CHICAGO – February 11, 2011

The Food and Drug Administration (FDA) released an amendment to 21 CFR Part 50 relating to the Basic Elements of Informed Consent. This amendment will require sites participating in drug and/or device clinical trials to add a statement specified by the FDA into informed consents pertaining to study results being publically accessible on the government’s clinical trial listing website (ClinTrials.gov). The site will not include information that can identify participants, but instead provides an aggregate summary of a study’s results.

The FDA believes that amending the required informed consent elements will have an overall positive public health effect by increasing transparency of clinical trials by providing readily available information to physicians and study participants that may aid in making more educated treatment decisions.

The effective date of this rule is March 7, 2011, with a compliance date of March 7, 2012 for clinical trials initiated on or after the compliance date. The consequences of non-compliance include the FDA seeking administrative, civil, and criminal penalties. “Revising operating procedures and training of the key staff involved in the consenting process will be key for sites to ensure compliance,” says Diandra Nuno, CCRC, Manager of Regulatory Operations for GuideStar® Clinical Trials Management. “GuideStar’s regulatory team is prepared to assist sites in effecting this change.”

About GuideStar®

GuideStar® Clinical Trials Management is a comprehensive, outsourced clinical research company for health care organizations 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.