Program Description

Hot Topics and Practical Considerations for Protecting Human Research Participants

This two-day conference for Clinical Research Professionals will study, explain, and discuss how ICH GCP and the Code of Federal regulations guide and direct investigator and sponsor responsibilities related to post approval monitoring, modernizing consent, adherence to and the NIH Data Management and Sharing policy. The attendee will understand and be able to convey the responsibilities of these very important functions, the complementary role of the clinical researcher as a fundamental contributor to successful clinical research and the protection of research subjects.

The program will focus on the relationships among clinical trial staff, investigators, IRBs the FDA, CROs and sponsors. The conference will highlight areas that present challenges to sponsors and investigational sites: navigating single IRB, writing effective informed consent documents, improving the informed consent process, use of genomic data, future use of stored bio-specimens, and risk-based monitoring communication. Discussion surrounding research in the virtual world since the recent pandemic and pain points that continue after the implementation of the Common Rule revisions will be explored. Insights about establishing a robust educational program and accessing effectiveness of the program on an ongoing basis will also be examined.

The program will identify best practices and strategies to provide potential solutions for these challenges. Insights about establishing a robust educational program and accessing effectiveness of the program on an ongoing basis will also be examined.

Learning Objectives: Upon completion of the program, the attendee should be able to:

  • Discuss challenges with informed consent, identify recommendations to improve and modernize informed consent documents, and the consent process
  • Describe the role and responsibilities of the Research Participant Advocate in the informed consent process
  • Describe the myriad of challenges associated with successful implementation of informed consent in research including vulnerable populations
  • Discuss Gene Therapy and the current regulatory environment
  • Discuss different post approval monitoring program structures, risk-based monitoring approaches, and present tools and tips for effectiveness
  • Discuss the benefits of certain changes in the Common Rule revisions
  • Identity and navigate pain points that still exist in the regulation, post Common Rule revisions
  • Provide overview and best practice for trial registration
  • Discuss the Institutional Review Board regulations and federal policies for single IRB
  • Identify how single IRB has affected roles and responsibilities of IRBs, relying institutions, study teams
  • Develop strategies for successfully navigating the single IRB process
  • Define which NIH studies are required to share data
  • Identify the elements of a data management sharing (DMS) plan and apply strategies for creating a DMS plan
  • Discuss required training and documentation in the research arena.