Participant Informed Consent in Cluster Randomized Trials: Review
نویسندگان
چکیده
منابع مشابه
Participant Informed Consent in Cluster Randomized Trials: Review
BACKGROUND The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participa...
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...
متن کاملWhen is informed consent required in cluster randomized trials in health research?
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent b...
متن کاملInadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials
OBJECTIVES To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has impro...
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 کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: PLoS ONE
سال: 2012
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0040436