Office of Research & Innovation
Annual Report

Research Compliance and Regulatory Affairs Milestones

Academic Year 2024-2025 Annual Report

RCRA’s mission continues to be ensuring that all the research conducted at Drexel University adheres to the highest ethical, legal, and regulatory standards, safeguarding the integrity of research and the welfare of our research participants and research models. This year, in addition to our regulatory reviews and day-to-day operations, the team focused on enhancing compliance education and guidance, streamlining regulatory processes, and adapting to evolving federal regulations.

Procedures and Guidance

The group implemented several new procedures and guidelines this year to help support the upcoming implementation of the new research administration system, Novelution, and address the changing regulatory framework. The latest procedures and guidelines can be found in the new compliance documents catalog:

  • ORI-005 Research Education and Training and Training Matrix
  • ORI-601 Research Quality Assurance Reviews
  • ORI-613 Guidelines for Site Initiation
  • ORI-615 Maintenance of Regulatory Files
  • ORI-616 Delegation of Authority
  • ORI-617 Completion of Form FDA 1572
  • ORI-618 Recruitment of Research Participants
  • ORI-619 Approval of Participants for Study Participation
  • ORI-620 Guidelines for Study Closeout
  • ORI-621 Good Documentation Practices
  • IBC-001 Institutional Biosafety Committee (IBC) Charter and Procedure Manual, and accompanying forms

They also completed several major revisions to their existing guidelines and implemented website updates to provide additional tools and resources to help support Drexel’s research community:

  • Completed the revision and release of 24 procedures and guidelines, primarily focused on our IACUC and animal welfare program in preparation for a successful AAALAC site visit. 
  • The Research Quality Assurance Program upholds ORI’s commitment to maintaining the highest standards of quality and research compliance. The new program webpage includes information on how the program can assist researchers and resources on common audit findings and how to conduct a root cause analysis.  
  • The Clinical Research Guidelines and Tools webpage includes pertinent information and resources for clinical research investigators and is being updated with new resources on an ongoing basis.

Training

RCRA has remained committed to delivering high-quality education and advancing their strategic educational goals. These goals focus on promoting inclusiveness in a safe and positive environment that is innovative, collaborative and compliant. Over the last year the team has implemented several improvements:

  • Developed and implemented an enterprise-wide learning course in collaboration with HR: Drexel University’s Research Compliance and Regulatory Affairs.
  • In collaboration with the Graduate College and the College of Nursing and Health Professionals, revised and delivered live Responsible Conduct of Research Training to 211 faculty, staff, and students.
  • Presented a six-session Clinical Research Training Series with over 195 registrants of faculty, staff, and students covering best practices and regulatory requirements for conducting clinical research. 

Accreditation, Operations and Metrics

The Research Compliance and Regulatory Affairs (RCRA) team continues to provide compliance reviews across their different areas (e.g., COI, Export Control, IRB, IACUC, IBC, Radiation Safety) and improve turn-around and completion timelines. 

Between July 1, 2024 and June 30, 2025, examples include:

  1. The IRB reviewed 548 initial, 601 modification, and 58 renewal submissions.
  2. Research Compliance processed over 1325 annual COI disclosures and over 5925 project-specific disclosures with 10 management plans developed/updated.
  3. The IACUC, IBC, and Radiation Safety cumulatively reviewed more than 263 submissions.
  4. Export Control and Research Security reviewed 3262 international travel requests, conducted 6269 restricted party screenings and 65 international visitor reviews, and developed six technology control plans. 

The RCRA team is working consistently on the Novelution implementation project, as part of the COEUS replacement system. One of their goals is to provide regular updates on metrics, turn-around times, and transparency to help the research community plan and support their projects.

This past October, they had their AAALAC site visit; AAALAC is a non-profit organization that promotes the human treatment of animals in science through a voluntary accreditation program. The ULAR (University Laboratory Animal Resources) and Animal Welfare Program worked diligently to ensure they had a successful site visit, and they received full reaccreditation. RCRA wants to thank Richard Huneke, Elizabeth Hann, Michael O’Connor, and Andrea McCurry for their leadership, along with the entire ULAR, IACUC, and Animal Welfare Program for their outstanding effort.

Conclusion

The past year presented opportunities and challenges to the Research Compliance and Regulatory Affairs team. Despite a complex regulatory environment and the need to adapt to new working conditions, RCRA has made significant strides in ensuring that research at Drexel University remains compliant, ethical, and innovative. RCRA looks forward to continuing this essential work in the coming year and building on the successes achieved.

Visit the Research Compliance and Regulatory Affairs Webpage