PM-138 Skills for Medical Scientists - Informed Consent
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Questions and Answers

What is the primary focus of the Human Tissue Act 1961?

  • Ensuring consent for the removal of tissue from deceased individuals for research (correct)
  • Mandating the immediate disposal of retained human tissue
  • Permitting the removal of tissue from living donors without consent
  • Requiring that all tissue samples be donated to educational institutions
  • Which of the following scenarios illustrates an ethical concern in the consent process?

  • A nurse administering a questionnaire while a patient waits for treatment
  • A doctor taking an extra blood sample before discussing eligibility (correct)
  • All patients receiving ample time to review the consent form
  • A participant being informed clearly about the study before consenting
  • What was the nature of the Alder Hey organs scandal?

  • Unauthorized removal and sale of organs and tissues without consent. (correct)
  • All tissue samples were used strictly for educational purposes.
  • Retained tissues were properly disposed of according to regulations.
  • Permission was gained for all tissue collections from deceased patients.
  • Why might the research nurse's request for the questionnaire during a 20-minute wait be problematic?

    <p>Participants may feel rushed and unable to provide quality responses. (C)</p> Signup and view all the answers

    What critical aspect is lacking in the second scenario regarding patient eligibility screening?

    <p>The patient should provide consent before any blood samples are taken. (C)</p> Signup and view all the answers

    What is the primary purpose of the Human Tissue Authority established by the Human Tissue Act?

    <p>To regulate the removal, storage, use, and disposal of human tissue (C)</p> Signup and view all the answers

    Which of the following is true about consent under the Human Tissue Act?

    <p>Consent is legally required for all scheduled purposes (C)</p> Signup and view all the answers

    What new offense was introduced under the Human Tissue Act regarding DNA?

    <p>DNA theft (A)</p> Signup and view all the answers

    Which activity is NOT considered a scheduled purpose under the Human Tissue Act?

    <p>Performance assessment (B)</p> Signup and view all the answers

    In which scenario is consent not required according to the Human Tissue Act?

    <p>Clinical audit involving living individuals (A)</p> Signup and view all the answers

    Which of the following is described as 'relevant material' under the Human Tissue Act?

    <p>Human cells excluding gametes (C)</p> Signup and view all the answers

    What criminal penalties may result from breaching the Human Tissue Act?

    <p>A fine and/or imprisonment for up to three years (D)</p> Signup and view all the answers

    Which of the following is a scheduled purpose that requires consent?

    <p>Research into the functioning of the human body (D)</p> Signup and view all the answers

    What is considered 'relevant material' under the Act?

    <p>Blood and organs (A)</p> Signup and view all the answers

    Which of the following items is NOT considered as 'relevant material'?

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

    What constitutes an offence under the Act regarding relevant material?

    <p>Removing relevant material without consent (A)</p> Signup and view all the answers

    Licensable activities under the HTA include which of the following?

    <p>Carrying out post-mortem examination (B)</p> Signup and view all the answers

    Which of the following scenarios requires an HTA license?

    <p>Storing residual material after NHS REC approval expires (A)</p> Signup and view all the answers

    What is a consequence of holding bodily material for DNA analysis without consent?

    <p>It is a violation of the Act (A)</p> Signup and view all the answers

    Which of the following statement about relevant material is true?

    <p>Stem cells are included in relevant material (D)</p> Signup and view all the answers

    What type of approval is required to store commercially sourced tissues for research?

    <p>HTA licence or NHS REC approval (C)</p> Signup and view all the answers

    What is the primary focus of informed consent in clinical research?

    <p>Ensure participants are volunteers and understand risks (A)</p> Signup and view all the answers

    Which statement most accurately describes the distinction between clinical care and research consent?

    <p>Research consent aims to protect participants through rigorous processes. (D)</p> Signup and view all the answers

    According to the Declaration of Helsinki, what is a key concern when obtaining consent?

