1. Data Requirements for Compliance with the Human
Tissue Act and Biobanking
Cheryl Gillett
King’s College London

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. 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. Human Tissue Authority data-associated standards
apply to both study-specific collections and biobanks
that come under a HTA licence

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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