In June, NIH announced plans for a new initiative to provide additional support to the next generation of researchers. We will be announcing policy details this month. Stay tuned to the notices published in the NIH Guide for Grants and Contracts. We will also include an announcement here on the NIH Extramural Nexus & Open Mike blog site, when the policy is published.
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 p.m. 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 at https://attendee.gotowebinar.com/register/8165062792709498114 . (**This webinar is limited to 1000 log-ins so act quickly. We highly recommend group viewing to maximize access.)
Prior to the webinar, check out the NIH RPPR web page with more “Who? What? And Where?” information.
If you have specific questions or topics you’d like covered, send them by Wednesday, August 23 to OPERAall@nih.gov. These questions and suggestions will be used to help build the presentation content and ensure we’re providing the answers you need. A recording and transcript will be available approximately 5-7 business days following the event on the NIH Grants YouTube channel.
Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRBs for multi-site studies. We are now entering the final phases of implementation of these initiatives – so, if you are contemplating research involving human subjects, please read on.
We’ve received queries from members of the research community seeking clarity on whether their human subjects research will be affected by these new policies, and if so, how. So, we want to call your attention to four questions researchers involved in human s studies need to ask, and answer. These questions are:
If the answer to all four questions is yes, then we consider your research a clinical trial.
The NIH definition of a clinical trial is “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”. The definition was published in 2014, after extensive public input, and affirmed, after even more public input, in our policy published in September 2016. The clinical trial definition encompasses a wide variety of study types, as shown in figure 1. These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.
The breadth of the NIH definition is intentional, given the nature of the NIH portfolio and imperatives for maximal transparency. Transparency shows respect for the participants who put their trust in us, in the face of unknown outcomes, to help advance science. Our concerns about transparency stem in part from the issues surrounding the reporting of clinical trials data. For both NIH-funded and non-NIH funded trials, unreported data and untimely dissemination of results has been documented over and over again. Others have expressed concern that the NIH has not collected needed trans-NIH data to enable it to function as proper stewards of clinical trials.
Some have argued that we should not expect trial registration and reporting for small or exploratory trials, for trials that focus on safety, or for trials that fail to meet enrollment targets. As we stated last September, NIH chose to emphasize the value of transparency for these kinds of trials as well, as “the benefits of transparency and the need to fulfill the ethical obligation to participants is as relevant to these types of trials as to any other type.” We have an ethical obligation to report results, and this is especially true when volunteers contribute their time as study participants in prospective experiments, whether large or small. And, to be effective stewards of precious and constrained taxpayer monies, we need to collect a minimum of standardized data.
This transparency complements existing efforts to promote data sharing, public access to NIH-funded research results, and scientifically rigorous research design, all of which ultimately benefit the research community directly, as well. By developing and sharing robust data, we maximize the value of NIH’s investment in research by allowing scientists to build upon solid results. The definition, and our clinical trial policies, are an integral part of our efforts to enhance scientific stewardship, dissemination of information, transparency, and to excel as a federal science agency that manages for results.
Why is it important to know whether you are proposing to conduct a clinical trial? Correctly identifying whether your study is a clinical trial is crucial to complying with NIH policies, many of which are now in effect, such as registering and reporting all NIH supported clinical trials in ClinicalTrials.gov and good clinical practice training. Very soon, your answer will be crucial to picking the appropriate NIH funding opportunity for your application, writing your research plan correctly (since some information will be captured in the new human subjects and clinical trials form), and ensuring that your application includes all the information required for peer review.
If you are having difficulty answering the four questions that determine whether a study meets the NIH definition of a clinical trial, we encourage you to consult the case studies and FAQs that are available on our webpage on clinical trial requirements for grants and contracts. We’ll be following up with additional blogs and NIH Extramural Nexus articles that provide more depth on the various initiatives. We strongly encourage you to look at these materials, and share them with your colleagues, to ensure that as an awardee conducting clinical trial research, you are aware of the need to register your trial and report its results.
Update: The two day seminar has reached capacity today. However, the following workshops are still available to attend without seminar registration: Human Research Reviews: Mastering the Process, Intellectual Property – Understanding Requirements and Recipient Responsibilities, and Intellectual Property – A Hands-on Demonstration of iEdison. Further details below.
To register for one of the available workshops above, please email firstname.lastname@example.org.
Thank you for your interest! – NIH Regional Seminar Staff, August 15, 2017
By now, you’ve hopefully heard about the upcoming NIH Regional Seminar on Program Funding and Grants Administration, October 26 & 27, 2017 in Baltimore, Maryland. (If you’re not familiar this event, see what was said about our 2017 spring seminar in this Open Mike blog post and an article on the Top 5 Reasons to Attend an NIH Regional Seminar.)
