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The European Forum for Good Clinical Practice says proposed restrictive access to clinical data would impede further progress in health research.
Many medical advances are founded on the use of personal data, such as health records, and without access to this data, further progress will be seriously impeded, according to the European Forum for Good Clinical Practice (EFGCP). The group was responding to proposed restrictive access to clinical information, which it says poses a serious and immediate threat to research.
"There is a real danger we will sleepwalk into a position where we undermine health research designed to provide healthcare benefit," noted EFGCP officials in a statement issued in advance of its 2015 annual conference, to be held in Brussels on Jan. 28 and 29. "While protection of privacy must be a central tenet of any legislation, some amendments will make vital research unworkable. The use of personal health data in research would become impossible in practice. This poses a significant risk to our health."
This danger has been recognized within the discussions around the new European Union clinical trial regulations, but it could be irreparably damaged by proposed data protection regulations, EFGCP continued. The Brussels meeting will address two important questions: How do we improve health without betraying confidentiality within current and upcoming EU regulations? What is the price of maintaining confidentiality for patients in health research?
"Our conference will seek to strike a balance in answering the key questions," EFGCP stated. "Progress in our understanding of the factors underpinning good health is leading us towards developing better treatments."
Organizers believe that tangible meeting outcomes will include a description and report on data protection arrangements in research across the EU through the EFGCP Research Ethics Committee survey, a debate on and development of a draft statement on secondary use of data in research, and a report and recommendations that will be provided to those involved in the legislative process.
— Philip Ward