Nexus January

Open Mike

Charting Your Small Business’ Course with NIH

At NIH, we maintain a broad and diverse portfolio of biomedical and behavioral research. To turn discovery into health, promising technologies must move from the laboratory into clinical trials, into the marketplace, into the doctor’s office, and into our every-day lives. A key way to transition promising technologies out of the laboratory is through the commercialization process. Continue reading

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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

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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.
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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

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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

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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

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Wait…It’s Not MY Grant?

Remembering back to my days as a PI, I can recall myself saying something like “yea, on my NIH grant…” when discussing my research. This may have been okay over coffee, but it is technically incorrect. We hear this confusion a lot. So, we thought it would be worthwhile to remind you about some of the respective roles of institutions and investigators working on an NIH award. Continue reading

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NIH Announces Stipend and Benefit Increases for National Research Service Award Recipients

We are pleased to announce that stipends will be increased for those supported by Ruth L. Kirschstein National Research Service Awards (NRSAs). As a result, approximately 15,000 NRSA training grant appointees and fellows spanning career stages from undergraduates, graduate students, and postdoctoral researchers will receive a two percent stipend increase for Fiscal Year 2018. Please see the recently released NIH Guide Notice NOT-OD-18-175 for the specific new stipend levels. Continue reading

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The Issue that Keeps Us Awake at Night

The most important resource for the successful future of biomedical research is not buildings, instruments, or new technologies – it’s the scientists doing the work. But by now, it’s no longer news that biomedical researchers are stressed – stressed by a hypercompetitive environment that’s particularly destructive for early- and mid-career investigators. But those are the researchers who, if we don’t lose them, will comprise the next generation of leaders and visionaries. Almost 10 years ago, the National Institutes of Health (NIH) took steps to improve funding opportunities for “early stage investigators”, those who were 10 years or less from their terminal research degree or clinical training. Those steps helped, but many stakeholders have concluded that more is needed. Continue reading

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Open Mike Perspective: Healthy Skepticism when Focusing Solely on Surrogate Endpoints in Clinical Research

I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram). Continue reading

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Rock Talk

It’s Just the Beginning . . .

Rock Talk ceases talking as of today, but someone else will be talking, so please keep your bookmarks active and stay tuned for continued dialog with NIH. I want to thank all of you for a conversation worth having and for making the last portion of my federal career spectacular. I am grateful that I have had the opportunity to know and interact with many of you, which was hands down the highlight of my travels around town and across the country to learn first-hand …. Continue reading

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All About Indirect Costs

When I started Rock Talk, one of my goals was to lift the curtain on NIH decision-making and to demystify NIH policies and processes. One topic that I have talked endlessly about throughout my tenure is indirect costs (IDCs). Indirect costs generate almost more discussion than any other topic and there are many misunderstandings about them. Comments and questions reflect a range of perspectives, such as: “Indirect costs are rising all the time and eating up funds that could go for research.” and “Why can’t NIH reduce the rate of indirect costs?”. Others have asked us, “NIH – please get rid of the 26% cap in administrative indirect costs!” or simply want to know …. Continue reading

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Core Facts About Core Facilities

Today, I’d like to blog about some interesting discussions and dispel some myths related to NIH-supported core facilities. Core facilities are important research resources, providing access to advanced instrumentation and technologies operated by experts. Cores provide opportunities to be hubs of innovation at an institution, connecting scientists with the tools and expertise that can take their research projects to the next level. In March, NIH co-hosted a workshop with the Association of Biomolecular Research Facilities to discuss core facility management and strategies for increasing core facility efficiency. The meeting resulted in a set of recommendations for NIH and institutions to consider, and a report from the workshop is now available, if you’d like to read more. In addition, the presenters’ slides are posted on the workshop website, and each session was recorded and can be viewed online. Much of the workshop discussion involved core resource sharing and NIH’s policies on sharing of cores. NIH actively encourages …. Continue reading

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Help Us Help You!

