Research Ethics Review Program

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• What are the Primary Investigator’s responsibilities regarding RERC documentation?

  • To review, understand and sign all documentation submitted to the RERC for consideration.

• What are the requirements for consent forms if a research subject is under the age of 18?

  • If the subject is able to fully understand* the nature and consequences of the study, the signature from a parent or legal guardian is not required.
  • If the subject is only able to partially understand* the nature and consequences of the study, the parent or legal guardian must sign a standard consent form, phrased in second or third person (you/your child). The subject must also sign an assent. If the subject refuses, participation in the study would not be permitted, even with a parent/guardian’s signed consent form.  
  • If the subject does not understand* the nature and consequences of the study, the parent or legal guardian must sign a standard consent form, phrased in second or third person (you/your child). No assent from the subject is required.
    • * The research subject’s level of understanding is determined by the Primary Investigator.
      

• What are the requirements for consent forms regarding procedures and length of visit?

  • Consent forms must include:
    • Purpose for each visit (i.e. Screening Visit, Visit 1, Visit 2, etc).
    • Process and procedures that will be performed
    • Approximate length of time for visits

• What are the requirements for consent forms regarding confidentiality and access to subject records?

  • The confidentiality section must note that the Research Ethics Review Committee, of the College of Physicians & Surgeons of Alberta, will have access to the subject's medical records.

• What are the requirements for consent forms regarding witnesses?

  • There is no requirement to have a witness for a consent form.
  • If a primary investigator wants a witness, he/she is allowed to decide who it will be.
  • Note: The witness is only confirming the research subject signed the form, and he/she may be called upon to verify this fact in court.
  • For further information, refer to:
    • ICH Good Clinical Practice Guidelines, Section 4.8.9.
       

• Can the process of consent be delegated to someone other than the Primary Investigator?

  • Yes. This responsibility can be delegated to researchers or designated representatives.
  • For more information go to Tri-Council Policy Statement (Article 2.1) and ICH GCP Guidelines (4.8.5 and 4.8.7).
  • Note: Regardless of who is delegated, the Primary Investigator is legally and ethically responsible for ensuring the subject:
    • is provided with all appropriate information
    • completely understands the information and has questions addressed adequately
    • has the capacity to consent.