![]() ![]() the process for seeking consent and assent.how potential harms will be minimized, including the risk of breach of privacy and confidentiality.potential benefits to subjects and others.The ethical aspects of the protocol should include a discussion of: definition of adverse and serious adverse events.a schematic timeline when the protocol proposes multiple interventions or multiple time points.the research design and methodology, such as inclusion or exclusion criteria, sample size or justification of statistical methods for assessing results.the relevant literature including animal and adult literature (where appropriate).the research problem, background analysis and hypothesis.The scientific aspects of the protocol should include a discussion of: With all submissions, we suggest that you include a full protocol that discusses the applicable scientific and ethical aspects of the study as outlined here.
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