In this module, we review two 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….
Start by reviewing the Ethics Case Analysis Toolkit…
Remember some of the fundamental ethics concepts we’ve covered so far:
Read this seminal article on the Tuskegee Syphilis study, which explores how racism impinges on research in a myriad of ways…
Allan M. Brandt. 1978. Racism and research: The case of the Tuskegee Syphilis study. The Hastings Center Report 8(6): 21-29. https://dash.harvard.edu/bitstream/handle/1/3372911/brandt_racism.pdf?sequence=1
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.
- Were the research subjects harmed or otherwise treated unjustly? How so? For instance, what obligations or rights were violated? Which virtues were neglected or failed?
- What is your assessment of this reasoning? How would you characterize the researchers justification? Were they referencing rules, rights, responsibilities, harms/benefits assessments?
- Can you imagine similar reasoning being used now, with other studies, other participants? What is at stake with this line of reasoning? What are other, counter-arguments you could use? In your analysis, refer to rules, principles, or benefit/risk assessments.
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.
- Was Mrs. Lacks harmed? Why or why not? How so?
- Was the Lacks family harmed? Why or why not? How so?
- 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?
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!