FDA Final Guidance on Informed Consent in Clinical Research: Key Revisions, Best Practices for Compliance
Responsibilities of IRBs, Clinical Investigators, and Sponsors; Research Subject Education; Disclosing Conflicts of Interest
Recording of a 90-minute CLE video webinar with Q&A
This CLE webinar will provide a detailed look at the FDA's recently released final guidance on informed consent for clinical investigations that reflects the technological and scientific advances made since the draft guidance was originally released in 2014. The panel will address notable changes and updates including those related to the responsibilities of IRBs, clinical investigators, and sponsors and educating research subjects. The panel will also discuss the relation to the 2018 Common Rule and describe best practices for compliance.
Outline
- History of FDA informed consent guidance
- FDA's final guidance
- Summary of consent process and regulatory requirements for informed consent
- IRB responsibilities
- Clinical investigator responsibilities
- Sponsor responsibilities
- FDA review considerations
- FAQs
- Relation to the 2018 Common Rule and possible future FDA rulemaking
- Best practices for compliance
Benefits
The panel will review these and other important issues:
- How does the final guidance differ from the draft guidance?
- How are the responsibilities of IRBs, clinical investigators, and sponsors revised in the final guidance?
- In what ways does the final guidance reflect changes in technology and how these may be used in the informed consent process?
- How does the final guidance relate to the 2018 Common Rule and what can be expected in future FDA rulemaking?
Faculty
Monica Chmielewski
Partner; Co-Chair Life Sciences Industry Team; Vice Chair Healthcare Industry Team
Foley & Lardner
Ms. Chmielewski’s practice is solely focused on the representation of healthcare providers, pharmaceutical and... | Read More
Ms. Chmielewski’s practice is solely focused on the representation of healthcare providers, pharmaceutical and medical device companies, and pharmacies in healthcare, healthcare transactions, clinical research, supply chain, and food and drug law. She provides daily counsel to numerous health systems, hospitals, academic medical centers, pharmacies, and biotech, pharmaceutical and medical device companies. Ms. Chmielewski regularly assists clients with the following issues: regulatory compliance governing all aspects of clinical research, investigations of research misconduct, Institutional Review Board issues, the conduct of U.S. and international clinical trials, research grants and funding, government investigations and audits, pharmaceutical product promotion (including counsel on off-label promotion), 510K applications, the regulation of software as a medical device, preparation of research contracts, among other matters.
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Melissa L. Markey, CISSP
Attorney
Hall Render Killian Heath & Lyman
Ms. Markey focuses her practice on developing practical, operationally focused cybersecurity, privacy and life sciences... | Read More
Ms. Markey focuses her practice on developing practical, operationally focused cybersecurity, privacy and life sciences recommendations for clients. Her patient care background and qualification as a Certified Information Services Security Professional allows her to bring a functional perspective to complex privacy, security and research issues with a focus on solutions that work in the real world. Ms. Markey has significant experience with medical device cybersecurity and cross-border privacy transactions. She assists with risk assessments, incident and breach response, and information governance, as well as IRB issues, clinical trial agreements, conflicts of interest, advice regarding research operations and structure and research misconduct inquiries and investigations.
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Elizabeth Smith
Attorney
Perkins Coie
Ms. Smith advises clients on matters involving Stark Law, False Claims Act, and Anti-Kickback Statute compliance.... | Read More
Ms. Smith advises clients on matters involving Stark Law, False Claims Act, and Anti-Kickback Statute compliance. She has defended clients in government investigations related to Medicare and Medicaid billing and has managed due diligence for major hospital transactions, including M&As. Ms. Smith also assists clients with contesting alleged over-payments, self-disclosing over-payments, and analyzing arrangements under state and federal fraud and abuse authorities. She has experience drafting and reviewing contracts, including clinical trial agreements, clinical product manufacturing agreements, non-disclosure agreements, and consulting agreements. Ms. Smith has advised management on HIPAA compliance, provided guidance on FDA regulatory matters, and managed patent and trademark portfolios. She also has experience with data breaches, including a multistate breach involving sensitive health information.
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