Opportunities and Resources
- Funding International Research on Infectious Diseases
- After Outstanding Response, NIH Reissues Zika R21 FOA
- NIAID Joins Trans-NIH Effort to Develop Centers for ME/CFS Research
In The News
- News Briefs
- Don't Let Genomic Data Sharing Slow Your Award
- Reader Questions
New Funding Opportunities
As you may know, NIH has undertaken an important task: to enhance the quality, relevance, feasibility, efficiency, and transparency of the clinical trials it funds.
As part of this effort, which aims to enhance stewardship at each phase of a trial, from conception to sharing of results, NIH has put in place several reforms and continues working on others.
We covered a few of these reforms in previous articles but want to update you so that, if you’re conducting a clinical trial—or plan to conduct one—you’re reminded and aware of policies that have already gone into effect as well as those that have been announced and will become effective at a later time.
Policies Currently In Effect
NIH-funded investigators and clinical trial site staff who are responsible for conducting, managing, and overseeing NIH-funded clinical trials are now expected to take Good Clinical Practice training.
Principal investigators are responsible for identifying staff who coordinate studies as well as collect and manage data. That includes those who seek informed consent from prospective participants and manage participant recruitment and enrollment.
For more information, read the October 5, 2016 Funding News article “NIH Issues Multiple New Policy Requirements for Clinical Trials.”
Investigators conducting clinical trials that are funded in whole or in part by NIH must register these trials at—and submit summary results information* to—ClinicalTrials.gov. Keep in mind that this is for all clinical trials, even Phase I. To ensure policy compliance, researchers should know the NIH Definition of Clinical Trial.
As part of grant applications or contract proposals, applicants and offerors will be required to submit a plan for disseminating NIH-funded clinical trial information that addresses how they will meet the expectations of this policy.
If funded, the terms and conditions of award will include expectations for registering the proposed clinical trial and submitting summary results. Failure to comply with the terms and conditions may lead to enforcement actions, including termination.
The NIH policy applies to competing applications and contract proposals for new clinical trials submitted or starting on or after January 18, 2017. However, the final rule, discussed further below, will affect grants and contracts awarded before January 18, 2017.
For complete details on the NIH policy, including types of trials to which it does and does not apply, read Clinical Trials Registration and Results Information in the Federal Register and the Guide notice linked in the box above.
*Must be submitted no later than one year after the primary completion date (i.e., last subject, last visit) of the applicable clinical trial.
Policies To Go Into Effect Late 2017, Early 2018
To enhance and streamline the process of institutional review board (IRB) review, NIH introduced this policy last June.
It expects that all domestic sites participating in multisite studies using the same protocol involving nonexempt human subjects research will use a single IRB to conduct the reviews required for protecting human subjects.
For more information, including on determining costs, see our July 20, 2016 article “Use a Single Institutional Review Board for Multisite Protocols Beginning With May 2017 Applications.” Note: NIH changed the May date to September 25, 2017, as announced in a December 16, 2016 Guide notice.
Also see NIH Single IRB Policy FAQs for Extramural Community from the Office of Science Policy.
If your research involves a clinical trial, you will have to submit an application in response to a FOA that is specifically designed for clinical trials.
NIH’s Office of Extramural Research plans to:
- Issue standard Parent Announcements that will state that clinical trials will not be accepted as well as clinical trial FOAs that state only clinical trials will be accepted.
- Reissue existing FOAs to include new language and a new SF 424 (R&R) Form, which is currently under review by the Office of Management and Budget and is expected to be approved this Spring. There will be an extensive revamping of the human subjects sections to include clinical trial requirements. Be on the lookout for further developments.
For receipt dates on or after September 27, 2017, responding to a nonclinical trial FOA with an application that includes a clinical trial will result in your application’s being returned without review.
On a related note, you may know that NIAID already has a set of investigator-initiated clinical trial (IICT) FOAs as part of its IICT policy, an updated version of which is in the September 28, 2016 Guide notice.
For more information on the Institute’s IICT policy, read our October 19, 2016 article “NIAID Issues Updated Investigator-Initiated Clinical Trial Policy,” and go to Investigator-Initiated Clinical Trial Resources.
Be aware that though NIH’s Policy on Funding Opportunity Announcements (FOA) for Clinical Trials is not effective until September 27, 2017, NIAID has already implemented it. That means you cannot submit a clinical trial to the Parent unsolicited R01 or R21 FOAs if your application will be assigned to NIAID.
A years-long process culminated last month with the publication of the final rule on the Federal Policy for the Protection of Human Research Subjects, more “commonly” known as the Common Rule. NIH issued a notice of publication in a January 19, 2017 Guide notice.
The final rule 1) strengthens protections for people who volunteer to participate in research and 2) reduces administrative burdens, delays, and ambiguity for investigators, institutions, and IRBs.
The recently published rule reflects significant changes to the Common Rule, including:
- Establishing new requirements for the information potential research subjects must receive as part of the informed consent process
- Establishing new exempt categories of research based on their risk profile
- Removing the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects
For complete details, read the Common Rule. A link is in the box above.
