Human Research Ethics Committee Application Process for Personal Health Information Version: 26 July 2012
Contents 1. Preamble... 2 2. Health data collections and the data linkage system... 2 3. Overview of governance and ethics processes... 3 3.1 Overview of data governance processes... 3 3.2 Overview of ethics processes... 3 4. Data application and governance processes... 3 4.1 Application for personal health information from a statewide data collection... 4 Figure 1. Overview of data application process from a statewide health collection. 4 4.2 Application for linked data... 4 Figure 2. Overview of application for linked data... 5 5. Department of Health WA Human Research Ethics Committee - Scope of responsibility... 6 6. Ethics application process... 6 6.1 WA Health Ethics Application Form... 7 6.2 The National Ethics Application Form and the Western Australian Specific Module... 7 6.3 Western Australian Aboriginal Health Ethics Committee approval... 7 7. Submission of ethics application forms and supporting documentation... 8
1. Preamble The Department of Health (the Department) 1 collects a vast amount of information, much of which is confidential personal health information that is used for the benefit of all Western Australians. In order to achieve the greatest benefits, information must be accessible and available to end users within legal and ethical constraints. Access to personal health information held by the Department must also satisfy data governance and ethics approval processes. This document outlines the data and ethics application processes in light of the use and disclosure of personal health information from the data collections held by the Department. 2. Health Data Collections and the Data Linkage System The Department is responsible for a number of statewide health data collections that contain summaries of patient information collected from health service providers. The statewide collections capture information about the contact Western Australians have with the State s health system. For example, information is collected about the diagnosis and treatment of patients admitted to public and private hospitals, emergency departments and all reported instances of cancer in Western Australia (WA). The collections held by the Department contain personal health information about an individual or patient. Personal health information includes information or opinions that relate to the health of a person where the identity of a person is apparent or can reasonably be ascertained from the information. This personal health information has been collected for many years and is used to improve the quality of health care, plan for future health services, and to meet funding, performance and legislative reporting obligations. The personal health information can also be used by researchers internal and external to the Department for health related research. Further details about the statewide health data collections are available from: http://www.health.wa.gov.au/healthdata/statewide/index.cfm The Data Linkage Branch, within the Department, maintains the Western Australian Data Linkage System (WADLS), which comprises a system of linkages connecting data about the health events of Western Australians. The WADLS is used to link the statewide health data collections held by the Department and some other organisations. The WADLS can be used for ethically approved research, planning and evaluation projects that aim to improve the health of Western Australians. Further details about the WADLS are available from: http://www.datalinkage-wa.org/ 1 In the present context, the Department of Health and the five Health Services are considered separate entities and comprise WA Health. 2
3. Overview of governance and ethics processes Access to personal health information held by the Department must comply with existing data governance and ethics review processes. 3.1 Overview of data governance processes The Data Steward is responsible for granting approval for the use and disclosure of personal health information. The Data Custodians of the statewide data collections contribute to the data governance process by performing a review of the data request application and providing advice to the Data Steward. The process of seeking support from Data Custodians via the data application process is outlined in Section 4. 3.2 Overview of ethics processes The Department of Health WA Human Research Ethics Committee (DOH HREC) was established in April 2008 and is registered with the National Health and Medical Research Council (NHMRC). The DOH HREC has special responsibility for oversight of the use and disclosure of personal health information from data collections held by the Department. The DOH HREC reviews projects involving personal health information and other research projects in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007). A brief overview 2 of the role and responsibility of DOH HREC, the types of projects within scope of DOH HREC, and the ethics application process is provided in Section 5 and thereafter. It is important to note that although the Department s support is conditional upon receiving DOH HREC approval, Data Custodians may refuse to release data on grounds unrelated to ethical issues (e.g. data integrity issues). Therefore, applicants should be aware that granting of approval by DOH HREC does not take precedence over the authority of Data Custodians or guarantee support for the release of data by the Department. 4. Data application and governance processes If the proposed project requires personal health information from the Department s data collections, applicants must seek preliminary support from the Data Custodian/s for their project before submitting their proposal for ethical review to DOH HREC. This is achieved through the data application process and is necessary 3 when the project requires personal health information from: (i) a single data collection held by the Department, or (ii) linked data using the WADLS. 2 For further information about the scope and operations of DOH HREC, please refer to the Terms of Reference and Standard Operating Procedures available on the DOH HREC website. 3 It is important to note that the Data Linkage Branch requires ethics approval for applications that require the use of existing links to extract health information from the Department s collection/s that is not identifiable or aggregated. However, this may not necessarily require DOH HREC approval. Researchers are encouraged to discuss these types of requests with Data Custodian/s prior to submitting an application to DOH HREC. 3
