Internal approvals, known as “institutional review board” or “internal review board” approvals, are required for all research involving human subjects. In their retractions, the newspapers called the problems a “serious problem”.
Arroyo was a professor at Harvard Medical School and director of the 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 he was made aware of 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 preferred not to discuss the retractions and said he preferred not to say anything about when he was leaving BIDMC.
“It’s a complicated question, and all I can say is that people make mistakes,” he said.
He later added in a statement that the items were removed “as part of my cooperation with Beth Israel Deaconess Medical Center in their review of this matter.”
Retractions include studies that used noninvasive technology to measure blood flow in the retina, dozens of people who received oxygen through face masks for several hours, and volunteers who inhaled rich air in CO2, 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 Beth Israel Deaconess Medical Center Eye Clinic. Another used subjects diagnosed by retina services at Beth Israel Deaconess Medical Center.
Beth Israel Lahey Health, the parent company of BIDMC, said the hospital did not notify patients who participated in the retracted clinical trials because they were receiving supplemental oxygen as part of their clinical care and not just in the part of a clinical trial. The health system also said the patients consented to the treatment and were not harmed by the treatment. The health system noted that Arroyo no longer worked for the hospital.
“We adhere to the highest research standards and rigorously maintain the integrity of our research,” said BILH spokesperson Terri Janos. “Any concerns are carefully considered in accordance with institutional policies and applicable regulations.”
The Clinical Investigations Committee, which oversees clinical trials at BIDMC and functions as the institution’s IRB, did not respond to requests for comment. Harvard Medical School referred the questions to BIDMC, saying the institution oversaw the research.
Industry experts have expressed concern about retractions and said seeking IRB approval is so fundamental to conducting clinical trials with human subjects that it is almost trivial.
“You can’t recruit research subjects without IRB approval, and it knows that,” said George Annas, director of the Center for Health Law, Ethics & Human Rights at Boston University School of Public Health. “People hate IRBs, they think they’re bureaucratic. But they understand that it is essential. If you want to be a researcher, you go to the IRB. Usually you say that on every request that goes to a log, it’s been approved by the IRB. … This is not a trivial omission.
Arroyo is also not new to clinical research. According to his biography with Boston Vision, he has published more than 60 studies in peer-reviewed journals.
Institutions that conduct research involving human subjects typically convene a panel of experts who must review clinical trials before they begin. According to the Food and Drug Administration, which has developed regulations on the operation of institutional review boards, this board reviews research protocols, consent documents, investigator brochures, etc., to protect the rights and well-being of people who agree to participate.
The BIDMC Clinical Investigations Committee stipulates that before the Committee reviews a research proposal, the proposal is analyzed by the Scientific Review Officer, assessing whether there is merit to justify the use of human subjects, that the risks of clinical trials with humans outweigh the benefits, that the potential risks have been accurately and completely described in the consent form, and that there is adequate oversight of the safety of the research.
More importantly, IRB reviews help patients tell the difference between things that are treatment and things that are research, Annas said.
“You need outside experts to distinguish between research and treatment, and whoever is doing the research knows what they’re doing,” Annas said.
Providing oxygen is also not so trivial that it does not require supervision. Annas said the risks of large amounts of oxygen are well known, and 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 is usually done before people are recruited for a trial. Even studies involving polls must be approved by the IRB.
“There are historically horrific examples where things under the name of research have 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 take are worth it.”
Art Caplan, a bioethicist at NYU Grossman School of Medicine, said no regulations require researchers or institutional review boards to notify patients who participate in retracted research, but scientists have an ethical duty.
“When you recant, you have an ethical duty to tell the subjects what happened,” Caplan said. “Why was their participation in vain?