NIH Pain Consortium: Grant Mechanism Webinar Series

The goal of the series is to inform the pain research community of funding opportunities and other resources provided by the NIH.

View all archived videos below:

Title
Clinical Mentoring Grants
Pre-Clinical and Translational Grants
Early Career Grants
Institutional Training Grants
ESI, NI, and Established Investigators
Technology Development/ Therapeutic Development
Clinical Phased Mechanisms
NIH Staff roles in the process and high-level overview of before and after grant submission
Preparing/writing the application/submitting the grant
How to build a budget
Programs to support technology development and SBIR
CTSA and patient engagement studios
NIH data policy and data harmonization
Clinical trial oversight

 

View previous Webinars:

 

April 8, 2021 - Clinical Mentoring Grants

After an introduction from Dr. Walter Koroshetz (NINDS), Dr. Wendy Weber (NCCIH) explained how clinical mentoring grants fit in to the NIH training context (focusing on the K01 and K23 funding opportunities), as well as guidance for applying to mentoring awards, eligibility criteria, and the application reviewal process for K awards. Next, Dr. Ericka Boone (Division of Loan Repayment) provided background on the NIH Loan Repayment Program (LRP), how the program works to keep health professionals in research careers, and the 6 extramural NIH LRP subcategories for which individuals can apply. Finally, Danielle Haney (OPPP) spoke about the patient engagement activities within the NIH HEAL initiative, such as the HEAL Community Council (HCC) and supplements to increase participant diversity, inclusion, and engagement.

 
Question and Answer Summary: April 8, 2021, Webinar 1: Clinical Mentoring Grants

K-Series

Q: Which Institutes participate in the K24 award program?
A: Information about participating Institutes and their specific requirements can be found here: https://grants.nih.gov/grants/guide/contacts/parent-K24-CT-required.html

Eligibility

Q: Must I apply for a K01 grant within a certain timeframe after completing my terminal degree?
A: Generally, the timeframe is less important than whether you have an independent grant, which would disqualify you for a K01 award. Check with the Program Officer at the Institute or Center where you submit your application.

Q: I was previously funded by a K23 award. Am I eligible for a K24 award?
A: Yes, some K24-funded investigators were previously funded by a K23 award, but it is not a requirement. The K24 award is intended for investigators who wish to mentor clinician scientists.

Q: I was previously funded by an institutional K12 award. Am I still eligible for a K01 award?
A: Typically, you can be funded by an early career development award for a total of five years across the K12 and K01. Your K01 application should explain your need for additional mentoring time after completing the K12.

Q: Can I apply for a K23 grant while in residency?
A: You can submit your application during residency, but your clinical training must be complete before you begin work under the career development award.

Q: I’m a post-doc. Am I eligible for a K award?
A: Typically, you must hold a full-time faculty position and receive a letter of support from your institution to receive a K award. You can apply for a K award during your post-doc, but for most Institutes and Centers, you cannot receive an award until you have completed your post-doc. However, the K99R00 is intended for post-docs.

Q: I completed my residency or post-doc in the United States but am originally from and was otherwise trained in another country. Am I eligible for a K23 or K24 award?
A: You must be a U.S. citizen, non-citizen U.S. national, or U.S. permanent resident to be eligible for a K23 or K24 award. Check the specific Funding Opportunity Announcement to confirm that you meet the residency or citizenship requirements.

Competitiveness

Q: How many publications make me competitive for a K01 award?
A: This answer depends on the field and specific Institute or Center to which you will submit your application. Speak with the Program Officer about the typical number of publications for K01 applicants at their Institute or Center.

Q: How many first author publications should I have to make me competitive for a K award?
A: This varies by field of research, but most K01/K23 applicants have some first author publications.

Q: Does NIH plan to prioritize pain researchers under career development mechanisms?
A: This answer is very dependent on the specific Institute and Center to which you will submit your application. There is no NIH-wide prioritization for pain researchers.

Q: How much funding must I have to be competitive for a K24 award?
A: This answer depends on the specific Institute or Center, but you must be able to show that you have the funding necessary to conduct research and mentor future clinician scientists. Some Institutes and Centers require applicants to hold an R01 or comparable award.

Q: I earned a PhD in an indirectly related field that normally does not perform clinical trials. Could I still successfully apply for a K01 award (clinical trial required)?
A: The reviewers generally favor multidisciplinary teams with relevant expertise, so teams may include intervention specialists, biostatisticians, epidemiologists, and more. A large interdisciplinary team may compensate for less than sufficient relevant expertise. Speak with the Program Officer at the Institute or Center to which you will submit your application to determine the range of fields of funded researchers doing clinical trials.

