Research Integrity and Ethics Flashcards
Outline the Tuskegee Syphilis Study (1932-1972) US Public Health Service
- 600 impoverished AA agricultural workers
- Promised health care as an incentive
- No diagnosis, advice, treatment or cure was given (despite penicillin cure being widely available halfway through)
- Researchers intended to watch progress of the disease to its conclusion (death)
- more than 128 participants died (and also passed it on to their family and friends)
Outline the Nuremberg Trials of Nazi War Criminals after WW2
German doctors tried for conducting unethical experiments on prisoners
This led to the adoption of the Nuremberg Code
Which 2 physicians were already thinking about ethics in research?
Claude Bernard and William Osler
Outline the Nuremberg Code?
- Free and informed consent
- needs to be fruitful
- scientific basis justifies the experiment
- avoid unnecessary suffering / injuries
- no research if death / disabling is likely
- risk should not exceed research benefits
- adequate facilities provided to protect against risk
- researchers must be skilled and qualified
- freedom to withdraw
- duty to stop if injury is likely
What are the limitations of the Nuremberg code?
not legally binding
decisions left to the discretion of the researcher
many scientists thought it only applied to very inhumane experiments - not to them
What were example of mistreatment continuing in the 60s after the development of the code?
Dr Chestern Southam injected 22 geriatric hospital patients with live cancer cells and avoided telling them what they were.
Milgram had a study where participants believed they were administering shocks.
What was the next ‘code’
The Declaration of Helsinki
- this is still the gold standard
- transmitted to a specially appointed independent committee for consideration / comment / guidance (what is and what isn’t ethical) –> leading to the birth of the ethics committee
- if you do experiments that haven’t been approved, you won’t get your research published
Takes the decision out of the hands of the researcher and into independent groups.
What is the Australian Code?
Australian Code for the Responsible Conduct of Research
Purpose: to guide research conduct, providing a reference for the development of policies and procedures
Compliance is a prereq for National Health and Medical Rsearch Councail and Australian Research Council funding
What are some principles and practices to encourage responsible research?
- general principles of responsible research
- management of research data and primary material
- supervision of research trainees
- publication and dissemination of research findings
- authorship
- peer review
- conflict of interest
- collaborative research across institutions
The national statement on ethical conduct in human research
Purpose: to promote ethical human research
1. Requires participants be accorded respect and protection
2. Involves the fostering of research that is of benefit to the community
Human research involves
- taking part in surveys / interviews / focus groups
- undergoing psychological, physiological, medical testing / treatment
- being observed by researchers
- researchers having access to personal documents
- collection and use of body organs, tissues / fluids, exhaled breath
- access to information as part of an existing published or unpublished source / database
What is the code for the use of animals?
The Australian Code of Practice for the Care and Use of Animals for Scientific Purposes
common framework for ensuring ethical and humane care and use of animals in scientific activities
What are the governing principles for the Australian code of practice for the care and use of animals for scientific purposes
Respect for animals must underpin all decisions and actions involving care and use of animals for scientific purposes.
Replacement (where possible, use alternative methods)
Reduction (reducing number of animals used)
Refinement (minimizing of pain, suffering and distress)
What is a conflict of interest?
Any situation in which financial or personal considerations have potential to compromise scientific or professional conduct.
What are some financial conflicts of interest?
Research psychiatrists who received consulting fees from companies whose drugs they were studying:
for all of them, their industry income which was disclosed was only a small fraction of their total payment received (i.e. financial incentives)
