Tech Transfer Central
Industry-Sponsored Research Management sample issue

Preserving Sponsored Research Integrity: Fortifying Contractual Language and University Policy to Prevent Bias and COI

Format: On-Demand Video, DVD, or PDF Transcript
Originally presented: May 29, 2018

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Research collaborations between universities and industry have become commonplace and often offer critical benefits to both parties, advancing potentially valuable technologies that may have otherwise been delayed or discontinued.  

But, these complex agreements come with great responsibility related to the integrity of research data, and the principal investigator’s ability to conduct, review and publish the research independently and without any hint of bias.

As more for-profit actors are added to the research stage, the spotlight also focuses more directly on the various conflicts of interest that can harm reputations and bring research partnerships to a screeching halt. That’s why Industry-Sponsored Research Management’s Distance Learning Division has secured two experts from UNeMed – the University Nebraska Medical Center’s tech transfer arm — to present this important, detailed webinar:

This critical program will dive into best practices that universities can draw upon to ensure the integrity of their corporate-sponsored research through carefully drafted contractual language as well as optimal compliance and COI policies. Please join Joe Runge, Business Development Manager, and Tara Scrogin, Associate General Counsel for Health Sciences, for this session that will cover:

Contract issues:

  • Intellectual property
    • Bayh Dole
    • Appropriate obligations on IP
    • Investigator-led projects
    • Sponsor-led projects
    • Appropriate commercialization terms
  • Research integrity
    • Publication must be absolute
    • Appropriate delay for review
    • No editorial control by sponsor

Compliance issues:

  • Ensuring appropriate data maintenance
  • Ensuring appropriate regulatory control
    • IACUC
    • IRB
    • FDA
  • Identifying conflicts of interest
  • Appropriate COI management plans

Meet Your Presenters:

Joe RungeJoe Runge
Business Development Manager
UNeMed

Mr. Runge is a registered patent lawyer and has lectured on bioentrepreneurship, intellectual property and regulatory law and writes regularly for a number of websites. At UNeMed, Mr. Runge is involved with all facets of technology transfer: invention evaluation, technology marketing, intellectual property strategy, license negotiation and license enforcement. In addition, he collaborates with faculty to create and develop new intellectual property. He also sits on the state SBIR/STTR advisory board, served as a mentor to multiple start-up accelerators, and is actively involved with the technology start-up ecosystem in Omaha and Nebraska.

Tara ScroginTara Scrogin
Associate General Counsel for Health Sciences
UNeMed

Tara Scrogin is an attorney who is currently serving as Associate General Counsel – Health Sciences at the University of Nebraska. Her areas of practice include healthcare research, contracting, healthcare compliance, risk assessment, research misconduct, human subject research and related regulatory matters.

Prior to the current position, Tara served as the Interim Compliance Officer at the University of Nebraska Medical Center (UNMC) and Interim Privacy Office for UNMC and The Nebraska Medical Center d/b/a Nebraska Medicine. She was responsible for standing up UNeHealth as contracting arm for UNMC for industry sponsored clinical trial research. She had served as a contract specialist for clinical trial contracting at UNMC from 2008 through 2015, which included two (2) years as the manager of UNeHealth.  Tara started at UNMC at UNeMed, the technology transfer arm for UNMC in 2008.

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