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The second thing that makes informed consent complicated is the “informed” part. Scientists making a conscientious effort to secure informed consent must wrestle with translating complex issues for a lay audience. A section of The Immortal Life of Henrietta Lacks describes Hopkins researchers, including renowned geneticist Victor McKusick, Med ’46, taking blood samples from members of the Lacks family in 1976. McKusick and his assistant at the time, Susan Hsu, were searching for DNA markers that could identify HeLa cells in any lab sample. They could not recall for Skloot how well they had informed Deborah Lacks about why they wanted some of her blood. But years later Lacks told Skloot that she believed she had submitted to a test for cancer. Hsu recalled for Skloot giving David Lacks, Henrietta’s husband, a technical explanation of why she wanted to draw blood, using terms like “HLA androgen [sic],” “genetic marker profile,” and “genotype.” David had a fourth-grade education. Did Hsu inform him, or baffle him? Says Skloot, “People get this stuff if you can explain it to them clearly. There is a science literacy problem, but there’s a bigger problem with a lack of communication from the scientists. If you go to a hospital and you don’t speak English, you’re going to get a translator—French, Spanish, whatever. If you walk in and you don’t speak science, they’re not going to call in the science translator who says, ‘Let me help explain this to you.’”
Finally, current consent regulations cover only studies done by researchers who have firsthand contact with tissue donors. If you are a scientist working with anonymized tissue samples taken from a repository, that is not considered research on a human subject and no informed consent is required.
Ruth Faden, director of the Berman Institute, raises one more ethical issue: when to ask for informed consent. Is it proper, when patients are about to undergo surgery and have to deal with consent for the operations, to present them with another set of decisions regarding what might be done with their tissues? Faden recently had surgery to repair her shoulder’s rotator cuff; she notes that like anyone, she has a finite amount of emotional energy, and in this case wanted to apply it to thinking clearly about her impending procedure, not what might be done with some of “the gunk,” as she puts it, that was cleaned out of her shoulder. Says Scott, “How much are people going to be paying attention? They’re under stress from their condition, then you’ve got this other thing that you shove underneath their noses.”
IN THE JANUARY 30, 1976, issue of Science, McKusick co-authored a paper, “Genetic Characteristics of the HeLa Cell.” That paper published the analysis of the blood drawn from Deborah Lacks and others in her family and listed 43 genetic markers found in the Lackses’ DNA. The paper identified Henrietta and listed family members as “Husband,” “Child 1,” and “Child 2.” Your DNA reveals who you are in the most fundamental sense—your genetic abnormalities if you have any, your predisposition to certain diseases such as breast cancer, whether your parents are really your parents or your sister is really your sister. Today no ethical researcher would publish the sort of genetic information complete with identifiers that McKusick published in 1976.
The Immortal Life of Henrietta Lacks reports other examples of violations of the Lackses’ privacy. For example, someone, presumably at Hopkins, gave Henrietta’s medical records to journalist Michael Gold, who quoted from them in his 1985 book A Conspiracy of Cells: One Woman’s Immortal Legacy and the Medical Scandal It Caused. According to Skloot, no one in the Lacks family had ever seen those records or given permission for their release. Gold included a stomach-churning description of Henrietta’s autopsy. He later told Skloot that he recalled unsuccessful attempts to contact the family; she quotes him as telling her, “And to be honest, the family wasn’t really my focus. . . . I just thought they might make some interesting color for the scientific story.”
The privacy of medical information remains an ever-growing concern as biomedical research, both academic and commercial, has burgeoned. In 1999, RAND Corporation estimated, in a monograph titled Handbook of Human Tissue Sources, that 307.1 million human tissue samples were stored in various repositories throughout the United States. No doubt that number is significantly larger today. The term “biobank” has entered the lexicon. A biobank is a collection of human tissue, like a living database of human cells. National biobanks now exist in Estonia, Canada, Japan, Latvia, Singapore, Sweden, Iceland, and the United Kingdom. Biobanks have been created by disease advocacy groups, commercial research companies, and academic centers such as Howard University, which founded the National Human Genome Center to foster genomic research on African Americans and African diaspora populations. “Recently, there’s a biobank on every corner,” says Scott. “That may be a slight exaggeration, but not by much.”