National Institutes Of Health Officials Research Articles

An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of "Healthy Divas" to Improve HIV Care Outcomes.

Introduction: Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the Healthy Divas intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV.Methods and Analysis: We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH (N = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = < 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations.Clinical Trial Registration: Clinicaltrials.gov, identifier NCT03081559.

New round of awards announced for cutting‐edge brain research

The National Institutes of Health (NIH) announced Nov. 2 funding of more than 200 new awards, totaling over $220 million, through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, an exciting transagency effort to arm researchers with revolutionary tools to fundamentally understand the neural circuits that underlie the healthy and diseased brain, NIH officials stated in a press release. Supported by Congress through both the regular appropriations process and the 21st Century Cures Act, this brings the total 2018 support for the program to more than $400 million, which is 50 percent more than the amount spent last year. Many of the new awards explore the human brain directly. Furthermore, the NIH is trying to leverage some BRAIN Initiative advances to help tackle the pain and opioid crisis. “The BRAIN Initiative is laying the foundation for improved ways to target brain circuits disrupted in brain disorders,” said Joshua A. Gordon, M.D., Ph.D., director of the NIH's National Institute of Mental Health.

NIH policy supports broader sharing of genomic data, strengthens informed-consent rules: research participants must give consent for secondary sharing, even if data are de-identified.

NIH policy supports broader sharing of genomic data, strengthens informed-consent rules: research participants must give consent for secondary sharing, even if data are de-identified.

Does family always matter? Public genomes and their effect on relatives

Coinciding with the publication of the genome sequence of the HeLa cancer cell line last summer [1], US National Institutes of Health (NIH) administrators announced that they had been working closely with the family of Henrietta Lacks [2], the woman from whom the HeLa immortal cell line was derived, to address the family’s concerns regarding privacy and informed consent. NIH officials noted that ‘the full [HeLa] sequence data could potentially uncover unwanted information about people whose identity is widely known’ - namely the family of Ms Lacks [2]. Such unwanted information could include disease risks, response to drugs, ancestral roots, and in some cases an individual’s actual identity [3]. This article followed on the heels of another study published in March of this year that likewise presented a detailed account of the HeLa genome and included public posting of the data [4]. Days after publication of that article, a firestorm of commentary erupted on social media [5,6] and formal news outlets, questioning the ethics of the study and public deposition of the data. The posting of the data also reportedly upset the Lacks family, with one family member quoted as saying, ‘That is private family information…It shouldn’t have been published without our consent’ [7]. The NIH responded by entering into a much needed dialogue with the Lacks family to address these concerns. These events call attention to the issue of the impact of public release of an individual’s identified data on biological family members, and the need for empirical research in this area to inform policy-making with regard to data sharing.

Uncommon disorders in the spotlight

Uncommon disorders in the spotlight

Autism Research to Get Big Slice of Stimulus Pie

Back to table of contents Previous article Next article Government NewsFull AccessAutism Research to Get Big Slice of Stimulus PieRich DalyRich DalySearch for more papers by this authorPublished Online:17 Apr 2009https://doi.org/10.1176/pn.44.8.0008Among the details that have begun to emerge on how federal stimulus-package money will be spent on disease research is a planned new focus on autism studies.The National Institutes of Health (NIH) announced in March that at least $60 million of the $10.4 billion allocated to it by the American Recovery and Reinvestment Act (ARRA, PL111-5) federal stimulus law will be devoted to support autism research. The NIH set-aside for autism spectrum disorders (ASD) research is the largest investment yet by the federal government in research on the disorder, according to NIH.The funding “represents a surge in NIH's commitment to finding the causes and treatments for autism,” NIH said in a written statement. The autism research grants will be awarded through the National Institute of Mental Health (NIMH).The autism grants will be used for research over the next two years that includes developing and testing diagnostic screening tools, assessing risks from prenatal or early-life exposures, and performing clinical trials to test potential early interventions.Although few clinical trials are likely to be completed within the two years for which ARRA funds are available, NIH officials said the funding will help by “jump-starting projects” and building the infrastructure for longer-term autism research efforts.The autism research reflects the short-term objectives described in the Inter-agency Autism Coordinating Committee's (IACC's) Strategic Plan for Autism Spectrum Disorder Research, which was issued in March. The IACC consists of federal health officials, outside autism experts, and advocates who recommend ways to coordinate the federal government's autism efforts.“As reflected in the IACC strategic plan, we have a growing sense of urgency to help the increasing number of children being diagnosed with ASD,” said psychiatrist Thomas Insel, M.D., director of NIMH, in a press release. “With the arrival of new funds, we can immediately start on many of the short-term objectives in the plan and use ARRA funds to support science that will facilitate the best possible outcomes for people with ASD and their families.”NIMH, which is a division of NIH, plans to allocate all of the stimulus funds appropriated for autism research by September 30, 2010.Other recent developments related to the stimulus law's research-funding boost included NIH's announcement in March that it had begun to accept applications for $1.5 billion in economic-stimulus funds for studies, improvement, and construction of research facilities and for purchasing scientific equipment.More than $200 million in grants will be focused on studies “that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant two-year jumpstart funds,” according to NIH. Comparative-effectiveness research will also be a target area for the research funds.The highest-priority research areas in mental health identified by NIH include identifying biomarkers in patients with mental disorders that predict the course of disease and patients' responsiveness to treatments. Other priority initiatives on which NIH plans to spend the stimulus money are“ person-centered” data analysis for alcohol treatment research, behavioral and medical treatments for drug addiction in nonspecialty settings, and the cost-effectiveness of available psychiatric illness treatments.Information on NIH's highest priorities for the new grant money is posted at<http://grants.nih.gov/grants/funding/challenge_award>.▪ ISSUES NewArchived

