Recent Developments in Human Research Protection in Canada

Introduction Martin Letendre is the Director of Ethics and Legal Affairs at ethica Clinical Research Inc., a Canadian full-service Contract Research Organization (CRO) that conducts and manages ethical clinical research on three continents, ethica Clinical Research Inc. was both the first Canadian entity and the first CRO to become accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), earning its accreditation in December 2006, and re-accreditation in 2009. Veritas IRB, a non-profit division of ethica, remains the only Canadian-based Independent Review Board to be accredited by AAHRPP. As Director of Ethics and Legal Affairs, Mr. Letendre has been responsible for the creation of ethica Clinical Research Inc.'s Government Affairs and Legal departments, its continuing AAHRPP accreditation, and the expansion of Veritas IRB's ethics review services to Latin America. Mr. Letendre was a research associate for the Genetics and Society Project of Universite de Montreal, where he worked on policy analysis and drafting in the fields of research ethics and human genetics. He was also a member of several research ethics boards, and was actively involved in the creation of an on-line tutorial for institutional research ethics boards in Quebec for the Ministry of Health and Social Services (http://ethique.msss.gouv.qc.ca/didacticiel/). Still active in research ethics and scientific integrity activities, Mr. Letendre published several reports and articles in peer-reviewed journals and has been invited as guest speaker to numerous academic and industry conferences. He has also acted as an expert witness in research ethics in court proceedings. Mr. Letendre is the Chair of the Research Integrity Committee of the Canadian Institutes of Health Research (CIHR). As the next SRA Annual Meeting will take place in Montreal, Quebec, SRA sought Mr. Letendre's opinion on the current state of the normative framework governing human research protection and scientific integrity in Canada. In this article, Mr. Letendre answers a series of questions on the status of research in Canada, recent normative developments, their impact on the administration of research in Canada, and his perspective on participant protection and scientific integrity in his country. VOE: You have been, in the past, very critical of the normative framework in Canada for its lack of effectiveness in protecting human research participants. Has your opinion changed on the matter? ML: Criticisms raised by several scholars in Canada (Lexchin, 2008: Shuchman, 2008; Schuppli & McDonald, 2005; Lemmens, 2005: Letendre & Lanctot, 2007; Letendre & Lanctot, 2009) regarding the normative framework in Canada were essentially based on the following factors: 1) Research participant protection in Canada is the result of a patchwork of laws and regulations often adopted for another purpose. Additionally, the principal standard of practice in research ethics in Canada, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (1998), only applies to clinical research funded by the three federal funding agencies, which represents less than 50% of the overall health research conducted in the country: 2) Canadian federal and provincial governments chose to delegate the authority to oversee the conduct of clinical research to Research Ethics Boards (REBs)--without clarifying the extent of their mandate or the standards by which they should operate: 3) The clinical trials inspection process by Health Canada lacks the appropriate regulatory support to enforce compliance with the regulations and the necessary transparency to educate researchers, research institutions and sponsors of research about the findings resulting from routine inspections and for-cause investigations; 4) Finally, the current system of oversight of clinical research in Canada is based not on accountability but rather on the good faith of researchers, research administrators, REB members, and sponsors of research to provide high quality research in accordance with internationally recognized standards of research. …