Working Groups

Research Ethics & Regulatory Affairs (RERA) Core

Refer to the Resources section for Ethics information.

RERA is developing strategies to harmonize and streamline ethics and regulatory processes nationally. To accomplish this goal, RERA leaders are collecting and preparing review articles and policy documents, developing educational materials regarding ethical, legal and scientific aspects of basic and clinical maternal, child and youth health research, and contributing guidance documents to the Canadian research community. In addition, RERA leaders will provide education and guidance in ethics review, regulatory compliance, process management, quality assurance, and study monitoring, and will host regular workshops to assess emerging ethical issues. In particular, discrepancies in ethics reviews nationally, and the ethical considerations surrounding biobank operations will be examined, using the experience and interest of key MICYRN partners, including the Canadian Neonatal Network, Canadian Pediatric Network, and Canadian Pediatric Surgery Network.

Outputs



Initiatives

Refer to http://www.pediagen.org for an extensive, searchable library.

  • Work with NCEHR continues in order to achieve consensus on the Best Practices document by holding focus group meetings with key stakeholders through summer 2010.
  • RERA is working closely with the Data Management Core to develop tools for the sharing and protection of data.
  • RERA is working closely with the Training Core for the development of web-based tools promoting awareness of the socio-cultural, legal and ethical issues surrounding research involving pregnant women, fetuses, infants, children and youth.
  • RERA is developing templates to be used as tools for consent and assent, to be used with birth cohorts, registries, biobanking, and research studies.  The goal is to introduce a more cohesive and harmonized set of templates in order to assist in the national streamlining of the ethics and regulatory procedures.
  • A first national consensus-building , review harmonization workshop is being organized by MICYRN to bring together the Chairs and ethicists of the 6 self-standing child/child-maternal REBs in Canada.  See the proposed workshop agenda .

If you are interested in joining the RERA working group or have issues to discuss, contact the co-chairs:

Dr. Denise Avard, Research Director, Centre of Genomics and Policy
Faculty of Medicine, Dept. of Human Genetics, McGill University denise.avard@mcgill.ca . 

Professor, Bartha Knoppers.  Director of the Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University bartha.knoppers@mcgill.ca.