Understanding what you need to know and do to apply for a grant can be a challenge. NIH’s application instruction guide is long, with lots of background information that you may only occasionally need. On top of that, funding opportunity announcements have instructions that often add to those in the application instruction guide. …. Continue reading

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Welcoming the Inaugural Director of the NIH Division of Biomedical Research Workforce Programs

I am pleased and excited to announce that in August, Dr. Kay Lund will join NIH as the inaugural director of the NIH Division of Biomedical Research Workforce Programs. As you might recall, the NIH Advisory Committee to the Director‘s Biomedical Workforce Working Group recommended that NIH recruit a leader and establish a dedicated office to guide NIH’s training and development of a well-prepared biomedical workforce…. Continue reading

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Understanding the Capacity of NIH’s Peer Review System

My office devotes a lot of effort to evaluating its grants policies and practices. Since the introduction of the Enhancing Peer Review changes, NIH has sponsored an ongoing evaluation of peer review, involving formal surveys about the peer review process, as well as other types of analyses. We are keenly interested in your responses to our surveys, so if you receive an invitation to take a peer review survey, I hope you can find the time to respond. The importance of participating in these surveys is nicely illustrated …. Continue reading

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Your Input Requested on a Framework for an NIH-wide Strategic Plan

NIH is beginning the process of developing a 5-year strategic plan, at the request of Congress. NIH developed a framework to identify crosscutting areas of research …. Continue reading

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Get To Know OER

My office, the Office of Extramural Research (OER), works closely with the extramural research community to support NIH’s mission of funding science that will enhance our knowledge of living systems, improve health, lengthen life, and reduce illness and disability. While frequent readers of Rock Talk may be familiar with OER through the topics I blog about, there is much, much more that my office provides in support of NIH’s extramural program…. Continue reading

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NIH Regional Seminar Heads West to San Diego in October 2015

I’m excited to let you know about a wonderful opportunity for our extramural research community that’s headed to the west coast this fall! For the first time in several years, the NIH Regional Seminar on Program Funding and Grants Administration will be offered in the western half of the United States. This 2-day event, with an optional pre-seminar workshop day, will take place in San Diego from October 14 to October 16, 2015. …. Continue reading

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What are the Chances of Getting Funded?

A Look at the Latest Success, Award and Funding Rates…and More

We frequently talk about the different ways of analyzing NIH funding. Let’s revisit this topic so I can provide you with the latest numbers. As a reminder, ….. Continue reading

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From the Leadership

Reminder of Your Responsibilities in Upholding Civil Rights

We’ve published many posts discussing the importance of diversity in the workforce. However, one related aspect we haven’t yet discussed here is how you can, and do, contribute to protecting the civil rights for all individuals, and eliminating barriers and providing equal access to activities supported by NIH funds. Before NIH makes an award to an applicant organization, the organization enters an agreement with the Department of Health and Human Services (HHS) that the institution, as well as any researchers and key personnel supported by NIH funding, will comply with Federal laws that prohibit discrimination on the basis of …. Continue reading

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Top Stories

Working with Human Subjects? New Human Subjects System Replaces NIH’s Inclusion Management System

On June 9 a new Human Subjects System will replace the Inclusion Management System (IMS) currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The new system consolidates human subject information submitted in applications and progress reports and will be used for all human subject-related post-submission updates as of its release. Continue reading

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xTRACT Anticipated to be Required in Fiscal Year 2020

In October 2015, eRA introduced xTRACT as an electronic system within eRA Commons for creating research training data tables and tracking trainee outcomes. xTRACT permits users to leverage data already in eRA Commons to pre-populate training tables with trainee names, institution information, award information, etc., which can be used both in new application submissions and for progress reports [the Research Performance Progress Report (RPPR)]. While use of xTRACT is not required currently, it is anticipated to be required as of FY 2020 for certain types of training grant applications. …. Continue reading