Did you know that on the day before the two-day seminar, NIH also offers a variety of optional workshops that will help you delve deeper into specific topic areas? On Wednesday, October 25, 2017, you have the opportunity to participate in one or more of the following workshops:
Registration for the optional pre-seminar workshops requires participation in the two-day seminar (unless noted otherwise.) Space is very limited! Register today!
Now that the NIH fiscal year 2017 budget is signed into law, NIH published its final fiscal policy and salary cap guidance for this year.
In general, NIH will restore reductions to non-competing continuation awards made this year while we were operating under a pending budget (continuing resolution). Additional details on fiscal operations, including specific funding strategies for ICs and any exceptions, will be posted at the NIH funding strategies page.
The salary cap remains unchanged from the interim guidance published in March. The direct salary limitation follows Executive Level II of the Federal Executive pay scale, which was previously set at $185,100, and increased to $187,000 effective January 8, 2017. This means that for awards issued in previous years that were restricted to Executive Level II, including competing awards already issued in fiscal year 2017, grantees may rebudget to accommodate the current Executive Level II salary level as long as:
Have questions about your specific award(s)? Contact the Grants Management Specialist identified on your Notice of Award.
If you are a researcher who works with animal models, or are involved in IACUCs (Institutional Animal Care and Use Committees), you’ll want to stay on top of news, training opportunities, and resources from the NIH Office of Laboratory Animal Welfare (OLAW). These include:
NIH’s fiscal year 2017 budget was signed into law on May 5. As we do every year, we have posted a list of the current statutory limits on the use of NIH grant, cooperative agreement, and contract awards. Read NIH Guide Notice NOT-OD-17-075 for more information about these legislative mandates.
If you are a recipient of NIH funding, then you are required to report on scientific progress and financial expenditures. Submitting timely, accurate, and complete reports are an essential part of the stewardship of federally-supported research, and maintaining the public’s trust in science.
We recently reminded all NIH recipients of their reporting responsibilities in an NIH Guide notice published June 5. The Guide notice summarizes the required information, and due dates, for Research Performance Progress Reports (RPPRs) and Financial Expenditure –Federal Financial Reports (FFRs).
We encourage you to share this information with your colleagues at your research organization. Failure to submit complete and accurate reports doesn’t just affect one individual – it can affect future funding to the entire organization, and can result in a delay of continued support. Read more in NIH Guide Notice NOT-OD-17-074.
A feature within eRA Commons called the xTRACT module is available to help applicants create training data tables for institutional training grant applications, and to help grantees update these tables for their progress reports (RPPRs).
xTRACT is available to all institutions through eRA Commons. If you or your institution works with institutional training grant applications or progress reports, and are not taking advantage of this tool yet, consider the time-saving features the module provides.
We’ve received great feedback since xTRACT’s launch in October 2015. xTRACT users say that the system is very helpful in saving time preparing training table information. As of June 2017, xTRACT has been used by more than 160 institutions, with over 110 new applicants using xTRACT for their initial application, and over 1,000 existing grantees using xTRACT for RPPRs and renewals.
While using the xTRACT module is an option, and not yet a requirement, it can save research administrators and principal investigators time when creating and completing data tables for new applications for institutional training grants (T32, TL1, T90/R90, and T15), progress reports, and most types of renewal applications.
Applicants for renewal T90/R90s and other predoctoral, postdoctoral, and career-level training, education, and career development activities that use training data tables (e.g., T35, R25, K12/KL2 awards) can also use xTRACT, but the system does not yet include features tailored to their specific types of awards. Programs targeted to undergraduates (e.g., T34 awards) should not use the xTRACT system at all at this time, but should instead use the fillable tables designed for undergraduate programs available on the NIH website.
Want to learn more? Visit the eRA web page on xTRACT for more information. Looking for help in using the module? Check out the xTRACT user guide, instructional videos, and FAQs for additional help using the system.
“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 as reasonably possible. Where complete historical data are not available, applicants should indicate that in their applications and begin collecting the relevant information, so that it will be available in the future.
Have other questions about completing training grant data tables? Visit our FAQs.
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:
Have other questions about training grant data tables? Visit our FAQs.
For more information on institutional training grants, generally, visit the “T Kiosk” page on researchtraining.nih.gov.
There’s only one you, and we want your identification in eRA Commons to represent that! If you have more than one eRA Commons account, look for an email coming your way this summer notifying you of potential duplicate accounts, and providing instructions on how to select your preferred account once you are logged into eRA Commons.