Q: Will NIH fund K awards from midcareer investigators who want to learn new research skills to expand their line of research?
A: The focus of the K24 award is on the applicant mentoring the next generation of clinician scientists. Some Institute or Centers may use the K01 award to expand research to a new field, but most do not. Speak with the Program Officer at the Institute or Center to which you will submit your application.

Mentors

Q: I want to work with a new mentor to gain training and skills in a new area, but we don’t have a prior collaboration or relationship. How should we present that information?
A: A mix of mentors with whom you have and have not worked is often helpful. The letter of support from the new mentor should be especially strong and clearly describe how you will work together. If you have served on committees together or worked together on other activities, that information should also be mentioned. Speak with the Program Officer at the specific Institute or Center to which you will submit your application.

Q: I recently completed my PhD, and my dissertation chair retired. How can I identify new mentors?
A: We recommend that you start with other faculty members in your department, your PhD advisory committee, your collaborators, and anyone involved with a CTSA program or mentoring group if your institution has one. Good candidates are people with a good funding record and with whom you might want to work.

Recipients

Q: Once I receive a K01 award, which other funding mechanisms can I apply for?
A: You will be eligible for most awards except for another career development award or an earlier career award, such as a post-doc specific grant. You can speak with a Program Officer about other opportunities when you have your K01 award.

Q: Does NIH require or encourage that the candidate change institutions when transitioning from the K99 to R00 phase of the award?
A: Each Institute and Center has different answers to this question. Speak with the Program Officer for your K99 award.

HEAL Initiative

Q: Do NIH or the HEAL Initiative provide training or other resources to researchers develop skills in recruitment or retention strategies and patient engagement among diverse groups? I would like to include this information in my grant application.
A: The HEAL Initiative has held multiple webinars and workshops on recruitment and retention strategies in pain and opioid use disorder patient populations. They are or will be available on the HEAL Initiative’s website.

Q: Does the HEAL Initiative offer any specific programs for early-stage investigators?
A: No, not currently. The HEAL Initiative posts funding opportunities in a timely manner, so you should regularly check for Funding Opportunity Announcements.

Q: How can I learn which research projects have been funded by the HEAL Initiative?
A: Under “Funding” on the Initiative’s website, you can find details on every grant awarded. See here: https://heal.nih.gov/funding

 

 

May 13, 2021 - Pre-Clinical and Translational Grants

In this webinar, Dr. Leslie Frieden (NIDCR) and Dr. D.P. Mohapatra (NINDS) provided an overview of NRSA (National Research Service Award) Fellowships (F30, F31, and F32 awards) and Predoctoral to Postdoctoral Fellow Transitions (F99/K00 awards). They discuss the purpose of the NRSA program, eligibility criteria, application process and requirements, and review criteria. The webinar also reiterated information on the Loan Repayment Program (LRP).

 
Question and Answer Summary: May 13, 2021, Webinar 2: Pre-Clinical and Translational Grants

General

Q: What is the most useful general tip I should keep in mind?
A: Your mentors are successful in part because they have garnered communications and relationships with Program Officers over years. Always contact Program Officers and build those relationships.

F series

Q: Should only first-author publications be included in the biosketch for an F series application?
A: No. Your biosketch can include publications for which you are a contributing author or first author.

Q: How important is it to provide preliminary data in the approach section for a predoctoral application?
A: Expectations for preliminary data are lower for predoctoral applications than for postdoctoral applications, and preliminary data are never required for a fellowship application. In general, preliminary data are used strategically to support the feasibility of a novel technique or a concept that is not widely available in the literature. You may not know whether your reviewers want preliminary data until you receive a summary statement requesting those data. Reviewers want to learn about your approach to the science so the Research Strategy section—which is limited to six pages—should not be filled with preliminary data.

Q: I’m an MD/PhD student interested in studying basic pain mechanisms. Can I apply for an F series award from NINDS or NIDCR?
A: Neither NIDCR nor NINDS support the F30 dual degree individual fellowship, but an applicant could apply for an F31 award to support the PhD portion of their training. Different Institutes have different eligibility requirements, and you are welcome to contact Program Officers with an abstract and specific aims. Program Officers will direct you to the best fit.

Q: Should I use a specific format to respond to critiques on an F31 submission (e.g., a single page with bullet points describing edits made based on critiques)?
A: No, there is no specific format. Your response should be respectful and at most one page long. The types of critiques you receive will determine your approach to the response; for example, you might address varying concerns from a specific reviewer or critiques raised by all three reviewers. If you notice a poor score for a particular category, you should focus your response on that one. You are encouraged to write to the Program Officer to discuss the summary statement upon receiving it.

