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Lab Study or Testing Agreement?

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Introduction

 Most lab studies involve the kind of basic research that makes it difficult to predict whether an invention might result from the study, so we protect ourselves by including a contract clause that lets the University own such inventions. There is, however, one class of lab studies that we will call "testing" agreements for which we can fairly safely predict there will be no University inventions. This is very similar to the conclusion we draw for clinical trials, but whereas it may be true for all or nearly all clinical trials, it is not true for all, or even most, lab studies. The trick then is to accurately classify a lab study so that we only require University ownership of intellectual property when it will benefit us and not when it will do no more than impede negotiation of the study terms. That is the purpose of this checklist. It should help you classify lab studies based on who wrote the protocol, how detailed it is and whether it requires mere testing or more detailed analysis of data.  

General Concerns

 Please use the Sponsored Research Agreement Checklist to review all lab studies for the standard problems that any sponsored research agreement presents. The special problem that this checklist addresses is whether it might be permissible to grant the Sponsor ownership of intellectual property resulting from the study, as we do in clinical trials.  

Checklist

1. Who developed the protocol?

Sponsor

Principle Investigator

Principle Investigator with direction from the Sponsor

Sponsor with direction from the Principle Investigator

2. How detailed are protocol procedures and requirements?

The protocol specifies all procedures in detail and leaves no room for the Principle Investigator to experiment on his or her own.

The protocol is moderately specific, but leaves some room for the Principle Investigator to experiment and interject his or her own ideas.

The protocol only specifies broad requirements and leaves considerable room for the Principle Investigator to experiment and interject his or her own ideas.

3. Characterize the type of work required:

Testing

Testing and data analysis

 

  

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Comments to Intellectual Property
intellectualproperty@utsystem.edu
Last updated: August 28, 2001

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