Human Research

Jake Kirkland, Camila Villacreses, Gabriel

Roberts, Gray Ransom, Megan OBrien
Case Study || Tuskegee Study

1932-1972 Macon County, Alabama

Run by the US Public Health Service
Government attempted to learn more about lack of treatment for syphilis in
African American males.
Treatment for syphilis was withheld
Aftermath of experiment led to protection of volunteers
Informed consent of participants
Board reviews for human experiments
Run by Office for Human Research Protections and Department of Health and Human
Services
Background
What is Research?

Use of methods to discover and further human knowledge

Scientific research uses the scientific method
Human research uses humans as test subjects to test a hypothesis
Can either be medical (clinical) or non-medical
Background

Clinical Trials

Develop new information about medical methods, treatments, devices

strategies
Are they safe and/or effective?
If so, they can be used extensively in the US.
Initially used in laboratory setting
Background

Three Stages of Clinical Trials

Phase I: Safety of device/drug

How is it metabolized? Any serious side effects? How does dosage effect physiology?
Phase II: Comparative testing
Involves a lot more patients
Randomized testing || Experimental vs. Control
Often, both researchers and test subjects are unaware of which group theyre in
Phase III: Further Data Collection
Up to 3,000 volunteers
Once phase III is complete, pharmaceutical company can request to market the drug/device
Background

Post Marketing trials

After drug/device is put on market, it is carefully monitored

Compared to other drugs/devices on market
FDA can take it off market or recalled if it is deemed harmful/ineffective
Controversy

AIDs Clinical Trials Group (ACTG)

Conducted in several underdeveloped countries
extensive regimen of zidovudine
Reduced the vertical transmission of HIV from mother to child from 25.5% to 8.3%
Nonetheless, still presented ethical concerns
Controversy

Denial of proven therapy

Coercion vs. Volunteering

Exploitation
Denial of proven therapy (placebo)

In any medical study, every patient, including those of a control group, if any,
should be assured of the best proven diagnostic and therapeutic method.

The treatment receiving group in the ACTG study displayed a significant

reduction of vertical transmission of HIV
However, the placebo groups received no treatment
Coercion vs. Volunteering

Subjects have no other option - desperate

Research subjects can receive in some cases a substantial sum of money

for participating
Lower socio-economic standing can influence subjects willingness
Exploitation

Research is often conducted using people of underdeveloped countries

The findings most often help people of more developed countries
Ex. The prices of the drugs found to provide treatment are too high for a third world country
citizen to afford
Often times the treatment needs to continue after the experiment concludes
Subjects risk harm to their well-being for information that a wealthier person
will be able to take advantage of
Our Stance

The role of physician and scientist must be kept separate in order to maintain a
nonbiased approach to the experiment. The scientist would perform the
randomized clinical trials while a third-party physician would assess each
patient. Clinical trials with human subjects must be conducted in accordance to
the Declaration of Helsinki making sure to address the appropriate use of
placebo groups, eliminate coercion to participate, and reduce exploitation of
subjects from Third World countries.
Physician vs. Scientist

Conflicting roles in a randomized clinical trial

Physician- act in the best interest of the patient
Scientist- finding answers to questions
If a researcher thinks that a treatment has promise (even if its not proven),
then the physician within them would feel morally obligated to give all
patients that treatment.
In turn, the reliability of the study would be lost.
As a result, these roles must be kept separate.
Patient must give informed consent.
Necessary for the continuation of medical research
United States

Regulations- legally binding

FDA- Good Clinical Practice
Guidelines for clinical research involving human subjects
Less morally authoritative- especially in areas of concern
45 CFR 46- The Common Rule
Basic Health and Human Services policy for protection of human subjects
Guidelines- morally suggested
Declaration of Helsinki
Belmont Report
Creation prompted by the Tuskegee Syphilis Study
Respect for persons, beneficence, and justice
Declaration of Helsinki
Created in 1964 by the World Medical Association
For medical research with human subjects
Most recently updated in 2013
Must be enforceable by the CIOMS
International law
Notable aspects
Appropriate compensation and treatment
All vulnerable groups and individuals should receive specially considered protection.
...only justified if the research is responsive to the health needs of the group and cannot be
carried out in a non-vulnerable group.
...group should stand to benefit...
Participation ...must be voluntary and cautious of the physician-patient relationship.
New interventions tested against those of the best proven intervention.
Reducing Exploitation

Researchers shouldnt pick subjects that wont benefit.

