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Advance look at AUTM Survey Results for FY 2011

Posted on September 4, 2012 by Jeffrey Waldin |

The number of academic responses received for FY 2011 appears effectively the same as FY 2010. The roster of institutions with highest reported revenue also appears effectively the same. Northwestern retains its position due in no small part to particularly sucessful drug licensing, as do many of the…

Tips for handling problem PIs

Posted on September 4, 2012 by Matthew Tanner |

Do you recognize any of these PIs? Dr. Studies, AKA Dr. “We Can Do That” Dr. Enrollment, AKA Dr. “I Want to Enroll an Incarcerated Schizophrenic Patient with Dual Primaries” Dr. Yes, AKA Dr. “I’ll Do It by the End of the Day”…

FDA issues draft guidance on prospective assessment of suicidal ideation and behavior in clinical trial participants

Posted on August 28, 2012 by Matthew Tanner |

FDA recently issued a draft guidance addressing the issue of suicidal ideation and behavior that emerges during clinical trials of investigational drugs and biologics. The guidance includes recommendations for assessment and for determining which clinical trial protocols should include assessment procedures.…

Public workshop on FDA clinical trial requirements

Posted on August 28, 2012 by Matthew Tanner |

FDA and the Society of Clinical Research Associates (SoCRA) will co-sponsor a public workshop to be held November 14-15, 2012 in Baltimore, MD. The target audience includes clinical research professionals and IRB professionals. More information is available on SoCRA’s website.

USPTO roadshow information sessions for AIA start September 10

Posted on August 28, 2012 by Jeffrey Waldin |

Eight information sessions will be held at different regional locations starting September 10 and ending September 28. The agenda includes separate slide presentations covering final and proposed rules, with a separate question and answer session following each. No advance registration is…

Federal appeals court upholds 2011 ruling on federal funding of hESC research

Posted on August 27, 2012 by Matthew Tanner |

A panel of the US Circuit Court of Appeals for the District of Columbia determined late last week that federal funding of research involving human embryonic stem cells (hESCs) is permissible and may continue. The decision upheld a lower court’s…

NIH Announces Rollout of RPPR for most SNAP and Fellowship Awards

Posted on August 25, 2012 by Roger Wood | 65 Comments

The Research Performance Progress Report (RPPR) is a standard federal form for progress reporting on Federally-funded research and related activities. All federal agencies sponsoring research awards has or is transitioning to the RPPR for interim progress reporting. While the RPPR…

Court Rules that NIH may Continue to Fund Stem Cell Research

Posted on August 24, 2012 by Roger Wood |

A three judge panel of the US Court of Appeals in Washington ruled today that President Obama, in his March 9, 2009 Executive Order and subsequent guidance issued by NIH, correctly interpreted the 1996 Dickey-Wicker Amendment, which bars use of…

Electronic Submission Pilot for NIH Type 6 and Type 7 Applications

Posted on August 24, 2012 by Roger Wood | 1 Comment

NIH published guidelines and procedures (and also Grants.gov packages) for submitting Successor-in-Interest (Type 6) and Change of Grantee Institution (Type 7) applications electronically. • Notice of Pilot for Processing Post-Award Changes in Grantee Organizational Status: Successor-in-Interest (NOT-OD-12-133) • Notice…

NIH Changes Policies and Procedures for Foreign Institutions

Posted on August 24, 2012 by Roger Wood | 1 Comment

In a recent Notice (NOT-OD-12-139), NIH published changes “in payment method, policies, and processes for awards to foreign institutions made on or after October 1, 2012” and also changes to FFR requirements for foreign institutions. Note that these changes do…