2006)
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From page 149... ...
. The clinical utility of a test is an indication of whether it can provide information that can be used to inform patient–clinician decisions regarding the prevention, management, or treatment of a disease or health condition -- and, in particular, information that would be expected to yield measurable improvement in clinical outcomes (Teutsch et al., 2009)
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From page 150... ...
. Despite this overlap between clinical and personal utility, existing frameworks and decision tools suggest a hierarchy among the characteristics of research results that may be returned to participants, and they tend to prioritize clinical utility over personal utility in assessing the value of research results (Fabsitz et al., 2010; Ravitsky and Wilfond, 2006)
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From page 151... ...
In a notable departure from the approaches of past expert groups, the committee has chosen to deemphasize the respective influences of clinical and personal utility in decisions regarding the return of individual research results by focusing more inclusively on results that have "value to participants," with the understanding that the value of a result from the perspective of the participant might entail either clinical utility or personal utility or both and may also arise from the result having personal meaning (see Box 4-2 for a summary of previous expert group recommendations)
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From page 152... ...
• Of unknown importance or personal utility (Wolf et al., 2008, 2012) Additional work is ongoing to determine best practices for the return of genetic results with funding from by the National Institutes of Health's National Human Genome Research Institute.
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From page 153... ...
The study design and the timing for returning individual research results can also influence perceptions of value for some kinds of results. For example, in the case of blinded clinical trials, returning test results may be prohibited until the end of the study in order to maintain the integrity of the research (MRCT Center, 2017)
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From page 154... ...
. There is a range of engagement in research, including consultation, collaboration, and partnership (CTSA Community Engagement Key Function Committee Task Force on the Principles of Community Engagement, 2011)
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From page 155... ...
The methods of engaging stakeholders in research have evolved, as have the roles and types of activities that patients and community members play in research. A gold standard for engagement has been community-based participatory research (CBPR)
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From page 156... ...
Study-specific engagement will not be necessary if individual results cannot be returned to participants -- e.g., when biospecimens have been de-identified -- and may not be required if investigators can reasonably rely on existing documentation of participant needs, preferences, and values in the literature or from past experiences working with community groups. Table 4-1 describes the range of stakeholder engagement that can be applied in the return of individual research results.
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From page 157... ...
They are community-based participatory responsible for all aspects of the study and research, patient powered research are directly involved in all decision making network Research Partner or Part of team making Stakeholders are members of the research Community-engaged research, 2–6 Team Member decisions team and have direct involvement in the engaged team science design, conduct, and dissemination of research; including helping to understand and make decisions on the return of research results Governance or Advisory Provides oversight Stakeholders consider feedback and findings Advisory boards, councils and 4–25 Group or guidance to make on participants' needs, priorities, and values committees decisions and provide guidance to the research team to make decisions on the return of research results Consultants, Provides detailed Stakeholders serve in specific, time- Focus groups, semi-structured 10– Interviewees, Panelists, input on participant limited roles and provide detailed input on interviews, Delphi techniques, 100 Reviewers, etc. needs, preferences participants' needs, preferences, and values community engagement studios and values on the return of research results Knowledge Users and Provides input on par- Stakeholders engage using methods de- Surveys, online polling, crowdsourc- 100+ Experiencers (general ticipant needs, prefer- signed to reach a large number of people and ing, social media, town hall meetings population affected by ences and values provide perspectives on participants' needs, preferences, and values related to return of condition being studied)
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From page 158... ...
Extensive engagement processes may be proposed as a part of the research to be funded. If a decision is made to prospectively offer at least some individual research results, it creates an imperative for investigators to later engage the enrolled study participants in discussions (likely during the consent process)
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From page 159... ...
The cost, time, and effort of engagement can be minimized by leveraging existing knowledge resources and engagement infrastructure to assess the preferences and needs of communities. Research funding agencies and sponsors can further support investigators by providing guidance and other resources to ensure that engagement needs are not viewed as a barrier to returning individual research results.
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From page 160... ...
Engagement models, guidance, and numerous informational resources have been developed to guide and support patient and community engagement. Investigators may need to be made aware of their existence or to receive training to effectively engage participants in decision making about the return of individual research results.
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From page 161... ...
The resources needed to return research results include money, time, expertise, infrastructure, and personnel. The sections below detail some of the major challenges investigators have encountered when returning research results and some of the issues they should consider when making determinations on a caseby-case basis about returning individual research results.
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From page 162... ...
162 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS BOX 4-4 Challenges in Reporting Back Personal Exposure Results Below are the main challenges reported in a survey of investigators and institutional review boards that returned results from biomonitoring and environmental exposure studies. ONGOING CONTACT WITH STUDY PARTICIPANTS • Maintaining connections with participants in the face of the long periods of time between collecting samples and report results • Post hoc contact with study participants if new health guidelines emerge • Protocols for the timing of reporting back results for chemicals without health guidelines DEVELOPING MEANINGFUL REPORTS • Deciding on clear takeaway messages and summaries, including conveying scientific uncertainty about health outcomes • Avoiding information overload • Representing intra-individual temporal variability for rapidly metabolized chemicals SHARING DATA BEYOND THE STUDY PARTICIPANT • Deciding whom to share research results with (e.g., physicians, family members, and wider communities)
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From page 163... ...
Langbaum, a principal scientist at Banner Alzheimer's Institute, said that one barrier to returning results in a national study had been that state licensure laws for genetic counselors varied and that the costs could be prohibitive for a counselor to become licensed in multiple states. Investigators and IRBs will need to consider various literacies of research participants -- e.g., general literacy, health literacy, and relevant aspects of scientific literacy -- when planning the return of results, which likely will require new or increased interactions with and the involvement of social scientists, communication experts, the community, and patient advocacy groups.