Q: I am a predoctoral candidate in the process of getting published. Should I state in my application that I have papers in the process of submission?
A: Yes. You cannot cite those papers unless they are available as preprints, but they should be mentioned in your personal statement, career development plan, or training plan.

Q: Is the F99/K00 meant to support an applicant in the same lab over the course of the pre- and postdoctoral training period? Is it possible to change laboratories during the transition?
A: It is both possible and strongly encouraged. In fact, most FOAs on the topic state that you must move to a new lab and often to a new institution. When applying, you do not need to identify a postdoctoral mentor, but you should plan a general research direction.

Q: Are the study sections for peer review the same for F awards as typical R01 awards?
A: No, they are not the same study sections.

Q: Are there any restrictions on the type of study I can propose for an F series award?
A: Yes. Freestanding clinical trials cannot be funded by an F series award. NICCH further prohibits any freestanding clinical study, so any applicant planning to work with human subjects needs to define that project within the context of a sponsor’s ongoing work or needs to be conducting secondary data analysis on a completed trial.

Q: Can I be considered for an F series award at more than one Institute?
A: You are strongly encouraged to use the optional assignment request form to identify your top choice and secondary choices for Institutes to review your work. However, CSR will make the final decision on where to send your application, and an Institute that believes an application is not a good fit will send it to secondary Institutes for consideration. In addition, you are strongly encouraged to speak with program staff before submission, because they might be able to direct you in the best direction.

Q: How should I choose the Institute to which I submit my application?
A: First, write your abstract identifying the gap in knowledge, what has been studied, and what you propose to do. Use the NIH Matchmaker (https://reporter.nih.gov/matchmaker) for initial guidance on which Institute to apply to and under which mechanism. Then contact that Program Officer. You cannot know the current priority areas for a given Institute without asking, and it is in your best interest to speak with Program Officers before applying.  They can direct you to a better fit if the Matchmaker misdirects you.

Q: How should I approach research applications for diversity awards?
A: First, confirm that you meet the eligibility requirements described in the FOA. If you apply for an F31 Diversity award, your sponsoring institution will need to provide a “description of the candidate’s contribution to the program goals.”  Otherwise, most recommendations for other F series awards will apply to Diversity awards. Please refer to the table in this link for Institute-specific F31 Diversity application eligibility, requirements, and contacts: https://grants.nih.gov/grants/guide/contacts/parent_F31_Ddiversity.html

Q: Can non-U.S. citizens apply for an F series award?
A: Most funding mechanisms are reserved for citizens, non-citizen U.S. nationals, or U.S. permanent residents. However, you can apply while permanent residency is pending if you are confident that you will receive your Green card within 1 year. Other mechanisms may have different eligibility requirements, and you are encouraged to check individual FOAs.

LRP

Q: When will last year’s LRP contract applicants know the status of their application?
A: Awardees will be notified starting at the end of July. If you pass the first round of selections, you will be asked to provide information about student loan debt. Please gather that information ahead of time to accelerate your response.

Q: Is the LRP available for postdoctoral researchers only or is it open to predoctoral students as well?
A: Individuals are eligible to apply for and receive the LRP award after receipt of their doctoral level degree is conferred. However, as an example, if you will graduate in December, you can still apply during the September to November cycle because awards are not finalized until July 1.

Q: I am a postdoc currently funded by a T32. Can I apply for an LRP?
A: Yes, you are eligible to apply for an LRP.

Q: Can I be considered for an LRP award at more than one Institute?
A: When you apply for an LRP, you can select primary and secondary Institutes that you would like to review your application. If the primary Institute initially identified by CSR determines that your proposed project does not align with its current priorities, it will send your application to the secondary Institutes.

Q: Can I renew for a second year of LRP if I am also awarded a career development/K award that same year?
A: Yes. The two are not interdependent, and you are expected to apply for other funding opportunities after receiving an LRP. Because the LRP will not provide resources or funding for your research or salary, you are allowed to use the same project to apply for each. Also, please mention that you were able to secure additional research funding in subsequent applications.

 

 

June 10, 2021 - Early Career Grants

In this webinar, Dr. Roger Sorenson (NIDA) provided an overview of the following career development awards: K02 (Independent Scientist), K08 (Mentored Clinical Scientist), and K99/R00 grants (with specifics regarding the Parent, MOSAIC, and BRAIN K99 awards). The discussion focused on the importance of contacting Program Officials (POs), the basics and eligibility of each award, how to prepare applications, and mentorship. The webinar also reiterated the purpose and basics of the NIH Loan Repayment Program (LRP) and Dr. Michelle Jones-London (NINDS) highlighted diversity efforts at NIH, such as UNITE, NIH FIRST, and research supplements to promote diversity.