Note that while the final rule will not take effect till January 19, 2018, NIH will be implementing many of its requirements through new and upcoming policies.
For example, since the ClinicalTrials.gov registration requirement is determined by the study start date, the final rule will affect some grants and contracts awarded before January 18, 2017. In addition, the primary completion date of a trial determines what resulting data must be reported.
View the Final Rule Webinar Series to confirm which requirements apply to registration and resulting data for your individual trial. Read Changes From Current Practice Described in the Final Rule to review other requirements that may apply to your grant or contract. Provide additional information for your trial by beginning April 18, 2017, the policy enforcement date for registering trials at ClinicalTrials.gov.
Works In Progress
As we mentioned at the outset, NIH is working on other reforms. These include updating a clinical trial protocol template.
You may recall the NIH and FDA Request for Public Comment on Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies, issued last March. Both agencies will consider public responses before taking next steps.
While using the template will not be mandatory, we encourage investigators to do so for continuity of information across all clinical trials and for ease of information flow when seeking FDA approvals and registering trials on ClinicalTrials.gov.
To find the draft template and other related items, go to Clinical Trial Protocol Template Documents on NIH’s Office of Science Policy website.
We will keep you posted on NIH’s ongoing efforts to enhance clinical trial stewardship, so stay tuned.
Opportunities and Resources
Foreign researchers, take note of this reissued R01 funding opportunity announcement (FOA) from NIAID: International Research in Infectious Diseases, Including AIDS (IRIDA).
The FOA supports infectious disease research by building independent research capacity in qualifying countries. Check these eligibility requirements before you read on:
- You cannot be the PI of an award currently funded by NIH (other than an expiring grant from the previous IRIDA opportunity).
- You must have a primary appointment at an institution in a resource-constrained country, i.e., one that the World Bank defines as having a low-income, lower-middle-income, or upper-middle-income economy. To see if your institution qualifies, check the income group shown on the World Bank List of Economies.
Funding will support research on infectious disease topics of public health significance within the applicant country. Topics of interest include tuberculosis, malaria, influenza, HIV/AIDS, and drug resistance. Many more examples are listed in the FOA.
Clinical trials are not supported; see NIH Definition of Clinical Trial.
If you plan HIV-related research, your study must address the NIAID priorities described at Division of AIDS Overview.
We strongly encourage you to create multi-institutional collaborations and include transfer of technologies and research methods, sharing of core resources and grant administration, and expanding your connections to other sites by attending scientific meetings. Since the FOA does not require a U.S. partner, your collaborators could be from other international sites or the U.S.
The first of three deadlines is May 22, 2017, for non-AIDS applications and August 22, 2017, for AIDS-related applications. Submit your optional letter of intent one month before the relevant application due date.
Read more and find NIAID contacts in the January 27, 2017 Guide announcement.
Last February, several NIH institutes collaborated to release a funding opportunity announcement (FOA) for rapid assessment of Zika virus complications. The FOA generated an incredible response, garnering enough meritorious applications for NIAID to issue more than a dozen awards, with several more on the way.
That FOA has been reissued, this time titled Zika Virus (ZIKV) Complications (R21).
The new version of the FOA includes three key changes you’ll want to note.
First, the new FOA will follow standard Application Due Dates for receipt and review, which means the due dates for non-AIDS applications are February 16, June 16, and October 16, and for AIDS and AIDS-related applications are May 7, September 7, and January 7. The previous iteration of the FOA had rolling application due dates, as we needed to quickly build a base of research on the emerging disease, which we’ve accomplished.
Second, the new FOA differs from the previous version in that applications will be reviewed by standing NIH Center for Scientific Review study sections, rather than by special emphasis panels convened specifically to review applications for this initiative.
Third, the new FOA lists several additional examples of high-priority areas of research. They are:
- Studies of Guillain-Barré Syndrome, encephalitis, or encephalomyelitis associated with ZIKV infection to develop novel treatments and determine disease course and outcomes, causality, disease mechanisms, and effectiveness of current treatments
- Studies to understand the effects of ZIKV infection on the development of epilepsy and its sequelae
- Studies related to both the short- and long-term effects of ZIKV infection on hearing
Before writing an application, contact a program officer to verify that your proposed work is within the scope of this initiative. NIAID’s scientific/research contact is Dr. Mark Challberg.
As was the case for the previous iteration of the FOA, NIAID will fund applications following our exploratory/developmental grants (R21) payline, rather than using set-aside money.
NIH and NIAID are committed to supporting research that furthers understanding of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). To that end, NIAID has joined two companion funding opportunity announcements (FOAs) that foster a multidisciplinary research approach.
Both FOAs will be funded through cooperative agreements; to learn about this type of award, refer to Just for “U”: A Closer Look at Cooperative Agreements, in our May 4, 2016 issue.
ME/CFS Collaborative Research Centers (CRCs) – U54
This initiative’s overarching goal is to establish a network of Centers that will work collaboratively to identify the causes of and discover improved treatments for ME/CFS. A more immediate goal for the Centers is to rapidly advance interdisciplinary research programs and serve as local resources and national leaders in ME/CFS research.
