National Institutes Of Health Scientists Research Articles

A Personal Perspective on My Scientific Career

A Personal Perspective on My Scientific Career

Apheresis at the National Institutes of Health: A unique nursing experience

The National Institutes of Health (NIH) Clinical Center (CC) is the largest hospital in the world dedicated entirely to clinical research. For over 50 years, NIH scientists have been involved in the development and refinement of apheresis technology that is essential for new and emerging clinical applications of immunotherapy and personalized medicine. NIH investigators have studied the structure and function of blood cells, looking for characteristics that can be exploited to create these new and innovative therapies. Since the very beginning, NIH apheresis nurses have played a pivotal role in providing the raw materials needed for these innovations. The NIH CC Department of Transfusion Medicine (DTM) provides essential services to support investigators and patients when apheresis nurses collect Hematopoietic Progenitor Cells (HPCs), lymphocytes, platelets, plasma and granulocytes from patients and donors enrolled in clinical research protocols at NIH. While balancing patient safety needs, regulatory requirements and research protocol integrity, DTM apheresis nurses face unique challenges.

SUPPORTING RESEARCH ON INTEGRATIVE MECHANISMS OF RESILIENCE ACROSS TIME AND SCALE

There is a general understanding across the public and among academic researchers that resilience describes the ability of an individual, group, or institution to experience adversities and challenges and to persevere or to recover over time. In some academic literature, resilience can be operationalized as a trait while in other literature, resilience is more a process that can occur innately over time; be restored, or built in advance through learning, for example. In 2016, the National Institutes of Health (NIH) issued a one-time funding opportunity to fund cooperative projects to build integrative scientific frameworks to illuminate the processes and mechanisms involved with resilience that subsequently could be used across research disciplines and in contexts of health, illness, recovery, and overall well-being. This introduction describes the perspectives that informed the original funding opportunity, the original funded projects, and some collaborative activities between NIH scientists and the grantees.

Fetal tissue ban blocks study of potential coronavirus therapies

The Trump administration’s 2019 ban on the use of human fetal tissue by scientists at the National Institutes of Health (NIH) is preventing a leading researcher from using special mice to test potential therapies for coronavirus disease 2019 (COVID-19), The Washington Post reports According to the Post, Kim Hasenkrug, an immunologist at NIH’s Rocky Mountain Laboratories, has spent nearly 1 month appealing to the Trump administration to grant him an exemption to the administration’s strict policy Federal restrictions imposed in June 2019 ban NIH scientists from using human fetal tissue donated after elective abortions

Implementing a 3D printing service in a biomedical library

Three-dimensional (3D) printing is opening new opportunities in biomedicine by enabling creative problem solving, faster prototyping of ideas, advances in tissue engineering, and customized patient solutions. The National Institutes of Health (NIH) Library purchased a Makerbot Replicator 2 3D printer to give scientists a chance to try out this technology. To launch the service, the library offered training, conducted a survey on service model preferences, and tracked usage and class attendance. 3D printing was very popular, with new lab equipment prototypes being the most common model type. Most survey respondents indicated they would use the service again and be willing to pay for models. There was high interest in training for 3D modeling, which has a steep learning curve. 3D printers also require significant care and repairs. NIH scientists are using 3D printing to improve their research, and it is opening new avenues for problem solving in labs. Several scientists found the 3D printer so helpful they bought one for their labs. Having a printer in a central and open location like a library can help scientists, doctors, and students learn how to use this technology in their work.

Clinical Translation of the National Institutes of Health's Investments in Nanodrug Products and Devices.

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting biomedical research. The NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. In support of this mission, NIH has invested about $4.4 billion since 2001 in nanotechnology (NT) research. This investment is leading to fundamental changes in understanding biological processes in health and disease, as well as enabling novel diagnostics and interventions for treating disease. NIH scientists are developing molecular agents and methods for earlier and more accurate diagnosis and therapies aimed directly and selectively at diseased cells, and are exploring root causes of common and rare diseases at the nanoscale. Work is also underway to move these research tools and devices into clinical practice. This particular investigative review examines the NIH NT portfolio linked to clinical trials from FY2008 to FY2015 to assess the progress of clinical translation. Among the subset of trials identified, 70% target drug or combination drug-device products used in treating cancer, AIDS, and other various diseases. The review also provides insight into trends observed from studying the clinical research portfolio.

