Human Tissue Act 2004 Overview
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What is one of the main objectives of the internal audit at Brunel University London?

  • To promote innovation in tissue research
  • To increase the number of human tissue samples processed
  • To ensure compliance with external funding regulations
  • To determine whether the tissue is covered by the license (correct)

    • Which of the following is NOT an objective of the internal audit procedure?

  • Identify problems and suggest solutions
  • Develop new protocols for tissue research (correct)
  • Ensure SOPs are being followed
  • Ensure that essential documentation is held

    • The internal audit aims to protect which aspect related to staff at Brunel University London?

  • The health and safety of staff (correct)
  • The financial investments of the department
  • The effectiveness of the marketing strategy
  • The approval processes for research

    • Which aspect is ensured through the internal audit process regarding human tissue handling?

    <p>An audit trail is in place from sample receipt to disposal (B)</p> Signup and view all the answers

    What is expected of staff involved in the handling of human tissue according to the internal audit objectives?

    <p>They must receive appropriate training and be experienced (B)</p> Signup and view all the answers

    What was one of the main reasons for the introduction of the Human Tissue Act 2004?

    <p>To restore public confidence in medical research after scandals. (D)</p> Signup and view all the answers

    What did the Redfern report recommend regarding the collection of organs?

    <p>An independent commission should oversee the return of retained organs. (B)</p> Signup and view all the answers

    Which of the following is NOT a role held by Dr. Hassan Khonsari?

    <p>Director of Medical Research (A)</p> Signup and view all the answers

    What is one of the key focuses of the Human Tissue Act 2004 in Scotland?

    <p>The use of tissue from the deceased. (D)</p> Signup and view all the answers

    What type of support was recommended for trusts according to the Redfern report?

    <p>Employment of bereavement counselors. (D)</p> Signup and view all the answers

    What societal issue prompted the review of the coroner's system as per the Redfern report?

    <p>Scandals related to organ retention. (A)</p> Signup and view all the answers

    What does the Human Tissue Act 2004 require of researchers?

    <p>Strict adherence to ethical guidelines in the use of human tissue. (A)</p> Signup and view all the answers

    What historical event significantly influenced the creation of the Human Tissue Act 2004?

    <p>The Alder Hey organ retention scandal. (D)</p> Signup and view all the answers

    What is the primary function of the Human Tissue Authority (HTA)?

    <p>To regulate human tissue storage and usage (A)</p> Signup and view all the answers

    Which of the following activities is NOT covered by the Human Tissue Act 2004?

    <p>Performing live surgeries using human tissue (B)</p> Signup and view all the answers

    What is the purpose of the legislation regarding human tissue for DNA analysis in the UK?

    <p>To ensure ethical standards in human tissue usage (B)</p> Signup and view all the answers

    Who holds the licenses for research involving human tissue?

    <p>Designated Individuals within institutions (A)</p> Signup and view all the answers

    What types of material can be stored under the Human Tissue Act without specific ethical approval?

    <p>Relevant material from both deceased and living persons (B)</p> Signup and view all the answers

    What is a Designated Individual (DI) in the context of the Human Tissue Act?

    <p>A person responsible for overseeing research licenses (B)</p> Signup and view all the answers

    Which of the following is true regarding the storage of human tissue?

    <p>Storage must comply with licensing conditions (B)</p> Signup and view all the answers

    Which regulation governs establishments that require a license for human application of tissues?

    <p>Human Tissue (Quality and Safety for Human Application) Regulations 2007 (C)</p> Signup and view all the answers

    What is the role of the Designated Individual (DI)?

    <p>To ensure compliance with the Act and license conditions (C)</p> Signup and view all the answers

    Who currently holds the research license at Brunel University London?

    <p>Dr. Hassan Khonsari (D)</p> Signup and view all the answers

    What must be true for a research license to not be required when holding relevant material?

    <p>The material is for an ethically approved study by an NHS Research Ethics Committee. (D)</p> Signup and view all the answers

    Under which condition is a license not required for transferring tissue?

    <p>When relevant material is only on premises for up to one week pending transfer. (B)</p> Signup and view all the answers

    What is a situation where a license is not needed due to the age of the donor?

    <p>When the donor's death occurred more than 100 years ago. (B)</p> Signup and view all the answers

    Which individuals are designated persons (PDs) for the research license?

    <p>Dr. Mathew Themis and Ms. Amelia Dingley (C)</p> Signup and view all the answers

    What is required for all relevant samples at Brunel University London?

    <p>They must be logged onto the central database. (D)</p> Signup and view all the answers

    What is the requirement for processing to render acellular in terms of time?

    <p>The relevant material must be processed within one week. (A)</p> Signup and view all the answers

    What is required to hold relevant material for research under the Human Tissue Act?

    <p>Research license (C)</p> Signup and view all the answers

    Which of the following qualifies as bodily material under the Human Tissue Act?

    <p>Tissue samples taken from deceased persons (C), Hair and nails from a living person (D)</p> Signup and view all the answers

    What type of consent is needed when holding bodily material intended for DNA analysis?

    <p>Written consent (D)</p> Signup and view all the answers

    Which of the following statements about cell lines is true?

    <p>Storage of established cell lines does not require an HTA license (D)</p> Signup and view all the answers

    What is considered as relevant material under the Human Tissue Act?

    <p>Human tissues containing human cells (B)</p> Signup and view all the answers

    Which of the following types of samples does NOT require consent under the Human Tissue Act?

