Class 2 Flashcards
(42 cards)
The good physician
Hippocratic oath
Albert Neisser’s syphilis experiment (1892)
He administered syphilis serum to many patients without consent
•
Many of his subjects came down with syphilis. He argued that while the vaccination failed, the patients acquired syphilis because they worked as prostitutes
•
Inflamed by the press, the Prussian Government issued “Instructions to the Directors of Clinics, Out Patient Clinics, and Other Medical Facilities”
The Doctor’s trial
23 physicians were accused
Nuremburg code
1st international document on ethics of human experimentation: informed consent risk-benefit ratio primacy of individuals well-being qualifications of the researchers
World Medical Association’s declaration of Helsinki
external review by an independent ethics committee
dr focused
explicit ethical principles for medical research involving human subjects
Principlism
In bioethics and research ethics, a ‘principled approach’ is
used to invoke values that are perhaps as close to universal as is possible
Belmont report
Beneficience
Justice
Respect for persons
Respect for persons
- free choice to make decisions about their health
- health prof respect own decisions & protect those with diminished autonomy
- an autonomous decision must be informed: informed consent
Beneficence
- a health prof should act in a way that benefits the pt
- balance of ben vs risks
- prevent harm (not only medical)
Justice
- fair, equitable treatment
- persons who are equals should get similar trx
- distributive justice: distributing equally benefits, risks and costs of healthcare
- consideration of context of where a decision is made
Guidelines for biomedical research involving human subjects of the council for international organizations of medical sciences (CIOMS-WHO)
special att to the conditions and needs of low-income country research
special att to vulnerabel grps
CIOMS-WHO guideline 2: research in pop and comm with limited ressources
- must make sure that the research is responsive to the health needs of the community
- make every effort to cooperate with local gov
- consult with and engage comm.
If it’s bad science…
it’s bad ethics: participant risk, waste of resources and time, for a study that cannot answer the question
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
- Good clinical practice (GCP) is an international quality standard for conducting clinical trials that is provided by ICH.
Ethics committee
independant
protection of rights and safety of human subjects
public assurance of that protection
documents its’ procedures (accountability)
stringency of ethics review goes according to
potential harm of research
What an ethics review board is not
ethics police high priests of ethics blocker of research bureaucratic red tape one time hurdle
What an ethics review board is
valuable resource requirement conversation neutral part of good research process
informed consent form
should be piloted an validated, translated and back translated
assent and consent must be written/verbal
usually explicit
participant information sheet
- Title of Research Project
- List of Investigators
- Purpose of the Research
- Description of the Research
- Data protection
- Potential Harm, Injuries, Discomforts or Inconvenience
- Potential Benefits
- Treatment Alternatives
- Confidentiality
- Reimbursement
- Contact information
- Signature page consent form
Nutrition experiments performed in Canada on Indigenous
children at six residential schools
no consent, not minimal standard of care, impoverished community, purposely being harmed
CIA funded LSD experiments at McGill University
blank slate brain, psychiatry pt, no consent, lied
The Milgram experiments
teacher vs student, test obediance and authority. different rooms, shocks when wrong answer, pressure teachers to go on, psych distress, dishonest
Andrew Wakefield et al . linking the measles vaccine to autism
funding, falsified
