Lab Study or Testing Agreement?

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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, 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. The purpose of this checklist is to 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.

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 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.

To proceed, answer Questions 1-3. Then, with your answers in hand, compare your responses to Options 1-4, below, to accurately classify your lab study and determine if it is permissible to grant Sponsor ownership of any resulting intellectual property.
 

1. Who developed the protocol?

  • Sponsor
  • Principal Investigator
  • Principal Investigator, with input from the Sponsor
  • Sponsor, with input from the Principal Investigator


2. How detailed are protocol procedures and requirements?

  • The protocol specifies all procedures in detail and leaves no room for the Principal Investigator to experiment on his or her own.
  • The protocol is moderately specific, but leaves some room for the Principal Investigator to experiment and interject his or her own ideas.
  • The protocol only specifies broad requirements and leaves considerable room for the Principal Investigator to experiment and interject his or her own ideas.


3. Characterize the type of work required:

  • Testing
  • Testing and data analysis


The options below are assembled from all possible answer combinations for the three questions above:  

 


Option 1
  1. Who Developed the Protocol?  Sponsor
  2. How detailed are protocol procedures and requirements?  Detailed
  3. Type of work required:  Testing

Classification

This is a Testing Agreement. Sponsor writes protocol, and there is no leeway for Principal Investigator to interject his/her ideas.

The protocol suggests that the likelihood of an invention in which the University should claim an interest is small and that the agreement may grant Sponsor the right to own intellectual property resulting from the study. Please be sure that the grant language is similar to the language we have approved for clinical trials.

 


Option 2
  1. Who Developed the Protocol? 
    • Principal Investigator; or,  
    • Principal Investigator, with input from the Sponsor; or,
    • Sponsor, with input from the Principal Investigator
  2. How detailed are protocol procedures and requirements? 
    • Moderately Specific; or,
    • Broad Requirements
  3. Type of work required:  Testing

Classification

This is a Lab Study Agreement.

The protocol suggests that there may be some meaningful likelihood that an invention in which the University should claim an interest (a "University invention") will result from this study.

Please check with the Principal Investigator to determine whether his or her participation in the development of the protocol means that the study may serve some purpose other than the purpose for which the Sponsor is funding it.

 


Option 3
  1. Who Developed the Protocol?  Sponsor
  2. How detailed are protocol procedures and requirements?  Detailed
  3. Type of work required:  Testing and data analysis

Classification

This is a Lab Study Agreement.

The protocol suggests that there may be some meaningful likelihood that an invention in which the University should claim an interest (a "University invention") will result from this study.

A protocol that requires data analysis probably should not be characterized as a Testing Agreement and, therefore, be characterized as a Lab Study Agreement. Data analysis is the kind of activity that often involves inventive contributions. Please discuss with the Principal Investigator and your institution's research administrators whether inventive contributions are likely in this case.

 


Option 4
  1. Who Developed the Protocol? 
    • Principal Investigator; or,
    • Principal Investigator, with input from the Sponsor; or,
    • Sponsor, with input from the Principal Investigator
  2. How detailed are protocol procedures and requirements?  
    • Moderately Specific; or,
    • Broad Requirements
  3. Type of work required:  Testing and data analysis

Classification

This is a Lab Study Agreement.

The protocol suggests that there may be some meaningful likelihood that an invention in which the University should claim an interest (a "University invention") will result from this study.

Please check with the Principal Investigator to determine whether his or her participation in the development of the protocol means that the study may serve some purpose other than the purpose for which the Sponsor is funding it.

A protocol that requires data analysis probably should not be characterized as a Testing Agreement and, therefore, be characterized as a Lab Study Agreement. Data analysis is the kind of activity that often involves inventive contributions. Please discuss with the Principal Investigator and your institution's research administrators whether inventive contributions are likely in this case.