Biomaterial Database

Informed consent: revisiting the issues. 2010

Judith A Erlen

Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, PA, USA.

Informed consent has been widely discussed in the ethics, legal, research, and clinical literature. Authors have addressed the ethical and legal bases for informed consent, its components, and its implementation both in research and in healthcare delivery. However, although there is considerable literature on the subject and the inclusion of this content within the curricula of the various schools of the health sciences, questions continue to arise regarding the process of informed consent and whether the person's right to self-determine was actually upheld. This article revisits issues of informed consent as related to research with human subjects and briefly defines informed consent, addresses selected issues, and offers some potential strategies to improve the process of obtaining informed consent when conducting research with human subjects.

UI	MeSH Term	Description	Entries
D007258	Informed Consent	Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.	Consent, Informed
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D020377	Self Efficacy	Cognitive mechanism based on expectations or beliefs about one's ability to perform actions necessary to produce a given effect. It is also a theoretical component of behavior change in various therapeutic treatments. (APA, Thesaurus of Psychological Index Terms, 1994)	Efficacy, Self
D030881	Disclosure	Revealing of information, by oral or written communication.	Financial Disclosure,Information Disclosure,Disclosure, Financial,Disclosure, Information,Disclosures, Financial,Financial Disclosures