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NIH announces initiatives to advance the development of medical products for the globe

Today the White House hosted the “Science, Technology, and Innovation for Global Development” conference.  Dr. Francis Collins, NIH Director, was among the principal speakers.  In his opening remarks, he introduced two new initiatives from the NIH Office of Technology Transfer (OTT) that will facilitate the development of technologies and therapeutics to help fight disease around the world.  OTT has developed a model license agreement for non-profits to license technologies from NIH and FDA laboratories for neglected tropical diseases, HIV, TB, and malaria. The Global Health Connect website will bring neglected tropical diseases data and information together into a one-stop source. These two efforts will be vital for the entire effort of developing medical products for some of the most serious diseases, with the ultimate goal of bringing them to the global market.

HHS Issues Revised Financial Conflict of Interest Regulations

I am pleased to announce that the Department of Health and Human Services is issuing a Final Rule amending regulations on Financial Conflict of Interest .  We at the NIH have worked together with others in the Department to carefully revise the 1995 regulations to update the regulations and enhance the way in which we maintain the objectivity of the research process.  The NIH is committed to ensuring that Federally-supported research is conducted with the highest scientific and ethical standards and to safeguarding the public’s trust.

The revised and strengthened regulations enhance the requirements for Investigator disclosure of financial interests, institutional management of financial conflicts, and Federal oversight.  In particular, the revised regulations:  

  • Require Investigators to disclose to their Institutions all of their Significant Financial Interests related to their institutional responsibilities.
  • Lower the monetary threshold at which Significant Financial Interests require disclosure, generally from $10,000 to $5,000.
  • Require Institutions to report to the PHS Awarding Component additional information on identified Financial Conflicts of Interest and how they are being managed.
  • Require Institutions to make certain information accessible to the public concerning identified Financial Conflicts of Interest held by senior/key personnel.
  • Require Investigators to complete training related to the regulations and their Institution’s Financial Conflict of Interest policy. 

 Additional details about the major changes to the 1995 regulations can be found on the Office of Extramural Research website.

A victory for access to research resources

Earlier this week, a company, the Alzheimer’s Institute of America, Inc. (AIA), signed an agreement with The Jackson Laboratory stating that the company will drop Jackson from a patent infringement lawsuit related to mice used as models of Alzheimer’s disease. This is great news not only for those involved in Alzheimer’s disease research, but for the entire biomedical research community.

When I first learned about this lawsuit, I knew that NIH had to seek a solution. The research community relies on access to these special transgenic mice to carry out important work aimed at understanding the mechanisms involved in Alzheimer’s disease and developing possible interventions.  Jackson, which is a non-profit research institute that receives funding from NIH, has been distributing mouse models of Alzheimer’s disease to researchers at non profit institutions across the nation since 2003.   At NIH, we believe that science advances most rapidly when new technologies and research tools resulting from federal funding are made available to others.

In June, NIH sent a letter to Jackson relieving the lab of any liability and allowing it to continue to distribute the Alzheimer’s mice to researchers.  In July, the Department of Justice filed a Statement of Interest letting the Court know of our position. I was gratified to see that the actions taken by NIH and the Department of Justice were noted in the Aug. 9 agreement as the impetus for reaching a resolution between Jackson and AIA.

More than a decade ago, NIH published a policy on the dissemination of research resources.  One of the four principles is to ensure dissemination of research resources developed with NIH funds. I am enormously gratified that our work together with the Department of Justice and the Jackson Laboratory helped to uphold this important policy to the benefit of the American people.

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