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Concept
Institutional review board
Summary
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 (or reject), 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 purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of people participating in a research study. A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects, and seeks to maximize the safety of subjects. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted.
IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology. Such studies may be clinical trials of new drugs or medical devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved. Many types of research that involves humans, such as research into which teaching methods are appropriate, unstructured research such as oral histories, journalistic research, research conducted by private individuals, and research that does not involve human subjects, are not typically required to have IRB approval.
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Declaration of Helsinki
The Declaration of Helsinki (DoH, Helsingin julistus, ) 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. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.
Human subject research
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question.
Medical ethics
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.