Informed Consent

Free and informed consent is essential in ethical research involving human subjects. It involves a process that begins with the initial contact and continues until the participants' involvement in the project ends. The process of obtaining free and informed consent involves dialogue, information sharing, and ensuring participants' voluntary decision to participate in the research.

Research approved by the REB may begin only if:
  1. The prospective participant, or authorized third parties, have been given the opportunity to freely and voluntarily consent to participate in the research.
  2. Consent has been obtained and is maintained throughout their participation in the research, with necessary re-affirmation as required.

The informed consent process must comply with the following:

  1. The requirements of the TCPS 2022, Section 3 - The Consent Process.
  2. Where appropriate, the ICH Good Clinical Practice: Consolidated Guidelines, Section 4.8, Informed Consent of Trial Subjects.

Content of Informed Consent

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.
  • Assurance of voluntary participation and the right to withdraw without prejudice.
  • Timely provision of relevant information throughout the research project for informed decision-making.
  • Information on the participant's right to request data or material withdrawal.
  • Disclosure of commercialization potential, conflicts of interest, and dissemination plans for research results.
  • Designated representative contact information for scientific queries.
  • Contact details of external individuals for addressing ethical concerns.
  • Description of collected information, confidentiality measures, and data usage.
  • Payment, incentives, reimbursement, and compensation details.
  • Clarification that participants retain legal recourse rights in case of research-related harm.
  • Clinical trial-specific information on stopping rules and participant removal criteria.

Documentation of Informed Consent

To document informed consent, researchers can use a signed consent form or other appropriate means, such as an oral consent process script.

While written consent is commonly used, there are other ethically acceptable methods. Researchers may employ oral consent, field notes, or other strategies to document the consent process. In some cases, participant actions (e.g., completing a questionnaire or participating in research activities) can demonstrate consent. If there are valid reasons for not recording consent in writing, such as participant safety, the consent procedures must be documented in the ethics application.

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