Working With Human Tissue 2025 PDF - Brunel University London

Working with Human Tissue Dr. Hassan Khonsari BSc (Hons), MSc, PhD, FHEA, IOSH Health, Safety & Environment officer (HSEO) Designated Individual and Human Tissue Risk and Compliance Officer (DI) Biological Safety Officer (BSO) Radiation Protection Officer (RPO) Brunel University London Health, Safe...

Working with Human Tissue Dr. Hassan Khonsari BSc (Hons), MSc, PhD, FHEA, IOSH Health, Safety & Environment officer (HSEO) Designated Individual and Human Tissue Risk and Compliance Officer (DI) Biological Safety Officer (BSO) Radiation Protection Officer (RPO) Brunel University London Health, Safety & Environment Team Governance & Secretariat Located in Saltash, Room 103 E [email protected] Course Objectives and Aims 15 January 2025 Overview of the Human Tissue Act 2004 Overview of the remit of the HTA Overview of what the act requires of researchers Processes here at BUL Brunel University London 2  15 January 2025 About Human Tissue Legislation In response to the media fuelled storm in the late 80s early1990s that related to the research of human tissue, public confidence in medical research was seriously compromised. Brunel University London 3  15 January 2025 “MONSTER” declaimed The Express. “He stole their hearts,brains, lungs, kidneys, livers, eyes, stomachs and EVERYTHING but theirsouls,” said The Mirror. “Brutal betrayal of the innocents,” announced the Daily Mail. Brunel University London 4  15 January 2025 Redfern report The official report from the independent investigation about the Alder Hey organ retention scandal and subsequent inquiry. Recommendations of Redfern report and chief medical officer: ❖ Independent commission to oversee cataloguing and return of 105,000 organs retained by hospitals in England ❖ New law on informed consent ❖ Review of coroner's system ❖ Trusts to employ bereavement counsellors ❖ Review by the education secretary of arrangements for joint hospital/university posts Brunel University London 5  15 January 2025 New Legislation developed: The Human Tissue Act 2004 In Scotland the resulting legislation focused on the use of tissue from the deceased. While in England, Wales and NI it was more comprehensive, covering the use of tissues from both the deceased and the living. The law governing the use of human tissue for DNA Analysis is the same across the whole of the UK. The legislation covers a wide range of uses of human tissue (relevant material). Brunel University London 6  15 January 2025 Human Tissue Authority The Human tissue Act 2004 brought into being the “Human Tissue Authority (HTA)”. The HTA is the watchdog that protects public confidence by licensing organisations that store and use human tissue for the purposes of research, patient treatment, post-mortem examination, teaching and public exhibitions. The HTA aims to set standards that are clear and reasonable (published in their codes of practice) and in which both the public and professionals have confidence. Brunel University London 7 What activities and Tissues are covered? 15 January 2025 The activities licensed by the HTA are: ❑ Carrying out of an anatomical examination ❑ Making of a post-mortem examination ❑ Removal of relevant material from a deceased person ❑ Storage of relevant material from a deceased person (other than for a specific ethically approved project) ❑ Storage of anatomical specimens ❑ Storage of relevant material from a living person for research (other than for a specific ethically approved project) or for human application ❑ Public display of a body or material from a deceased person Human Application ❑ This sector is for establishments that require a licence under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Brunel University London 8 Licensing responsibilities 15 January 2025 Licences are usually held by an establishment and cover holding relevant material for research on specific premises. A Designated Individual (DI) is named on each research licence. The DI is responsible for all activities covered under that licence. They are expected to put processes in place to ensure compliance with the Act and with the conditions of the licence. Your DI will nominate a team of persons designated (PDs) who will support them in their role Current DI for research licence: Dr. Hassan Khonsari Current DI for Anatomy licence: Prof. Michael Ferenczi Current PD for Research licence: Dr. Mathew Themis and Ms. Amelia Dingley Brunel University London 9  15 January 2025 The Human Tissue Authority issues research licenses for the storage of relevant material for research in England, Wales and Northern Ireland. However, there are some exceptions to this: Ethics Approval: A license is not required if relevant material is being held for an ethically approved study. Provided that the ethics approval is granted by an NHS Research Ethics Committee, a research license is not required. Be aware that a review by a university ethics committee is not sufficient here. Ethics approval only covers the storage of relevant material for the activity approved by the ethics committee. Please note that at Brunel University London all relevant samples must be logged onto the central database, this includes NHS samples. Transferring Tissue You will not require a license when relevant material will only be on your premises for hours, days and certainly no more than one week, pending transfer to another establishment. Brunel University London 10  15 January 2025 Processing to Render Acellular You will not require a licence when relevant material will only be on your premises for hours, days or certainly no more than one week, before it is rendered acellular (and therefore no longer relevant material). Very Old Samples A license is not required when holding relevant material that has come from a donor who died more than 100 years ago. Brunel University London 11 How the act applies to Research 15 January 2025 ❑ You are required to store relevant material for research under a research license unless an exception applies ❑ Consent is required to hold relevant material for research or Anatomical study. ❑ Consent is also required to hold bodily material with the intent to analyse its DNA. Here at Brunel We hold a Research Licence and an Anatomy licence Research idea Brunel University London 12 What Tissues are covered? 