NSF, Threats to independence, GAGAS, ORI, Original Paper, Management of Technology and Innovation, Yellow Book, HHS, Health Policy, Audit, Health(social science), Inspector General, Research misconduct, Issues, ethics and legal aspects, and Conflicts of interest
Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and the Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards (GAGAS/Yellow Book), if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct. Electronic supplementary material The online version of this article (doi:10.1007/s11948-016-9798-6) contains supplementary material, which is available to authorized users.
Editorial David Pimentel is a professor of ecology and agricultural sciences at Cornell University, Ithaca, NY 14853–0901. His Ph.D. is from Cornell University and had postdoctoral research at the University of Chicago, MIT, and fellowship at Oxford University (England). He was awarded a distinguished honorary degree from the University of Massachusetts. His research spans the fields of energy, population ecology, biological pest control, pesticides, sustainable agriculture, land and water conservation, livestock, and environmental policy. Pimentel has published more than 700 scientific papers and 37 books and has served on many national and government committees including the National Academy of Sciences; President’s Science Advisory Council; U.S Department of Agriculture; U.S. Department of Energy; U.S. Department of Health, Education and Welfare; Office of Technology Assessment of the U.S. Congress; and the U.S. State Department. He is currently Editorial Advisor for BMC Ecology. In this article, he reflects on 50 years since the publication of Rachel Carson’s influential book, Silent Spring.
The prevalence of opioid abuse in the United States has been steadily increasing over the last several years among many major demographics, including pregnant women. Rise in prenatal opioid abuse has resulted in subsequent escalation of neonatal abstinence syndrome incidence, prompting the US Congress to pass the Protecting Our Infants Act of 2015. This act specifically calls for a critical review of current treatment options for prenatal opioid abuse which may ultimately lead to the development of better therapies and a decreased incidence of neonatal abstinence syndrome. Currently, the American College of Obstetricians and Gynecologists recommends methadone, buprenorphine, or buprenorphine/naloxone in the treatment of prenatal opioid abuse. In this review, each maintenance therapy treatment option is discussed and compared revealing inconsistencies in postpartum retention rates, effects on fetal development, and availability to patients due to restrictions in health care coverage. Although each of these treatment options reduces opioid abuse and potential negative outcomes for the fetus, the shortcomings of these drugs highlight the overarching need for an improved standard of care. Drug developers and lawmakers should consider that affordability, coverage by health insurance, and success in retention rates substantially impacts the decision of the patient and healthcare provider regarding utilization of a particular opioid maintenance therapy.
Meeting Report, education, 4th ACEM, Asian Association of Environmental Mutagen Societies, India, and AAEMS
The 4th Asian Conference on Environmental Mutagens was held at CSIR Indian Institute of Chemical Biology, Kolkata, during December 10–12, 2014, in collaboration with All India Congress of Cytology and Genetics. Seventy international delegates from Australia, Austria, Belgium, Canada, China, Germany, Iran, Japan, Kazakhstan, Korea and USA along with 150 Indian delegates and students participated in the conference. The conference was inaugurated by Dr. Takehiko Nohmi, President of the International Association of Environmental Mutagenesis and Genomics Societies and Dr. Ashok K. Giri, President of the Asian Association of Environmental Mutagen Societies. The main objective of the conference was to discuss the present scenario of various hazardous chemicals and environmental pollutants in various areas, and their impacts on human health and scientific measure to combat such environmental threats. The organizer truly thanks those who took part in the conference and made the meet a grand success.
Yang, Mary, Athey, Brian D, Arabnia, Hamid R, Sung, Andrew H, Liu, Qingzhong, Yang, Jack Y, Mao, Jinghe, and Deng, Youping
BMC Genomics. 10
Biotechnology, Genetics, and Introduction
The advent of high-throughput next generation sequencing technologies have fostered enormous potential applications of supercomputing techniques in genome sequencing, epi-genetics, metagenomics, personalized medicine, discovery of non-coding RNAs and protein-binding sites. To this end, the 2008 International Conference on Bioinformatics and Computational Biology (Biocomp) – 2008 World Congress on Computer Science, Computer Engineering and Applied Computing (Worldcomp) was designed to promote synergistic inter/multidisciplinary research and education in response to the current research trends and advances. The conference attracted more than two thousand scientists, medical doctors, engineers, professors and students gathered at Las Vegas, Nevada, USA during July 14–17 and received great success. Supported by International Society of Intelligent Biological Medicine (ISIBM), International Journal of Computational Biology and Drug Design (IJCBDD), International Journal of Functional Informatics and Personalized Medicine (IJFIPM) and the leading research laboratories from Harvard, M.I.T., Purdue, UIUC, UCLA, Georgia Tech, UT Austin, U. of Minnesota, U. of Iowa etc, the conference received thousands of research papers. Each submitted paper was reviewed by at least three reviewers and accepted papers were required to satisfy reviewers' comments. Finally, the review board and the committee decided to select only 19 high-quality research papers for inclusion in this supplement to BMC Genomics based on the peer reviews only. The conference committee was very grateful for the Plenary Keynote Lectures given by: Dr. Brian D. Athey (University of Michigan Medical School), Dr. Vladimir N. Uversky (Indiana University School of Medicine), Dr. David A. Patterson (Member of United States National Academy of Sciences and National Academy of Engineering, University of California at Berkeley) and Anousheh Ansari (Prodea Systems, Space Ambassador). The theme of the conference to promote synergistic research and education has been achieved successfully.
