- Please detail the core elements of a Biobank for clinical research, and the necessary steps required to ensure success.
- Make this relevant to your own specific Discipline - what sample types would you be interested in banking, and discuss potential pitfalls or issues that may be faced. Include any experience you may have had in this area.
Technical and operational factors:
Management and operational
There are many different essential responsibilities and roles required to ensure efficient biospecimen resource management. Management should be responsible for appropriate planning of the design of the space, identifying infrastructure requirements and regular evaluation of resources and operational issues.
Biospecimen collection, processing, storage, disposal
All personal involved in the use of biospecimens should be aware of the purpose of the biobank and of the relevant Standard Operating Protocols (SOPs). This will involve training of personnel. The biobank infrastructure can vary depending on the type of specimen. However, at a minimum there needs to be a laboratory, office and other living space such as kitchen/toilets etc. As well as the space, IT, equipment storage, telecommunications and waste disposal infrastructure also needs to be considered.
Standardised operating protocols must be applied always in storing biospecimens to reduce variability in research. Any breach or deviation from SOPs should be recorded.
Each specimen should have a unique identifier number attached to the container while ensuring confidentiality. This is necessary so that the biospecimens can be located should a research participant decide they no longer wish to participate and also so that the biospecimen can be matched with the relevant clinical information.
Collection, processing, management and distribution of biospecimens must be carried out within a quality management system which has documented quality assurance and quality control policies with written SOPs. It is also advised that where possible, the QMS should be managed by people not involved in the repository operations.
It should be assumed that all specimens are potentially infective and biohazardous. E.g. all staff dealing with specimens are advised to have hep B vaccination. Standard precautions should be in place for handling biospecimens and all specimens should be labelled according to their relevant level of biohazard. Hands should be washed frequently and face protection and gloves should be worn when handling biospecimens or working around freezers which store biospecimens.
There should be clear policies regarding biospecimens with varying levels of risk. Biospecimen resource staff members should be trained to perform risk assessments and determine appropriate levels of containment. Necessary training of staff should be implemented.
Collecting and managing clinical information
This should be done in accordance with the relative privacy/GDPR regulations. Clinical data should be used only for research purposes under the conditions covered by the relevant ethics approval.
Storage of coded data associated with a biospecimen allows for a secure link to identify the research participant to allow additional longitudinal data to be obtained, if permitted by law and by the research participant’s consent.
Ethical and legal factors:
All systems that store personally identifiable information should adhere to security regulations for such data.
All potential research participants must be provided with enough information in order to make an informed decision with regards to study participation. This includes a clear description to the aims of gathering/utilizing data, how and what data/specimen will be gathered and how it will be stored, how their privacy will be protected, who will have access to the specimen/data.
Biobanking involves maintaining research participant privacy and confidentiality of associated clinical data. There should be clear policies in place for protecting identifiable information which may include coding, data encryption, limiting access and non-disclosure agreements.
Access to data and specimens
Guidelines for sample distribution and clinical data sharing should be consistent with ethical approval, regulations and in keeping with informed consent.
When considering Biobanking for Vascular Surgery, all of the above factors need to be considered.
Some tissue samples that may be obtained for research in vascular surgery include arterial plaque in cardiovascular disease, which can be obtained intraoperatively during endarterectomy surgery either from femoral or carotid arteries. The composition of the plaque can be analysed to assess whether certain medical targets could be used to slow disease progression in peripheral vascular disease.
Others samples that can be collected and stored for research purposes included varicose vein samples that are removed during avulsions for varicose vein surgery. This allows for assessment of the composition of the varicose vein and how it is different to the normal vein due to prolonged exposure to higher pressures.
Potential pitfalls with the above biospecimens could be the number of variable clinical factors which are necessary to consider and record. For example; it would be crucial to include the patients’ full medical history for other risk factors for cardiovascular disease such as hypertension, hyperlipidaemia, presence of chronic kidney disease, age, gender, use and duration of use of relevant medications etc. Therefore, storage of appropriate data and clinical information should be meticulous.
For the second example of varicose vein samples, the method of extracting the sample could potentially alter the composition of the specimen (e.g the stretching/tearing of the veins during the avulsion process) and it would be important to take this into consideration when analysing and interpreting the results from these specimens.
- Rao, Abhi, et al. “Abstract 5947: The NCI Best Practices for Biospecimen Resources : 2016 Revised Recommendations.” Cancer Research, vol. 77, no. 13 Supplement, 2017, p. 5947.
- Parry-Jones, Alison. “ISBER Best Practices: Recommendations for Repositories, 4th Edition.” Cryobiology, vol. 85, 2018, p. 152.
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