ethics Flashcards
Describe the history of biomedical research ethics?
Research ethics has been debated and discussed since World War Jl. Prior to the war,
research was more or less a cottage industry with smaJJ-scale research being conducted by individual researchers on individual patients on a trial-and-error basis,
From World War II onwards, there was a significant expansion in research activity.
Such research was supported by governments that during and subsequent ro the
war viewed research as a matter of national security to protect both the armed forces
and the nation from infectious diseases and other illnesseshe early days of research ethics are almost exclusively associated with the field of medicine.
In the context of the development of modern medical science and experimental methods, some interesting reflections were made regarding how one should proceed when the research process involves people or animals
what are ethics?
norms of right and wrong behavior that govern the way research is conducted.
the moral principles that govern the conduct of certain activities or a person’s behavior.
ethical standards are discipline specific.
what is research ethics?
are ethical guidelines provided for the responsible conduct of research, to educate and monitor scientists to maintain high ethical standards?
why is it important to have ethical norms in reseach
promote moral and social values. These include human rights, social responsibility, compliance with the law, animal welfare, including public health and safety.
why ethical norms in research: WHY ARE THEY THERE
TO PROMOTE MORAL AND SOCIAL VALUES: These include human rights, social responsibility, compliance with the law, animal welfare, including public health and safety
TO PROMOTE THE AIM OF THE RESEARCH:
The aim or reason people conduct research is for truth, knowledge, and avoidance of error. Research gives room for more research, leading to advancement in the said field or subject.
HELP BUILD PUBLIC SUPPORT:
Many people will be more than willing to fund research work if they trust the researcher and the quality of work.
ENSURE RESEARCHERS ARE HELD -ACCOUNTABLE: It helps ensure researchers are accountable to the public.
So, there’s a need for federal policymakers to address issues relating to research misconduct, human subject protections, conflicts of interest, and animal care.
PROMOTE VALUES ESSENTIAL TO- COLLABORATIVE WORK:
The values include accountability, trust, fairness, and mutual respect.
Historical Development: (5)
Nazi atrocities and Nuremberg code
Thalidomide tragedy
Declaration of Helsinki
Tuskegee syphilis study and Belmont report
Good clinical practice.
The Nazi atrocities- trail
conducted in 1946
“Doctors case”
conducted in concentration camps
cruell and often used lethal experiments on human subjects including children.
The Nuremberg code
and 22 doctors were
found guilty of research atrocities. In 1947, the Nuremberg Code was developed (Annas & Grodin 1992). This code is based on ten principles, the most striking
of which are the importance of research being based on good science and the
concept of voluntary consent.
defendants’ lawyers; no legal restrictions, experimentation commonplace
based on 10 ethical principles on what medical experiments are permissible in humans
10 principles of Nuremberg code
> informed consent
social value and no other means
prior animal studies
avoid suffering and injury
death or disability not expected
risk vs benefit
protect subjects- injury, disability, death
>subjects can end participation
research can end study in injury, death, >disability likely
scientifically qualified researchers
TUSKEGEE SYPHILIS STUDY
began in 1932 us public health -1973 public outrage
used 600 African American men from Alabama
of these men 400 had syphilis and 200 were used as controls. Both patients and controls were told that they
had “bad blood” and should have regular medical examinations, including lumbar
punctures. These men had been promised free transportation to and from hospital,
hot lunches, free medical care for any disease other than syphilis and free burial.
However, they were not aware that they were subjects in a research study! When the
study began, there was no definitive treatment for syphilis. Heavy metals were used.
However, when penicillin was discovered in 1945 and was found to be effective
against syphilis, this treatment was deliberately withheld from the men in this studY
as the researchers wanted to see what the natural history of syphilis would be.
GUATEMALAN syphilis study
While Tuskegee was still in progress, 696 Guatemalans were deliberately infected
with syphilis between 1946 and 1948. The study was conducted to establish whether
penicillin could be used “immediately after sex to prevent infection with several sexually transmitted diseases, especially syphilis”. The study participants included female sex workers, soldiers, prison inmates and mental hospital patients. Prostitutes
who were known to be infected with syphilis were sent into the prison involved to
deliberately infect the inmates with syphilis. None of the participants consented to
participate.
2010 – President Obama apologized to Guatemalan president on behalf of US
government & researchers.
The Balmont report
Tuskegee resulted in national health act in us in 1974
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, which produced the Belmont
Report in 1979
based on 3 basic principles of ethical research on humans:
1.Respect for autonomy (person) - informed consent -subjects are autonomous agen1s and should be
treated as such. Protection should be provided for subjects with diminished
autonomy, such as children and mentally incapacitated adults.
2. Beneficence (risk-benefit assessment) - researchers working with human subjects should maximize
benefits and minimize harm to subjects.
3. Justice (fair selection of subjects) - there should be a balance in research between benefit and risk and
subjects should be treated fairly.
Thalidomide Tragedy
1950’S: Thalidomide (sedative) approved in Europe
o US: not FDA approved – manufacturer provided samples to doctors
to trial on patients to study drug safety and efficacy
o Used off-label for nausea, prevent morning sickness, premature delivery, and abortion in pregnant women
o Linked to severe birth defects - Phocomelia
The declaration Helsinki
o Following Nuremberg Code – Declaration of Geneva 1948
(physician’s ethical duties)
o Other research atrocities like Thalidomide tragedy
o World Medical Association adopted the Declaration of Helsinki in
1964 : Guidelines for ethical conduct of research
o SAMA is a member of WMA – SA researchers required by Research
Ethics Committees to adhere (2013 update
Helsinki principles/ highlights
> The use of placebos:
The benefits, risks, burdens and effectiveness of a new intervention must be
tested against those of the best proven intervention
The post-trial obligations:
use of unproven intervention
participants compensation for harm and guaranteed access to discovered treatments