    <p>Dependent relationships that may influence decision-making (B)</p> Signup and view all the answers

    What does the Human Tissue Act primarily govern?

    <p>The use of human tissue for research and consent procedures (B)</p> Signup and view all the answers

    What does informed consent entail, according to the ICH E6 Good Clinical Practice?

    <p>Participants should understand all relevant aspects before deciding. (A)</p> Signup and view all the answers

    Which group is notably included in the updated Declaration of Helsinki to ensure fair representation?

    <p>Under-represented groups in clinical research (C)</p> Signup and view all the answers

    What must be ensured if a participant is harmed during research, according to the Declaration of Helsinki?

    <p>Compensation and treatment must be provided. (C)</p> Signup and view all the answers

    Which approach is advocated for improving participant understanding during the consent process?

    <p>Employing innovative consent methods like videos and recordings (C)</p> Signup and view all the answers

    Flashcards

    Human Tissue Act 1961

    The Human Tissue Act (1961) is a UK law that regulates the use and storage of human tissue for research and education. It's built on the idea that people implicitly consent to the use of their tissue after death unless they explicitly object.

    Alder Hey organs scandal

    The Alder Hey organs scandal involved the inappropriate taking, keeping, and disposal of human tissue from children without proper consent. It led to crucial changes in how tissue is handled.

    Informed Consent & Human Tissue

    The Alder Hey scandal showed the importance of getting informed consent before using human tissue. This means people must understand the risks and benefits before agreeing to donate their tissue.

    Amendments to the Human Tissue Act

    The Human Tissue Act was amended after the Alder Hey scandal to increase emphasis on obtaining explicit consent for the use of human tissue for research and education.

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    Ethical Practice in Research

    The scandal highlighted the need for strict guidelines and regulations surrounding the handling of human tissue in research and medical settings. It reinforced the importance of ethical practice.

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    Informed Consent in Research

    A formal process where a person freely agrees to participate in a research study after understanding all relevant details.

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    Consent for Clinical Care

    The process of providing information to patients about their care, aiming to protect the clinician.

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    Declaration of Helsinki

    The ethical guidelines for biomedical research involving human subjects, emphasizing informed consent and patient autonomy.

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    Informed Consent Form

    A formal document outlining the risks, benefits, and procedures involved in a research study.

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    Consent for Vulnerable Participants

    The process of seeking consent from individuals who may not be able to fully understand the research, such as children or people with cognitive impairments.

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    Research Governance

    A set of rules and regulations that govern the conduct of research, ensuring ethical and legal standards are met.

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    Human Tissue Act

    A legal framework governing the use and storage of human tissue and organs for research purposes.

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    Consent for Obtaining Material under the HTA

    The process of obtaining consent from individuals for the use of their tissue or organs for research purposes, following specific legal requirements.

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    Human Tissue Act (UK)

    A legal framework for regulating the removal, storage, use, and disposal of human tissue.

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    Human Tissue Authority (HTA)

    An organization that regulates the use of human tissue in the UK, ensuring it is handled ethically and legally.

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    Human Tissue Act 2004

    This Act ensures that informed consent is legally required before using someone's tissue for research or other purposes.

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    Relevant Material

    Material that includes human cells, excluding gametes (sperm and eggs), that's subject to the Human Tissue Act.

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    Scheduled Purpose

    The specific actions for which consent is needed under the Human Tissue Act.

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    DNA Theft

    A new crime created under the Human Tissue Act involving the unauthorized taking of someone's DNA.

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    Criminal Penalties (Human Tissue Act)

    Penalties for violating the Human Tissue Act, including fines and possible imprisonment.

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    Activities Covered by the Human Tissue Act

    The Human Tissue Act covers a broad range of activities including anatomical examinations, research, public displays, and organ transplant.

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    What is 'relevant material' under the Human Tissue Act?

    Bodily matter containing human cells, including blood, tissues, organs, and even waste products like breast milk. It excludes things like gametes, embryos, and hair/nails from living people.

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    What are the main offenses under the Human Tissue Act?

