Committees
Research Ethics and Regulatory Affairs (RERA)
Co-Chairs: Bartha M. Knoppers/Denise Avard (Université de Montréal) Members: K. Brodeur-Robb, M. Farren, K. Glass, D. Malkin, W. Robinson, M. Shevell, R. Woodgate
This Core will develop strategies to harmonize and streamline ethics and regulatory processes nationally. To accomplish this goal, we will collect and prepare review articles and policy documents, develop educational materials regarding ethical, legal and scientific aspects of basic and clinical maternal, child and youth health research, and contribute 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. The Ethics Core is currently collaborating with the National Council on Ethics in Human Research (NCEHR) to develop Best Practices for Research Involving Children and Adolescents.
Primary RERA Core initiatives will include the following:
- Develop recommendations regarding the ethical, legal and social issues related to the MICYRN obesity theme research projects and address 4 issues: i) inclusion/exclusion criteria; ii) informing the registry/biobank (consent); iii) informing about the results (which?, when?, to whom?, by whom?); and iv) stigmatization/discrimination.
- Collaborate with the Biobanking Core for the construction of a framework for the data management and governance of the MICYRN biobank as well as a policy framework which will encompass the constitution, management and use of the biobank to ensure respectful treatment of research participants. It will also address consent and privacy protection measures for sample collection, authorization for access, protection of confidentiality, use of samples, commercialization, withdrawal and discontinuance of the biobank.
- Work closely with the Data Management Core to develop tools for the sharing and protection of data contained in the MICYRN biobank, the obesity registry, and any additional studies.
- Work 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.
