Ethical Issues Related to the Use of Humans in Human Factors and Ergonomics

Author(s):  
William F. Moroney

As professionals, we must be aware of our ethical responsibilities when engaged in research and testing. The purpose of this paper is threefold: 1) to increase the reader's awareness of some of the issues specific to our discipline, 2) to provide some guidelines and references regarding the use of human subjects, and 3) to increase the dialog in this critical area. The material discussed focuses on Federal Regulations related to the protection of human subjects. The changing role of the human subject from “research material” to “participant partners” is also discussed.

2007 ◽  
Vol 21 (3) ◽  
pp. 156-173 ◽  
Author(s):  
Elizabeth R. A. Beattie ◽  
Terry M. VandenBosch

This article provides an overview of the concept of vulnerability through the lens of the U.S. federal regulations for the protection of human subjects of research. General issues that emerge for nurse researchers working with regulated vulnerable populations are identified. Points of current controversy in the application of the regulations and current discourse about vulnerable groups are highlighted. Suggestions for negotiating the tension between federally regulated human subject requirements and the realities of research with vulnerable subjects are given. The limitations of the designation of vulnerable as a protection for human subjects will also be discussed.


1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso

Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.


Author(s):  
Daniel Wikler

Medical ethics was once concerned with the professional obligations of physicians, spelled out in codes of conduct such as the ancient Hippocratic oath and elaborated by contemporary professional societies. Today this subject is a broad, loosely defined collection of issues of morality and justice in health, health care and related fields. The term ‘bioethics’ is often used interchangeably, though it is also used with its original broad meaning, which included issues in ecology. The range of concerns grouped under ‘medical ethics’ begins with the relationship of doctor to patient, including such issues as consent to treatment, truth-telling, paternalism, confidentiality and the duty to treat. Particular moral uncertainty is engendered by contexts which demand divided allegiances of physicians, such as medical experimentation on human subjects, public health emergencies and for-profit medicine. Issues in medical ethics arise in every stage of life, from the fate of defective newborns to the withholding of life-sustaining therapies from the very old. Medical practices with patients who may not be competent to make their own medical decisions, including paediatrics and psychiatry, raise a distinctive set of ethical issues, as does medical genetics, which involves choices affecting family members, future individuals and offspring in utero. In recent years, medical ethics has broadened its focus beyond the individual physician or nurse to include the organization, operation and financing of the health care system as a whole, including difficult theoretical and practical uncertainties regarding the fair allocation of health care resources. Medical ethics is at once a field of scholarship and a reform movement. The latter has campaigned in many countries on behalf of patients’ rights, better care of the dying and freedom for women in reproductive decisions. As a field of scholarship, medical ethics addresses these and many other issues, but is not defined by positions taken on any of them. Though ethicists often favour an emphasis on informed consent, oppose paternalism, urge permission to end life-sustaining therapy (or choose suicide) and seek protection of human subjects of experimentation, a diversity of viewpoints finds expression in the medical ethics literature.


2003 ◽  
Vol 31 (1) ◽  
pp. 149-153 ◽  
Author(s):  
T. Howard Stone

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.


2017 ◽  
Vol 24 (6) ◽  
pp. 686-693 ◽  
Author(s):  
Rini Rachmawaty

Background: Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. Objectives: This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. Methods: A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Results: Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Discussion: Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Conclusion: Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies understand the research ethics on human subjects and apply it into their practice.


1993 ◽  
Vol 8 (S1) ◽  
pp. S11-S14 ◽  
Author(s):  
Eric A. Davis ◽  
Ronald F. Maio

The atrocities committed by Nazi physicians and scientists, in the name of furthering medical science, is an appalling page of the history of medical research. In the wake of World War II, the scientific community strived to develop regulations to guard against future abuses in medical research. However, a particularly sobering thought is that the atrocities in Germany were being carried out in a country that had specific regulations for protecting human research subjects: Nazi Germany was the only European country to have such regulations. A more in-depth look at these regulations reveals institutional or department heads were held accountable, but not the individual researcher. The lesson from this analysis is clear: individual investigators must bear the responsibility of conducting ethical research. Governmental regulations and Institutional Review Boards never can replace investigators who are advocates for the protection of human subjects.The purpose of this paper is to address issues broadly regarding ethics and prehospital research, with a focus on the topic of informed consent.


2011 ◽  
Vol 39 (2) ◽  
pp. 243-253 ◽  
Author(s):  
Trisha B. Phillips

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Some critics question whether researchers should be allowed to offer money at all, citing concerns about commodification of the research subject, invalidation of study results, and increased risks to subjects. Other critics are comfortable with the idea of monetary payments but question how much researchers can pay their subjects, citing concerns about undue inducement, crowding out, and monetary exploitation. Focusing only on the amount researchers can pay their subjects, this paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage.


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