Flashcards in case unit 5 Deck (12):
Respect for autonomy
Justice / human rights
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.
Untreated Syphilis in the Negro Male’
lied about giving treatment
what did the Tuskegee study lead to
Institutional Review Bodies set up
Alder Hey tissue scandal
Tissue obtained and stored from children who died at the hospital without consent
implications of unethical research
ethical approval committees
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
Seven requirements for ethical clinical research
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
Implications of unethical research
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
improving the MMR study
Better study design
Several other papers showing no link