tag:blogger.com,1999:blog-2748732718839062382023-06-21T00:36:18.642-04:00research law postsI am a practicing attorney specializing in research-related legal issues, such as clinical research contracts, human subjects, research ethics and misconduct, and intellectual property originating from research activity. This blog is primarily to post links to cases, regulations, laws and policies, and other items that may be of interest to lawyers and research administrators in universities, hospitals, government research organizations, and commercial labs.Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.comBlogger755125tag:blogger.com,1999:blog-274873271883906238.post-28781338542989661552012-11-22T21:41:00.001-05:002012-11-22T21:41:45.004-05:00Federal Register | Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2<a href="https://www.federalregister.gov/articles/2012/09/04/2012-21050/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-2">Federal Register | Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2</a>: <br />
<span style="background-color: white; font-family: Arial, Tahoma, Verdana, Helvetica; font-size: 13px;">On September 4, 2012, the U.S. Department of Health and Human Services (HHS) issued the </span><a href="https://www.federalregister.gov/articles/2012/09/04/2012-21050/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-2" style="background-color: white; font-family: Arial, Tahoma, Verdana, Helvetica; font-size: 13px;" target="_blank">Stage 2 Meaningful Use Regulations</a><span style="background-color: white; font-family: Arial, Tahoma, Verdana, Helvetica; font-size: 13px;"> that include several core objectives to promote patient engagement through EHR technology. Specifically, under the Stage 2 Meaningful Use Regulations, a provider must demonstrate that its EHR is able to perform certain tasks with a defined percentage of its patients: 1) to send messages to and from the patient; 2) the permit the patient to view online, download and transmit his or her health information within certain time frames; and 3) to identify patient-specific education resources and provide those resources to the patient. Ultimately, a provider's EHR technology will have to be able to meet these core objectives for all of its patients. HHS will add further meaningful use requirements over the next few years.</span><br />
<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-19974821931003140902012-11-22T21:37:00.001-05:002012-11-22T21:37:55.744-05:00Improving care delivery through enhanced communications among providers, patients, and payers<br />
While mHealth traditionally stands for “mobile health,” this Task Force adopted the term more broadly to refer to mobile health, wireless health, and e‐Care technologies that improve patient care and the efficiency of healthcare delivery.<br />
<br />
This Task Force report sets goals and recommendations for the FCC, other federal agencies, and industry to help leverage communication technologies to improve healthcare quality, access and efficiency.<br />
This report is delivered with the overarching goal that by 2017 mHealth, wireless health and e‐Care solutions will be routinely available as part of best practices for medical care. FCC leadership as well as interagency collaborations will be needed to address technical and policy barriers, including developing appropriate reimbursement and financial incentives.<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-91860145063780058882012-11-22T10:14:00.001-05:002012-11-22T10:14:27.606-05:00Confronting the Social Determinants of Health — Obesity, Neglect, and Inequity — NEJM<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1209420?query=TOC">Confronting the Social Determinants of Health — Obesity, Neglect, and Inequity — NEJM</a>: "If we are to break the vicious cycle of inequality and uphold the tradition of physicians as champions of social justice in the global arena, we must widen our perspective beyond the individual to confront the “causes of the causes” at multiple levels, so as to help create social and physical environments that promote good health for all. In the same vein, multipronged approaches that include cross-sectorial collaboration among nontraditional partners (including health care providers, lawmakers, and welfare workers) and bold change in social policy are needed to ensure equal health and justice for all. As Theodore Roosevelt once said, “The welfare of each of us is dependent fundamentally upon the welfare of all of us.”"