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Cheryl Gillet - The HTA and Biobanking

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Cheryl Gillet - The HTA and Biobanking

  1. 1. Data Requirements for Compliance with the Human Tissue Act and Biobanking Cheryl Gillett King’s College London
  2. 2. Human Tissue Act 2004 Section 53: Powers of inspection, entry, search and seizure* Schedule 6 (which makes provision about powers of inspection, entry, search and seizure for the purposes of this Act) has effect. Schedule 6 Part 1: Inspection of statutory records (1) A duly authorised person may require a person to produce for inspection any records which he is required to keep by, or by virtue of, this Act. (2) Where records which a person is so required to keep are stored in any electronic form, the power under sub-paragraph (1) includes power to require the records to be made available for inspection— (a) in a visible and legible form, or (b) in a form from which they can readily be produced in a visible and legible form. (3) A duly authorised person may inspect and take copies of any records produced for inspection in pursuance of a requirement under this paragraph. *A duly authorised person may at any reasonable time enter and inspect any premises in respect of which a licence is in force.
  3. 3. Human Tissue Authority Data-Associated Standards Participant • A coding and records system facilitates traceability of bodies, body parts, tissues and cells, ensuring a robust audit trail (GQ6) . • The reasons for disposal and the methods used are carefully documented (D2). • Equipment is appropriate for use, maintained, quality assured, validated and where appropriate monitored (PFE5) Staff • Staff involved in seeking consent receive training and support in the implications and essential requirements of taking consent (C3). • Staff are appropriately qualified and trained in techniques relevant to their work and are continuously updating their skills (GQ3). Documents • There is a documented system of quality management and audit (GQ2). • There is a systematic and planned approach to the management of records (GQ4) • There are documented procedures for distribution of bodies, body parts, tissues or cells (GQ5)
  4. 4. Human Tissue Authority data-associated standards apply to both study-specific collections and biobanks that come under a HTA licence
  5. 5. What is a Biobank? • Biobanks collect biological samples and data from donors for a general research purpose rather than a specific study. • As the exact use of the samples/data at the time of collection is unknown, donors may consent to different types of research use. • Biobanks must have a HTA licence and Research Ethics Committee approval to collect and distribute material and data • Biobanks are long-term facilities where samples may be used to exhaustion for multiple studies and data used indefinitely.
  6. 6. Any cells or tissue obtained during my diagnosis, surgery and any subsequent procedures may be kept for future research. Including samples left over from previous diagnostic tests These samples may be used for genetic research These samples may be used for research involving animals These samples may be used to create cell lines Specific individuals contracted to GSTT may look at relevant sections of my medical notes to obtain information about my condition. My samples and data will be stored and used anonymously. My GP can be contacted for information relevant to my condition and ongoing treatment in the event that I stop attending GSTT. Surplus Tissue Consent
  7. 7. Research Specific Tissue Consent Extra tissue samples being taken for research purposes at the time of my planned diagnostic biopsy or procedure (up to 4 extra cores) Extra tissue samples being taken for research purposes during treatment and understand that this will involve an extra biopsy procedure (up to 4 extra cores) Donate blood for research purposes (20mL or approximately 4 teaspoons). Provide a urine sample (Urology biobank only) The use of my donated samples for genetic research The use of my donated samples for research involving animals The use of my donated samples to create cell lines The use of my anonymised clinical details together with my donated samples. I am aware that no research information can be linked back to me
  8. 8. Data Collection Example from KHP Breast Biobank Biobank Database Trust Pathology Database Trust Patient Record Trust Cancer Information System Sample Format Sample Storage Location Collection Times Researcher Requests • Sample/Data supplied • Data generated GP/ Cancer Registry Legacy research data Research Clinical Database Pseodoanonymisation Clinical Genetic Services Consent
  9. 9. PROBLEMS - Dealing with historical consent forms! 2001 v1: “I agree that tissue removed from my breast during my operation may be used for future research, which may contribute to a better understanding of the causes and treatment of breast disease”(REC 01/03/09) 2001 v2: “I agree that a small amount of my breast tissue may be used for research that will contribute to our knowledge and understanding of breast disease” (REC 01/03/09) 2006 Surplus Tissue: Tiered consent • Read and understood PIS • Agree to current and future surplus tissue use for research • Agree to blood being taken • Agree to GP/ Cancer Registry being contacted • Agree to Clinical data being used, pseudoanonymisation and no access to research results • Understand can revoke consent (REC 06/Q0704/155)
