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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.
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.
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 involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed. 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.
Medical research, also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
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.
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 to 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.
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
In health care, a clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications or devices, or the standard medical treatment for a patient's condition.
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).
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 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was a bioethics organization in the United States.
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
Françoise Elvina BaylisFISC is a Canadian bioethicist whose work is at the intersection of applied ethics, health policy, and practice. The focus of her research is on issues of women's health and assisted reproductive technologies, but her research and publication record also extend to such topics as research involving humans, gene editing, novel genetic technologies, public health, the role of bioethics consultants, and neuroethics. Baylis' interest in the impact of bioethics on health and public policy as well as her commitment to citizen engagement]and participatory democracy sees her engage with print, radio, television, and other online publications.
Christine I. Mitchell is an American filmmaker and bioethicist and until her retirement in September 2022, the executive director of the Center for Bioethics at Harvard Medical School (HMS).
Marion Danis is an American bioethicist and physician-scientist. She is head of the section on ethics and health policy and chief of the bioethics consultation service at the National Institutes of Health Clinical Center.
References
- ↑ Emanuel, EJ (Dec 1998). "The blossoming of bioethics at NIH". Kennedy Inst Ethics J . 8 (4): 455–66. doi:10.1353/ken.1998.0030. PMID 11657322. S2CID 12392680.
- ↑ Danis, Marion (2012). Research Ethics Consultation: A Casebook. USA: Oxford University Press. ISBN 978-0199798032.
- ↑ Cho, MK; Tobin SL; Greely HT; et al. (2008a). "Strangers at the benchside: Research ethics consultation". Am J Bioeth . 8 (3): 4–13. doi:10.1080/15265160802132951. PMC 2585006 . PMID 18570086.
- ↑ Havard, M; Cho MK; Magnus D (25 Jan 2012). "Triggers for research ethics consultation". Sci Transl Med . 4 (118): 118cm1. doi: 10.1126/scitranslmed.3002734 . PMID 22277965.