Training Program Title

'Hot Topics' and Practical Considerations for Protecting Human Research Participants

CTSA Hub Administered


Contact Information

Contact us by email at or by phone at 215-822-8644.

Training Program Description

This 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, communication, and research fraud. The program will identify best practices and strategies to provide potential solutions for these challenges.

Competency Keywords

IRB, Research participants, Responsible conduct of research, Regulation, Best practice, Documentation, Research study management, Communication

Digital Commons Disciplines

Medical Education



Cost to Access


Competency Domains

Ethical and Participant Safety Considerations; Clinical Trials Operations; Study and Site Management

Learning Objectives

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 the challenges of minority recruitment
  • Discuss the revised Common Rule and its impact
  • 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
  • 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
  • Discuss research fraud issues through case study examples
  • Discuss the landscape of research integrity in clinical research
  • Recognize the areas of intersection at which poor research reduces patient outcomes
  • Identify best practices and strategies that can improve transparency, rigor and reproducibility in clinical research
  • Utilize tools to enhance clinical research trial effectiveness

Delivery Method


Target Learners

Clinical Research Professionals (other than PI)

Learning Level






Time Needed

2 Day Conference (12.5 hours of CE credit available)

Associated Assessment


Assessment Methods

Overall satisfaction