Vulnerability in Research with Prisoners

Prisoners are often described as a vulnerable research population. This designation, while intuitively appealing, leaves unclear what is meant by “vulnerability” in the context of research with incarcerated individuals. Conceptual clarity would provide the ethical foundation needed to identify the full scope of research protections to afford prisoners. It would also militate against a tendency among some to view all prison research as irredeemably problematic and prohibitive. Drawing on a prior taxonomy of vulnerability, this chapter specifies eight vulnerability types that apply to prisoner research. It describes their predisposing factors and the ethical concerns they raise. It also considers possible strategies for addressing these concerns and highlights areas where effective strategies are lacking or need further development. This framework is intended to guide researchers and institutional review boards in the planning and review of protocols involving prisoners so that they may safeguard prisoners from abuse and promote the ethical advancement of science.

Ancillary-Care Obligations

Medical researchers’ ancillary-care obligations have, until recently, been ignored by the authoritative guidelines on the ethics of medical research. Ancillary care is medical care, often unrelated to what is under study, that is not required by sound science, safe trial conduct, morally optional promises, or redressing research injuries. The question is when medical researchers have moral responsibilities to provide such care if their study participants need it. This question shows up insistently in studies done in resource-poor areas and—as the question of whether to return incidental findings—in genomic and imaging studies. After laying out six desiderata for a fully adequate account of medical researchers’ ancillary-care obligations, this chapter critically evaluates six potential grounds for such obligations—the duty of rescue, human rights, rectificatory justice, professional-role obligations, the researcher–participant relationship, and partial entrustment. It closes by suggesting the possibility of combining two or more of these grounds.

Clinical Translation, Ethics, and Policy

Many representations of clinical translation present it as a linear process by which bench discoveries are advanced into clinical practice. The present chapter offers a conceptual framework that highlights distinctive ethical aspects of clinical translation. The framework understands clinical translation as a process not so much as developing new treatments but rather generating evidence on how to use (and how not to use) new as well as old interventions. It also emphasizes attending to the relationship of different studies with each other and the importance of coordinating different studies with each other. The model presented here foregrounds the role of coordination in realizing societal objectives of clinical translation at minimal burden and cost for patients and study volunteers.

Decolonizing Research Ethics

Globally, there is widespread agreement that research involving indigenous peoples must be conducted with the consent, consultation, or collaboration of communities. However, there are practical challenges to implementing this ideal. This chapter critically engages with scholarship on research ethics in relation to indigenous communities, focusing on the challenges inherent in the global movement toward decolonizing methodologies and indigenous governance of research. The chapter presents recommendations for a decolonizing approach to research ethics. It emphasizes that research institutions need to take seriously that an indigenous group has the right to say “no” to research that has been deemed ethical by an institutional research ethics board. The authors argue further that this requires attention to the “politics of risk,” including the ways in which collective identity and research risks are co-constructed.

Current Issues in Behavioral and Social Science Research Ethics

Many researchers consider behavioral and social science (BSS) studies as “soft” science with negligible ethical risk. However, specific ethical issues arise in BSS research that require special consideration on the part of researchers and ethics review committees. This chapter focuses on these issues within the context of three studies that demonstrate concerns that may arise in conducting BSS research. Topics include deciding what BSS studies should be defined as “research” (or not), risks inherent in specific types of BSS research, protection of privacy and confidentiality, and special considerations in informed consent for BSS studies. Special topics addressed in this chapter include the ethical issues associated with studies utilizing social media and community-based participatory research, as well as the importance of rigor and reproducibility in BSS research in the context of ethical review. Finally, the chapter highlights the necessity of empirical study of ethical issues in BSS research to assess decision-making in an ever-evolving social landscape.

Guidelines, Codes, and Regulations

Research involving human subjects is increasingly global in scope. This research is governed by over 1,000 guidelines, codes, and regulations spanning 130 countries. While there have been some attempts to construct international codes of conduct, particularly in the area of biomedical research, the reality is that these universal codes are superimposed over national and institutional norms, resulting in idiosyncrasies and discrepancies. Even within the United States as a single example, human subjects research is subject to a “patchwork quilt” of regulation, depending on the nature of the research and the source of funding. This chapter will provide an overview of these governing standards, recounting their historical evolution, discussing their key elements, and describing the challenges faced by researchers, sponsors, and regulatory bodies who must navigate this landscape.

Military Medical Research Ethics

Military medicine presents unique challenges for medical research. Landing in Iraq, Coalition forces required investigational drugs to combat the threat of poison gas. As the fighting progressed, battlefield conditions necessitated rapid innovation to control bleeding, manage fluid resuscitation and transfusion, conduct field surgery, treat traumatic brain injury, develop limb prosthetics, and enhance performance. While clinicians delivered high-quality retrospective and survey studies, conditions unique to the military made it difficult to obtain informed consent and conduct controlled clinical trials of emerging therapies and medical devices. The result was a dearth of sufficient studies. Remedying the situation requires reformulating the rules of informed consent for military medical research and enlisting civilian subjects while protecting the rights and privileges of each group.

Research in Adults with Diminished Capacity

Informed consent is often identified as a condition of ethical research. Therefore, ethical challenges arise when conducting research with adults who lack the capacity to provide informed consent. In this chapter, the authors consider these challenges using two principal cases: adults with dementia and adults with acute, emergent health conditions. As this pair of cases shows, decisional capacity can be “diminished” in many ways, and a number of strategies are available to address diminished capacity. In this chapter, the authors highlight surrogate consent and the partial-involvement strategies of assent and dissent and note additional protections afforded to these vulnerable populations.

Biomedical Research Using Nonhuman Animals

This chapter considers the ethical significance of the translational value of biomedical research using live nonhuman animals. By “translational value” is meant how well or poorly animal research results in specific improvements in human medicine. While other animal as well as environmental benefits may also result from biomedical research using animals, the primary objective of most such research continues to be human health benefit. The translational value of animal research is first considered in light of a historical and regulatory perspective on the nexus of human and nonhuman animal experimentation. Next, common competing perceptions about the value of animal research for human health are addressed. Finally, consideration of intellectual virtue and barriers to its achievement are introduced as crucial and little recognized factors in these debates.

Research Ethics Consultation

This chapter provides a history of the development of research ethics consultation (REC) and an evaluation of its role in the conduct of research with human participants. It provides a brief overview of how and where REC is currently practiced. It also reviews and engages current debates on the appropriate methods and purpose of REC. Controversies are addressed, including the relationship of REC to research review committees, competency requirements for REC, the appropriate level of confidentiality of REC recommendations, who should have access to RECs, and handling of divergence between ethics guidance and the law. Finally, it explores the question of appropriate breadth of REC.