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  • NEW: Sample Consent Form
  • Sample Confidentiality Agreement
  • Participating in Research: Educational Resource from the Panel on Research Ethics
  • NEW: REB Reviewer Ethical Merit Assessment Form

                                                                                 

    Ethical Merit Assessment Form

    The REB reviewers use this form to structure and ground the review according to research ethics themes and principles of the Tri-Council Policy Statement 2 (TCPS2), institutional, provincial and federal regulatory requirements.  To promote transparency and to facilitate with the review process, researchers are encouraged to use this form to guide their ethics application submissions and to self-assess the submission according to the criteria outlined in the form. 

    Research Proposal/Design:  (TCPS2, Article 2.7)

    1. For reference purposes, what is the research question?
    2. Are there any general ethical issues with the research design question?
    3. Is there any missing information?
    4. Is any of the information inconsistent?

    Risks:  (TCPS2, Article 2.8 B)

    (Trivial or profound, physical or psychological, individual or social, known or unknown)

    1. Thinking about the study population, what is the probability and magnitude of possible harms implied by participation in the research? Are risks greater or no greater than those encountered by participants in those aspects of their everyday life that relate to the research?
    2. Has the researcher adequately identified and addressed the risks to the participants? Does the researcher describe minimizing or reducing the risks, or providing services to offset the risks (i.e. debriefing, counselling, medical treatments, etc.)?
    3. Are there any risks to the participants that have not been identified? If there are risks that have not been identified, do you have a suggestion to provide to the researcher as to how these might be mitigated or addressed?
    4. Is the researcher exposing participants to unnecessary risks?

    Benefits:  (TCPS2, Article 2.8 B)

    1. Has the researcher adequately assessed the benefits to the participants?

    Risks-Benefit Assessment to Participants:  (TCPS2, Article 2.8 B)

    (Risks minimized? Benefits maximized?)

    1. Did the researcher attempt to achieve the most favourable balance of risks and potential benefits in a research proposal?

    Deception (if applicable):  (TCPS2, Article 3.7A)

    1. Is there any deception involved in the study? If yes, does the researcher provide:
      1. Good rationale for the necessity of deception?
      2. Adequate debriefing for the participants?
      3. If no debriefing, does the researcher provide adequate justification for the deception?

    Recruitment and Consent Process:  (TCPS2, Articles 3.1. 3.3, 4.1)

    1. Who approaches the potential participants?
    2. Method for obtaining consent appropriate?
    3. Justification for substitute consent if necessary?
    4. Coercive elements? E.g., power imbalance.
    5. Privacy or confidentiality issues?

    Conflict of interests declared (if any):  (TCPS2, Chapter 7)

    1. Real, potential or perceived conflict of interest issues declared. (E.g. financial, personal). 

    Letter of Invitation/Consent Form Elements:  (TCPS2, Article 3.2)

    (REB consent template followed to a reasonable extent? At an appropriate level of understanding? Privacy issues addressed, particularly those involving personal health information?)

    First page of consent:

    1. Written in lay language.
    2. Study title included. Title must indicate that this is a “research” study. 
    3. Researchers/Institutions are identified.
    4. Researchers’ contact information (phone/email) located on first page.
    5. External Funder/Sponsor named, if applicable.

    Purpose and Procedures:

    1. Purpose of research stated.
    2. Reason the individual/group is being asked to partake in the study.
    3. General description of procedures/research techniques as the participant would experience the research.
    4. Anticipated duration identified for each study procedure/intervention.
    5. Indication of where the research will take place.

    Potential Benefits:

    1. Potential benefits (direct/potential to individual/society) described.
    2. If there is no benefit, the statement “You may not benefit directly from participating in this study” must be included.
    3. Benefits to study participation are not overstated.

    Potential Risks or Discomforts:

    1. Potential risks identified (e.g. physical, psychological or social) for each study procedure. For instance, risk of confidentiality breaches, anxiety, distress, embarrassment, feelings of sadness that may arise from questionnaires and interviews about sensitive issues (e.g. mental health, sexuality).
    2. Steps that will be taken to minimize those risks are described (e.g. where appropriate, referrals for counseling and other services).
    3. Suggested wording for unknown risks: “There is also a possibility of risks that we do not know about and have not been seen in humans to date.”

    Storage of Data: 

    1. Indicate if identifying information (e.g., interview tapes, contact information for follow up studies, digital records, etc.) will be collected.
    2. Who will collect and have access to the data/information?
    3. Describe how the data will be stored.
    4. Duration of data retention.
    5. When the data is no longer required, will the data be appropriately destroyed?

    Confidentiality:

    1. Procedures to safeguard information described (e.g. de-identified information, unique participant study identification code with the master code breaking list stored separate from the research records, anonymous information collected, encryption).
    2. Indicate if data will be shared outside of the institution.
    3. Are there any limits in which confidentiality cannot be guaranteed? (E.g., email exchanges, focus group settings). 
    4. Includes standard confidentiality clause: “Your privacy shall be respected. No information about your identity will be shared or published without your permission, unless required by law. Confidentiality will be provided to the fullest extent possible by law, professional practice, and ethical codes of conduct. Please note that confidentiality cannot be guaranteed while data are in transit over the Internet.”

    Right to withdraw:

    1. Voluntary participation is emphasized.  Include standard clause:  “Your participation is voluntary, and you can answer only those questions that you are comfortable with answering. The information that is shared will be held in strict confidence and discussed only with the research team.”
    2. Are there alternatives to study participation? E.g., a comparable assignment for SONA studies issuing bonus marks. 
    3. Statement that participants can withdraw without penalty. Suggested wording:  “You may withdraw at any time without loss of relevant entitlements, will not affect your medical care, access to services, grades in a course, payment, research credit, etc.”  Ensure appropriate examples are used. 
    4. Include the standard clause: “If you withdraw from the research project at any time, any data or human biological materials that you have contributed will be removed from the study and you need not offer any reason for doing making this request.”  Ensure the appropriate examples are selected. 
    5. Have withdrawal limits been identified? g., when personal information has been anonymized and added to a data pool, once they have been published or otherwise disseminated withdrawal of data may not be feasible. 
    6. Include standard clause: “You will be given information that is relevant to your decision to continue or withdraw from participation.”

    Other considerations:

    1. If this study is a clinical trial, please include information on stopping rules and when researchers may remove participants from trial.
    2. If deemed a clinical trial, registration is required. (Refer to Chapter 11 of TCPS2).

    Conflict of Interest:

    1. Any real, potential or perceived conflicts of interest are disclosed. E.g. past consultation, past service on advisory board, financial, stocks etc.
    2. If applicable, commercialization intent is described.

    Compensation:

    1. Compensation described (e.g. incentives for participants, gift cards).
    2. Reimbursement described for study related expenses (e.g. reimbursement for reasonable travel/transportation to study site).
    3. Participation-related expenses and compensation for injury described?

    Debriefing and Dissemination of Results:

    1. Return of/dissemination of research results to participants are described.
  • NEW: Pre-Submission REB Checklist