A state medical board approved a rule change Wednesday that -- under a very narrow set of circumstances -- allows studies on patients unable to give their consent.
After the state Medical Care Commission's preliminary decision Wednesday, the rule change must work its way through the state's process before possibly becoming official as early as March 17. But Duke University officials said they are preparing to restart a controversial blood substitute trial halted earlier this year after a conflict between state and federal rules governing human research was identified.
Dr. Ross McKinney, vice dean for research at the Duke School of Medicine, confirmed for the first time Wednesday that trials of PolyHeme, a blood substitute, had technically begun in Durham during the first week of January. During that brief time, however, no subjects were identified for the trial, McKinney said.
That same week, an unidentified person brought the PolyHeme trial to the attention of the state Attorney General's Office.
People bleeding heavily as a result of an accident, gunshot wound or other trauma could have been entered into the PolyHeme study at random. Most recipients would have been too critically injured to give their consent. Those entered into the study would have continued to receive PolyHeme for up to 12 hours after arriving at Duke, unless they or a family member objected.
The Durham trial was halted in early January, after Duke was contacted by the Attorney General's Office. McKinney and officials at some of the state's other major medical centers have said they were unaware of a state rule that until Wednesday barred research on human subjects without their consent.
While PolyHeme is being tested in other states, research on patients unable to give their consent remains rare. It is allowed under a narrow set of circumstances outlined by the Food and Drug Administration in 1996. That year, North Carolina strengthened its patient's bill of rights, requiring doctors and hospitals to inform patients if they were being considered for a study. Now, like the federal rule, North Carolina's allows hospitals in the state to conduct such studies rarely.
About 2,500 studies, ranging from clinical trials to mall surveys, are conducted by students, staff and physicians affiliated with Duke, McKinney said. This year, the university hopes to conduct the PolyHeme trial under the FDA's informed consent waiver rule and is considering one other study on patients too injured to give their consent. Nancy King, professor of social medicine at the University of North Carolina Medical School in Chapel Hill, said it considers one to two such studies each year.
When the state Medical Care Commission, which oversees hospital licensing, announced that it would consider a rules change, research officials from Duke, UNC-CH and Wake Forest University joined together. The institutions wanted to secure a broader change allowing everything from the type of critical-care research involved in the PolyHeme trial to social science research on topics that patients might be unwilling to acknowledge, such as child abuse, and noninvasive studies, such as chart comparisons.
In the end, Duke, UNC-Chapel Hill, Wake Forest, East Carolina University, Carolinas Medical Center and Pitt Memorial Hospital developed the language the commission approved Wednesday. But the institutions were not the only authors of the state's new research rule. King helped to insert language that requires hospitals to advise the Medical Care Commission when they plan to conduct studies on patients unable to give their consent.
King's amendments also would allow the commission to publish information about these studies in the North Carolina State Register and ask the institutions conducting these studies to present information about proposed trials and efforts to inform the public about the proposal.
King grew concerned about the PolyHeme trial after watching what she considered an anemic level of community participation at a series of public meetings Duke organized last summer.
When the state Medical Care Commission first considered the rules change in February, questions about how the public's interest might be served by research on patients unable to give consent came up. Some commission members were also concerned about the oversight of research conducted without patient consent and the financial relationship between institutions and drug companies.
The commission invited public comment on the proposed rules change, and a virtual flood of responses followed. Many expressed real fear about the implications of Durham gunshot and car crash victims being entered into a study without their consent; others objected to Duke's financial arrangement with the makers of PolyHeme.
As do the other hospitals, Duke would receive a fee for each patient enrolled in the PolyHeme trial.
The temporary rule will likely be considered by the state Rules Review Commission on March 17. If approved, the rule will go into effect March 28. McKinney said Wednesday that the university is poised to restart the PolyHeme trial immediately thereafter.
Staff writer Janell Ross can be reached at 956-2415 or firstname.lastname@example.org.