Author Disambiguation in PubMed: Evidence on the Precision and Recall of Author-ity among NIH-Funded Scientists.

We examined the usefulness (precision) and completeness (recall) of the Author-ity author disambiguation for PubMed articles by associating articles with scientists funded by the National Institutes of Health (NIH). In doing so, we exploited established unique identifiers—Principal Investigator (PI) IDs—that the NIH assigns to funded scientists. Analyzing a set of 36,987 NIH scientists who received their first R01 grant between 1985 and 2009, we identified 355,921 articles appearing in PubMed that would allow us to evaluate the precision and recall of the Author-ity disambiguation. We found that Author-ity identified the NIH scientists with 99.51% precision across the articles. It had a corresponding recall of 99.64%. Precision and recall, moreover, appeared stable across common and uncommon last names, across ethnic backgrounds, and across levels of scientist productivity.

Design considerations for clinical trials of autonomic modulation therapies targeting hypertension and heart failure.

Several device-based approaches to autonomic nervous system modulation are under investigation for the treatment of resistant hypertension and heart failure (Table 1).1 This line of research has evolved from the recognition that these diseases originate or are worsened by excess sympathetic activity and loss of parasympathetic tone.9–13 Drug therapies, including β-blockers, α-blockers, and centrally acting antihypertensive drugs, can modulate these neurohormonal systems, but they are often insufficient to control blood pressure (BP) or are limited by side effects or nonadherence. Technological innovations have produced devices that modulate the autonomic nervous system, including renal denervation, carotid baroreceptor stimulation, vagal nerve stimulation, and spinal cord stimulation. View this table: Table 1. Select Completed and Ongoing Clinical Trials of Autonomic Modulation Therapies in Hypertension and Heart Failure In Europe, several autonomic modulation therapy devices have received the Conformite Europeenne mark.14 US Food and Drug Administration evaluation of these devices is ongoing. The need for adequately powered, randomized, controlled studies with longer follow-up to capture definitive evidence of safety and effectiveness has been noted.14–17 The 9th and 10th Global Cardiovascular Clinical Trialists Forum (Paris, France, December 2012 and December 2013) convened a panel of primary investigators of ongoing trials, along with biostatisticians, National Institutes of Health scientists, European, and United States regulators, and medical device and pharmaceutical industry scientists to discuss the strengths and limitations of current clinical trials, optimal designs for future trials, approvability of new devices, and considerations for integrating these technologies into practice. This article summarizes the key discussion points and identifies knowledge gaps in this field that need to be addressed by additional research. The mechanisms of autonomic modulation are complex, and a comprehensive review of these mechanisms is outside the scope of this article. Briefly, all existing strategies aim to decrease central sympathetic outflow. Renal …

Global Contributions to the Understanding of DNA Repair and Skin Cancer

Living organisms exposed to sunlight have developed mechanisms to repair the damage that UVR induces in their DNA. These DNA repair systems are present in most life forms including bacteria, yeast, rodents, and mammals. Three rare human genetic diseases have defects in the DNA repair system called nucleotide excision repair (NER). Patients with xeroderma pigmentosum (XP) have defective NER and a more than 10,000-fold increased frequency of skin cancer, whereas patients with Cockayne syndrome (CS) or with trichothiodystrophy (TTD) have NER defects without increase in cancer. These are strikingly different clinical phenotypes (Figure 1). The dramatic differences in their manifestations reflect the complexity of DNA repair and the broad scope and central role of DNA repair on preservation of diverse biological functions. This article will review the major milestones in our understanding of DNA repair and skin cancer (Table 1). These include recognition of the clinical diseases, understanding the types of damage sunlight causes in the DNA, recognition of DNA repair in different organisms, discovery of defective DNA repair in humans, cloning of multiple human DNA repair genes, and identification of UV-type mutations in skin cancer.

