| 1) Governance & Oversight Committee (IGOC) |
| Membership of the committee: The composition of the independent Governance & Oversight Committee is guided by the recommendations of “Guidelines for human biobanks, genetics research databases and associated data”, published by the Government of Western Australia Department of Health. IGOC shall be composed of members from both the research and lay community, together with a representative from the WAPB. The composition of the committee is: • Senior scientist (external to WNHS) with extensive biobank experience and expertise (Chair). • Director, WAPB (Biobank representative) • Accountant, WIRF (Financial presentative) • Lay/Community organisation presentative • WNHS Ethics Committee/Legal presentative • Maternal-Fetal Medicine/Clinical presentative • Researcher/Biobank advisor |
| Purpose of the committee |
| To provide independent oversight and governance of the WABP, ensuring that samples are collected and stored ethically and safely; that participants rights and expectations are respected; that requests for sample access are processed and considered appropriately and transparently, without bias or favour; that the WABP is compliant with legislation and the principles of good governance; and that annual reporting requirements are met. |
| Functions |
| The Governance & Oversight Committee has responsibility for: • Providing independent scientific, financial and ethical oversight of the WAPB. • Reviewing the conduct and results of the process of assessment of applications for access to the biobank and its data. • Ensuring that the WAPB operates in accordance with its own rules, guidelines and best practice. • Providing an avenue to assess and respond to complaints and resolve issues pertaining to the establishment, use and access to the biobank and associated data. • Provide an annual report on activities of the biobank, compliance with operational guidelines and any ethical/scientific issues. |
| Meetings |
| The IGOC shall meet yearly, or as required if extraordinary issues arise. A quorum shall be a majority of members. Decisions and statements shall be made by consensus. |
| Term of Office |
| For the duration of the project (5 years initially, with options to renew for one additional term). |
| 2) Management Committee |
| Membership of the committee: |
| • Director, Biobank and WIRF Laboratories, SWIH (Chair) • Director, Preterm Birth Prevention Clinic • Head, Biostatistics Group, WIRF Additional members with specific expertise or knowledge may be invited to attend meetings as required; the Head of The WA Preterm Birth Prevention Initiative, may sit in attendance. The subcommittee will hold expanded meetings at least biannually with all biobank-associated staff to communicated matters widely within the group and garner feedback and advice on current issues. Personnel to be included are: Research staff/investigators and postgraduate students working within the Biobank and Microbiology group; SWIH & WIRF Research midwives; WIRF statistical/programming staff; Database programmers/developers |
| Functions of the committee |
| • Manage the WAPB and its operations on a day-today basis. • Organise and oversee the development of the Biobank database, questionnaires, sample record management system, and website. • Establish standard operating procedures (SOPs) for sample collection and curation. • Supervise participant recruitment, patient access, sample collection, data entry and reporting, sample archiving/curation, staff management and organisation. • Manage resources and oversee/allocate budgets and expenditure. • Ensure that participant confidentiality and data integrity are maintained • Liaise with the Western Australia Preterm Birth Prevention Initiative, the Governance and Oversight Committee, the Scientific Assessment and Advisory Committee, the UWA School of Women’s and Infants’ Health, and the executive leadership of King Edward Memorial Hospital (KEMH). |
| Meetings |
| The committee shall meet monthly, with expanded meetings for all Biobank staff and students as frequently as needed, but at least half-yearly. A quorum shall be a majority of members. Decisions and statements shall be made by consensus. |
| Term of Office |
| For the duration of the project (5 years initially, with options to renew for one additional term). |
| 3) Scientific Assessment & Advisory Committee (SAAC) |
| Membership |
| The Scientific Assessment and Advisory Committee will be comprised of: • The Director of the WAPB • The Director of the Preterm Birth Prevention Clinic • The Director of the WA Preterm Birth Prevention Initiative • Head of WIRF Biostatistics and Study Design Unit • External Professor, Faculty of Science, UWA (or similar) |
| Functions |
|
• Receive and process applications for access to WAPB samples and data in a timely fashion. • Assess applications on the basis of scientific quality, resource requirements and implications, credentials and location of the applicants, and consistency with the goals of the WAPB. • Provide a timely written acceptance or rejection of applications; in the case of rejection, provide explanation and rationale to applicants. • Provide an annual report of the committee’s activities to the Independent Governance and Oversight Committee. • Complete the annual report to the WNHS HREC. • Liaise with the Management Committee. |
| Meetings |
| The Committee shall meet on an ‘as needed’ basis, within 10 working days of receipt of an application for sample access. Email meetings will be undertaken where members are not able to meet physically. If unanimous, approvals for applications for access to samples will be accepted when meetings are conducted by email. |
| Term of Office |
| For the duration of the project (5 years initially, with options to renew for one additional term). |