Researchers Could Face More Scrutiny of Outside Income

NATIONAL INSTITUTES OF HEALTHAs controversy escalates about researchers who allegedly broke rules on reporting income from drug companies, U.S. National Institutes of Health officials outlined plans last week to tighten federal conflict-of-interest regulations for NIH grantees within the next 6 to 12 months.

NIH Tells Universities to Pay More for Graduate Training

The NIH Ruth Kirschstein National Research Service Award (NRSA) program, which supports more than 17,000 PhD students and postdoctoral fellows, primarily through institutional training grants, is facing a fiscal crunch, according to a report in Science, December 9, 2005. The report notes that National Institutes of Health officials have told universities they must shoulder more of the costs of training the next generation of biomedical scientists, or face a decline in the number of graduate students and postdoctoral trainees that NIH supports. NIH currently provides the major share of trainees’ tuition, paying the first $3000 plus 60% of the remainder, and covers a share of each trainee’s health insurance. But the Science journal report points out that steadily rising tuition and health care costs, along with a flat budget, will move NIH to transfer more of the burden to universities or reduce the number of NRSA trainees. Without an increase in program funding, NIH has projected a loss of 4000 training positions by 2015. NIH says it is considering 3 options: (1) retain the existing formula by capping the reimbursable amount at $16,000 to $18,000, roughly the current average subsidy; (2) a fixed allowance capped at $16,000 to $18,000; (3) continue the current policy, staying on budget by squeezing both the number of institutional grants and the number of trainees per grant. A decision by NIH is expected by spring. Deputy director for extramural research Dr. Norka Ruiz Bravo views prudent policy as requiring “an appropriate balance between training budgets and the funds available for research support. However,” she acknowledges, “an annual loss in training positions would threaten the stability of ongoing programs and impede consideration of training programs in new and emerging scientific fields.”

Détente Declared on NIH Biodefense Funding

At a meeting last week, microbiologists concerned that the buildup of biodefense research could be hurting basic research and top National Institutes of Health officials agreed that they should both look at what scientific areas are falling through the cracks.

Basic Microbiology Pushed

Seventy-seven intramural scientists at the National Institutes of Health (NIH) have joined calls for more funding of nonbiodefense microbiology. In a 17 March letter to Director Elias Zerhouni, they argue that support is declining for basic microbiology. Although the plea echoes an open letter signed by more than 700 academic scientists last month ( Science , 4 March, p. [1409][1]) and cites similar grants data, the scientists are careful not to blame the purported drop on biodefense spending. The letter, organized by Michael Yarmolinsky of the National Cancer Institute, asks Zerhouni to form a committee to review the situation. NIH officials say support for nonbiodefense grants has held steady (see p. [49][2]). [1]: /lookup/doi/10.1126/science.307.5714.1409c [2]: /lookup/doi/10.1126/science.308.5718.49b

Financial Conflicts of Interest and the NIH

The National Institutes of Health (NIH) is widely regarded as the world's premier biomedical research institution. The doubling of the NIH budget over the past decade reflects the trust that the American people place in this federal government agency and its employees, as well as the importance of its work. Recently, however, this confidence has been called into question by a report in the Los Angeles Times about consulting payments from pharmaceutical companies to high-ranking NIH officials.1 According to Dr. Elias A. Zerhouni, the director of the NIH, to date there is “no evidence that patients were harmed or that . . .

The Office of Scientific Integrity.

