Data coding and deidentification
Biobank curation and operation complies with best practice to ensure privacy and integrity, in accordance with Guidelines for Human Biobanks, Genetic Research Databases and Associated Data (2010), Office of Population Health Genomics, Department of Health WA.
The WAPB has adopted policies and procedures to ensure that all specimens and personal health information are fully de-identified prior to their distribution to investigators. All data will be anonymized, and confidential and clinical details/identity will only be accessible by the clinical consent team. All personal identifiers will be removed and each participant and their samples will be identified by a unique study number. This study number will be used to define all samples and data and will be the only mode of identification given to researchers who access the biorepository.
Informed consent
Samples and clinical/outcome data will be collected with informed consent from participants, according to the conditions of approval from the Human Research Ethics Committee (HREC) of the Women and Newborn Health Service (WNHS) of Western Australia. Samples will be used for multiple studies, some not yet even envisaged, so general consent for future research will be requested. Optional approvals for the sending of samples (including DNA) overseas for IRB-approved research projects will be sought from the participants.
The participant information sheet clearly states that any donated specimens will be used for research purposes only and that participant confidentiality will be safe-guarded. The possible benefits of participating in the research by donating samples and providing questionnaire data, as well the obligations and risks associated with participation, are fully disclosed prior to the provision of consent. Signed consent forms are stored together with the master list of participants in a secure location, accessed only by the consent team (research midwives).
All attempts have been made to reduce the burden of compliance on the participants/donors. Nevertheless, frequent sampling may entail some inconvenience for participants; therefore, options for opting out of non-scheduled sampling visits have been provided on the consent form.
Data Security and Protection
All clinical and/or personal information that is collected for the purpose of the biobank and associated research will be stored on secure servers with password encryption, anti-virus software and secure firewalls. Data will be backed up daily, stored on internal drives, and will be managed by IT staff of the University of Western Australia. The WAPB will operate under the ownership and joint custodianship of the Women and Infants Research Foundation (WIRF) and The University of Western Australia.
Non-confidential documents such as meeting agendas and minutes will be circulated by email to members; governance documents and forms (non-confidential) will also be accessible via the WABP internet page. Access to other confidential documents will be protected via secure password access.