Week 5 Research Ethics Flashcards
Why is human research
ethics review
necessary?
To protect:
* Research Participants
* Researchers
* Society
To promote the ethical conduct of
research involving human subjects as they are the ones bearing the risks of
research.
In Canada, public research funding is tied
with good research practices:
funding (or continued funding) can
only be awarded to individuals and
institutions which certify
compliance with research ethics
policies and norms
Research ethics pertains to
- methodologies/research questions
- participant recruitment
- disclosure of purpose and risks/benefits
- voluntary, informed, ongoing consent, right to withdraw
- privacy and confidentiality
- conflicts of interest
Key Tensions in Research Ethics - Balancing
*Scientific imperatives vs. research ethics
*Individual rights vs. public benefit
*Inclusion vs. exploitation
Key Tensions in Research Ethics - International settings
Should ethics guidelines apply universally?
Key Tensions in Research Ethics - Practices and technologies
Standards are challenged by new practices and new technologies.
Different Conceptions of Research Ethics
- rigid/police-like application of ethical framework
- a deontology of research
- looks at how research is done (ethos)
- reflection on research, values, principles, integrity -> upstream (research prep), during research (execution), downstream (use of results)
How it started?
Historic look at research ethics
- Claude Bernard, 1865
- William Osler, 1907
- Walter Cannon, 1916
What is research ethics as a field of reflection and field of intervention?
*Field of reflection: examines relationship b/w researchers and participants + methodology w/ human dignity
*Field of intervention: regulating deontological standards + submitting all human research to evolution of research ethics committee (REB)
Prussian Consent Guidelines: Albert Neisser, discoverer of causative agent of gonorrhea
*1898: Publication of a research study conducted with female patients (uniformed sex workers), which consisted of injecting them with the serum of syphilitic patients -> vaccination didn’t work and some contracted syphilis
*Newspaper publications and public debate, Neisser must simply pay a fine.
*The court bases its decision on legal recognition of consent
*In 1900, the Ministry of Religious, Educational and Medical Affairs issued a directive to hospitals and clinics:
*No activity other than those aimed at diagnosis, cure or immunization may be conducted with a person without his “clear consent” and after having explained to him the “possible negative consequences”.
*Minors are excluded (because they are unfit).
*All information must be documented in the medical record.
Richtlinien 1931: The Lübeck vaccination scandal
*A disaster caused by the use of Bacillus Calmette-Guérin (BCG) for TB vaccination struck the German city of Lübeck -> 72 babies died
*Two basic concepts of the Richtlinien:
1. protecting subjects and patients;
2. encouraging new therapy and human
experimentation.
* Distinction between novel treatments and scientific experimentation
* No new treatment can be undertaken without animal testing, consent
* The exploitation of a state of social distress for the application of a new
treatment is not compatible with medical ethics.
* Prohibition of research on: children and dying persons, on humans if animals can be used as a substitute
Research atrocities have been conducted on all sides
- Intentional infection with diseases and poisons to observe course of death
- Shot to simulate wounds from battle
- Forced hypothermia, starvation, sterilization, mutilation
- Studies of twins to compare amputations, transfuse blood, infect with diseases
- Japanese intentionally infected Chinese prisoners with diseases
- American soldiers exposed to mustard gas, radiation
The modern era of research ethics (arguably) begins with the Nuremberg Code (1947)
As a response to the research atrocities of World War II (A series of 12 trials)
*Consent and right of withdrawal of the subject (points 1 and 9)
*The social relevance of the research and its scientificity, with testing on animals (points 2 and 3) and qualified personnel (8)
*Avoidance of unnecessary suffering (4)
*Prohibition of studies where death or great injury will occur (5); and requirement to have the necessary preparation and facilities to prevent the dangers of injury and of death (7)
*The risk must not exceed the “humanitarian importance of the problem that the experiment is attempting to solve” (6)
*Researcher must be prepared to stop the research if there is a risk injury or death to the subject (10)
The Tuskegee Study (1932-1972)
*Syphilis victims in US study went untreated for 40 years -> public outcry -> Belmont report for research ethics
Nuremberg’s key element
Voluntary consent of the human subject is absolutely essential
Beecher’s paper has been eye opening (US)
*Reported 22 studies (out of the 50 he collected) that had unethical practices.
*Beecher noted that a common element in these studies was that some experimental subjects (such as military personnel or “mentally handicapped children” in institutions) were not in a position to freely decline consent.
*He called for more rigorous self-scrutiny rather than public review.
*Beecher’s relied thus on a rather problematic conscientiousness from investigators (A bit paternalistic, no?)
*Focusing on benefits and harms to the exclusion of other moral criteria. (A bit too utilitarian, no?)
*According to him, there are two safeguards to research ethics: 1. informed consent 2. virtuous researchers
*He worked both to define the rules and conditions for informed consent, and to establish institutional review boards as an additional layer of oversight regarding research protocols.
*Beecher’s article contributed to the implementation of federal rules in the US on human experimentation and informed consent.
