Ethics Approval: Research Tissue Bank

Ethical Approval: Research Tissue Bank

The UCL/UCLH Biobank for Studying Health and Disease has been awarded ethical approval as a Research Tissue Bank. Many of the tissue samples collected will be for specific projects, however the consent proposed will permit long term storage of samples to be used for future projects. Standardised consent forms and patient information sheets have been developed as part of the ethical approval, and can be utilised by users of the biobank. Examples of consent forms and patient consent forms can be found here, but you should contact Nick Henriquez for further information (and up to date versions) before using any forms:

Consent form: Adult patient; Adult Healthy Volunteers; Parent/Guardian consent for child; Child 5 years and under; Young Patient; Adult patient and Parent/Guardian consent to approach family member; Family members of patient

PIS: Adult patient; Adult Healthy Volunteers; Parent/Guardian consent for child; Child 5 years and under; Child 6-10; Child 11-15;

The Ethical Review Committee for the biobank will review requests for new sample collections and also requests for use of samples/data for research, including those which do not already have ethical approval and ensure they satisfy conditions laid down by NRES for the release of tissues by the Research Tissue Bank. The biobank Ethical Review Committee B-ERC been set up and is now reviewing requests, a number of which have already been approved. If you wish to start a new sample collection or wish to use existing samples please contact Nick Henriquez (n.henriquez@ucl.ac.uk) for further information. You will have to complete an application form, as well as providing other information including SOPs and evidence of HTA training. If you are requesting access to samples in the diagnostic archive you will have to have agreement of the lead pathologist for access to the samples and have appropriate funding in place before applying to the biobank. Explanation of all the requirements to make an application to the B-ERC will be provided by Kirstin and Nadege.

The Research Programme covered within the ethical approval includes:

1. Search for biomarkers, molecular targets and profiles related to prognostic and predictive markers of disease but also disease progression and disease outcome.

2. Investigating the causes of disease, damage and degeneration in cells and tissues

3. Examining the unique effects of the bone marrow microenvironment on tumour cell homing.

4. Developing assays to determine the in vivo role of growth factors, hypoxia, angiogenesis, matrix attachment and cytokine response signalling pathways in disease and repair of tissues and in relevant tumours

5. Establishing novel culture methodologies for generating distinct cell types from sources including blood and tissue. Cells obtained from these sources may have stem cell properties and therefore can be manipulated to produce a variety of tissues (e.g. bone, cartilage, tendon, muscle, brain cells).

6. Examining the relationship between assay findings and response to therapy and pathological variables in tissues and primary tumours.

7. Establishing methods to discriminate structure/function relationships based on mechanical testing and biochemical composition of tissues

Developing xenograft models for ‘biobanking’, understanding disease related biology and testing drug response prior to clinical trials.

9. Developing and validating 3-dimensional models of tissue explanted intact or reconstructed on grafts and implants for studying tumour biology environment and metastatic disease prior to clinical trials.

10. Developing and validating models to predict responses to novel adjuvant treatments and agents.

11. Searching for evidence of age and disease relevant epigenetic modifications in tissue and investigating the mechanisms.

12. Analysing tissue for disease-causing somatic alterations that are tissue-specific or chimeric and not expressed in blood.

13. Developing non-invasive measuring tools to assess mechanical properties and early damage or repair markers to target more appropriately preventative strategies for rapid assessment of response to novel treatments and side effects on tissues.

14. Pharmacodynamic and pharmacokinetic evaluation and monitoring of drugs or therapeutic agents in target or surrogate tissue in early phase clinical trials.

15. Evaluate the association between molecular characteristics and profiles of tissue with therapeutic modulation.

16. Evaluation of potential therapeutic targets using clinical samples and models derived from tumour tissue.

17. Examine the influence of genetic variation on drug response to develop rational means to optimise drug therapy.

The research Techniques covered by the ethical approval include:

- Immunohistochemical, molecular biology and biochemical studies

- Immunoassays and flow cytometry

- Genetic analysis including whole human deep genomic sequencing

- Genotyping and epigenetic typing, including genomewide searches

- Gene expression profiling

- Development of appropriate in vivo models

- Proteomics

- Metabonomics

- Imaging

- Quantification of RNA and other cellular molecules

- Genetic Modification: not Reproductive Cloning

- Cell/explant culture and biochemistry (including stem cells)

- Mechanical testing of specimens and of explants / scaffolds

Page last modified on 30 jul 14 16:04 by Kirstin Goldring