CHICAGO – August 4, 2011

The Food and Drug Administration (FDA) recently released guidance for institutional review boards (IRBs), clinical investigators, and sponsors on Exception from Informed Consent Requirements for Emergency Research.

“An emergency situation is defined in this guidance as involving human subjects who have a life-threatening medical condition requiring immediate intervention for which he or she, or the legally authorized representative (LAR), cannot provide informed consent,” says Manda Materne, RN, BSN, MBA, Manager of Clinical Operations for GuideStar® Clinical Trials Management.

In order to waive informed consent, the research must have the potential to directly benefit the subject, must be a circumstance where the investigational product must be given before the subject or LAR has the opportunity to give consent to be effective, or instances where there is no reasonable way to identify potential subjects likely to become eligible to participate. Additionally, available treatments must have been proven unsatisfactory, participation holds the potential for direct benefit to the subject, and the collection of valid results is necessary to determine the safety of the intervention.

“The guidance outlines the requirements set forth to waive consent, in addition to the myriad of measures that the IRB, investigators, and sponsors must follow to remain compliant to FDA regulations,” says Materne. “GuideStar® is committed to educating research personnel, guiding and documenting this process for sites conducting research under emergency situations.”

About GuideStar®

GuideStar® Clinical Trials Management is a comprehensive, outsourced clinical research company for medical facilities across the country. It provides “private label” clinical research departments for hospitals, physician practice groups and health care centers. Through GuideStar®, these facilities have a cost-effective means to be at the forefront of clinical trials for the benefit of patients, attractiveness to physicians, and enhancement of their own reputation.

GuideStar® holds in the highest regard the principles governing clinical research. It recognizes the precision of execution, efficiency and operational excellence needed to navigate client partners through the complex, multi-layered processes of FDA compliance and industry regulations. For more information, please visit www.GuideStarClinical.com.