Examples of responsive research projects within NIAID’s mission are as follows:
- Studies, including microbiome-related studies, on the etiology and pathogenesis in ME/CFS, such as the elucidation of infectious etiology of ME/CFS and physiological and genetic host determinants involved in ME/CFS manifestations
- Identification of potential triggers or modifiers of immune responses or immune cell metabolism that contribute to ME/CFS
- Application of current methodologies (e.g., immune phenotyping) or computational modeling to better characterize human immune responses triggered in ME/CFS
- Identification of immune/inflammatory biomarkers in cerebrospinal fluid, blood, urine, and other accessible bodily samples that can identify physiologically relevant subgroups of ME/CFS
Note that applications proposing clinical trials will be considered nonresponsive. See NIH Definition of Clinical Trial.
Your application budget, which is limited to $1.2 million in annual direct costs, must reflect the project’s actual needs. The maximum project period is five years.
Data Management and Coordinating Center (DMCC) for the ME/CFS CRCs – U24
This FOA invites applications for a single DMCC that will provide infrastructure and support to the individual ME/CFS Centers. Functions include overall project coordination, administration, data management, and statistical and regulatory support.
You may request up to $750,000 in annual direct costs. The project period is limited to five years.
Due Dates and More Information
Optional letters of intent for either FOA are due 30 days before the application due date. For both opportunities, the earliest submission date is April 2, 2017, and the application deadline is May 2, 2017.
Find full application details in the January 27, 2017 U54 and U24 Guide announcements. Direct your NIAID-related scientific/research questions to Dr. Joseph Breen and financial/grants management questions to Jason Lundgren.
To further explore NIH-supported ME/CFS research, see Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Working Group.
In The News
The NIAID Career Transition Award (K22) requires that applicants have no more than five years of postdoctoral research experience at the time of submission. Time spent on parental leave, other well-justified leave, and clinical training do not count against the research training limit. Read the January 27, 2017 Guide notice for additional details.
Whether you’re new to the NIH grant review process or simply in need of a refresher, check out these three new videos from the NIH Center for Scientific Review: NIH Peer Review Briefing for Basic Research Applicants and Reviewers; 8 Ways to Successfully Navigate NIH Peer Review and Get an R01 Grant; and 8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant.
Applicants interested in the NRSA Predoctoral Fellowship To Promote Diversity in Health-Related Research (F31-Diversity) should follow the standard Application Due Dates for fellowships (F): April 8, August 8, and December 8 for non-AIDS applications.
If your research project is likely to generate large-scale genomic data, we recommend that you take steps before and after you apply to avoid award delays.
As a reminder, NIH's Genomic Data Sharing (GDS) Policy has been in effect for two years now and may impact your application process and award, if selected for funding. For a refresher, see NIH's GDS website, the links below, or reread our November 2015 article "Genomic Data Sharing and You."
For NIH's definition of large-scale genomic data, see Supplemental Information to the NIH GDS Policy.
Before You Apply
When preparing your application, if your proposed studies will generate large-scale genomic data, highlight that in your cover letter. Also include a GDS plan in the Resource Sharing Plan of the application.
By identifying whether your research is subject to the GDS policy early in the process, you help NIAID staff properly instruct reviewers to review the data sharing plan in your application.
Before writing a GDS plan, see NIH's Guidance for Investigators Developing Genomic Data Sharing Plans. It lists the standard elements for your plan, including what type of data you will share as well as where and when it will be publicly available. The site also offers examples of GDS plans.
After You Apply
If NIAID considers your application for funding, we will ask for GDS-related information before award or through our just-in-time process. Avoid delays by preparing that information before we request it.
Here are two examples of documentation that may take time to prepare:
- If a grant involves human genomic data, we will send a just-in-time request for an Institutional Certification, which requires the authorized organizational representative's signature.
- If the GDS plan doesn't meet requirements, is missing elements, or wasn't included in the application, we will ask for the plan before award.
Find More Information
Learn more at NIH's Genomic Data Sharing website and the Guidance for Institutions Submitting Applications and Contract Proposals Under the NIH GDS Policy (PDF). The page for Researchers covers how to register your studies once you're funded, access data, and more.
We also plan to publish a GDS article specific to NIAID in the coming months. Stay tuned.
You can ask us a question at firstname.lastname@example.org. After responding, we may ask your permission to include your question in the newsletter.
You need a biosketch, including research support information, for everyone you designate as a “senior/key person” or “other significant contributor.” For further information, see NIH’s Biosketch Format Pages, Instructions, and Samples.
No. Because paylines may not change, we advise you not to wait for possible funding later in the year.
If you revise and resubmit, you can improve your application based on the feedback from the initial peer review and hopefully get a better percentile or score and likelihood of getting an award.
Make sure to check for changes to the funding opportunity announcement, forms, and policies since you last applied.
Contact your program officer for more advice and read Options if Your Application Isn't Funded.
- RFA-AI-17-001, Cellular Therapies for Treatment of Radiation Injuries (U01)
See other announcements at Opportunities & Announcements.