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NIH Extramural News - June/Early July 2018

Open Mike

The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You

Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive. Continue reading 

 

Rigorous Resources for Rigorous Research

Over two years ago, NIH rolled out a policy to enhance reproducibility of its supported research through rigor and transparency. Applicants and reviewers were required to devote more attention to four areas: the rigor of the prior research (scientific premise), the rigor of the proposed research (scientific rigor), consideration of biological variables including sex, and the authentication of key biological and/or chemical resources. When the 21st Century Cures Act was passed later that same year, we were required, amongst other things, to assemble a working group of the Advisory Council to the NIH Director (ACD). These experts were charged with recommending ways to further enhance reproducibility of the research we fund, while being informed by the current policy.Continue reading 

 

When to Share or When Not to Share, that is the Privacy Question

Looking for a grant award you heard about? Go here! Perhaps how many trainees NIH supported? You got it! Research spending on a certain disease? Done! Comparing NIH to another federal funder? Look no further! As you can see, NIH shares a quite diverse array of data associated with our funded grants in a transparent way. But, that does not mean we share everything. Continue reading 

 

NIH Wants You! – Apply to Be Our Next Director of the Center for Scientific Review

Do you have a vision for the future of improving scientific reviews? Are you a first-rate Scientific Leader seeking a career at the Center for supporting the most preeminent biomedical research institutes in the nation and the world? If so, the NIH has the perfect opportunity for you! Continue reading 

 

RCDeCade: 10 Years and Still Counting

Remember hearing those stories about how your grand-PIs had to walk five miles, in the snow, uphill, with no shoes just to learn how NIH spent its research budget? Well, believe it or not, but that was just ten years ago. Today, we have the Research, Condition, and Disease Categorization (RCDC) webtool to do this in a blink of an eye. Now, following the official release of Fiscal Year (FY) 2017 data and updated estimates for FYs 2018 and 2019 last month, we wanted to celebrate a successful decade of service. Continue reading 

Top Story

If You Run Into SAM Registration Processing Delays, We’ve Got Your Back

GSA now requires entities who are updating or renewing their SAM registration  to provide an original, signed and notarized letter stating that the organizational official registering the organization is the authorized administrator. The new process is slowing processing time for … Continue reading 

Resources

New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review

Have you ever wondered why your grant application must undergo a separate round of peer review—even after a panel of experts initially weighed in on its scientific merit and provided a score to consider when making funding decisions? A new … Continue reading 

 

Expiring Appropriations and What it Means for You – New Video and Podcast

Did you know that grant funds can expire?  A recent interview with NIH experts on the topic of “Expiring Appropriations” addresses how you know if you have expiring funds, what to do if you find yourself in this situation, and whether money can be restored.  This 10 minute conversation is available as both a video and a podcast.  Continue reading 

 

Fall 2018 NIH Regional Seminar Heads to the “City by the Bay” – San Francisco, CA

In just a few months, approximately 65 NIH & HHS grants process and policy experts will be bringing their expertise to the San Francisco Bay area for the NIH Regional Seminar on Program Funding and Grants Administration.  Plan to meet, share, and learn with us over the course of 2-3 days, October 17-19, 2018!Continue reading 

 

You Ask, We Answer

Does the NIH inclusion policy apply to research using existing datasets or other types of existing resources involving human subjects?

If the study is considered human subjects’ research and meets the NIH definition of clinical research, then it is subject to the NIH inclusion policy.

What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?

If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited.  The existing dataset sample can … Continue reading 

 

In part D of the F-RPPR (participants), should we report time worked for the final budget period or time worked for the final budget period + the no cost extension period?

In the Final RPPR you should report on the individuals that worked on the project during the last budget period minus any approved no-cost extensions. You can find this and more in the RPPR FAQs.