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    • A member of the study staff

      • A member of the study staff must obtain consent. This may be the principal investigator or designate. Consideration must be given to possible coercion by virtue of pre-existing relationships (i.e., physician-patient, professor-student). When feasible, to minimize any possible coercion, another member of the study staff should obtain consent.
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  1. This section provides researchers an overview of the key considerations regarding the process for obtaining consent or assent from research participants, as well as templates and sample forms for obtaining their consent or assent.

  2. Who can obtain informed consent from research participants? A member of the study staff must obtain consent. This may be the principal investigator or designate. Consideration must be given to possible coercion by virtue of pre-existing relationships (i.e., physician-patient, professor-student).

  3. Obtaining genuine informed consent from research participants is best thought of as a process of sharing information and addressing questions and concerns, rather than simply obtaining a signature on a prescribed form.

  4. Normally, written evidence of informed consent should be obtained. If a written consent is not possible, the researcher may use an alternative method to document consent, and the reasons for using a modified method of obtaining must be explained in the application to the UHREB.

  5. The information generally required for informed consent includes: information that the individual is being invited to participate in a research project;

  6. 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.

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  8. Guidance. Frequently Asked Questions. Informed Consent FAQs. What is informed consent and when, why, and how must it be obtained? Is it possible to obtain legally effective informed consent to research in an urgent or emergency care setting? What are the basic elements of informed consent?

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