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Comment Sought on ClinicalTrials.gov Registration Burden

Posted on February 13, 2012 by Matthew Tanner |

The US National Institutes of Health is soliciting public comments on its estimate of the time and effort required to register a study on ClinicalTrials.gov. While there is no specific deadline, the agency recommends submitting comments within 60 days. For more…

New FDA Consent Requirement Becomes Mandatory on March 7, 2012

Posted on February 13, 2012 by Matthew Tanner |

The US Food and Drug Administration has issued a guidance document explaining a new requirement to include language about ClinicalTrials.gov in consent forms for drug and device studies. Consent forms for covered studies that begin on or after the implementation deadline of…

Antiparasitic Drug Use and Resistance in Ruminants and Equines; Public Meeting; Request for Comments

Posted on February 13, 2012 by Matthew Tanner |

Docket No. FDA–2012–N–0102 The Food and Drug Administration (FDA) is announcing a public meeting entitled “Antiparasitic Drug Use and Resistance in Ruminants and Equines.’’ The purpose of the meeting is to discuss the current state of anthelmintic resistance in…

Nature Profiles John Cutler, Lead Investigator of 1940s Guatemala Experiments

Posted on February 13, 2012 by Matthew Tanner |

Nature recently published a news feature on the US Public Health Service experiments in Guatemala and other officially sanctioned efforts during the 1940s to fight STDs. Letters written by Dr. John Cutler show that he and others involved in the research knew…

NPR Story Offers Patient Perspectives on Clinical Trials

Posted on February 13, 2012 by Matthew Tanner |

A recent story on National Public Radio’s Talk of the Nation featured an interview with Mary Elizabeth Williams, a writer for Salon who took part in a clinical trial of a new therapy for malignant melanoma. Other patients and family members called…

Request for Information (RFI): Input into the Deliberations of the Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research

Posted on February 13, 2012 by Matthew Tanner |

From the NIH: The Council of Councils has established a working group to provide recommendations to the Council on: (1) implementing the guiding principles and criteria contained within the Institute of Medicine report, “Chimpanzees in Biomedical and Behavioral Research: Assessing…

NIH Request for Information – Input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders

Posted on February 11, 2012 by Roger Wood |

On February 8th, NIH published a request for input into the development of the Scientifc Strategic Plan for a proposed new Institute. NIH proposes to create a new Institute, with the working name of the National Institute of Substance Use…

The Great Public Access Debate Continues

Posted on February 11, 2012 by Roger Wood |

On Dec 16th, Rep. Darrell Issa introduced legislation (H.R. 3699) that would end the experiment in public access that has been ongoing at the NIH since implementing PL 110-161 (<a href="” target=”_blank”>Jan 11, 2008 NIH Guide notice). Essentially, the NIH policy…

US FY 2013 Budget Request – NIH To Do More With Flat Budget

Posted on February 11, 2012 by Roger Wood | 1 Comment

The President’s budget request to Congress for FY 2013 will be released shortly and the formal discussions will ensue. The White House released a fact sheet on the budget in advance of the full budget release next week. > Included in…

NIH Update – Administrative Supplements and Complex Projects

Posted on February 11, 2012 by Roger Wood |

The National Institutes of Health (NIH) staff are taking further steps toward the goal of fully electronic proposal and award management. And, they are focused on making sure that S2S systems are full partners in that process to the extent…