Program Description

Hot Topics and Practical Considerations for Protecting Human Research Participants

As the field of research evolves, new ethical and regulatory challenges arise, making it essential for researchers to stay up-to-date with emerging issues. This workshop aims to provide strategies for doing just that. Participants will leave with a better understanding of their responsibilities as researchers and the steps they can take to protect human research participants.

Topics of discussion will include emerging models of clinical research, such as decentralized clinical trials (DCTs), the use of post approval monitoring using a risk-based approach and the use of telemedicine in research. The FDA guidance for DCTs emphasizes the importance of ensuring that remote data collection methods used in these trials are reliable and accurate, and that patient privacy and safety are protected. Additionally, the workshop will explore health disparities, the importance of diverse study populations, and the challenges of health literacy.

As research continues to change, training for research staff is essential. This workshop will describe a unique use of REDCap to train research staff. This innovative approach allows staff members to experience different scenarios and make decisions on how to proceed, providing a more engaging and interactive learning experience.

Finally, the workshop will explore the challenges and opportunities involved in administering clinical research in an academic setting. A large coordinating center will be used as an example to highlight the unique challenges involved in this model of the research workforce. By attending this workshop, participants will gain a better understanding of the evolving landscape of research and how to stay up-to-date with emerging issues.


Objectives:

  • Analyze the de-centralization of clinical trials, evaluate virtual research tools, and identify barriers to virtual research participation.
  • Evaluate the elements of conducting decentralized clinical trials of FDA regulated investigational products while ensuring FDA regulations are met, including those covering human subject protection and electronic records.
  • Recognize the importance of diverse study participants in ensuring equitable and comprehensive research outcomes.
  • Assess compliance issues when using telemedicine in decentralized clinical trials.
  • Demonstrate the use of REDCap and apply strategies to ensure that only qualified participants are enrolled in a clinical trial.
  • Evaluate different post-approval monitoring program structures, risk-based monitoring approaches, and present tools and tips for effectiveness.
  • Learn from experiences in creating a sustainable and scalable structure for an academic coordinating center.
  • Examine the impact of health disparities when engaging study participants and its effect on the validity, generalizability, and impact of clinical research findings.
  • Develop strategies to enhance clinical trial recruitment by mitigating health literacy barriers.
  • Provide an overview of clinicaltrials.gov and best practices for trial registration.