PM-138 Skills for Medical Scientists: Consent & HTA

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Questions and Answers

What prompts a research nurse to ask potential participants to complete questionnaires in a waiting room?

Maximizing data collection efficiency

The need to fill time while waiting for treatment (correct)

Providing entertainment during the wait

Ensuring participants are less anxious about the wait

What was a significant issue highlighted by the Alder Hey organs scandal?

Tissue was removed with the consent of the parents

Tissues were only used for educational purposes

Removal of tissue was carried out by multiple institutions

Consent was not obtained for tissue removal (correct)

What was the main intention of conducting additional blood tests before approaching patients in the second scenario?

To ensure compliance with hospital regulations

To guarantee participation in the study

To complete the study without doctors' involvement

To save patients time and effort (correct)

Which statement best defines the Human Tissue Act?

It is based on the lack of objection to tissue removal from deceased individuals (C) Signup and view all the answers

What was a consequence of the practices highlighted by the Alder Hey inquiry?

Stricter regulations on tissue removal for research (D) Signup and view all the answers

What does the Human Tissue Authority regulate?

Removal, storage, use and disposal of human tissue (C) Signup and view all the answers

Which of the following is a requirement for consent under the Human Tissue Act?

Consent must be obtained for all scheduled purposes (A) Signup and view all the answers

What is the consequence of breaching the Human Tissue Act?

Criminal penalties including imprisonment (C) Signup and view all the answers

Which of the following activities requires consent when involving human tissue?

Anatomical examination of deceased individuals (C) Signup and view all the answers

What does 'relevant material' refer to under the Human Tissue Act?

Material made of or including human cells other than gametes (B) Signup and view all the answers

For which of the following purposes is consent NOT required if samples are obtained from the living?

Education and training (D) Signup and view all the answers

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

Quality assurance in healthcare organizations (C) Signup and view all the answers

What is a potential new offence introduced by the Human Tissue Act?

DNA theft (A) Signup and view all the answers

What is a primary component that distinguishes informed consent for research from consent for clinical care?

Research consent is more rigorous and requires thorough information. (C) Signup and view all the answers

Which of the following is NOT a component that participants must understand for informed consent in clinical research?

The timeline of the research study. (C) Signup and view all the answers

What does the Human Tissue Act primarily cover?

The use of human tissue in all types of research. (B) Signup and view all the answers

What is an important consideration from the Declaration of Helsinki regarding informed consent?

It emphasizes the need for caution in potential dependent relationships. (D) Signup and view all the answers

Which group does the Declaration of Helsinki specifically aim to include in research?

Under-represented groups. (D) Signup and view all the answers

What does informed consent aim to protect in the context of research?

The autonomy and safety of the participants. (B) Signup and view all the answers

Which of the following is an exception where the Human Tissue Act may not apply?

When research does not involve human tissue. (C) Signup and view all the answers

What type of methods are encouraged for use in obtaining informed consent according to the updated Declaration of Helsinki?

Innovative consent methods like recordings and videos. (A) Signup and view all the answers

What does 'relevant material' include according to the Act?

Blood and bodily fluids (A) Signup and view all the answers

Which of the following is specifically excluded from the definition of 'relevant material'?

Acellular material (A) Signup and view all the answers

An example of a licensable activity under the HTA is?

Carrying out anatomical examinations (D) Signup and view all the answers

What is required to legally store relevant material for research after NHS REC approval expires?

HTA licence (C) Signup and view all the answers

Which of the following constitutes an offence under the Act?

Using relevant material for an unapproved purpose (C) Signup and view all the answers

What type of bodily material is included as 'relevant material'?

Stem cells (A) Signup and view all the answers

What action is not considered a licensable activity under the HTA?

Removing relevant material from a living person (D) Signup and view all the answers

What can result from trafficking human tissue for transplantation without proper authority?

Severe penalties under the Act (B) Signup and view all the answers

Why is it significant that the Human Tissue Act is based on a lack of objection to tissue removal?

