Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Institutional Pathology and the Death of Dan Markingson

In the spring of 2015, 11 years after a mentally ill young man named Dan Markingson stabbed himself to death in an industry-sponsored drug study, officials at the University of Minnesota suspended recruitment of subjects into drug trials in its Department of Psychiatry. University officials agreed to act only after a scathing investigation by Minnesota Office of the Legislative Auditor found damning evidence of coerced recruitment, inadequate clinical care, superficial research oversight, a web of serious, disturbing conflicts of interest, and a pattern of misleading public statements by university officials aimed at deflecting scrutiny. In this article, I examine the larger institutional factors leading up to Markingson’s suicide and prevented corrective action for so long.     

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.     

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.     

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.     

Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

Despite more than thirty years of debate, disagreement persists among research ethicists about the most appropriate way to interpret the U.S. regulations on pediatric research, specifically the categories of “minimal risk” and a “minor increase over minimal risk.” Focusing primarily on the definition of “minimal risk,” we argue in this article that the continued debate about the pediatric risk categories is at least partly because their conceptual status is seldom considered directly. Once this is done, it becomes clear that the most popular strategy for interpreting “minimal risk”—defining it as a specific set of risks—is indefensible and, from a pragmatic perspective, unlikely to resolve disagreement. Primarily this is because judgments about minimal risk are both normative and heavily intuitive in nature and thus cannot easily be captured by reductions to a given set of risks. We suggest instead that a more defensible approach to evaluating risk should incorporate room for reflection and deliberation. This dispositional, deliberative framework can nonetheless accommodate a number of intellectual resources for reducing reliance on sheer intuition and improving the quality of risk evaluations.     

EXCLUDING PARTICULAR INFORMATION FROM CONSENT FORMS

Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor’s name on the consent form may allow the form to serve as a surrogate for subjects’ HIV status.

There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.     

'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.     

National,independent oversight: Reinforcing the safety net for human subjects research*

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.     

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

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.     

Who Cares about Consent Requirements for Sourcing Human Embryonic Stem Cells? Are Errors In the Past Really Errors Of the Past?

Through an Access to Information Act request, we have obtained the consent forms used by the providers of every human embryonic stem cell (hESC) line approved for use by the Canadian Institutes of Health Research (CIHR), and examined them to verify whether or not they meet the consent requirements established by Canadian law and regulations. Our findings show that at least seven out of ten consent forms studied did not satisfy these minimum requirements. We then outline various options for responding to this situation in terms of: (i) remedial measures for dealing with executive problems with regulatory oversight procedures; and (ii) remedial measures for dealing with the impugned lines.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Informed Consent of Very Sick Subjects in Nigeria

This article highlights a number of ethical challenges I face in obtaining informed consent from very sick subjects with suspected pulmonary tuberculosis (TB). Some of the subjects with TB have an associated human immunodeficiency virus (HIV) infection. From my experience in administering informed consent and health surveys, I found the subjects to be generally mentally stable but physically exhausted. Many of the very sick subjects cough excessively and cannot tolerate a 45-minute conversation with the study staff in order for them to administer consent and conduct a survey after the routine clinical evaluation. In this situation, the administration of a qualitative consent that preserves the subject's right and autonomy becomes a challenge.     

The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

Accountability in research using persons with mental illness

Although medical research involving the use of persons with mental illness is critically important, in order for the research to be ethical and legal there are certain considerations and restrictions which should be immediately readdressed in order to insure that the welfare of these vulnerable research subjects is protected, and their best interests are assured. A brief historical examination of medical research codes, guidelines, recommendations and Federal Regulations reveals the various considerations and restrictions on informed consent and accountability applicable to the use of persons with mental illness in medical research. Several concerns are raised about how these considerations and restrictions have been interpreted, and specific recommendations are offered to improve them immediately by means of representation from consumers and/or their families, and organizations, e.g., NAMI members.     

Competence and consent to research: A critique of the recommendations of the national bioethics advisory commission*

Concern about the participation of incompetent subjects in psychiatric research has grown in the last several years. In response, the National Bioethics Advisory Commission (NBAC) recommended in its recent report that all investigations involving persons with mental disorders that may be associated with cognitive impairment that may pose greater than minimal risk to subjects utilize independent assessors to verify the capacities of subjects prior to entry into the study. This recommendation poses several problems for the conduct of research and the protection of research subjects. First, it fails to target that group of subjects most likely to be at risk for incapacity. Second, it focuses on too broad a range of research projects, many of which pose little risk to participants. The substantial costs of this approach are therefore not likely to be outweighed by concomitant benefits. In place of the NBAC recommendation, the author proposes a more flexible system of capacity assessment, designed to balance the costs with a greater likelihood of achieving meaningful protection for research subjects with mental disorders.     

Critical Commentary: Who Decides Now? Protecting and Empowering Vulnerable Adults Who Lose the Capacity to Make Decisions for Themselves

The implementation of the 2005 Mental Capacity Act in Englandand Wales heralds a new era for social work practitioners andresearchers. Protecting and empowering vulnerable adults—animportant element of adult-care social work—relies ona legal framework that attempts to balance adults’ rightswith the desire to protect them. The new Act is part of thatframework, addressing the fundamental issue of when and howdecisions can be made on behalf of people who lose decision-makingabilities (‘capacity’). The Act encompasses themeaning of incapacity and best interests, advance directivesconcerning treatment, managing people’s affairs and makingdecisions for them, overseeing the delegation process, and research.In explaining how the Act addresses some of these challenges,the article alerts practitioners and researchers to the keyareas in which the Act will make a major impact.     

The Inappropriate Use of Risk-Benefit Analysis in the Risk Assessment of Experimental Trauma-Focused Research

A large body of research has explored the impact of questioning participants about traumatic experiences. To determine the level of risk, these studies have relied, to various degrees, upon a risk-benefit calculus, whereby risks are weighed against the benefits that an individual can receive from participating. In the case of trauma-focused studies this approach is erroneous. The procedures involved in trauma-focused studies do not meet the criteria to be considered therapeutic, and the benefits associated with these procedures do not carry the moral weight to offset risk. Applying the risk-benefit calculus to non-therapeutic procedures inevitably leads to inaccurate risk assessments and ethically problematic claims, examples of which can be found throughout traumatic stress literature. This article outlines how the standard approach to risk assessment in trauma-focused studies is fallacious, and presents an established alternative model that researchers can use to accurately assess the risks of asking participants about their traumatic experiences.     

The nature and quality of engineering research

Engineering is the application oí science to design and development of products intended for useful social purposes. Engineering research consists of a wide variety of activities ranging from study of material properties for possible future application to the testing necessary to establish design parameters or to verify the adequacy of new design concepts. Professors of engineering are generally expected to conduct research, preferably in the “engineering sciences”; (e.g. thermodynamics, metallurgy), to publish their results, and find their own sources of funding. Many private corporations maintain departments of research and development, the findings of which are often proprietary and not subject to peer review. Managers of engineering research projects attempt to assure the quality of their results by “instrumental”; or “organizational”; methods. Instrumental methods assure accuracy in data collection and processing, while organization methods maintain a work environment conducive to creativity and integrity among researchers. Organizational conditions can affect research quality adversely, by giving rise to ethical problems associated with conflicts between corporate interests and those of individuals.