Women's College Research Institute

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Standard Operating Procedures

Women’s College Hospital’s REB Standard Operating Procedures are designed to facilitate compliance with the principles, guidelines, and regulations that apply to the ethical review and oversight of research involving humans. These procedures ensure that the rights and welfare of the participants of all research approved by the REB are overseen and protected in a uniform manner.

 

Section 1: General

SOP Number

Name

Summary

REB-SOP-I-01.003

 

SOP Development and Maintenance

Describes the processes necessary to establish and maintain written SOPs to facilitate compliance with the principles, guidelines, and regulations regarding application to ethical review and oversight of research involving human participants or human materials.

REB-SOP-I-02.003

 

The Use of OCREB as a Board of Record

Describes the types of research being conducted at Women’s College Hospital (WCH) that may use the Ontario Cancer Research Ethics Board (OCREB) as a Research Ethics Board (REB) of Record and the mechanism of notifying the WCH REB when OCREB is used as the Research Ethics Board of Record (BOR).

REB-SOP-I-3.003

Authorized Signing Authority

Defines the individual who has authority to sign documents on behalf of the Women’s College Hospital (WCH) Research Ethics Board (REB), and to describe the responsibilities of such individuals and the circumstances under which signing authority may be delegated.

REB-SOP-I-04.003

 

Training and Education

Describes the training and education requirements for Women’s College Hospital (WCH) Research Ethics Board (REB) members and WCH Research Ethics Office (REO) staff.

REB-SOP-I-05.003

 

Management of Research Ethics Staff

Describe the overall management of the REO office staff.

REB-SOP-I-06.002

REB and REO Role in Use and Disclosure of PHI

Describes the duties of the Women’s College Hospital (WCH) Research Ethics Board (REB) and the Research Ethics Office (REO) in the protection of personal health information (PHI) disclosed to the REB by physicians, staff and trainees of WCH.

REB-SOP-I-07.002

Disclosure and Documentation of Conflicts of Interest

Addresses the risk of possible conflicts of interest (COI) for Women’s College Hospital (WCH) Research Ethics Board (REB) members and Research Ethics Office (REO) staff.

REB-SOP-I-08-002

REB Guidelines for Unique Study Identifiers, Key Files and Access Logs

Direct the creation, use and storage of unique study identifiers, key files and access logs to ensure the confidentiality and privacy of research participants.

Section 2: REB Organization

REB-SOP-II-01.003

 

Composition and Management of the REB

Describes the membership composition and management requirements of the Women’s College Hospital (WCH) Research Ethics Board (REB).

REB-SOP-II-02.003

 

Duties of the Research Ethics Board Members

Describe the duties of Women’s College Hospital (WCH) Research Ethics Board (REB) members.

Section 3: REB Operations

REB-SOP-III-01.003

 

Submission Requirements and Initial Review of REB Submissions

Describe the duties of Women’s College Hospital (WCH) Research Ethics Board (REB) members.

REB-SOP-III-02.003

 

Research Ethics Board Meeting Administration

Describes the required activities for the preparation, management, and documentation of convened Women’s College Hospital (WCH) Research Ethics Board (REB) meetings.

REB-SOP-III-03.003

 

REB Document Management

Describes the requirements for document management, including document retention and archiving. This SOP applies to documents submitted to and reviewed by the Women’s College Hospital (WCH) Research Ethics Board (REB), as well as REB administrative documents.

REB-SOP-III-04.003

 

Health Canada Research Ethics Board Attestation (REBA)

Purpose of this Standard Operating Procedure (SOP) is to facilitate the regulatory requirement of a Research Ethics Board Attestation (REBA) for Health Canada regulated research at Women’s College Hospital (WCH).

Section 4: REB Review of Research

REB-SOP-IV-01.003

 

REB Review Determinations

Describes the decisions that the Women’s College Hospital (WCH) Research Ethics Board (REB) may make resulting from its review of proposed research.

REB-SOP-IV-02.003

 

Delegated Review Procedures

Describes the procedures for determining whether research meets the criteria for delegated ethics review and the delegated review procedures.

REB-SOP-IV-03.003

 

Initial Review of Research and Criteria for REB Approval

Describes the requirements of research proposals involving human participants for approval by the Women’s College Hospital (WCH) Research Ethics Board (REB).

REB-SOP-IV-04.003

 

Amendments, Notifications, Change in Study Personnel, and Ongoing Communication Submissions and Review Procedures

Describes the process for submission and review of amendments, change in study personnel notifications, and ongoing communications associated with the Women’s College Hospital (WCH) Research Ethics Board (REB) approved research.

