NBB-SOP-02.v6
STANDARD OPERATING PROCEDURE NUMBER: / NBB-SOP-02.v6
NEWCASTLE BIOMEDICINE BIOBANKS
TITLE / Roles and Responsibilities under the Newcastle University Research Human Tissue Act Licence (Ref. 12534)
AUTHOR / Mhairi Anderson
Quality Assurance Manager
Newcastle Biomedicine Biobanks
APPROVAL / Professor Andy Hall
Designated Individual
Newcastle University
Distribution
Q-Pulse
Revision Category
Category 1 / This is a new/revised document. All personnel required to follow content must read this version and complete trainingCategory 2 / This is a revised document in which only the area of applicability has changed. All newly impacted personnel required to follow content must read this version and complete training
Category 3 / This is a new/revised document. All personnel required to follow content must read this version / ü
Category 4 / No significant change to document content – no requirement to read or train
Note: As applicable, documentation of reading and/or training must be completed prior to performing the procedure.
1. BACKGROUND
The Human Tissue Act is a legal framework which regulates the “removal, storage, use and disposal of human bodies, organs and tissues”. The Act came into effect on the 1st September 2006 and applies to England Wales and Northern Ireland.
Under the terms of this Act, in order to store human organs, tissues and cells for research purposes other than for a specific ethically approved research project, a Research Human Tissue Act (HTA) licence is require, which can be obtained through application to the Human Tissue Authority. On this licence, key individuals from the licensed institution must be named to undertake a number of roles to ensure compliance with Act.
This SOP provides information on the roles and responsibilities required under the Newcastle University Research Human Tissue Act licence (Ref. 12534).
2. SCOPE
This SOP applies to all personnel involved in research activities under the Newcastle University Research Human Tissue Act licence (Ref. 12534).
3. PROCEDURE
3.1. Roles and responsibilities
Three compulsory roles are required under the terms and conditions of a HTA licence – namely, the Licence Holder, the Designated Individual, and Persons Designate (as shown in figure 1). The responsibilities associated with each of these roles are provided in section 3.1.1 to 3.1.3, and the individuals named on the Newcastle University Research HTA licence provided in Appendix A. Anyone acting under the direction of the DI or PD is a person to whom the licence applies.
In addition, a voluntary role of “Human Tissue Act Coordinator” has been implemented at Newcastle University to support the Person Designate. This is not a compulsory role under the Act, but has been adopted to support the Persons Designate role and ensure compliance. This role is described in section 3.1.4.
Figure 1: Roles under the Human Tissue Act
3.1.1. Licence Holder
The Licence Holder (LH) is the person, or corporate body (organisation/institution) responsible for applying for the licence, and under whose name the licence is associated. Where acorporate body wishes to act as the licence holder, an individual must be named as a point of contact for correspondence, to represent the corporate body and the HTA must obtain written acknowledgement from the LH to allow the licence to become valid.
The role of this individual is to:
· Appoint/change the Designated Individual (DI - see section 3.2) –the individual should therefore be more senior than the DI to allow the LH to appoint/substitute the DI where necessary.
· Apply for any changes to the licence - The HTA are required to provide all notices of licence decisions to both the LH and the DI.
· Along with the DI, receive all relevant Notices of licence decisions from the Human Tissue Authority (HTA),
However, the LH is not under any duty comparable to the DI to supervise the activities concerned. Where the DI must be substituted, the LH must also have the consent of the proposed new DI to be named on the Licence prior to application for the variation.
The name of the licence holder is provided in Appendix 1.
3.1.2. Designated Individual
The Designated Individual (DI) is the person under whose supervision the licensed activity is authorised to be carried out. They have the responsibility under the Human Tissue Act to ensure:
· that suitable practices are used in undertaking the licensed activity
· that the other persons who work under the licence are suitable
· and that the conditions of the licence are complied with
The DI needs to have knowledge and understanding of the HT Act and the relevant Codes of Practice issued by the HTA, and to keep up to date with any changes that come into force. Failure to undertake the responsibilities expected of the DI could lead to prosecution of the DI, and/or the revocation of the licence.
The name of the Designated Individual is provided in Appendix 1.
