March 4, 1997

VUMC set to implement new consent regulations

VUMC set to implement new consent regulations

A new federal regulation giving research institutions the authority to treat gravely ill patients with investigational drugs or devices in some emergency situations without their consent is being implemented at Vanderbilt University Medical Center.

The government's guidelines apply to a limited class of research activities ‹ those involving persons in desparate need of possible life-saving treatment but who are unable to give consent and have no family or someone to legally represent them.

"The community-at-large must now be made aware of the specific research being proposed," said Virginia Wiley, director of VUMC's Institutional Review Board.

"It's an additional step in the approval process," she said, "but it also means some people will now have access to care they may not have had before."

The U.S. Food and Drug Administration and U.S. Department of Health and Human Services regulation will come into play when:

€ subjects are in a life-threatening situation;

€ available treatment is either unproven or unsatisfactory;

€ obtaining consent is not feasible;

€ there is potentially a direct benefit to the patient but the investigational treatment cannot be administered without waiving consent.

VUMC is currently forming a panel of Nashville community leaders to serve as a liaison between the university's Institutional Review Board and the various sectors of the city. The group will be responsible for informing their own community of the purpose, risks, benefits and results of the research.

Additional safeguards have been included in the regulation calling for specific reporting and record-keeping, an independent data monitoring committee and full disclosure of the results and demographics upon completion of the study.

Historically, approval by institutional review boards throughout the country has been a rigorous process, one that ensures that the patient's rights are protected.

"Currently, the process for reviewing emergency research protocols requires that the investigator submit a proposal with appropriate documentation to the IRB," Wiley said.

"It is reviewed by the IRB and, following satisfactory response by the investigator to the concerns and issues raised by the committee, final approval is extended.

"When the research has involved subjects who could not give consent and it was not possible to obtain consent from a legally authorized representative, the research usually could not be approved by the IRB because federal regulations did not permit research without consent in most cases," she said.