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Diethylstilbestrol Studies with Ethical Violations

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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/

Published in: Health & Medicine
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Diethylstilbestrol Studies with Ethical Violations

  1. 1. Lacey-Clemens Friday Nicole Skrabacz Heather Perez
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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