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Why Attend the Spring 2018 NIH Regional Seminar in Washington, DC

You’ve heard about it and may even know someone who attended, but is it right for you? With the next NIH Regional Seminar on Program Funding and Grants Administration coming to Washington DC May 2-4, let us help you decide. Or check out our YouTube video to get thoughts from previous attendees. If you are an investigator or research administrator new to working with the NIH grants process, don’t let the 2018 NIH Regional Seminar in Washington, D.C. pass you by. Registration is underway now and seminars typically sell out! Learn about the NIH grants process and polices directly from ~ 70 NIH & HHS program, grants management, review and policy staff. …. Continue reading

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Due Dates on Holidays/Weekends/NIH Office Closures

With winter weather upon us, remember that when a due date falls on a weekend, Federal holiday, or when Washington, D.C.-area Federal offices close (due to severe weather, for example), the application deadline is automatically extended to the next business day. See NIH Guide Notice NOT-OD-17-041 for additional details. If you suspect Federal offices in D.C. are closed due to severe weather you can …. Continue reading

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Reminder: Changes for January 25, 2018 Application Due Dates

Two major changes impact applications submitted for due dates on or after January 25, 2018.

Applicants are required to use FORMS-E. Wondering what this means for late applications or reviewers submitting under the continuous submission policies? See NIH Guide Notice NOT-OD-17-062 to learn more.
Applications that include one or more clinical trials must be submitted in response to funding opportunity announcements that allow for clinical trials. See NIH Guide… Continue reading

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Cold Weather Blues? Think Spring and the 2018 NIH Regional Seminar in Washington, D.C.

Are you an investigator or research administrator new to working with the NIH grants process?  If so, then don’t let the 2018 NIH Regional Seminar on Program Funding and Grants Administration pass you by.  Registration is underway for the spring … Continue reading

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Tips for Describing Human Subjects Studies in Multi-project Applications

The PHS Human Subjects and Clinical Trials Information form is new to all of us and will take some time to get used to this new approach to collecting human subjects information. If your Program Project or Center multi-project application involves human subjects research, here are a few things to keep in mind. …. Continue reading

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New Electronic Submission Requirement for Diversity Supplements

The funds provided in response to Diversity Supplement requests are used to improve the diversity of the biomedical research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research. Currently, NIH does not require that diversity supplements be submitted electronically, which poses a challenge to NIH staff when trying to identify and track diversity supplement awardees and their subsequent research careers. Effective January 25, 2018, all single and multi-project diversity supplement requests MUST be submitted electronically …. Continue reading

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NIH Single IRB Policy Reminder

As we approach the implementation date for NIH’s Policy on the Use of a Single Institutional Review Board (Single IRB) for Multi-Site Research, we would like to remind you of the resources available for understanding this policy. 

The policy affects multi-site studies involving non-exempt human subjects research funded by NIH, and applies to grant applications with due dates on or after January 25, 2018 and R&D contracts in response to solicitations issued on or after January 25, 2018.

We encourage you to familiarize yourself with the single IRB plan, considerations in the selection of the sIRB, costs, exceptions to the policy, and where you should include this information as part of your grant application or contract proposal.

Visit the following resources to learn more: …. Continue reading

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2018 NIH Regional Seminar in Washington, DC – Rates Increase on December 16!

If you are new to working with the NIH grants application and awards process….you need to read on!  With only one NIH Regional Seminar on Program Funding and Grants Administration scheduled for 2018, you will not want to miss out on this unique opportunity in Washington, DC, from May 2-4, 2018. …. Continue reading

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New Resources

New Podcast: Data Privacy, Access, and Security of the Personal Data NIH Collects on Grantees, Applicants, Investigators, and Trainees

NIH takes the security and privacy of data of people supported by NIH grants seriously. Some of this information is made public if we make an award—such as name and contact information. Other data is protected by the Privacy Act.  … Continue reading

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Working with Human Subjects? New Human Subjects System Replaces NIH’s Inclusion Management System

On June 9 a new Human Subjects System will replace the Inclusion Management System (IMS) currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The new system consolidates human subject information submitted in applications and progress reports and will be used for all human subject-related post-submission updates as of its release. Continue reading

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Principal Investigators, Delegate!

