CMB2000/L07 Human Participants in Clinical Research

Question 1

What was the outcome of the Nuremberg trials?

Answer 1

Unauthorised medical experimentation occurred in Nazi concentration camps (1947)
Realisation that there were no generally accepted guidelines for medical research

Question 2

Give 4 of the 10 principles of the Nuremberg Code.

Answer 2

Voluntary consent
Research for the good of society
Justification based on previous knowledge
Avoids unnecessary physical and mental suffering
Research avoided if suspected death will occur
Risk needs to be mitigated against and proportionate
Adequate facilities
Conducted by qualified persons
Subjects can withdraw
Should not continue if injury is likely

Question 3

What is the Helsinki Declaration?

Answer 3

Guidance for doctors operating in dual role as clinician and researcher
ICH-GCP routed in Declaration of Helsinki Principles

Question 4

Give 4 classifications of humans in research.

Answer 4

Living human being
Human beings who have recently died
Foetuses
Embryos

Question 5

Describe informed consent.

Answer 5

Act of providing information to a potential research participant
Gives full understanding of their involvement
Understand researcher’s responsibilities

Question 6

Give the 4 steps of informed consent.

Answer 6

Giving of information
Discussion, clarification and review of information
Obtaining written and/or verbal consent
Process consent (ongoing revalidation of consent)

Question 7

How is consent given with children?

Answer 7

16+ can give consent (generally accepted)
u16 must gain child and legal guardian’s consent (can assess Gillick Competence)

Question 8

Which 2 legal frameworks describe informed consent in vulnerable adults?

Answer 8

Mental Capacity Act 2007
Medicines for Human Use (Clinical Trials) Regulations 2004 Common Law

Question 9

What are HeLa cells?

Answer 9

First immortal human cell line
Taken from Henrietta Lacks’ cervical adeno-carcinoma in 1951

Question 10

How have HeLa cells helped advance science?

Answer 10

Polio vaccine
Chemotherapy
Cloning
Gene mapping
In vitro fertilisation

Question 11

Describe the Alder-Hay Organ Retention Scandal.

Answer 11

Pathologist collected organs from children at post-mortem examination 1988-1996
No permission from parents
Not clear how samples were used

Question 12

What is the Human Tissue Act 2004?

Answer 12

A framework for the regulation of storage and use of human tissue from the living and the removal, storage and use of tissue and organs from the deceased for specified purposes

Question 13

What is inducement?

Answer 13

The provision of an incentive to entice a person to carry out an action
Requires great care and ethical approval in trials

Question 14

Describe the Tuskagee Syphilis Study.

Answer 14

US Public Health Service 1932-1972
600 low-income black males recruited
Free medical care, meals and burial insurance
None treated or informed of disease
Prevented access to treatment and men, their partners and newborns died

Question 15

What law defines the confidentiality of patients?

Answer 15

General Data Protection Regulation (GDPR)

Question 16

Give 4 of the 7 GDPR principles.

Answer 16

Lawfulness, fairness and transparency
Purpose limitation
Data minimisation
Accuracy
Storage limitation
Integrity and confidentiality
The Accountability Principle

Question 17

Give 3 types of personal data.

Answer 17

Identifiable data
Confidential information
Coded data
Linked anonymised
Unlinked anonymised
Data relating to an individual

Question 18

Describe the thalidomide scandal.

Answer 18

Developed as sleeping tablet
Given for morning sickness in first trimester
Resulted in 10,000s of children born with severe congenital abnormalities
Highlighted insufficient safeguards in relation to efficacy and toxicity testing

Question 19

Describe the UK Medicines Act 1968.

Answer 19

Broad legal standard on manufacture and supply of medicines relating to general practice

Question 20

What are the 3 medicine classifications according to the Medicines Act 1968?

Answer 20

Prescription only medicines
Pharmacy medication
General medication

Question 21

Define the UK Policy Framework for Health and Social Care Research 2018.

Answer 21

Designed to set principles of good practice across all areas of health and social care research in the UK

Question 22

Describe the Northwick Park experiment 2006.

Answer 22

Healthy male volunteers
Given experimental antibody TGN 1412
Anticipated drug would be used in RA and other autoimmune disorders
First human trial to test for safety

Question 23

Describe the response to TGN 1412.

Answer 23

Undesirable symptoms
Patients taken to ICU
Ventilators and breathing support required
6 suffered multi-organ failure

Question 24

What is the role of the UK Research Ethics Committee?

Answer 24

Ensure dignity, rights, safety and well-being of individuals are protected
Reducing risks involved with research