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NIH Technology Transfer and Ethics
Pat Lake, Deputy Director
Extramural Technology Transfer
NIDDK, NIH
FLC – Mid Atlantic Regional Meeting, Rocky Gap, Maryland
September 15, 2005
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National Institutes of Health• Mission: The National Institutes of Health
is the steward of medical and behavioral research for the Nation.
• 27 Institutes, Centers and Divisions
• 18,000 employees
• Total FY 2004 budget 27 billion dollars
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NIH IC Offices of Technology Transfer
• Evaluates new inventions generated by scientists
• Assists in marketing Institute patents/ inventions to industry
• Assists scientists in implementing transactional agreements, i.e. Material Transfer Agreements (MTAs), Confidential Disclosure Agreements (CDAs)
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NIH IC Offices of Technology Transfer (Cont’d)
• Assists scientists in setting up collaborations with profit and not for profit entities through CRADAs and Clinical Trial Agreements (CTAs)
• Acts as a resource to our scientists for a wide variety of technology transfer & intellectual property matters
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CRADAs & Ethics
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NIH CRADA Review Process
• Institute & Collaborator PIs develop Research Plan
• Institute performs actual negotiations with CRADA Collaborator
• NIH Office of Technology Transfer, IC Ethics Office and Office General Counsel review the CRADA
• Internal NIH CRADA Subcommittee reviews and makes the recommendation for approval
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Conflict of Interest & Fair Access Review
• COIFA Form
• PIs complete and Ethics Office reviews
• Questions include: Financial or Personal relationships PI has with CRADA Collaborator
• Fair Access Issues-why was this Collaborator chosen
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Other Case Studies\Examples
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Royalties going directly to a Charity
• Sorry! According to HHS OGC not possible
• Royalties must go directly to inventor
• Inventor can then make arrangements with a charity of choice
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Employee Owned Inventions
• New employee hired by NIH from European research institute
• He personally was prosecuting his own patent application
• Wanted to continue research in this area covered in patent
• PI assigned IP rights to NIH who assumed patent prosecution costs
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Sponsored Travel
• Sponsored travel is handled differently amongst the NIH institutes.
• Some Institutes don’t allow their scientists to accept sponsored travel from industry without a one year cooling-off period before a collaboration can begin.
• Since sponsored travel is technically a gift to the Institute and not the scientist, it is not a conflict. This is a policy issue for the institutes.
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Recap of NIH’s New Ethics Rules
• No consulting in personal capacity
• Scientist are encouraged to consult with industry in their official capacity!!!
• See our ethics website for summary of new rules….
• Http://www.nih.gov/about/ethics/summary_ammendments
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Please feel free to contact:
Pat LakeDeputy DirectorExtramural Technology Transfer NIDDK, NIHOffice of Technology Transfer and Development6707 Democracy Plaza, Suite 906B, MSC 5343Bethesda, MD 20892-5343Ph. 301-594-6762Fax: 301-480-7546Email: [email protected]