Did you know that the eRA Commons allows principal investigators the ability to grant permission to have others at their institution help with some grants administration tasks?  You might want to consider whether delegating any or all of the following tasks is right for you… Continue reading

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Having Challenges Tracking Down Students and Postdocs at the Time of the RPPR? Here is a Tip to Make It Easier…

Establishing a process where you have students and postdocs establish an eRA Commons account at the time they start working on an NIH grant award can save you a lot of time and energy trying to track down people who may no longer be at your institution at the time of your Research Performance Progress Report (RPPR) submission. You may even want to have them create an ORCID ID as well! …. Continue reading

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New to eRA Commons?

Sometimes when you are trying something for the first time, it can appear to be somewhat confusing, intimidating, and possibly overwhelming.  eRA is continuously developing new resources for our applicants and grantees to eliminate that perception. Recently eRA has focused on ways to help people new to navigating eRA Commons for the NIH grant application, award, and reporting processes. Because these processes require attention to detail and patience, it can often be overwhelming for those who have never done it before. …. Continue reading

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Two New “All About Grants” Podcasts: 2018 Appendix Policy Changes, and Why We Encourage You to Submit Your Application Early

NIH’s Office of Extramural Research brings you two new “All About Grants”  podcasts to ring in the new year. In “Why it’s so Important to Submit Applications Early”, Dr. Cathie Cooper, director of the Division of Receipt and Referral in the NIH’s Center for Scientific Review, talks about the importance of submitting application early due to changes in NIH’s policies and application forms for 2018…. Continue reading

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Resources Available for Preparing Your Application Using ASSIST

Our new Preparing Your Application Using ASSIST page provides step-by-step guidance for navigating the submission process using ASSIST, NIH’s online submission system for the preparation, submission and tracking of grant applications to NIH. …. Continue reading

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New Podcast: “Understanding the Definition of a Clinical Trial and What That Means for You”

A new “All About Grants” podcast is now available! In “Understanding the Definition of a Clinical Trial and What That Means for You” (mp3, transcript), Dr. Mike Lauer, NIH deputy director for extramural research, discusses the changes to clinical trial policies, addresses community questions, and speaks to how these changes will impact applicants and grantees. All About Grants podcast episodes are produced by the NIH Office of Extramural Research, and …. Continue reading

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New Video Provides Overview of New NIH Policies on Human Subjects Research and Clinical Trials

Do you do research with human participants? If so, you play an important role in NIH initiatives to improve accountability and transparency in the human subject research we fund. This 15 minute video Overview of New NIH Policies on Human Subjects Research and Clinical Trials provides a succinct explanation of the various policy changes and what they mean for you. Continue reading

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New NIH Resource for Studies that Randomize Groups or Clusters or that Deliver Interventions to Groups

Experiments, including clinical trials, differ in the methods used to assign participants to study conditions or arms and to deliver interventions. Thanks to the Office of Disease Prevention, the NIH has a new website that provides resources on research methods related to … Continue reading

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You Ask, We Answer

After My Application is Submitted, Can I Include a Copy or Citation of a Preprint as Post-submission Materials?

No. Pre-prints are not included in the list of allowable post-submission materials, because they do not fall in the category of unanticipated events.

Post-submission materials are not intended to correct oversights or errors discovered after submission of the application, but rather …. Continue reading

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How do you define a “study” for the purposes of providing information on the PHS Human Subject and Clinical Trial form and registering in ClinicalTrials.gov?

Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research.

Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies? Find more FAQs and their answers at grants.nih.gov. Continue reading

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Where Can I Find the New PHS Human Subjects and Clinical Trials Information Form?

