Keeping Up with the Clinical Research Compliance Landscape

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If there’s one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, it’s change. In the early months of 2024 alone, the U.S. Food and Drug Administration (FDA), has published a number of guidance documents and final rules related to:

  • Data monitoring committees
  • Charging for drugs under investigational new drug applications (INDs)
  • Informed consent
  • Genome editing and cell therapy
  • Classification of Laboratory Developed Tests (LDTs) as medical devices

In addition, the FDA has issued discussion papers regarding artificial intelligence (AI) and machine learning in drug development, updated its guidance on the collection of race and ethnicity data for clinical trials, and is being urged to publish draft guidance on the diversity action plans for clinical trials that was outlined in the Food and Drug Omnibus Reform Act of 2022.

In short, there are a multitude of regulations and best practices that can impact the efficacy and integrity of your research, and, as you likely know all too well, they evolve over time. As new technologies, global demands, and societal expectations change, so do expectations around healthcare research and its perceived validity.

The Health Care Compliance Association® (HCCA®), a nonprofit professional organization supporting healthcare compliance practitioners, was founded, in part, to be your eyes and ears for compliance updates and regulatory changes. It’s our mission to stay up to date on laws, guidance, and best practices, and to relay the information through publications and educational conferences as efficiently as possible.

HCCA’s upcoming event, the Higher Education and Healthcare Research Compliance Conference, is one such opportunity, with a learning track devoted specifically to the challenges, strategies, and latest developments in healthcare research compliance. It’s a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country.

The 2024 conference will take place June 10–12 at the Hyatt Regency in New Orleans, La., and will feature more than 50 educational sessions—with more than half of those focused on healthcare research topics such as animal research, patient rights, conflict of interest, data security, risk assessments, and AI and machine learning.

Specific session titles demonstrate the breadth and variety of content available:

  • Conducting Research Across Borders: Issues for Human Research Compliance Officials
  • The Compliance Framework for Animal Research in the U.S.
  • Financial Toxicity as a Study Risk: Why Not?
  • Overview of Developments in False Claims Act Cases and Research
  • HHS OIG: A Review of the New 2023 Compliance Guidance
  • Trial Transparency, Study Protocols, and Reporting Results in
  • FDA Inspections: Preparedness and Lessons Learned
  • Research Compliance 2024: Year in Review

Session speakers represent a variety of institutions, roles, and backgrounds, including:

  • Director for Research Compliance, Harvard University
  • Director, Research Compliance, Massachusetts General Hospital
  • Research Compliance Officer, Mayo Clinic
  • Director, Research Ethics and Compliance, Council on Governmental Relations (COGR)
  • Research Financial Compliance Officer, H. Lee Moffitt Cancer Center and Research Institute, Inc.
  • Senior Regulatory Specialist, University of Michigan Medicine
  • Vice President, Privacy and Compliance, Clearwater Compliance
  • Nurse Practitioner and Manager, Research Quality Assurance, LCMC Health

For a look at the full selection of educational sessions and speakers, view the agenda.

In addition to the valuable education and networking opportunities, participants can also register to sit for the Certified in Healthcare Research Compliance (CHRC®) certification exam, which will be offered onsite the morning of Thursday, June 13. Professional certification demonstrates your depth of knowledge and can enhance your credibility among colleagues and industry leaders. Learn more about certification and how to apply for the exam here.

This conference is approved for up to 21.6 Compliance Certification Board (CCB®) live continuing education units (CEUs), NASBA continuing professional education credits, and California Board of Registered Nursing contact hours. It has also been approved for 18 clock hours of pre-approved ACHE Qualified Education credit. Other external CEUs are pending; check here for the latest updates.

We’d love to see you in New Orleans! Registration options include the full conference experience (Monday–Wednesday), or the main conference (Tuesday and Wednesday only). Group discounts are available; bring your team for shared learning!

Register now

About HCCA

Established in 1996, Health Care Compliance Association® (HCCA®) supports healthcare compliance professionals as part of the overarching mission of SCCE & HCCA, a nonprofit member-based association with more than 19,000 members in more than 100 countries.

SCCE & HCCA is dedicated to enabling the lasting success and integrity of organizations worldwide by promoting high standards in compliance and ethics programs, nurturing a community of compliance and ethics practitioners, and offering valuable and relevant educational opportunities.

 Learn more about HCCA