<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-53158840392657919052012-11-22T10:13:00.001-05:002012-11-22T10:13:31.351-05:00Drug Policy for an Aging Population — The European Medicines Agency's Geriatric Medicines Strategy — NEJM<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1209034?query=TOC">Drug Policy for an Aging Population — The European Medicines Agency's Geriatric Medicines Strategy — NEJM</a>: "Although population aging is a mark of the success of public health policies, it also challenges the established way of implementing such policies. In the case of the European Medicines Agency (EMA), it has prompted an analysis of whether the regulatory system is adapted to taking the needs of older people into account in the development, approval, and use of medications."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-45350480889122251202012-11-22T10:12:00.003-05:002012-11-22T10:12:48.187-05:00Lessons from Sandy — Preparing Health Systems for Future Disasters — NEJM<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1213486?query=TOC">Lessons from Sandy — Preparing Health Systems for Future Disasters — NEJM</a>: "Although experience is a great teacher, science can and should also inform disaster policy. Too often it does not. Careful tracking of important health and mental health problems that confound recovery, for instance, may lead to appropriate interventions that can help reduce morbidity associated with the inevitable next catastrophe."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-61691889970476103252012-11-22T10:12:00.001-05:002012-11-22T10:12:00.880-05:00The Future of Obamacare — NEJM<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1213674?query=TOC">The Future of Obamacare — NEJM</a>: "Even as repeal fades from the agenda, then, there are many important political fights to come that will shape the future of Obamacare. The outcome of struggles over insurance subsidies and benefits, costs and financing, Medicaid and many other issues will determine whether the ACA is maintained, expanded, or undermined."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-26551092048182356222012-11-21T11:25:00.001-05:002012-11-21T11:25:22.188-05:00USDOJ: South Carolina-based Harmony Care Hospice Inc. and CEO/Owner Daniel J. Burton to Pay U.S. $1.286 Million to Resolve False Claims Act Allegations<a href="http://www.justice.gov/opa/pr/2012/November/12-civ-1401.html">USDOJ: South Carolina-based Harmony Care Hospice Inc. and CEO/Owner Daniel J. Burton to Pay U.S. $1.286 Million to Resolve False Claims Act Allegations</a>: "<br />
Today’s settlement with Harmony and Burton resolves a lawsuit filed by former Harmony employees Mona Singletary and Lynda Fulton under the qui tam, or whistleblower, provisions of the False Claims Act. Under the False Claims Act, private citizens can bring suit for false claims on behalf of the United States and share in any recovery. Together, Singletary and Fulton will receive $244,529.87 as their share of the government’s recovery.<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-71058215697991254452012-11-21T11:23:00.001-05:002012-11-21T11:23:57.301-05:00USDOJ: Two Plead Guilty in Miami for Roles in $63 Million Mental Health Care Fraud Scheme<a href="http://www.justice.gov/opa/pr/2012/November/12-crm-1398.html">USDOJ: Two Plead Guilty in Miami for Roles in $63 Million Mental Health Care Fraud Scheme</a>: <br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-53302046353715345752012-11-20T15:40:00.001-05:002012-11-20T15:40:18.652-05:00UTICA, NEW YORK PHYSICIAN INDICTED IN $12,000,000 HEALTH CARE FRAUD SCHEME<br />
that certain medical services, which are described in medical codes, known as CPT codes, have<br />
“typical” time components associated with them, and that during the course of the fraud scheme, the<br />
<b>aggregate of the “typical” time</b> in the codes submitted for reimbursement by KACHARE consistently<br />
<b>exceeded 24 hours per day.</b><br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-88513594837696944562012-11-20T15:37:00.001-05:002012-11-20T15:37:53.024-05:00Coventry Health Care, Inc. Agrees to Pay $3 Million to the U.S. as Part of a Non-prosecution Agreement<a href="http://www.justice.gov/usao/md/Public-Affairs/press_releases/Press12/CoventryHealthCareInc.AgreestoPay3MilliontotheU.S.asPartofaNon-prosecutionAgreement.html">Coventry Health Care, Inc. Agrees to Pay $3 Million to the U.S. as Part of a Non-prosecution Agreement</a>: "some employees of Coventry and/or First Health Priority Services, a subsidiary, inappropriately accessed the Medicare database to obtain Medicare eligibility information for the sale of Medicare set-aside products"<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-16036222935316335262012-11-20T15:35:00.001-05:002012-11-20T15:35:03.865-05:00NEW DRAFT GUIDANCE<br />
