Dr. Kang Zhang, an acclaimed eye doctor at UC San Diego and the Chief of Ophthalmic Genetics at the Institute of Genetic Medicine, was recently suspended by the university following a routine Food and Drug Administration inspection which found Dr. Zhang to be practicing studies under “objectionable conditions.” The FDA audit has previously gone unnoticed before an investigation by inewsource made the information public.

Before the incident, Dr. Zhang’s work included the removal of cataracts from infants and stem cell regeneration. Additionally, he has a lab named after him on campus at UCSD, and he had traveled across the country for speaking engagements as a leading expert in the field of ophthalmology.

In 2017, the U.S. Food and Drug Administration issued Dr. Zhang a warning letter for practicing under “objectionable conditions.” The letter cited that some of his test subjects did not meet specified eligibility requirements, there was a lack of details in his plan for implementing additional procedures and measures during his studies, and there was a failure to account for “the [disposal] of unused supplies of the study drug” in his study logs.

Dr. Zhang’s lab did not respond immediately to emails from the UCSD Guardian regarding the incident. A follow up email from Jacqueline Carr, the Assistant Executive Director of Communications at UC San Diego Health, confirmed that Dr. Zhang is on leave, however “he remains on faculty and retains all current titles. Dr. Zhang is suspended indefinitely from serving on all UCSD IRB protocols.”

Carr concluded her email by saying that the investigation for this case is ongoing.

Likewise, Scott LaFee, the Director of Media Relations at UC San Diego Health, issued a media statement stating that Dr. Zhang was “suspended from serving as a principal investigator on any clinical protocols.”

Dr. Spencer Hey, a faculty member at the Harvard Center for Bioethics who has published many articles on ethics in the medical field, has recently spoken out on Dr. Zhang’s case.

“What I found troublesome was that the FDA report mentioned asking Zhang and his team if they were aware of the requirements, and they seemed to not know,” Dr. Hey told the Guardian.

Dr. Hey also noted a bigger issue about the lack of oversight that universities have in medicinal research.

“I think that the university bears the responsibility to some extent for overseeing activities that are going on at their institution,” Dr. Hey said. “There are no adequate checks. Some necessary steps that universities need to take [are] to have more regular lab checks and regular audits.”

Dr. Hey mentioned that it is important to preserve trust and research interest, which he proposes addressing by having ethics officers working alongside both the researchers in the lab as well as the ethics investigators from the beginning of the study.

Dr. Hey’s comment brought light to the fact that ethical violations are common during studies due to the complexity of research.

“The ways in which information isn’t recorded properly is pretty common,” Dr. Hey said. “I don’t think it is because people have bad intentions. Research is hard and complicated and if there isn’t a really good positive culture of rigor and consistent oversight, then it is easy for things to slide.”

UCSD has safeguards and programs in place to ensure that ethical research values are upheld. According to its website, the UC San Diego Research Ethics Program “serves as a resource for the campus community to identify and address ethical challenges intrinsic to the conduct of science, engineering, and other academic scholarship.” It is currently unknown why these safeguards did not prevent the unethical practices in Dr. Zhang’s lab.

Dr. Michael Kalichman, the founder of the program, stated that “From an overall perspective, by supporting the Research Ethics Program, UC San Diego is recognized internationally as a leader in providing diverse activities and approaches to raise institutional awareness of the ethical challenges in research.”

UCSD has currently not made any public plans to update their research safeguards following the incident in Dr. Zhang’s lab.

Photo courtesy of UC San Diego.