24
Oct2012

by Elizabeth Cooper, program assistant 

October 2012 marks the 40th anniversary of the end of the 40-year-long Public Health Service (PHS) Syphilis Study at Tuskegee. Partly because of this significant milestone, the study and its legacy for the research ethics field have been on our minds here, at the PRIM&R office, and were the topics of discussion during a recent staff meeting. To stimulate our discussion, the staff read excerpts from Tuskegee’s Truths: Rethinking the Tuskegee Syphilis Study, Susan Reverby’s excellent, comprehensive collection of primary and secondary documents, which when viewed together present a range of perspectives on this infamous study.

As many readers may know, the “Tuskegee Study of Untreated Syphilis in the Negro Male” was initiated in 1932 and ran until 1972, when a whistleblower notified the press of the unethical nature of the experiments prompting an investigation and closure of the study. We noted in our staff conversation that the disregard for what we now consider basic rights of research subjects exhibited in this study was almost certainly not unique in that era. However, the public condemnation of this study marked a turning point in the evolution of research ethics attitudes and policy.

Indeed, the ethical problems of the study are so flagrant and numerous that, as we reflected on them—with the perspective afforded by 40 years—it was easy to understand how the recognition of these atrocities contributed to the development of the Belmont principles and their application in law.

During our conversation, we discussed some of the most blatant ethical problems of the study including the racist subject selection process, deceptive recruitment practices, lack of informed consent, withholding of treatment, and lack of continuing review of the study. These failures are all the more shocking in light of the fact that  the medical research community was privy to the study details throughout its 40-year duration.

Clearly, the implications of this study have been far-reaching, and our conversation led us to further probe the historical significance of the study and the reaction to it. We questioned how an atrocity such as this could have gone unexamined and unstopped for so long on the heels of the Nazi crimes involving human experimentation and  subsequent codification of the principles of ethical research in the Nuremberg Code. How could the research community tolerate such practices?

The Belmont Report was written, in part, in reaction to the PHS Syphilis study, and became the foundation for legislation governing protection of human subjects in research.  Reflecting on the protectionist pendulum swing that occurred in the aftermath of the syphilis study and in the writing of Belmont, we could not help but notice that research ethics has been and seems to continue to be born out of scandal. Therefore, how can we know when we have done “enough” to ensure that atrocities such as these do not happen again? We wondered, would we even have Belmont without the PHS Syphilis Study? Or, if not that tragedy, would some other unethical study have gained equal infamy at a later point in time to have spurred the development of human subjects protections?

As we prepare to reflect on the end of the study at our 2012 Advancing Ethical Research Conference this December in San Diego, we are aware that much progress has been made but that there is work yet to be done to protect the rights and welfare of research subjects.

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