We are beginning this effort in July to support accurate counts of applications and grants, and the proper association of committee service to an investigator. One of the most common reasons for duplicate accounts is when researchers use one login for their peer reviewer role, and another account when submitting an application. We realize you may wear many hats, and the Commons is designed to allow a single account to perform multiple functions, even at more than one organization. For example, a person can have an account with a principal investigator (PI) role at a university, and a PI role at another university or at a small business. The same account may have a trainee role as well as a PI role, as well.
In late July 2017, we will begin sending notifications to individuals who likely have more than one Commons account. For security, these emails will only include instructions on how to determine whether you have duplicate accounts. The process for identifying and selecting the preferred account takes place within eRA Commons, after logging in with your credentials.
Thank you for your time and helping improve the accuracy and reliability of the eRA Commons account data.
At the NIH Regional Seminar this past May, I had the pleasure of giving the keynote talk and presenting different perspectives on how NIH can further the impact of our research funding. Some of the topics I presented in this talk will be familiar to frequent Open Mike blog readers – our concerns about the hypercompetitive nature of applying for NIH support, for example. Others we haven’t discussed in depth here yet – such as how we might measure the contributions of NIH-supported research to treating diseases. My staff recorded this talk and has made it available to you on the NIH Grants YouTube channel. If you’re interested in the topics covered here on the blog (which I hope you are, since you are reading this now!) then you may be interested in this talk.
At the Advisory Committee to the Director meeting last week, NIH Principal Deputy Director Dr. Larry Tabak presented a new NIH initiative to strengthen the biomedical workforce. This presentation followed extensive discussions with stakeholders both here through this blog, at stakeholder meetings, and at NIH advisory council meetings over the last month. We heard unequivocal endorsements for supporting early-career and mid-career researchers given the hypercompetitive funding environment — a challenge we have addressed many times in our blog posts. However, many voiced concerns about our taking a formulaic approach to capping grant funding and called on us to be more direct in enabling greater support for the next generation of biomedical researchers.
For this reason, we have shifted our approach to a focused initiative to support early- and mid-career investigators. As described in a June 8 NIH Director’s statement, and in recognition of the call for such action in the 21st Century Cures Act, we are naming this effort the Next Generation Researchers Initiative. We will take a multi-pronged approach to increase the number of NIH-funded early-stage and mid-career investigators and stabilize the career trajectory of scientists. We describe these approaches on a new web page that we will continue to update. Our activities address both research workforce stability, and evaluation of our investments in research. In brief, NIH will:
Applicants do not need to do anything special to be eligible for this funding consideration. Beginning this fiscal year, the NIH institute or center (IC) who would fund the grant will give your application special consideration for support if you are:
NIH ICs make funding decisions to support their mission, and this plan provides flexibility in how ICs will meet the NIH-wide goal of supporting highly scoring early-stage and mid-career researchers. Each IC will make its decisions about how it will prioritize funding to support this initiative.
As further details are announced, we will be updating the Next Generation Researchers Initiative web page with this information. In the meantime, we encourage you to read the NIH Director’s statement, and look at the Advisory Committee to the Director presentation and webcast recording.
We appreciate your feedback in addressing the very important issue of stabilizing the biomedical research workforce. Your comments to this blog (or via email, if preferred) are welcome. With the continued input from individuals at every career stage, as well as research institutions and other stakeholders, we can work together to make changes that ensure the long-term stability and strength of the U.S. biomedical research enterprise, and that advance science to improve health for all.
NIH recently updated its policy for what materials will be accepted as post-submission application materials. Beginning with applications submitted for due dates on or after September 25, 2017, citations of newly issued patents can be included in post-submission materials.
The NIH post-submission materials policy allows grant applicants to submit limited information arising from unforeseen events that occur after submission of an application but prior to initial peer review. The updated policy adds citations of issued patents to the list of acceptable post-submission materials. Copies of patent applications or any other materials related to a patent application or issued patent will not be accepted as post-submission materials, unless specified in the Funding Opportunity Announcement (FOA) for which the application was submitted or in a special Guide Notice.
Read the NIH Guide Notice NOT-OD-17-066 for additional details on citing issued patents in post-submission materials.
Interested in more background on our post-submission policy and allowable materials? Check out our recent podcast on this topic!
Working with NIH applicants and awardees as an extramural program division director, I often shared the NIH RePORTER resource as a tool for exploring the research topics NIH supports. Learning what projects we support, using a robust database of historical and newly-funded projects (updated weekly), provides researchers valuable insight as they consider developing their own research programs and applications for funding.
Another valuable tool which you might be familiar with is Federal RePORTER, which expands the RePORTER concept to support searching over 800,000 projects across 17 Federal research agencies, with trans-agency data updated annually. As Federal RePORTER recently received an update to introduce some new functions and additional agency data we’d like to highlight some of the ways it helps both the public and scientific researchers alike understand the government’s research portfolio and trace its impact through published articles and patents.
