Research Ethics Training

Research ethics training is offered online to members of the research community:

•  The TCPS 2 Tutorial  -2 tutorial helps to translate into practice the guidelines formed by the Tri-Council Policy Statement (TCPS-2). This course presents content in a variety of formats, interactive exercises and multidisciplinary examples. The tutorial comprises ten modules, ranging from basic principles to the evaluation of projects by an REC.
   
•  The MSSS Tutorial- The online training course “Training in Research Ethics” was created specifically for members of research ethics committees (RECs) and support staff of RECs who work in establishments in the Québec research network, health and social services. Thus, while dealing with many national and international texts, this program pays particular attention to the normative framework specific to Quebec.
   
•  Webinaires du Groupe en éthique de la recherche  (GER) (Group webinars on research ethics)

Selection of documents for Research Ethics Review

•  WMA's Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
•  TCPS 2—2nd edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
•  MSSS webography for research ethics
•  FRSQ webography for research ethics
•  Health Canada - Guideline for good clinical practice
•  Canada Food and Drug Regulations: Part C, Division 5 "Drugs For Clinical Trials Involving Human Subjects"
•  FDA Regulations Relating to Good Clinical Practice and Clinical Trials

How to conduct research at a distance? - RRISIQ event•March 10 2021

Conducting research in the context of the current pandemic is challenging. Many traditional research practices are no longer viable as research must frequently be conducted at a distance. How do researchers adapt or change these practices and ensure the highest ethical standards are maintained? How are recruitment strategies implemented? How is the consent process conducted? What information should be included in consent forms? How can data be collected? What are the best methods to store these different types of data? What type of challenges may researchers encounter with these new practices? In this presentation, these questions will be addressed and practical solutions proposed. The ethical principles that underlie best ethical practices will be highlighted.

Consult the presentation by Dr. Linda Furlini* :

         «  At a Distance : Changing and Adapting Research Practices Ethically During a Pandemic »

*The information contained in this presentation excludes research falling under the jurisdiction of Health Canada, such as drug and medical device clinical trials. 

Public web conference on ICH E6

On behalf of the International Council for Harmonisation (ICH), the ICH E6 Guideline for Good Clinical Practice (GCP) Expert Working Group (EWG) will hold a free public web conference on May 18-19, 2021 to provide an update on the progress to revise this important and impactful guideline.  The web conference will be convened by the Clinical Trials Transformation Initiative (CTTI).

There will be two similar meetings on Tuesday, May 18 from 8-11 a.m. EDT and Wednesday, May 19 from 5-8 a.m. EDT to reach a broad global audience across time zones. The same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English.

ICH E6 guideline for good clinical practice (GCP) is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee is taking this unique step to provide a status update on the revisions to this guideline.

In this web conference, members of the EWG will discuss the work-in-progress to develop principles and annexes for ICH E6 GCP (third version or R3) that are intended to be responsive across clinical trial types and settings and remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on April 19 are designed to be flexible and applicable to a broad range of clinical trials. View the  principles on the ICH website.  The EWG is not taking public comments on the principles at this stage.  However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.

For more information and to register for the web conference:

Day 1 Registration:  https://duke.zoom.us/webinar/register/WN_6MVjr6qsQxSgYrCuJ-6Xyw

Day 2 Registration:  https://duke.zoom.us/webinar/register/WN_OzK4XPh_Shq-XniAxpKKJw