1950’s illegal studies that violated the Hippocratic Oath, the Nuremberg Code, and the Declaration of Helsinki. by Lacey-Clemens Friday, Nicole Skrabacz, Heather Perez Read http://diethylstilbestrol.co.uk/des-tested-on-pregnant-women-without-consent/

1. Lacey-Clemens Friday
Nicole Skrabacz
Heather Perez

2. What is DES?
 Synthetic Estrogen
When was it developed?
 1938
Where was it developed?
 London
Why was it developed?
 To prevent spontaneous
abortions
Where was DES studied?
 Harvard University
 Tulane University
 University of Chicago
Common Uses:
 Prevent miscarriages
 Treat Pregnancy
Disorders
(Preeclampsia)
Diethylstilbesterol

3. What did the DES studies
include and conclude?
 Study conducted in 1940
 Harvard University Physicians
 The study was not controlled
 Concluded: DES was effective against
complications in pregnancy and contributed to a
healthier maternal environment.
 Study was conducted in 1950
 Tulane University
 The study was controlled
 Concluded: DES-treated women had more
miscarriages and premature births than those who
did not receive DES had healthier babies.

4.  Conducted in the 1950’s.
 Chicago University Lying-In
Hospital
 Clinical Trial
½ the women received DES
and ½ were given a placebo
University of Chicago
DES Case Study Consideration
What was the hypothesis?
 Women who are treated with DES
will have LESS miscarriages and
premature births in comparison to
mothers who had not used DES
Who would have benefited
from the case results?
 The population as a whole,
physicians, and women who were
being treated with DES or had the
potential to be treated with DES
What are the ethical violations in this case?

5. Ethical Violations
Informed Consent
The women in this study did not know that the study
was taking place and did not know about the study.
Voluntary Participation
These women did not choose to participate in the study.
Failure to prevent unnecessary harm
The Tulane University study should have been
considered before proceeding with this case and
ultimately leading to harm.
 Self-determination
The women did not have the choice to participate or
decline participation in the study.

6. Ethical Violations
Declaration of Helsinki
A statement of ethical principles involving human subjects
Developed by the World Medical Association
Physician first researcher second?
DES DECLARATION OF HELSINKI VIOLATIONS
 The risk and benefits were not weighed in this study.
 The loyalty of the doctor did not lie with the women, but to research and the general
population.
 The women did not have self-determination prior to or during the study

7. Should this study have been
conducted?
No, this study should not have been
conducted…
 Sacrificed the health of millions for the potential to do good
 Irresponsible research conduct
 The benefits did not outweigh the risk
 Women were not given the opportunity to exercise their freedom to choose (informed
consent, voluntary participation, self-determination)
 Violated the Hippocratic Oath, the Nuremberg Code, and the Declaration of Helsinki
 Risk of harmful health effects (later studies suggested cancer was a result of the babies that
were exposed in utero)

8. Should the data results from this study
be utilized?
Yes, the data can be used with caution.
Results
:Adverse pregnancy outcomes were not
reduced in women who were given DES= it
did not reduce the risk of miscarriage or
pregnancy problems.
Why should it be used?
 No benefit to refraining from publication
 No further harm can be caused by publishing the
data
 The harm and suffering that took place would have
been caused with no true benefit.
 Data may have been the same even if the ethical
violations would not have occurred.
 The data prevents FUTURE harm.
The actions of the researchers are in no way excusable in this case

9. What are the professional implications?
The utilization of ethical codes, principles, and
guidelines in the development of professional
research is increased.
Violators are penalized more harshly.
Distrust for the medical professionals involved can
impact the professions ability to conduct future
research.
The field as a whole is judged by the misconduct of
a few individuals who conducted a study in an
unethical manner

10. What are the implications for subjects?
Health Risks for mothers and infants
-There are several studies that have been conducted
that determined that exposure to DES in utero caused
health risks in the adult exposed children (CANCER)
 Protections and interventions were established with
the results of this data in reference to the use of DES.
 Future harm reduced
Individuals have to be active in own care and question
physicians who are prescribing medications and the
purpose behind the medication.
Valid reason for mistrust in medical professionals and
in research that is done ethically is discredited.
The belief above is passed on in the family.

11. Study Redesign
 Obtain Informed Consent
Allow for self-determination
Identify Risk and Benefit
Inform participants of potential risk and
benefits
Do a literature study prior to conducting
research in any way for this particular
study