Research ethics is a discipline within the study of applied ethics. It is concerned with the moral issues that arise or as part of scientific research, as well as the conduct of individual researchers. It has implications for research communities.[1]
Ethical issues may arise in the design and implementation of research involving human or animal experimentation. Consequences for the environment, for society and for future generations must be considered.
Historically, scandals such as Nazi human experimentation and the Tuskegee syphilis experiment led to the realisation that clear measures are needed for the ethical governance of research to avoid undue harm from scientific inquiry. No approach has been universally accepted.[2][3][4] Declarations, treaties, and best practices have been proposed. Research ethics committees (institutional review boards in the US) are one governance mechanism.
Fields of study that involve human and animal experimentation are the subject of research ethics. The discipline is most developed in medical research. Typically cited codes are the 1947 Nuremberg Code, the 1964 Declaration of Helsinki, and the 1978 Belmont Report. Informed consent is a key concept in biomedical research.
Research in other fields such as social sciences, information technology, biotechnology, or engineering may generate ethical concerns.[2][3][5][6][7][8]
Research ethics may be included as part of the broader field of responsible conduct of research (RCR in North America) or Responsible Research and Innovation in Europe. Government agencies such as the United States Office of Research Integrity or the Canadian Interagency Advisory Panel on Responsible Conduct of Research promote/require relevant training for researchers. Research integrity part of RCR, but is distinct from research ethics. The former includes issues such as scientific misconduct (e.g. fraud, fabrication of data or plagiarism).
In Canada, mandatory research ethics training is required for students, professors and others who work in research.[9][10] The US first legislated institutional review boards procedures in the 1974 National Research Act.
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research.[11] 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.[12] Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.[13] 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.[14] 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.[15] Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.
There are several codes of conduct. The Hippocratic Oath discusses basic principles for medical professionals.[15] This document dates back to the fifth century BCE.[16] Both The Declaration of Helsinki (1964) and The Nuremberg Code (1947) are two well-known and well respected documents contributing to medical ethics. Other important markings in the history of medical ethics include Roe v. Wade[why?] in 1973 and the development of hemodialysis in the 1960s. With hemodialysis now available, but a limited number of dialysis machines to treat patients, an ethical question arose on which patients to treat and which ones not to treat, and which factors to use in making such a decision.[17] More recently, new techniques for gene editing aiming at treating, preventing and curing diseases utilizing gene editing, are raising important moral questions about their applications in medicine and treatments as well as societal impacts on future generations,[18][19] yet remain controversial due to their association with eugenics.[20]
As this field continues to develop and change throughout history, the focus remains on fair, balanced, and moral thinking across all cultural and religious backgrounds around the world.[21][22] The field of medical ethics encompasses both practical application in clinical settings and scholarly work in philosophy, history, and sociology.
Medical ethics encompasses beneficence, autonomy, and justice as they relate to conflicts such as euthanasia, patient confidentiality, informed consent, and conflicts of interest in healthcare.[23][24][25] In addition, medical ethics and culture are interconnected as different cultures implement ethical values differently, sometimes placing more emphasis on family values and downplaying the importance of autonomy. This leads to an increasing need for culturally sensitive physicians and ethical committees in hospitals and other healthcare settings.[21][22][26]The main points of the 1931 Guidelines for Human Experimentation are:[27]
JUnambiguous and informed consent from test subjects is required, except in extreme extenuating circumstances. Risks must be balanced by potential benefits. Caution must be taken for juvenile subjects. Extreme caution should be taken if microorganisms are involved. Poor or socially disadvantaged subjects must not be exploited. Animal testing must be conducted first, and human experiments are to be avoided if other means of collecting data are still available.