It protects the rights of deceased individuals concerning their tissues. (A) Signup and view all the answers

What ethical issue does the Alder Hey organs scandal most clearly highlight?

The importance of obtaining consent for the use of human tissues. (D) Signup and view all the answers

In what situation is it acceptable to approach a patient after conducting additional blood tests?

If screening criteria are made available to the patient beforehand. (D) Signup and view all the answers

Which of the following scenarios would likely contravene the Human Tissue Act?

Retention of a child’s tissue without parental consent. (A) Signup and view all the answers

What does the Human Tissue Act primarily regulate regarding deceased individuals?

The authorized uses of retained tissue after death. (B) Signup and view all the answers

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

To ensure participants understand the procedures and risks (A) Signup and view all the answers

Which aspect of the Declaration of Helsinki has specific attention regarding conditions of duress?

Caution regarding dependent relationships (B) Signup and view all the answers

According to the updated Declaration of Helsinki, what innovative method is suggested for obtaining informed consent?

Recordings and videos (C) Signup and view all the answers

What is a significant characteristic differentiating consent for clinical practice from consent for research?

Research consent has a more rigorous informing process (B) Signup and view all the answers

Which of the following must researchers be cautious about in the consent process according to the Declaration of Helsinki?

Psychological influences on decision-making (C) Signup and view all the answers

What is an essential element for informed consent documentation in clinical research?

A written, signed, and dated consent form (A) Signup and view all the answers

When is it especially important to consider the individual information needs of research participants?

According to the Declaration of Helsinki guidelines (B) Signup and view all the answers

Which of the following is indicated as a focus of the Declaration of Helsinki relating to resource-limited settings?

Empowerment through strengthened international standards (A) Signup and view all the answers

What is required before storing and using 'relevant material' for research purposes?

Written consent from the individual or the next of kin for deceased donors (D) Signup and view all the answers

Which of the following is NOT classified as a scheduled purpose under the Human Tissue Act?

Creating art from human tissue (A) Signup and view all the answers

Which activity does NOT legally require consent when using tissue obtained from living individuals?

Transplantation procedures (A) Signup and view all the answers

Which of the following materials is included in the definition of 'relevant material' under the Act?

Breast milk (A) Signup and view all the answers

Which of the following is considered a criminal penalty for breaching the Human Tissue Act?

Imprisonment for up to 3 years (B) Signup and view all the answers

What does the term 'relevant material' exclude under the Human Tissue Act?

Gametes such as sperm and eggs (D) Signup and view all the answers

What is a requirement for storing relevant material for research after NHS REC approval expires?

Approval from the HTA (D) Signup and view all the answers

Which of the following actions is classified as an offence under the Act?

Conducting anatomical examinations without a license (D) Signup and view all the answers

In relation to children donating bone marrow, which statement is true under the Human Tissue Act?

Special considerations are needed if there is a lack of capacity (D) Signup and view all the answers

Which element is NOT a responsibility of the Human Tissue Authority?

Monitoring quality assurance in public health programs (D) Signup and view all the answers

Which of the following is NOT considered relevant material according to the Act?

Embryos created outside the body (B) Signup and view all the answers

What governs the storage of commercially sourced tissues according to the Act?

HTA licence and NHS REC approval (C) Signup and view all the answers

What defines 'scheduled purpose' in the context of the Human Tissue Act?

Activities that require consent to be obtained before proceeding (B) Signup and view all the answers

Which of the following bodily products is specifically mentioned as relevant material?

Wound fluid (B) Signup and view all the answers

Which activity does NOT require a HTA license?

Publicly displaying a living person's body (A) Signup and view all the answers

Under which condition is it acceptable to hold bodily material intended for DNA analysis without consent?

If the material is from a deceased person (A) Signup and view all the answers

Is it appropriate for a research nurse to ask a potential participant to complete a questionnaire while they are waiting at the emergency department?

