A former Harvard professor and Beth Israel Deaconess Medical Center doctor has had eight research studies or abstracts retracted by three different medical journals for problems with critical oversight approvals for the research.
The retracted studies, led by ophthalmologist Dr. Jorge Arroyo, include one published in Wiley Online Library in June 2021 that was retracted in February because the study was conducted in a way that differed from the protocol approved by BIDMC. Another study, published in March 2021 in Translational Vision Science & Technology, was retracted in March for failing to obtain institutional approval at all.
Six abstracts — summaries of clinical trials — that were led by Arroyo and presented at the Association for Research in Vision and Ophthalmology Annual Meetings in 2019, 2020, and 2021, were published in Investigative Ophthalmology & Visual Science journals and also were retracted in March for either failing to obtain approvals at all or failing to stick to the approved procedures.
Internal approvals, known as “institutional review board” or “internal review board” approvals, are required for all research involving human subjects. In their retractions, the journals called the problems “a serious issue.”
The news was first reported by the blog Retraction Watch.
Arroyo was a Harvard Medical School teacher and director of Retina Service at Beth Israel Deaconess Medical Center for 18 years. According to his LinkedIn page, he left those positions in December 2021. That same month, Wiley said they were notified of the IRB issues.
Arroyo now works as a vitreoretinal surgeon for Boston Vision, a private practice with multiple locations in Massachusetts, according to the company’s website.
When reached by phone, Arroyo said he would rather not discuss the retractions and said he preferred not to say anything about the timing of his departure from BIDMC.
“It’s a complicated issue, and all I can say is people make mistakes,” he said.
He later added in a statement that the articles were retracted “as part of my cooperation with the Beth Israel Deaconess Medical Center during their review of this matter.”
The retractions include studies that used noninvasive technology to measure blood flow in the retina, dozens of people given oxygen through face masks for several hours, and volunteers who inhaled CO2 rich air, oxygen, and a medical gas mixture of carbon dioxide in medical oxygen to study changes in the eye.
At least one study recruited patients from the Beth Israel Deaconess Medical Center Eye Clinic. Another used subjects diagnosed by Beth Israel Deaconess Medical Center’s retina services.
Beth Israel Lahey Health, the parent company of BIDMC, said the hospital did not inform patients who were in the retracted clinical trials because they were receiving supplemental oxygen as part of their clinical care and not just through a clinical trial. The health system also said the patients consented to the treatment and weren’t harmed by the treatment. The health system noted Arroyo no longer worked for the hospital.
“We uphold the highest research standards and rigorously maintain the integrity of our research,” said Terri Janos, a spokeswoman for BILH. “Any concerns are thoroughly reviewed in accordance with institutional policies and applicable regulations.”
The Committee on Clinical Investigations, which oversees clinical trials at BIDMC and functions as the institution’s IRB, did not respond to requests for comment. Harvard Medical School referred questions to BIDMC, saying the institution oversaw the research.
Industry experts voiced concern about the retractions and said seeking IRB approval is so fundamental to conducting clinical trials with human subjects that it is almost mundane.
“You cannot recruit research subjects without IRB approval, and he knows that,” said George Annas, the director of the Center for Health Law, Ethics & Human Rights at Boston University School of Public Health. “People hate the IRBs, they think they are bureaucratic. But they understand it is essential. If you want to be a researcher, you go to the IRB. Usually you say that on every application that goes to a journal, that this was approved by the IRB. … That is not a trivial omission.”
Arroyo is also not new to clinical research. According to his biography with Boston Vision, he has published over 60 studies in peer-reviewed journals.
Institutions that conduct research involving human subjects typically convene a panel of experts that must review clinical trials before they commence. According to the Food and Drug Administration, which has developed regulations overseeing how institutional review boards function, this board reviews research protocols, consent documents, investigator brochures, and more to protect the rights and welfare of the people who agree to participate.
BIDMC’s Committee on Clinical Investigations stipulates that before the committee reviews a research proposal, the proposal is analyzed by the scientific review officer, evaluating if there is merit to justify using human subjects, that the risks of clinical trials with humans outweigh the rewards, that the potential risks have been accurately and fully described in the consent form, and that there is adequate safety monitoring of the research.
Most critically, IRB reviews help patients differentiate between things that are treatment and things that are research, Annas said.
“You need expert outside people to distinguish between research and treatment, and that whoever is doing the research knows what they are doing,” Annas said.
Delivering oxygen also isn’t so innocuous as to not require oversight. Annas said the risks of high amounts of oxygen are well known and said premature babies given too much oxygen are at risk of going blind.
Dr. Steven Woloshin, founder of the Lisa Schwartz Foundation for Truth in Medicine, said IRB approval typically is conducted before people are recruited for a trial. Even studies involving surveys must go through IRB approval.
“There are historically horrible examples that stuff under the name of research has gone horribly wrong,” he said. “The idea is to protect people and the system works so people feel good about being involved and the risks they are taking are worthwhile.”
Art Caplan, a bioethicist at NYU Grossman School of Medicine, said there are no regulations that require researchers or institutional review boards to notify patients who participate in retracted research, but scientists have an ethical duty.
“When you retract, you have an ethical duty to tell subjects what happened,” Caplan said. “Why was their participation in vain?”
This story has been updated to reflect that news of the retractions was first reported by the blog Retraction Watch.