Like all NIH application forms, the new PHS Human Subjects and Clinical trials Information form is accessed through the submission method you are using. ASSIST, Workspace and all system-to-system solutions provide a way to access and complete the forms. …. Continue reading

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Which Funding Opportunity Announcement (FOA) Should I Use if My Human Subject Research Study is Delayed Onset?

The type of FOA you will need depends on whether you anticipate that your delayed onset human subject study will meet the definition of a clinical trial.

If it will, you will need to choose a funding opportunity that explicitly allows clinical trials (it will be designated ‘Clinical Trial Optional’ or ‘Clinical Trial Required’). Be sure to check the ‘Anticipated Clinical Trial’ box when completing your Delayed Onset Study record within the application.

If no clinical trial is involved, you will need to choose a funding opportunity designated as ‘Clinical Trial Optional’ or ‘Clinical Trial Not Allowed.’

When completing your application, follow the SF 424’s Delayed Onset Study instructions …. Continue reading

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What is “Delayed Onset”?

“Delayed Onset” generally means that human subjects research is anticipated within the period of award but definite plans for this involvement cannot be described in the application. It does not apply to a study that can be described but will not start immediately.

Have other questions about clinical trials? Visit …. Continue reading

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We’re preparing a training grant application but don’t have all the historical data requested in the new data tables…. What should we do?

“We’re preparing a training grant application but don’t have all the historical data requested in the new data tables, such as the length of prior, full-time research experience for trainees entering the program five years ago. What should we do?”

Because reviewers are asked to assess a training program and its record based, in part, on data presented in the tables, applicants should provide as much data…. Continue reading

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What are Institutional Training Table Data Used For?

NIH institutional training grant applications request past and present faculty and trainee data, which are used by peer reviewers and NIH program staff in the evaluation of the application and making funding decisions. For active training grants, NIH requests trainee and faculty data to assess the progress of these ongoing training awards. These data provide insight into: …. Continue reading

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What Kind of Information Should I Include in the “Authentication of Key Biological and/or Chemical Resources” Attachment?

Applicants proposing to use established key biological and/or chemical resources are expected to include an authentication plan in the “Authentication of Key Biological and/or Chemical Resources” attachment, even if the key resources were purchased or obtained from an outside source that provided data on prior authentication. The authentication plan must include only a description of the methods proposed to authenticate key resources prior to use and at regular intervals, if appropriate. The plan should be no more than one page. Key resources and the methods for authentication will vary by research field. For example, …. Continue reading

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What Are “Key Biological and/or Chemical Resources” That Should Be Addressed In My Application’s Authentication Plan?

The quality of resources used to conduct research is critical to the ability to reproduce the results, so to address scientific rigor in your NIH application, we ask you to include an authentication plan.

Key resources refer to established resources that will be used in the proposed research.

Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Key biological and/or chemical resources may or may not have been generated with NIH funds and: …. Continue reading

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What is a “Person Month” & How Do I Calculate It?

A “person month” is the metric for expressing the effort (amount of time) principal investigators (PIs), faculty and other senior personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year (CY), academic year (AY), and/or summer term (SM); and the organization’s definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment.

Conversion of percentage of effort to person months is straight-forward. To calculate person months, multiply the percentage of your effort associated with the project times the number of months of your appointment. For example: …. Continue reading

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Eye on PI

Start Your Application Now for the NIH Loan Repayment Programs

This is an excellent opportunity for researchers who have incurred significant financial debt to remove this barrier to continue to pursue a career in research. The 2010 application cycle opens September 1 and closes December 1. Our data show that individuals, who begin preparing their application early, are more likely to complete their submission by the December 1 deadline.

