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.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or causes prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- May have caused a congenital anomaly/birth defect
- Requires intervention to prevent permanent impairment or damage
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 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 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.
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance centres in regard to the benefits, harm, effectiveness and risks of drugs.
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
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.
The Nuffield Council on Bioethics is a UK-based independent charitable body, which examines and reports on bioethical issues raised by new advances in biological and medical research. Established in 1991, the Council is funded by the Nuffield Foundation, the Medical Research Council and the Wellcome Trust. The Council has been described by the media as a 'leading ethics watchdog', which 'never shrinks from the unthinkable'.
Wendy K. Mariner is an American academic who is the Edward R. Utley Professor of Health Law, Bioethics & Human Rights in the Department of Health Law, Bioethics & Human Rights, at the Boston University School of Public Health. She is also a professor of law at Boston University School of Law and a professor of socio-medical sciences and community medicine at Boston University School of Medicine.
Ruth Macklin is an American philosopher and retired professor of bioethics.
Clinical ethics support services initially developed in the United States of America, following court cases such as the Karen Ann Quinlan case, which stressed the need for mechanisms to resolve ethical disputes within health care. The Joint Commission on Accreditation of Healthcare Organizations requirement for hospitals, nursing homes, and home care agencies to have a standing mechanism to address ethical issues has also fostered this development.
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.
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice.
Ranjit Roy Chaudhury, was an Indian clinical pharmacologist, medical academic and health planner, who headed the National Committee for formulating the policy and guidelines on drugs and clinical trials in India. He was the chairman of the joint programme of World Health Organization and Government of India on Rational Use of Drugs in India. He was the founder president of the Delhi Medical Council and the president of the Delhi Society for Promotion of Rational Use of Drugs.
Abha Saxena is a bioethicist and global health specialist. She was trained as an anesthesiologist, and practiced medicine for several years before moving to the World Health Organization in 2001. There she was heavily involved in bioethics work, coordinating the WHO Research ethics committee and Global Health Ethics Team. Since 2018, Saxena has been a visiting professor at the University of Geneva and a Senior Bioethics adviser at the INCLEN Trust International.
Eric M. Meslin PhD FRSC FCAHS is a Canadian-American philosopher-bioethicist and current President and CEO of the Council of Canadian Academies (CCA).
Eftychia ("Effy") Vayena is a Greek and Swiss bioethicist. Since 2017 she has held the position of chair of bioethics at the Swiss Institute of Technology in Zurich, ETH Zurich. She is an elected member of the Swiss Academy of Medical Sciences.
Vasantha Muthuswamy was an Indian physician and bioethicist, head of the Indian Council of Medical Research's Division of Basic Medical Sciences, Traditional Medicine, and Bioethics, and the Division of Reproductive Health and Nutrition, from 1990 to 2008. She was a leader in establishing, revising, and promoting ethical guidelines for medical research in India. She participated in international organizations and projects focused on bioethics, and was a noted critic of ethics dumping.
