Resources


BERC Protocol

BERC Workflow


Request for Access to Exisiting Specimen Collections

B-ERC Pre Application Checklist (1Page)

B-ERC Ethics Application Form (9 Page)


Links

For information on Ethical approval for use of human samples see

National Research Ethics Service (NRES) http://www.nres.npsa.nhs.uk/

Integrated Research Application System (IRAS) https://www.myresearchproject.org.uk/Signin.aspx


Research Tissue Bank Ethics approval

Ethical Approval: Research Tissue Bank

The UCl-RFH biobank has been awarded ethical approval as a Research Tissue Bank (see biobank ethics protocol). All of the tissue samples collected as part of the biobank will have been collected for specific projects, however the collections owners are encouraged to include in the consent process permission for long term storage of samples to be used for future projects.

The UCL Biobank Ethical Review Committee (BERC) will review requests for any future use of exisitng samples/data stored in the biobank for further research, as long as they satisfy conditions laid down by NRES for the release of tissues by the Research Tissue Bank. The B-ERC been set up and is now reviewing requests.

If you wish to use existing samples within the UCL-RFH biobank and you have the agreement of the person who has collected the samples, please contact the UCL-RFH biobank (uclrfhbiobank@ucl.ac.uk) or Kirstin Goldring (k.goldring@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. Explanation of all the requirements to make an application to the B-ERC will be provided by biobank staff or Kirstin. 

Biobank Ethics workflow

Approved Techniques

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 animal 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

  • Primary cell cloning (not reproductive)

Approved Areas of Research

The Research Areas covered within the ethical approval include:

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

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

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

  • 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

  • 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).

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

  • 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.

  • 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.

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

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

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

  • 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.

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

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

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

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