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Research ethics is a discipline within the study of
applied ethics Applied ethics is the practical aspect of morality, moral considerations. It is ethics with respect to real-world actions and their moral considerations in private and public life, the professions, health, technology, law, and leadership. For ex ...
. Its scope ranges from general scientific integrity and
misconduct Misconduct is wrongful, improper, or unlawful conduct motivated by premeditated or intentional purpose or by obstinate indifference to the consequences of one's acts. It is an act which is forbidden or a failure to do that which is required. Misc ...
to the treatment of human and animal subjects. The social responsibilities of scientists and researchers are not traditionally included and are less well defined. The discipline is most developed in
medical research Medical research (or biomedical 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 ...
. Beyond the issues of falsification, fabrication, and plagiarism that arise in every scientific field,
research design Research design refers to the overall strategy utilized to answer research questions. A research design typically outlines the theories and models underlying a project; the research question(s) of a project; a strategy for gathering data and info ...
in
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 r ...
and
animal testing Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of animals, as model organisms, in experiments that seek answers to scientific and medical questions. This approach can be contrasted ...
are the areas that raise ethical questions most often. The list of historic cases includes many large-scale violations and crimes against humanity such as Nazi human experimentation and the Tuskegee syphilis experiment which led to international codes of research ethics. No approach has been universally accepted, but typically cited codes are the 1947
Nuremberg Code The Nuremberg Code () is a set of research ethics, ethical research principles for human experimentation created by the court in ''Doctors' trial, U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the World War II, Seco ...
, the 1964
Declaration of Helsinki The Declaration of Helsinki (DoH, ) 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 o ...
, and the 1978
Belmont Report 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 o ...
. Today, research ethics committees, such as those of the US, UK, and EU, govern and oversee the responsible conduct of research. One major goal being to reduce questionable research practices. Research in other fields such as
social sciences Social science (often rendered in the plural as the social sciences) is one of the branches of science, devoted to the study of society, societies and the Social relation, relationships among members within those societies. The term was former ...
,
information technology Information technology (IT) is a set of related fields within information and communications technology (ICT), that encompass computer systems, software, programming languages, data processing, data and information processing, and storage. Inf ...
,
biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...
, or
engineering Engineering is the practice of using natural science, mathematics, and the engineering design process to Problem solving#Engineering, solve problems within technology, increase efficiency and productivity, and improve Systems engineering, s ...
may generate ethical concerns.


History

The list of historic cases includes many large scale violations and crimes against humanity such as Nazi human experimentation and the Tuskegee syphilis experiment which led to international codes of research ethics.
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. T ...
developed out of centuries of general malpractice and science motivated only by results. Medical ethics in turn led to today's more broad understanding in bioethics.


Scientific conduct


Scientific integrity


Scientific misconduct


Discipline specific ethics

Research ethics for
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 r ...
and
Animal testing Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of animals, as model organisms, in experiments that seek answers to scientific and medical questions. This approach can be contrasted ...
derives, historically, from
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. T ...
and, in modern times, from the much more broad field of Bioethics.


Medical ethics


Bioethics


Clinical research ethics


Study participant rights

Participants in a
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
in
clinical research Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. The ...
have rights which they expect to be honored, including: *
informed consent Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatme ...
* shared decision-making * privacy for research participants * return of results * to withdraw


Vulnerable populations

Study participants are entitled to some degree of autonomy in deciding their participation. One measure for safeguarding this right is the use of
informed consent Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatme ...
for clinical research. Researchers refer to populations with limited autonomy as "vulnerable populations"; these are subjects who may not be able to fairly decide for themselves whether to participate. Examples of vulnerable populations include incarcerated persons, children, prisoners, soldiers, people under detention, migrants, persons exhibiting insanity or any other condition that precludes their autonomy, and to a lesser extent, any population for which there is reason to believe that the research study could seem particularly or unfairly persuasive or misleading. Ethical problems particularly encumber using children in clinical trials.


Society

Consequences for the environment, for society and for future generations must be considered.


Governance

* In the United Kingdom, the National Research Ethics Service is the responsible quango that forms Research Ethic Committees. * In the United States, the Institutional review board is the relevant ethics committee. *In Canada, there are different committees for different agencies. The committees are the Research Ethics Board (REB) as well as two others that split their committee duties between conduct ( PRCR) and ethics committee ( PRE). *The European Union only sets the guidelines for its member's ethics committees. * Large international organizations like the WHO have their own ethics committees. In Canada, mandatory research ethics training is required for students, professors and others who work in research. The US first legislated institutional review boards procedures in the 1974
National Research Act 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, d ...
.


Criticism

Published in ''Social Sciences & Medicine (2009)'' several authors suggested that research ethics in a medical context is dominated by principlism.Shaw SE, Petchey RP, Chapman J, Abbott S (2009). "A double-edged sword? Health research and research governance in UK primary care." ''Social Science & Medicine'', 68: 912-918


See also

* List of medical ethics cases * Children in clinical research * Unethical human experimentation * Self-experimentation in medicine *
Clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
*
Academic freedom Academic freedom is the right of a teacher to instruct and the right of a student to learn in an academic setting unhampered by outside interference. It may also include the right of academics to engage in social and political criticism. Academic ...
* Scientific literature § Ethics * Psychology § Ethics * Information ethics * Regulation of genetic engineering * Engineering ethics * Ethics of technology * Research Integrity Risk Index * Philosophy of engineering *
Philosophy of science Philosophy of science is the branch of philosophy concerned with the foundations, methods, and implications of science. Amongst its central questions are the difference between science and non-science, the reliability of scientific theories, ...


References


Sources

*


Further reading

* * '' The Oxford Textbook of Clinical Research Ethics'', Ezekiel Emanuel, Christine Grady, Robert Crouch, Reidar Lie, Franklin Miller, David Wendler, Oxford University Press, 2008


External links


list of research participant rights
from Harvard School of Public Health {{Research participant rights
ethics Ethics is the philosophy, philosophical study of Morality, moral phenomena. Also called moral philosophy, it investigates Normativity, normative questions about what people ought to do or which behavior is morally right. Its main branches inclu ...
Research ethics Research ethics is a discipline within the study of Ethics, applied ethics. Its scope ranges from general scientific integrity and scientific misconduct, misconduct to the treatment of human and animal subjects. The social responsibilities of sc ...
Methodology Scientific method