The Office of Scientific Integrity David P. Hamilton (bio) For most of the 1980s, the specter of scientific fraud popped into public view every few years, usually only to submerge again. Faced with several well-publicized cases of scientists who blatantly faked their data—among the best-known being Harvard cardiologist John Darsee (whose colleagues watched him forge data) (Broad and Wade 1982, p. 14) and Sloan-Kettering Institute immunologist William Summerlin (who painted black spots on white mice to simulate tissue grafts) (Broad and Wade 1982, p. 155)—the scientific community as a whole tended to dismiss the phenomenon as the work of a few deviants. Called in 1981 to testify before then-Representative Albert Gore Jr.'s subcommittee on investigations and oversight, Philip Handler, then-president of the National Academy of Sciences, told the panel that science was perfectly capable of regulating itself, and that the problem of scientific fraud had been "grossly exaggerated" by the press (Broad and Wade 1982). The message was clear: Congress should stick to its knitting, and science would take care of itself. Now, however, scientists are faced with a very different situation: a permanent federal bureaucracy, known as the Office of Scientific Integrity (OSI), devoted to the investigation of alleged scientific wrongdoing. The transition from the days of laissez-faire, when universities were entrusted with all investigations unless they were handled so badly that the federal government was forced to take notice, has been an uncomfortable one for many researchers. Lately, this discomfort has taken shape as a vocal protest against OSI. Largely as a result of this protest, federal officials recently promoted a plan to restructure OSI and change some of its operating procedures, a move with unpredictable consequences for universities and researchers alike. OSI was born largely because of investigations by two influential congressmen: Representatives John Dingell of Michigan and Ted Weiss of New York. While both claimed they acted mainly to make sure taxpayer dollars were not spent on fraudulent research, both also maintained a strong interest in protecting "whistleblowers," the often vulnerable, and usually junior, scientists who first raise questions about bad research. And Dingell seemed to take special pleasure in pointing up the deficiencies of investigations run by universities and by the National Institutes of Health (NIH) itself. (For reasons that are not well understood, [End Page 171] biomedical research seems far more prone to fraud than any other field of science. As a result, NIH, which funds most biomedical research in the United States, has held ultimate responsibility for most prominent cases of fraud.) Plagued as they often were by conflicts of interest, shoddy methodologies, and, in some cases, a willingness to believe any excuse by the accused, no matter how far-fetched, these investigations made easy targets. And the notion that science could "govern itself" grew harder to sustain. In late 1988, Dingell and other congressmen began circulating draft bills that would have created a new office for investigating scientific fraud. Dingell would have placed such an office under the aegis of the Inspector General of the Department of Health and Human Services, raising the possibility that scientific fraud might be probed by the same criminal investigators who unravel Medicare fraud. Unsettled by this vision of the "science police," NIH officials moved quickly to pre-empt Congress. On March 16, 1989, they published a notice in the Federal Register announcing the creation of OSI, an office with responsibility for ensuring thorough university investigations of misconduct and the authority to conduct its own investigations when necessary. From the beginning, OSI took an unusual approach to its work. For one thing, the office had a broad mandate: Although located within NIH, it was responsible for research funded throughout the entire Public Health Service, including the Food and Drug Administration, the Alcohol, Drug, and Mental Health Administration, and the Centers for Disease Control. Furthermore, it was not restricted to scientific fraud. Departmental lawyers, wishing to avoid the legal connotations of the term "fraud"—in particular, a requirement that fraudulent actions not only mislead others but also cause them noticeable harm—decided instead to adopt the term "scientific misconduct," defined as "fabrication, falsification, plagiarism, or other practices that deviate...

Disposal of antineoplastic wastes at the National Institutes of Health

The process of developing disposal guidelines for antineoplastic wastes at the National Institutes of Health (NIH) is described. Because of the large volume of hazardous wastes generated, NIH must comply with Environmental Protection Agency (EPA) guidelines for disposal. Seven antineoplastic agents are defined by EPA as hazardous wastes. Because of the similar toxicities and pharmacologic drugs, NIH officials elected to dispose of all such agents as hazardous wastes. Available options are presented. The NIH procedure divides antineoplastic wastes into trace- and bulk-contaminated categories. Trace-contaminated wastes contain minimal or trace amounts of drugs and are disposed of by one-site incineration. Bulk-contaminated materials (defined as intravenous solutions or containers whose contents weigh more than 3% of the capacity of the container) are disposed of by land internment and incineration at EPA-approved sites. Syringes and i.v. bottles containing antineoplastic drugs are labeled with bright red-orange labels instructing personnel to return the materials to the pharmacy for disposal. General decision-making procedures for other institutions are recommended.