Office of Research & Innovation
Annual Report

Regulatory Affairs & Research Compliance Milestones

Academic Year 2023-2024 Annual Report

Our 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, we focused on enhancing compliance education and guidance, streamlining regulatory processes, and adapting to evolving federal regulations.

Procedures and Guidance

We implemented several new procedures and guidelines this year to help support our upcoming implementation of a new research administration system and address the changing regulatory framework:

  • ORI-002 Procedures for Principal Investigator Eligibility and Responsibilities
  • ORI-004 Procedures for Drexel Research Agent Eligibility and Responsibilities
  • ORI-006 Addressing Harassment and Discrimination in Research
  • CITI Research Training Matrix

We also completed several major revisions to our existing guidelines, developed “Did you knows” with common questions about IRB, IACUC, and COI reviews, implemented website updates, and initiated workgroups to help support our research community:

  • Revised and released 24 procedures and guidelines, primarily focused on our IACUC and animal welfare program in preparation for a successful AAALAC site visit. 
  • Substantial updates and content revision to the Research Conflict of Interest and Export Control website pages and a new landing page and content for Research Security.
  • In response to NSPM-33, we have initiated a Research Security Tier Workgroup with representation from IT, Privacy Program Services, and other key stakeholders across the institution to develop guidance that can be embedded, implement user-friendly tools, and support our faculty and Drexel University’s commitments to participants, funders, regulatory agencies, and collaborators.

Training

We have remained committed to delivering high-quality education and advancing our 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 we have 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.
  • Provided additional Research Blood Draw Training, with over 35 Faculty, Staff, and Students having now obtained certification.
  • Implemented revisions to the existing Drexel University CITI training, including standardized acceptance of active previously completed training, incorporating required modules for NSF and NIH funded research, and transferring Salus University’s Faculty, Staff, and Students.

Salus Research Integration

Over the last year, we have transitioned Salus University’s research to Drexel University; this transition was effective 07/01/2024:

  • Conducted an on-site overview and transition planning session between senior research administration leadership in March of 2024.
  • Integrated assurances, CITI training, SOP’s, and provided transition guidance in preparation for July, 01, 2024. 
  • Hosted several Research Compliance and Regulatory Overview sessions for Salus Faculty, Staff, and Students in July and August 2024.
  • Welcomed Jacqueline Stults (Magnarelli) from Salus University to our Drexel University RCRA Team.

Accreditation, Operations and Metrics

The Research Compliance and Regulatory Affairs Team continues to increase year-over-year reviews as a team across our different areas (e.g., COI, Export Control, IRB, IACUC, IBC, Radiation Safety), and improve turn-around and completion timelines.

Since January 1, 2024 examples include:

  1. The IRB reviewed over 1100 initial, modification, and renewal submissions.
  2. Over 1500 annual COI disclosures and over 5500 project-specific disclosures.
  3. The IACUC, IBC, and Radiation Safety cumulatively reviewed more than 260 submissions.

We are looking forward to the replacement of COEUS and implementation of Novelution, as one of our goals is to provide regular updates on metrics, turn-around times, and transparency to help our research community plan and support their projects.

This November, we had our AAALAC site visit; AAALAC is a non-profit organization that promotes the human treatment of animals in science through a voluntary accreditation program. Our ULAR (University Laboratory Animal Resources) and Animal Welfare Program worked diligently to ensure we had a successful site visit. Although we are waiting for final confirmation from AAALAC regarding our reaccreditation status, we want 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 (RCRA) 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. We look forward to continuing this essential work in the coming year and building on the successes achieved.