Question and Answer Summary: June 10, 2021, Webinar 3: Early Career Grants

Early Stage Investigator Status

Q: If I am awarded a K99-R00 and complete the R00 stage, am I still considered an Early Stage Investigator (ESI) for future grant submissions (e.g., R01)?
A: Yes, you are still considered an ESI. The R00 does NOT remove that designation.

Q: Can I extend my ESI status due to COVID-19-caused research interruptions?
A: Yes. Be sure to describe the nature of the disruption to your research in your ESI extension request. We suggest that you submit the request once you know the amount of lost research time, unless your upcoming application deadline is imminent and an ESI extension is urgently needed. In that case, you would be able to submit another extension once you know the full extent of the time lost.

Q:  How is “early-stage development research” defined?
A: Research projects in early-stage development explore novel scientific topics or phenomena that are not well-known to the field. For example, such a project could study the unknown role of a biological process, signaling cascade, or neural circuit in contributing to a disease state (e.g., pain). Early-stage development research grant applications propose to test hypotheses that are typically based on experimental research findings found in the literature and have limited preliminary supporting data. Early-stage development research may establish new directions of research for the field; it is not research that adds incremental results to existing knowledge.

Q: What are the benefits of being an ESI?
A: When you apply for an R01 as an ESI, your application will be reviewed separately from R01 applications submitted by established investigators. The reviewers will consider your career status when deciding funding; for example, they will understand that you may have less preliminary data than a more established investigator.

K99/R00

Q: If I already completed a postdoctoral fellowship and secured a faculty position, can I apply for a K99/R00?
A: You must be under a mentored relationship, such as a postdoctoral fellowship, to be eligible to submit a K99/R00 application. Having a faculty position suggests that you are already an independent researcher, and the intent of the K99 program is to make researchers independent.

Q: Does the 4-year limit for K99 start after the PhD degree was granted or the official postdoctoral fellow position began?
A: This is Institute-specific, and we encourage you to speak with a Program Officer. For both NIDA and NCCIH, the eligibility period begins when the postdoctoral fellowship begins; in other words, if you defend your dissertation in May and begin your fellowship in August, NIDA and NCCIH will record the beginning of that 4-year period in August.

K01 and K02

Q: To be eligible for the K02, do I need to be funded by a certain NIH grant? What is the difference from K01?
A: To be eligible for a K02, you must have an ongoing independent research program and you must be a PI on an R01 or equivalent grant. The intent of the K02 is to enhance an existing R01 or equivalent research project by incorporating another technique or approach. The K01 award is intended for researchers obtaining additional mentoring or training to enhance their skill set, and you would devote the first 3 years to additional training and learning techniques while conducting research. At the end, you would apply for funding mechanisms such as R01s and R21s.

Q: Can I apply for a K02 as a co-PI with someone who does have an R01?
A: Applying as a co-PI with an R01-supported researcher is not recommended. The K02 is intended to support an independent research program. Applying with someone who holds an R01 may cause reviewers to ask whether you are enhancing your program or theirs. The existing support should be yours.

Q: Can I apply for a NINDS K01 as a non-tenure track Assistant Professor of Research?
A: No, the NINDS K01 requires either a tenure-track position or a position as a postdoctoral fellow. Please note that this requirement for tenure track varies across Institutes.

Q: Am I eligible for a K01 if I don’t have a postdoctoral appointment?
A: Both postdoctoral researchers and junior investigators are eligible for a K01 Career Development Award. Applicants must be a U.S. citizen or permanent resident with a research or clinical doctoral degree. In your application, you must justify your need for additional mentored training and professional development.

K08

Q: What is considered a “clinical doctoral degree?” For example, do MDs, OTDs, and DPTs qualify?
A: MD is a clinical doctoral degree. We do not know of an official NIH list designating clinical doctorates. Please feel free to contact a Program Officer to ask whether you are eligible.

Q: Do I need to have an MD to apply for K08, or could I apply with a PhD?
A: With a PhD, you would apply for a K01 Mentored Career Development Award instead.

Q: Am I still eligible for the K08 if I have both a clinical doctorate AND a PhD?
A: Yes. You can have combined advanced degrees as long as one of them is a clinical doctorate.

