Issue | november-december-2018



Always Check Your FOA for New Related Notices 30 Days Before Submission

You found a funding opportunity announcement (FOA) that fits your research, you’ve read it carefully, and have been working for months perfecting your application. Don’t forget to return to the FOA within 30 days of the due date to check for any new related notices which could impact  your submission.The Related Notices in Part 1 of the FOA could alert you to a changes in key dates, updates to application instructions, notices of new policies and other “need to know” information. This simple step will help ensure that there are no surprises when it comes time to submit your application to NIH!

For more helpful hints, see our Understand Funding Opportunities page.

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Can My Application be Considered a Resubmission Even if I am Not Re-Submitting to the Same FOA?

It depends on whether the FOAs are Program Announcements (PA, PAR, PAS or Parent) or Requests for Applications (RFA).

An application originally submitted as “new” to a Program Announcement may be resubmitted as an A1 (resubmission) to any other Program Announcement so long as that Program Announcement accepts resubmissions and you are within 37 months of the A0 (original) submission date.

For RFAs the situation is a little different. If you originally submitted to an RFA and want to resubmit to a Program Announcement, this will be considered a new application. Similarly, if your original application was submitted to a Program Announcement and you want to now submit to an RFA, it would also be considered a new application.

For more on resubmission policies, check out our Resubmission FAQs page. To learn more about types of funding opportunities, see our Understanding Funding Opportunities page.

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Don’t Wait to Spring Into Action: Early Registration Rates End Soon for Spring 2019 NIH Regional Seminar

Banner image for NIH spring regional seminar in BaltimoreOn Monday, December 31st, Early Registration Rates end for this valuable and unique learning opportunity, designed for those new to working with the NIH grants process. If you are interested in attending the next NIH Regional Seminar in Baltimore, MD (May 15-17) and have not registered yet, then now is the time!

Check it out for yourself:

  • Over 700 investigators, research administrators, grant writers and others working with NIH grants and contracts will be in attendance from almost every state and numerous countries around the globe. (This means session questions and discussions from those with roles similar to yours.)
  • Over 65 presenters including NIH officials representing Program, Grants Management, Review, and the OER Policy office. HHS experts from OHRP, OIG & ORI.
  • Over 40 additional NIH experts available from numerous NIH Institutes and Centers available for smaller, more personal discussion opportunities in our “1:1 Meet the Experts” chats and/or at our NIH exhibits. As a participant, you’ll have the opportunity to sign up in advance to meet with specific faculty members during the 2-day seminar in 15 minute time slots. Past attendees repeatedly tell us how valuable these discussions were for them.
  • Over 45 different topics during the 2-day seminar within 3 unique tracks based on roles: Administrators, Investigators, and All Interests (specialty topics). This seminar provides a comprehensive program focusing on the NIH grants process and related policies, including such topics as NIH grant fundamentals, compliance, peer review, grant writing guidance, research integrity, pre-award and post-award issues for administrators and investigators, animal and human subject research, foreign collaborations, and how to interact electronically with NIH. View the sample agenda  for more details.
  • Over-the-top opportunities to learn even more during the Optional Pre-Seminar Workshops on topics such as electronic Research Administration (eRA), Human Subject Research Protections (collaboration between OHRP & NIH), Intellectual Property & iEdison, and an Administrators Boot Camp.

Register and find additional information at https://regionalseminars.od.nih.gov/baltimore2019/.

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Comments Welcomed on the Draft Report Recommending How to Reduce Administrative Burden in Research with Laboratory Animals: A Next Step in Implementing the 21st Century Cures Act

The 21st Century Cures Act requires federal agencies to “review applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research finding and protection of research animals.” This past March we requested feedback from the public on ways to reduce regulatory burden while also maintaining the highest standards for protecting animal welfare and scientific integrity. You responded with constructive and helpful feedback with more than 19,000 comments. Generally, many responses supported the actions initially proposed in the request, but they were balanced with concerns from animal advocacy and other groups.

A working group of animal welfare experts from NIH, the US Department of Agriculture and the Food and Drug Administration thoroughly reviewed and carefully considered all public comments. The working group integrated their analysis of the public comments with their previous studies of relevant published reports, survey findings from diverse animal welfare organizations, and feedback provided by engaged stakeholders at listening sessions during professional meetings. They have now released a draft report (see also the Federal Register Notice), which includes proposed actions to address inconsistent, overlapping, or unnecessarily duplicative laboratory animal welfare regulations and policies (NOT-OD-19-028).

