(AP) - The Mayo Clinic for years failed to get written consent from patients before surgery - standard practice and required under federal rules.
Officials at the clinic said this week they have changed their practice and are now getting written consent from patients, but that none were ever at risk under their old policy of oral consent.
Mayo changed its procedures after a state inspector visited one of Mayo's two hospitals in Rochester last year.
The state found that the medical center was not complying with federal regulations for hospitals participating in Medicare, specifically a rule requiring written consent before surgical or other invasive procedures.
“It's not the first time there's been a problem with ... sloppy [informed consent] issues, it's just startling to see it at Mayo.”Medical ethicist Arthur Caplan
Mayo's long-standing practice had been for doctors to give patients detailed oral explanations of the risks, benefits and alternatives to a procedure and to get verbal consent and document it in patients' charts, spokesman Brian Anderson said. Patients weren't asked to sign specific consent forms, he said.
"We've always had an informed consent process," Anderson said. "That is certainly critical, ethically paramount."
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the conversations between doctor and patient were important but "not by any means sufficient."
"You need it in writing, and you need a document showing the person when given the information gave their informed consent in writing to it," he said.
The inspection report by the Minnesota Department of Health looked at 12 patients who had major surgery or other procedures at Mayo. While all 12 apparently did consent, none did so in writing.
Mayo officials told the inspector they only got written consent for research studies and a few other specific procedures, such as electric shock therapy and transfusions.
The report noted that Mayo officials agreed to phase in written consents by the end of 2008. Those changes are now in place, Anderson said.
The policy change was first reported last month by the Pittsburgh Tribune-Review.
Anderson said Mayo was never sanctioned for not using written consent forms.
The state's inspection of Mayo last spring came in the wake of a long-running lawsuit by a federal prisoner who underwent cancer surgery there in 2001. The prisoner alleges he never gave his consent - in writing or otherwise.
In its court filings, Mayo claims the patient understood and consented to all the treatment he received. Anderson declined to comment on the lawsuit, which was filed in 2005 and is scheduled to go to trial next month.
In a separate matter, first reported by the Tribune-Review this week, federal regulators cited Mayo for lapses in complying with rules on oversight of research on human subjects - about 140 instances in a review of 1,060 studies.
The issues, cited in two letters from the Office of Human Research Protections to Mayo officials, involved institutional review boards at Mayo that oversee medical research.
The office wrote Dec. 4 that Mayo had taken corrective actions that satisfactorily addressed most of the problems first raised last July.
The OHRP determined that Mayo's review boards did not review some research at least once a year as required by federal regulations, and that in some cases, Mayo researchers extended studies beyond the expiration dates set by the review board. It also cited some record-keeping issues.
Mayo spokesman Bob Nellis said the clinic is committed to protecting people who participate in its research, and that none of the problems cited affected the quality of patient care.
"No people, no participants, were placed in jeopardy as a result of this," Nellis said.
Mayo is not facing any penalties over the issue. Pat Elhinnawy, a spokeswoman for the OHRP, said the office orders corrective actions when needed but doesn't have the authority to levy fines.
But Caplan said the OHRP gave Mayo "a pretty strong slap on the wrist" and sent an important message about the need to protect patients.
"That's not the first time that there's been a problem with an institution with sloppy IRB issues, it's just startling to see it at Mayo," Caplan said. "Mayo has a reputation for being very precise and careful about managing these kinds of activities."
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