Q: Am I eligible for a K08 if I am an occupational therapist with both a PhD and Master of Physical Therapy?
A: You need a clinical doctorate to be eligible for the K08, not a master’s degree. You must be an independent clinician and researcher.

Loan Repayment Programs

Q: When in my career can I apply for an LRP? Can I apply while completing my PhD?
A:  You can apply at any point in your career so long as you have sufficient debt. However, you will need to have obtained your doctorate before the expected LRP award start date. Please note that approximately 50% of applications result in an award. You can find more information on success rates on the LRP Dashboard.

Q: Does the LRP renewal pay an additional $100,000?
A: For LRP renewal awards, the repayment amount is equal to one-half of the remaining educational debt at the start date of the renewal award, up to $50,000 per year.

HEAL Initiative

Q: I heard that comparative effectiveness studies are a priority for the NIH Pain Consortium.  Are there specific announcements addressing this priority?
A: The HEAL initiative has issued a few comparative effectiveness Funding Opportunity Announcements.

Q: Are there any diversity initiatives within NINDS or HEAL for R-series grants?
A: Yes, there are diversity supplements you can apply to if you have a grant through HEAL. Notice number: NOT-NS-20-107

Q: Does HEAL fund any K01 grants?
A: No, HEAL does not fund any K01 grants.

High School Researchers

Q: Are there any grants I can apply for while earning a high school diploma or GED?
A: Grant mechanisms all begin at the predoctoral level. However, NIH Institutes want to encourage scientific engagement, so if you can find a PI with whom you want to complete a summer or winter research internship, they can receive funding to support your addition to their research program. NINDS provides some research opportunities for high school and undergraduate students, and NIH provides some summer research programs for high school students as well.

 

 

July 8, 2021 - Institutional Training Grants

In this webinar, Dr. Stephen Korn (NINDS) discussed the T32 institutional training award (using the NINDS T32 as an example). H explained the grant requirements, how to apply, what the T32 provides, and the overall benefits of receiving the award. Next, Dr. Inna Belfer (NCCIH) discussed the purpose, benefits, and application requirements for the Conference Grant Awards (R13). Finally, Dr. Ericka Boone discussed the NIH Loan Repayment Program (LRP), and Dr. Michelle Jones-London (NINDS) provided a brief presentation on how to enhance workforce diversity.

 

Question and Answer Summary: July 8, 2021, Webinar 4: Institutional Training Grants

T32

Q: How many Institutes support T32 grant mechanisms?
A: Nineteen NIH Institutes and Centers support T32 grants. Specific requirements for and details regarding T32s vary across different Institutes and Centers.

Q: How should I decide to which Institute or Center my institution should submit a T32 application?
A: To decide which Institute or Center would be the best fit for your application, first review the Funding Opportunity Announcements. You should determine which Institutes fund most of the faculty who will be involved in the program, because their research will likely support the mission of whichever Institute funds them, and your program will need to support the mission of the Institute. You should also contact the Program or Grant Officers of each Institute, who can direct you to the most appropriate Institute.

Q: What amount of funds is provided in a typical T32 award covering four training positions?
A: A formula determines how much funding a T32 grant recipient receives. However, this formula includes multiple factors, including an institution’s tuition cost, and therefore a single answer cannot be provided. Prior award quantities can be found at NIH RePORTER. Predoctoral students receive a stipend of approximately $25,000 under a T32, funding for travel ranges from $500 to $1,000, and tuition expenses are capped at $16,000 (as of July 8, 2021).

Q: What percentage of T32 applications to NINDS receive funding each cycle?
A: In any given year, NINDS funds between 35 and 50 percent of the T32 applications it receives. T32 applications are not as hypercompetitive as R01 applications; however, T32 applications are generally written by seasoned grant writers who are accomplished scientists with a long training background, so these applications are very high quality. Please contact Program Officers before you submit your application, because they can alert you to problems with the application. Further information can be found at NIH RePORTER.

Q: To be funded with a T32 grant, does my program need to be based in lab research?
A: Some programs funded by T32 grants are purely clinical. A program is eligible regardless of research type (e.g., clinical, laboratory, translational), though some individual Funding Opportunities may require specific research types.

Q: How many faculty members should I involve in a T32 program? Is there a minimum number I should include before applying?
A: There is no right answer to this question. However, 7-10 faculty members would be a relatively small number among funded programs, while a program with 50 faculty members and only 4 positions would seem imbalanced. If you can justify your plan, it may be funded.

Q: Can a T32 program be multi-institutional?
A: A T32 program can involve more than one educational institution, and some multi-institutional T32 programs have been funded. However, T32 programs are expected to develop a cohort of students, and that task is difficult when trainees are distributed across multiple institutions.

