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 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 responsibilities, IRB management issues, audits, the informed consent process, and administrative activities. 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, communication, 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:

• Discuss the fundamentals, history, ethics, and regulatory aspects of the informed consent process and the informed consent document

• 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 how we can improve the status of racial and ethnic minority health and representation in clinical research

• Discuss the revised Common Rule and the changes that have had the biggest impact on researchers and other potential changes in the future

• Discuss quality assurance approach to integrating risk-based monitoring with applicable requirements and standards

• Discuss the operation of the legal system and its impact on research

• Discuss best practices for subject enrollment and retention

• Discuss practical approaches to training in the realm of research practice

• Define human subject research relative to Institutional Review Board oversight

• Discuss the Institutional Review Board regulations and organization-specific requirements to help expedite the IRB submission process with local and Central IRB’s

• Explore how risk-based monitoring assist in ensuring patient safety

• Discuss the use of REDCap towards personalized informed consent (electronic consent)