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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…

Thanksgiving perspective

Posted on November 13, 2012 by Eddie Johnson Jr. |

It started out as ‘one of those days’… I got up early and went to make a cup of coffee only to find that there was not one coffee bean to be had. It really bothers me when people in…

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…

Animal Facility Disaster Planning and Response

Posted on November 12, 2012 by Matthew Tanner | 0 Comments

With recent storm related destruction from Superstorm Sandy, here are some helpful suggestions for creating and implementing a disaster recovery plan for your animal facility. As we have seen from the devastation at the NYU hospital, even the best preparation…

InfoEd PD Support for NIH Multi-Project Applications as they Transition to Electronic Submission

Posted on November 12, 2012 by Roger Wood |

National Institutes of Health (NIH) multi-project or complex applications including most P and U series applications as well as a few other activity codes, are the last remaining NIH applications currently being handled via paper submission. They represent approximately 6%…

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…