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the<br />
Determination of Whether an IND/IDE is Needed<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-75684795999100301482012-11-19T16:22:00.001-05:002012-11-19T16:22:04.832-05:00Research breakthrough selectively represses the immune system, November 18, 2012 News Release - National Institutes of Health (NIH)<a href="http://www.nih.gov/news/health/nov2012/nibib-18.htm">Research breakthrough selectively represses the immune system, November 18, 2012 News Release - National Institutes of Health (NIH)</a>: " researchers funded by the National Institutes of Health have developed innovative technology to selectively inhibit the part of the immune system responsible for attacking myelin—the insulating material that encases nerve fibers and facilitates electrical communication between brain cells."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-70254744223716272902012-11-19T16:01:00.001-05:002012-11-19T16:01:26.399-05:00Dozens of Genes Linked to Bowel Diseases - NIH Research Matters - National Institutes of Health (NIH)<a href="http://www.nih.gov/researchmatters/november2012/11192012bowel.htm">Dozens of Genes Linked to Bowel Diseases - NIH Research Matters - National Institutes of Health (NIH)</a>: <br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-11590955868385623652012-11-19T16:00:00.001-05:002012-11-19T16:00:18.470-05:00Brain Wave Synchronization Key to Working Visual Memory - NIH Research Matters - National Institutes of Health (NIH)<a href="http://www.nih.gov/researchmatters/november2012/11192012memory.htm">Brain Wave Synchronization Key to Working Visual Memory - NIH Research Matters - National Institutes of Health (NIH)</a>: "Short-term memories are stored as synchronized signals between 2 key brain hubs, according to a new study in monkeys. The findings show for the first time how the brain stores visual information for working memory tasks."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-53989681065172158192012-11-19T15:59:00.001-05:002012-11-19T15:59:21.279-05:00Cataloging Human Genetic Variation - NIH Research Matters - National Institutes of Health (NIH)<a href="http://www.nih.gov/researchmatters/november2012/11192012catalog.htm">Cataloging Human Genetic Variation - NIH Research Matters - National Institutes of Health (NIH)</a>: "The world's largest, most detailed catalog of human genetic variation—used by disease researchers around the world—has more than doubled in size. The newly published information will provide deeper insights into the genomic basis of human disease."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-7505705616403119512012-11-16T16:19:00.001-05:002012-11-16T16:19:48.473-05:00This is your brain on freestyle rap, Thursday, November 15, 2012 News Release - National Institutes of Health (NIH)<a href="http://www.nih.gov/news/health/nov2012/nidcd-15.htm">This is your brain on freestyle rap, Thursday, November 15, 2012 News Release - National Institutes of Health (NIH)</a>: "The findings, published online in the Nov. 15 issue of the journal Scientific Reports, reveal that this form of vocal improvisation is associated with a unique functional reallocation of brain activity in the prefrontal cortex and proposes a novel neural network that appears to be intimately involved in improvisatory and creative endeavors."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-31303758632682927422012-11-16T15:35:00.001-05:002012-11-16T15:35:13.992-05:00Wow! busy crooked doctor<br />
A Chicago psychiatrist received illegal kickbacks from pharmaceutical<br />
companies and submitted at least <b>140,000</b> false claims to Medicare and Medicaid for antipsychotic<br />
medications he prescribed for thousands of mentally ill patients in area nursing homes, according<br />
to a civil health care fraud lawsuit filed today by the United States. The defendant, Dr. Michael J.<br />
Reinstein, also submitted at least <b>50,000</b> claims to Medicare and Medicaid, falsely stating that he<br />
provided “pharmacologic management” for his patients at more than 30 area nursing homes and<br />
