Distracted by the COVID pandemic, clinical investigator sites that haven’t been paying attention to new privacy laws may find it difficult to conduct trials in 2021.
“Nine out of ten investigator sites in the U.S. don’t know anywhere near enough,” and “don’t have the right tools to be in compliance,” says an article on the Association Of Clinical Research Professionals blog.
An interview with Al O. Pacino II, president and CEO of BlueCloud by HealthCarePoint, discusses the details of two key privacy laws: the EU’s General Data Protection Regulation and California’s Consumer Privacy Act. Both impose significant restrictions on how personal data is collected, stored, used and shared. Both require businesses and organizations to inform individuals of the information they have and make it available to them. The California law exempts government and nonprofits.
In the European Union, the GDPR is supplemented by local privacy rules and, for clinical trials and medical data sharing, by organizational rules and governance. A study published in BMC Medical Informatics and Decision Making found enough lack of specificity and clarity among the privacy rules of each of the various study teams in just one EU program to give rise to challenges.
Noting that “Responsible data sharing in health research entails more than compliance with the GDPR,” the researchers found there was a need to reconcile local and individual investigative rules when creating “Big Data-driven translational research platforms” such as the BigData@Heart platform.
As in Europe, academic researchers in the US regularly share data. “The combination of even larger datasets into so-called ‘Big Data’ is considered to offer even greater benefits for science, medicine and society,” the Medical Informatics and Decision Making article observes.
With California’s privacy act – the toughest in the US – and other state laws now in effect and new ones under consideration, clinical researchers need to be aware of the rules, including the GDPR.
Investigator site leaders, says Pacino, must “understand modern laws and regulations that protect one’s personal data and privacy, learn how to take ownership of [their site data], and leverage modern e-vehicles that benefit healthcare professionals, sponsors, contract research organizations, and others.”