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

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Health
- event Date
Tuesday, November 14, 2023
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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on informed consent for clinical investigations that reflects the technological and scientific advances made since the draft guidance was originally released in 2014.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.
Faculty

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.

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.

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.
Description
On Aug. 15, 2023, the FDA released Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors providing final guidance on informed consent for clinical investigations (the final guidance). In the nearly 10 years since the draft guidance was released, the processes by which clinical trials and human subject research are conducted have evolved with expanded scientific knowledge and technological advances. Therefore, the final guidance reflects those changes and provides important clarifications and examples for IRBs, investigators, and sponsors to ensure compliance.
The final guidance summarizes the informed consent process and outlines the FDA's informed consent requirements; addresses the responsibilities for IRBs, clinical investigators, and sponsors; and concludes with a series of updated FAQs. Notable and substantial updates from the initial draft guidance include: streamlining IRB review of consent forms; using innovative methods and technologies in informed consent to assist with communicating and educating research subjects; determining what constitutes coercion and undue influence in obtaining informed consent; and disclosing possible conflicts of interest to subjects.
Healthcare counsel and their clients should understand the final guidance and the noteworthy updates so that they can review current policies, procedures, and consent forms for compliance. Counsel should also be aware of how the new guidance relates to the 2018 Common Rule and how this may affect future FDA rulemaking.
Listen as our expert panel provides a detailed look at the FDA's final guidance. The panel will address notable changes and updates in the final guidance from the initial draft guidance, 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?
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