Informed consent for randomised controlled trials in neonates
نویسندگان
چکیده
منابع مشابه
Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)
BACKGROUND Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative e...
متن کاملEvaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set
Background The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of i...
متن کاملRandomised trials and informed consent in neonatal medicine.
Any new treatment should be subjected to the rigours of a proper clinical trial before it has a chance to become so entrenched that the profession is likely to judge that any such trial is unethical, said Michael Lockwood, a lecturer on medical law and ethics. But he favoured the observational approach rather than the experimental one when there is strong evidence that a new treatment is benefi...
متن کاملAcupuncture trials and informed consent.
Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informe...
متن کاملInformed consent for clinical trials: a review.
OBJECTIVE To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. DATA SOURCES Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. DESIGN Review of peer-reviewed articles. DATA EXTRACTION Online searches wer...
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ژورنال
عنوان ژورنال: Archives of Disease in Childhood - Fetal and Neonatal Edition
سال: 1998
ISSN: 1359-2998,1468-2052
DOI: 10.1136/fn.78.2.f156a