Product Details
The space between data privacy and research transparency is a minefield. Overstep one way or the other and the consequences are severe.
Yet the dual push for protecting individuals’ private information and the requirements of ClinicalTrials.gov and other trial registries continues, complicating the calculus of separating trial results data from the data that can be used to identify individual participants whenever possible.
With Data Privacy and Research Transparency: Balancing Opposing Priorities, your bases are covered in the U.S. and the EU.
This single source covers all the latest privacy developments and trial transparency requirements, and discusses how regulations can affect how and what trial data can be disclosed.
This resource answers all your questions and provides information on what you must do to comply with trial registries’ sharing requirements while protecting subject privacy. It covers the evolution of privacy policies; obtaining authorization to use and disclose private information; methods of de-identifying data; and the special challenges presented by data transfer, cybersecurity and the use of personal data in future research.
Key Takeaways:
- What the FDA requires in reporting to ClinicalTrials.gov
- How well — or not — research institutions and trial sponsors are complying with transparency requirements
- Categories of personal information — which ones must be protected?
- The status of U.S. states’ development of data privacy legislation
- What the EU’s General Data Protection Regulation covers — and what the exceptions are
- Status of privacy legislation/policies in other countries
- HIPAA privacy requirements — what is covered, who is responsible?
Crossing the line between personal privacy and research transparency requirements triggers serious consequences. Data Privacy and Research Transparency: Balancing Opposing Priorities will make sure you never encounter them.
About the Contributors
Darshan Kulkarni is principal attorney at the Kulkarni Law Firm, a visiting professor at the University of the Sciences and is vice chair of the Life Sciences Interest Group of the American Bar Association. He focuses his practice on helping FDA-regulated companies successfully bring their products to market. He has more than 20 years’ experience in providing legal, medical and regulatory services and has served as a pharmacist for over a decade.
Leanne Tran is principal of JD MD Solutions, a firm that works at the convergence of law, medicine, science and research, and managing research counsel at LTRI, Sinai Health System. She has worked in-house and at health law and global law firms. Tran has expertise in contracting, regulatory, commercialization, data security and privacy matters. She provides consulting in medical, scientific and research due diligence, product liability and class actions. Tran has conducted research at academic hospitals and at NASA and has published papers and a book.
Candida Barlow is a critical care nurse at Ascension. She is an experienced clinical research RN, with a diverse background and proficiency in clinical trial management from study start-up to study closeout. Barlow is proficient in creating and establishing new programs and highly effective teams. She successfully established a high-priority clinical project to develop the first clinical research institute within a large community non-profit health system.
Phil Reed Boyce is principal of Boyce Life Sciences, which provides legal and trial startup support to sites, universities, CROs and sponsors. A former commercial litigator, Boyce has seven years’ experience drafting and negotiating research contracts, providing legal advice and managing clinical trial operations at the University of Virginia School of Medicine.
Who Will Benefit
- Sponsors’ regulatory and legal departments
- Clinical research coordinators
- Principal investigators
- Research operations directors
- Clinical research nurses
Add to Cart
Contributors:
Darshan Kulkarni, Leanne Tran, Candida Barlow and Phil Reed Boyce
ISBN-13:
978-1-60430-172-4
Publication date:
Sept. 2021
Page count:
129
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