Experimentation on Human Subjects

2017 ◽  
Author(s):  
Robert M. Veatch ◽  
Amy Haddad ◽  
E. J. Last
Keyword(s):  
Ethical Issues ◽  
Human Subjects ◽  
Medical Science ◽  
Nuremberg Code ◽  
Subject Selection ◽  
Research Guidelines ◽  
Voluntary Consent ◽  
Nuremberg Trials ◽  
Privacy And Confidentiality ◽  
International Document

This chapter examines ethical issues in research involving human subjects. The Nuremberg trials, which exposed to all humankind the outrageous things that could be done in the name of medical science, led to the Nuremberg Code, the first international document from public sources setting out an ethic for research on human subjects. Basic differences are outlined between the goals of therapy for the good of a patient and those of research that focus on attainment of knowledge and the good of society. To protect the interests of human subjects who take part in research, guidelines such as the Declaration of Helsinki have been established for assessing risks and benefits, voluntary consent, protection of privacy and confidentiality, and equity in subject selection. The chapter focuses on the difficulty in calculating harms and benefits to subjects and challenges of obtaining informed consent for participation in research.

How Important Is Consent for Controlled Clinical Trials?

1996 ◽  
Vol 5 (2) ◽  
pp. 221-227 ◽  
Author(s):  
Barbara MacKinnon
Keyword(s):  
Biomedical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Medical Knowledge ◽  
Experimental Therapy ◽  
Human Beings ◽  
Nuremberg Code ◽  
Declaration Of Helsinki ◽  
Voluntary Consent ◽  
Risk And Benefit

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and scientific soundness. However, it also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research (i.e., “medical research combined with profession care”) and nonclinical biomedical research (i.e., “nontherapeutic biomedical research involving human subjects”). In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee.

Environmental Health Research and Ethics

2019 ◽  
pp. 753-764
Author(s):  
David B. Resnik
Keyword(s):  
Environmental Health ◽  
Health Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Environmental Interventions ◽  
Environmental Health Research ◽  
Research Designs ◽  
Research Regulations ◽  
Kennedy Krieger Institute ◽  
Privacy And Confidentiality

This chapter discusses some of the key ethical issues that arise in environmental health research involving human subjects, including returning individualized research results, protecting privacy and confidentiality, research on environmental interventions, intentional exposure studies, research regulations, autonomy, beneficence, informed consent, payments to subjects, and protecting vulnerable human subjects. The chapter will discuss issues that are common to all research designs, as well as those unique to certain types of designs, such as intentional exposure studies. It will also address ethical issues that arose in two important cases, the Kennedy Krieger Institute lead abatement study, and the Children’s Environmental Exposure Research Study.

scholarly journals Ethics in Research with Human Subjects - A Brief Review

1970 ◽  
pp. 24-26
Author(s):  
Md Uzire Azam Khan ◽  
Md Ruhul Amin ◽  
Firoza Begum ◽  
Momotaz Begum
Keyword(s):  
Human Subjects ◽  
Basic Research ◽  
Research Protocol ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Benefit Ratio ◽  
Subject Selection ◽  
Independent Review ◽  
Ethics In Research ◽  
Guide Lines

Ethics in research involving humans were first codified in 1946 as Nuremberg code. Subsequently other ethical declarations and guide lines were developed to protect the research participants as well as the researchers. The basic research bioethics includes three principles-respects for person, beneficence, and justice. To make a research with human subjects ethically sound the research protocol should have social and scientific values, fair subject selection, favorable risk benefit ratio, independent review, and informed consent of and respect for the participants. Above all the researcher should be honest and responsible enough to safeguard the rights and welfare of the research subjects. DOI: 10.3329/bjpp.v24i1.5734Bangladesh J Physiol Pharmacol 2008; 24(1&2) : 24-26

Children as Research Subjects: A Dilemma

2000 ◽  
Vol 25 (6) ◽  
pp. 745-764 ◽  
Author(s):  
Loretta M. Kopelman
Keyword(s):  
Medical Science ◽  
Ethics Committees ◽  
Complex Problem ◽  
Best Interests ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Research Guidelines ◽  
Institutional Review

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include (1) improving standardizing of risk assessment, (2) rejecting crude utilitarianism, (3) identifying and justifying normative or moral judg-ments, and (4) acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children.

Ethical Issues in Prehospital Research

1993 ◽  
Vol 8 (S1) ◽  
pp. S11-S14 ◽  
Author(s):  
Eric A. Davis ◽  
Ronald F. Maio
Keyword(s):  
World War Ii ◽  
Medical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Medical Science ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
The Individual

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.

The neuroethical future of wearable and mobile health technology

2017 ◽  
Author(s):  
Karola V. Kreitmair ◽  
Mildred K. Cho
Keyword(s):  
Mobile Health ◽  
Ethical Issues ◽  
Health Technology ◽  
The Self ◽  
Ethical Challenges ◽  
Mobile Health Technology ◽  
Healthcare Settings ◽  
Healthcare It ◽  
Mobile Mental Health ◽  
Privacy And Confidentiality

Wearable and mobile health technology is becoming increasingly pervasive, both in professional healthcare settings and with individual consumers. This chapter delineates the various functionalities of this technology and identifies its different purposes. It then addresses the ethical challenges that this pervasiveness poses in the areas of accuracy and reliability of the technology, privacy and confidentiality of data, consent, and the democratization of healthcare. It also looks at mobile mental health apps as a case study to elucidate the discussion of ethical issues. Finally, the chapter turns to the question of how this technology and the associated “quantification of the self” affect traditional modes of epistemic access to and phenomenological conceptions of the self.

The ethical issues of biotechnology: Religious culture and the value of life

2011 ◽  
Vol 59 (2) ◽  
pp. 160-172 ◽  
Author(s):  
Shimazono Susumu
Keyword(s):  
Catholic Church ◽  
Ethical Issues ◽  
Human Life ◽  
Science And Technology ◽  
Medical Science ◽  
Genetic Diagnosis ◽  
Value Of Life ◽  
Great Expectations ◽  
Early Embryonic Stage ◽  
Religious Cultures

Advances in biotechnology and medical science, especially breakthroughs in cloning and stem cell research, have raised great expectations for curing diseases, repairing damaged body tissue and organs, enabling conception at advanced age and selecting embryos based on genetic diagnosis. However, the question arises whether these advances will improve the happiness of humankind or whether human bodies are being assaulted as development resources in order to procure greater profits. This article investigates how the value of life is conceptualized by religious cultures vis-a-vis the emerging threats. With regard to the early embryonic stage of human life, the Catholic Church, for example, has raised a loud voice against the artificial termination of pregnancy. As a matter of fact, various religious cultures have showed and underpinned to a considerable extent the value of life and the direction that science and technology should take in this respect. It is argued that the globalized competition in science and technology makes it necessary to transcend the views concerning the value of life propagated by particular religious cultures.

scholarly journals Ethical Issues of Fair Subject Selection in the Research

2016 ◽  
Vol 6 (3) ◽  
pp. 37-40 ◽  
Author(s):  
Sifat Rahman
Keyword(s):  
Human Activity ◽  
Ethical Issues ◽  
Ethical Principles ◽  
International Review ◽  
Exclusion Criteria ◽  
Research Project ◽  
Subject Selection ◽  
Conducting Research ◽  
Oversight System

Ethics and ethical principles extend to all spheres of human activity. They apply to our dealings with each other, with animals and the environment. They should govern our interactions not only in conducting research but also in commerce, employment and politics. Ethics serve to identify good, desirable or acceptable conduct and provide reasons for those conclusions. Fair subject selection is the first and foremost concern which must be ensured before initiating a research project.  Which subjects may enroll in the research is determined by the study’s inclusion or exclusion criteria. One of the important aspects of fair subject selection is to have an oversight system through International Review Board (IRB) to review to conduct the research and to have approval whether subject selection is fair or not.

Participants' Perceptions of Ethical Issues in Research with Humans

1983 ◽  
Vol 52 (1) ◽  
pp. 231-238 ◽  
Author(s):  
Denis Lynch ◽  
Wayne Graves
Keyword(s):  
Normative Data ◽  
Ethical Issues ◽  
Human Subjects ◽  
Introductory Psychology ◽  
Academic Major ◽  
Willingness To Participate ◽  
Empirical Methods ◽  
Class Standing ◽  
Subject Pool ◽  
Typical Subject

The recent concern about ethical issues in research with human subjects has fostered an interest in learning more through empirical methods. The present study provides information from potential participants regarding (1) their perception of the likelihood of physical or emotional harm from various experimental procedures and (2) their willingness to participate in experiments using such procedures. Responses were obtained from 1,586 students in introductory psychology classes and were analyzed on the basis of the respondents' age, sex, class standing, and academic major. Besides providing normative data from a typical subject pool, the present study suggests a method of using a research questionnaire as a way of minimizing the chances of offending individual subjects.

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