Participation Guidelines 1. Background 1.1 PUBLIC HEALTH ONTARIO
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1 PHO s Ethics Review Services - Public Health Unit Pilot Participation Guidelines 1. Background 1.1 PUBLIC HEALTH ONTARIO Public Health Ontario (PHO) is a Crown corporation dedicated to protecting and promoting the health of all Ontarians and reducing inequities in health. As a hub organization, PHO links public health practitioners, front-line health workers and researchers to the best scientific intelligence and knowledge from around the world. 1.2 SRKE PROGRAM AND ETHICS SUPPORT Applied research and program evaluation, education and professional development, and knowledge exchange are critical functions to support public health practice. The SRKE (Supporting Research and Program Evaluation, Education and Knowledge Exchange in public health) program works with an Advisory Committee and public health units to build capacity and strengthen the public health system. The program includes the following five elements: (1) Library Services, (2) Knowledge Exchange Support, (3) Locally Driven Collaborative Projects, (4) Ethics Support, and (5) Student Education and Preceptor Support. As part of the SRKE program, PHO has developed a set of services to support the ethical conduct of public health initiatives. These services are meant to build capacity and strengthen the public health system so that reliance is not made on central review services. To date, these services include: Ethics advisory services Ethics education Review Forms and tools Public health ethics resources 1.3 PHO S ETHICS REVIEW SERVICES In February 2013, an integrated approach for ethics review was launched within PHO of all evidencegenerating initiatives including research, evaluation, surveillance, and quality improvement projects involving people, their biological materials, or their personal information. The model is based on PHO s conceptual framework, A framework to guide the ethical conduct of evidence-generating public health initiatives, and is compliant with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Second editions (TCPS2), as well as other relevant regulations, policies, and guidelines.
2 PHO s innovative model for ethics review applies a proportionate approach to review, so that as risk to participants increase, so does the level of ethical scrutiny. The integrative aspect means that initiatives included in this ethics review process are not limited to research. Rather, review level assigned is based on the level of risk. Review level is determined through a two-step ethics risk screening process: (1) a self-assessment guided by PHO s Risk Screening Tool (RST) and (2) validation by PHO s ethics office. As described in Table 1, review levels include audit, level 1 delegated, level 2 delegated and level 3 full board review as well as continuing review. Table 1: Level of Ethics Review Using PHO s Ethics Risk Screening Process Review Level Level of Risk Follow-up Action Required Level 0 Audit No risks are identified Projects may begin without further review but are archived for periodic audit. Level 1 Delegated Level 2 Delegated Level 3 Full Board Project is identified as minimal risk and meets criteria for Level 1 review. Project is identified as minimal risk. Project is identified as greater than minimal risk. A streamlined delegated review is completed that does not require submission of an Ethics Review Board (ERB) application form. An ERB application form is completed and the project is reviewed through regular delegated process. An ERB application form is completed and the project is reviewed by the full ERB at the next available meeting. The purpose of the pilot program is to help PHO determine how to provide sustainable ethics review services for public health units across Ontario. The following are specific objectives of the pilot: 1. To adapt the PHO ethics review model to public health unit context 2. To assess the feasibility of delivering ethics review services to public health units 3. To develop procedures and tools to operationalize service delivery to public health units Page 2 of 6
3 2. Call for Expressions of Interest 2.1 PURPOSE The purpose for the Call for Expressions of Interest is to determine the level of interest and capacity of public health units to participate in the pilot program. All participants in the pilot will have access to a TCPS2 compliant ethics review board. PHO will enroll up to six public health units with training for health unit staff to begin in 2014 and review of projects in 2015 We wish to explore review models that will complement and build on existing review mechanisms. Thus, we hope to include a variety of PHU s in our pilot phase, including: Public health units with no current access to any formal or informal ethics review Public health units that have access to an institutional TCPS2 compliant Research Ethics Board but where the scope of projects being reviewed does not include all evidence-generating public health initiatives Public health units that have access to an informal ethics review process that is not TCPS2 compliant 2.2 SUPPORTS PROVIDED BY PHO PHO will support local ethics review processes by providing the following services to the pilot s public health unit participants: Risk Screening Tool: Consistent procedure for ethics risk assessment of evidence-generating initiatives using PHO s innovative Risk Screening Tool to help determine the appropriate level of ethical review for projects. Ethics Review of Evidence Generating Initiatives: Access to a centrally coordinated process that includes 4 distinct review levels to approve, reject, propose modifications or halt any initiatives that are not ethically acceptable. Audit and level 1 reviews provide a balanced amount of ethical scrutiny proportionate to risk to minimize administrative burden. Level 2 Delegated and Full Board Reviews include review of full project protocols by the ERB members. Training: Skill development and training (in-person and webinar) to enable the identified health unit staff person(s), ethics designate(s), to enhance their knowledge and skills to support the local ethics review process and promote ethical reflection. Educational resources: Educational resources for health unit staff conducting ethics-generating initiatives. Research ethics officer: Access to a PHO research ethics officer to support the ethics designate in addressing ethical concerns at the local level. Advisory services: Access to ethics advisory services for staff conducting ethics-generating initiatives. This includes guidance in identifying and/or addressing ethical issues that may be associated with a public health initiative or in the development of local ethics support. Page 3 of 6
