Samples, Checklists, Templates & Instructions

MREB Reviewers Checklist
(Revised15August 2011)

GENERAL POINTS:

When conducting your reviews please keep in mind the following general questions:

  • Have I employed the proportionate approach* (see info box on page 2) to my review? 
  • If I have good suggestion for how to solve an issue, have I passed it on to the chair?
  • Have I organized my comments in my review in terms of:
  • “Major ethical concerns”
  • “Minor ethical concerns”
  • “Collegial comments” (i.e., suggestions that might improve the study, but do not have ethical implications and are up to the researcher to utilize.

 

REVIEWING THE APPLICATION FORM AND SUPPORTING DOCUMENTS:

1. Purpose of the Research:
a) Is the research question clearly stated?
b) Is there some value in the project which justifies the involvement of human participants?

 

2. Methods – The Data Collection Tools
a) Are the data collection tools (interviews, questionnaires, exercises, tasks etc.) provided and described in enough detail for you to assess their ethical appropriateness, and how they might pose a risk to study participants?  Have the “Who (researcher or assistant)”, “What”, “When”, “How long”, “Where”, “How “been adequately answered for the population or sub-populations to be studied?
b) Do the data collection tools involve any personal, sensitive or incriminating topics or questions? If so, is there a reasonable justification for their inclusion?
c) Is deception/non-disclosure proposed? Is the use of deception adequately justified?

 

3. Recruiting of Participants:
a) Are the criteria for the choice of participant population equitable? (i.e., no unjustified exclusions based on race, gender, culture, religion, sexual orientation, etc.)
b) Is incentive/compensation appropriate to study, population and context? Too much? Too little?
c)  Does the researcher have dual roles with participants (e.g., researcher as well as participant’s teacher)? If so, has this been managed adequately?
d) Is the recruitment (including the phone, e-mail, and other recruitment scripts) appropriate and complete for the population/sub-populations?
e) Does the recruitment process violate the participant’s privacy in any way?
f) Is community engagement/consultation, where appropriate, adequately described?

4. Benefits and Harms to Participants
a) Is the risk level acceptable for the benefits anticipated?
b) Has the researcher adequately identified possible risks?
c) Has the researcher adequately proposed reasonable ways to manage/reduce risk to participants?

 

 

5. Letter of Information and the Consent Process
a) Is the process by which informed consent is obtained appropriate to the study’s participants (i.e., written, verbal, implied consent)?
b) Is the information required for informed consent and assent provided?
c) Are the Letters of Information/Consent forms or consent scripts for verbal consent devoid of technical jargon, where appropriate to the populations to be studied?
d) Has the researcher made use of the suggested wording from the MREB sample Letter of Information/Consent form  (LOI/CF) using  terms like “You/Your” and “I/me” rather than “the participant” or “the researcher”. 
e) Will consent be reconfirmed once debriefing has been conducted in studies that use deception as a method?

 

g) Does the Letter of Information and the consent form or other content scripts/processes adequately and clearly address the following elements?

  • The nature and purpose of the research;
  • What the participants will be invited to do in the study;
  • The nature and extent of risks and benefits to participants 
  • That participants will be free to withdraw from participation at any time with no adverse consequences;
  • How the data will be stored, and whether or not confidentiality and/or anonymity are assured;
  • Who will be ready to answer questions about the research, including researchers as well as MREB contact information
  • Legally required disclosure, when required.

 

6. Anonymity, Confidentiality and Data Security
a) Is the participant’s anonymity confidentiality respected and protected?
b) Has the researcher adequately explained how the participants’ data will be kept electronically and physically secure?


7. Feedback
a) Will the participants be advised of the results of the project in an accessible and reasonable way?

 

Information Box:

 

*The Proportionate Approach - Link to TCPS2 guidance:

Page24 - Article 2.9
The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary step, the level of review is determined by the level of risk presented by the research: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research.”

Note: In addition to Article 2.9, the proportionate approach is mentioned and integrated throughout the TCPS2.