Stephanie Solomon

Research Ethics Education for Community-Engaged Research: A Review and Research Agenda

Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.

Why and When Should We Use Public Deliberation

Public deliberation is an approach policy-makers can use to tackle public policy problems that require the consideration of both values and evidence. However, there is much uncertainty about why and when to choose it rather than more familiar approaches, such as public opinion polls or expert panels. With guidance on the why and when of public deliberation, policy-makers can use it appropriately to inform public policy.

Return of individual genetic results in a high-risk sample: enthusiasm and positive behavioral change

Purpose:The goal of this study was to examine participant responses to disclosure of genetic results in a minority population at high risk for depression and anxiety.Methods:Eighty-two subjects in a genetic study of nicotine dependence were offered personalized genetic results. All were nicotine-dependent and 64% self-identified as African American. Pathway Genomics was used to evaluate genetic risks for five complex diseases. Participants returned 4–8 weeks after enrollment for in-person genetic counseling interviews and evaluation of baseline measures. A telephone follow-up was performed 4–8 weeks later to assess responses to results.Results:Fifty of the 82 subjects (61%) were interested in receiving genetic results. These participants had multiple risk factors, including high baseline measures of depression (66%) and anxiety (32%), as well as low rates of employment (46%), adequate health literacy (46%), and health insurance (45%). Pathway Genomics reported “increased risk” for at least one disease in 77% of subjects. Ninety-five percent of participants reported that they appreciated the genetic results, and receiving these results was not associated with changes in symptoms of depression or anxiety. Furthermore, after return of genetic results, smoking cessation attempts increased (P = 0.003).Conclusion:Even in an underserved population at high risk for adverse psychological reactions, subjects responded positively to personalized genetic results.Genet Med 17 5, 374–379.

Biobanking: shifting the analogy from consent to surrogacy.

intROdUctiOn Biobanks of various kinds are proliferating. Particularly noteworthy is the expanding development of highly institutionalized, broad population–based biobanks that collect and store blood or tissue to provide samples to the diverse scientific research community. Both the research potential and the ethical challenges of biobanks are attracting deserved public attention. The practice of using banked tissue samples in research without the knowledge of donors has become widely criticized, popularized by the best-selling book about Henrietta Lacks.1 (We use the problematic conventional term “donors” without regard to intent, to describe those who provide tissue to biobanks.) People have interests in how their banked tissue is used, even if their tissue is “de-identified”: interests in the protection of privacy and confidentiality, and interests in supporting research consonant with their values while avoiding participation in research that contravenes them.2 A coherent, consistent, and cohesive approach to the ethics of biobanking is needed. The prevailing ethical response has been to incorporate formal “informed consent” procedures into biobanking practice. Although well intended, this development is based on a flawed analogy—between the provision of a sample to a biobank and other forms of research participation. This analogy deserves to be critically examined, with both its insights and distortions explicitly highlighted. Since biobanking is a unique endeavor compared to other research, multiple analogies may be necessary to “think through” biobanking ethics. In this commentary, we (i) call attention to the fact that current ethical conversation and regulatory approaches presume a straightforward analogy between biobanking and other forms of nontherapeutic research, without acknowledging that analogical reasoning is at play, (ii) elaborate the conceptual inadequacies of the presumed analogy between research and biobanking, particularly drawbacks of the informed consent model, (iii) invite a broadening of analytic scope to include other possible analogies, specifically considering an analogy between biobanking and clinical surrogacy, (iv) propose several ways that the surrogacy analogy better fits aspects of biobanking than the informed consent model, (v) suggest that multiple ethical analogies should illuminate the development of regulatory oversight. tHe incOHeRence OF cOnsent Biobanking does share some significant ethical features with other nontherapeutic research: the goal of collective benefits, the intrinsic conflict of interest that goal generates regarding the necessary instrumental use of human subjects, and the need for ethical protections of human subjects to ensure they are treated as “ends in themselves” and not merely means to an end. The positive intent of regulatory frameworks that treat biobanking as research is to bring biobank participants under the umbrella of such protections. Those frameworks include the Department of Health and Human Services Office of Research Protection’s definition of biobanking as an act of research. As a result, biobanks have been both subjected to institutional review board (IRB) oversight and required to meet concomitant requirements for consent and reporting. Proposed revisions to Common Rule 45 Cfr 46 would reaffirm the equation of biobanking with research while modifying review processes by perceived risk. However, there are also fundamental disanalogies between biobanking and nontherapeutic research. An ethically central feature of informed consent for research is the opportunity for the research recruit to weigh potential risks and benefits of participation in a specific study. But that feature is not applicable to biobanking. The potential risks and benefits of the biobank’s undetermined future research cannot be speculated. Biobanks do pose some risks, both to the informational security of donors and to the dignity of donors whose values may alternatively support or contraindicate certain forms of research. Significantly, however, these are not the risks of the actual future research. This distinction leads to four other major differences between informed consent for research and informed consent for biobanking: (i) the difference between participating in an activity versus participating in an institution; (ii) the difference between one-time versus ongoing decision-making; (iii) the difference between unidirectional versus multidirectional information flows; and (iv) the difference between active versus detached research participation. (i) In other forms of nontherapeutic research, the participant consents to participate in a specific activity—for example, a clinical drug trial. But in biobanking, the participant “consents” to contribute to an institution, the biobank. The biobank Biobanking: shifting the analogy from consent to surrogacy

Protecting and respecting the vulnerable: existing regulations or further protections?