No, it may pressure the patient in distress. (A) Signup and view all the answers

What issue arose from the additional blood sample taken before approaching patients in the screening process?

Patients may be misinformed about testing. (D) Signup and view all the answers

What was a significant finding of the Alder Hey organs scandal?

Human tissue was sold for profit without consent. (B) Signup and view all the answers

Under the Human Tissue Act, which principle primarily guides the removal of tissue from deceased individuals?

Lack of objection is the basis for consent. (B) Signup and view all the answers

Which of the following describes a potential consequence of non-consensual tissue removal as seen in the Alder Hey scandal?

Legal penalties and loss of public funding. (B) Signup and view all the answers

Which of the following activities is NOT a scheduled purpose under the Human Tissue Act?

Analyzing patient satisfaction (C) Signup and view all the answers

Which statement correctly reflects the consent requirements for tissue from living individuals?

Consent is not necessary for public health monitoring. (C) Signup and view all the answers

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

Human cells excluding gametes (A) Signup and view all the answers

What is the legal consequence of breaching the Human Tissue Act?

Imprisonment up to 3 years or fines (C) Signup and view all the answers

Which of these purposes requires consent under the Human Tissue Act?

Anatomical examination (D) Signup and view all the answers

What does the term 'scheduled purpose' encompass under the Human Tissue Act?

All activities regarding human tissue that require consent (A) Signup and view all the answers

When is DNA theft considered a new offence under the Human Tissue Act?

Any unauthorized acquisition of DNA samples (A) Signup and view all the answers

Which of the following materials is explicitly included as 'relevant material' under the Act?

Breast milk (A) Signup and view all the answers

What type of permission is required to carry out activities involving relevant material?

License from the HTA (B), Informed consent (C) Signup and view all the answers

Which of the following is NOT classified as an offence under the Act?

Storing relevant material for scheduled purposes (B) Signup and view all the answers

Which bodily product is considered relevant material under the Act?

Saliva (B) Signup and view all the answers

Which activity requires a license from the HTA?

Carrying out post-mortem examinations (A) Signup and view all the answers

What happens when NHS REC approval for a study involving relevant material expires?

An HTA license is required for residual material. (D) Signup and view all the answers

Which of the following must be obtained before conducting activities involving relevant material?

Consent from the living individual (C) Signup and view all the answers

What is NOT a requirement for informed consent in clinical research?

Agreement to share personal health history (A) Signup and view all the answers

Which of the following statements about informed consent in research is true?

Participants must be informed of voluntary withdrawal at any time. (A) Signup and view all the answers

What key aspect does the Declaration of Helsinki emphasize regarding participant relationships?

Caution if a dependent relationship exists (A) Signup and view all the answers

Which innovation is suggested for improving the consent process according to the updated Declaration of Helsinki?

Recordings and videos for information delivery (D) Signup and view all the answers

What is one key element that distinguishes research consent from clinical consent?

Research consent requires information about alternative therapies. (A) Signup and view all the answers

Under the Human Tissue Act, which type of material is generally NOT classified as 'relevant material'?

Blood samples for diagnostic testing (D) Signup and view all the answers

Which of the following describes an exception where the Human Tissue Act may not apply?

When the tissue is used for education with no risk to individuals. (B) Signup and view all the answers

What does informed consent primarily aim to protect in a clinical research context?

The rights and welfare of the participants (B) Signup and view all the answers

What ethical principle is violated by unauthorized removal and retention of human tissue?

Autonomy of the participant (B) Signup and view all the answers

In the context of the Human Tissue Act, what does 'relevant material' primarily encompass?

Deceased human tissue samples (A) Signup and view all the answers

Why might conducting additional blood tests before obtaining consent be problematic?

It could invalidate the consent process (A) Signup and view all the answers

What major event led to the revision of laws and regulations regarding human tissue in the UK?

The Alder Hey organs scandal (C) Signup and view all the answers

Under the Human Tissue Act, what must researchers ensure regarding consent for using tissue obtained from living individuals?