Today, we again seek your thoughts. Scientists, research institutions, animal welfare advocacy groups, professional societies, and the public are invited to comment on the recommendations outlined in the draft report. Your comments must be submitted electronically here over the next sixty days until February 5, 2019.

The draft report outlines areas in which we can make oversight more efficient and reduce burden without compromising animal welfare or scientific integrity: these areas include Institutional Animal Care and Use Committee Inspections, protocol reviews, and annual progress reporting. The draft report recommends increased coordination across federal agencies by refining guidance on federal standards and harmonizing agency requirements, training, and resources.

We appreciate your thoughtful and substantive comments. Your views on the actions proposed will continue to help ensure NIH promotes the highest level of well-being for laboratory animals, scientific integrity, public accountability, and social responsibility in the conduct of science.

This is not the end of the story. Together with our federal partners, we will continue to identify redundancies in federal requirements and to harmonize policies which affect laboratory animal welfare. Moreover, we will continue to provide federal oversight to ensure that when animal research is necessary, the animals are responsibly cared for and humanely used in federally funded studies.

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New Financial Conflict of Interest Training Module Available

Looking for a training to satisfy the requirement for investigators to complete training in financial conflict of interest (FCOI) regulations? NIH has developed a new training that institutions can use to help satisfy this need. This interactive training module allows for printing of a certificate at the end. Remember, as per the NIH Grants Policy Statement, institutions will require investigators to complete the training prior to engaging in NIH-supported research and at least every four years, and immediately under the designated circumstances:

  • Institutional FCOI policies change in a manner that affects Investigator requirements
  • An Investigator is new to an Institution
  • An Institution finds an Investigator noncompliant with the Institution’s FCOI policy or management plan.
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Changes to the R15 Academic Research Enhancement Award (AREA), and Introducing the R15 Research Enhancement Award Program (REAP)

Photo of Alexandra Ainsztein

Alexandra Ainsztein, Ph.D., is a Program Director at the National Institute of General Medical Sciences.

photo of John Lorsch

John Lorsch, Ph.D., is the Director of the National Institute of General Medical Sciences.

Students in institutions with significant amounts of NIH funding, whether they be undergraduate or graduate students, generally have plenty of opportunities to gain exposure to biomedical research. This early exposure is key to engendering interest in exploring careers in science and enhancing understanding of the value of the research process.

Institutions with little NIH funding often offer significantly fewer opportunities for students to do hands-on research. That’s where NIH’s AREA program comes in. Historically the goal of the AREA program has been to support meritorious research while exposing undergraduates to research and strengthening the research environment of schools that have not been major recipients of NIH support. The AREA program has also supported graduate students at eligible schools, and students at eligible health professional schools.

As announced in this guide notice, as of January 2019, NIH is shifting its approach to how we use the R15 activity code. While NIH will continue to provide R15 research enhancement opportunities for health professional and graduate schools, the name, AREA, will be reserved for grants to undergraduate-focused institutions that do not receive substantial funding from NIH. Today’s undergraduates represent the future of biomedical research and, as such, it is imperative that we support access to research opportunities for students at undergraduate schools across the country.

The AREA program will have its own set of FOAs, distinct from those issued for health professional schools and graduate schools of arts and sciences. This approach will allow us to better track the undergraduates we support at under resourced institutions. Institutions applying for AREA grants must have an undergraduate student enrollment that is greater than graduate student enrollment and, in order to qualify for the AREA program, all the non-health professional components of the institution together cannot have received support from the NIH totaling more than $6 million per year in total costs in 4 of the last 7 years.

NIH will also offer R15 opportunities to support graduate schools of arts and sciences and health professional schools that grant baccalaureate or advanced degrees. We will be calling this the Research Enhancement Award Program (REAP). For these grants the applicant organization (all components) may not receive research support from the NIH totaling more than $6 million per year in total costs in 4 of the last 7 years.

Another change for 2019 involves how an institution determines eligibility and how that is reflected in the application. Since early this year the National Institute of General Medical Sciences, who historically has funded the majority of AREA projects, has been piloting the inclusion of a signed letter in the application from the Provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission. The pilot has been successful and as of January 24, 2019, NIH will no longer maintain its list of institutions ineligible for R15 grants. For R15 applications submitted for due dates on or after February 25, 2019, NIH will rely on the institutional letter verifying eligibility that will be required in the application as part of the letters of support attachment.

How will this impact funding opportunity announcements (FOAs)? Existing R15 FOAs referencing the ineligibility list will be expired, including the parent AREA FOA. The AREA Parent Announcement, PA-18-504, will expire after the January 7, 2019, AIDS due date and will not be reissued. Instead, the following announcements will be available in December:

Be sure to look closely at the list of participating institutes and centers on each announcement. Not all Institutes and Centers participate on the R15 FOAs. We encourage you to consult with the scientific contacts listed in section VII of the FOA to ensure that the funding opportunity you plan to apply to is suitable for your science.

