Resources

Policies & Procedures

To view a comprehensive listing of UBC policies, standard operating procedures, regulations and guidance that apply to research involving human subjects, please click on the link below.

UBC Policies & Standard Operating Procedures

This page also provides a broad list of policies applicable to research involving human subjects in Canada, USA, and the international community.

British Columbia

Office of the Information and Privacy Commissioner
Personal Information Protection Act

Canada

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2 – 2018)
Health Canada Food & Drug Regulations Part C Division 5
Health Canada Application for Investigational Testing, Medical Devices
Health Canada Regulatory Requirements Governing Drugs in Clinical Trials
Good Clinical Practice Guideline - Health Canada Regulation 1997
Natural Health Products Regulations
Personal Information Protection and Electronic Documents Act (PIPEDA)
Ethics Office of the Canadian Institutes of Health Research (CIHR)
CIHR Guidelines for Health Research Involving Aboriginal People
Clinical Trial Application (CTA)
Principles of Ethical Metis Research (National Aboriginal Health Organization-NAHO

United States

Food and Drug Administration (FDA)
Health Insurance Portability and Accountability Act (HIPAA)
Office of Human Research Protections (OHRP)
National Institutes of Health (NIH)
US Federalwide Assurance
US Department of Health and Human Services - Title 45 Code of Federal Regulations Part 46 (45 CFR 46)
US Department of Health and Human Services - Title 21 Code of Federal Regulations Part 50 (21 CFR 50)

International

The Declaration of Helsinki (2008)
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Education & Training

There is a variety of resources to help members of the UBC PHC research community confidently engage in ethical research involving human subjects.

Online Tutorials & Training
Training for UBC Researchers 
Educational Resources
Professional Associations
Clinical Research Professional Development

Online Tutorials & Training

CORE: Tri-Council Policy Statement (TCPS2) Online Tutorial

The new TCPS2 tutorial 'CORE' (Course in Research Ethics) is available at the following links, English Version / French Version. This interactive online tutorial can be completed in approximately two hours and provides an essential orientation to the Tri Council Policy Statement 2 (2018).

A certificate is available in English or French for printing upon completion. Once available, it is recommended that all individuals involved with research involving human participants complete this tutorial.

Graduate students and medical residents are required to complete this tutorial if their names are to be listed in applications for ethical review submitted to any UBC Research Ethics Boards (REB). The tutorial must be completed by all applicants before the application is submitted to the REB.

** If you have completed the original TCPS tutorial or the CHRPP tutorial, you do not need to complete the CORE tutorial, although it is recommended that you familiarize yourself with the new TCPS**

Network of Networks (N2)

This Clinical Trials BC initiative is made possible through a provincial membership agreement with Michael Smith Health Research BC, funded through the BC SUPPORT Unit’s Training & Capacity Development initiative.

For more information on N2, www.n2canada.ca or Contact N2: n2@n2canada.ca

There are 25 ACRP courses available and ongoing education and professional development that are delivered on a regular basis to Providence researchers.

ACRP learning management system (LMS)

This e-learning platform offered by the Association of Clinical Research Professionals (ACRP) is available free of charge to any clinical research professional in BC.

ACRP’s eLearning catalog of 30+ programs covers the essentials of clinical research, including the new “Introduction to Good Clinical Practice” eLearning course, which provides training on the new ICH GCP E6(R2) as the international industry standard for designing, conducting, and reporting clinical trials.

Since our Clinical Trials BC program began, more than 300 people have signed up for access to the ACRP LMS. We continue to encourage the BC research community to register and complete courses.

LOGIN TO ACRP LMS HERE

If you’re a new user, you can gain access by contacting us at Clinical Trials BC. Simply send a request along with your first and last name, email address and research location to: info@clinicaltrialsbc.ca. Instructions on how to login and begin training will be provided within one week.

Social Sciences Ethics Training

This free online module was created by a team of anthropologists at Macquarie University in Australia to provide ethics training specifically for social scientists. It deals with the distinctive ethical issues that social scientists face in conducting research with human participants.

It also has an extensive section on research in Indigenous communities which, although tailored to an Australian context, has insights relevant to Canada. Please click here to register.

The Lab: Avoiding Research Misconduct

In this training program, you become the lead characters in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices. Please click here to view the website.

Training for UBC Researchers

As part of ongoing education for researchers the UBC Clinical Research Ethics Board has developed two 30 minute online educational workshops: one as an introduction to ethics, and one that goes into more dept about common errors seen on ethics submissions.

Basic Introduction for the Clinical Research Ethics Process

Common Challenges in Ethics submissions

Educational Resources

Joint Centre for Bioethics Research Ethics Education Portal
Contains research ethics educational materials from the Toronto Academic Health Sciences Network and the University of Toronto.

Developing a Framework for Social Science Research Ethics, York University
Provides links to a variety of international resources dealing with research ethics in the social sciences.

Social Science Research Ethics, Lancaster University
Provides a range of resources designed to help new social science researchers increase their knowledge of the processes and practices involved in ethically sound research. Designed for UK researchers, but many of the resources are relevant to all social science researchers.

Interagency Advisory Panel on Research Ethics (PRE)
Promotes the ethical conduct of research involving human participants. Develops, interprets and implements the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).

Institute of Translational Health Sciences (ITHS)
A partnership among the University of Washington, Seattle Children’s, and the Fred Hutchinson Cancer Research Center. Provides academic programs, short courses, and both live and archived online seminars on issues relevant to those conducting research involving human subjects.

Professional Associations

Canadian Association of Research Ethics Boards (CAREB)
A grassroots national organization intended to represent the interests of all Canadian REBs and to reflect REB perspectives and concerns.

Public Responsibility in Medicine & Research (PRIM&R)
Advances the highest ethical standards in the conduct of biomedical, social science, behavioral, and educational research.

Society of Clinical Research Associates (SOCRA)
A non-profit, professional organization dedicated to the continuing education and development of clinical research professionals. Provides training, and continuing education.

Privacy

Privacy and Confidentiality for Researchers Working from Home in Response to COVID-19

To respond to COVID-19 pandemic, many researchers are now needing to work from home and therefore, may need to adapt their project.  This document will provide some guidance to working from home.

Data Encryption Guideline

Encryption enhances the security of information by scrambling it and then making it legible only to authorized, authenticated users. Encryption can be applied to USB keys, hard drives, specific files and mobile devices. This guideline provides recommendations for options and best practices with encryption.

VCH-PHC Quality Improvement Intake

Confidentiality Acknowledgement For Remote Monitors