RERC Reviewer Form

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• Clinical Trial Agreement (CTA)

  • Has the agreement been signed by the investigator and sponsor?
  • Does the investigator have the ability to publish research findings?
    • Notes:
      • Complete prohibitions on publication are unethical and give the sponsor control over whether information from the study is released publicly.
      • It is acceptable for sponsors to require advance notice from the investigator and delay publication to ensure the sponsor’s intellectual property rights are protected.
      • The investigator must have final authority over the content of the publication (Tri-Council Policy Statement (TCPS 2 11E)
  • Does the investigator have the ability to disclose information that is reasonable to:
    • publish their research, and 
    • safeguard subjects' health and safety?
  • Does the investigator have discretion to determine when disclosure should be made to subjects, and what that disclosure should include?
    • Obligations agreed to between the investigator and sponsor as outlined in the CTA does not release the investigator from his/her legal obligations and duty to the research subject.
    • Investigators must be aware of who makes the final determination on disclosure to subjects regarding safety information. If determination is left with the sponsor or third party, the following could ultimately leave the investigator at risk for legal liability:
      • disclosing safety information to subjects that would breach contractual obligations with the sponsor
      • breaching legal obligation to the subject by withholding risks of participation information 
  • Does the CTA include details regarding what law governs disputes that arise pursuant to the agreement?
    • Investigators should be aware of legal rules for different jurisdictions. Clauses that state the law of another jurisdiction will govern disputes may create unexpected problems for investigators.

• Budget

  • Does the budget accurately reflect the work being performed at the investigator’s site?
  • Does the budget accurately reflect the Clinical Trial Agreement (CTA)?
  • Is the budget free from inducement for the investigator or subjects to participate? If no, is the inducement appropriate?

• Service Provider Agreements

  • Is there a separate Service Provider Agreement outlined in the budget for third-party services (e.g. laboratory, x-ray, pharmacy)? If no, which services are still required?

• Health Information Act Requirements

  Note: The investigator must provide the Research Ethics Review Committee (RERC) with acceptable written documentation of his/her methods for compliance with Health Information Act requirements.

  • [HIA Section 50(1)(b)(iii)]
    • Are methods documented to safeguard subjects’ personal health information in compliance with Health Information Act requirements?
    • Do the documented safeguards conform to this section of the HIA? If ‘no’ please explain.
  • [HIA Section 34(2)] – The consent referred to in subsection 34 (1) must be provided in writing and include:
    • Authorization for the custodian to disclose the specified health information,
    • The purpose for which the health information is disclosed,
    • The identity of whom the health information may be disclosed to,
    • Acknowledgment that:
      • The individual providing the consent is aware of why the health information is needed and
      •  The risks and benefits of consenting or refusing to consent,
    • Date the consent is effective/expires (if applicable). The custodian will not know the date at which 'at the end of my participation in this study' occurs. Please provide a specific timeline.
      • Effective/expiry dates notify the custodian of when he/she is permitted to disclose the requested information.
    • Statement that consent may be revoked at any time by the individual providing it.
  • Do the documented safeguards conform to this section of the HIA?
  • Do references to other privacy legislations conflict with the HIA?

• IB/Product Monograph

  • Has the investigator provided the IB or Product Monograph for each drug being used?
  • If yes, is the IB or Product Monograph the most current version? (Check the date on each document)

• Advertising

  • Is advertising being proposed? If yes, has a sample been included?
  • Does the advertising adhere to the following principles:
    • Clearly states the project is research.
    • Errs on the side of underestimating benefits and overestimating risks.
    • Does not make claims of safety, equivalence, or superiority.
    • Avoids phrases such as “new treatment,” “new medicine”, or “new drug”.
    • Avoids using the term "free" in reference to treatment and procedures.
    • Does not emphasize compensation.
    • Obtains approval to post advertisements from all applicable groups.
  • Is the cost of advertising included in the overall budget?

• Curriculum Vitae (CVs)

  • An investigator must provide acceptable typed documentation that:
    • outlines his/her qualifications to conduct research and
    • lists past and present research experience.
      • If the investigator does not have research experience, he/she must conifirm applicable training in relation to ICH Good Clinical Practice Guidelines and/or the Tri-Council Policy Statement (TCPS 2). Note: approval cannot be granted until the training is completed.
  • Is a Curriculum Vitae (CV) included for each physician?
  • Does each physician have the appropriate qualifications for carrying out the study?

• Conflict of Interest Forms

  • Has a completed/signed document been included for each physician?
    • The Conflict of Interest Policy, developed by the College of Physicians & Surgeons of Alberta (CPSA), is available at: http://www.cpsa.ab.ca/Resources/policiesandguidelines.aspx. The policy states: 
      • “Conflict of interest is defined as a clash between an individual’s duty to act in the public’s best interest, and that individual’s opportunity for personal gain. It must be distinguished from bias. Bias refers to “… a tendency to support or oppose a particular person or thing in an unfair way by allowing personal opinions to influence ones judgement”. Every person has biases; awareness of them is crucial to endeavoring to exercise judgement as objectively as possible.”