title: A risk screening tool for ethical appraisal of evidence-generating initiatives.
abstract: BACKGROUND
  The boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice (e.g., quality improvement, program evaluation) increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as "non-research" are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and determination of risk level across a broad range of projects (e.g., clinical research, laboratory-based projects, population-based surveillance, and program evaluation) and health-related contexts. This paper describes the development of the Public Health Ontario (PHO) Risk Screening Tool.
  
  
  METHODS
  Development of the PHO Risk Screening Tool included: (1) preparation of a draft risk tool (n = 47 items); (2) expert appraisal; (3) internal stakeholder validation; (4) external validation; (5) pilot testing and evalution of the draft tool; and (6) revision after 1 year of testing.
  
  
  RESULTS
  A risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score (0-3) associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.
  
  
  CONCLUSIONS
  The PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions.
authors.affiliation: Public Health Ontario | Santé publique Ontario, 480 University Avenue, Suite 300, Toronto, ON, M5G 1 V2, Canada. Nancy.Ondrusek@oahpp.ca.
authors.forename: Nancy K
authors.initials: NK
authors.lastname: Ondrusek
authors.affiliation: Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON, M5T 3 M6, Canada. Don.Willison@utoronto.ca.|Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, 1280 Main St. W., Hamilton, ON, L8S 4 L8, Canada. Don.Willison@utoronto.ca.
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Willison
authors.affiliation: Ontario Long Term Care Association, 425 University Avenue, Suite 500, Markham, M5G 1 T6, Canada. VHaroun@oltca.com.
authors.forename: Vinita
authors.initials: V
authors.lastname: Haroun
authors.affiliation: University Health Network, Bioethics Programme and Department of Psychosocial Oncology and Palliative Care, Princess Margaret Hospital, 610 University Ave., Toronto, ON, M5T 2 M9, Canada. Jennifer.Bell2@uhn.ca.|Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, ON, M5T 1R8, Canada. Jennifer.Bell2@uhn.ca.
authors.forename: Jennifer A H
authors.initials: JA
authors.lastname: Bell
authors.affiliation: Public Health Ontario | Santé publique Ontario, 480 University Avenue, Suite 300, Toronto, ON, M5G 1 V2, Canada. Catherine.Bornbaum@oahpp.ca.|Health & Rehabilitation Sciences, University of Western Ontario, Elborn College, Room 1041, London, ON, N6A 1H1, Canada. Catherine.Bornbaum@oahpp.ca.
authors.forename: Catherine C
authors.initials: CC
authors.lastname: Bornbaum
mesh_terms: D035843:Biomedical Research / Q000941:ethics; D026724:Ethical Review; D032984:Ethics, Research; D006302:Health Services Research / Q000941:ethics; D006801:Humans; D011159:Population Surveillance; D015397:Program Evaluation; D011634:Public Health / Q000941:ethics* / Q000379:methods; D018570:Risk Assessment / Q000379:methods*; D012941:Social Responsibility