Further details on the responsibilities of the DI are provided below:
· The DI must complete HTA accredited training by attending HTA workshops and/or completing the e-learning package available on the HTA website. This must be completed to the HTA’s satisfaction within a period of 12 months from the date of the licence or such other period as maybe specified by the HTA.
· The DI should ensure that a standard set of procedures are in place to ensure the requirements of the HT Act are met.
· The DI keeps a record of the consent of the individuals to the role of the Person Designated.
· The DI should ensure that a programme for audits is available and adhered to.
· The DI should ensure that personnel are being given training and development opportunities to update their skills.
· The DI should ensure the safety of staff undertaking research, by documented risk assessments.
· Any Adverse Events reported to the DI should be classified and any considered severe in nature must be reported to the HTA.
· If relevant material is stored for use in a specific project, the HTA consider it advisable that the DI has a log of the relevant material so that he is aware of when the relevant material will need to be stored under a HTA licence.
· The DI should ensure that where necessary to reduce the risk of contamination, there should be environmental controls and appropriate equipment available.
· The DI must consider the risks to the relevant material such as theft or damage, and the measures put into place to mitigate these risks.
· The DI will delegate responsibilities to a PD when absent on business or vacation.
3.1.3. Person Designated
As the University is spread over a large campus, the DI relies on the support of a number of key individuals to supervise the licensable activities within their groups to ensure compliance with the Act. These persons are called “Person Designate”.
A Person Designate must be assigned to supervise each tissue collection stored for research under the licence and is accountable to the Designated Individual on behalf of the Licence Holder for ensuring that the requirements for licensing relevant activities under the Human Tissue Act are met. The role of PD does not impose any legal responsibility.
Each Person Designate must record their formal written acceptance of the role to allow the DI to provide the HTA with an official list of the University’s assigned Persons Designate. These names will then be added to the University’s HTA licence.
The HTA do not need to approve the names of the individuals put forward, however the DI is responsible for ensuring that suitable persons are chosen.
The PD may be substituted at any time, as required, however a PD cannot be substituted or added without prior notification to the HTA. Once approved, the name of the new PD will be communicated to all relevant personnel, and Appendix 1 in this SOP updated.
A list of all Persons Designate under the Newcastle University HTA licence is provided in appendix 1. A role description is also provided in appendix 2.
3.1.4. Human Tissue Act Coordinator
The role of Human Tissue Act Coordinator” has been implemented at Newcastle University to support the Person Designate. This is a locally appointed role only, and the names of these individuals do not need to be provided to the HTA.
The main purpose of the HTAC is to operate at a local level to help coordinate and maintain the governance support for research using human tissue within their local research environment. This role does not impose any legal responsibility, but plays a vital function in assisting the PD to help meet the HTA regulatory requirements.
A role description for a Human Tissue Act Coordinator is provided in appendix 2.
3.1.5. Any personnel carrying out licensed activity on licensed premises
It is not a requirement to name all researchers working under the Human Tissue Act licence. However anyone acting under the direction of the DI or PD should be aware of the governance arrangements in place and should be represented at governance meetings.
4. DOCUMENT REVISION HISTORY
Section affected / Description of changes / Reason for change /Page 1 / New SOP title changed from “Research Personnel responsibilities” to “Roles and Responsibilities under the Newcastle University Research Human Tissue Act Licence (Ref. 12534)” / Title did not stipulate the roles related to the Human Tissue Act. Title changed to reflect this and clarify the contents.
Page 1 / New front page added / New template implemented to capture names of approver and author on printed versions and capture training requirements
Section 1 / Background information reworded to include a summary of the human tissue act and clarify the text / Previous version did not give a background introduction to the Act.
Section 3.1 / Introductory section added under section 3.1 with organogram of roles / Previous SOP did not include an introduction or visual representation of the structure.
Section 3.1.1 / Licence holder details reworded / Previous wording was unclear.
Section 3.1.3 / Person Designated information reduced and rewritten and role description added in appendix. / Information now contained in new role description in appendix and not required in the body text.
Section 3.1.4. / Human Tissue Act Coordinator role added and role description added to appendix. / New role to help support the Person Designate.