    This act focuses on preventing unlawful or unethical use of human tissue. It addresses issues like storing material without proper consent, using donated material for a different purpose, and illegal tissue trafficking.

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    Why is informed consent important with regards to 'relevant material'?

    This refers to the legal process of getting permission from a person before taking or using their tissue. It is crucial for respecting a person's autonomy over their body.

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    What does the Human Tissue Authority (HTA) license?

    The HTA requires a license for activities like anatomical examination, post-mortem, storing tissue for research, public body displays, and more. This ensures quality control and ethical standards.

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    What is the requirement for storing 'relevant material' for research?

    Research involving 'relevant material' needs either a HTA license or approval from the NHS Research Ethics Committee (REC). It prevents unauthorized use or storage.

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    How does the misuse of donated tissue occur?

    This happens when individuals donate their tissue for a specific purpose, like research, but it's later used for something else without their permission.

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    What is 'taking relevant material' without consent?

    This refers to the use of tissue that was taken from a deceased person without the consent of their loved ones. It is unethical and against the law.

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    Why is the Human Tissue Act 2004 important?

    The HTA regulates and licenses activities involving human tissue to ensure ethical practices and prevent misuse. It is essential for safeguarding human dignity and ensuring public health.

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    Study Notes

    • The module covers informed consent procedures, focusing on the legal and ethical considerations for research involving vulnerable individuals and the Human Tissue Act (HTA).

    Learning Outcomes

    • Students will develop a comprehensive understanding of consent processes, including those related to vulnerable participants.
    • They will demonstrate knowledge of relevant laws and regulations surrounding research consent.
    • Students will provide a concise description of the Human Tissue Act.
    • They will provide examples of materials and activities covered by the HTA.
    • Students will understand when the HTA applies and its exceptions.
    • Discussion of the consent process for obtaining materials under the HTA.
    • A subtle difference exists in consent for clinical care versus research.
    • Clinical consent is often implied and focuses on informing patients and protecting clinicians.
    • Research consent focuses on informing participants and protecting them, often with more rigorous standards.
    • The participant must understand what is being done.
    • The rationale behind the procedure.
    • Participation is voluntary.
    • Potential risks.
    • Alternatives to participating in the research.

    ICH EG Good Clinical Practice 1996

    • A process defining informed consent as a subject voluntarily agreeing to be in a trial after being informed about every aspect of the trial relevant to their decision.
    • Informed consent must be documented via an informed consent form that is signed, dated, and written.

    Research Governance

    • This is overseen by multiple bodies and advisory groups.
    • The bodies involved include the European Medicines Agency, the Medicines & Healthcare products Regulatory Agency, the NHS Health Research Authority, and the Human Tissue Authority (HTA).

    Declaration of Helsinki (1964)

    • Expanding the 10 principles in the Nuremberg Code to focus on minimum information for subjects.
    • Procedures involving subjects are to be conducted with caution if the subject has a dependent relationship, or if there is a possibility of duress.
    • Special attention should be paid to the information needs of subjects and how the information is delivered.

    Declaration of Helsinki (Updated 2013)

    • Aims to enhance research standards globally, particularly for developing countries with limited resources.
    • Emphasizes the inclusion of underrepresented groups.
    • Includes provisions for compensation for harmed participants, access to new interventions, and innovative consent methodologies (e.g., using recordings and videos).
    • Feedback is essential following research to demystify the process and maintain respectful procedures.
    • The presentation outlines a five-step process for obtaining consent: invitation to participate, opportunity to consider, discussion, formal agreement, and willingness to continue.

    Scenarios 1 and 2

    • Two scenarios are presented illustrating situations in healthcare settings where ethical concerns regarding informed consent may arise.
    • Additional components focus on the acceptability and reasons behind the situations.

    The Human Tissue Act 2004

    • Establishes the Human Tissue Authority (HTA) designed to regulate the removal, storage, use, and disposal of human tissue.
    • Effective from September 1st, 2006.