Q: Does NINDS give preference to pain-related T32 grant applications?
A: Applications are always funded based on quality and merit and not on program focus. However, NINDS is eager to find more pain-related institutional training programs. NINDS has funded three pain-focused programs through the T32 grant mechanism, of which two are ongoing. To be the next pain-focused T32-funded program, you will need to gather a group of faculty members committed to developing and supporting that program.

Q: How important are Diversity, Equity, and Inclusion to T32 programs?
A: A major component of the T32 grant mechanism is increasing workforce diversity. Therefore, Institutes expect a diverse group of trainees, faculty members, and planned seminar speakers for these programs.

Workforce Diversity Grants

Q: How should I decide to which Institute or Center my institution should submit a workforce diversity grant application?
A: To decide which Institute or Center would be the best fit for your application, first review the Funding Opportunity Announcements. Your overall goals will need to support the mission of the Institute—if it does not, the application will not receive funding and may be rejected without review. You should also contact the Program or Grant Officers of each Institute, who can direct you to the most appropriate Institute.

Q: What percentage of workforce diversity grant applications receive funding each cycle?
A: Although exact odds of success are not available, information regarding past success rates are publicly available at NIH Data Book.

Other Institutional Training Grants

Q: What other Institutional Training Grants does NIH fund?
A: All Institutional Training Grant mechanisms are available on the NIH website.

Q: What is the difference between the T32 and T34 grant mechanism?
A: T34 grants fund undergraduate and postbaccalaureate students and are primarily funded by NIGMS, whereas T32 grants fund predoctoral students or postdoctoral fellows

 

 

 

August 12, 2021 - ESI, NI, and Established Investigators

Dr. Devin Oskvig (NIA) kicked off the webinar by distinguishing between New Investigators (NI), Early Stage Investigators (ESI), and Established Investigators, and then discussed some special early career programs for early scientists (DP2 and DP5) as well as the R01 and R21 research grants. Next, Dr. Ted Zheng (NIAMS) highlighted information for applying to the following grant mechanisms: NIH Research Enhancement Award (R15) - AREA and REAP, NIGMS Institutional Development Award (IDeA) Program, and Maximizing Investigators’ Research Award (MIRA) (R35).

Question and Answer Summary: August 12, 2021, Webinar 5: ESI, NIH and Established Investigators

Early Stage and New Investigator Status

Q: New Investigator (NI) status is revoked after “substantial” funding is received. How is “substantial” defined? For example, if I was funded by an F31 award during graduate school, am I still considered an NI?
A: The definition of an NI is “an investigator who has not previously competed successfully for substantial independent funding from NIH.” Many grants can still be held while maintaining NI status, including an F-series grant.

Q: Are NIs eligible for an R35 award?
A: No—for most Institutes and Centers (ICs), only established investigators who have an active R01 award from that IC are eligible for an R35 award. The purpose of the R35 award mechanism is to support a research program rather than a project. However, some ICs (e.g., NIGMS) may offer an R35 award for applicants with Early Stage Investigator (ESI) status.

Q: Are investigator-initiated studies eligible for R01 and R21 grants even if the investigator has not received any prior NIH grants?
A: Yes, investigator-initiated studies are eligible for R01 and R21 grants even if the investigator has not received any prior NIH funding.

Q: Are ESI status extension requests managed by individual NIH ICs or by central NIH administration?
A: You will submit the ESI status extension request through eRA Commons. These decisions are controlled by a standing committee within the Office of Intramural Research that includes representatives from multiple ICs. ESI extensions may be granted for a variety of reasons on a case-by-case basis, and recent changes to NIH policy include automatically granting a 1-year extension to ESI status after childbirth.

Q: If I submit an application for an R01 grant and my ESI status ends during the review process, will that impact how my application is scored? Will the Program Officer (PO) notify the review committee of my status change, or should I submit the application as a non-ESI from the start?
A: By definition, an NI has not yet received any R01 awards. R01 applications from NIs and ESIs are reviewed in a single pool separate from established investigators’ applications. Even if your ESI status expires during application, the NI status will still be valid until you receive your first R01 award, and thus, your application will still be reviewed separately from established investigators’ applications.

Q: If I submit two R01 applications simultaneously, is my ESI status active for both applications or neither?
A: If one of the R01 applications is funded, the other application will then be considered  submitted by an established investigator. That change will be made by NIH and is not your responsibility.

