Hot Topics and Practical Considerations for Protecting Human Research Participants

2023 AGENDA 

Day One - Thursday

8:00 - 8:15 Registration and Continental Breakfast

8:15 - 8:30 Welcome and Introduction

8:30 – 9:45 Research in the Virtual World

Michelle Brignac, CIP, CCRP, Manager-Clinical Research Operations - Hematology Department, Office of Human Subjects Protection, St. Jude Children’s Research Hospital
The COVID pandemic substantially impacted trial sites as they experienced difficulty in the continuation of trial activities which hampered the progress of the trials and delayed study timelines. Some sites are still struggling due to delayed subject enrollment, shortfalls in monitoring, and risks of compromised data integrity. In this presentation, we will discuss navigating the changing clinical trial landscape while conducting research virtually and we will look at some case studies on how some sites are navigating clinical trials in a virtual climate.

9:45 - 10:00 Break 

10:00 - 11:15 Decentralized Clinical Trials: IRB and Other Regulatory Issues

Scott Lipkin, DPM, CIP, Vice President for Research, Baptist Health South Florida
Nichelle Cobb, PhD, Senior Advisor for Strategic Initiatives Association for the Accreditation of Human Research Protection

11:15 - 12:15 Understanding the 2023 NIH Data Management and Sharing Policy

Natalie Dilts, MHP, Senior Research Strategy & Program Specialist, Vanderbilt University Medical Center

Ms. Dilts will provide information on the new NIH policy for Data Management and Sharing (DMS), the required elements for DMS plans, the implications for genomic data sharing, budgeting guidance, and data repository guidance.

12:15 - 1:00 Lunch provided

1:00 – 2:00 The Informed Consent Process and the Role of the Research Participant Advocate

Wendy Hayes, MSN, RN, CPHON, Research Participant Advocate, Office of Human Subjects Protection, St. Jude Children’s Research Hospital
It is not good enough that we just inform possible participants of the required information about research studies. We must also ensure understanding. Ms. Hayes will detail the informed consent process and describe the role and responsibilities of the Research Participant Advocate during this discussion. As a result of attending this session, attendees will understand the required elements of an informed consent discussion and be able to describe the role and responsibilities of the Research Participant Advocate.

2:00 - 3:15 Navigating Single IRB

Nichelle Cobb, PhD, Senior Advisor for Strategic Initiatives Association for the Accreditation of Human Research Protection

The expansion of single IRB significantly altered the relationship between research teams and IRBs as well as increased responsibilities for some research teams. This talk will provide an overview of single IRB requirements, examine the effect of single IRB on study teams, and share strategies for successfully navigating the single IRB process.

3:15 - 3:30 Break 

3:30 – 4:30 – 21st Century Cures Act & ORA’s Innovative Role

L’Oreal Walker and Joan Briones, FDA/ORA Bioresearch Monitoring Program Division Director for Division II, US Food and Drug Administration

4:30 - 5:00 Q&A, Day 1 Wrap up

Day Two 

8:00 - 8:15 Continental Breakfast

8:15 - 9:15

Cristina Ferrazzano Yaussy, MPH, CCRP, Research Regulatory Affairs Specialist, Dartmouth-Hitchcock Medical Center

Ms. Ferrazzano Yaussy will provide guidance for managing trials, in addition to reviewing the registration and results entry process in Best practices and helpful tips for both Administrators and users will be provided. Attendees are invited to bring their own scenarios for group discussion and should leave the workshop with skills to successfully manage trials within

9:15 - 10:30 Post Approval Monitoring Using a Risk-Based Approach

Jessica Rowe, Associate MA, MS, CCRP, CIP, Associate Director, HRPP and Yale Human Research Protection Program

This presentation will discuss current trends of post-approval monitoring programs. Ms. Rowe will discuss different Post-Approval Monitoring program structures, risk-based approaches, and present tools and tips for effectiveness.

10:30 - 10:45 Break

10:45 - 11:45 The Journey of Achieving a Quality Research Program Through Required Education and Training

Wendy Lloyd, BA, LPN, CCRP, Senior Clinical Quality Research Analyst, Vanderbilt Institute for Clinical and Translational Research

Ms. Lloyd will discuss the merging of why, who, what, where, when and how of protection of human research participants, compliance and training. Attendees will discuss practical approaches to training in the realm of research practice.

11:45 - 12:45 Lunch Provided

12:45 - 2:00 Revised Common Rule: 4 Years Out

Brian Stage, JD, BA, CIP, Research Compliance Consultant for Regulatory Affairs, Indiana University Human Subjects Office
The final Revised Common Rule was implemented in January of 2019. Now that researchers and IRBs have 4 years of working under the new rules, we can clearly see that some changes have worked to make regulatory review faster and easier. However, there are still regulatory issues that exist, and will require more changes, guidance, and creative solutions in the future.

2:00-2:15 Break 

2:15 - 3:15 The Current Gene Therapy Research Boom and Future Challenges

Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of BioSafety Services, Advarra
Research involving engineered genetic materials is booming. The technology is coming to the forefront regardless of whether we’re looking at infectious disease vaccines, CAR T cells in oncology or correcting mutations that cause rare diseases. Dr. Eisenman will provide an introduction to the field of gene therapy and the science behind it as well as provide an overview of the regulatory requirements and how to prepare to conduct a gene therapy study.

3:15 – 3:45 - Q & A / Wrap up