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Open Access Highly Accessed Debate

What makes public health studies ethical? Dissolving the boundary between research and practice

Donald J Willison123*, Nancy Ondrusek4, Angus Dawson5, Claudia Emerson67, Lorraine E Ferris1, Raphael Saginur8, Heather Sampson1011 and Ross Upshur1109

Author Affiliations

1 University of Toronto, Dalla Lana School of Public Health, 155 College Street, 6th Floor, Toronto, ON M5T 3 M7, Canada

2 Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON M5T 3 M6, Canada

3 Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St W, Hamilton, ON L8S 4 K1, Canada

4 Public Health Ontario, Suite 300, 480 University Avenue, Toronto, ON M5G 1 V2, Canada

5 Medicine, Ethics, Society and History (MESH), 90 Vincent Drive, School of Health and Population Studies, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, West Midlands B15 2TT, UK

6 Sandra Rotman Centre – University Health Network & University of Toronto, MaRS Centre, South Tower, 101 College St., Suite 406, Toronto, ON M5G 1 L7, Canada

7 Department of Philosophy, McMaster University, 1280 Main St W, Hamilton, ON L8S 4 K1, Canada

8 Ottawa Hospital Research Institute, 725 Parkdale Ave, Ottawa, ON K1Y 4E9, Canada

9 Bridgepoint Health, 14 St Matthews Rd, Toronto, ON M4M 2B5, Canada

10 Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, ON M5G 1 V7, Canada

11 Toronto East General Hospital, 825 Coxwell Avenue, Toronto, ON M4C 3E7, Canada

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BMC Medical Ethics 2014, 15:61  doi:10.1186/1472-6939-15-61

Published: 8 August 2014

Abstract

Background

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory.

Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle – from initial planning through to knowledge exchange.

Discussion

The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.

The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond.

Summary

Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond.

Keywords:
Ethics; Public health; Research; Quality improvement; Program evaluation