Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subject's free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subject's safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.     

Research ethics and clinical trials: Fostering collaboration with research participants

Accountability in research is a concept that applies to researchers and study participants alike. Human subjects play an active part in the success or failure of a clinical trial by virtue of their understanding of a study's goals expectations of personal gain, and adherence to study design. Trials must be designed to address patient concerns, offer an improved consent process, and move beyond our narrow conception of “patient rights.”; Problems with protocol adherence may be reduced by conceptualizing clinical research as an endeavor with mutual accountability within a relational ethic.     

Accountability and academic freedom: The battle concerning research on cold fusion at Texas A&M university

abstract

The Massachusetts Task Force on Human Subject Research has so far been the only serious attempt to investigate radiation experiments on humans. No other federal, state or private agency has looked at a specific experiment in detail. The President's Advisory Committee on Human Radiation Experiments (ACHRE) provided an overview of the entire nationwide research project, but without a thorough evaluation of any single experiment. The Massachusetts Task Force examined a group of experiments using institutionalized children at two state facilities, the Fernald and Wrentham schools, from 1943 to 1973. The experiments were performed under supervision by scientists at Harvard and MIT, and were funded by several federal agencies. The Task Force found that these experiments were conducted according to the ethical and protocol standard of their day. This did not prevent the Task Force from judging that the experiments violated human rights, and recommending apology and compensation to the victims.     

Engaging the public in policy development: The national bioethics advisory commission report on research involving persons with mental disorders that may affect decisionmaking capacity

U.S. bioethics commissions have used a variety of methods to involve the public. All share a common requirement: as federal advisory committees they are required to comply with the Federal Advisory Committee Act, the federal law established during the Nixon administration which provides the public with an assurance that groups established by the government to advise the government should be publicly accountable. This paper will describe some of the ways the National Bioethics Advisory Commission (NBAC) sought to involve the public in its report on Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity.     

The Responsible Conduct of Bioethics Research

The responsible conduct of research in the biomedical and behavioral sciences has received significant attention since the late 1980s. However, very little has been written about the responsible conduct of bioethics research. Bioethics is an interdisciplinary field and brings together divergent ethical standards and practices which may be the source of tension or conflict. This article argues that bioethicists should reflect more on ethical issues in the responsible conduct of bioethics research through examination of authorship practices and peer review. I also outline three possible approaches to promote research integrity in bioethics.     

Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research

Specialized and up-to-date knowledge is required to identify and manage the risks associated with advanced biomedical research. Additional complexities need to be considered when the research involves infants or young children. In this article, we focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps. With an eye to assisting institutional review boards and researchers, we consider strategies for the management of these risks and formulate key questions aimed at exposing hidden hazards. Institutional review boards should ask these questions, and researchers should bear them in mind as they develop research protocols.     

Ethics of research design

Discussions of ethical issues in research involving human subjects most usually provoke concerns about valid informed consent procedures. However, considering the recognized limitations of informed consent, arguably the way a study is designed is a more consequential concern for subject well‐being. This paper summarizes ethical issues in the design of clinical research, with reference to historic and current guidelines. Special attention is given to randomized clinical trials (RCTs) and psychiatric research.     

The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

The protection of unrepresented patients in emergency care research

In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations.     

The Vanishing Physician Scientist: A Critical Review and Analysis

Review of the concept of “the vanishing physician-scientist” shows: 1) medical school admissions reject most students wanting medical research careers; 2) college years before medical school are the best time for students to begin research; 3) efforts to entice admitted medical students and residents to do research are too little too late, yielding people not equipped to compete for grants with PhD track peers and less motivated because they have clinical careers to fall back on; 4) the MD/PhD could be replaced by the PhD/MD with uninterrupted research: a full PhD in parallel with part-time medical school followed by part-time residencies. Supplemental materials are available for this article. Go to the publisher's online edition of Accountability in Research to view the free supplemental file.     

Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.     

Building a More Connected DSMB: Better Integrating Ethics Review and Safety Monitoring

Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards’ composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of clinical trials. Particular tensions stem from DSMBs’ sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs’ monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision making through the life of a trial.     

'Text-work' in Research Ethics Review: The significance of documents in and beyond committee meetings

ABSTRACT

This article analyzes how a formal text (the Ethics Review Form) available at National Health Service Research Ethics Committees (NHSRECs) in the United Kingdom was used in meetings. Derived from the work of Dorothy Smith on incorporating texts into institutional ethnography (IE), it proposes the concept of “text work” as a way into understanding more about decision-making in ethics review and describes the extent to which this formal text shaped and influenced review work. The research study used observations of committee meetings, field-notes and interviews to produce an ethnographic mapping of Research Ethics Committees’ (RECs) work. This article draws on one aspect of the research which was the process of isolating a particular, ubiquitous text and analyzing how it worked and was worked on in the meetings. The analysis contributes to contemporary discussion offering an alternative to ongoing debates about idealized ways of conducting ethics review. Finally, some tentative suggestions are made about improving training, based on and starting from the work which reviewers undertake.     

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.