DuBois, James M, Kraus, Elena M, Gursahani, Kamal, Mikulec, Anthony, and Bakanas, Erin
BMC Medical Education. 14
Graduate medical education, Healthcare industry, Delphi consensus, Professional ethics, Research Article, Education, Medical education, Business in medicine, Medical ethics, Medicine(all), Medical business ethics, and Clinical ethics
Background No published curricula in the area of medical business ethics exist. This is surprising given that physicians wrestle daily with business decisions and that professional associations, the Institute of Medicine, Health and Human Services, Congress, and industry have issued related guidelines over the past 5 years. To fill this gap, the authors aimed (1) to identify the full range of medical business ethics topics that experts consider important to teach, and (2) to establish curricular priorities through expert consensus. Methods In spring 2012, the authors conducted an online Delphi survey with two heterogeneous panels of experts recruited in the United States. One panel focused on business ethics in medical practice (n = 14), and 1 focused on business ethics in medical research (n = 12). Results Panel 1 generated an initial list of 14 major topics related to business ethics in medical practice, and subsequently rated 6 topics as very important or essential to teach. Panel 2 generated an initial list of 10 major topics related to business ethics in medical research, and subsequently rated 5 as very important or essential. In both domains, the panel strongly recommended addressing problems that conflicts of interest can cause, legal guidelines, and the goals or ideals of the profession. Conclusions The Bander Center for Medical Business Ethics at Saint Louis University will use the results of the Delphi panel to develop online curricular resources for each of the highest rated topics. Electronic supplementary material The online version of this article (doi:10.1186/1472-6920-14-235) contains supplementary material, which is available to authorized users.
Orthopaedics, Research Article, Decision-making process, Internet-based, Orthopedics and Sports Medicine, Survey, Online evaluation, Evidence-based medicine, and Opinion
Background Manufacturers of implants and materials in the field of orthopaedics use significant amounts of funding to produce informational material to influence the decision-making process of orthopaedic surgeons with regards to choice between novel implants and techniques. It remains unclear how far orthopaedic surgeons are really influenced by the materials supplied by companies or whether other, evidence-based publications have a higher impact on their decision-making. The objective was to evaluate the subjective usefulness and usage of different sources of information upon which orthopaedic surgeons base their decisions when acquiring new implants or techniques. Methods We undertook an online survey of 1174 orthopaedic surgeons worldwide (of whom n = 305 were head of their department). The questionnaire included 34 items. Sequences were randomized to reduce possible bias. Questions were closed or semi-open with single or multiple answers. The usage and relevance of different sources of information when learning about and selecting orthopaedic treatments were evaluated. Orthopaedic surgeons and trainees were targeted, and were only allowed to respond once over a period of two weeks. Baseline information included country of workplace, level of experience and orthopaedic subspecialisation. The results were statistically evaluated. Results Independent scientific proof had the highest influence on decisions for treatment while OEM (Original Equipment Manufacturer) driven activities like newsletters, white papers or workshops had the least impact. Comparison of answers from the three best-represented countries in this study (Germany, UK and USA) showed some significant differences: Scientific literature and congresses are significantly more important in the US than in the UK or Germany, although they are very important in all countries. Conclusions Independent and peer-reviewed sources of information are preferred by surgeons when choosing between methods and implants. Manufacturers of medical devices in orthopaedics employ a considerable workforce to inform or influence hospital managers and leading doctors with marketing activities. Our results indicate that it might be far more effective to channel at least some of these funds into peer-reviewed research projects, thereby assuring significantly higher acceptance of the related products.