PM-138 Skills for Medical Scientists

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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?

Participants may feel rushed and unable to provide quality responses. Signup and view all the answers

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

The patient should provide consent before any blood samples are taken. Signup and view all the answers

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

To regulate the removal, storage, use, and disposal of human tissue Signup and view all the answers

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

Consent is legally required for all scheduled purposes Signup and view all the answers

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

DNA theft Signup and view all the answers

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

Performance assessment Signup and view all the answers

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

Clinical audit involving living individuals Signup and view all the answers

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

Human cells excluding gametes Signup and view all the answers

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

A fine and/or imprisonment for up to three years Signup and view all the answers

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

Research into the functioning of the human body Signup and view all the answers

What is considered 'relevant material' under the Act?

Blood and organs Signup and view all the answers

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

Embryos outside the body Signup and view all the answers

What constitutes an offence under the Act regarding relevant material?

Removing relevant material without consent Signup and view all the answers

Licensable activities under the HTA include which of the following?

Carrying out post-mortem examination Signup and view all the answers

Which of the following scenarios requires an HTA license?

Storing residual material after NHS REC approval expires Signup and view all the answers

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

It is a violation of the Act Signup and view all the answers

Which of the following statement about relevant material is true?

Stem cells are included in relevant material Signup and view all the answers

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

HTA licence or NHS REC approval Signup and view all the answers

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

Ensure participants are volunteers and understand risks Signup and view all the answers

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

Research consent aims to protect participants through rigorous processes. Signup and view all the answers

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

Dependent relationships that may influence decision-making Signup and view all the answers

What does the Human Tissue Act primarily govern?

The use of human tissue for research and consent procedures Signup and view all the answers

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

Participants should understand all relevant aspects before deciding. Signup and view all the answers

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

Under-represented groups in clinical research Signup and view all the answers

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

Compensation and treatment must be provided. Signup and view all the answers

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

Employing innovative consent methods like videos and recordings Signup and view all the answers

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.

PM-138 Skills for Medical Scientists - Informed Consent

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