Legal Series: Understanding FDA
The Food and Drug Administration issued a new consent form requirement for certain FDA-regulated clinical trials effective this March 7, 2012. Consent forms of drugs, biological products or devices that are subject to FDA regulation are required to contain a specific statement provided by the FDA. The statement is required for applicable clinical trials initiated on or after March 7, 2012, the statement is intended to advise the participants that clinical trial information may be available on the ClinicalTrials.gov database. The question now is how should the industry comply in a cost effective manner that does not compromise the integrity of the science.
The Knowledge Group has assembled a panel of key thought leaders and regulators to help health executives understand all the important issues with respect to this important topic. This live webcast is a must attend for all health executives who need to be in the know with respect to FDA’s new consent form requirement. The panel will address the key issues and will answer the following main concerns:
- The Applicable Clinical Trial – What are those trials and how to identify an applicable clinical trial?
- What clinical trials are specifically excluded from the definition of “applicable clinical trials?”
- Do sponsors and/or investigators need to obtain approval for informed consent documents with the new statement – Why and How?
- Can the new requirements be waived? In what specific situations?
- Do informed consent documents for studies conducted outside of the United States have to comply with the new regulations?
- What new responsibilities of an IRB will be faced under the new rule?
Jarilyn Dupont , Director of Regulatory Policy,
FDA/Office of Policy
- The informed consent regulations (21 CFR 50.25(c)) require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into the ClinicalTrials.gov databank.
- Submission of certain clinical trial information, including certain results information, to ClinicalTrials.gov is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
- Under 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials: “A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” Additional information can be provided but changes cannot be made to the statement.
The requirements can apply to foreign clinical trials if the clinical trial is an applicable clinical trial as defined by FDAAA.
Lisa Murtha, Esq., Partner,
SNR Denton US LLP
- The FDA Informed Consent Reporting requirements will need to be monitored on an ongoing basis and the Research Compliance Department is well-suited to provide this monitoring and oversight.
- The Research Compliance Department should develop a training module to allow for training of PIs and research administrative, and IRB staff alike so that they fully understand the requirements of the regulations and how to effectively implement those requirements.
- The Research Compliance Team must develop a plan to monitor compliance with these requirements including audits of Informed Consent documents to ensure that the applicable language is in place, and monitoring of ClinicalTrials.gov to validate that the appropriate reporting is accurate and timely.
Harry Nelson, Co-Founder,
- Although the 2012 FDA revision to informed consent requirements is on its face fairly minor and technical, it reflects a more significant and substantive trend towards leveraging the clinicaltrials.gov as a vehicle for greater transparency in clinical research.
- Clinical research compliance programs should be attuned not only to minimal compliance with FDA consent requirements, but also the need for meaningful disclosure of risks in a manner that increases the integrity of the informed consent process.
Who Should Attend:
- FDA Attorneys
- Legal Executive
- Health Care Law Attorneys
- Health Industry Advisors
- Health Policy Directors
- Compliance Officers
- State Health Executives/Professionals
- General Counsel
- Senior Management
- Senior Executives
- Professionals coming from Food and Drug Industries
- Consultants & Clients in the Food and Drug Industries
Jarilyn Dupont has been with FDA since 1996 and is currently in the Office of Policy as Director of Regulatory Policy. She has worked in the Office of Legislation in a supervisory capacity and was detailed to in the Office of Chief Counsel as a staff attorney and the Office of Crisis Management as Acting Director. Previous legal experience includes Counsel for the House Judiciary Subcommittee on Intellectual Property and Judicial Administration and Legislative Counsel/Analyst for a House Member. She has experience in private practice, state and local legislative and administrative experience, and non-profit legal services organizations.
Jarilyn Dupont has been with FDA since 1996 and is currently in the Office of Policy as Director of Regulatory …
Lisa has over 25 years of experience working on complex clinical research and healthcare compliance issues. She focuses her practice in clinical research compliance, which includes human subject protections, effort reporting, scientific misconduct, conflicts of interest, and clinical trial billing and process improvement.
Lisa also provides guidance regarding revenue cycle work, billing and coding issues, internal investigations, corporate governance/ethics, and HIPAA-related matters.
Lisa has over 25 years of experience working on complex clinical research and healthcare compliance issues. She focuses her practice …
Harry Nelson is an attorney who counsels healthcare providers on strategy and regulatory compliance, principally focusing on Medicare, FDA, and state healthcare licensing. He is a co-founding and managing partner of Fenton Nelson, a Los Angeles-based healthcare law firm, where he oversees compliance as outside counsel for over 150 healthcare facilities and businesses, from physician organizations to long-term and behavioral care to life sciences. Under his leadership, the firm has, among other accomplishments, become the only boutique healthcare law firm in California to be designated as “top tier” by U.S. News and World Reports in each of its annual surveys. In addition to his expertise in establishing proactive compliance programs, Harry has successfully resolved hundreds of investigations by federal and state government agencies. Harry is included annually in Southern California Super Lawyers and Best Lawyers in America, among other honors, and speaks frequently on subjects of interest to healthcare business and healthcare attorney groups.
Harry Nelson is an attorney who counsels healthcare providers on strategy and regulatory compliance, principally focusing on Medicare, FDA, and …
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FDA/Office of Policy
About FDA/Office of Policy
About SNR Denton US LLP
SNR Denton is a client-focused international legal practice delivering quality and value. We serve clients in key business and financial centers from more than 60 locations worldwide, through offices, associate firms and special alliances across the US, UK, Europe, the Middle East, Russia and the CIS, Asia Pacific and Africa, making us a top 25 legal services provider by lawyers and professionals. Joining the complementary top tier practices of its founding firms – Sonnenschein Nath & Rosenthal LLP and Denton Wilde Sapte LLP – SNR Denton offers business, government and institutional clients premier service and a disciplined focus to meet evolving needs in eight key industry sectors: Financial Institutions and Funds (including derivatives); Energy, Transport and Infrastructure; Government; Health and Life Sciences; Insurance; Manufacturing; Real Estate, Retail and Hotels; and Technology, Media and Telecommunications. For more information, visit snrdenton.com.
About Fenton Nelson
Fenton Nelson represents healthcare providers, including healthcare professionals, facilities, and other organizations, in litigation, business transactions, and regulatory matters. Although we are based in California, our practice is national in scope.
As a result of our landmark victories on behalf of California providers over the past 25 years, we have earned a reputation as a “go-to” firm for healthcare matters. Fenton Nelson is the only boutique firm in California to receive a Top-Tier Firm rating in regulatory and administrative law from U.S. News & World Report. Fenton Nelson attorneys defend healthcare providers in investigations before the Medicare Program and its contractors, the FDA, and the widest range of other federal and state regulatory agencies. The firm has tried cases and argued to the California Supreme Court on fraud and abuse, peer review, reimbursement, and healthcare administrative issues, and we negotiated a broad range of transactions for healthcare providers. The firm also provides counsel in transactional and compliance matters to enable clients to achieve their business objectives, implements compliance programs, and oversees compliance as outside counsel for hospitals, long-term and behavioral healthcare organizations, and life sciences companies.
Clients rely on our detailed knowledge and deep understanding of the complexities of the healthcare industries, from the widest range of physician organizations to skilled nursing facilities, medical device companies, hospice and home health providers, drug treatment, autism care, and countless other niches of healthcare practice. We make it our business to be up to date in the regulatory requirements with which firm clients are required to comply and to give strategic advice on the direction of change ahead. As a result, we are able to offer smart, effective counsel and representation in a manner that is highly responsive, efficient, and strategic.