15 January 2025 The human Tissue Act 2004 refers to both relevant material and bodily material Relevant Material Bodily Material as used in Section 45 of the act “any tissue or sample that consist of or Bodily material is material which: includes human cells” 1.has come from a human body, and 2.consists of or includes human cells Bodily material includes relevant material but also embryos outside the human body DNA in itself is not bodily material so and hair and nail from the body of a living person. someone holding extracted DNA does not commit an offence under the Act if they analyse it and use the results with appropriate consent. Brunel University London 13 What about cell lines? 15 January 2025 Primary human tissue and cells (i.e. tissues and cells removed directly from a person) are defined as relevant material under the HT Act. Cell lines resulting from expansion of primary cell cultures are not relevant material, as all the original cells have divided and so have been created outside the human body. The storage of established cell lines for research does not require an HTA licence. Brunel University London 14 Consent 15 January 2025 Appropriate consent must be in place to use and to store relevant material, taken from the living or deceased, for research. Appropriate consent is also required to hold bodily material with the intention of analysing its DNA. Consent is required to: ❑ Store and use dead bodies ❑ Remove, store and use relevant material from a dead body ❑ Store and use relevant material from the living. Remember: “Consent is a process, not a signature on a form!” Brunel University London 15 Anonymisation 15 January 2025 Within the human Tissue Act 2004 anonymisation means that the researcher is not able to identify the donor, and it is unlikely they will be able to do so in the future. Brunel University London 16 Obtaining Approval at BUL 15 January 2025 “Any research that involves human participants, the collection or study of their data, and/or the use of their organs and/or tissue, that is carried out by Brunel University London staff, or students under the supervision of Brunel University London staff, requires research ethics approval.” Ethical approval can be granted by your local College Research Ethics Committee (CREC) in some cases, but all human tissue research ethics applications go through the University Research Ethics Committee (UREC) Image result for teamwork cartoon Brunel University London 17 Practicalities of working with Human Tissue 15 January 2025 All HTA activities must be supported by approved and documented policies and procedures. The Licence granted to the University by the HTA must be clearly displayed in all areas where work with Human Tissue is undertaken. Standard Operating Procedures (SOPs) must be written for each area and must clearly describe methods of use, storage, record keeping and disposal of all samples. Risk assessments relating specifically to work with the human tissue samples in each individual area must be produced. Staff named on the Licence (Designated Individual DI/Persons Designated PDs) must be appropriately qualified and trained as relevant to their remit. All staff permitted by the PD to work with human tissue samples must be appropriately trained to do so; evidence of this training must be recorded. For further Guidance consult the “BUL – Working with Human Tissue Samples” Brunel University London 18 What should you consider in your risk 15 January 2025 assessment? ❑ Handling of bodily fluids you must consider blood borne pathogens!/Vaccinations ❑ Sample Labelling and Storage Traceability is of the utmost importance ❑ Equipment Failure Are your systems on backup (freezers etc.)? Is your equipment serviced and maintained regularly ❑ Laboratory Security Is access restricted? How are you ensuring the security of your samples? ❑ Adverse Events Log Is there a system in place to report and record adverse events? (loos of samples etc.) Brunel University London 19  15 January 2025 Offences under the Human Tissue Act 2004 Offences under the HT Act and the Regulations include (but are not limited to): ❑ Removing, storing or using Relevant Material for Scheduled Purposes, on unlicensed premises; ❑ Removing, storing or using Relevant Material for Scheduled Purposes, without appropriate consent for that purpose; ❑ Carrying out licensable activities without holding a licence from the HTA; ❑ Failing to produce records or otherwise obstructing the HTA in carrying out its statutory responsibilities; ❑ Storing Relevant Material with the intention of extracting and analysing the DNA without the consent of the individual from whom the Relevant Material came (with exemptions for medical diagnosis and treatment, and for criminal investigations). Brunel University London 20 Ensuring Compliance at BUL 15 January 2025 In order to ensure compliance with the guidelines issued here at BUL we have an internal audit procedure. The objectives of internal audit are to: ❑ determine whether or not the tissue is covered by the license; ❑ ensure the premises and equipment used for the storage of human tissue is compliant with HTA guidance and requirements; ❑ ensure that essential documentation relating to all aspects of the human tissue are held by the department/unit; ❑ ensure that SOPs are being followed during the handling/processing of tissue; ❑ ensure that an audit trail is in place from receipt of sample to disposal; ❑ ensure that the health and safety of staff are protected; ❑ identify any problems and suggest solutions; ❑ ensure that those involved are fully trained and experienced and that staff have received the appropriate level of training Further guidance on the internal audit process can be found in the “Human Tissue Work - Internal Audit Procedure” SOP. Brunel University London 21  15 January 2025 Brunel University London 22  15 January 2025 Thank You For Listening! Any Questions? 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