Clinical research ethics are the set of relevant

ethics Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns m ...

considered in the conduct of a

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

in the field of

clinical research Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatm ...

. It borrows from the broader fields of

research ethics Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness ...

and

medical ethics Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. T ...

Governance

Most directly a local

institutional review board An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ens ...

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 The ''Belmont Report'' is a 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 of Human ...

'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: *right to

informed consent Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...

shared decision-making Shared decision-making in medicine (SDM) is a process in which both the patient and physician contribute to the medical decision-making process and agree on treatment decisions. Health care providers explain treatments and alternatives to pa ...

privacy for research participants Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyo ...

return of results Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant. Return of results is particularly discussed in the field of biobanks, ...

right to withdraw The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will. According to ICH GCP guidelines, a person can withdraw from the research at any poin ...

Vulnerable populations

There is a range of autonomy which study participants may have in deciding their participation in clinical research. One of the measures for safeguarding this right is the use of

for clinical researches. 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 Insanity, madness, lunacy, and craziness are behaviors performed by certain abnormal mental or behavioral patterns. Insanity can be manifest as violations of societal norms, including a person or persons becoming a danger to themselves or to ...

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 In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-alike), other medications or devices, or the standard medical treatment for a patient's c ...

References

External links

list of research participant rights
from Harvard School of Public Health {{Research participant rights Research ethics

Governance

Study participant rights

Vulnerable populations

See also

References

Further reading

External links