WASHINGTON--(BUSINESS WIRE)-- Doug Peddicord, Ph.D., Executive Director of the Association of Clinical Research Organizations, is the lead author of “A Proposal To Protect Privacy Of Health Information While Accelerating Comparative Effectiveness Research” appearing in the November 2010 issue of Health Affairs.
The article proposes a policy framework that balances the needs of researchers to access data with the desire to maintain the privacy of sensitive individual health information. In general, the article proposes encouraging the use of health data in comparative effectiveness research by limiting Institutional Review Board involvement in privacy matters and ensuring that individual consent is not required. In exchange, researchers would fall under a “safe harbor” provided that they maintained strict data security controls, standards, and practices promulgated by the Secretary of Health and Human Services and ensured compliance though an annual third-party audit of data security procedures.
“More research today, including CER and drug safety surveillance, is driven by accessing large databases of health information,” said Dr. Peddicord. “The policy framework we discuss in this article would ensure that researchers have access to the information they need to support our health policy objectives while providing a level of comfort around privacy concerns, which we all share.”
Co-authors of the article included: Ann B. Waldo, Senior Counsel to the Genetic Alliance; Marc Boutin, Executive Vice President and COO of the National Health Council; Tina Grande, Senior Vice President for policy at the Healthcare Leadership Council; and Luis Gutierrez, Jr., formerly of Covance.
The Association of Clinical Research Organizations (ACRO) represents companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 70,000 professionals worldwide and annually conduct more than 9,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.acrohealth.org.
Association of Clinical Research Organizations (ACRO)
John Lewis, 202-464-2310
KEYWORDS: United States North America District of Columbia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Public Policy/Government Healthcare Reform Pharmaceutical Research FDA Science