‘Kicking the can’: science, Congress and a Ponzi scheme

AIDS researcher Yuntao Wu, Professor of microbiology and infectious diseases at George Mason University (Manassas, VA USA), is finding imaginative ways to maintain his cell lines, not to mention his life's work on developing therapeutics against HIV infection. As his funding from the US National Institutes of Health (NIH) has dried up, Wu has become dependent on the kindness of strangers and friends to cover the US$3,000 a month he needs to keep his lab running. To help repay a US$35,000 loan from his university, he has so far raised more than US$21,000 on CrowdRise, a crowd‐sourced fundraising website. In previous years, Wu had little trouble funding his research the ‘usual’ way. He received more than US$1 million in grant money from NIH over the past 4 years, and his lab published 18 papers in that period. But his application to renew the grant for another 5 years was rejected this past spring. Wu blames the tight NIH budget. Desperate for funds, he is now applying to other sections of the US National Institute for Allergy and Infection Diseases to see whether they will be more forthcoming than the molecular biology section that did not renew his grant. He expects to hear this month whether he will receive any NIH money, as the 16‐day government shutdown in October last year delayed the grant review process. Wu's grant applications are not the only ones to be affected by the shutdown: The closure of the government temporarily delayed the assessment of 300,000 extramural research groups for funding. Another 14,000 NIH scientists—designated as ‘non‐essential’ federal employees—were sent home, virtually closing some laboratories. Though the obvious effects of the shutdown were temporary, there are concerns about the longer‐term consequences of the unstable funding environment. In an 11th hour deal, leaders from the conservative‐dominated House of Representatives …

Commentary: A Delicate Balance: Weighing the Effects of Conflict-of-Interest Rules on Intramural Research at the National Institutes of Health

In 2005, in response to increasing public concerns about potential conflicts of interest in biomedical research, the Department of Health and Human Services (DHHS) tightened its ethics rules to prohibit National Institutes of Health (NIH) employees from receiving consulting fees from "significantly affected organizations." In response, NIH took steps to implement these regulations and ensure that relationships between intramural NIH researchers and industry could proceed without threatening the integrity of federally funded research. Examples of these steps include creating an ethics advisory committee to review outside activities of NIH scientists and subjecting its researchers to special scrutiny to eliminate any perception of personal profit or conflict of interest. In the authors' experiences, interactions between NIH scientists and industry have continued relatively unaffected by these regulations. The continuing success of the technology transfer program at NIH and the number and types of cooperative research and development agreements with industry are good measures of the extent of productive interactions with industry since the implementation of the 2005 ethics rules. Although recruitment of outstanding scientists to the intramural program has continued, these regulations also have challenged NIH's ability to attract and retain some of the most qualified scientists, who fear they may miss certain opportunities because of the tighter regulations. As DHHS revises the regulations governing oversight of financial conflicts of interest in the extramural community, the authors recognize that the NIH intramural experience may provide valuable lessons about developing and implementing the next generation of financial conflict-of-interest rules.

From the Science Policy Blog

Science 's policy blog, Science Insider, reported this week on the decision to maintain limits on travel by National Institutes of Health scientists, proposals for dealing with asteroids heading toward Earth , and scientists' disappointment in the U.K. government's new budget , among other stories.

Informationist programme in support of biomedical research: a programme description and preliminary findings of an evaluation

The informationist programme at the Library of the National Institutes of Health (NIH) in Bethesda, MD, USA has grown to 14 informationists working with 40 clinical and basic science research teams. This case report, intended to contribute to the literature on informationist programmes, describes the NIH informationist programme, including implementation experiences, the informationists' training programme, their job responsibilities and programme outcomes. The NIH informationist programme was designed to enhance the library's service capacity. Over time, the steps for introducing the service to new groups were formalized to ensure support by leadership, the team being served and the library. Job responsibilities also evolved from traditional library roles to a wide range of knowledge management activities. The commitment by the informationist, the team and the library to continuous learning is critical to the programme's success. RESULTS / OUTCOMES: NIH scientists reported that informationists saved them time and contributed to teamwork with expert searching and point-of-need instruction. Process evaluation helped refine the programme. High-level, preliminary outcomes were identified from a survey of scientists receiving informationist services, along with key informant interviews. Process evaluation examined service implementation, informationists' training and service components. Anecdotal evidence has also indicated a favourable response to the programme.

