Regulations governing the protection of human research subjects are based on the ethical principles identified in the 1978 Belmont Report, the Nuremberg Code and the Declaration of Helsinki. Many of these ethical principles relate to patient consent. Informed consent is a written acceptance, directly from the donor, to participate in a research project based on an understanding of the study’s purpose, its risks and benefits and the planned collection of specimens and data.
Human biospecimens is a broad term that refers to any biological material obtained from a person including tissue, blood, urine and other body fluids. It also includes any derivative of these, such as cell lines and organoids. Ethical considerations related to laboratory-based research involving human biospecimens vary according to the structure of the ethics approval. Generally, biospecimens collected as part of a biobank are available for use in “other ethically approved projects” whereas the use of biospecimens collected for a specific project may be more restricted.
All human biospecimens collected for research purposes require ethical review and approval by a Human Research Ethics Committee (HREC). The HREC will review participant consent and sample collection, processing, storage and distribution or disposal. There are approximately 200 HRECs in research organisations across Australia. HRECs at most institutes/ universities are constituted and operate in accordance with the National Statement on Ethical Conduct in Human Research and relevant state and national legislation, regulations and guidelines.
Once appropriate ethics approval has been obtained for a project, biospecimens can be accessed from biobanks or bioresource centres. There are a number of considerations for accessing biospecimens:
The consent provided by the patient will determine what their tissue samples can be used for.
The availability of a biospecimen – is it readily available or a limited resource.
The scope of the research project – biospecimens can only be used for research that has been reviewed and approved by a HREC.
Often access to biospecimens will be via a collaborative arrangement that might include clinical and research partners.
Phenomics Australia supports the generation of cell lines, induced pluripotent stem cells, organoids and tumoroids. The use of these biospecimens requires Material Transfer Agreements (MTAs) between institutes or universities and discussions around collaboration and IP fall within the scope of the MTA. Phenomics Australia does not hold any IP for the work performed by our service nodes. IP remains with the host institute/ university or as specified in the MTA.
” As curators of biobanks and biorepositories we are responsible for the appropriate management of biospecimens. We oversee the processing, storage, and distribution of biospecimens as agreed to by each participant. Mostly tissue is provided to a repository to support the development of new treatments for life-threatening diseases. This means we also have a responsibility to ensure that biospecimens are accessible to the research community.”
Additional information
1978 Belmont ReportLink https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html and https://pubmed.ncbi.nlm.nih.gov/25951677/
The Nuremberg Code : org/library/ethics/nuremberg/
The Declaration of Helsinki: net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566407/
Generating organoids and IPS cells from tissue is a complex process often involving collaborative arrangements with clinical and research colleagues. To facilitate these discussions you should, in the first instance, contact biorepository staff:
Perkins Cancer Biobank – cancerbiobank@perkins.org.au