4 2.3 SCOPE OF RESPONSIBILITIES FOR PARTICIPATING PUBLIC HEALTH UNITS In order to ensure ethics review procedures can be implemented effectively, we have identified several requirements for participating public health units: 1. Local quality assurance: Public health units must ensure sufficient methodological rigour in quality of projects through local quality assurance or peer-review processes prior to submitting to PHO for ethics review. PHO will return initiatives that are not of sufficient quality without undergoing ethics review. 2. Change Management: Public health units must collaborate with PHO to support change management processes including refinement, implementation, and evaluation of policies, processes, procedures, and tools to implement PHO s model of ethics review at the local level. 3. Staff resources: Public health units must support ethics service delivery internally through dedicated staff resources, including release time for staff, to meet the requirements set out by PHO for the role, responsibilities, training, and mentorship of an ethics designate (see Appendix 1 for draft role descriptions). This function is critical to the PHO model, which aims to build local rather than central capacity. 3. Application Process 3.1 APPLICATIONS To be considered for the pilot service, interested public health units should submit a completed application form, and résumé of the nominated ethics designate. Submission deadline is August 8, Completed application forms should be submitted to Carly Heung, Program Analyst, Research and Ethics Services (carly.heung@oahpp.ca). PHO will use the following criteria to select public health units to participate in the pilot program: 1) Capacity for local approvals the degree to which a public health unit has an established local approval process to ensure that all protocols have organizational support, adequate funding, and are of sufficient scientific quality; 2) Capacity for staffing resources the degree to which the qualifications and commitment of the ethics designate role are met based on the available resources and expertise of public health unit staff; 3) Ethics review needs the current complement of ethics review available to the public health unit, and volume of projects expected 4) Diversity among selected participants PHO wishes to have a diversity of public health units participate in the pilot. PHO will review the following factors of the public health unit: size based on number of full-time staff, geographic location, types of projects conducted PHO will notify selected public health units in writing by fall Page 4 of 6
5 Table 2 provides an overview of the key dates to launch the pilot program. Table 2: Timeline and Key Activities for PHO s Ethics Review Service Public Health Unit Pilot Timeline Key Activities August 8, 2014 Deadline to submit completed Application Form Summer 2014 Review of applications Fall 2014 Notification of decisions sent to health units Fall 2014 Training of Ethics Designate(s) Winter 2015 Pilot review service begins For any questions regarding the application process, please contact our ethics program analyst Carly Heung at carly.heung@oahpp.ca ( ). Page 5 of 6
6 Appendix 1: Role Description for Ethics Designates Each public health unit participating in the pilot program must identify a current staff member who will receive training and fulfill functions as an ethics designate. Since this is a newly created role to enable review services for health units PHO will assess the feasibility and impact of this role and the capacity of public health units to support it over the long-term. ROLE AND RESPONSIBILITIES The following are the key responsibilities of an ethics designate: Participate in and complete compulsory ethics training, including two in-person meetings in Toronto Provide support to their public health unit s staff in applying PHO s Risk Screening Tool to specific initiatives; With support of PHO s research ethics officer, complete risk assessments for their public health unit level 1 initiatives; Serve as an liaison between their public health unit and PHO s ethics office; Participate in the pilot evaluation activities and attend monthly teleconference meetings ELIGIBILITY Public health units may select their ethics designate based on the following criteria: Previous training or experience with ethics involving human participants is not a requirement. However, experience participating in local ethics review at the public health unit level is considered an asset (e.g., as part of a scientific or methodological review committee, or ethics review board) Have management support for dedicating FTE (1-2 days/month), in addition to time dedicated towards required training and mentorship Must be able to dedicate eighteen months minimum commitment after the completion of required training and mentorship. TRAINING AND MENTORSHIP Beginning in Fall 2014, PHO will provide mandatory training and mentorship to develop and support ethics designates with successfully carrying out their duties. The training program is currently in development but at a minimum, requirements will include completion of the TCPS2 CORE online tutorial, reading of selected materials, and in-person attendance of two workshops in Toronto. Costs related to training (e.g., travel and accommodation) will be covered by PHO according to PHO policies. Page 6 of 6
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