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