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NIH Seeks High Risk, High Impact Proposals through NIH Director's Pioneer, New Innovator, and Transformative R01 Initiatives

NIH welcomes proposals for 2010 NIH Director’s Pioneer Awards and New Innovator Awards. Both programs are part of the NIH Roadmap for Medical Research http://nihroadmap.nih.gov and support exceptionally creative scientists who take highly innovative, potentially high-impact approaches to major challenges in biomedical or behavioral research.

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Attention NIH SBIR Phase II Awardees – Past and Present!

Don’t miss your opportunity to apply for the 2009-2010 Commercialization Assistance Program (CAP), designed to help selected NIH SBIR Phase II awardees develop their commercial businesses and transition their SBIR-funded technologies into the marketplace.

  • Has your company had an active NIH SBIR Phase II award within the past six (6) years?
  • Does your company meet current SBIR small business eligibility criteria?

If you answered “yes” to both of these questions, then read on! The application deadline is September 14, 2009.

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The NIH Loan Repayment Program

NIH wants outstanding health professionals to pursue their careers in biomedical, behavioral, social, and clinical research without feeling limited by educational loan debt. The NIH Loan Repayment Programs (LRPs) aim to help investigators do just that.

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Tips for Great Grant Writing (Part 5): Developing Your Budget

There’s a lot to consider when you are developing a budget for your research grant application. While the best resources at your disposal are the sponsored research programs office at your institution, your departmental administrative officials, your mentors and your peers, we have compiled some tips and reminders that may be helpful for preparing your budget. For more detailed information, visit our Developing Your Budget webpage . We offer a brief overview below.

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Need Help Interpreting the New Review Scores?

Implementation of many of the Enhancements to Peer Review began with the May 2009 review meetings, and some applicants are already receiving summary statements with scores determined under the new system. If you need help understanding your grant application’s review scores, read on…

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Tips for Great Grant Writing (Part 3): Organize Your Research Plan

Help reviewers find exactly what they are looking for in your research plan by breaking your proposal down according to the primary review criteria: significance, investigator(s), innovation, approach, and environment. Begin each section with clear, descriptive headers that effectively frame your research plan.

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Tips for Great Grant Writing, Part 2: Get to Know the Projects and Activities of NIH-funded PIs

Learning more about projects already funded by NIH can be a great help when you are preparing your grant proposal. Using the Research Portfolio Online Reporting Tool (RePORT), you can craft a comprehensive search of all NIH funding activities according to your specific interests. This search will result in a list of funded projects, for each of which you will be able to view an abstract and statement of public health relevance, as well as contact information for the project’s PI.

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Get a Handle on Changes from the Enhancing Peer Review Process

There are lots of changes in the works related to the peer review process. Here we compare existing and new peer review processes on scoring. Continue reading

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Tips for Great Grant Writing, Part 1: What is NIH Looking For?

The OER Extramural Nexus is pleased to introduce a new, regular feature: “Tips for Great Grant Writing.” Although we will begin by addressing the very basics of grant writing, stay tuned because we will soon advance to addressing more complex aspects of the grant writing process. This month’s inaugural column addresses the basic question: what does NIH look for in a grant application? Continue reading

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eRA News

Working with Human Subjects? New Human Subjects System Replaces NIH’s Inclusion Management System

On June 9 a new Human Subjects System will replace the Inclusion Management System (IMS) currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The new system consolidates human subject information submitted in applications and progress reports and will be used for all human subject-related post-submission updates as of its release. Continue reading

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Principal Investigators, Delegate!

Did you know that the eRA Commons allows principal investigators the ability to grant permission to have others at their institution help with some grants administration tasks?  You might want to consider whether delegating any or all of the following tasks is right for you… Continue reading

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New eRA Web Site Provides Ready Answers to Common Questions

Tailored to the specific needs of our applicant, grantee, reviewer and trainee communities, the redesigned eRA site integrates rich content such as newly developed step-by-step how to’s for common tasks, associated policy links, FAQs, communication resources and more. Check us … Continue reading

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Commons Hits 5 Million Mark in Log-ins

The feedback after eRA’s infrastructure upgrade in late May has been that after that bumpy road, the journey is much improved. Performance of eRA applications, even during heavy ARRA loads, is markedly enhanced. During this busy time, eRA marked a … Continue reading

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eRA Thanks Users for Their Patience

We have had an eventful two weeks at NIH following eRA’s major infrastructure upgrade, which took place May 22-26. Foremost, we want to thank you for your patience and help in identifying some of the issues that arose. We have seen an extraordinary willingness on the part of our users to be supportive of our efforts.

