As I said off-line. You need to work with your Technology Transfer Office.

This is intellectual property owned by your institution.  Knowing just enough about this project to be dangerous, at the very least a material transfer agreement (MTA) language which is expanded to address the licensing, data use and reciprocity issues would be a suggestion. 

It seems you need more than a simple participation agreement and if you are participating in building the facility, you’ll need a more involved agreement that discusses the set up and running of the biorepository.  If your organization is going to be partially responsible for the enterprise, it may be money well spent to involve your institution’s legal department, you are correct, it seems the other institution has not written a specific agreement for this either.  Maybe the institutions working to set it up should work together on the proper type of agreement. You could also contact another bio-rep and ask how they set theirs up.

Alex

Hi, medical school research administrators.  I need your help.

We have been asked to participate in building a biorepository (providing specimens and clinical data) at another (non-IHE) organization.  They’ve given us a clinical trial agreement, calling this an observational study, but there is no protocol that addresses a research question.  The agreement gives this organization ownership of the database and specimens, and there are no provisions (other than a recital that indicates intent) that give access to the biorepository to institutions/researchers who contribute.  They also are asking that we assign our IP rights to them, as a corporate CTA would do.  I’m new to the world of med schools, but this feels like they’re trying to use a type of agreement that doesn’t fit with the nature of the activity.  Data use agreements don’t seem to fit well, either, as they appear to be used after the biorepository is established and accessible.     

What kind of agreement should be used for participation in building a biorepository?  Does anyone have an agreement template you can share? 

Thanks much.

Barbara      

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