Protecting Subjects with Decisional Impairment in Research

Silverman, Henry; Luce, John M.; Schwartz, Jack

doi:10.1164/rccm.200303-430cp

Cited by 50 publications

(34 citation statements)

References 14 publications

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“…The findings that increasing harm decreased decision makers' perceptions of capacity to consent and increased perceptions of risk and level of protections were also predicted. These findings provide empirical evidence that the decision-makers appear likely to create different conditions of access to research according to how much harm is posed to participants and have generally accepted the principle to augment protections in parallel with increasing risks (Becker et al 2004;Levine et al 2004;Silverman et al 2004). These findings suggest that decision-makers make determinations based on the individuals-in-context, as an ecological perspective suggests is appropriate (Clegg 2000;Dye et al 2004;Fendrich 2004;Fisher 2003;Kelly 1968;Labott and Johnson 2004;Oakes 2002;Singer 2004;Trickett et al 1985).…”

Section: Study Characteristics Main Effectsmentioning

confidence: 78%

“…These interactions suggest a ''multiplicative risk'' posed by including vulnerable individuals in high harm research (Becker et al 2004;Dye et al 2004;Freedman 2001;Levine et al 2004;NIH 1999;Silverman et al 2004) and emphasize the importance of the interaction of contextual factors in decision-makers' access determinations. These findings highlight that, relative to others without intellectual disabilities, adults with intellectual disabilities may encounter more restricted access to settings that pose greater potential harm to them.…”

Section: Study Characteristic Interactionsmentioning

confidence: 99%

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How the Powerful Decide: Access to Research Participation by those at the Margins

McDonald

Keys

2008

American J of Comm Psychol

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How do those in power decide to include and exclude those at the margins from community life? We used simulated review of research vignettes to examine how researchers and members of Institutional Review Boards make decisions concerning the research participation of adults with and without intellectual disabilities. Results indicate that decision-makers are influenced by the disability status of the sample, characteristics of the research in which they are engaged, and their attitudes toward the research participation of adults with intellectual disabilities as well as their own relationship to the research process. For example, decision-makers may create situations that limit the self-determination of adults with intellectual disabilities and adults without disabilities within the research context, particularly when the research poses some risk of harm to participants. Implications for theory, action and research are explored.

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Section: Study Characteristics Main Effectsmentioning

confidence: 78%

Section: Study Characteristic Interactionsmentioning

confidence: 99%

How the Powerful Decide: Access to Research Participation by those at the Margins

McDonald

Keys

2008

American J of Comm Psychol

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“…Furthermore, the legality of proxy consent for research in some states remains unclear. 36 There is no regulatory guidance as to the necessary additional protections for the vulnerable subjects enrolled in these studies. The Acute Respiratory Distress Syndrome Network (ARDSNet) studies, in particular, have been criticized for failing to offer any additional protections beyond proxy consent.…”

Section: Absence Of Regulatory Guidance For Research Enrolling Incapamentioning

confidence: 99%

“…The Acute Respiratory Distress Syndrome Network (ARDSNet) studies, in particular, have been criticized for failing to offer any additional protections beyond proxy consent. 36 In response to difficulties with IRB approval of geriatric research, investigators have suggested that specific regulations for research enrolling incapacitated adults be enacted. 21 New regulations should include the following basic elements: 1) a requirement that the use of incapacitated adult subjects be essential for answering the study's scientific question, 2) protections for subjects' privacy that are compatible with the Common Rule and HIPAA requirements, 3) requirements and procedures for obtaining consent from substitute decision-makers on behalf of incapacitated subjects, and 4) a limit of no more than a minor increase above minimal risk for nontherapeutic procedures.…”

Section: Absence Of Regulatory Guidance For Research Enrolling Incapamentioning

confidence: 99%

U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary

McRae

Weijer²

2008

Academic Emergency Medicine

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Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. ACADEMIC EMERGENCY MEDICINE 2008; 15:88-97 ª 2008 by the Society for Academic Emergency MedicineKeywords: emergency research, research ethics, federal regulations, bioethics, community consultation E mergency medicine has a broad scope of practice. The spectrum of clinical research that is required to advance emergency care is correspondingly broad. To examine clinical problems ranging from minor to life-threatening conditions, emergency research enrolls subject populations with differing decision-making capacities, including capable adults, adults incapacitated by acute illness or injury, and children. These different categories of subjects are protected by several overlapping U.S. federal regulations. Investigators should be familiar with the federal regulations that govern emergency research. Knowledge of the regulations will facilitate the IRB review process by enabling researchers to design studies that comply with the rules and preserve the rights of vulnerable research subjects.This article is intended as a guide for emergency researchers and for IRB members who oversee emergency research. It reviews the federal regulations that govern emergency research, examines necessary protections for subjects in research for which few regulations exist, and explores potential solutions to regulatory problems that present barriers to the conduct of emergency research.

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“…In contrast, some commentators suggest that the definition of minimal risk should be measured against risks ordinarily encountered by healthy persons. 222 In psychiatric research, data on differential risk assessment is available from a recent study by Roberts and colleagues. The authors examined psychiatrists' and schizophrenia patients' perceptions of the level of risk of a number of research procedures.…”

Section: Key Safeguards: Protocol Review and Participant Advocatesmentioning

confidence: 99%

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

Dunn

Candilis

Roberts

2005

Schizophrenia Bulletin

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Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics.

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Protecting Subjects with Decisional Impairment in Research

Cited by 50 publications

References 14 publications

How the Powerful Decide: Access to Research Participation by those at the Margins

How the Powerful Decide: Access to Research Participation by those at the Margins

U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

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