Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants' understanding of IC conclude that recall and understanding ...
Informed Consent for Clinical Trials for People with Disabilities Complement your general informed consent form with this template, which can be used with clinical trial subjects with disabilities. Use this form when enrolling subjects with physical challenges (e.g., subjects unable to speak or write...
Requirements for Informed Consent in Clinical Trials BackgroundBefore enrolling in a clinical trial, subjects have to be informed about the nature of the study and every possible benefit and risk, in order to consciously decide whether to participate. For this reason, during the evaluation... S ...
Informed consent in clinical trials. Consent may not be possible P Chinnery,George_Asimakopoulos,R Kenny - 《Bmj Clinical Research》 被引量: 0发表: 1994年 Genetic and neurochemical modulation of prefrontal cognitive functions in children. The catechol O-methyltransferase (COMT) gene affects how ...
in clinical trials Quality of informed consent in clinical trialsQuality of informed consent in clinical trialsK., AdlerC.L., JohnsonS., BrewL., PlowmanK., Askew
doi:10.1016/0197-2456(91)90173-JPhilippa EasterbrookJoan HoughtonMike BaumControlled Clinical TrialsEasterbrook PJ, Houghton J. Towards a more informed consent in clinical trials. evaluation of a patient information booklet. Pharm Med 1992; 6: 297±307....
There is no more important principle in the conduct of legitimate therapeutic investigation than ensuring the adequacy of informed consent of the prospective clinical trial participant.
OBJECTIVES: To identify the proportion of critically ill patients able to consent to participation in a randomised controlled trial (RCT) and to assess to what extent patient consent and relative assent processes could be conducted according to ethics committee permission. DESIGN: Descriptive study nest...
Clinical researchers in acute emergency settings are commonly faced with the difficulty of satisfying the conventional ethical requirement of obtaining informed consent, whilst ensuring a representative group of patients is recruited into studies. We discuss our own experience in addressing institutional ethic...
Paternalism has slowly gone the way of the long-play record, and in its place has emerged a consent process in which the patient is a more fully informed and active participant. This process takes time however, and for the busy health-care provider there is often the temptation to hand ...