Ethical approval for all studies involving human participants

We read with interest Dr. Fletcher's timely editorial on the value of ethics approval for all studies involving human participants as a condition of publication, and the critical role of having this done by ethics review boards as knowledgeable and unbiased third parties.[1] As noted, although now standard for experimental studies, the practice for observational studies is inconsistent and there are often calls for exemption from ethics review of quality improvement, practice audits, and similar endeavours. We agree with Dr. Fletcher's analysis of the current conundrum: Attempts to classify these studies as universally unproblematic overlook potential risk to participants; however, it is impracticable for all these studies to undergo full or even delegated ethics review.

Dr. Fletcher points to streamlined ethics review processes introduced in New Zealand [2] and the United Kingdom. In addition, there is a Canadian solution. Public Health Ontario (PHO) developed a process wherein all studies involving human participants, receive an initial risk- screening to determine the required level of ethical scrutiny.[3] Similar to the New Zealand protocol with 24 questions,[4] the PHO process involves a 20 item risk screening tool, which sorts projects into one of four review levels: full ethics board review, a conventional delegated review process, an expedited delegated review process, or no further review with periodic audit (manuscript currently under review). The conceptual framework underpinning the PHO review process builds on the Canadian "Tri- Council Policy Statement: Ethical Conduct for Research Involving Humans," commonly referred to as TCPS-2,[5] to ensure a conceptual continuity for ethical considerations when dealing with research and other evaluative activities involving humans. The framework is intended to assist those designing and conducting community-based and public health evaluations, and not only for those charged with ethics review of projects.

PHO created a harmonized and streamlined approach to the ethical conduct of all studies involving human participants. . This approach supports CMAJ's encouragement for an expanded yet balanced scope of ethics review and is broadly applicable in other settings where quality improvement and other observational studies are conducted.

Donald Willison, ScD Associate Professor, Institute of Health Policy, Management and Evaluation, University of Toronto don.willison@utoronto.ca

Nancy Ondrusek, PhD Acting Manager, Research and Ethics, Public Health Ontario nancy.ondrusek@oahpp.ca

John McLaughlin, PhD Chief Science Officer and Senior Scientist, Public Health Ontario john.mclaughlin@oahpp.ca

References:

1. Fletcher J. Ethical approval for all studies involving human participants. CMAJ: Canadian Medical Association journal. December 15, 2014. doi:141538

2. Approval and notification procedures for human research ethics. 2014; http://www.massey.ac.nz/massey/research/research-ethics/human- ethics/forms-and-procedures.cfm Accessed December 20, 2014.

3. Willison DJ, Ondrusek N, Dawson A, et al. What makes public health studies ethical? Dissolving the boundary between research and practice. BMC medical ethics. 2014;15:61. doi: 10.1186/1472-6939-15-61

4. Screening questionnaire to determine the approval procedure. 2014; http://www.massey.ac.nz/massey/fms/Human Ethics/Documents/Screening Questionnaire 2014.pdf?CDD92E43F055FB7C1469096065058403 Accessed December 20, 2014.

5. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement : ethical conduct for research involving humans. Ottawa: Interagency Secretariat on Research Ethics; 2014.

Conflict of Interest:

None declared