In Race to Ameliorate COVID-19, Some Research Compliance Went Awry, Is Ripe for Audit

With COVID-19 patients often in quarantine and personal protective equipment (PPE) a precious commodity, hospitals may not always have gotten fully compliant informed consent from patients included in clinical trials for treatments and vaccines. Consents and other research-related requirements sometimes were overlooked or afterthoughts in the more panicked days of the pandemic, often at community hospitals and physician practices that joined the race to tame the virus without a research infrastructure, experts say.

“We have noticed fairly rampant noncompliance going on with consent requirements in COVID research participants,” said attorney Lisa Murtha, with Moses & Singer in Philadelphia. The documents may have been shoved under the door of the ICU, with the clinician explaining them over the phone to the patient. In some cases, if patients were intubated, clinicians contacted their family members by phone to get their consent to be included in the research. “Consent is hard enough under normal circumstances, but add in a patient in quarantine and PPE restrictions,” she said, “and you have a whole recipe for noncompliance.”

The rush to develop therapeutics and vaccines also led to mistakes with regulatory requirements on documentation and reporting, among other things. “It was all on hyper speed,” said attorney Genevieve deLemos, former research compliance officer at Atrium Health in Charlotte, North Carolina, who is now with deLemos and Wever PLLC. “A lot of methodical processes you would typically have didn’t happen. It was well intentioned and all to benefit patients and provide therapeutic options, but a lot of things got skipped along the way.”

Now that things have calmed down partly because of vaccinations, hospitals have a chance to improve their compliance with research requirements and look back at what happened during the darkest days of the pandemic. Consents are a good example. Hospitals should monitor to ensure consent documents are signed, dated, countersigned by the person obtaining consent and placed in the research files, Murtha said. Noncompliance must be reported to the IRB. “Some IRBs have been flexible in terms of what they do with noncompliance because of the situation everyone was in, but the IRB may have to report certain instances of serious noncompliance to the [HHS] Office for Human Research Protection.”

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