ROCHESTER, Minn., Jan. 6 (UPI) -- The Mayo Clinic failed to follow federal regulations for about 140 human research projects spanning two decades, letters to the Minnesota facility indicated.
Among the violations of federal rules governing human health was the failure to perform mandatory annual reviews for four straight years, the Pittsburgh Tribune-Review reported Tuesday.
The violations were outlined in two letters to the Rochester, Minn., facility, which has until this week to provide final responses.
A Mayo spokesman said the clinic has been working with Office of Human Research Protection and resolved most of the issues, the Pittsburgh newspaper said. He would not identify any of the research studies cited by the agency, under the umbrella of the Department of Health and Human Services.
Spokesman Robert Nellis said in an e-mail to the newspaper no human subjects "were placed in jeopardy" because of the lapses.
The first letter sent in July cited Mayo for failure to perform mandatory annual reviews on 140 of 1,060 federally funded active research projects. The second letter in December said key records involved in one study were not included in a file submitted to the agency and cited two other research projects for deficient records.
"Mayo Clinic is committed to protecting human subjects in research and has been cooperating with the OHRP throughout its inquiry," Nellis wrote. He said remaining issues about documentation and conversion to an electronic recordkeeping system "are currently being resolved."
