Clinical Research Ethics
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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 The Tuskegee Study of Untreated Syphilis in the Negro Male (informally referred to as the Tuskegee Experiment or Tuskegee Syphilis Study) was a study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Cent ...
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 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. By jurisdiction European Union An Ethics commit ...
, 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 {{Short pages monitor *


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