Research Compliance Archives - Page 9 of 29 - ResearchAdministrationDigest.com - Reading the industry so you don't have to

New FDA Guidance for IRBs, Investigators and Sponsors

Posted on November 20, 2012 by Matthew Tanner |

A new FDA guidance was announced today in the Federal Register (emphasis added): FDA is announcing the availability of a draft guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and…

FDA warning letter study

Posted on November 19, 2012 by Matthew Tanner |

An article in the October 2012 issue of Applied Clinical Trials describes a warning letter study that was undertaken by Rajendra Talele of Lambda Therapeutic Research and Dr. Suresh K. Bowalekar of Pharmanet Clinical Services. Although both authors are located in Mumbai, India, their article is…

OHRP provides update for IRBs affected by Sandy

Posted on November 13, 2012 by Matthew Tanner |

OHRP sent out an email update this morning regarding Superstorm Sandy’s potential disruption of IRB operations. The following actions are recommended for institutions and IRBs affected by Sandy: Refer oversight of research to unaffected IRBs, if possible OHRP acknowledges that…

Presidential Commission report on whole genome sequencing

Posted on November 12, 2012 by Matthew Tanner |

In mid-October, after studying the issue for more than a year, the Presidential Commission for the Study of Bioethical Issues issued its report on whole genome sequencing. The introduction gets right to the point: Collections of whole genome sequence data have already been key to…

How resilient is your IRB?

Posted on November 10, 2012 by Matthew Tanner |

Extreme situations like Hurricane Sandy pose obvious threats to business continuity. It’s important to recognize that routine occurrences also have significant disruptive potential, particularly if organizations don’t anticipate them and develop backup plans in advance. Emergency plans are explicitly required…

Annual Reports to OLAW due January 31, 2013

Posted on November 8, 2012 by Matthew Tanner |

From OLAW: Annual reports for the period January 1, 2012 through December 31, 2012 are due to OLAW by January 31, 2013 as required by the Public Health Service Policy on Humane Care and Use of Laboratory Animals. 2012 Annual…

Corrections to OLAW Guidance Resources on Departures from the Guide

Posted on November 2, 2012 by Matthew Tanner |

From OLAW: Corrections to OLAW Guidance Resources on Departures from the Guide Posted: November 1, 2012 Corrections have been made on several resource materials providing guidance on reporting departures from the Guide. On the Table of Reporting Requirements (PDF…

Hackers raise concern about medical device safety

Posted on October 29, 2012 by Matthew Tanner |

The capability to remotely monitor, interrogate and reprogram implanted medical devices provides important benefits for patients. It also makes the devices vulnerable to attack, similar to the way garage door openers, remote start systems and even cars can be exploited if they…

IACUC Administrators’ Best Practices Meeting

Posted on October 26, 2012 by Matthew Tanner |

The IACUC Administrators Association (IAA) will be presenting a Best Practices Meeting on November 8-9, 2012 in Boston, MA. This 2-day meeting is for IACUC staff and animal program operations personnel to present and share best practices in the humane…

Texas IRB shut down for significant violations of 21 CFR 56

Posted on October 19, 2012 by Matthew Tanner |

In a warning letter dated September 24, 2012, FDA says the Texas Applied Biomedical Services Research Review Committee (TABS RRC) “significantly violated…21 CFR Part 56”. The agency is withholding approval of all new trials reviewed by TABS RRC, and the IRB…