BANK CF

BANK CF, The Respiratory Centre’s Cystic Fibrosis Biobank has been established, governed and managed in accordance with applicable domestic law, guidelines and international instruments. These include but are not limited to the Western Australian Department of Health, Guideline for Human Biobanks, Genetic Research Databases and Associated Data, the NHMRC Biobanks Information Paper, the NHMRC National Statement on Ethical Conduct in Human Research and the Commonwealth Privacy Act. 

Telethon Kids Institute is the sponsor of BANK CF and is responsible for the oversight of the biobank. 

AREST CF Executive Committee 

The AREST CF Executive Committee (EC), comprising three study Principal Investigators, the AREST CF Program Manager and a consumer representative, oversee the research, including the biobank and database(s). The EC meets quarterly to discuss:

• Strategic plans and directions for cystic fibrosis research
• Financial aspects of the program
• Membership of the AREST CF Scientific Management Committee 

The AREST CF Scientific Management Committee 

• The AREST CF Scientific Management Committee (the SMC), comprising researchers invited by the Executive Committee, the AREST CF Program Manager and two consumer representatives, monitor, review and report on the management and operation of the Biobank and activities pertaining to resources. The SMC meets monthly to discuss sample and data governance, ongoing studies and issues pertaining to publications. 

Responsibilities of the SMC in relation to the Biobank are to:

• Monitor the operations of the Biobank for compliance with the applicable domestic law, ethics, guidelines and international instruments
• Monitor compliance with standards for the physical and electronic security of:
  • Biological samples,
  • Biological and genetic data that is generated from the samples, and
  • The information technology system for the Biobank.
• Report to the Executive Committee on compliance or otherwise.
• Review the Biobank’s documentation, including but not limited to:
  • Standard Operating Procedures (SOPs),
  • Material Transfer Agreements (MTAs),
  • Collaborative Agreements.
• Be responsible for access to samples from the biobank and corresponding data for external and internal researchers via the Scientific Management Committee (SMC) request workflow. 

The cystic fibrosis consumer reference group provide input into respiratory research, including the structure and use of the biobank. This helps to ensure that the participant’s rights and expectations are considered and respected. 

The AREST CF Operations group, comprising a data manager, biobank manager and project officer, led by the program manager, manage the day to day operations of the Biobank. They ensure that the biobank operation is consistent with best practice, with input from the SMC. Members of this team have significant experience and appropriate qualifications and competence in the collection, curation, processing, storage and cataloguing of biological specimens and associated data. 

The Respiratory Centre Cystic Fibrosis Biobank (BANK CF) is available for the purposes of advancing health outcomes and medical research in cystic fibrosis. To achieve this outcome, AREST CF will invite and approve, if thought fit, new research proposals submitted by Telethon Kids Institute researchers, MCRI researchers and stakeholders, and third-party researchers (to be reviewed by the AREST CF SMC). 

Audits of samples and associated data are performed in accordance with guidelines for biobanks and databanks. Regular reports will be submitted to Ethics Committees as per local requirements. 

The AREST CF team will audit samples and data routinely and expect to engage an independent auditor in the future with the aim of an external audit every 3 years, unless required by the result of the first audit, to be done more frequently.

 A member of the biobank research team can be contacted, by calling Telethon Kids Institute on (08) 6319 1000, to answer any questions you have about the use of your child’s samples in research.  

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research have been approved by the Perth Children’s Hospital HREC. BANK CF will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). If you have any concerns and/or complaints about BANK CF, the way it is being conducted or your child’s rights as a research participant and would like to speak to someone independent of the project, please contact The Executive Director of Medical Services at PCH on (08) 6456 2222. Your concerns will be drawn to the attention of the Ethics Committee who is monitoring the study.