The AREA and REAP programs are important complements to NIH’s other types of funding programs. It’s so important to ensure that we are tapping into all the talent pools across the country, not just those in research-intensive institutions and regions, to bring the broadest thinking possible to the research enterprise. To assist you in navigating the program changes, we updated the R15 web page and created a resource to assist institutions in calculating eligibility.

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New Funding Opportunities for Basic Experimental Studies Involving Humans

Photo of Bill Riley

William T. Riley, Ph.D., Associate Director of Behavioral and Social Sciences Research

Over the past year, since we published an essay in Nature Human Behaviour on “NIH policies on experimental studies with humans,” NIH has engaged in a discussion with the basic science community to find ways to meet our shared obligations to study participants and taxpayers, while respecting the unique goals and outcomes of basic science.  While we are still in the midst of that conversation, we are pleased to announce real progress in the form of new funding opportunity announcements for Basic Experimental Studies Involving Humans.

Since October 2014, the NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” (NOT-OD-15-015).  We appreciate that not all studies meeting this NIH definition of a “clinical trial” are “clinical” in nature.  Some studies involve preventive interventions with healthy individuals or interventions with patients in settings other than the healthcare system.  Other studies constitute basic research, defined as the “systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” (32 CFR 272.3).  Indeed, over 10,000 trials registered in ClinicalTrials.gov indicate that their primary purpose is basic research.

We have heard the community input regarding the breadth of the NIH clinical trials definition and the concerns about the applicability of some clinical trials policies to fundamental, basic science studies.  In response to these concerns, the NIH has developed new funding opportunities specifically for basic experimental studies involving humans scheduled for release this week (see the NIH Parent Announcements page). These funding opportunities, designated as “Basic Experimental Studies with Humans Required” are for studies that meet the definition of basic research and also are subject to clinical trials policies based on the NIH definition of a clinical trial.

Over the next several weeks, we will be rolling out a variety of resources to help inform applicants about these new funding opportunities including tools for choosing the correct FOA. FAQs and a table comparing Funding Opportunity Types by Clinical Trial Allowability are already available.

NIH appreciates that representatives of the basic science community have argued that registering and reporting in ClinicalTrials.gov poses a challenge for some studies, particularly those conducting basic experiments with human participants. As such, NIH is postponing enforcement of the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information for studies submitted to Basic Experimental Studies with Humans FOAs. NIH will continue to expect registration and results reporting for these studies but is allowing additional flexibility to report on alternative portals instead of ClinicalTrials.gov.  We are already working on developing software by which information included in grant applications can be directly ported to ClinicalTrials.gov, substantially streamlining the registration process, and ClinicalTrials.gov continues to work to make its registration and reporting systems more flexible for a broader array of studies.

We are pleased at the robust response to the recent Request for Information which was focused on obtaining input regarding registration and reporting standards for fundamental studies involving humans. NIH is conducting a thorough analysis of the comments and plans to engage in additional stakeholder outreach to gain a better understanding of the current challenges with ClinicalTrials.gov. We are committed to working with the community to explore possible solutions to reduce the burden for investigators while also increasing transparency for studies involving human participants.

The research community and the NIH share an ethical commitment to research participants and to taxpayers to ensure that the findings from prospective studies involving humans are made public and contribute to the advancement of public health.  Study participants donate their time and accept both known and unknown risks to help advance our understanding of health and disease. They, as well as the taxpayers who support the work, rightly expect that their efforts and dollars will benefit scientific progress, especially when participating in basic research in which possible personal benefits of participation are minimal.

We look forward to working closely with the basic research community on ways to improve upon current registration and results reporting standards to meet our shared goal of research transparency.

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FY 2019 Fiscal Policies for Grant Awards: Funding Levels, Salary Limits, and Stipend Levels

NIH issued guidance for NIH Fiscal Operations for FY 2019 including the following new policies:

  • FY 2019 Funding Levels – Non-competing continuation awards made in FY 2019 will generally be issued at the commitment level indicated on the Notice of Award.
  • Ruth L. Kirschstein National Research Service Awards (NRSA) – Increase of NRSA stipends by ~2% on average.
  • Next Generation Researchers Initiative Policy – Prioritizing meritorious R01- equivalent applications from early stage investigator (ESI) principal investigators.
  • Salary Limits – Salary limit is set at $189,600.

For additional guidance and details, see NOT-OD-19-031.

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