March 2, 2015
On February 5, NIH announced its “NIH Interim Grant General Conditions”, our first step toward implementing Fed-wide administrative requirements for the use of Federal funds.
The Office of Management and Budget (OMB)’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” (2 CFR part 200), (you may also hear it referred to as the “Uniform Guidance” or “UG”), published in December 2013, provided a government-wide framework for administrative requirements, cost principles, and audit requirements when ….
February 20, 2015
Last year we highlighted a new section of the NIH Data Book that provides statistics about peer review across NIH, including peer review organized by the Center of Scientific Review as well as peer review organized by NIH institutes and centers. Then, and now, these data truly demonstrate how you, our peer reviewers, are the lifeline of the scientific process. During 2014 nearly 24,000 reviewers participated in more than 2,500 peer review meetings to assess the scientific and technical merit of NIH applications, and many of those reviewers participated in multiple meetings. Your service to NIH expands our capacity to fund the best science, and provides an essential breadth of perspectives on the research projects and research training that NIH supports. In the lab and in the study section, we’re grateful for the myriad ways you work with us to advance human health and benefit the health of our nation, and the world. ….
January 7, 2015
Happy 2015! Just a quick blog to let you know that last week, NIH announced policies for fiscal operations for fiscal year (FY) 2015, implementing the 2015 Consolidated Appropriations Act signed by President Obama on December 16, 2014. NIH has a budget of $30.31 billion, an increase of approximately $240 million over the FY 2014 final budget allocations of $30.07 billion. We also announced the stipend levels for Ruth L. Kirschstein National Research Service Awards (NRSA), and salary limits ….
December 22, 2014
We’ve received some questions about shipment and receipt of biological samples, particularly in the context of the ongoing Ebola outbreak in West Africa; for example, whether grantees can accept biological materials from Africa, and whether NIH has in place any requirements for transporting such research materials. In light of these incoming questions, I think this is a good time to remind you that a number of regulations are in place to ensure ….
December 9, 2014
We certainly heard a lot of input on the blog on the issue of the new biosketch format. I really appreciate the dialog. Even when the input is critical it is so important to hear what you think. Remember that the blog is just one of many points of input when we make policy decisions, however. In this case NIH ….
December 3, 2014
For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. ….
November 19, 2014
Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants can make informed decisions about potential trial participation and know how their participation may have helped others. …. Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. …. Importantly, today NIH also announced a proposal to apply these same proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that every NIH-funded clinical trial be registered ….
October 17, 2014
The White House announced today that U.S. government agencies will institute a pause in the funding of new “gain-of-function” research on influenza, SARS, and MERS viruses that could increase the pathogenicity or transmissibility to mammals …. During this funding pause, the government will carry out a deliberative process to assess the risks and benefits of such studies and will develop a new Federal policy regarding the funding of this research. ….
September 11, 2014
We as a scientific community have made major progress toward balancing the number of men and women who volunteer as participants in biomedical research studies; in fact, women now account for roughly half of the participants in NIH-funded clinical trials. However, we haven’t seen a similar pattern in the pre-clinical research involving animals and cells. …. Thus, as announced in May, NIH intends to develop and implement policies requiring NIH applicants to consider sex as a variable in biomedical research involving animals and cells. …. today we announced a formal request for information (RFI) to get input from the research community, and others. As described in the RFI, we want to hear your thoughts on several topics – for example, whether consideration of sex as a biological variable is an issue affecting the reproducibility of research findings ….
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