Changes in Enforcement at the
Office for Protection from Research Risks

By James D. Kelso, J.D., LL.M. Candidate

The Office for Protection from Research Risks (OPRR) is part of the National Institutes of Health (NIH) and was established to ensure that human research subjects are properly protected from health related risks arising from experimental treatment and research. The system regulating research involving human subjects has come under attack for not providing enough protection for human subjects. Strong and well-supported accusations have been directed at both OPRR and NIH from ethicists, patient advocacy groups and federal investigatory commissions. OPRR is responding by increasing enforcement of the federal regulations governing human research.

Critics have attacked the present system because they feel the present system is inadequate to regulate research involving human subjects. Critics point to the lack of funding and lack of personnel, only two full time investigators, at OPRR, which limits the ability of OPRR to effectively monitor roughly 3,500 Institutional Review Boards (IRBs) at institutions throughout the United States. Historically, investigations languish for several years before their conclusion and often do not result in heavy sanctions.

The fears ethicists, patient advocacy groups, and governmental review committees have expressed regarding the inadequacies of the present system is that researchers might be enlisting human subjects without obtaining informed consent or that researchers might be performing unethical research on human subjects. The critics cite examples of abuses of human subjects which include coercion, inducement, and the use of human subjects who lack the mental ability to comprehend the information which is required to satisfy the elements of informed consent. These types of abuses can and do occur when IRBs are not vigorous in their review of research protocols proposed by the researchers at their institutions. The history of research involving human subjects is full of examples where human subjects were used in unscrupulous research when research was not properly regulated. It is a widely held and factually supported belief that if the present system does not provide adequate protection human subjects will be taken advantage of by unethical members of the research community.

To combat the problem of unethical research, to change the perception of inadequate protection for human research subjects, and to justify its existence, the OPRR has recently become aggressive in regulating research involving human subjects. On April 14, 1999, CNN posted an article entitled, "More Veterans Hospitals Suspected of Unauthorized Experiments." This article described OPRR’s suspension of over 1,000 experimental studies due to violations of informed consent. In the most egregious violation of the federal regulations at the VA hospital, OPRR found four veterans who were in enrolled in experimentation without their informed consent, and three of these four had psychiatric disorders. OPRR’s actions led to a congressional investigation and hearings which were held on April 21, 1999 to remedy these problems.

Additionally, on May 10, 1999, OPRR suspended all federally financed medical research on humans at the Duke University Medical Center (Duke). This was only the fourth action taken by the OPRR in a decade and jeopardized $175 million in federal aid. However, Duke responded quickly to the action and proposed a plan to remedy the deficiencies OPRR found. This rapid response led to the removal of the ban on research involving human subjects at Duke. Gary B. Ellis, the Director of OPRR, stated the quick reversal of Duke’s suspension was a tribute to the university’s rapid response to the federal action.

Duke remedied its deficiencies by establishing a task force with the help of OPRR, creating an educational program for committee members who oversee human research, which includes sending members to national conferences on human research, hiring extra staff, establishing a new research committee to lessen the first research committee’s workload, re-designing a record keeping system for research studies, and a second review of 274 human studies where the committee quorum may not have been met.

Duke’s suspension occurred after OPRR made several attempts to get Duke to remedy deficiencies it found during a random site inspection in December 1998. Duke was selected for a random site inspection because it was the only institution out of the top 15 institutions which received federal research funds which had not been in contact with OPRR for several years.

To ensure human subjects will not be taken advantage of by the research community and to avoid possible dismantling of the present system for regulating research involving human subjects, OPRR has become active in enforcing the federal regulations and is now willing to take significant steps to protect humans from unethical research. Researchers and research institutions beware, OPRR has a new and stronger attitude towards enforcement.

06/09/99