4.1 Application for personal health information from a statewide data collection Projects that require the use and disclosure of personal health information from a statewide data collection must liaise with the appropriate Data Custodian about the data requirements of their project and the data application process. Details about some of the statewide health data collections are available from http://www.health.wa.gov.au/healthdata/statewide/index.cfm As part of the data governance process, applications for data will be formally reviewed by the appropriate Data Custodian in order to provide advice to the Data Steward on release of the data. Therefore, applicants must consult with the Data Custodian about relevant forms so the Data Custodian can provide suitable advice on the release of the data. The relevant application form and supporting documentation must be reviewed and endorsed in principle by the Data Custodian prior to submitting the proposal to DOH HREC. Applicants are also encouraged to review relevant DOH HREC documentation (e.g. Terms of Reference), to ascertain whether DOH HREC approval is required for their project. Figure 1 summarises the application process for requesting personal health information from statewide data collections. Figure 1. Overview of data application process from a statewide health collection Consult with relevant Data Custodian regarding the data request Complete the data application form and supporting documentation (e.g. confidentiality agreement, variable lists) Submit data application form and any relevant supporting documentation to Data Custodian for review and endorsement Submit final data application form and relevant DOH HREC ethics application form to Executive Officer, DOH HREC, where appropriate 4.2 Application for linked data The WADLS was established in 1995 to connect all available health and related information for the WA population. The information is used for ethically approved research and operational projects that aim to improve the health of Western Australians. Access to 4
linked data is granted to applicants who have obtained approval from the relevant Data Custodians and ethics approval from the DOH HREC. Where an application is made for linked data, the initial consultation with the data custodians is coordinated by the Project Officer, Data Services. The data application process comprises two steps involving the same Application for Data Form (DS001). All applicants must submit the Application for Data Form as an Expression of Interest (EOI) to the Project Officer, Data Services, Data Linkage Branch, before submitting the formal Application for Data. The relevant Data Custodians will provide feedback to the applicant as part of the EOI and data governance review process. The applicant is then required to submit a final draft of the Application for Data Form to the Project Officer in light of the feedback from the data governance review process. The Project Officer will then send a feasibility letter to the applicant to notify them when the Application for Data Form is approved for final submission to DOH HREC. Details about the EOI and formal data application processes, including relevant forms, are available from the Data Linkage Branch website: http://www.datalinkage-wa.org/accessand-application For assistance with completing the requirements for accessing linked patient-level data via the WADLS, contact the Project Officer, Data Linkage Branch at DataServices@health.wa.gov.au Figure 2 summarises the application process for requesting linked health information via the WADLS. Figure 2. Overview of application for linked data Consult with Project Officer, Data Services, or relevant Data Custodians regarding the data request Complete the Data Application Form (DS001) as an Expression of Interest (EOI) and supporting documentation. Submit documents to Project Officer, Data Services, for EOI review Revise DS001 and supporting documentation based on Data Custodians' comments. Resubmit a final copy of these documents to Project Officer, Data Services, to obtain feasibility letter. After receiving feasibility letter, submit final copy of DS001, supporting documentation and relevant DOH HREC ethics application form to Executive Officer, DOH HREC, where appropriate 5
