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Departures from the Guide: OLAW Webinar, September 13

Posted on September 7, 2012 by Matthew Tanner |

A webinar entitled “Departures from the Guide” will be presented on September 13, 2012 from 1:00 to 2:00 pm ET by OLAW. The 8th Edition of the Guide emphasizes performance standards and provides increased flexibility in the management and oversight of…

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FDA issues draft guidance on prospective assessment of suicidal ideation and behavior in clinical trial participants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FDA recently issued a draft guidance addressing the issue of suicidal ideation and behavior that emerges during clinical trials of investigational drugs and biologics.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.

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…

Reproducibility Initiative to Increase the Value of Biomedical Research

Posted on August 21, 2012 by Matthew Tanner |

Science Exchange, in partnership with the open-access publisher PLOS and open data repository figshare, announced today the launch of the Reproducibility Initiative (www.reproducibilityinitiative.org) – a new program to help scientists, institutions and funding agencies validate their critical research findings. The…

Multiple Pathways for Conflict of Interest Management

Posted on August 13, 2012 by Jeffrey Waldin |

As the effective date approaches for implementation of the new PHS regulations, some institutions are still defining their processes for disclosure and certification. Among the most robust processes are those that include multiple pathways: Annual Disclosure – collected for all…

So what do you do?

Posted on August 13, 2012 by Matthew Tanner |

When someone asks, “What do you do?”; how do you reply, if you happen to work in an IACUC office, are a member, or work in an animal research facility? Do you describe your daily work, or try to anticipate…

Maintaining IRB Membership Documentation

Posted on August 13, 2012 by Matthew Tanner |

Warning letters issued by FDA in recent months highlight the importance of documentation in IRB operations. Although written procedures are required by regulation, they are not sufficient by themselves. As FDA noted in one recent letter, “Maintaining records, as required…

World Stem Cell Summit set for December 2012

Posted on August 10, 2012 by Matthew Tanner |

The 8th annual World Stem Cell Summit will be held December 3-5 in West Palm Beach, FL. The event will include a variety of sessions and workshops of interest to IRBs, ESCRO/SCROs, research administrators, investigators and others involved in the conduct…