Feds open new office to oversee clinical trials

Medical researchers will have a new U.S. government agency to contend with. As part of efforts first announced last month to curtail patient abuse in clinical trials, the U.S. Department of Health and Human Services (HHS) said this week it is creating a department to ensure that researchers who receive government funding for studies follow certain safety requirements.

The new Office for Human Research Protections (OHRP) is due to begin operations this month. It replaces the existing Office for Protection from Research Risks (OPRR), which was part of the National Institutes of Health (NIH). Damon Thompson, a spokesperson for the office of Surgeon General Dr. David Satcher, said in a Reuters report that the new office will have a "substantial increase" in funding over OPRR, although exactly how much is yet to be determined.

The first director of the new office will be Dr. Edward Greg Koski, a researcher from Harvard Medical School.

Among the functions of the new OHRP is to lead 17 federal agencies that carry out research involving human subjects under a common regulation. It will monitor protection programs at more than 4,000 HHS-funded research institutions worldwide.

A key part of creating the new system was delegating areas of focus. Under the old setup, the OPRR was responsible for human and animal subjects. The dual responsibilities will now be handled by separate agencies -- the new OHRP and a new Office of Laboratory Animal Welfare at NIH.

Under the new structure, the FDA retains its enforcement authority to ensure that researchers carrying out FDA-authorized drug and medical device clinical trials are complying with HHS patient protection and consent requirements.

"With strong leadership and coherent policy guidance for all HHS agencies, researchers will get a single set of messages, they will understand their responsibilities better, and they will understand they are being held more closely accountable," Satcher said.

All of the maneuvering is a response to a series of reports by the government's Office of the Inspector General (OIG) critical of agencies' oversight of patient safety in medical research. The reports culminated in a missive released in April that took the FDA and NIH to task for their lack of progress in instituting reforms advocated two years earlier.

The OIG said poor oversight left too much responsibility for patient safety in the hands of overworked and sometimes under-trained local institutional review boards (IRBs). But little progress was made on several reforms the OIG had recommended to HHS, according to the report.

The death in September 1999 of a teenager who was part of a gene transfer clinical trial sponsored by the NIH brought the issue back into prominence, and HHS Secretary Donna Shalala announced new oversight measures last month.

One of the proposals is a system of fines reaching up to $1 million. Universities or other research institutions could incur such a fine if they are found to violate federal research rules. Individual researchers who violate the rules could be fined up to $250,000 each. Currently, violators are issued warnings and research is halted until corrective steps are implemented, but no fines are levied.

Other changes proposed by the HHS are expanding education and training for all clinical investigators and IRB members and staff; enhancing the informed consent process and ensuring more vigilant monitoring and oversight; ensuring that researchers understand and comply with federal conflict-of-interest regulations; and beefing up FDA staff and budget for better enforcement.

"Medical research today is exploding with opportunity," Shalala said in a statement Tuesday. "But to achieve the benefits of that research, we need a solid foundation of thoughtfully designed and thoroughly executed research patient protections. The new OHRP will work with HHS agencies and with research institutions and sponsors to ensure that this foundation is in place and working productively."

The NIH released Tuesday two new guidelines and a set of issues for investigators and IRBs to consider on financial conflict of interest and research objectivity.

Last month, when she announced the proposals for better oversight and penalties, Shalala promised to write the presidents of all the nation's research institutions within days advising that the government will hold the entire university at fault--not just the researcher in question--when patient safety rules are broken.

"What's at stake is the integrity of research, and public confidence in that research," Shalala said.

Source: Medical Data International Inc.