5. Department of Health WA Human Research Ethics Committee - Scope of responsibility The DOH HREC is a Human Research Ethics Committee (HREC) with special responsibility for oversight of the use and disclosure of personal health information held in the Department s data collections. The DOH HREC will review and provide oversight, monitoring and advice for: All research projects involving the use and disclosure of personal health information from the data collections held by the Department (linked or otherwise); All projects involving the establishment of new linkages with data collections held by the Department; All projects for funding, management, planning, monitoring, improvement or evaluation of health services that involve the disclosure of personal health information from data collections held by the Department 4 ; The DOH HREC may also consider research projects conducted by employees of the Department involving participants for whom the Department has a duty of care and research proposals involving humans conducted by external organisations and researchers, where an agreement exists between the Department and the external organisation. For further information, refer to the DOH HREC Terms of Reference, available from the DOH HREC website: http://www.health.wa.gov.au/healthdata/docs/hrec_terms_of_reference.pdf 6. Ethics application process Within WA Health, the Research Governance Framework (Framework) has been developed to standardise ethical and governance review and monitoring of research across all WA Health institutions and HRECs. This framework encompasses the scientific, ethical and governance review and monitoring of research, as well as the accompanying ethics and site specific assessment forms. In accordance with the Framework, two ethics application forms will be available for use throughout WA Health for the ethical and scientific review of research projects. These forms will apply to all projects requiring ethics approval from DOH HREC and/or any other HREC within WA Health. The relevant form will need to be completed and submitted to the Executive Officer, DOH HREC, to obtain personal health information from statewide data collections held by the Department. Further information about the submission of applications to DOH HREC is provided in section 7. Further details about the forms are provided in the following sections. 4 Except where information is required to meet clinical patient management requirements or mandatory reporting obligations such as the National Health Care Agreement or any other funding agreements, and reporting required by legislation. 6
6.1 The National Ethics Application Form and the Western Australian Specific Module Currently, HRECs within WA Health, including DOH HREC, accept the National Health Ethics Application Form, Version 2.0 (NEAF). The NEAF is a web-based ethics application form that is used nationally for the ethical and scientific review of single-centre and multicentre research projects involving humans. From July 2012, the Western Australian Specific Module (Module) must be completed with the NEAF where research is to be conducted in WA. The Module is comprised of seven sections that provide information and questions about legislation and specialised HRECs pertaining to the state of WA. Applicants for cross-jurisdictional projects (i.e. multi-centre projects which span jurisdictional boundaries) that require personal health information from the Department are encouraged to use the NEAF and Module when applying to DOH HREC. The NEAF must be used for projects utilising the National Approach to Single Ethical Review of Multicentre Research (i.e. National Approach). Further details about the National Approach are available at http://hrep.nhmrc.gov.au/national-approach Applicants are encouraged to consult with the Executive Officer, DOH HREC, to ascertain whether the NEAF and Module should be completed as part of their full ethics application. 6.2 WA Health Ethics Application Form The WA Health Ethics Application Form provides applicants with an alternative to the NEAF and is recommended for use by applicants (internal or external to WA Health) performing human research projects involving WA Health. The form may also be used for projects requiring access to participants, their tissue or data from WA Health, including personal health information from the Department s statewide health data collections. With respect to DOH HREC, applicants are encouraged to use WA Health Ethics Application Form for any projects that are within the committee s scope of responsibilities, as outlined in Section 5. Applicants may submit the NEAF to DOH HREC if they prefer, for example, where they are required to prepare and submit the NEAF to another HREC. Therefore, applicants are encouraged to consult with all relevant HRECs about the appropriate ethics application form before preparing their application. 6.3 Western Australian Aboriginal Health Ethics Committee approval If the data is requested to perform health-related research involving Aboriginal peoples, ethics approval must also be sought from the Western Australian Aboriginal Health Ethics Committee (WAAHEC). In particular, projects should be submitted to WAAHEC if one or more of the following apply: Aboriginality or Torres Strait Islander (TSI) status is a key determinant; data collection is explicitly directed at Aboriginal or TSI peoples; 7
Aboriginal or TSI peoples, as a group, will be examined in the results; the information has an impact on one or more Aboriginal or TSI communities; Aboriginal or TSI health funds are a source of funding. Further information is available from the WAAHEC Internet site: http://www.ahcwa.org.au/index.php/programs/ethics 7. Submission of ethics application forms and supporting documentation Meetings of the DOH HREC take place on the second Wednesday of each month, except January when the committee is in recess. New applications must be received by the closing date for receipt of new business, which is normally two weeks before the scheduled meeting. The meeting calendar is available from the DOH HREC website. The relevant ethics application form will need to be completed and submitted to the Executive Officer, DOH HREC, with supporting documentation by the closing date to be considered at the next scheduled meeting. Please see the submission instruction page to view full details about submitting a complete application to the Executive Officer, DOH HREC, for ethics review. Detailed submission instructions for accessing WA linked data are available from the Data Linkage Western Australia website: http://www.datalinkage-wa.org/access-andapplication/submission-instructions 8