The current issue of AAMC News and Leadership Announcements is now available:
The HHS Office of Human Research Protections (OHRP), citing strong disagreement by many with its earlier determination critical of the informed consent form in the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT), has “put on hold all compliance actions against UAB relating to the SUPPORT case, and plan to take no further action involving similar designs until the process of producing appropriate guidance is completed.” In taking the action, which appears to be unprecedented, OHRP acknowledged that “applying the ‘reasonable foreseeable risk’ concept to randomized studies of standard of care treatments is a complex undertaking.” The Office said that it now recognizes its “obligation to provide clear guidance on what the rules are with regard to disclosure of risks in randomized studies whose treatments fall within the range of standard of care.” OHRP said it will develop such guidance in an open process.
In response to a call from the Obama administration to further the national dialogue on mental health, the AAMC and the American Psychological Association (APA) on Monday announced a collaboration to expand a free, online collection of mental health educational resources to equip health care professionals and medical students with the knowledge they need to improve mental health screenings and early identification of mental health concerns. The announcement was made the same day both organizations joined President Obama and Vice President Biden – along with mental health advocates, health care providers, faith leaders, government officials, educators, and individuals who have experienced mental health problems – for the National Conference on Mental Health that was convened at the White House.
NIH on Monday posted a fact sheet on the impact of sequestration on the NIH. The summary includes a set of FAQs on the impact of the cuts on grantees. NIH reported that due to sequestration approximately 700 fewer competitive research project grants will be issued this fiscal year.
Four leaders of Florida Atlantic University wrote a commentary in Wednesday’s South Florida Sun Sentinel, stating that proposed cuts to the NIH budget would be devestating to research and to the patients researchers are trying to help. The four FAU authors were David J. Bjorkman, Dean and Executive Director of Medical Affairs, College of Medicine; Gary W. Perry, Dean, College of Science; Barry T. Rosson, Vice President for Research and Dean of the Graduate College; and Marlaine Smith, Dean, College of Nursing.
The Pharmaceutical Research and Manufacturers of America (PhRMA) on Monday announced that Dr. William Chin will become Executive Vice President of Science and Regulatory Affairs, effective July 1. Dr. Chin is currently the Executive Dean for Research at Harvard Medical School. He rejoined Harvard from Lilly in 2010. At PhRMA, he will oversee the organization’s scientific and regulatory affairs portfolio, including implementation of the Prescription Drug User Fee Act (PDUFA), clinical trials, and drug discovery and research collaboration, among other key issues. Dr. Chin is an internist and endocrinologist.
E. Gordon Gee, president of The Ohio State University, and Robert H. Schottenstein, chairman of the OSU Board of Trustees, announced on Tuesday that Dr. Gee plans to retire from the OSU presidency, effective July 1. Executive Vice President and Provost Joseph A. Alutto will be named interim president. Dr. Alutto, whose Ph.D. is in organizational behavior, previously served as interim president in 2007.
The New York Times on Monday reported that “Government officials, drug companies and medical experts, faced with outbreaks of antibiotic-resistant ‘superbugs,’ are pushing to speed up the approval of new antibiotics, a move that is raising safety concerns among some critics. The need for new antibiotics is so urgent, supporters of an overhaul say, that lengthy studies involving hundreds or thousands of patients should be waived in favor of directly testing such drugs in very sick patients. Influential lawmakers have said they are prepared to support legislation that allows for faster testing.”
The Boston Globe on Tuesday reported that Boston Medical Center “is considering closing a portion of its campus and eliminating 85 beds to address state and federal budget cuts and to shift more resources to outpatient services.” Commenting on the story, one reader wrote “that this could be the first wave of such changes, as the days when ‘health care was a sort of bomb shelter from the economy’ may be ending.”
The National Institute of General Medical Sciences has posted a summary of the November workshop on “Research on Women in Biomedical Careers.” The workshop focused on recent studies on causal factors and possible interventions affecting the representation of women in biomedical and behavioral research and engineering.
HHS on Monday announced that the Centers for Medicare & Medicaid Services (CMS) “released new data – including county-level data on Medicare spending and utilization for the first time, as well as selected data on hospital outpatient charges. In addition, the HHS Office of the National Coordinator for Health Information Technology (ONC) released additional information on the adoption of specific electronic health record (EHR) systems, as well as the winners of new opportunities for building innovative tools that build off health data.”
The Episcopal Diocese of Texas on Friday announced that the sale of St. Luke’s Episcopal Health System to Catholic Health Initiatives (CHI), the nation’s third-largest faith-based health system, has been finalized. The transfer of the system, which now will be the St. Luke’s Health System, includes the Texas Medical Center campus, as well as suburban hospital locations in The Woodlands, Sugar Land, Pasadena and The Vintage. According to the announcement, “CHI will continue to grow and enhance St. Luke’s significant affiliations with Baylor College of Medicine, Texas Heart Institute, Kelsey-Seybold Clinic, Texas Children’s Hospital and MD Anderson Cancer Center.”
Wednesday’s Federal Register contains a formal request from the Presidential Commission for the Study of Bioethical Issues for public comment “on the ethical, legal, and social issues raised by incidental findings that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and direct-to-consumer contexts.” Comments are due by July 5.
Media reports in Los Angeles and in Minnesota report, “The boards of the Hazelden Foundation and the Betty Ford Center — two of the country’s largest and most preeminent addiction treatment providers — have engaged in talks of a possible ‘alliance,’ officials from both organizations announced Tuesday.” A merger has not been ruled out. According to the Pioneer Press, Hazelden had $130 million in annual income and $211 million in net assets, according to its 2011 tax filing. The Betty Ford Center had about $40 million in annual income and $56 million in net assets.
Monday’s issue of The Oregonian, published in Portland, featured a profile of Dr. Shoukhrat Mitalipov, the OHSU researcher whose paper on SCNT was recently published by Cell.
The Office of Management and Budget (OMB) last week issued new guidance to all federal agencies and employees concerning travel and conference expenses. The guidance was welcomed by many scientific societies as it states that federal agencies are encouraged to approve federal employee attendance at conferences that support agency missions.
Peter L. Elkin, MD, vice president and professor of medicine at the Mount Sinai School of Medicine and director of its Center for Biomedical Informatics, has been appointed professor and founding chair of the University at Buffalo’s new Department of Biomedical Informatics.
Our colleagues at Public Responsibility in Medicine & Research have announced the program and opened registration for the 2013 Advancing Ethical Research (AER) Conference. The meeting will be held in Boston on November 7-9, with pre-conference programs on November 6. This is considered an essential meeting for those interested in learning the latest regulatory updates, strategies, and best practices in human subjects protections.
Jeanne M. Nerbonne, PhD, the Alumni Endowed Professor of Molecular Biology and Pharmacology, has been named director of the Center for Cardiovascular Research at the Washington University School of Medicine.
Dr. Sidney Wolfe, founder and longtime director of Public Citizen Health, has announced he is stepping down. He will be succeeded by Dr. Michael Carome, who has been deputy director. Dr. Carome, a nephrologist, was on the staff of the HHS Office for Human Research Protections before joining Public Citizen in 2010.
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