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.

Developing community partner training: regulations and relationships.

While funders increasingly support research that partners with communities, community partners still must submit to a regulatory oversight structure that does not reflect their unique research ethics challenges and needs. In recognition of the importance of collaborative research endeavors, the authors engaged in a process of reconnaissance and negotiations with local community partners and research ethics boards (REBs) at the University of Michigan to begin to address the mismatch between regulatory demands and community-based research realities. This preliminary process yielded both changes in the REB oversight structure and training required of community partnered research. While the ultimate impact of these changes remains to be seen, the process itself yielded insights and materials of use to both our local REBs, and hopefully those at other institutions as well. This article will present those insights and provide links to those materials.

Stakeholders or Experts? On the Ambiguous Implications of Public Participation in Science

Critiques of the social sciences have emphasized the broad and categorical exclusions of certain groups from their discussions and both the political and epistemic ramifications of these exclusions. For example, feminists have pointed out how the exclusion of women’s voices have shaped sociological conceptions of labor and rape, psychological conceptions of hysteria, and legal definitions of harassment in ways that both misinterpreted social reality and defined it in ways that benefited men and disenfranchised women. Postcolonial theorists like Edward Said have charged anthropological interpretations of “primitive” peoples with both being complicit with imperialist and colonizing political programs and dividing explanations of non-Western groups into rationalizing denials of difference or interpretations that leave non-Western peoples as completely Other.

Piloting a Nationally Disseminated, Interactive Human Subjects Protection Program for Community Partners: Design, Content, and Evaluation

Funders, institutions, and research organizations are increasingly recognizing the need for human subjects protections training programs for those engaged in academic research. Current programs tend to be online and directed toward an audience of academic researchers. Research teams now include many nonacademic members, such as community partners, who are less likely to respond to either the method or the content of current online trainings. A team at the CTSA‐supported Michigan Institute for Clinical and Health Research at the University of Michigan developed a pilot human subjects protection training program for community partners that is both locally implemented and adaptable to local contexts, yet nationally consistent and deliverable from a central administrative source. Here, the developers and the analysts of this program discuss its development, its content, and the results of its evaluation.

Where Can We Find Justice

Jecker makes three major points in her article, “A Broader View of Justice” (2008). First, she argues that justice in healthcare relates to justice in the broader social conditions of society as these conditions influence how, when, and how often people develop health problems. Second, she argues that the bioethics literature has, with few exceptions, ignored the implications of broader institutional and social issues, instead using a medical paradigm of justice that focuses predominately on clinical and research questions. Finally, she recommends that bioethics ought to be pursued from a broader (social) paradigm of justice that examines and normatively engages these broader conditions. She uses the example of access to healthcare as a case in which society helps or hinders individuals’ health. The first point, that social conditions such as education, poverty, availability of preventative care, exposure to crime, income inequalities, and poor nutrition play an important role in people’s subsequent health conditions has been demonstrated by numerous studies in various fields. Jecker (2008) argues that we ought to examine the environmental and social factors in people’s lives, as well as their direct interactions with the healthcare system, in order to fully address health problems in society. Although not a new argument, it loses little in the repetition. Jecker (2008) next argues that these issues are not the focus of bioethics literature, and should be. Jecker is not the first to complain that bioethics, and bioethicists, pay too little attention to justice, or that there is a disproportionate emphasis on clinical issues related to justice, when she states that “concerns related to just access to healthcare, organizational ethics, healthcare systems, and the social determinants of health have not been a dominant focus” (2). In a country with gross inequalities in access to care and well-documented health disparities, one wouldn’t be surprised if, like other academics, bioethicists contribute to the status quo by overemphasizing new technologies, break-

Too Many Rationales, Not Enough Reason: A Call to Examine the Goals of Including Lay Members on Institutional Review Boards

ABSTRACT Every major U.S. commission appointed to review Institutional Review Boards (IRBs) as well as numerous reports and scholarly articles have recommended increasing the number of lay (nonscientist and unaffiliated) members on IRBs. Meanwhile, qualitative studies have shown that lay IRB members experience confusion about their roles, including ambiguity whether their roles are different from other members of the board. Without articulating the unique reasons why unaffiliated and nonscientist members are needed, IRBs have little guidance on how to recruit and train these members, and how many should be at the table. By looking back through the history of IRB regulations, policies, and commentaries we can articulate unique contributions these members can make. Only with these contributions in mind can we make arguments for how to best achieve them and make the case that increasing their numbers is necessary.