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eRA Commons, eSubmission Systems Unavailable May 22 to May 26 as eRA Upgrades Major Hardware

With an eye to improving system performance and creating a more stable environment, NIH’s electronic Research Administration (eRA) has planned a major infrastructure upgrade for the end of May around the Memorial Day weekend. Months of meticulous planning will culminate in a switchover to new database servers, a new operating environment, and new storage area networks. Due to the complexity of this major infrastructure upgrade, all eRA systems–including eRA Commons and the eSubmission system–will be unavailable from May 22 through May 26 as eRA implements the cutover.

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2008: A Year of New E-Tools for Grants Processing

The past year brought major changes in grants processing and administration at NIH that was made possible by new electronic systems support. Continue reading

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Reviewers Soon to Have Easier Accessibility to Encrypted CDs

A CD encryption process will not only make encrypted reviewer CDs as secure as before, but will greatly reduce the effort required by the reviewers to access the data within. Continue reading

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NIH Announces New Business Process for Reporting Identified Financial Conflict of Interest for Grants and Cooperative Agreements Beginning October 10, 2008

The National Institutes of Health (NIH) invites all Federal Demonstration Partnership (FDP) members to participate in a pilot of a Financial Conflict of Interest (FCOI) Module, a new feature of the NIH electronic Research Administration (eRA) Commons. The FCOI Module … Continue reading

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xTrain Promises Streamlined Electronic Admin of Research Training Grants

A new feature of the NIH electronic Research Administration (eRA) Commons lets users electronically prepare and submit key documents required for Kirschstein-NRSA research training grants.

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Calendar

NIH Webinar: Single IRB & Exceptions Process – October 18, 2017

Would you like to learn more about the implementation of the NIH single Institutional Review Board (sIRB) policy and receive guidance on how to effectively request an exception to the policy directly from NIH experts?  If so, then make plans to join the NIH Office of Extramural Research (OER) on October 18 from 2:00-3:30pm ET for a webinar on scope and applicability and the single IRB plan. …. Continue reading

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NIH Webinars on Peer Review Focus on AREA/R15 & SBIR/STTR – October 16 & 18, 2017

The NIH Center for Scientific Review (CSR) is the portal for receipt and referral of NIH grant applications, and, for the majority of those applications, carries out the peer review process for assessing scientific and technical merit. In October, CSR will host two “online briefings” on peer review focused on the Academic Research Enhancement AREA/R15 program, and NIH small business (SBIR/STTR) programs. For more information and to register…. Continue reading

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August 30: NIH Webinar on Research Performance Progress Reports (RPPRs)…Test your Knowledge!

Did you know there are three types of Research Performance Progress Reports (RPPRs) that are associated with an NIH grant award? Can you name them? If you said “Annual, Interim, & Final RPPRs”…way to go! What does each one include? How and when do you submit each? What changes have been made in 2017 and what are still to come? On Wednesday, August 30, from 2:00-3:30 ET, NIH experts are planning to answer these questions, along with sharing the latest updates on RPPR policies and process updates. This webinar is designed for principal investigators, signing officials, and delegated officials responsible for the development and submission of progress reports to the NIH.  Registration is now open …. Continue reading

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July 18-19, 2017: NIH Hosts Policy Workshop on Biosafety and Emerging Technologies

