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Questions and Answers
What is the primary focus of the Human Tissue Act 1961?
What is the primary focus of the Human Tissue Act 1961?
Which of the following scenarios illustrates an ethical concern in the consent process?
Which of the following scenarios illustrates an ethical concern in the consent process?
What was the nature of the Alder Hey organs scandal?
What was the nature of the Alder Hey organs scandal?
Why might the research nurse's request for the questionnaire during a 20-minute wait be problematic?
Why might the research nurse's request for the questionnaire during a 20-minute wait be problematic?
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What critical aspect is lacking in the second scenario regarding patient eligibility screening?
What critical aspect is lacking in the second scenario regarding patient eligibility screening?
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What is the primary purpose of the Human Tissue Authority established by the Human Tissue Act?
What is the primary purpose of the Human Tissue Authority established by the Human Tissue Act?
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Which of the following is true about consent under the Human Tissue Act?
Which of the following is true about consent under the Human Tissue Act?
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What new offense was introduced under the Human Tissue Act regarding DNA?
What new offense was introduced under the Human Tissue Act regarding DNA?
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Which activity is NOT considered a scheduled purpose under the Human Tissue Act?
Which activity is NOT considered a scheduled purpose under the Human Tissue Act?
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In which scenario is consent not required according to the Human Tissue Act?
In which scenario is consent not required according to the Human Tissue Act?
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Which of the following is described as 'relevant material' under the Human Tissue Act?
Which of the following is described as 'relevant material' under the Human Tissue Act?
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What criminal penalties may result from breaching the Human Tissue Act?
What criminal penalties may result from breaching the Human Tissue Act?
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Which of the following is a scheduled purpose that requires consent?
Which of the following is a scheduled purpose that requires consent?
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What is considered 'relevant material' under the Act?
What is considered 'relevant material' under the Act?
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Which of the following items is NOT considered as 'relevant material'?
Which of the following items is NOT considered as 'relevant material'?
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What constitutes an offence under the Act regarding relevant material?
What constitutes an offence under the Act regarding relevant material?
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Licensable activities under the HTA include which of the following?
Licensable activities under the HTA include which of the following?
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Which of the following scenarios requires an HTA license?
Which of the following scenarios requires an HTA license?
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What is a consequence of holding bodily material for DNA analysis without consent?
What is a consequence of holding bodily material for DNA analysis without consent?
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Which of the following statement about relevant material is true?
Which of the following statement about relevant material is true?
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What type of approval is required to store commercially sourced tissues for research?
What type of approval is required to store commercially sourced tissues for research?
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What is the primary focus of informed consent in clinical research?
What is the primary focus of informed consent in clinical research?
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Which statement most accurately describes the distinction between clinical care and research consent?
Which statement most accurately describes the distinction between clinical care and research consent?
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According to the Declaration of Helsinki, what is a key concern when obtaining consent?
According to the Declaration of Helsinki, what is a key concern when obtaining consent?
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What does the Human Tissue Act primarily govern?
What does the Human Tissue Act primarily govern?
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What does informed consent entail, according to the ICH E6 Good Clinical Practice?
What does informed consent entail, according to the ICH E6 Good Clinical Practice?
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Which group is notably included in the updated Declaration of Helsinki to ensure fair representation?
Which group is notably included in the updated Declaration of Helsinki to ensure fair representation?
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What must be ensured if a participant is harmed during research, according to the Declaration of Helsinki?
What must be ensured if a participant is harmed during research, according to the Declaration of Helsinki?
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Which approach is advocated for improving participant understanding during the consent process?
Which approach is advocated for improving participant understanding during the consent process?
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Flashcards
Human Tissue Act 1961
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
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
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
Amendments to the Human Tissue Act
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Ethical Practice in Research
Ethical Practice in Research
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Informed Consent in Research
Informed Consent in Research
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Consent for Clinical Care
Consent for Clinical Care
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Declaration of Helsinki
Declaration of Helsinki
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Informed Consent Form
Informed Consent Form
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Consent for Vulnerable Participants
Consent for Vulnerable Participants
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Research Governance
Research Governance
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Human Tissue Act
Human Tissue Act
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Consent for Obtaining Material under the HTA
Consent for Obtaining Material under the HTA
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Human Tissue Act (UK)
Human Tissue Act (UK)
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Human Tissue Authority (HTA)
Human Tissue Authority (HTA)
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Human Tissue Act 2004
Human Tissue Act 2004
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Relevant Material
Relevant Material
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Scheduled Purpose
Scheduled Purpose
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DNA Theft
DNA Theft
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Criminal Penalties (Human Tissue Act)
Criminal Penalties (Human Tissue Act)
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Activities Covered by the Human Tissue Act
Activities Covered by the Human Tissue Act
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What is 'relevant material' under the Human Tissue Act?
What is 'relevant material' under the Human Tissue Act?
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What are the main offenses under the Human Tissue Act?
What are the main offenses under the Human Tissue Act?
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Why is informed consent important with regards to 'relevant material'?
Why is informed consent important with regards to 'relevant material'?
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What does the Human Tissue Authority (HTA) license?
What does the Human Tissue Authority (HTA) license?
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What is the requirement for storing 'relevant material' for research?
What is the requirement for storing 'relevant material' for research?
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How does the misuse of donated tissue occur?
How does the misuse of donated tissue occur?
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What is 'taking relevant material' without consent?
What is 'taking relevant material' without consent?
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Why is the Human Tissue Act 2004 important?
Why is the Human Tissue Act 2004 important?
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Study Notes
PM-138 Skills for Medical Scientists - Informed Consent and the HTA
- 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.
Informed Consent
- 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.
Informed Consent for Research
- 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 Consent Process
- 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).
When Consent is Not Needed
- 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 for HTA Licensing
- Consent is required to remove, store, and use relevant materials from living and deceased individuals.
- Consent must meet appropriate criteria of validity.
Appropriate Consent (Living/Deceased)
- 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).
Exemptions to Consent
- 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.
Consent and DNA
- 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.