Ethical and legal issues in conducting research involving elderly subjects

Older people are increasingly the focus of biomedical and behavioral research not only because the elderly constitute the fastest growing segment of our population but because there is a societal concern to improve the elderly's quality of life. The profound need to advance that research carries with it an equally profound obligation to protect the rights and welfare of elderly research subjects, and thus raises difficult ethical and legal issues. Against a background of foundational principles for the protection of human subjects, we discuss whether older subjects should be treated as a special class, the ethical and legal issues over informed consent, capacities for consent, and special problems related to cognitive impairment. We discuss surrogate/proxy consent procedures in research, recruitment of elderly subjects, conflicts of interest, special problems regarding institutional research, and risk/benefit analyses. We offer recommendations and practical guidelines for conducting current and future research involving elderly participants.     

Challenging research on human subjects: justice and uncompensated harms

Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent.     

Protecting people in research: a comparison between biomedical and traffic research

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed.     

Moral reasoning and the review of research involving human subjects

The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are drawn for changes to the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research.     

Scientific rewards and conflicts of ethical choices in human subjects research.

The primary responsibility of the American Psychological Association's (APA) Committee on Standards in Research (CSR) is to advise the APA on issues and standards related to the protection of human participants in psychological research. A related goal is to enhance the use of good ethical practices by APA members. The purpose of this article is to foster the view of research ethics not as an affront to the integrity of sound research, but as opportunities for scientific rewards, including increased understanding of the meaning of data, enhanced recruitment, and the inclusion of more representative samples. Three ethical practices are discussed as examples of this general premise: respect for confidentiality, use of debriefing, and assurance that participants are noncoerced volunteers. The Committee's intent is to promote consideration of these issues, not to promulgate specific guidelines or procedures.     

Conflict of interest in biomedical research: a view from Europe

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine. The opinions here expressed are personal and do not commit the European Commission. An earlier version of this paper was delivered at a Conference on Conflict of Interest and Its Significance in Science and Medicine, 5–6 April, 2002, Warsaw, Poland. The author is a Scientific Officer in the Programme Science and Society dealing with ethics and science (Unit C.3).     

Legal and ethical issues in neuroimaging research: human subjects protection,medical privacy,and the public communication of research results

Humans subjects research entails significant legal and ethical obligations. Neuroimaging researchers must be familiar with the requirements of human subjects protection, including evolving standards for the protection of privacy and the disclosure of risk in "non-therapeutic" research. Techniques for creating veridical surface renderings from volumetric anatomical imaging data raise new privacy concerns, particularly under the federal medical privacy regulation. Additionally, neuroimaging researchers must consider their obligation to communicate research results responsibly. The emerging field of neuroethics should strive to raise awareness of these issues and to involve neuroimaging researchers in the legal, ethical, and policy debates that currently surround human subjects research.