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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 specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Here, we ...
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
When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117. [Food and Drug Administration (FDA) regulations at 21 CFR part 50 may also apply if the research involves a clinical investigation regulated by FDA.]
Consent to participate in a research study should be understood as a process rather than an event. Researchers should plan for and articulate the steps by which consent is initially obtained and the steps by which it is reviewed throughout the study.
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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Participants must then give their individual consent to participate on an informed consent form (ICF) developed specifically for the research project. There are very few research situations which do not require the participant's signature on an informed consent form.