Have taken advantage of subjects because of their poverty and inability to obtain care
The goal of the research should be of importance to the population.
Subjects in underdeveloped countries may not be able to afford the
treatment discovered.
Must not test treatments that subjects would never be able to afford on the market.
Principle of distributive justice
Shouldnt use vulnerable populations if research could be reasonably carried
out in developed countries.
Appropriate Use of Placebo Groups

No proven intervention use of placebo or no intervention

Best proven intervention as the control group
Unproven interventions allowed with informed consent
Only if it saves their life, re-establishes health, or alleviates suffering
Essential that treatment is what subjects should have received not what
they would have received.
Reducing Coercion
Consent must be voluntary and informed
Right to refuse to participate
Without adversely affecting the patient-physician relationship
Aware of anticipated benefits and potential risks
Vulnerable groups
Third World countries- must be culturally sensitive
Responsive to education level
Appropriate compensation and treatment
Without making the benefits so lofty they amount to coercion
Objections

Physicians should not be forced to participate.

Counterargument: Physicians do not have to participate

if they do not feel comfortable.
 Objections
Underdeveloped countries contribute participants but do not
benefit.

Counterargument: The subjects would not get the

medications otherwise and they are often benefitting either
monetarily or medically.
 Objections

Participants often do not feel like they have another

choice & are not in a stable mindset.

Counterargument: Autonomy states that participants have

a right to make these decisions & are tested for mental
health beforehand.
 Objections

The Hippocratic Oath states that physicians should provide

equal treatment & beneficence.

Counterargument: The line between physicians &

scientists is very clear.
Ethical Views

Utilitarianism:

- Burden on the Individual Vs. Societal Gain from the Experiment

- AIDS Treatment: Zidovudine, lamivudine, nevirapine
- Thai CDC Trials (18.9-9.4%)
- The PETRA Trials
- HIVNET 012 Trials

Individuals involved did not experience any severe side effects from the trials

All showed a greatly reduced cost in the treatment with just about the same effect as the
original treatment

The Thai CDC and PETRA Trials used placebos instead of a viable treatment
Ethical Views: Utilitarianism Cont.

AIDS Example:

Hypothetical:

Treatments were successful but have a small chance to inflict defects

upon the child afterwards.

Role of the Physician? Scientist?

Ethical Views: Kantianism

The Humanity Formulation

- As long as the individual involved receives a direct benefit from the

treatment/procedure being tested and their dignity remains intact then we
believe that human research is acceptable.
- Randomized Clinical Trials
- Control Group
Ethical Views: Virtue Ethics

Physician as a Virtuous Agent

- On one hand the physician must tend and care for the subjects
- On the other if the physician is conducting the trial, he must not sacrifice the
research completely for the sake of the patients
Ethical Views: Natural Law Theory

Double - Edged Sword

Must maintain an ethical and humane approach to the

test subjects

Untested Experimental Drugs

Ethical Views: Principlism

- As with the human trials, we must focus on the well-being of the patient first
- Are they informed of the procedure?
- Did they volunteer themselves?
- Will they gain anything from participating?
- If not were they compensated?

Did the country or society that the trial was conducted in receive any benefit?
Discussion Questions

1. Is having a placebo group ethical?

2. Is the monetary compensation given to individuals for participating in
clinical trials a form of coercion?
3. Do you consider it exploitation if the country does not receive the treatment
their citizens were tested for, or is it just a good use of resources if the
citizens are already monetarily compensated?
4. Do you think that the role of the physician should be kept apart from the role
of the scientist, or can they be one in the same?
Works Cited
http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

http://specialtyclinics.med.sc.edu/clinical_trials.asp

https://blackboard.sc.edu/bbcswebdav/pid-9995108-dt-content-rid-23604063_2/courses/PHIL321-001-FALL-2016/Glantz
%20-Taking%20Benefits%20Seriously%20in%20Developing%20Countries.pdf

https://blackboard.sc.edu/bbcswebdav/pid-9995109-dt-content-rid-23604065_2/courses/PHIL321-001-FALL-2016/Hellma
n%20-%20Of%20Mice%20but%20not%20Men.pdf

https://docs.google.com/presentation/d/1EOTI1oRbmkzbmi8j9F2XTM5mVS7blBBXO14NbTQl_bA/edit#slide=id.g18e01f2
10c_0_0

https://blackboard.sc.edu/bbcswebdav/pid-9995111-dt-content-rid-23604064_2/courses/PHIL321-001-FALL-2016/The%2
0Declaration%20of%20Helsinki.pdf?target=blank

http://www.cdc.gov/tuskegee/index.html

https://blackboard.sc.edu/bbcswebdav/pid-9995107-dt-content-rid-23604062_2/courses/PHIL321-001-FALL-2016/Brody
%20-%20Ethical%20Issues%20in%20Clinical%20Trials%20in%20Developing%20Countries.pdf