RRO News update

RRO News

NAGANO Training workshops 2023:

  • To come

To register, please contact Jordan:  cer@jgh.mcgill.ca.


2023 – On behalf of Canada’s research funding agencies (CIHR, NSERC and SSHRC), the Secretariat on Responsible Conduct of Research announces the publication of the  Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022).TCPS 2 (2022) replaces TCPS 2 (2018) as the official human research ethics policy of the three Agencies.

TCPS 2 (2022) includes guidance on the following research ethics themes:

  • Broad consent for the storage of data and human biological materials for future unspecified research (Chapters 3 and 12);
  • Streamlining multi-jurisdictional research ethics review of minimal risk research (Chapter 8);
  • Research involving totipotent stem cells (Chapter 12); and
  • Review of research involving human cell lines (Chapter 12).

TCPS Research Ethics Course Update! The  online tutorial CORE-2022 (Course on Research Ethics) is an introduction to the TCPS 2 for the research community. It focuses on the TCPS 2 ethics guidance that is applicable to all research involving human participants, regardless of discipline or methodology.

This free 4-hour training is recommended for all researchers, students and REB members of our CIUSSS.


Clinical Trials in Quebec

2021: Two new features to harmonize the evaluation of clinical trials across Quebec :

  • Updated "Standard Legal Clauses of Information and Consent Forms in Clinical Trials" ( MSSS,2021).
     
  • Updated multicenter evaluation process in Nagano (March 15, 2021). Consult the video clips intended for researchers and research teams:

 http://formations.nagano.ca/

2022:Food and Drug Administration Regulatory Standard:  form FDA 1572 clinical trials: exemption in Quebec

CATALIS and its network of private and public partners have prepared a memo which serves to clarify the requirements for the signing of form FDA 1572 in both Quebec and the rest of Canada as applicable to clinical trials.

Although signing FDA 1572 is a regulatory obligation and thus a contractual requirement in agreements for sites in the United States that are participating in clinical trials regulated by the Food and Drug Administration (FDA), sites located within Quebec’s health and social services network must be exempt from this requirement and from the requirements relating to research ethics boards’ composition and operating methods.

See further information on CATALIS web site: in  English.


 

Page last updated on 

We always seek feedback to make our site better.