Pragmatic clinical trials and the consent process

Abstract

Pragmatic clinical trials (PCTs) are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in the context of Canadian research ethics policies, legislation, common law, professional codes of ethics, and professional standards of practice. We find that Canadian law and policy relating to informed consent clearly applies to any clinician who might be involved in a PCT. In addition, existing consent norms seem unable to accommodate alternative consent models for pragmatic research if such models would involve lowering the standard of disclosure. The strong emphasis on the primacy of individual rights that exist in law and in research ethics norms cannot easily coexist with strategies that involve either waiver of consent requirements or the provision of incomplete information about the research prior to enrolment. If Canadian policy-makers wish to create the regulatory flexibility necessary to accommodate altered consent and disclosure, it is likely this will require the alteration of existing health information legislation, national research ethics policy, and professional standards.