№ lp_1_19116
File format: docx
Character count: 19156
File size: 90 KB
This document provides guidelines for reporting unanticipated problems, including serious adverse events, within clinical and non-intervention research trials at Mount Sinai Hospital.
Year:
2003
Region / City:
Mount Sinai Hospital
Subject:
Clinical Research
Document Type:
Guideline
Organization / Institution:
Mount Sinai Hospital REB
Author:
REB Chair
Target Audience:
Clinical Investigators, Research Staff
Effective Period:
Ongoing
Approval Date:
November 6, 2003
Revision Date:
July 8, 2015
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Year:
2021
Region / City:
Minnesota
Topic:
Mental Health Services, Licensing Requirements
Document Type:
Regulatory/Policy Document
Organization:
Minnesota Department of Human Services
Author:
Minnesota Department of Human Services
Target Audience:
Mental Health Professionals, Health Care Providers
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2016
Region / City:
N/A
Topic:
Clinical Research, Adverse Events Reporting
Document Type:
Guideline
Organization:
William Osler Health System
Author:
N/A
Target Audience:
Researchers, Investigators, REB Members
Effective Period:
N/A
Approval Date:
22 November 2016
Date of Changes:
N/A
Context:
A guideline for reporting unanticipated problems and serious adverse events in clinical research trials.
Year:
2024
Region / City:
Ottawa
Theme:
Research ethics, health research
Document Type:
Job posting
Institution:
CHEO Research Institute
Author:
N/A
Target audience:
Job seekers, health research professionals
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2023
Region / city:
Toronto, Canada
Subject:
Medical ethics, human research
Document type:
Guideline
Institution:
University Health Network (UHN)
Author:
UHN Research Ethics Board (REB)
Target audience:
Healthcare professionals, researchers
Effective period:
Not specified
Approval date:
Not specified
Date of revisions:
Not specified
Note:
Year
Theme:
Research ethics
Document type:
Checklist
Organization / institution:
Research Ethics Board
Target audience:
Principal Investigators
Year:
2023
Region / City:
British Columbia
Topic:
Health Research, Recruitment
Document Type:
Guide
Organization / Institution:
Michael Smith Health Research BC
Author:
Not specified
Target Audience:
Researchers, Ethics Boards, Health Researchers
Effective Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
January 2023
Document Type:
Application form
Purpose:
Determination of exemption from REB review
Reviewing Body:
Research Ethics Board (REB)
Related Policy:
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2)
Scope:
Program evaluation and quality improvement projects involving human participants
Required Information:
Program background, evaluation goals and questions, evaluation plan, consenting process, analysis plan
Ethics Requirements:
TCPS-2 certification status for evaluation team members
Risk Assessment:
Potential risks including confidentiality and privacy considerations
Benefit Assessment:
Potential benefits associated with the evaluation
Data Governance:
Data sharing, ownership, access, retention, and destruction provisions
Legal Considerations:
Legal agreements and third-party user agreements
Privacy and Security:
Privacy safeguards and e-Health/IT security measures
Human Resources:
Staffing requirements and roles in the evaluation
Knowledge Dissemination:
Plans for reporting and dissemination of findings
Application Fields:
Date of application, program name, institution, evaluation team members
Year:
2026
Region / City:
Ottawa, Canada
Topic:
Research Ethics Review
Document Type:
Guidelines
Institution:
Bruyère Health
Author:
Bruyère Health Research Ethics Board
Target Audience:
Researchers conducting studies involving human participants at Bruyère Health
Period of Validity:
Ongoing
Approval Date:
2026
Date of Revisions:
Not specified
Context:
Guidelines for submitting research studies involving human participants to the Bruyère Health Research Ethics Board (REB), detailing review types, necessary forms, and ethical requirements.
Note:
Year
Organization / Institution:
University of Guelph
Target Audience:
Research Personnel
Year:
2016
Region / City:
N/A
Topic:
Clinical Research, Adverse Events Reporting
Document Type:
Guideline
Organization:
William Osler Health System
Author:
N/A
Target Audience:
Researchers, Investigators, REB Members
Effective Period:
N/A
Approval Date:
22 November 2016
Date of Changes:
N/A
Context:
A guideline for reporting unanticipated problems and serious adverse events in clinical research trials.
Organization:
CHEO Research Ethics Board (REB)
Country:
Canada
Document type:
Guidance document
Subject:
Electronic written informed consent in human research
Related policy:
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2-2018)
Legal framework:
Canada Evidence Act; Personal Information Protection and Electronic Documents Act (PIPEDA); US Code of Federal Regulations Title 21 Part 11
Applicable sector:
Human research and clinical trials
Target audience:
Researchers and investigators conducting human participant research
Key topics:
electronic consent procedures, digital signatures, participant identity verification, consent documentation, privacy and confidentiality requirements
Special context:
COVID-19 pandemic procedures for remote consent
Research setting:
Clinical trials and health research involving human participants
Document components:
consent procedures, electronic signature requirements, study protocol documentation, email consent attestation template
Year:
2023
Region / City:
Thunder Bay, Ontario
Topic:
Research Ethics Board (REB) Application
Document Type:
Research Ethics Application
Organization / Institution:
Thunder Bay Regional Health Sciences Centre
Author:
Not provided
Target Audience:
Research ethics committee members
Effective Date:
2023
Date of Changes:
N/A
Year:
2024
Organization:
CHEO Research Ethics Board (REB)
Type of Document:
Schedule
Content:
Submission deadlines and corresponding meeting dates
Audience:
Researchers submitting to CHEO REB
Period Covered:
January–December 2024
No Meeting Period:
August 2024
Document Format:
Table
Note:
Year
Contextual Description:
A revision of a consent form template for verbal consent in research studies, outlining the necessary adjustments and additional language to ensure understanding and participation.
Year:
2023
Region / City:
Ottawa, Canada
Subject:
Research Ethics, Medical Consent Forms
Document Type:
Policy Guidelines
Author:
CHEO Research Ethics Board (REB)
Target Audience:
Researchers, Ethics Committees, Medical Practitioners
Validity Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2004
Region / City:
Ontario
Topic:
Research Ethics Board Application
Document Type:
Application Form
Institution:
Humber River Health
Author:
Humber River Health
Target Audience:
Researchers, Institutional Review Board
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified