A study led by Harvard Medical School professor and gerontologist Douglas P. Kiel has become the focus of attention once more after the Department of Health and Human Services alleged that efforts to correct the study’s ethical violations were insufficient.
The Office of Human Research Protections issued a follow-up letter on Feb. 17 to Kiel and two of his colleagues regarding their corrective action plan for addressing previous infractions in their research methods.
Kiel’s research team—which gave more than 2,000 subjects hip-protective underwear that was padded on only one side—had failed to inform the participants about the risk of “falling more often to the ‘protected hip’ side,” according to a June 23, 2011 letter from the HHS Division of Compliance Oversight.
The HHS-OHRP has said that it is dissatisfied with the corrective action plans proposed by Kiel and his team in response to the first letter notifying the researchers of their violation.
The proposed plan did not clearly define the populations that needed to be notified and the draft letters were missing crucial information that would be helpful to study participants, according to HHS Compliance Oversight Coordinators Lisa Buchanan and Lisa A. Rooney in their Feb. 17 letter.
The study, called the Hip Impact Protection Project (HIP PRO), was launched in 2002 by Kiel, Jay S. Magaziner of University of Maryland School of Medicine, and Stanley J. Birge of Washington University School of Medicine in St. Louis.
It was intended to “assess the efficacy of hip pads in preventing hip fractures,” wrote Rachel J. Whitehouse, vice president of communications at Hebrew SeniorLife, in an email statement. Hebrew SeniorLife is home to the Institute of Aging Research where Kiel is based.
“The Feb. 17 letter from the OHRP was a procedural step, primarily focused on asking all three institutions involved in the HIP PRO study to more tightly focus and coordinate their subject notification plans. OHRP will not close this matter until the subject notification process is settled,” Whitehouse wrote.
Whitehouse said that Hebrew SeniorLife is taking the appropriate steps to implement the corrective actions that were outlined in the Feb. 17 letter.
The federal health investigation is not the first time that Kiel been implicated in a legal controversy.
In 2008, Kiel was sued by HipSaver—a hip protector manufacturer—for commercial disparagement. HipSaver representatives argued that Kiel’s paper, which included the results from his study, was not accurate in claiming that all hip protectors are ineffective. The case was dismissed in 2011.