NIH’s Office of Science Policy works across NIH and with external stakeholders to promote science, safety and ethics in biomedical technology assessment, biosafety, and biosecurity. In July, they will be hosting a workshop entitled NIH Guidelines: Honoring the Past, Charting the Future. …. Continue reading

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February 20 (Monday), 2017: NIH Closed For the Federal Holiday

NIH (including help desks) will be closed Monday, February 20, 2017, for the federal holiday (Washington’s Birthday). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day. Continue reading

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January 16 (Monday), 2017: NIH Closed For the Federal Holiday

NIH (including help desks) will be closed Monday, January 16, 2017, for the federal holiday (Birthday of Martin Luther King, Jr.). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day. Continue reading

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January 2 (Monday), 2017: NIH Closed For the Federal Holiday

NIH (including help desks) will be closed Monday, January 2, 2017 (Monday is the legal federal holiday for New Year’s Day, as New Year’s Day falls on a Sunday in 2017). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day. Continue reading

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December 26 (Monday), 2016: NIH Closed for Federal Holiday

NIH (including help desks) will be closed Monday, December 26, 2016 (Monday is the legal federal holiday for Christmas Day, as Christmas Day falls on a Sunday in 2016). If a grant application due date falls on a federal holiday, the application deadline is … Continue reading

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November 24 (Thursday), 2016: NIH Closed for Federal Holiday

NIH (including help desks) will be closed Thursday, November 24, 2016 (Thanksgiving Day).  If a grant application due date falls on this federal holiday, the application deadline is automatically extended to the next business day.

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November 11 (Friday), 2016: NIH Closed for Federal Holiday

NIH (including help desks) will be closed Friday, November 11, 2016 (Veterans Day).  If a grant application due date falls on this federal holiday, the application deadline is automatically extended to the next business day.

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Other NIH Happenings

Register Early & Save for Fall 2018 NIH Regional Seminar in San Francisco, CA

Could you benefit from learning more about applying to NIH and our policies, processes, and resources?  Do you know colleagues, whether they be faculty, research administrators or trainees at your institution who might also benefit?  If so, then spread the word about the NIH Regional Seminar on Program Funding and Grants Administration taking place in San Francisco, California – October 17 -19, 2018.  Register by June 22 and save while Early Registration rates are still available.  Continue reading

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In Memoriam: Dr. Rod Ulane, NIH Training Officer and Director of the Division of Scientific Programs

NIH mourns the loss of Dr. Rod Ulane, NIH Training Officer and Director of the Division of Scientific Programs in the Office of Extramural Programs. Dr. Ulane passed away unexpectedly March 7. He was an ardent and dedicated supporter of biomedical research workforce training. Continue reading

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OER Welcomes Michelle Bulls

On November 4, Ms. Michelle Bulls began her position as director of the Office of Policy for Extramural Research Administration, also known as OPERA, within the Office of Extramural Research. Continue reading

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Joe Ellis, Director of OPERA, Retires from NIH

After 34 years at NIH, Joe Ellis, the director of the Office of Policy for Extramural Research Administration, is bidding NIH adieu. Continue reading

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OER Vacancy Announcement: Director for Office of Policy for Extramural Research Administration

NIH is currently seeking a director for the Office of Policy for Extramural Research Administration. Continue reading

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OER Welcomes Dr. Matthew Portnoy

Please join us in welcoming Dr. Matthew Portnoy to the OER team! Continue reading

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OER Welcomes Dr. Rick Ikeda

Dr. Rick Ikeda joins OER as Director of the Office of Research Information Systems (ORIS).

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OER Welcomes Della Hann

Dr. Della Hann joins OER as Deputy Director for the Office of Extramural Research.

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OER Welcomes Lisa Scott-Morring

Lisa Scott-Morring joins OER as an Assistant Grants Compliance Officer in the Office of Policy for Extramural Research Administration.

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OER Welcomes Joel Snyderman

Joel Snyderman joins OER as an Assistant Grants Compliance Officer in the Office of Policy for Extramural Research Administration.

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