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 rightsfrom 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