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Consent process. 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 ...
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.
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.]
The following discussion explores how to apply the TCPS guidance that consent be voluntary (Article 3.1), informed (Article 3.2) and ongoing (Article 3.3) in the context of seeking consent for the storage of data or human biological materials for unspecified research.
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.
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The informed consent process includes the following information, as per TCPS 2022: Purpose of the research project, researcher's identity, funding details, expected participation duration, and research procedures. Plain language explanation of foreseeable risks and potential benefits for participants and in general.
