With increased scrutiny by Congress about enforcement of the Bayh-Dole act, institutions with federally funded research programs are under the gun to structure an effective and comprehensive program for compliance and reporting. World-class medical and academic institutions may find they are unable to close current research initiatives or apply for new grants if they are unable to respond to the notices for compliance. (As a side note, if the rumors that Bayh-Dole compliance may be moved out of NIH to Department of Commerce are correct, be prepared for greater vigilance and more serious outcomes).
Why is compliance and reporting for federally fund research so challenging?
Data is out of control. Noncompliance notifications can number in the 1000’s. To uncover where disclosures were not made properly, extensive research into the history (electronic and hard copy) is required to correct data sets that may be incomplete and corrupt. This presents a time-consuming and often overwhelming endeavor.
Licensing history is hard to reconstruct. Confirmatory licenses and supporting language is often inconsistent. Who owns the original license? What is the financial trail along the path to commercialization?
Resources and skill sets are lacking in-house. Your tech transfer staff has their day jobs. Even large research centers recognize they lack the skills and know-how for the intensive data forensics and mediation that is required.
Financial and IT systems fall short. This is not a one-time deal. Current systems and processes need to be configured in a way that assures compliance and ease of reporting going forward. Concurrently, a change in behavior and training for current staff is necessary so that new procedures are adopted and stick.
Bayh-Dole compliance is a mandate but if institutions only respond when under extreme pressure and fail to address the underlying data, finance and systems considerations, the same issues will crop up in the future. It may be time to consult with a trusted advisor who can help your research program focus on outcomes and fulfill its mission as a good steward of innovation.
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