Are study measurements standardised across arms? Are they objective? Will validated tools be used?.Are investigators/study team blinded where appropriate and possible?.For clinical trials, is allocation randomised with allocation concealment?.Is allocation to exposure/control arm appropriate?.Are reasonable measures planned to reduce risk of bias? This is particularly important in observational or cross-sectional studies where several sources of bias may undermine the validity of research findings.Is the recruitment strategy described and appropriate to avoid bias?.Is the participant risk/prognostic profile appropriate for the study objectives?.Is the setting/study population appropriate given the study objectives?.Are patient populations and associated criteria for inclusion/exclusion well defined?.Is the study appropriately designed to meet the objectives?.Are the primary and secondary objectives scientifically sound?.For clinical trials, do preclinical/clinical studies demonstrate promising results regarding safety and potential efficacy?.Is there convincing clinical and/or preclinical evidence that the study will produce valuable results/address the study question?.Is there a convincing scientific rationale and/or scientific data to support the proposed hypothesis?.Is the protocol scientifically sound and based on well-established scientific principles?.Is there a clearly defined problem statement, research question or hypothesis?.Please note that not all questions are relevant for every study and there may be additional questions to address for a given study. These guidelines provide examples of questions to consider when reviewing a protocol for scientific merit. Minor reviewer comments: Suggestions for changes that, in the opinion of the reviewer, might improve the research proposal, but with which the investigators will not be obliged to comply, prior to HRC approval. Major reviewer comments : Suggestions for changes that, in the opinion of the reviewer, are required to improve the study design or scientific approach, and with which the investigators will be obliged to comply, prior to HRC approval. When providing your review we ask you to divide your comments into two sections: Major ethical concerns identified by scientific reviewers, however, are also addressed during the IDM HRC meeting and provided as feedback to the researchers as the two aspects are integrally linked. If approved by the HRC the study is then subsequently reviewed by the UCT FHS Human Research Ethics Committee (HREC). The IDM HRC undertakes scientific review of protocols – to be approved a study must demonstrate relevance, sound rationale and study design and the proposed use of acceptable methods.
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