Written consent must be obtained (B) Signup and view all the answers

Which of the following is NOT classified as 'relevant material' according to the Act?

Hair and nails from a living person (A) Signup and view all the answers

What is required to legally store relevant material after NHS REC approval has expired?

HTA licence (C) Signup and view all the answers

Which of the following is considered a licensable activity under the HTA?

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

What does 'relevant material' explicitly exclude under the Act?

Embryos created outside the body (D) Signup and view all the answers

What distinguishes informed consent for research from consent for clinical care?

Research requires more comprehensive information. (C) Signup and view all the answers

Which body is responsible for overseeing research governance?

Multiple regulatory bodies and advisory groups (A) Signup and view all the answers

Which component is NOT required for informed consent documentation in clinical research?

Participant's personal identification number (D) Signup and view all the answers

According to the Declaration of Helsinki, what should researchers exercise caution about?

Dependent relationships and potential duress (A) Signup and view all the answers

Which of the following is a significant aim of the updated Declaration of Helsinki?

Strengthening international standards in resource-limited settings (D) Signup and view all the answers

What aspect must be ensured when obtaining informed consent from research participants?

Participants should be fully informed of risks and alternatives (D) Signup and view all the answers

What is a key requirement outlined by the Human Tissue Act?

Consent must be obtained for all activities involving living human tissue. (B) Signup and view all the answers

Which innovative consent method is encouraged by the updated Declaration of Helsinki?

Video recordings as consent (B) Signup and view all the answers

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

Legal consent from donors (D) Signup and view all the answers

Which of the following is considered a 'scheduled purpose' under the Human Tissue Act?

Anatomical examination (A) Signup and view all the answers

For which purpose is consent not required when obtaining tissue from living individuals?

Quality assurance (C) Signup and view all the answers

What constitutes a new offense introduced by the Human Tissue Act?

DNA theft (D) Signup and view all the answers

Which of the following best describes 'relevant material' as per the Human Tissue Act?

Tissue containing or made up of human cells except for gametes (C) Signup and view all the answers

What type of penalties may be imposed for breaching the Human Tissue Act?

Fine, imprisonment, or both (A) Signup and view all the answers

What is the main principle guiding the Human Tissue Act?

Consent and licensing are essential (A) Signup and view all the answers

Which of the following activities is specifically NOT classified as a scheduled purpose under the Human Tissue Act?

Personal research experiments (C) Signup and view all the answers

Study Notes

The course covers the consent process, including vulnerable participants, and the laws and regulations surrounding research and consent.
The Human Tissue Act (HTA) is discussed, including examples of covered materials and activities, and its exceptions.
The process of obtaining material under the HTA is also discussed.
A subtle distinction between clinical care consent and research consent is highlighted; clinical consent is often implied, while research consent requires more rigorous procedures.
Crucial components of informed consent for clinical research involve ensuring participants understand: what is being done, why it is being done, the voluntary nature of participation, the risks involved, and the available alternatives.
The ICH EG Good Clinical Practice (1996) applies to all health and social care research.
Research governance is overseen by various regulatory bodies and advisory groups.
The Human Tissue Authority (HTA) is the regulator for human tissue and organs.

Learning Outcomes

Students will develop an understanding of the consent process, including for vulnerable participants.
They will demonstrate awareness of laws and regulations surrounding research and consent.
A brief overview of the Human Tissue Act will be provided.
Examples of materials and activities covered by the HTA will be given.
Students will become aware of when the HTA is relevant and its exceptions.
The consent process for obtaining material under the HTA will be discussed.

Informed consent is a process where participants confirm their willingness to participate in a trial after being fully informed about all aspects relevant to their decision.
It must be documented in a signed and dated consent form.
Clinical consent is often implied, but for research, it requires explicit and more formal documentation. A crucial part of research consent is ensuring the participant is made fully aware of the nature of the study.

