Research Ethics

Question 1

What are the stages of making a medicine?

Answer 1

• Research
  
  • Understanding our bodies in health and disease.
• Finding new treatments
  
  • Identifying new targets, developing and screening treatments.
• Narrowing the field
  
  • Focusing on efficacy, safety and dose selection.
• Clinical trials
  
  • Phase 1
  • Phase 2
  • Phase 3
  • Phase 4
• Approval
  
  • Medicine is licensed

Question 2

What are the phases of clinical trials?

Answer 2

• Phase 1
  
  • Safety, dose and how it works in volunteers.
• Phase 2
  
  • Does it work in patients?
• Phase 3
  
  • Getting evidence in larger population
• Phase 4
  
  • Continuous monitoring and maintaining safety oversight

Question 3

What are the arguments cited against animal research (from Bowman)?

Answer 3

• Benefits
• Model
• Sentience
• Value
• Moral agency
• Spiritual / religious potential
• Human achievement

Question 4

Explain the 3 principles governing the current use of animals in research (from the Home Office policy).

Answer 4

• Home office:
  
  • In determining whether and on what basis to grant a project license the Secretary of State shall weigh the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the license.
• Replacement
  
  • ​Alternative technologies (in vitro, biochemical, mathematical and computer models); use lower organisms.
• Reduction
  
  • ​Better study design to allow use of fewer animals; better storage of data.
• Refinement
  
  • ​Improve housing; minimise pain; improve welfare.

Question 5

Describe what the home office does.

Answer 5

• The home office is advised by Animal Procedures Inspectorate.
• Each local arena has an animal ethics committe - they review and monitor all eligible research, using ASPA and home office guidelines.
• Licenses are granted:
  
  • Site license
  • Personal license
  • Project license
• Concordat on openness.

Question 6

Describe the importance of the Declaration of Helsinki (2013) in human research.

Answer 6

• Declaration of Helsinki:
• The World Medical Association (WMA) has developed the declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
  
  • Consent (also be aware of coercion)
  • Confidentiality (including resulting data)
  • Risks and burdens
  • Post-trial provision
  • Publication
• The Declaration of Helsinki is a statement, not a law.

Question 7

Which local ethics committees does human reseach have to go through in the UK?

Answer 7

• If human research - participants, data or tissue:
  
  • If involving NHS staff, patients or premises - National Research Ethics Service (NRES).
    
    • At local level - NHS
  • If not involving NHS - local level Research Ethics Committee (REC).

Question 8

What are the 4 criteria for valid consent in clinical practice?

Answer 8

• Patient must have capacity
• Patient must give consent voluntarily
• Patient must be informed
• Consent must be continuing

Question 9

What is the first principle of the Nuremberg code?

Answer 9

• Informed consent
• Several articles address this in the Declaration of Helsinki.
• Be alert to:
  
  • Participant feeling pressured into agreeing.
  • The problem with incentives.
  • Sufficient information.
  • Vulnerable patients.

Question 10

Outline the distinction between therapeutic and non-therapeutic research.

Answer 10

• Therapeutic research is that which might have direct benefit for the patient.
• Non-therapeutic research is that which provides additional knowledge without direct benefit for the patient.

Question 11

Outline the different ethical principles breached by the Tuskegee Syphilis trial.

Answer 11

• Known as “Tuskegee Study of Untreated Syphilis in the Negro Male” (1932).
  
  • “A study to record the natural history of syphilis in hopes of justifying treatment programmes for blacks”.
• US Public Health Service (President Clinton apologised in 1997).
• 600 African-Americans; 399 with syphilis, 201 without.
• No informed consent - participants told they were being treated for ‘bad blood’ (not even given a diagnosis, nor effective treatment).
• Trial was meant to last 6 months, instead it lasted for 40 years.
• Incentives - free medical exams, free meals and burial insurance.
• Examined regularly but not treated for the disease, even after penicillin became drug of choice in 1947 (nor were they allowed to be treated in clinics / hospitals in the area).
• 1974 - $10 million out-of-court settlement was reached for participants and their families.

Question 12

Outline the different ethical principles breached by the Guatemalan STD trials.

Answer 12

• The Guatemalan experiments were uncovered in 2010; took place in 1946-1948.
• President Barack Obama apologised to Guatemala, launched an investigation:
  
  • “the Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers’ own understanding of the practices and requirements of medical ethics of the day”.
• The US government, with Guatemalan colleagues, experimented on 5000+ Guatemalan soldiers, prisoners, people with psychiatric disorders, orphans and prostitutes.
• Justified as “results would have widespread benefits and help Guatemala to improve its public health service”.
• No evidence that consent was sought.
• Exposed 558 soldiers, 486 patients at a psychiatric hospital, 219 prisoners, 6 prostitutes and 39 others to gonorrhoea, syphilis or chancroid.
• Measured accuracy of diagnostic tests on orphans, those with leprosy, people at psychiatric hospital, prison and army.

Question 13

Outline the different ethical principles breached by the case of Henrietta Lacks.

Answer 13

• 1951: cells from Henrietta’s cervix are cultures in vitro, and become the first immortal human cell line: HeLa.
• 1951: Henrietta dies from cervical cancer.
• HeLa cells are shipped all over the world, and used in all kinds of medical research.
• But, Henrietta herself did not know this, nor did her family.
• No knowledge shared or consent sought.
• HeLa cells have made some people a lot of money, Lack’s family have struggled to access the healthcare they need.
• Justification?
  
  • Material was no longer ‘hers’, material would have been thrown away; it is for the common good.