Written by Katie Wiedeman, MSW candidate, Brown School and practicum student at the Center for Community Health Partnership & Research at the Institute for Public Health
In 1951, Henrietta Lacks, a 31-year-old mother of five children from Virginia, went to Johns Hopkins University to seek treatment for her new diagnosis of cervical cancer. She went to this hospital specifically because it was one of the only in the area at the time, that treated Black people. While there, some of her cells were extracted without her knowledge or permission, and these cells were found to be the first ‘immortal’ line. These ‘immortal’ cells duplicated rapidly and continuously, providing scientists with a key discovery. They would become the foundation for a number of advances in modern medicine, including the development of vaccines and cancer treatments. In fact, these cells, known as HeLa cells, even traveled to space and were the foundation for three Nobel Prize-winning studies!
However, the collection of cells and subsequent research were found to be conducted without Henrietta Lacks’ permission or awareness. Her family did not find out for another twenty years. In addition, the Lacks family has not received any financial compensation even though the cells have been used to create many new treatments and products. These ethical concerns are important considerations for informed consent.
Since 1991, the standard for research ethics has been outlined in the ‘Common Rule,’ a set of provisions created by the U.S. Department of Health and Human Services and the Food and Drug Administration to protect human subjects. The ‘Common Rule’ standardizes best practices for informed consent, but more importantly, it has somewhat different regulations for biological or blood samples, such as those collected from Henrietta Lacks. According to the ‘Common Rule,’ as long as these samples were collected for some other reason (such as for diagnosis or a different study), these samples can be used without getting consent. This stipulation is, however, based on the premise that the samples are unidentified and that information obtained from their analysis could not be used to identify their origin. However, there is some concern that, due to technological advances, future identification of samples could be possible. In that situation, these rules would need to be revised.
Since the popularization of Henrietta Lacks’ story, a number of changes have been made in medical policy and ethics. In 2013, in response to the first full sequence of the HeLa genome, the National Institutes of Health created a six-member panel, including two members of the Lacks family, to review any requests for utilizing the genome sequence. In addition, the ‘Common Rule’ was revised in 2017 to require that informed consent paperwork is clear and understandable. Researchers themselves can now take action in their own work to ensure that their processes, especially informed consent, are communicated simply and clearly.
To this end, the Center for Community Health Partnership & Research has a helpful library guide with more information and informational toolkits about health literacy. These strides and the story of Henrietta Lacks exemplify the message at the heart of community-engaged research – that community members should have a thorough understanding of their participation and informed consent should always be clear and fully understood.