    Underlying Principles of the HTA

    • Consent and licensing are essential aspects of the HTA.
    • Consent is legally necessary for storing and using relevant materials, with some exceptions.
    • Consent requirements differ between living and deceased individuals.
    • DNA theft (new offense).
    • Severe penalties apply for violations of the Act.

    HTA Regulated Sectors

    • The act covers various sectors, including anatomy, bone marrow donation (including capacity), human application (e.g., skin, stem cells, bone marrow, and bone tissue), living organ donation assessments, post-mortems, public display, research, and organ donation/transplantation.

    Key Terms

    • Scheduled Purpose: All activities/purposes under the Human Tissue Act.
    • Relevant Material: Material consisting of/including human cells, excluding embryos and living person's hair/nails.

    Activities Covered by the Act

    • The Act encompasses all activities, including research (removal, storage, and use of relevant materials for human body disorders).
    • Consent isn't needed for clinical audits, education/training, performance assessments, public health monitoring, and quality assurance processes if the tissue is sampled from a living person and is anonymised.

    Relevant Tissues

    Any bodily product likely to contain a single cell, including blood, tissues, organs, waste products, stem cells, bone marrow, primary cell cultures, teeth/bones, placentas, bodily fluids, and the body of a deceased individual.

    Relevant Material Exclusions

    • Acellular material like serum or plasma (depending on preparation).
    • Gametes (sperm/eggs)
    • Embryos outside the body.
    • Cell lines.
    • DNA.
    • Hair and nails from living persons.

    HTA Offences

    • Removing, storing, or using relevant materials without consent for scheduled purposes.
    • Using materials donated for scheduled purposes for other purposes.
    • Holding bodily materials to analyse DNA for research without consent.
    • Carrying out licensable activities without a HTA licence.
    • Trafficking human tissue for transplantation.

    Licensable Activities

    • Performing anatomical/post-mortem examinations.
    • Removing relevant materials from a deceased person.
    • Storing relevant materials for scheduled purposes.
    • Storing anatomical specimens.
    • Publicly displaying a body/relevant materials from a deceased person.

    Relevant Material Storage

    • Commercially sourced tissues/samples from healthy individuals can be stored for research, but only with a HTA licence or NHS REC approval (university's approval isn't enough).
    • A HTA licence is needed after the expiry of NHS REC approval for continuing storage of any residual material.

    Exceptions to HTA Licensing

    • REC-approved projects (or pending projects).
    • Material pending transfer/processing (less than a week for processing; less than a week to transfer).
    • Material rendered acellular.
    • Supplied by HTA-licensed tissue banks.
    • Someone who died over 100 years ago.
    • Short-term storage of samples prior to analysis.
    • Consent is required to remove, store, and use relevant materials from living and deceased individuals.
    • Consent must meet appropriate criteria of validity.
    • For living: the donor/individual themselves; children 12 and older, capable of making decisions on their own decisions can authorize donation.
    • For deceased: the donor (if possible); nominated representative; qualifying relatives (spouse, parent, child, sibling, grandparent, grandchild, niece, nephew, step-family members, long-term partner or friend).
    • Relevant material is from the living.
    • Anonymised material.
    • Part of a valid NHS REC-approved project.
    • Material collected before September 1st, 2006.
    • Material from a person who died over 100 years ago.
    • Imported tissues.
    • DNA is not considered relevant material under the Act.
    • Exception of holding bodily material to analyse DNA from living, anonymised people with REC approval, 100+ years since death, existing holdings pre-2006, medical diagnosis, criminal investigations.
    • Requires consent in other cases, penalties apply.

    Additional Examples

    • A series of scenarios are used to illustrate when HTA licensing and consent are needed.

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    Description

    This module examines the informed consent process, emphasizing legal and ethical considerations in research involving vulnerable individuals. Students will gain insights into the Human Tissue Act (HTA) and learn to navigate consent requirements in clinical and research settings.

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