Clinical research ethics

Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics.

## Governance[edit]

Main article: Guidelines for human subject research

A local institutional review board (IRB) oversees the clinical research ethics of any given clinical trial. The IRB acts according to local and national law. Each country's national law is guided by international principles, such as the Belmont Report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical research.

## Study participant rights[edit]

Participants in clinical research have rights which they expect to be honored, including:[1]

* informed consent
* shared decision-making
* privacy for research participants
* return of results
* to withdraw

## Vulnerable populations[edit]

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 researches.[2] 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 which 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.

## See also[edit]

* Unethical human experimentation

## References[edit]

1. ^ Beecher, Henry K. (June 16, 1966). "Ethics and Clinical Research". N Engl J Med. 274 (24): 1354–1360. doi:10.1056/NEJM196606162742405. PMC 2566401. PMID 5327352.
2. ^ Mohamadi, Amin; Asghari, Fariba; Rashidian, Arash (2014). "Continuing review of ethics in clinical trials: a surveillance study in Iran". Journal of Medical Ethics and History of Medicine. 7: 22. PMC 4648212. PMID 26587202.

## Further reading[edit]

* Speid, Lorna (2010). Clinical trials : what patients and healthy volunteers need to know. Oxford: Oxford University Press. ISBN 978-0-19-973416-0.
* 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[edit]

* list of research participant rights from Harvard School of Public Health

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* t
* e

Research participant rights

Rights|

* Beneficence
* Justice
* Respect for persons
* Privacy for research participants
* Right to withdraw
* Return of results
* Informed consent

Human subject research|

* Clinical research
* Biobank
* Social research

Ethical systems|

* Research ethics
* Medical ethics
* Bioethics
* Clinical research ethics
* Biobank ethics

Guidelines for human subject research|

* List of medical ethics cases
* Nuremberg Code
* Declaration of Helsinki
* Belmont Report
* Common Rule

Monitoring in clinical trials|

* Ethics committee
* Institutional review board
* Data monitoring committee
* Community advisory board

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