In this module, we review three landmark cases for U.S. research ethics history and explore their impact on contemporary research practices. Today, it is routine to use residual samples collected for clinical practice, or medical records, to answer research questions. We often do this with waivers of consent (without asking or informing patients). This is changing, and our history helps us understand why….
Remember some of the fundamental ethics concepts we’ve covered so far:
Read this seminal article on the Tuskegee Syphilis study (the study was originally/officially titled “The Effects of Untreated Syphilis in the Negro Male”), which provides an overview of the study and the injustices found within the study itself and its aftermath…
Baker S.M., O.M. Brawley, L.S. Marks. Effects of Untreated Syphilis in the Negro Male, 1932 to 1972: A closure comes to the Tuskegee study, 2004. Urology (2005): http://usrf.org/uro-video/Tuskegee_2004/Tuskegee_study.html [NOTE: Embedded videos give you a bit more background and are recommended, but not required.]
As you’re reading, consider the following:
In 1932 when the U.S. Public Health Service Study of Untreated Syphillis began, there was no effective treatment for syphilis. When penicillin became available in the 1950s, researchers ‘justified’ their decision to continue the observational study without treatment because they wanted to make good on the time the men had already invested in the study. In their mind, good science required they continue to get the longitudinal data. They justified their decision further noting that men in the study were from poverty and did not have access to healthcare without the study.
- How were the research subjects harmed or otherwise treated unjustly? For instance, what obligations or rights were violated? Which virtues were neglected or failed?
- Can you imagine similar reasoning being used now, with other studies, other participants?
Then take a look at a more contemporary piece in the NYTimes, which focuses on a recent manifestation of similar norms…
Harmon A. Where did you go with my DNA? New York Times (2010): http://www.nytimes.com/2010/04/25/weekinreview/25harmon.html?_r=0
As you’re reading, consider the following:
In 1951, clinical researchers grew cells from Mrs. Henrietta Lacks’ cervical cancer biopsy. These cells became an immortal cell line that contributed to several ground-breaking health innovations, including the polio vaccine. Mrs. Lacks was never asked to contribute to research or told about the cell line. In keeping with the ethics of the day (and now), consent was not required to use residual tissues for research purposes if de-identified so no regulations or laws were broken.
- How was Ms. Lacks harmed?
- How was the Lacks family harmed?
- In 2013, European researchers published the DNA of the HeLa cell line without asking permission of the family. Later that year, UW researchers did it differently. Who had the best approach, and why?
Here is a second more contemporary piece in the NYTimes…
Harmon A. Indian Tribe Wins Fight to Limit Research with DNA. New York Times (2010): https://www.nytimes.com/2010/04/22/us/22dna.html
As you read, consider…
In 1999, an Arizona State University researcher approached the Havasupai tribe with a proposal to study genetics of diabetes, which was a condition from which many in the tribe suffered. After building relationships with tribal leaders, they gave consent for the blood draws and genetic study of diabetes, in hopes that something could be found that would help their people. The genetic analysis did not find anything specific so the samples were de-identified and frozen. Later, other researchers including graduate students in the research group used the samples for other research, such as migration patterns, schizophrenia, and inbreeding.
- How were the Havasupai people harmed by these additional uses of their samples?
- What could be done differently to bridge the gap between research regulations and what the tribe needed for ethical research conduct?
As always, your Ethics Resources are there to help guide your reasoning in these complex moral issues. Remember to push yourself by considering how a skeptic might respond!
For further investigation…
You can see the OHRP Guidance on Research Involving Coded Private Information and Biospecimens: http://www.hhs.gov/ohrp/policy/cdebiol.html.
The Belmont Report is a thorough report on the ethical principles and guidelines for research with human subjects. It was a significant interdisciplinary effort in response to grievous harms on human subjects as seen above. You can find it here: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.
Lastly, see this fantastic TED Talk on the demand for diversity in genetic research and why current research is insufficient: Fox K. Why genetic research must be more diverse. TED Talk, February 2016. ted.com/talks/keolu_fox_why_genetic_research_must_be_more_diverse.