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

Most directly a local institutional review board oversees the clinical research ethics of any given clinical trial. The institutional review board understands and acts according to local and national law. Each countries 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

Participants in clinical research have rights which they should expect, including the following:^[1]

• right to Informed consent
• Shared decision-making
• Privacy for research participants
• Return of results
• Right to withdraw

Vulnerable populations

There is a range of autonomy which study participants may have in deciding their participation in clinical research. Researchers refer to populations which have low autonomy as "vulnerable populations"; these are groups which may not be able to fairly decide for themselves whether to participate in clinical trials. Examples of groups which are 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. There are particular ethical problems using children in clinical trials.

References

1. Beecher, Henry K. (June 16, 1966). "Ethics and Clinical Research". N Engl J Med. 274 (24): 1354–1360. doi:10.1056/NEJM196606162742405. PMID 5327352. Retrieved 11 January 2012.

Further reading

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

External links

• list of research participant rights from Harvard School of Public Health
• Clinical Trial Ethics Ethics in Clinical Trial