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January 12, 2012

Panel urges human-use research changes

A federal ethics panel commissioned by President Barack Obama has released a report that recommends changes to further safeguard participants in federally funded research.

In its Dec. 15 report, “Moral Science: Protecting Participants in Human Subjects Research,” the Presidential Commission for the Study of Bioethical Issues found that the current U.S. system “provides substantial protections for the health, rights and welfare of research subjects” and, in general, protects human research volunteers from harm or unethical treatment in federally supported scientific studies.

However, it stated, “because of the currently limited ability of some governmental agencies to identify basic information about all of their human subjects research, the commission cannot conclude that all federally funded research provides optimal protections against avoidable harms and unethical treatment.”

The commission was assigned to investigate human subjects research ethics following the 2010 discovery that U.S. Public Health Service (PHS) doctors in the 1940s conducted studies in Guatemala in which prisoners, mental hospital patients and soldiers were infected with syphilis without their consent.

The unethical research was uncovered in Pitt’s archives among papers donated by former Pitt professor John Cutler, who conducted the experiments as a young PHS doctor. He joined the Pitt faculty in 1967 and donated his papers to the University when he retired from Pitt in 1993.

The papers since have been moved to the National Archives in Atlanta.

(See Sept. 1, 2011, and March 31, 2011, University Times.)

In addition to issuing an apology to the Guatemalan government after the documents came to light, President Obama gave the commission a two-fold assignment: to review the syphilis study and to report on current regulations and standards to ensure that subjects of government-funded research are protected from harm or unethical treatment.

The commission released its report on the experiments, “Ethically Impossible: STD Research in Guatemala 1946 to 1948,” last September.

In its more recent report, the commission made 14 recommendations to improve the current system.

It advocated broader discussion and education on the ethical design and conduct of research involving human subjects and called for better access to information about government-funded research to improve accountability. It called for the Department of Health and Human Services (HHS) and the Office of Science and Technology Policy to state explicitly the ethical principles underlying current regulations and expressed its support for federal policy reform efforts that already are underway.

Proposed revisions to the federal policy on human subjects protection known as the “Common Rule” are being reviewed, although a decision by HHS on changes to the policy is likely years away.

The commission stated it supports efforts to align the level of research review with the level of risk to human subjects, to eliminate continuing review for some lower-risk studies and to reduce redundant institutional review in multi-site studies. It also expressed support for standardized consent forms containing easy-to-understand language, streamlined systems for reporting adverse events, and the adoption by all federal agencies of consistent ethics regulations regarding human subjects research.

Randy P. Juhl, vice chancellor for Research Conduct and Compliance, agreed in principle with the presidential commission’s conclusions.

“The kinds of studies done in Guatemala 60 years ago would be objectionable to anyone involved in medical research today,” he said. “I agree that such would not be able to happen for a variety of reasons in the current day.”

He said his office had been following the commission’s work.

Juhl submitted comments on the University’s behalf concerning the proposed Common Rule changes in October, and while he characterized the presidential commission’s recommendations as “motherhood and apple pie” — not objectionable in principle — he expressed concern that some well-intentioned suggestions directed toward government agencies could spark further complexity and regulatory burden for researchers. “I would prefer to see people who deal with patients and subjects have at least a little say” in determining policy, he said.

Juhl has administrative oversight of the University’s Institutional Review Board (IRB), which must review and approve all research activities involving human subjects.

He said Pitt’s IRB has some 8,000 protocols in various stages — seeking approval, approved or being closed out — in its system. For fiscal year 2011, the IRB reviewed nearly 1,300 new submissions and renewals, almost 6,000 expedited protocols and nearly 1,000 exempt protocols. “That’s a huge workload for the IRB,” he said.

Faculty are inundated with requirements, he said, adding that some regulations are put into place with good intentions, but without being tested to determine whether they actually increase safety.

“Protecting human subjects is central to our mission,” he said, adding that regulation needs to be done in a way that allows researchers to do their work.

“Faculty don’t get up in the morning intending to violate human subjects ethics. They really want to do the right thing,” but that can be increasingly difficult to accomplish because regulations are increasingly complex, Juhl said.

The presidential commission’s reports can be found online at Details on proposed changes to the Common Rule are available at

The University’s comments on the proposed changes to the Common Rule can be found at using the ID HHS-OPHS-2011-0005 then searching within the results for “University of Pittsburgh.”

—Kimberly K. Barlow

Filed under: Feature,Volume 44 Issue 9

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