Information needs and information seeking in a biomedical research setting: a study of scientists and science administrators

An information needs study of clinical specialists and biomedical researchers was conducted at the US National Institutes of Health (NIH) to inform library services and contribute to a broader understanding of information use in academic and research settings. A random stratified sample by job category of 500 NIH scientists was surveyed by telephone by an independent consultant using a standardized information industry instrument, augmented with locally developed questions. Results were analyzed for statistical significance using t- tests and chi square. Findings were compared with published studies and an aggregated dataset of information users in business, government, and health care from Outsell. The study results highlighted similarities and differences with other studies and the industry standard, providing insights into user preferences, including new technologies. NIH scientists overwhelmingly used the NIH Library (424/500), began their searches at the library's Website rather than Google (P = or< 0.001), were likely to seek information themselves (474/500), and valued desktop resources and services. While NIH staff work in a unique setting, they share some information characteristics with other researchers. The findings underscored the need to continue assessing specialized needs and seek innovative solutions. The study led to improvements or expansion of services such as developing a Website search engine, organizing gene sequence data, and assisting with manuscript preparation.

Imaging Probe Development Center: a National Institutes of Health core synthesis resource for imaging probes

The Imaging Probe Development Center (IPDC) has been set up under the auspices of the National Institutes of Health (NIH) Roadmap as part of the molecular libraries and imaging initiatives. It comprises a core synthesis facility dedicated to the preparation of imaging probes, initially for intramural NIH scientists, and later, for the extramural scientific community. The facility opened fully in late 2006, in refurbished laboratories in Rockville, Maryland, and a staff of around a dozen was recruited into place by early 2007; the director was hired in late 2005. The IPDC provides a mechanism for the production of sensitive probes for use by imaging scientists who cannot obtain such probes commercially. The probes to be made will encompass all major imaging modalities including radionuclide, magnetic resonance, and optical. The operation of the IPDC is outlined, together with the results of interim achievements while the IPDC maintained a small temporary laboratory in Bethesda. As of December 2006, a total of eleven probe compositions had been made, and several of these are described with particular mention of those probes intended for use in optical applications.

Final NIH Rules Ease Stock Limits

BIOETHICSThe National Institutes of Health (NIH) in Bethesda, Maryland, has relaxed ethics rules issued 6 months ago that many feared would drive talent away from the agency. The revised rules seem to please both NIH scientists and outside critics.

When Ethicists Have Conflicts of Interest

In February, the online magazine Slate published an article with the title, "Go Away, Ethics Police; Leave the NIH Alone." The author of the piece was Richard Epstein, a law professor at the University of Chicago and a senior fellow at the Maclean Center for Clinical Medical Ethics. The "ethics police" to whom Epstein objected were the critics who had pushed the National Institutes of Health (NIH) into adopting a strict new set of conflict-of-interest regulations. Last year, a muckraking series of reports in the Los Angeles Times revealed that some NIH scientists had parlayed their elite scientific positions into lucrative consulting contracts with the pharmaceutical industry. Several NIH scientists had received more than $2.2 million in company fees and stock options. The director of one NIH institute received more than $600,000 from Schering AG and other companies at the same time that his institute conducted studies for Schering and pledged it $1.7 million in grants. Another scientist wrote national cholesterol guidelines while accepting $114,000 from the makers of cholesterol-lowering drugs.

NIH Scientists Raise Fuss About Scope of New Rules

CONFLICTS OF INTERESTScientists at the National Institutes of Health (NIH) are rallying to challenge strict new ethics rules that many feel go much too far.

Off with their Heads: The Need to Criminalize some forms of Scientific Misconduct

Improvement in policy for the management of scientific misconduct has been slow. While assurance of due process at the ORI level is now in place, similar protections at the institutional level and institutional responsibility for further oversight and a workplace where the responsible conduct of research can be practiced have not yet been addressed. In contrast, policy regarding human subject protection has evolved rapidly to reflect firmer norms, with decisive priority given to subject protection over scientific or social needs. Perhaps because scientific misconduct policy has the potential to harm the careers of individual scientists and harms to individual subjects are thought to be indirect, the scientific community has been successful in blocking every move toward testing more rigorous regulation. The mantras that scientists can discipline their own, and the price of competitive science is some level of scientific misconduct are not persuasive. The standards by which science is judged should not be an exception to those governing others who deal with the public's money and have a duty to the public interest.

Can Outsiders Do Better in Managing NIH Grants?

FEDERAL WORK FORCEA White House push to contract out federal jobs is stirring fears that any shakeup could touch a sacred cow: the system used by the National Institutes of Health (NIH) for reviewing grant proposals. At stake, say NIH scientists, is the continuity and expertise they bring to their jobs.