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.     

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.     

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.     

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.     

Understanding sex: the right to legal capacity to consent to sex

This article addresses the right to legal capacity to consent to sex of people with intellectual disabilities. Article 12 of the Convention on the Rights of Persons with Disabilities guarantees the right to legal capacity on an equal basis in all areas of life. This article discusses sex as an area of life in which people with intellectual disabilities are frequently not being granted legal capacity on an equal basis. The article examines current capacity to consent to sex law in Ireland, England and Wales in light of Article 12. It proposes an ‘agreement model’ as a potential alternative that would be Article 12 compliant.     

Engaging Indigeneity in Development Policy

This article explores how development programming in rural poverty and the environment can work with indigenous peoples. It draws on research conducted in Asia and Latin America to suggest how indigeneity can be understood as specific kinds of marginalisation intersecting with self‐identification and recognition as indigenous. Current obstacles to effective engagement with indigenous peoples are outlined, and suggestions are offered for pro‐actively addressing their experience. Two critical areas where there are opportunities for donors to support indigenous peoples' priorities include ‘FPIC’ (Free Prior and Informed Consent) and a careful consideration of the implications of niche‐market engagement.     

同意的困境——基于以同意理论证成政府家长式干预的视角

在自由主义语境中,对政府家长式干预行为可行性的分析诉诸于对个人意愿真实性的探求,而同意理论作为个人意愿的有效表达方式成为家长主义和反家长主义者论辩的重点。但是,由于同意本身所具有的局限性,使得通过诉诸于个人意愿的方式证成政府家长式干预行为的路径遭遇了不可避免的困境。     

同意的概念及其政治意蕴

在解释公民与国家的新型关系时,由于存在历史事实上的困难,诉诸“明确的同意”（overt consent）显然不那么成功,诉诸“默示的同意”（implied consent）似乎更合理。然而,问题在于,按照后者,要保证同意的效力,就必须以“自愿性”或者“意图性”为必要条件,可现实的情况却未必都是如此的,因为人们对政府的行为予以默认的理由有时是非常“工具性”的。      

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.