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Regulatory Knowledge and Support

The ACTRI aims to continuously improve the efficiency and quality of regulatory submissions and the ethical conduct of research by providing consultation, resources, and training. Guided by principles dedicated to the highest ethical standards, the unit remains current with evolving regulations while fostering safety, quality, and research excellence.   

Transforming Regulatory Support: Driving Innovation, Safety, and Ethical Research

Regulatory challenges are a critical barrier to translating scientific discoveries into impactful research. The Regulatory unit addresses these challenges by offering consultations, training, and a suite of services, documents, and tools to ensure human-centered research is safe, efficient, and compliant. 

All activities are reviewed quarterly by the ACTRI Community Advisory Board (CAB), which provides valuable community feedback. These efforts range from prioritizing research competencies for community health workers to building community trust and promoting responsible mentoring. 

The anticipated outcome is that innovative tools, community-engaged IRB models, and broad support services will revolutionize regulatory submissions and research ethics, enhancing both safety and efficiency. 

Where ACTRI Investigators go for Regulatory Knowledge and Support

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Led by Anthony Magit, MD, the Regulatory unit conducts pre-reviews of protocols and IRB submissions tailored to investigator needs. This service is especially valuable for multi-site trials, including those from the ACTRI Hub Liaison Team (HLT) that engage the CTSA network. Efficiency is monitored by tracking the number of review cycles required to achieve IRB approval.

To address challenges for non-native English speakers, the Regulatory unit provides: 

  • Certified translation services 
  • Support for qualitative methods to evaluate consenting practices 
  • Connections with the ACTRI CAB for community review prior to IRB submission 

These community-focused efforts were vital for partner institutions like El Centro Regional Medical Center (ECRMC) during the COVID-19 pandemic. The Regulatory unit collaborated with ACTRI BMI to develop standardized procedures for remote consenting (e.g., using DocuSign) to ensure compliant signatures. 

Community-Centered IRB 
Looking ahead, the Regulatory unit will create a Community-Centered IRB for community-based research protocols. This new IRB will: 

  • Challenge the concept that only scientists can determine community-based research 
  • Be nested within the UCSD IRB 
  • Feature a majority of community and non-scientist members alongside subject matter experts 
  • Include training for IRB members on processes and responsibilities 

This innovation aims to establish a national model for IRB review that prioritizes community perspectives, often overlooked in current reviews. 

DAC serves as the ideation and testing hub of medical devices at UC San Diego by providing translational science training, identifying unmet clinical needs amenable to clinician-engineer collaboration, prototype testing, and commercialization.

 

Device Acceleration Center

At ACTRI, research ethics is the cornerstone of all our endeavors. Upholding the highest ethical standards ensures the integrity, safety, and efficiency of our research while fostering trust among participants, researchers, and institutions. Our goal is to address the ethical, legal, and societal implications of cutting-edge research, including decentralized trials, digital health, and AI. 

Through innovative tools, community-engaged Institutional Review Board (IRB) models, and comprehensive support services, we aim to transform regulatory submissions and enhance research ethics to create a safer, more efficient research environment. 

 

Research Integrity and Ethics

The Clinical Trial Support Service (CTSS) team plays a crucial role in aiding investigators through high-quality services that facilitate the planning, execution, and completion of clinical trials and research studies. This team provides comprehensive regulatory affairs support, including product classification determination, FDA IND/IDE/510K guidance, protocol development, and assistance with applications. Moreover, the CTSS is equipped with staff experienced in regulatory matters, offering help with IRB and ancillary committee submissions, which covers preparing new applications, amendments, renewals, and reportable events for both UCSD and non-UCSD IRBs. Their services extend to developing informed consent documents, coordinating with Ancillary Committees to address concerns like conflict of interest and biosafety, and facilitating collaborations with sponsors, Clinical Research Organizations, and ACTRI Research Coordinators, ensuring a streamlined and compliant research process.

 

CTSS Unit

Located on the ACTRI Center for Clinical Research page under the dropdowns "Clinical Trial Support Services:"

ACTRI is committed to enhancing research quality through its Quality Assurance (QA) initiatives, ensuring Institutional Review Boards (IRBs) adhere to standardized best practices. ACTRI’s QA team works diligently to identify challenges, streamline institutional processes, and provide critical consultation to investigators. By monitoring IRB reviews, responses, and approval times, ACTRI drives improvements that elevate ethical research standards.

 

Research Quality Assurance

UCSD ACTRI offers a variety of consultations designed to support researchers throughout the research process, focusing on regulatory compliance, ethical standards, and knowledge support. Consultation areas include: 

  • Regulatory 
  • Research Integrity and Ethics 
  • Research Quality Assurance 
  • Grant Funding and Support
  • Community and Translational Resarch Support

 

Consultation Support

The Regulatory unit developed the Research Compass, a web-based portal consolidating resources and information on regulations, IRB processes, templates, clinical trial billing coverage analysis, contracting, conflict of interest, and biosafety review and training. The portal also links to NCATS SMART IRB resources, providing investigators with continuously updated regulatory tools in one easy-to-access location. 

 

ACTRI Research Compass

After much extended collaborative efforts between the ACTRI and MCC along with multiple research subject matter experts from other UCSD departments, we are now launching our new eRegulatory (eReg) services powered by the Florence application platform.  The goal of implementing the Florence platform at UCSD is to enable us to move away from reliance on paper forms and physical research binders, thereby enhancing health research compliance through improving both our electronic regulatory and clinical documentation workflows.

New System Highlights

  • Centralized integrated platform to meet the regulatory requirements of health research studies
  • Digitized research processes to lower risks and improve efficiencies for fulfilling critical internal and regulatory requirements
  • Eliminates manual processes through automation of complex workflows, by the integrated leveraging of cross-dependent services in Kuali research
  • Streamlines core regulatory needs surrounding startup, operational, and secure collaboration

If you are interested in using UCSD’s Florence eReg platform, please send an email to actri-florence@health.ucsd.edu and we will reach out to you to initiate a consultation and discussion. 

For more information on UCSD’s eReg Florence platform, you can visit our Florence Pulse website:  https://pulse.ucsd.edu/departments/clinical-research/Pages/Florence-eReg-System.aspx

All UCSD Research units are welcome to utilize Florence eRegulatory platform and can request study and user creations using this  https://ucsd-actri.jotform.com/232994806487978 request form. ACTRI BIDS Team manages this system.

Learn more about the Florence eRegulatory platform on the Pulse Website below:

https://pulse.ucsd.edu/departments/clinical-research/Pages/Florence-eReg-System.aspx

Access the Florence eRegulatory platform SOP here.

 

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