Section 4 / “Summary and reason for change” changed to “Document revision history” and tabulated. / Easier format to read.
Section 5 / Section 5 “Training” from previous version of the SOP removed. / Training requirement now documented on page 1.
Appendix 1 / Named individuals updated / Reflects recent changes in Person Designate since last edition of SOP
Appendix 2 / Role descriptions added / New role descriptions created to be provided to PDs and HTACs to clarify responsibilities.
6. References
The Human Tissue Authority www.hta.gov.uk
Appendix 1
Named Individuals on the Newcastle Biomedicine Biobank Research Licence
Licence Holder: / Newcastle University - Professor Chris Day, PVC for Medical Faculty, named for correspondenceMedical Sciences Faculty Office, Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH
Email:
Telephone: +44 (0) 191 222 7003
Designated Individual: / Professor Andrew Hall
Director of Northern Institute for Cancer Research (NICR) and Director of Central Biobank
Newcastle University, Medical School, Paul O'Gorman Building, Framlington Place, Newcastle Upon Tyne, NE2 4HH
Email:
Telephone: +44 (0) 191 246 4411
Persons Designate:
Persons Designate may be substituted at any time. Where a PD is substituted, the HTA will be informed in writing and all personnel informed of the new PD by email.
PD / Collection name and PD address / Satellite premises /Central Collection:
Dr Amy Peasland / Central Bank
Faculty of Medical Sciences, 4th Floor Leech Building, Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH
Email:
Telephone: +44 (0) 191 282 4285 / No
Dr Zoe Davison / Paul O’Gorman Building
Northern Institute for Cancer Research, Medical School, Newcastle University, Framlington Place, Newcastle upon Tyne
NE2 4HH
Telephone: +44 (0) 191 246 4442
Email: / No
Dr Christopher Morris / Centre for Ageing and Vitality
Medical Toxicology Centre, Wolfson Unit of Clinical Pharmacology, Claremont Place, Newcastle Upon Tyne, NE2 4AA Telephone: +44 (0) 191 222 5827 Email: / Yes
Dr Christopher Ward / Freeman Hospital
Institute of Cellular Medicine (Respiratory) and ICaMB Room Cookson 1.072, Floor1 , Cookson Building Medical School
Newcastle University
Newcastle upon Tyne NE2 4HH
Telephone: 0191 222 8460
Email: / Yes
Prof. Susan Lindsay / International Centre for Life
Institute of Human Genetics, Newcastle University, International Centre for Life, Central Parkway, Newcastle upon Tyne, NE1 3BZ
Telephone: +44 (0) 191 241 8656
Email: / Yes
Other collections:
Mrs B Innes / Uteroplacental
Institute of Cellular Medicine, 3rd Floor, William Leech Building, The Medical School, Framlington Place
Newcastle University, Newcastle upon Tyne, NE2 4HH
Telephone: 0191 222 7160 or 0191 282 4313
Email: / No
Mr T Williamson / Musculoskeletal
Institute of Cellular Medicine, 4th Floor Catherine, Cookson Building, Medical School, Newcastle University, NE2 4HH
Email: / No
Mrs D Jones / Mitochondrial Disease
Institute for Ageing and Health, Mitochondrial Research Group, 4th Floor Catherine Cookson Building, The Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH
+44 (0) 191 222 5137
Email: / No
Dr P M Preshaw / Dental
School of Dental Sciences and Institute of Cellular Medicine, Framlington Place, Newcastle University, Newcastle Upon Tyne, NE2 4BW Telephone: +44 (0) 191 222 8193
Email: / No
Wendy Bal / School of Agriculture, Food and Rural Development Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, University of Newcastle, Agriculture Building, King's Road, Newcastle upon Tyne, NE1 7RU Telephone: +44 (0) 191 222 6619
Email: / Yes
Other Persons Designate
Mhairi Anderson / N/A
Quality Assurance Manager for the Newcastle Biomedicine Biobanks
Joint Research Office, Level 6, Leazes Wing, Royal Victoria Infirmary, Newcastle Upon Tyne, NE1 4PL
Telephone: +44 (0) 191 282 5501
Email: / N/A