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

How to Address Resume Gaps
General Interest Green Key News Worklife

How to Address Resume Gaps

#WeAreGreenKey: Spotlight on Emily Gelman
General Interest Green Key News Professional Support Worklife

#WeAreGreenKey: Spotlight on Emily Gelman

Green Key Unlocked: Why It Pays to be a Paralegal
Accounting + Finance Financial Services General Interest Green Key News Legal Support Worklife

Green Key Unlocked: Why It Pays to be a Paralegal

Perks of a Hybrid Work Schedule
General Interest Green Key News Worklife

Perks of a Hybrid Work Schedule

Green Key Announces New Partners and Principals
Accounting + Finance Architecture + Engineering Financial Services General Interest Green Key News Healthcare Human Resources Information Technology Leadership + Management Pharma Professional Support Worklife

Green Key Announces New Partners and Principals

#WeAreGreenKey: Spotlight on Todd Bernard
Accounting + Finance General Interest Green Key News Human Resources Leadership + Management Worklife

#WeAreGreenKey: Spotlight on Todd Bernard

Employee Benefits for a Supportive Workplace
General Interest Green Key News Worklife

Employee Benefits for a Supportive Workplace

Forbes Names Green Key on America’s Best Temp Staffing Firms 2021
Green Key News

Forbes Names Green Key on America’s Best Temp Staffing Firms 2021

SIA Names Green Key Resources among Largest Staffing Firms in the US
Green Key News

SIA Names Green Key Resources among Largest Staffing Firms in the US

Wrapped Up: 2021 Corporate Trends
General Interest Green Key News Worklife

Wrapped Up: 2021 Corporate Trends

#WeAreGreenKey: Spotlight on Kelsey Kirk
General Interest Green Key News Professional Support Worklife

#WeAreGreenKey: Spotlight on Kelsey Kirk

Advantages of the “Stay Interview”
General Interest Green Key News Worklife

Advantages of the “Stay Interview”

Green Key Unlocked: What’s New in Architecture, Engineering, & Construction
Architecture + Engineering General Interest Green Key News Worklife

Green Key Unlocked: What’s New in Architecture, Engineering, & Construction

#WeAreGreenKey: Spotlight on Lisa Figuccio
Accounting + Finance General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Lisa Figuccio

Tips for Writing Job Descriptions
General Interest Green Key News Worklife

Tips for Writing Job Descriptions

#WeAreGreenKey: Spotlight on Alexa Perrone
Accounting + Finance General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Alexa Perrone

Tips for Employee Retention
General Interest

Tips for Employee Retention

#WeAreGreenKey: Spotlight on Brooke Stemen
General Interest Green Key News Worklife

#WeAreGreenKey: Spotlight on Brooke Stemen

Green Key Unlocked: The Value of the MBA
Accounting + Finance Financial Services General Interest Green Key News Marketing Technology Worklife

Green Key Unlocked: The Value of the MBA

#WeAreGreenKey: Spotlight on Amy Raymond
General Interest Green Key News Professional Support Worklife

#WeAreGreenKey: Spotlight on Amy Raymond

Latest Blog Posts
View All Posts
How to Address Resume Gaps

How to Address Resume Gaps

Knowing how to address resume gaps, both from a candidate and client perspective, can help move the hiring process along...
Read More
#WeAreGreenKey: Spotlight on Emily Gelman

#WeAreGreenKey: Spotlight on Emily Gelman

Today we catch up with Emily Gelman, Senior Recruiter on the Professional Support team at Green Key. Gelman joined the...
Read More
Green Key Unlocked: Why It Pays to be a Paralegal

Green Key Unlocked: Why It Pays to be a Paralegal

Paralegals are not only imperative to the industry, but recently in high demand. Due to law firms encouraging their entry...
Read More