Advancing science, while protecting patients
Clinical trials can offer a glimmer of hope for patients, especially when their options appear limited. Trials are conducted in a variety of clinical areas at Cape Cod Hospital and Falmouth Hospital for a variety of diseases and conditions, and, for every one, there is a quiet, guiding light: the Institutional Review Board (IRB).
The group, representatives of the community and Cape Cod and Falmouth hospital, oversee each clinical trial and decide which of the dozens each year will be conducted. While the issue is a critically important component of healthcare today, the Cape’s IRB does its work quietly, with no fanfare.
“It’s all about protecting the rights of human subjects,” says Spiros Thomas, current co-chair with Walter Rymzo, MD of the IRB. Each clinical trial must comply with institutional, ethical, and federal guidelines that serve to protect human subjects from harm and keep subjects’ information confidential.
IRB members are chosen with great care – there are currently 15 members – to represent the myriad issues involved, including medical, ethical, and legal. Thomas formalized the local IRB in 1982, when he moved from Boston (where he had served on an IRB) to become pharmacy director at Cape Cod Hospital. One of the first people he recruited was Martha Ramsey, a Hyannis attorney who became a crucial IRB member.
Thomas recognized that a critical part of the IRB membership should be a nonmedical person, like Ramsey.
A local attorney since 1985, Ramsey brought with her an expertise in informed consent. She stepped down from the board recently, and sat down with Thomas and a OneCape Health News writer to reflect on the IRB’s work.
“The great thing about Cape Cod Healthcare is the caliber of the studies we’re doing here,” Ramsey said. “It can be a pretty tough choice if the only way you can participate in a study is to go to Boston.”
Joining the IRB was a natural for Ramsey.
“In the early years in my career, I was concentrating my practice in guardianship and incapacity cases; dealing with the interaction between the medical community and legal community and informed consent,” she said
Growing up in Hyannis, she left to attend college in Washington, D.C., and moved back when her husband, D.J. Ramsey, bought Hyannis Pharmacy and Medi-Aids. Today she considers herself semi-retired.
“My career has shifted,” she said. “I have a lot of clients I take care of, as opposed to building a practice.”
She has served on the boards of the Hyannis Public Library and Town of Barnstable Council on Aging, among others. She was the first president of Elder Services of Cape & the Islands under the age of 50. She will remain on the board of the Cooperative Bank of Cape Cod, which she has been on since around 1990. When asked how she accomplished so much, Ramsey laughed lightly. “You just have to get up early.”
The vigilance and oversight that the IRB must maintain over local clinical trials – the oncology area alone at Cape Cod Healthcare has hosted more than 100 trials through the years – are crucial to its success. The local IRB goes above and beyond to fulfill its mission, said Thomas. “Looking at IRB requirements, we are way over the top (of what is required)” he said. “That is representative of our commitment.”
Thomas knows that a big part of that commitment and excellence has come from Ramsey.
“Why did you stay for 25 years?” he asked her during their get-together to discuss her tenure on the board. Ramsey paused in thought. “I think why I stayed on was the overriding concern to protect human subjects, she said.
Thomas agreed that IRB members must first and foremost consider the human element of medical trials and be committed to the value they can have to advancing treatment.
“To do the work of the IRB, you have to have a giving-back commitment,” he said. “You have to say, “I’m going to give this knowledge to the community. I know the process and want to share it.”
He then glanced at Ramsey and said “she has it.”