long-term care facilities, the lawsuit alleges.<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-57585973556382444232012-11-16T06:43:00.001-05:002012-11-16T06:43:08.467-05:00US health reform still faces challenges : The Lancet<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961974-6/fulltext?elsca1=ETOC-LANCET&elsca2=email&elsca3=E24A35F">US health reform still faces challenges : The Lancet</a>: "Just 3 days after President Barack Obama's re-election preserved his signature legislative achievement, the Patient Protection and Affordable Care Act (ACA), his administration reset a deadline for states to take a crucial step toward implementing it."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-78069735017698606102012-11-16T06:42:00.001-05:002012-11-16T06:42:15.253-05:00Europe gives gene therapy the green light : The Lancet<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961992-8/fulltext?elsca1=ETOC-LANCET&elsca2=email&elsca3=E24A35F">Europe gives gene therapy the green light : The Lancet</a>: <br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-81162132704126315532012-11-16T06:41:00.001-05:002012-11-16T06:41:36.898-05:00Psychiatrist and journalist win prize for defending science : The Lancet<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961972-2/fulltext?elsca1=ETOC-LANCET&elsca2=email&elsca3=E24A35F">Psychiatrist and journalist win prize for defending science : The Lancet</a>: "In recognition of their efforts to champion science despite extreme opposition, a science journalist and psychiatrist have both received the 2012 John Maddox prize. Becky McCall reports.<br />
Last week, the inaugural John Maddox Prize for Standing up for Science 2012 was granted to UK psychiatrist Simon Wessely for his work on chronic fatigue syndrome (CFS) and Fang Shi-min, a freelance journalist from Beijing, China, for revealing clinics using unproven medicine."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-71610439500931500912012-11-15T09:04:00.001-05:002012-11-15T09:04:59.990-05:00Reducing Administrative Costs and Improving the Health Care System — NEJM<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1209711?query=TOC">Reducing Administrative Costs and Improving the Health Care System — NEJM</a>: "The average U.S. physician spends 43 minutes a day interacting with health plans about payment, dealing with formularies, and obtaining authorizations for procedures.1 In addition, physicians' offices must hire coders, who spend their days translating clinical records into billing forms and submitting and monitoring reimbursements. The amount of time and money spent on administrative tasks is one of the most frustrating aspects of modern medicine."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-8964658602583572432012-11-15T08:37:00.001-05:002012-11-15T08:37:38.662-05:00[PubKLaw-L] Whistleblower protection bill goes to the White House - jmichaelslocum@gmail.com - Gmail<a href="https://mail.google.com/mail/u/0/?tab=wm#inbox/13b03d50ac29a064">[PubKLaw-L] Whistleblower protection bill goes to the White House - jmichaelslocum@gmail.com - Gmail</a>: <br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-21026953337131810512012-11-15T08:29:00.001-05:002012-11-15T08:29:48.552-05:00A RESOURCE GUIDE TO THE U.S. FOREIGN CORRUPT PRACTICES ACT<br />
A RESOURCE GUIDE TO THE<br />
U.S. FOREIGN CORRUPT PRACTICES ACT<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-61327894920710369422012-11-14T19:28:00.001-05:002012-11-14T19:28:22.770-05:00Soaring college administrative costs pit bureaucrats against professors<a href="http://www.registerguard.com/web/news/29040575-57/purdue-university-administrative-vice-faculty.html.csp">Soaring college administrative costs pit bureaucrats against professors</a>: "Purdue has a $313,000-a-year acting provost and six vice and associate vice provosts, including a $198,000 chief diversity officer. It employs 16 deans and 11 vice presidents, among them a $253,000 marketing officer and a $433,000 business school chief.<br />
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Administrative costs on college campuses are soaring,"<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0tag:blogger.com,1999:blog-274873271883906238.post-64110108279503554532012-11-13T22:06:00.001-05:002012-11-13T22:06:11.934-05:00Obama reasserts research focus : Nature News & Comment<a href="http://www.nature.com/news/obama-reasserts-research-focus-1.11798">Obama reasserts research focus : Nature News & Comment</a>: Obamawants to ensure that the United States “is a global leader in research and technology and clean energy, which will attract new companies and high-wage jobs to America”."<br />
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<a href="https://chrome.google.com/webstore/detail/pengoopmcjnbflcjbmoeodbmoflcgjlk" style="font-size: 13px;">'via Blog this'</a>Anonymoushttp://www.blogger.com/profile/10306344445778614371noreply@blogger.com0