Summary of changes: March 20, 2020 Standard Operating Procedures of the McGill University Health Centre Research Ethics Board

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)

 

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)

 

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)

 

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)

 

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.

Take a look at the track changes version of MON 401.

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.

Take a look at the track changes version of MON 402.

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)

 

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)

 

601.001

Researcher Qualifications and Responsibilities

2020-03-20

N/A: new SOP

 

700 Quality Control (701-702)

 

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