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Did You Know?

Human Subject Research

When should an investigator report a study closure to the IRB?

Study closures should be reported to the IRB via a final report in COEUS when the human subjects research, including research that has received an exempt determination, is permanently closed to enrollment, all subjects have completed all protocol related interventions and interactions, and the collection and analysis of private identifiable information is complete.

Reporting that a study has been completed is best practice for several reasons: 

  1. Permits the institution and Drexel University’s HRPP to maintain accurate metrics, appropriately respond to monitoring or audit inquiries or accounting requests relevant to its human subject research portfolio, 
  2. Provides a start date on the record retention timeline required by the FDA, OHRP, HIPAA, and Drexel University’s records retention policy (OGC-4 Records Retention Policy) and records retention schedule [PDF]
  3. Allows the institution to properly manage and transfer IRB oversight to another IRB when necessary. 

The Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) require IRBs to function under written procedures. These procedures include keeping the IRB informed of study completion and close out to ensure record retention in compliance with 45 CFR 46.115(b) and/or 21 CFR 56.115(b). Additionally, per the FDA [21 CFR 56.108(a)(3)] procedures require ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB and the information provided may be used in the evaluation and approval of related studies. 

If Drexel investigators are relying on an external IRB, that IRB is responsible for indicating when the site’s IRB approval status has changed. The reliance agreement will typically require the reviewing IRB to inform our site/investigator when changes in the status of our site approval occur, and closing the study with the IRB is a change that is reported. When correspondence from the reviewing IRB has been received indicating the Drexel site has been closed and no longer carries approval by the reviewing IRB, the closure should be submitted via COEUS so that the project’s record may be closed with the Drexel IRB. 

The process for submitting a final report is the same as submitting for a continuing review. Reference the COEUS Lite-How to Submit Continuing Reviews (Renewals) [PDF] document for a step-by-step guide with screenshots.

Questions? Email John Roberts, Executive Director, Human Research Protection Program at

Applied Innovation

Drexel Applied Innovation offers resources to help you expand the impact of your research through comprehensive technology transfer services!

  • IP & Agreements: PROTECT Drexel innovation and innovators through IP development and high-quality license agreements
  • Industry Engagement: CONNECT Drexel IP and their inventors to industry’s unmet needs and innovation challenges
  • Entrepreneurial Development: PROMOTE impact-oriented mindset within the Drexel research enterprise, offering startup support and funding programs

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FACULTY MEMBERS: Expand the impact of your innovation through NSF I-Corps!

  • Immersive, experiential program
  • Explore the question: “Given my innovation, who would care about it the most, why, and by how much” with the members of your lab (postdocs and PhD students)
  • Applicable to a wide variety of research-based innovations
  • Prior NSF Funding is NOT required!
    • NOVUS
      • Learn the basics
      • Half-day program followed by self-paced introductory coursework
      • Four sessions (online) guiding you through customer discovery research – customer, problem, solution and value proposition testing
      • $3,000 NSF grant 
      • Seven weeks/15 hr per week commitment 
      • Engage with prospective customers, partners, and others in the ecosystem
      • $50,000 NSF grant
  • Opens the door for
    • Help with your future grant proposals
      • “Broader Impacts” - NSF and NIH - A summary paragraph describes the expected broader societal, commercial and educational outcomes of the proposed project.”
    • Expanding your rolodex of industry contacts
      • During I-Corps, you would be connecting with at least 100 industry companies and stakeholders
    • Exploring forming a startup
    • Access to Drexel Express Startup License
      • Startup and investor friendly licensing agreement with pre-set terms to eliminate barriers and open the doors for commercialization pathways
      • For more information, click here
    • Many other potential beneficial outcomes  

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Receive $150,000 to accelerate your entrepreneurial endeavor and shorten the time to the first round of professional investor capital with the Drexel University Innovation Fund!

  • Invests in both Drexel student and tech transfer startups
    • Investment candidates: NSF I-Corps, Drexel Coulter Translational Research program, Baiada incubator, Drexel Startups Fund, ic@3401, etc.
    • Investment size = $150K per company; up to 4 investments per year
  • “Early stage”
    • University to play the role of a “friends and family” investor; often too early stage for investors who are only focused on financial returns
    • Often the first check into the company

"This is a bold new initiative to empower our problem solvers to dream big and take on society’s most pressing challenges. We are doubling down on our entrepreneurial talent and research innovations." --President, John Fry

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Connect with Drexel Applied Innovation to chart your journey.

Drexel Applied Innovation would love to hear what you’re working on and discuss next steps! 

DAI will work with you to evaluate your invention, assess whether it might be of interest to industry/investors/entrepreneurs, protect it with intellectual property, market it, negotiate agreements, etc.

Questions? Email