Here are the highlights from the current issue:
An article in Sunday’s New York Times discussed the procedural and ethical issues related to returning genetic results to research study subjects or their families, especially when the results were not envisioned as part of the initial protocol or consent process and treatment options exist.
http://tinyurl.com/8ntm39b <http://echo4.bluehornet.com/ct/17466819:20164302279:m:1:1612442508:A8B58835630E3EEECF533EED3B7015BD:r>
The revised HHS financial conflict of interest regulations became effective on Friday. NIH on Friday issued a notice concerning FCOI reporting of certain awards. According to the notice, “Most grantees have already submitted their annual progress report for FY2012 noncompeting continuation awards and multi-year funded projects, which means that the Annual FCOI Report was due before the FCOI implementation date (i.e., 45 or 60 days prior to the start date). Therefore, out of synch reporting for this subset of FY2012 awards will be necessary to capture FCOI reporting information. This one-time guidance is intended to shift the burden of out of synch reporting from the grantee to NIH staff. Therefore, NIH will not require grantees to submit FCOI reports for FY 2012 noncompeting awards issued on or after August 24 until requested by NIH staff.”
http://tinyurl.com/9ys8jnh <http://echo4.bluehornet.com/ct/17466820:20164302279:m:1:1612442508:A8B58835630E3EEECF533EED3B7015BD:r>
Stanford has posted a podcast featuring Captain Chesley B. “Sully” Sullenberger III, best-known as the pilot who miraculously landed a US Airways flight in the Hudson River, after a flock of geese struck and disabled the plane’s engines. Mr. Sullenberger, who retired in 2010, is now focused on patient safety. According to the posting, “He is among a group of patient-safety advocates calling for an independent agency modeled on the National Transportation Safety Board to investigate and prevent cases of medical harm.”
http://med.stanford.edu/121/2012/sullenberger.html <http://echo4.bluehornet.com/ct/17466825:20164302279:m:1:1612442508:A8B58835630E3EEECF533EED3B7015BD:r>
Two articles posted by the McKinsey Quarterly discuss fundamental changes in the pharmaceutical industry. The publication asserts that the “…’blockbuster’ model of drug development has run its course, and the pharmaceutical industry is now struggling to rediscover its knack for creating value.” One article, “Pharma manufacturing for a new era,” argues that intently focusing on manufacturing innovation is one way to restore the sector’s appeal. Another is by tackling some of the excesses in R&D approaches. “Restoring value to biopharmaceutical R&D” explores several imperatives for pharma executives. (Free registration may be required.) http://www.mckinseyquarterly.com/home.aspx <http://echo4.bluehornet.com/ct/17466830:20164302279:m:1:1612442508:A8B58835630E3EEECF533EED3B7015BD:r>
The full list of announcements is below.
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