Responsibilities of Recipient Institutions in Communicating Research Misconduct to the NIH

A reminder that if a recipient institution initiates a research misconduct investigation, it must take any necessary steps to:
  • protect the scientific integrity of the project;
  • protect human participants, live vertebrate animals and the environment;
  • ensure the proper expenditure of funds and, if appropriate, continuation of the project during the investigation; and
  • provide reports to the HHS Office of Research Integrity

Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH SBIR Omnibus Solicitations

A ‘Direct-to-Phase II’ SBIR award is a Phase II award issued to a small business that did not receive a Phase I award for that research/research & development. Recent legislation has re-instated this SBIR Direct Phase II provision through Fiscal Year 2022 and NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). These will not be needed now.

Notice Regarding 2018 Bayh-Dole Act Final Rule - Rights to Federally Funded Inventions and Licensing of Government Owned Inventions

Effective October 1, 2018, NIH will implement the new final regulations of the Bayh-Dole Act.  The new regulations will apply to all NIH new (including renewals) and continuation awards beginning on or after October 1, 2018. The Bayh-Dole Act permits funding to retain ownership of the inventions made under federally funded research grants or contract programs, while also giving the government a license to practice the Subject Invention. See NOT-OD-18-233.

Notice of Change to Activity Codes allowed for Administrative Supplements to Promote Diversity in Research and Development Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed) PA-18-837