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For research with humans to be considered ethical, it is essential that participants provide their free, informed and ongoing consent. Research can begin only after the participants have provided their initial consent, and individuals must have the possibility to withdraw their consent at any point during the research project.
In order for participants to give meaningful consent, they should be able to understand the intent of the research, be clear about what they are being asked to do and if any risks are involved, and know how their information will be used. Consent may be documented in many ways.
These preliminary conversations – which may include negotiations concerning the terms on which a researcher may engage with a particular community or group – do not in themselves constitute research and therefore do not require consent (Chapter 2, Article 6.11, Articles 9.3 to 9.6 and Article 10.1). Critical Inquiry Article 3.6
Informed consent is “the process in which a competent individual authorizes a course of action based on sufficient relevant information, without coercion or undue inducement” (WHO, 2016). Thus, informed consent procedures must clearly delineate the differences between research participation and critical clinical care procedures. Research ...
1. Why do people participate in research? 2. What does participation in research mean? 3. How do researchers identify who they need to participate in their research? 4. Who can take part in a research study? 5. How do researchers ask people to join a research study? 6. What does consent mean? 7.
The more discretionary approach to deciding when to require informed consent works reasonably well because most research without consent (as in cluster randomized trials) or without valid informed consent (as in social and behavioral research that uses deception) is of relatively low visibility.
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The general categories of research that require REB review in accordance with this Policy are defined in Article 2.1. Some research is exempt from REB review where protections are available by other means (Articles 2.2 to 2.4).