  10. 10. PROBLEMS - Dealing with historical consent forms! 2007 Surplus Tissue: Tiered consent • Read and understood PIS • Agree to current and future surplus tissue use for research • Agree to blood being taken • Agree to genetic research • Agree to access to medical records • Agree to GP/ Cancer Registry being contacted • Agree to Clinical data being used, pseudoanonymisation and no access to research results • Understand can revoke consent (REC 07/H0804/131)
  11. 11. PROBLEMS - Dealing with historical consent forms! 2012 Surplus Tissue Form: Tiered consent • Agree to past, current and future surplus tissue use for research • Agree to genetic research • Agree to use in research involving animals • Agree to creation of cell lines • Agree to access to medical records • Agree to GP being contacted • Agree to pseudoanonymisation • Understand can revoke consent (REC 12/EE/0493) 2012 Research-Specific Tissue Form: Tiered consent • Extra tissue samples during diagnostic procedure • Extra tissue samples requiring extra biopsy procedure • Agree to donate blood • Agree to provide urine sample • Agree to genetic research • Agree to use in research involving animals • Agree to pseudoanonymisation • Understand can revoke consent (REC 12/EE/0493)
  12. 12. Dealing with historical consent forms Patient Asked? Date Not Asked Yes Refused Pre-Consent- Not Asked Pre-Consent - Asked Tissue Research Use Blood Research Use Genetic Research Use Medical Records Access GP/Registry Access Clinical Data Research Use Research Animals Creation of Cell Lines Retrospective Tissue Research Tissue Only Urine Yes No No Response Not Applicable
  13. 13. Harmonising and Benchmarking of Biobanks National Cancer Research Institute's (NCRI) Confederation of Cancer Biobanks Two related standards, for quality management and data Quality standard: Covers the management of quality in a biobank and provides basis of planned accreditation scheme. Data standard: Shows the data needed to support effective communication about biobanks and the samples they are able to provide. http://www2.ncri.org.uk/ccb/bestpractice.html
  14. 14. Quality Standard Section 32: Handling data 32.1 Data Compliance with legislation 32.2 Data protection Data protection documents to be reviewed by suitably qualified person 32.3 Data security Controlling access to biobank data, recovery plan, transfer policy 32.4 Data quality Assurance of validity, completeness, consistency, coverage, accuracy, timeliness, communications Section 33: Return of research data to the biobank Policy on the return of research data to the biobank
  15. 15. Standardisation of Data between Biobanks • MIABIS: Minimum Information About BIobank data Sharing BBMRI (Biobanking and Biomolecular Resources Research Infrastructure) • STRATUM: Strategic Tissue Repository Alliances Through Unified Methods project UK Consortia of commercial and academic stakeholders • SPREC: Standard Preanalytical Coding for Biospecimens: Defining the Sample PREanalytical Code International Society for Biological and Environmental Repositories (ISBER) • BRISQ: Biospecimen reporting for improved study quality. NCI Biospecimen Research Network • Biobank Data Standard: Collecting, storing and sharing data describing human biological material for research NCRI Confederation of Cancer Biobanks
  16. 16. NCRI/CCB Biobank Data Standard: “The data standard, built around existing standards, is intended to support effective data sharing and communications between research groups, organisations and consortia, and has already been adopted by some. It is intended to be compatible with the creation of a single central data portal for UK-based biobanks to facilitate the identification of and access to samples for research”. In Biopreservation and Biobanking
  17. 17. Data Elements Required of All Biobanks Biobank, Diagnoses, Organs, Available data Data Required to Meet the Minimum Standard Collection, Sample data, Collection to available data Data Required to Meet the Best Practice Standard Patient, Patient diagnosis, Sample group, Solid specimen, Tissue sample, Fluid sample, Sample to available data For each data field there must be: Field Name Format Description Source NCRI/CCB Biobank Data Standard: http://ccb.ncri.org.uk/wp-content/uploads/2014/03/CCB-Data-Standard-v1.pdf
  18. 18. And Finally…… Progress on a Combined Surgical and Research Consent Form Initaitive • Piloted combined form for patients with breast disease • Feedback from both patients and clinicians • Agreement in principle from GSTT TRaQ • Pending NHS REC approval for modified information leaflet and consent statements Aim to seek consent from all GSTT patients for their surplus surgical tissue to be used for a broad range of research studies

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