Q: On R01 grants, is there an upper or lower bound on the level of research effort (e.g., 20-50 percent) for ESIs?
A: No official guidance on level of research effort is in place for NIH as a whole; however, reviewers expect substantial principal investigator (PI) effort—less than 25 percent, for example, would be less effort than expected. Some ICs may have their own requirements.

R-Series Grants

Q: Are Instructor-level investigators eligible and competitive for R01s?
A: Reviewers will consider the expertise of the Investigator(s) and team (e.g., record of accomplishments, collaborations) while scoring an R01 application.

Q: Do I need to be a United States citizen to be eligible for an R01 award as an ESI?
A: Yes, you are typically eligible for an R01 award as a non-U.S. citizen. However, some Requests for Applications (RFAs) may specify narrower eligibility, and some universities or institutions may not support the application.

Q: Is the R35 grant mechanism intended to support multiple investigators or one primary PI for a research program?
A: The R35 mechanism is intended to support one primary PI.

K-Series Grants

Q: There are career development (K) grants for very early- to mid-career investigators, but not for more established investigators. NIH used to offer the K05 Senior Scientist Award, but this award has been absent for many years. Will NIH consider bringing back the K05 award, or a similar grant mechanism?
A: We are unaware of any changes for the K05 award. Please continue to check announcements to see whether the K05 or a similar mechanism has been reinstituted.

Q: How do I know whether I am eligible for K25 grants?
A: See the Funding Opportunity Announcement for more information about K25 grants.

Diversity Mechanisms

Q: How do I know whether I am eligible for the HEAL diversity mechanism?
A: See the Funding Opportunity Announcement for more information about the HEAL diversity mechanism.

Q: Are there any resources for trainees that are underrepresented in biomedical fields but are not included in the broad NIH classifications of underrepresented groups (e.g., cultural minorities that are broadly categorized as Asian American)?
A: Any training programs that use NIH diversity priority language will generally address all underrepresented groups and provide relevant resources.

Pain Research Grants

Q: Is the pain mechanism and models program announcement (PA) still active?
A: At present, this PA (PA-18-141) is not accepting submissions. We will inform the pain research community if any similar PA becomes available.

Q: Do any funding opportunities exist for animal model development (e.g., a large animal pain model)?
A: For more information on funding opportunities for animal model development, please consult the PO whose research portfolio most closely aligns with your research goals.

General NIH Grant Application Information

Q: I understand that we should talk with POs within the ICs most aligned with our research. How can I make that conversation as productive as possible?
A: First, keep in mind that each IC may have unique policies or best practices. Building a relationship with POs may help you to tailor your application to an IC’s interests, but you may not get that information if you don’t ask for it specifically. You can also provide a draft of your specific aims to facilitate conversations with POs; that information may help the PO guide you through grant mechanism requirements and determine how your proposals align with those requirements.

Q: If more than one IC could fit my research proposal, what should I consider when choosing where to submit my application?
A: If you believe that more than one IC fits your research proposal, you should seek guidance from the relevant POs; they can point you to the most appropriate IC for your application. You can also use NIH Matchmaker, which will help direct you toward the appropriate IC even before you contact POs.

A: Would faculty members with a DNP degree be eligible to apply for NIH funding?
A: Yes. Please work with your institution’s officials to create an eRA Commons account.

 

 

September 9, 2021 - Technology Development/ Therapeutic Development

Dr. Becky Roof (NINDS) presented on the IGNITE Program (including FOAs), as well as the goals and eligibility for both the R61 and R63 grant mechanisms programs. Next, Dr. Michael Oshinsky (NINDS) provided a brief overview of the U19 grant mechanism being used within HEAL (and the R61 planning grant). Finally, Dr. Chuck Cywin (NINDS) presented on the Small Molecules - Blueprint Neurotherapeutics Network (BPN), the BPN-Biologics Network and its related FOAs, NIH Small Business Programs, NIH CounterACT, the Epilepsy Therapy Screening Program (ETSP), the HEAL Analgesic Development Program, and the Preclinical Screening Platform for Pain (PSPP).

 

Question and Answer Summary: September 9, 2021, Webinar 6: Technology Development/ Therapeutic Development

General

Q: Where can I find information for all the pain-related grant mechanisms mentioned during the webinar?
A: One of the best places to look for pain-related awards is the Pain Consortium’s website. Specific mechanisms mentioned were for the Helping End Addiction Long-term (HEAL) Initiative’s Clinical Research,Preclinical and Translational grants. The HEAL Initiative’s resources page also has more information for grants focused on pain research and related areas.

