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.

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections (SACHRP), and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation.

Ethical Issues in the Neonatal SUPPORT Trial

The controversy over the neonatal Surfactant, Positive Pressure, and Oximetry Randomized Trial (SUPPORT) study of oxygen saturation targets in extremely premature babies was intense and polarizing. The fundamental issue turned on whether or not there were reasonably foreseeable risks to the babies who were enrolled in the study and, if so, whether that should have either (a) been disclosed in the consent form or (b) led institutional review boards to never approve the study in the first place. The federal Office for Human Research Protections (OHRP) took the first view. The advocacy group Public Citizen (PC) took the second. This chapter suggests that both views were wrong. Being in the study was, in fact, safer than not being in the study. The mistakes made by both OHRP and PC have dangerous implications for research ethics and regulation. They could lead to mandates for consent forms that are inaccurate and misleading.

Informed Consent for Comparative Effectiveness Research Should Not Consider the Risks of the Standard Therapies That Are Being Studied as Risks of the Research

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).” (CFR 46.111 (a)(2)). By contrast, the Office of Human Research Protections, in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.” (emphasis added).In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible.