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National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States.
Formed in the aftermath of the Tuskegee Experiment scandal, the commission was created in 1974 as Title II of the National Research Act. It was part of the United States Department of Health, Education, and Welfare (DHEW) until 1978. [1]
The commission had four goals that it needed to analyze: [2]
1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were
2) assessing the risks and benefits of the appropriateness of research involving human subjects
3) determining appropriate guidelines for how human subjects can be chosen for the participation in such research
4) defining what informed consent is in each research setting.
The commission also had the task of making recommendations to the Secretary of Health, Education, and Welfare and Congress for the protection of Human subjects. The commission produced their Reports and Recommendations on the following areas of research:
These reports contained their recommendations, [10] the underlying deliberations and conclusions, [11] a dissenting statement and additional statement by commission members and summaries of materials presented to the commission. An appendix was also included which contained complete text reports and papers prepared for the commission on the ethical, legal and medical aspects of the different research areas examined and other material reviewed by the commission in its deliberations.
The commission established limits on Biomedical research such that pregnant women and their fetuses were not harmed by researchers or exposed to any form of risk. The commission further established that the health of a pregnant woman or her fetus could not be compromised under any circumstance for the purposes of research no matter how minute the perceived risk may be. Furthermore, the commission suggested lifting the moratorium imposed on abortion research at that time under the condition that no inducements were offered to subjects to undergo an abortion for the purpose of research. However research on a dead fetus or dead fetal tissue was approved. Lastly, non-therapeutic research upon a pregnant woman or fetus was approved only under the extenuating circumstance that important biomedical knowledge could not be obtained through any other means and that permission was granted to researchers by the subject. [12]
The commission was succeeded by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.
Bioethics is both a field of study and professional practice, interested in ethical issues related to health, including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine, ethical education in science, animal, and environmental ethics, and public health.
Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research done at that institution to ensure that the projects are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.
The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as a successor to the International Medical Congress that organized 17 conferences from 1867 until the 1913 outbreak of World War One.
The Hastings Center is an independent, nonpartisan bioethics research institute and think tank based in Garrison, New York. It was instrumental in establishing the field of bioethics and is among the most prestigious bioethics and health policy institutes in the world.
The Comité Consultatif National d'Ethique is a French governmental advisory council on bioethics issues. It was created by a presidential decree of François Mitterrand in 1983.
Albert R. Jonsen was one of the founders of the field of Bioethics. He was Emeritus Professor of Ethics in Medicine at the University of Washington, School of Medicine, where he was Chairman of the Department of Medical History and Ethics from 1987-1999. After retiring from UW, he returned to San Francisco, where he co-founded the Program in Medicine and Human Values at Sutter Health's California Pacific Medical Center in 2003.
The National Research Act is an American law enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974. The law was passed following a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy.
Principlism is an applied ethics approach to the examination of moral dilemmas that is based upon the application of certain ethical principles. This approach to ethical decision-making has been adopted enthusiastically in many different professional fields, largely because it sidesteps complex debates in moral philosophy at the theoretical level.
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
Jonathan D. Moreno is an American philosopher and historian who specializes in the intersection of bioethics, culture, science, and national security, and has published seminal works on the history, sociology and politics of biology and medicine. He is an elected member of the National Academy of Medicine.
Tom Lamar Beauchamp is an American philosopher specializing in the work of David Hume, moral philosophy, bioethics, and animal ethics. He is Professor Emeritus of Philosophy at Georgetown University, where he was Senior Research Scholar at the Kennedy Institute of Ethics.
Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.
The Presidential Commission for the Study of Bioethical Issues was created by Executive Order 13521 on November 24, 2009. The Bioethics Commission advised President Barack Obama on bioethical issues arising from advances in biomedicine and related areas of science and technology. It replaced The President's Council on Bioethics appointed by United States President George W. Bush to advise his administration on bioethics, and the National Bioethics Advisory Commission (1996-2001). No national organization replaced it when its authorization expired; it "held its final meeting at the end of August 2016 and closed its doors."
The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was a bioethics organization in the United States.
Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit and receive expert ethical guidance related to biomedical research. The first REC service was established at the National Institutes of Health (NIH) Clinical Center in 1997. Today, most REC services are found at academic institutions, and the majority of current services were originally launched in response to the 2006 NIH Clinical and Translational Science Award program, as applicants to that program were required to have procedures in place to address ethical concerns raised by their research.
Patricia A. King is a professor of law emeritus at Georgetown University Law Center and an adjunct professor in the School of Hygiene and Public Health at Johns Hopkins University. Her expertise lies at the intersection of law, medicine, ethics, and public policy. In 1979, she became the first African-American woman law professor to receive tenure at Georgetown.