By Hannah Edelman
Boston University News Service
In the year since the World Health Organization officially declared COVID-19 a pandemic, biomedical research has undergone an unprecedented evolution. The timeline of the vaccine development and roll-out is the fastest in history, with the Pfizer-BioNTech shots “in arms” less than a year after the virus was first genetically sequenced.
On average, vaccines take nearly 10 years to pass through the Food and Drug Administration’s four-phase development process, according to the College of Physicians of Pennsylvania.
This rapid speed raises a new question: is COVID-19 changing research ethics?
The answer, according to Massachusetts Society for Medical Research President James O’Reilly, is no.
“It’s not really just a miracle that came out of the blue,” O’Reilly said in an interview. “It’s the result of many, many years of hard work and dedication.”
O’Reilly referenced the recently authorized Johnson & Johnson vaccine. This vaccine evolved from pre-existing research on viral vector vaccines. While the initial study was focused on potential cures for viruses such as Ebola, O’Reilly said that the head researcher pivoted his work, applying it to the novel coronavirus strain.
Similar to O’Reilly, Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said that despite the vaccine’s speedy implementation, research standards have not changed.
Current and future research ethics was a central discussion point during the University of Minnesota’s Annual Research Ethics Day Conference in early March 13 panelists spoke to a virtual audience on the theme of “Ethics in Emergency.”
Regarding the issue of vaccine development speed, panelists said that the rapid pace was due to prioritizing the COVID-19 pandemic; vaccine regulations were not compromised.
For example, Minnesota’s Institutional Review Board, a group required by the FDA to approve all biomedical research involving human subjects, created a separate panel designated specifically for COVID-19 studies. It also shifted its review and informed consent processes online.
These accommodations were built upon a consideration of scientific and social values, Christine Brady, chief of the department of bioethics at the National Institute of Health, said during a panel discussion. She referred to the overlap of research phases as an outbreak paradigm — one that is necessary because there is “so much at stake.”
There are other notable factors unique to the development of the COVID-19 vaccine besides the outside pressures of pandemic conditions. For instance, the three FDA-authorized vaccines all utilize “next-generation” technologies such as messenger RNA. Until now, these vaccines have never been successful.
However, the quick release of the vaccine can have unintended consequences.
As Dr. Nneka Sederstrom, chief health equity officer at Hennepin Healthcare in Minneapolis, said, diversity and inclusion are often pushed to the sideline for the sake of speed.
As a result of the speedy creation and disbursement of the vaccine, many minority communities feel overlooked. This manifests most significantly in the distrust by Black, Indigenous and people of color (BIPOC) individuals of vaccine research and roll-out efforts.
“Research has always struggled with communities of color because of distrust born from over 400 years of oppression and dehumanization,” Sederstrom said.
One such instance often cited by members of the BIPOC community is the Tuskegee Study of 1932, which sought to document the progression of untreated syphilis in Black men.
As part of the study, a group of 600 Black men volunteered to be treated for “bad blood,” a local term for illnesses such as syphilis and anemia. They received free medical care, meals and burial service in exchange for their participation.
Unbeknownst to them, two-thirds of the men had syphilis. The researchers refused to treat the misled subjects, even after the widespread development of drugs like penicillin. The study — initially slated to last for 6 months — went on for 40 years.
Sederstrom said that, in order to address the “historical trauma,” researchers need to implement explicitly anti-racist policies and make a concerted effort to include BIPOC individuals in the research process. She also proposed including race as a factor in vaccine distribution, as non-white people often don’t live to the arbitrary cut-off age of 65.
“We used warp speed to work on ending the COVID-19 pandemic; I am urging us to use the same warp speed to work on addressing the COVID-19 pandemic,” Sederstorm said, referencing the year the first slaves were taken to the U.S.
Fellow panelist Abigail Echo-Hawk, a member of the Pawnee Nation of Oklahoma and director of Urban Indian Health Institute, said that these “historical injustices” necessitate a change to the way society looks at the issue of equity, a topic which “requires us to be uncomfortable.”
Echo-Hawk proposed a shift away from the traditional debate of culture versus science towards a practice of cultural rigor that would prevent researchers from circumventing legal steps for tribal research protection. One potential example would be engaging of the entire community in the research process, she said — a stark contrast to the shipment of body bags her community received at the beginning of the pandemic instead of personal protective equipment.
“Come to us because you think we have the answers, not because you think we have all of the problems,” Echo-Hawk said.