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Biobanks and Biotechnology

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Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
CT -  Taipei City
CT -  Taipei City
TH -  Bangkok
NZ -  New Zealand
KR -  Seoul (Gangnam)
KR -  Gyeonggi-do
KR -  Seoul City Airport

North America

US -  Boston
US -  South Carolina

GLOBAL

English

Biobanks are storage facilities that house blood samples, DNA, tissue samples and tumour cells that are used for research purposes. Biobanks help researchers carry out clinical trials that improve the prevention, diagnosis and treatment of serious diseases. The use of biobanks has significantly increased over the past decade, and the demand will continue to grow as biospecimen research becomes more advanced and widespread.

History of Biobanks

The first biobanks started in universities where researchers took advantage of leftover biological materials. They would store the biological samples in a few freezers, and the data was written down in a notebook or a basic database. Over time, technological advances like automated sample processing, the internet and computerisation have revolutionised the management of biobanks.

Biobanks and Legislation

Although there is no official biobank legislation, there are common, general governance features that cover all biobanks, whether they have been established by publicly funded science bodies or local health care institutions. If a biobank is found to be breaking any governance rules, it will be likely to face sanctions. This self-regulatory approach allows for more flexibility as technologies change and provides more freedom to pursue international partnerships. Even though there is no specific governing body for biobanks, the storage and use of biological material, privacy legislation, and anti-discrimination guidelines may remove the need for a specialised governance body.

Before new biobanks are established, they must go through multiple levels of review by independent committees.

Roles of a Biobank

The European Commission has published a detailed document that discusses the main roles of a biobank. These roles include:

  • To collect and store biological materials related to medical data.
  • Continuous or long-term collection and storage.
  • To work with current and/or future research projects.
  • To apply coding or some form of anonymisation to ensure privacy and confidentiality and also have a re-identifiable process in place when clinically relevant information becomes available and can be provided to the patient.
  • To include established governance structures and procedures that protect a donor’s rights.

Population and Disease-Based Biobanks

Population-based biobanks store biological materials from volunteers without any specific inclusion or exclusion criteria. Population-based biobanks study the role of individual genetics and their reaction to external factors in the development of specific diseases by analysing molecular data and clinical data, lab test results and imaging data.

Disease-orientated biobanks study specific human illness pathogenesis to identify therapeutic strategies. Thanks to large biological samples, researchers are able to create large-scale research projects and collect valuable data on the wellbeing of the patients being examined.

The introduction of the internet forever changed the biobank administration and introduced new opportunities. By storing information about biological materials, virtual biobanks enable easy data sharing between different biobanks without the

need to physically use the biological materials, allowing for the easy and free sharing of medical data and the development of partnerships between national and international biobanks. This process also removes the need for biological samples to be transported between two biobanks which minimise the risk of contamination.

Bioethics and Biobanks

The development of such sophisticated genetic technologies has raised new questions about how to protect the safety and confidentiality of the participants of biobanking research. Bioethics is a growing area of interest. The main regulations and legislations that play a part in bioethics include:

  • Declaration of Helsinki: Provides general guidelines for the ethical principles regarding the safety, confidentiality, dignity and autonomy of participants taking part in medical research.
  • Declaration of Taipei: Established by the World Medical Association (WMA), it provides guidelines for the collection, storage and use of identifiable data and biological samples.
  • Informed Consent (IC): Competent individuals are able to make an informed decision about participating in medical research. Important points include:
    • Consent needs to be freely given
    • Consent needs to be informed
    • Consent needs to be given in a statement or clear message
    • The request for consent needs to be conveyed clearly
  • Ownership of biological material: The ownership of biological materials is a widely debated topic. The worldwide-recognised rule that no person can own another individual (as stated in Article 4 of the Universal Declaration of Human Rights) has caused most biobanks to declare that
  • they’re custodians of the biological material but not the owners. This recognition is in accordance with the International Agency for Research on Cancer (IARC) which declares that “no ownership of biological samples exists.”
  • The International Society for Biological and Environmental Repositories (ISBER): Founded in 2000, it is one of the most important international organisations that address the harmonisation of legal, ethical, scientific and technical issues that is relevant to the storage and use of biological and environmental samples.