Clinical Investigators Need to Know the Privacy Rules

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.”    

Photo by Lianhao Qu on Unsplash

What It Means to Be a Leader During a Time of Crisis
General Interest Leadership + Management Worklife

What It Means to Be a Leader During a Time of Crisis

Mid-Life Crisis? Consider a Mid-Life Career Switch
Accounting + Finance General Interest Information Technology Leadership + Management Worklife

Mid-Life Crisis? Consider a Mid-Life Career Switch

Lawyers Look to Move Firms to Keep Remote Work
Legal Support

Lawyers Look to Move Firms to Keep Remote Work

Is the Hybrid Workplace Sustainable?
Worklife

Is the Hybrid Workplace Sustainable?

Bank of America, Competitors to Raise Pay
Financial Services

Bank of America, Competitors to Raise Pay

Class of 2021 to Enter Job Market
Financial Services Healthcare Information Technology Marketing Technology Professional Support

Class of 2021 to Enter Job Market

Pharmacies Are Entering the Mental Health Market
Healthcare Pharma

Pharmacies Are Entering the Mental Health Market

Pandemic Challenges Create New Opportunities for Virtual Career Development
Worklife

Pandemic Challenges Create New Opportunities for Virtual Career Development

America’s New Tech Hubs
Information Technology

America’s New Tech Hubs

How to Recognize if a Manager Is Right for You
Worklife

How to Recognize if a Manager Is Right for You

Green Key Resources is Hiring!
Accounting + Finance Architecture + Engineering Creative Financial Services Healthcare Human Resources Information Technology Legal Support Marketing Technology Pharma Professional Support

Green Key Resources is Hiring!

How to Think Like a Lawyer
Legal Support

How to Think Like a Lawyer

3 Questions to Unlock Your Authentic Career
Creative Worklife

3 Questions to Unlock Your Authentic Career

Businesses Rethink “Necessary Travel”
Worklife

Businesses Rethink “Necessary Travel”

YOLO Is Sparking Riskier Career Moves
Worklife

YOLO Is Sparking Riskier Career Moves

21 Ways to Celebrate Earth Day Today & Beyond
Architecture + Engineering Worklife

21 Ways to Celebrate Earth Day Today & Beyond

Want to Feel More Connected? Try Some LOLs
Leadership + Management

Want to Feel More Connected? Try Some LOLs

In a Time of Crisis, What Makes a Good Leader?
Leadership + Management

In a Time of Crisis, What Makes a Good Leader?

The Pandemic Is Altering Data Privacy Expectations
Information Technology

The Pandemic Is Altering Data Privacy Expectations

Job Openings Hit a Two-Year High
Human Resources

Job Openings Hit a Two-Year High

Latest Blog Posts
View All Posts
What It Means to Be a Leader During a Time of Crisis

What It Means to Be a Leader During a Time of Crisis

During the early months of the pandemic, team leaders, managers, and company executives had to use cognitive reframing to build...
Read More
Mid-Life Crisis? Consider a Mid-Life Career Switch

Mid-Life Crisis? Consider a Mid-Life Career Switch

Far too often, ages and life stages are regarded as barriers to starting a new career. But the mid-life career...
Read More
Lawyers Look to Move Firms to Keep Remote Work

Lawyers Look to Move Firms to Keep Remote Work

As law firms across the country consider brining an end to remote work, some lawyers and other legal professionals are...
Read More