    <p>Extracted DNA from a living person (A)</p> Signup and view all the answers

    Which material is explicitly excluded from being classified as bodily material?

    <p>Embryos outside the human body (C)</p> Signup and view all the answers

    What defines primary human tissue according to the Human Tissue Act?

    <p>Tissue removed from a living body directly (C)</p> Signup and view all the answers

    What does appropriate consent ensure in research involving living or deceased individuals?

    <p>Use and storage of relevant material are permissible. (D)</p> Signup and view all the answers

    Which statement best describes the process of consent?

    <p>Consent involves ongoing communication and agreement. (A)</p> Signup and view all the answers

    What is required for human tissue research conducted by Brunel University staff?

    <p>Ethics approval from the University Research Ethics Committee. (B)</p> Signup and view all the answers

    What does anonymisation mean in the context of the Human Tissue Act 2004?

    <p>The donor should not be identifiable now or in the future. (C)</p> Signup and view all the answers

    What must be displayed in areas where work with Human Tissue is undertaken?

    <p>The Licence granted by the HTA. (D)</p> Signup and view all the answers

    What documentation is essential for HTA activities at Brunel University?

    <p>Approved and documented policies and procedures. (C)</p> Signup and view all the answers

    Which of the following is NOT a requirement for handling human tissue at Brunel University?

    <p>Approval from family members only. (A)</p> Signup and view all the answers

    What is a key aspect of Standard Operating Procedures (SOPs) for working with human tissue?

    <p>They need to be thorough in describing methods of use and storage. (B)</p> Signup and view all the answers

    Study Notes

    Human Tissue Act 2004

    • The Human Tissue Act 2004 was created in response to a media storm in the late 1980s and early 1990s concerning the ethical use and storage of human tissue.
    • This led to a significant decline in public confidence in medical research.
    • The Act aims to protect public confidence by licensing organizations that store and use human tissue.
    • The Act covers the use of tissue from deceased and living individuals in England, Wales, and Northern Ireland.
    • The law is also applicable to DNA analysis and is consistent across the UK.

    Human Tissue Authority (HTA)

    • The HTA is a regulatory body established by the Act, overseeing the licensing of tissue-handling organizations.
    • The HTA sets clear and reasonable standards for the storage and use of human tissue, with codes of practice for public and professional confidence.
    • The HTA licenses organizations handling and storing material.

    Activities Covered by the HTA

    • Anatomical examinations
    • Post-mortem examinations
    • Removal of tissue from deceased individuals (except in specific, ethically approved projects)
    • Storage of relevant material from deceased individuals (except in specific, ethically approved projects)
    • Storage of anatomical specimens
    • Storage of material from living individuals for research (except in specific, ethically approved projects)
    • Human application (licensing under specific regulations)
    • Public display of deceased individuals' remains or materials

    Exceptions to Licensing Requirements

    • No license is needed for relevant material being held for an ethically approved study, provided the ethics approval comes from an NHS Research Ethics Committee. In this case, a university ethics committee's review is inadequate (for licensing).
    • No license is needed if the relevant material is only held for a brief period (hours to a week) prior to transfer to another establishment.
    • No license is required for material from a donor who died over a century ago.

    Relevant vs. Bodily Material

    • Relevant material: any tissue or sample consisting of or including human cells.
    • Bodily material: any material from a human body that consists of or includes human cells. DNA itself is not considered bodily material.

    Cell Lines

    • Primary human tissue and cells are considered relevant material if directly taken from a person.
    • Cell lines created from the expansion of primary cultures are not considered relevant material since they are created outside the human body.
    • Storage of pre-existing cell lines doesn't require an HTA license.
    • Appropriate consent is essential for using and storing relevant material from both living and deceased individuals, particularly for research or anatomical study.
    • Consent is also required if the intent is to analyze the DNA of bodily material.
    • Consent is a process, not just a signature on a form.

    Anonymisation

    • Anonymization ensures that researchers cannot identify donors, and, in the future, donor identification is likely to become impossible.

    Research Ethics Approval

    • All research involving human participants, data, or use of organs/tissue within Brunel University London requires ethics approval.
    • This approval can be granted by the local College Research Ethics Committee (CREC) or, in all human tissue cases, the University's Research Ethics Committee (UREC). 

    Compliance with the Act at Brunel

    • Clear display of HTA license within all relevant areas
    • Established procedures (SOPs)
    • Dedicated risk assessments
    • Qualified individuals (DIs/PDs)

    Risk Assessments

    • Handling of bodily fluids/blood-borne pathogens/vaccinations
    • Labelling and storage of samples; traceability
    • Equipment maintenance/backup (e.g. freezers)
    • Security of samples
    • Adverse events/errors logging procedures

    Offences Under the Act

    • Removing, storing, or using relevant material without proper license
    • Carrying out licensable activities without license.
    • Failing to document procedures.
    • Storing material with intent to analyze DNA without consent.

    Ensuring Compliance at Brunel

    • Internal audit processes to ascertain compliance with regulations and guidelines
    • Procedures for handling, processing, and disposing of tissue samples
    • Ensuring appropriate staff training and qualification

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    Working With Human Tissue 2025 PDF - Brunel University London

    Description

    Explore the Human Tissue Act 2004, a critical piece of legislation that arose from public concerns over the ethical use and storage of human tissue. This quiz covers the Act's objectives, including licensing organizations and the establishment of the Human Tissue Authority (HTA). Understand the implications for medical research and public confidence in tissue handling.

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