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From page 164... ...
Thus, b if CLIA certification continues to be a requirement for the return of individual research results, it will not be feasible for many investigators to return results without significant additional resources from their institutions and funding agencies, and even then many laboratories would still be left out. If a new quality management system with a tiered approach was developed that was appropriate for research laboratories (Recommendation 2 in Chapter 3)
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From page 165... ...
. Required Resources The resources needed to return individual research results include funding, time, expertise, personnel, and infrastructure, and finding such resources is an inevitable challenge for researchers who wish to return results.
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From page 166... ...
A DECISION-MAKING FRAMEWORK FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS Decisions about the return of individual research results will vary on a studyby-study basis, depending on the characteristics of the research, the results, and the participants. Such decisions will require a significant amount of judgment and several groups have provided flowcharts or frameworks to aid in the decision to return research results (Beskow and Burke, 2010; Haines et al., 2011; Holm et al., 2014; MRCT Center, 2017; Ravitsky and Wilfond, 2006)
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From page 167... ...
Value in this context means the value of a result from the perspective of the participant and might entail clinical utility or personal utility as well as personal meaning. Feasibility is determined by multiple factors, including potential challenges, the costs and burdens of returning results, and whether participants' biospecimens are linked to the participant identity as well as the resources available to communicate the results effectively and appropriately.
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From page 168... ...
SOURCES: Bookman, 2006; Fabsitz, 2010; Jarvik et al., 2014; National Bioethics Advisory Committee, 1999; Wolf et al., 2008, 2012.
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From page 169... ...
. Even certain research results that lack clinical utility may still have significant personal value and would be expected to pose little risk.
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From page 170... ...
asserts that participants should have a right to decide whether to receive or share their results with their primary care physician, relatives, an executor, or others. Participants may need to decide whether to share research results with relatives who may be affected by the result while investigators may need to determine the timing of the return and potentially the handoff of the results to a physician if they require further clinical evaluation.
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From page 171... ...
The return of results to children or to individuals who lack capacity or are deceased hinges less on considerations such as transparency, reciprocity, or perceived value by the participant and more on considerations of potential benefits to the participant and his or her family members or significant others. Children In situations where children are participating in research, the return of research results should be addressed during the assent process with the older child and the informed consent process with parents (Anastasova et al., 2013; Avard et al., 2009)
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From page 172... ...
, and additional support should be made available during the informed consent process, such as supplementary educational activities, the presence of specially trained personnel, and genetic counseling. Researchers, IRBs, and participants' representatives are responsible for ensuring that this informed consent process sufficiently protects the participant's autonomy (Groisman et al., 2012)
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From page 173... ...
and should address access to research results by family members following the death of the participant during the informed consent process. If the participant's preference has not been determined in the consent process in advance of the study, HIPAA may prohibit the return of results to persons who are not the participant's executor; this is an issue because it has been found that participants may want an individual who is not the executor to be the recipient of any results (Goodman et al., 2017)
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From page 174... ...
. However, if the laboratory that produced the result is a HIPAA-covered entity and the results are part of the 13 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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From page 175... ...
Given that the research team did not anticipate the result and therefore did not seek input on participant preferences and values during the study design phase, investigators may need to rely on published or otherwise available documentation on potential personal utility and meaning as they carefully weigh the value to the participant and the risks of disclosure. PLANNING FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS The responsible return of individual research results requires careful forethought and preparation (MRCT Center, 2017)
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From page 176... ...
. Thus, developing a plan during the design phase of the study that addresses whether, when, and how results will be offered to participants or provided in response to a participant request can help maximize the benefits and prevent or mitigate the potential harms of returning individual research results.
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From page 177... ...
The Role of Research Sponsors in Supporting Appropriate Planning for the Return of Individual Research Results The National Bioethics Advisory Commission (NBAC) recommended in 1999 that investigators conducting research on human biospecimens be required to include in their study proposals documentation of whether and how individual research results will be returned to participants (National Bioethics Advisory Commission, 1999)
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From page 178... ...
Research sponsors and funding agencies should ensure that investiga tors are considering whether and how individual research results will be returned to participants, by A. equiring that applications for research funding consistently ad r dress the return of individual research results, indicating whether, and if so, when and how individual research results will be offered to research participants, as well as the rationale for these decisions; B. ncluding in the scientific review process for funding applications i an assessment of plans for the return of individual research results; and C. uilding funding into grants and contracts or providing adminis b trative supplements for the return of individual research results.
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From page 179... ...
. In surveys and interviews, IRB professionals have generally held the view that investigators should anticipate the return of results prior to a study's implementation and that the issue of returning individual research results should be covered in the IRB application and informed consent document for IRB review and approval (Beskow and O'Rourke, 2015; Dressler et al., 2012; Ohayon et al., 2017; Williams et al., 2012)
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From page 180... ...
. As with similar surveys of investigators, the positions of IRB professionals on returning individual research results have varied (Dressler et al., 2012;
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From page 181... ...
to consider the factors relevant to decisions on returning individual research results, including analytic validity, clinical validity, and the value of the results to participants; D. the consent process is aligned with the return of individual research results plan (see Recommendation 9) ; and E. he investigators have access to the necessary resources (e.g., core t resources)
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From page 182... ...
2010. Community engagement in research: Frameworks for education and peer review.
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From page 183... ...
Community Engagement Key Function Committee Task Force on the Principles of Community Engagement.
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From page 184... ...
2010. Ethical and practi cal guidelines for reporting genetic research results to study participants: Updated guidelines from a National Heart, Lung, and Blood Institute working group.
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From page 185... ...
2015. Community engagement studios: A structured ap proach to obtaining meaningful input from stakeholders to inform research.
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From page 186... ...
2006. Disclosing individual genetic results to research participants.
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2012. Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
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