Chapter 17 : Human Research Notes

Tuskegee

* Federally funded for 4 decades
* Considered along with genocide of native Americans one of the US MOST egregious unethical issues relevant to biomedical ethics
* NEVER told the subjects they had syphilis, just told them they had “bad blood”
* Preventing these men from going in the military because they didn’t want them to get tested for syphilis
* Studied CONTINUED until the 1970s
* Were NOT given informed consent
* This study didn’t infect people with syphilis, they already had it

Guidelines - Human Research

* Nuremburg Code 1947
* Started in the 1940s
* 6 articles extended into 10
* Voluntary informed consent to use people in medical research
* Ethical standards for biomedical research on humans
* RESPECT for human subjects as persons
* Voluntary informed consent
* Helsinki Code 1964
* Offered a qualified view of the centrality of informed consent in any morally permissible research involving human subjects
* The ethics of therapeutic (clinical) research whereby physicians conduct a trial in the context of treating a patient, and
* The requirements for proxy consent in cases where the research subject cannot give consent because she lacks capacity.
* Therapeutic research
* Any biomedical study with potential health benefits for the research subjects - e.g., an experimental cancer intervention tested on cancer patients

What Researchers Owe Subjects

FEDERAL guidelines


1. Valid informed consent


1. HAS TO BE FREE FROM COERCION
2. Informed → need to know risks vs. benefits of what is GOING ON


1. Have to have the medical capacity to understand what is going on
2. Proper balancing of benefits vs. harm PRIOR to study enrollment


1. PRIOR TO performing the study you have to inform risks vs. benefits
3. Fair distribution among human subjects

Justice

Requirements burdens of research


1. Shared among societies
2. Not fall arbitrarily among any groups of individuals or society

Underrepresented Groups

1. Women
2. Children
3. Minorities
4. Groups with HIV, Sickle Cell Anemia

Ethical Issues in Tuskegee Syphilis Study

* No syphilis treatment was administered to the infected men, even after the advent of penicillin
* They were kept ignorant of their STD
* Told they had bad blood for which they were being treated

Aim of Tuskegee Study

To learn about the progress of untreated syphilis

Distributive Justice

Fairness in the distribution of research’s benefits and burdens among all members of society

* The notion of justice that matters most for the topics at hand

Justice Argument

1. Human kind has benefitted from biomedical research on humans.


2. It is unjust to past generations that research’s burdens should fall only on them, and to future generations that they be deprived of possible research benefits.


3. (2) would be the case if there is no moral duty to promote and even participate in biomedical research.


4. Therefore, there is a moral duty to promote and even participate in biomedical research.