REB-SOP-IV-05.003

 

Annual Renewal Procedures

Describes the annual renewal procedures of research overseen by the Women’s College Hospital (WCH) Research Ethics Board (REB) and the criteria for continuation of WCH REB approval.

REB-SOP-IV-06.003

 

Suspension or Termination of REB Approval

Describes the procedures associated with suspension or termination of research previously approved by the Women’s College Hospital (WCH) Research Ethics Board (REB).

REB-SOP-IV-07.003

 

Notification of Study Completion

Describes the procedures for the closure of research studies with the Women’s College Hospital (WCH) Research Ethics Board (REB).

REB-SOP-IV-08.003

 

Internal Unanticipated Events including Adverse Events Reporting

Describes the procedures for reporting unanticipated events including adverse events to the WCH REB by referencing the Canadian Association of Research Ethics Boards Guidance on Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada guidance document issued July 2010.

REB-SOP-IV-09.003

 

Submitting External Safety Reports to the REB

Describe the procedures for how and when to submit external safety reports to the Women’s College Hospital (WCH) Research Ethics Board (REB) and the criteria for review of these reports.

REB-SOP-IV-10.003

 

Appeals

Describes how appeals of decisions made by the Women’s College Hospital (WCH) Research Ethics Board (REB) will be managed.

REB-SOP-IV-11.001

 

Administrative Review Procedures

This SOP describes the procedures for determining whether research meets the criteria for administrative ethics review and the administrative review procedures.

REB-SOP-IV-12.001

 

Guidelines for Internet-based Research

This SOP describes the decisions that the WCH REB may make resulting from its review in regards to using internet-based research.

REB-SOP-IV-13.001

 

Using SPIRIT Guidelines in clinical protocol development

This SOP is to provide Principal Investigators with guidance for developing clinical trial protocols based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement. SPIRIT provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.

Section 5: Reviews Requiring Special Consideration

REB-SOP-V-01.001

Research Involving Vulnerable populations

This SOP describes the decisions that the WCH REB may make resulting from its review of research involving groups that could be potentially vulnerable to coercion in regard to autonomy or bearing unequal burden in research. In accordance with TCPS2, its purpose is also to ensure, to the extent possible, that research involving potentially vulnerable populations is premised on respectful relationships.

REB-SOP-V-02.002

REB Review During Publicly Declared Emergencies

Describes the modified procedures, practices and preparedness plan of the Women’s College Hospital (WCH) Research Ethics Board (REB) during official publicly declared emergencies.

Section 6: Communications

REB-SOP-VI-01.003

 

Communication – Investigators and Research staff

Describes the Women’s College Hospital (WCH) Research Ethics Board (REB) communications with the principal investigator (PI) and his/her research staff.

REB-SOP-VI-02.003

 

Communication – Research Participants

Describes the Women’s College Hospital (WCH) Research Ethics Board (REB) communications with study participants involved in research overseen by the WCH REB.

Section 7: Informed Consent

REB-SOP-VII-01.002

Informed Consent Elements

Describes the necessary elements for disclosure of information to make an informed decision to participate in research.

REB-SOP-VII-02.002

Informed Consent Process

Describes the process for obtaining and documenting initial and ongoing informed consent.

REB-SOP-VII-03.002

Waiver or Alteration of Informed Consent

Describes the general requirement that must be met in order for a waiver or alteration of informed consent to be approved by the Women’s College Hospital (WCH) Research Ethics Board (REB).

Section 8: Responsibility of the Investigators

REB-SOP-VIII-01.003

Investigator Qualifications and Responsibilities

Describes the qualifications and responsibilities of the Principal Investigator at Women’s College Hospital (WCH) who engages in research involving human participants.

Section 9: Qualify Assurance

REB-SOP-IX-01.002

Audits and Inspections of REB Operations

Describes the procedures to be followed before, during and following an inspection or audit of Women’s College Hospital (WCH) Research Ethics Board (REB) operations.

REB-SOP-IX-02.003

 

Scientific Review for Research Ethics Applications

Defines the scientific review requirements for research being conducted at or under the auspices of Women’s College Hospital (WCH). While it is within the scope of the Research Ethics Board (REB) to review the scientific validity of research proposals, the primary focus of the WCH REB in evaluating a research project should be ethical acceptability.

REB-SOP-IX-03.002

Institutional Review of Research – UNDER REVISION

Defines the institutional review requirements for research being conducted at or under the auspices of Women’s College Hospital (WCH).

 

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  • Council of Academic Hospitals of Ontario (CAHO)