Community discusses ethics of biomedical research

The modern biomedical industry might not exist in its present form if not for the contribution of Henrietta Lacks, a Virginia tobacco farmworker who died of cervical cancer in 1951. Cells from her tumor biopsy became the first “immortalized” human cancer cell line: They grow in culture and reproduce indefinitely.

That cell line has been instrumental in countless studies since then, and is still used in laboratories around the world today. However, no one thought to ask Lacks for permission to use her cells in research, and neither she nor her family was ever compensated. Her story has become a touchstone in the debate over patients’ rights.

A special screening of “The Immortal Life of Henrietta Lacks,” a movie based on her life, was held on April 26 in the Jacobs School of Medicine and Biomedical Sciences to mark National DNA Day. Following the movie, a multicultural, multidisciplinary panel took part in a community-wide conversation about perceived barriers to participation in biomedical research, including issues of consent, privacy and trust.

The audience of about 250 included faculty and staff from the Buffalo Niagara Medical Campus and visitors from the surrounding Fruit Belt neighborhood.

The panel was moderated by Rev. Kinzer Pointer, pastor of Buffalo’s Agape Fellowship Baptist Church and chair of the Erie County Poverty Committee, and Timothy Murphy, SUNY Distinguished Professor of Medicine and director of UB’s Clinical and Translational Science Institute (CTSI).

“These cells launched a biomedical industry and led to landmark discoveries,” said Murphy. “However, if we as researchers are going to truly achieve our mission to improve health outcomes and reduce health disparities, it is critical for us to engage our community and value their participation.”

The event was sponsored by UB’s Genome, Environment and Microbiome (GEM) Community of Excellence. Jennifer Surtees, associate professor of biochemistry, is co-director. “We were particularly pleased to be able to hear directly from the community around UB to acknowledge and hopefully begin to address very real and valid community concerns,” she said. “Ultimately, we hope that these conversations will have a direct impact on the way that we improve and engage more people in the research process.”

The event was co-sponsored by UB’s CTSI, Mini Medical School and the Patient Voices Network, a patient advocacy group.

“From GEM’s perspective, it is important to foster conversations about how and when genetic information should be used, as well as exploring the issues of privacy with respect to this kind of very personal information,” said Surtees.

The current regulatory framework for human subjects research did not exist in the 1950s. Public outrage over the notorious Tuskegee Syphilis Study led to the creation of a national commission in 1972 to establish guidelines for federal regulations.

In 1974, Institutional Review Boards (IRBs) were mandated at all universities and medical centers that receive federal funding to conduct human research. IRBs review study plans in terms of risks and benefits, enforce full disclosure on the part of investigators, ensure the collection of signed patient consent forms and require training for clinical researchers in ethics and good clinical practice. IRBs consist of scientists and non-scientists, and must include at least one community member unaffiliated with the institution conducting the research to represent the interests of patients.

Kyle Mann, an IRB administrator in UB’s Office of Research Compliance, was one of the panelists at the film screening. He said that in addition to providing complete disclosure, investigators are required to write patient consent forms in plain, easily understood language rather than scientific jargon. “If we can understand one another,” he said, “we can trust one another.”

Teresa Edgerton, another panelist, is an instructor in the Nursing Department at Trocaire College, where she has conducted patient recruitment for clinical trials and teaches courses on professional ethics. “Above and beyond trust, understand that we now have laws in place to prevent what happened in the past,” she told the audience. “Back then we didn’t have IRBs and we didn’t have federal laws in place. Know that there are laws to prevent patient harm.”

Still, neighbors who came to the movie screening had some pointed questions for the experts. They wanted to know whether the panelists thought patients ought to be compensated for participating in clinical trials (most studies today do provide some form of compensation for participants), and what kind of training medical professionals receive in terms of interacting with African-American communities.

Pointer told the audience about a new course he’s teaching at the Jacobs School called Health in the Neighborhood. “The whole purpose of the course is to bring medical students off of the campus, out of the clinical setting, and remind them that you don’t just treat disease, you treat people,” he said.

“Trust isn’t something that comes easy,” said Veronica Meadows-Ray, a community consultant to the Jewels in our Genes study, the first national study of genes that increase breast cancer risk in African-American families. “Generally, it’s a byproduct of a relationship, a relationship that has good communication. What scientists and organizations like the CTSI are trying to do is to get the community involved, to help build relationships and strengthen the bonds of trust between the medical community and the wider community.”

Heather Ochs-Balcom, associate professor in the Department of Epidemiology and Environmental Health, is principal investigator on the Jewels in our Genes project. “As consumers and as patients we need to do a little work on our end so that when we get into that office we’re not afraid to ask questions,” she said. “But that doesn’t always happen.” She recommended inviting a patient advocate to the doctor’s office or hospital to act as a “middleman” to keep communication channels open.

One woman from the audience asked a question that was probably on a lot of peoples’ minds after watching the movie: “Do you think that if Henrietta Lacks had been a Caucasian American that her treatment would have been different?”

Panelist Michael Garrick, professor of biochemistry in the Jacobs School, is uniquely suited to answer that question. He completed his postdoctoral work at Johns Hopkins University with the scientists who developed the HeLa cell line. Later, he came to UB and developed a test for sickle cell anemia that has become mandatory for every child born in New York State.

“Hopkins gave her the standard best treatment for such a very, very bad case of cancer, as good as you could get probably anywhere in the world,” he said. “On the other hand, they treated her like she was deaf and dumb, by and large. Her treatment as a human being left a great deal to be desired. Even though I’m proud of the institution, the learning curve needs to improve.”

“This is the beginning of the discussion,” added Pointer, “not the end.”

In closing, Surtees said, “We will continue to work together to design opportunities for the community to engage more with researchers in these kinds of programs.”