Program Description

Hot Topics and Practical Considerations for Protecting Human Research Participants

SOCRA is proud to announce this conference on Protecting Human Research Participants. The conference is designed to aid the Clinical Research Professional’s understanding of current ‘Hot Topics’ as well as the practical considerations in human subjects research.

This three-day conference for Clinical Research Professionals will study, explain and discuss how ICH GCP and the Code of Federal regulations guide and direct investigator responsibilities, IRB management issues, audits, the informed consent process, and administrative activities in today’s evolving environment. The attendee will understand and be able to convey the responsibilities of these very important functions and 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: writing informed consent documents, the informed consent process, use of genomic data, future use of stored bio-specimens, risk-based monitoring, electronic communication and electronic documentation, and research fraud. The use of REDCap for operational and personal management tracking for multi study tracking purposes as well as electronic consent use towards personalized informed consent will also be explored. The program will identify best practices and strategies to provide potential solutions for these challenges.

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

  • Identify issues related to health disparities in clinical trials research
  • Learn strategies for addressing issues related to health disparities in clinical trials research
  • Understand the regulatory requirements for gene therapy studies.
  • Understand the growth in gene therapy and how to prepare for gene therapy research
  • Understand the benefits of certain changes in the Common Rule revisions
  • Identify and navigate pain points that still exist in the regulations
  • Watch for more upcoming changes that may affect their interactions with their IRBs
  • Describe the role and responsibilities of the Research Participant Advocate in the informed consent process
  • Discuss Part 11 Compliance and best practices to help ensure that your electronic systems are within the FDA regulations
  • Describe the myriad of challenges associated with successful implementation of informed consent in research including vulnerable populations
  • Discuss how we can improve the status of racial and ethnic minority health and representation in clinical research
  • Discuss quality assurance approach to integrating risk-based monitoring with applicable requirements and standards
  • Discuss best practices for subject enrollment and retention
  • Discuss practical approaches to training in the realm of research practice
  • Explore how risk-based monitoring assist in ensuring patient safety
  • Discuss the use of REDCap towards personalized informed consent (electronic consent)