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Conference Agenda | Overall Evaluation

Research Year in Review

Speaker: Lisa Murtha

  • Relevant new laws, regulations, and guidance from federal and state government agencies on the conduct of research
  • New OIG Workplan and its research initiatives as well as key enforcement initiatives and settlements related to research
  • Novel approaches to addressing these new government initiatives within research compliance programs

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Evaluation

Compliance with Psychedelics and Emerging Therapies

Speakers: Debbie Casey, Kelly Willenberg, Linda Iovanni

  • Discussion of emerging therapies including clinical trials and the future of psychotherapy 
  • Discussion of steps that can be taken to mitigate risk and increase protective factors for the subjects 
  • Review of integration techniques, resources, legal and ethical issues with these emerging therapies

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Why DEI Initiatives in Research are Not Working: Time for a Deeper Dive!

Speaker: Quincy Byrdsong

  • Define current and recent trends in DEI in research and associated precipitating influences
  • Dispel myths and address barriers to DEI initiatives leading to concrete gains
  • Transfer the overwhelming energy on identifying problems to generating solutions

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Enforcement Issues in Drug and Device Research

Speaker: Clint Narver

  • Overview of research misconduct in drug and device development
  • Discussion of federal enforcement efforts
  • Best practices for ensuring research integrity and compliance

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Research Security Updates

Speaker: Kristen West

  • Status of research security program standards and disclosure requirements
  • How are funding agencies reviewing and using information that is disclosed?
  • Steps institutions should be taking to develop compliance strategies

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Compliance Considerations for Decentralized Clinical Trials

Speaker: Adam Samson

  • Ethics & equity 
  • Technology adoption & implementation 
  • Control design for decentralization

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