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. METHOD: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.
journal_name
BMC Med Ethicsjournal_title
BMC medical ethicsauthors
Ondrusek NK,Willison DJ,Haroun V,Bell JA,Bornbaum CCdoi
10.1186/s12910-015-0039-3subject
Has Abstractpub_date
2015-07-07 00:00:00pages
47issn
1472-6939pii
10.1186/s12910-015-0039-3journal_volume
16pub_type
杂志文章abstract:BACKGROUND:Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and fur...
journal_title:BMC medical ethics
pub_type: 杂志文章,评审
doi:10.1186/s12910-015-0053-5
更新日期:2015-09-09 00:00:00
abstract:BACKGROUND:Efforts to improve patients' understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applicat...
journal_title:BMC medical ethics
pub_type: 杂志文章
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abstract:BACKGROUND:Professional guidelines have addressed ethical dilemmas posed by a few types of nontraditional procreative arrangements (e.g., gamete donations between family members), but many questions arise regarding how providers view and make decisions about these and other such arrangements. METHODS:Thirty-seven ART ...
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pub_type: 杂志文章
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更新日期:2017-02-28 00:00:00
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更新日期:2005-01-20 00:00:00
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pub_type: 杂志文章
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更新日期:2009-10-09 00:00:00
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pub_type: 杂志文章
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更新日期:2019-07-03 00:00:00
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pub_type: 杂志文章
doi:10.1186/s12910-020-00468-4
更新日期:2020-04-08 00:00:00
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pub_type: 杂志文章,多中心研究
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更新日期:2014-04-27 00:00:00
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更新日期:2014-05-20 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2016-11-10 00:00:00
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journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-5-5
更新日期:2004-10-04 00:00:00
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更新日期:2020-11-18 00:00:00
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pub_type: 杂志文章,随机对照试验
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更新日期:2014-05-12 00:00:00