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

BMC Medical Ethics

Ross Upshur⁷  Heather Sampson²  Raphael Saginur¹  Lorraine E Ferris⁸  Claudia Emerson³  Angus Dawson⁴  Nancy Ondrusek⁵  Donald J Willison⁶ 

[1] Ottawa Hospital Research Institute, 725 Parkdale Ave, Ottawa, ON K1Y 4E9, Canada;Toronto East General Hospital, 825 Coxwell Avenue, Toronto, ON M4C 3E7, Canada;Department of Philosophy, McMaster University, 1280 Main St W, Hamilton, ON L8S 4 K1, Canada;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;Public Health Ontario, Suite 300, 480 University Avenue, Toronto, ON M5G 1 V2, Canada;Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St W, Hamilton, ON L8S 4 K1, Canada;Bridgepoint Health, 14 St Matthews Rd, Toronto, ON M4M 2B5, Canada;University of Toronto, Dalla Lana School of Public Health, 155 College Street, 6th Floor, Toronto, ON M5T 3 M7, Canada

关键词: Program evaluation;    Quality improvement;    Research;    Public health;    Ethics;   

Others  :  1090124
DOI  :  10.1186/1472-6939-15-61

 received in 2014-04-23, accepted in 2014-07-31,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Willison et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Otto JL, Holodniy M, Robert FD: Research or practice? Public health practice is not research. Am J Public Health 2014, 104:596.
• [2]Alberta Research Ethics Community Consensus Initiative: ARECCI Recommendations - FINAL. Protecting People While Increasing Knowledge: Recommendations for a Province-Wide Approach to Ethics Review of Knowledge-Generating Projects (Research, Program Evaluation, and Quality Improvement) in Health Care. Edmonton, AB: Alberta Heritage Foundation for Medical Research; 2005. http://www.assembly.ab.ca/lao/library/egovdocs/2005/alhfm/173539.pdf webcite
• [3]Baily MA, Bottler M, Lynn J, Jennings B: The Ethics of Using QI Methods to Improve Health Care Quality and Safety. 2006. New York, NY: The Hastings Center; 2006.
• [4]Thurston WE, Vollman AR, Burgess MM: Ethical review of health promotion program evaluation proposals. Health Promot Pract 2003, 4:45-50.
• [5]MacQueen KM, Buehler JW: Ethics, practice, and research in public health. Am J Public Health 2004, 94:928-931.
• [6]Taylor HA, Pronovost PJ, Sugarman J: Ethics, oversight and quality improvement initiatives. Qual Saf Health Care 2010, 19:271-274.
• [7]National Research Ethics Service: Defining Research: NRES Guidance to Help you Decide if Your Project Requires Review by a Research Ethics Committee. Ottawa, Canada: National Patient Safety Agency; 2013. http://www.hra.nhs.uk/documents/2013/09/defining-research.pdf webcite
• [8]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, Canada: Her Majesty the Queen in Right of Canada; 2010. http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf webcite
• [9]National Health & Medical Research Council: When Does Quality Assurance in Health Care Require Independent Ethical Review?. Canberra: Commonwealth of Australia; 2003. https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e46.pdf webcite
• [10]Hodge JG Jr: An enhanced approach to distinguishing public health practice and human subjects research. J Law Med Ethics 2005, 33:125-141.
• [11]Fairchild AL, Bayer R: Ethics and the conduct of public health surveillance. Science 2004, 303:631-632.
• [12]Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL: The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent Rep Special Report 2013, 43(1):S4-S15.
• [13]Ontario Agency for Health Protection and Promotion Act. S.O. Chapter 10, Schedule K. Toronto: Queen’s Printer for Ontario; 2007.
• [14]Ontario Agency for Health Protection and Promotion (Public Health Ontario): A Framework for the Ethical Conduct of Public Health Initiatives. Toronto: Queen’s Printer for Ontario; 2012:11-4-0013. http://www.publichealthontario.ca/en/eRepository/PHO%20%20Framework%20for%20Ethical%20Conduct%20of%20Public%20Health%20Initiatives%20April%202012.pdf webcite
• [15]Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 2000, 283:2701-2711.
• [16]Kass NE: An ethics framework for public health. Am J Public Health 2001, 91:1776-1782.
• [17]Fleischman A, Levine C, Eckenwiler L, Grady C, Hammerschmidt DE, Sugarman J: Dealing with the long-term social implications of research. Am J Bioeth 2011, 11:5-9.
• [18]Anderson JA, Sawatsky-Girling B, McDonald M, Pullman D, Saginur R, Sampson HA, Willison DJ: Research ethics broadly writ: Beyond REB review. Health Law Review 2011, 19:12-24.
• [19]Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL: An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep Special Report 2013, 43(1):S16-S27.
• [20]Emanuel EJ, Menikoff J: Reforming the regulations governing research with human subjects. N Engl J Med 2011, 365(12):1145-1150.