Declaration of Helsinki (1964)

This declaration expands on the Nuremberg Code's principles, emphasizing the importance of:
- Providing sufficient information to competent subjects.
- Cautious consideration if dependent relationships exist.
- Recognizing potential duress.
- Giving due attention to individual needs and methods of delivering information.

Declaration of Helsinki (Updated 2013)

This version emphasizes strengthening international standards, particularly in developing countries with limited resources.
Key updates include:
- Including under-represented groups.
- Providing compensation and treatment for harmed participants.
- Ensuring access to new interventions, based on informed consent
  - Utilizing innovative consent methods (e.g., recordings and videos).
- Providing feedback to participants, emphasizing respect and demystifying the research process.

The consent process includes stages like invitation, time to consider, discussions, formal agreement, and willingness to continue.

Scenarios and Case Studies

Several case studies are presented, illustrating different situations and prompting students to consider whether informed consent and HTA requirements are being met.
Questions are posed to analyze ethical aspects and applicability of the HTA.

The Human Tissue Act (2004)

The Act established the Human Tissue Authority (HTA) to regulate the removal, storage, use, and disposal of human tissue.
It became effective on September 1, 2006.
Consent is legally required for storing and using relevant material for scheduled purposes, with certain exemptions.
Consent requirements differ for living and deceased individuals.
DNA theft is now a new criminal offense.
Criminal penalties exist for violating the Act.

HTA Regulated Sectors

The HTA governs various sectors;
- Anatomy, bone marrow donation (particularly from children), human tissue and cell applications (e.g. skin, bone marrow, bone).
- Living organ donation assessments, post-mortem examinations, public displays, research, and organ donation and transplantation.

Key Terms

Scheduled Purpose: All activities or purposes under the Human Tissue Act.
Relevant Material: Material composed of or containing human cells, excluding embryos outside the body, hair, and nails from living persons.

Activities Covered by the Act

Research is a scheduled purpose; removal, storage, and use of relevant material for research into human body disorders or functioning.

Scheduled Purposes (General)

Anatomical examination
Determining cause of death.
Efficacy of drug or treatment after death
Obtaining information about a person relevant to others.
Public display.
Research in connection with disorders or functioning of the human body.
Transplantation.

Exceptions to HTA Licensing

REC-approved (or pending) projects
Material pending processing, transfer, or to be rendered acellular.
Supplied by HTA-licensed tissue banks.
Individuals who died over 100 years ago.
Short-term storage prior to analysis.

Consent is needed for removal, storage, and use of relevant material (from both living and deceased individuals).
Consent must be appropriate and valid.

Consent is required from the living donor themselves or individuals (children greater than or equal to age 12), who have the capacity to make their own decisions regarding the donation.
Consent from a nominated representative or specific qualifying relatives for deceased individuals. (e.g., spouse, children, parents etc.).

Relevant material is from the living, is anonymized, part of an NHS REC-approved project
Material collected before September 1, 2006
Individuals who died over 100 years ago
Imported tissue (good practice prevails)

DNA is not considered relevant material.
"DNA Theft" involves holding bodily material intending to analyze DNA without valid consent, with exceptions.
Exceptions for DNA analysis include material from the living, anonymized and approved by an NHS REC, for medical diagnosis or criminal investigations.
There exists penalties for DNA theft.

Licensable Activities

The HTA licenses and inspects organizations carrying out anatomical or post-mortem examinations.
Removal of relevant material, storage, or display of relevant material

Relevant Material Storage and Research

Material from living healthy individuals (both commercially sourced and samples) require HTA license or university NHS REC approval for storage

Additional Examples (Scenarios)

Specific practical scenarios are presented for students to analyze and determine whether or not HTA licensing or consent are required.

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Description

This course explores the informed consent process in medical research, focusing on vulnerable participants and relevant laws like the Human Tissue Act (HTA). It differentiates between clinical and research consent and highlights essential components needed to ensure participant understanding and compliance. Understand the regulatory framework guiding research governance in health and social care settings.