Informed Consent. This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles. A. ." PDF 12 Vulnerable Subjects in Research - University of Virginia For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice. REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. Levels of Review | Human Research Protection Program (HRPP) In this document, beneficence is understood in a stronger sense, as an obligation. An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. The neighbourhood may be stigmatized should the findings show a high prevalence of STI in that neighbourhoods community. Research participants identified as having an STI can seek treatment. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct research in a way that protects participants from any unnecessary or avoidable risks. Information. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review. In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. The exemptions from the requirement for REB review allowed under this Policy are outlined below. Risks may differ among them. Risks to researchers may become a safety concern, especially for student researchers who are at a learning stage regarding the conduct of research and who may be subject to pressures from supervisors to conduct research in unsafe situations.
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