Research ethics

Template:Short description Template:Expand Portuguese Template:Research sidebar Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct 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. Beyond the issues of falsification, fabrication, and plagiarism that arise in every scientific field, research design in human subject research and animal testing 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 1964 Declaration of Helsinki, and the 1978 Belmont Report.

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, information technology, biotechnology, or engineering 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 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.

Discipline specific ethics

Research ethics for Human subject research and Animal testing derives, historically, from Medical ethics and, in modern times, from the much more broad field of Bioethics.

Clinical research ethics

Study participant rights

Participants in a clinical trial in clinical research have rights which they expect to be honored, including:

• informed consent
• 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 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.

Criticism

Published in Social Sciences & Medicine (2009) several authors suggested that research ethics in a medical context is dominated by principlism.

See also

• List of medical ethics cases
• Children in clinical research
• Unethical human experimentation
• Self-experimentation in medicine
• Clinical trial
• Academic freedom
• 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

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