Search or browse data across agencies: Federal RePORTER is designed for ease-of-use. The homepage offers quick search tools for the most commonly used fields, or you can skip the search and use the interactive bar charts and maps on the home page to quickly drill down to projects funded by a certain agency or projects occurring in a particular state. We’ve also added easy-to-follow walkthroughs as “Guided Tour” links on the home page, advanced search page, and results page to learn more. From your search results, you can refine results through links on the sidebar, or read more about individual projects (including a description, and details on the investigator, research organization, and funder.)
Explore search results even further: As with NIH RePORTER, you can export the results for further exploration and analysis, or use the built -in “Charts”, “Map”, or “Topics” tools from the sidebar to learn more about the projects, as in the examples shown below. For example, you can summarize the projects by agency, state, or fiscal year (Figure 2), or map where the research is taking place (Figure 3). You can also explore groups of scientific topics within your search results (for example, a search for “lead” and “drinking water” returns groups of projects covering “ground water”, “ early life”, “arsenic exposure”, and more.) From there, you can drill down into subgroups, to generate lists of projects in that group (Figure 4).
Identify research outcomes: Federal RePORTER aims to link Federal funding to the outcomes of research including publications and patents. Using agency-supplied information, the public can trace the impact of the funding by seeing what academic publications and patents cited the project funding.
With growing resources for identifying agency-supported publications, future plans include expanded coverage of these two important measures of research impact.
These are just a few of the excellent Federal RePORTER features that can help you find collaborators, get to know the research interests of federal science-funding agencies, understand your institution’s sources of support, and prepare your applications and research plan equipped with additional knowledge. We are grateful to all of the federal agencies and offices that provide data and support to Federal RePORTER and make this resource possible. These new functions, additional agency data, and modernized user interface make it easier for you – and all stakeholders in the U.S. scientific enterprise – to learn about the Federal science and engineering portfolio.
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, applicants proposing to use cell lines should describe the method they plan to use to verify the identity and purity of the lines, which might include short tandem repeat (STR) profiling and mycoplasma testing. Applicants proposing to use chemicals that are key to the research should describe the method used to validate the chemical, which might include liquid or gas chromatography or mass spectrometry. Applicants proposing to use genetically modified animals or cells should describe the method used to confirm the genome modification, which might include PCR amplification or Southern blot. When published consensus standards exist, these may be cited in this section as the procedure(s) that will be used for validation.
Authentication data should not be included in the plan.
NIH recently issued a reminder, highlighting this and other aspects of resource authentication: read NIH Guide Notice NOT-OD-17-068 for details.
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:
Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.
Depending on the research study, biological samples may be considered key biological resources that need to be authenticated if they are an established resource, particularly if the investigator received the samples from an outside source.
Each investigator will have to determine which resources used in their research fit these criteria and are therefore key to the proposed research.
NIH recently issued a reminder, highlighting this and other aspects of resource authentication: read NIH Guide Notice NOT-OD-17-068 for details.
We appreciate the many thoughtful comments posted to the blog about working together to improve NIH funding support for early- and mid-career investigators to stabilize the biomedical workforce and research enterprise using a measure called the Grant Support Index (GSI). Some clear themes have emerged, including:
Based on community feedback from the blog, council meetings, and other discussions with stakeholders, we have made changes to the planned policy to include additional measures beyond GSI to strengthen NIH funding support for early-and mid-career investigators. We will also provide greater flexibility in the use of GSI as a measure for guiding NIH funding decisions, and will make other changes to be sure that this approach does not discourage collaboration and training. These updates will be presented at the June meeting of the NIH Advisory Committee to the Director. We encourage you to tune in via NIH videocast to the presentation on Thursday, June 8.
To provide us with additional feedback, please post comments to this blog or send an email to PublicInput@od.nih.gov.
If you missed joining 850 of your peers in New Orleans this May, don’t worry! You still have one more chance in 2017 to participate in the NIH Regional Seminar on Program Funding and Grants Administration, a unique opportunity to learn more about the NIH process and hear the latest policies directly from over 65 NIH & HHS experts. Over 30 additional NIH Institute and Center staff will be on hand to talk with you in person during our 1:1 Meet the Expert chats, plus you’ll want to stop by our NIH and industry exhibits for more helpful information. Make plans now for the upcoming seminar in Baltimore, Maryland from October 25-27. But wait… there’s more good news! Through June 9, you can save on registration with our “early bird” seminar rate. Act now and don’t forget to reserve your hotel room too while the discounted room block for seminar attendees is still available!