What is DES?
When was it developed?
Where was it developed?
Why was it developed?
To prevent spontaneous
Where was DES studied?
University of Chicago
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
The study was controlled
Concluded: DES-treated women had more
miscarriages and premature births than those who
did not receive DES had healthier babies.
Conducted in the 1950’s.
Chicago University Lying-In
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?
The women in this study did not know that the study
was taking place and did not know about the study.
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.
The women did not have the choice to participate or
decline participation in the study.
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
The women did not have self-determination prior to or during the study
Should this study have been
No, this study should not have been
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)
Should the data results from this study
Yes, the data can be used with caution.
:Adverse pregnancy outcomes were not
reduced in women who were given DES= it
did not reduce the risk of miscarriage or
Why should it be used?
No benefit to refraining from publication
No further harm can be caused by publishing the
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
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
The field as a whole is judged by the misconduct of
a few individuals who conducted a study in an
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.
Obtain Informed Consent
Allow for self-determination
Identify Risk and Benefit
Inform participants of potential risk and
Do a literature study prior to conducting
research in any way for this particular