case unit 5

Question 1

ethics

Answer 1

Non-maleficence
Beneficence
Respect for autonomy
Justice / human rights

Question 2

Numemberg code

Answer 2

1. Voluntray concent .
2. results are furtiful for society and experiment is necessary
3. based on previous animal experiment and a knowledge of the disease so anticipated results can justify the experiments performance.
4. Avoid all unnecessary physical and mental suffering and injury.
5. no known risk of death or a disabling injury might occur, unless the physicians also act as subjects.
6. The degree of risk should not be more than the humanitarian importance.
7. Preparations should be made to protect against injury, disability or death.
8. Research should be conducted by scientifically qualified persons.
9. The subject is able to withdraw at any point.
10. Be prepared to terminate the experiment if injury or death may occur.

Question 3

Tuskegee study

Answer 3

Untreated Syphilis in the Negro Male’

lied about giving treatment

Question 4

what did the Tuskegee study lead to

Answer 4

Institutional Review Bodies set up

Question 5

Alder Hey tissue scandal

Answer 5

Tissue obtained and stored from children who died at the hospital without consent

Question 6

implications of unethical research

Answer 6

Guidelines introduced
Laws passed
Public mistrust
Conspiracy theories

Question 7

ethical approval committees

Answer 7

Every application for funding for medical research involving animals, people or human tissue has to satisfy an ethics committee
Comprise a cross-section of society
Institutional ethics panels as well

Question 8

Seven requirements for ethical clinical research

Answer 8

1. Societal/ Scientific value
   Research that will improve health and well being or increase knowledge
2. Scientific validity
   Use of acceptable scientific principles & methods and competent investigators, to produce reliable and valid data
3. Fair subject selection
   Selection of subjects so that vulnerable individuals are not targeted for risky research, and the rich and socially powerful not favored for potentially beneficial research
4. Favorable risk-benefit ratio
   Minimize risks, enhance potential benefits, risks are proportionate to the benefits to the subject or society
5. Respect for subjects
   Subjects should have their privacy protected, the opportunity to withdraw, their well-being monitored & maintained, be informed of new information concerning research, compensated for injury
6. Informed consent
   Provide adequate information to subject so that he or she can make voluntary decision
7. Independent review
   Review of the above by individuals unaffiliated with the research

Question 9

Implications of unethical research

Answer 9

Guidelines introduced
Laws passed
Public mistrust
Conspiracy theories

Question 10

Andrew wakefield

Answer 10

Author of paper suggesting link between MMR and Autism
Struck off for fraud
Limited paper – strong conclusions drawn from weak evidence
Doubts over MMR safety propagated by the media

Question 11

improving the MMR study

Answer 11

Conclusions checked
Better study design
No correlation
Several other papers showing no link

Question 12

Karl popper - distingushing science from psuedoscience

Answer 12

Tackled the ‘problem of induction’
Science must be falsifiable

Come up with an idea or hypothesis
Test it to destruction
You cannot prove a hypothesis is true – you can corroborate it
You can prove a hypothesis is false – falsification
Science provides falsifiable hypotheses
Pseudoscience does not