Below is a summary of the changes brought about by the adoption of the Standard Operating Procedures of the McGill University Health Centre Research Ethics Board (MUHC REB SOP) that come in effect as of March 20, 2020. Changes refer to the previously available version of the MUHC REB SOP. Much of the REB practices were previously documented in the Regulatory Framework in Health Research at the McGill University Health Centre and accompanying documents that were not necessarily publicly accessible. In such cases, no summary of change in practice is provided – indicated by the mention “N/A: new SOP”. Versions tracking changes from the previously available version of the MUHC REB SOP are provided as PDF documents. Highlighted in yellow in those documents are changes that research teams should be particular attention to.
|
REB SOP # |
title |
effective date |
highlight of changes |
|
100 General Administration (101-108) |
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|
101.001 |
Authority and Purpose |
2020-03-20 |
N/A: new SOP |
|
102.001 |
Research Requiring REB Review |
2020-03-20 |
N/A: new SOP |
|
103.001 |
Training and Education |
2020-03-20 |
N/A: new SOP |
|
104.001 |
Management of REB Support Staff |
2020-03-20 |
N/A: new SOP |
|
105A.001 |
Conflicts of Interest – REB Members and Support Staff |
2020-03-20 |
N/A: new SOP |
|
105B.001 |
Conflicts of Interest – Researcher |
2020-03-20 |
N/A: new SOP |
|
105C.001 |
Conflicts of Interest – Board of Directors |
2020-03-20 |
N/A: new SOP |
|
106.001 |
Signatory Authority |
2020-03-20 |
Terminology changes; Rephrasing for clarification; Clarification that all correspondence with the research team should be retained in the REB’s research file. Take a look at the track changes version of MON106. |
|
107.001 |
Use and Disclosure of Personal Information |
2020-03-20 |
N/A: new SOP |
|
108.001 |
Standard Operating Procedures Maintenance |
2020-03-20 |
N/A: new SOP |
|
200 REB Organization (201-204) |
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|
201.001 |
Composition of the REB |
2020-03-20 |
N/A: new SOP |
|
202.001 |
Management of REB Membership |
2020-03-20 |
N/A: new SOP |
|
203.001 |
Duties of REB Members |
2020-03-20 |
N/A: new SOP |
|
204.001 |
REB Support Staff Serving as REB Members |
TBA |
N/A |
|
300 Functions and Operations (301-350) |
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|
301.001 |
REB Submission Requirements and Administrative Review |
2020-03-20 |
N/A: new SOP |
|
302.001 |
REB Meeting Administration |
2020-03-20 |
N/A: new SOP |
|
303.001 |
Document Management |
2020-03-20 |
N/A: new SOP |
|
350.001 (MUHC REB only) |
Billing for services provided to private enterprise by the MUHC REB |
TBA |
N/A |
|
400 Reviews of Research (401-409) |
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|
401.001-1 |
REB Review Decisions |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Clarification of review procedure when conditional approval is granted; Shortening of delay to respond to REB from 6 months to 3 months; Clarification of effective date of approval; Changes to the process to appeal REB decisions; Clarification regarding REB meeting minutes; Clarification that research teams must obtain authorisation from the Person Formally Mandated (“Personne formellement mandatée) before initiating research activities. |
|
402.001 |
Delegated Review |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Clarification regarding projects that fall under Art. 21 of the Q.C.C.; Clarification about use of delegated review for annual renewal. |
|
403.001-1 |
Initial Review – Criteria for REB Approval |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Clarification regarding the submission of qualifications to conduct research; Clarifications regarding exclusion of specific groups of a population from research projects; Clarification of the concept of “vulnerable” participants; Clarification of the role of the Director of Professional Services (DPS) in accessing medical charts without consent. Take a look at the track changes version of MON 403. |
|
404.001-1 |
Recruitment and Informed Consent Requirements |
2020-03-20 |
N/A: new SOP |
|
405A.001-1 |
Ongoing REB Review Activities |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Addition of the notion of “well-being” in discussing events that must be reported to the REB; Clarification that changes to administrative research staff may be submitted at the time of annual renewal; Clarification that documents submitted in an amendment may be “acknowledged”, rather than “approved”; Reminder of what must be included in a report of a local serious adverse event; Update to what are considered “other reportable events”; Clarification that REB may put recruitment of new participants on hold; Clarification on how to deal with amendments to consent specifically. Take a look at the track changes version of MON 405A. |
|
405B.001 |
Continuing Review |
TBA |
N/A |
|
406.001 |
Annual Review – Renewal of REB Approval |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Clarification about the process to determine the length of ethics approval; Applications for ethics renewal now due 4 weeks prior to expiry; Clarification that incomplete applications may be returned to the research team; Clarification related to the REB delegation log; Clarification of the decisions and requests that may be put forth by the REB as part of ethics renewal; Clarification of what happens if ethics approval expires; Clarification that the REB does not grant retrospective renewals/approvals. Take a look at the track changes version of MON 406. |
|
407.001 |
Suspension or Termination of REB Approval |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Clarification that failure to submit a request for ethics renewal within 30 days after expiry date results in termination of the project; Clarification that, following a suspension, approvals from other parties than the REB may be required. Take a look at the track changes version of MON 407. |
|
408.001 |
Research Completion |
2020-03-20 |
Terminology changes; Rephrasing for clarity; Clarification of when a closure report must be submitted; Specification that a closure report must be submitted even when the study is prematurely stopped. Take a look at the track changes version of MON 408. |
|
409.001 |
Communication of REB Decisions |
2020-03-20 |
N/A: new SOP |
|
500 Reviews requiring Special Consideration (501-504) |
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|
501.001-1 |
REB Review During Publicly Declared Emergencies |
2020-03-20 |
N/A: new SOP |
|
502.001 |
Biobanks |
TBA |
N/A |
|
503.001 |
Multisite Research |
TBA |
N/A |
|
504.001 |
Research on Assisted Reproductive Technologies |
TBA |
N/A |
|
600 Researcher Qualifications and Responsibilities (601) |
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|
601.001 |
Researcher Qualifications and Responsibilities |
2020-03-20 |
N/A: new SOP |
|
700 Quality Control (701-702) |
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|
701.001 |
Quality Assurance |
2020-03-20 |
N/A: new SOP |
|
702.001 |
Non-Compliance with the Responsible Conduct of Research |
2020-03-20 |
N/A: new SOP |