Q: When I contact NIH staff for advice on my application, is the correspondence confidential?
A: Yes, all correspondence with NIH staff is confidential, but you should label any emails you send as confidential regardless.

Q: Which grant mechanisms might be appropriate for a compound with neurological therapeutic activity?
A: If the compound is a non-opioid analgesic with no or minimal abuse potential, HEAL Initiative U19 and R61 mechanisms may be appropriate. Innovation Grants to Nurture Initial Translational Efforts (IGNITE) funds neurological therapeutics that align with the NINDS mission.

Q: Whom should I contact to guide these applications?
A: Contact information for IGNITE is on the right panel of its main landing page. You can also contact Program Officers for Blueprint Neurotherapeutics Network for Small Molecules (BPN), HEAL, NINDS, and NCCIH, depending on your project. You should determine which program at different Institutes and Centers may be best for your project by using NIH RePORTER.

Q: Do biologics include cell-based therapies and tissue engineered constructs?
A: Yes, generally, the term “biologics” includes biotechnology products and biologics-based therapies (e.g., peptides, proteins), gene-based therapies (e.g., oligonucleotide and viral-based), cell therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies).

IGNITE

Q: How competitive are IGNITE grants?
A: IGNITE grants are very competitive, with more good applications than there is money to support. Contacting IGNITE Program Officers can help you avoid pitfalls in your application that may not be obvious to you, but are to us. One major problem that researchers encounter is with the milestones, especially when not accustomed to translational research.

Q: My group identified a small molecule that promotes neurogenesis and is working with different animal models. Which funding program might fit my project?
A: Consider PAR-21-122, and please contact the Program Officer if an appropriate fit. These funding mechanisms are translationally focused Funding Opportunity Announcements (FOAs), and you should identify an indication for your molecule. If you are conducting exploratory studies in multiple models to treat multiple indications to identify for which indication your molecule might best be used, IGNITE would not be a good fit.

Q: Do IGNITE grants support device development, or only molecular medicine?
A: No, IGNITE does not support devices. However, NINDS has a program specifically for developing and studying devices.

Q: Do IGNITE grants support app development?
A: No, IGNITE only supports small molecule or biologic therapeutics (PAR-21-122 or PAR-21-124) or animal model (PAR-21-123) development.

Q: Is there an example of an IGNITE grant application?
A: Unfortunately, we do not provide an example application. However, we do provide example milestones.

Q: Do IGNITE grants support lead compound optimization and further development?
A: It depends on the details of your specific project. Blueprint Neurotherapeutics Network (BPN) funding mechanisms might be a better fit, but we would need more information about your project to offer advice; please send an aims page to a relevant Program Officer for personalized guidance.

Q: Do IGNITE grants support cellular or human pilot studies?
A: IGNITE does not support clinical research but does support cellular work that aims to develop BPN or BPN-biologics. Please send an aims page to a relevant Program Officer for personalized guidance. NINDS funds clinical research through other grant mechanisms.

BPN

Q: Must a group have assay expertise for a BPN grant or can that work be outsourced on a contract basis to an outside company?
A: Disease biology must be a part of the grant, but that laboratory work can be conducted in collaboration with vendors or co-PIs.

SBIR

Q: I am a rehabilitation doctor who specializes in noninterventional pain management and is attempting to obtain funding through the SBIR program for a nonmolecular pain management strategy. Would that fit within NINDS or NCCIH’s mission?
A: Mechanisms within NCCIH may be appropriate for your project, and you should provide your aims page to Program Officers for specific guidance. NINDS also funds some rehabilitation projects, so you can also contact NINDS Program Officers.

Q: I am a Canadian doctor who has experienced difficulty applying to  the SBIR program. How can I best establish a relationship with U.S. partners and NIH Program Officers?
A: Being a Canadian doctor would make applying for the SBIR program difficult. Broadening your scope for potential mechanisms may be an appropriate approach—please use NIH RePORTER to identify which groups are working on similar projects and under which funding mechanisms. Regardless of which NIH mechanism you select, you will be expected to justify why the work cannot happen in the United States.

Non-Molecular Interventions

Q: Would virtual reality as a pain management tool fit within any NIH programs?
A: NINDS has a device development program, as does HEAL. NCCIH may also be interested in this project. It could be developed through a parent R01 or R21 in addition to specific grant options.

Q: Would machine learning-based pain assessment tools in animals be eligible for the mechanisms mentioned today?
A: If this tool is designed as a readout for existing animal models, the answer is likely yes. However, you should send an aims page to relevant Program Officers. Development of such a tool would not be funded independently but could be a component of a U19-funded project or as the Animal Model component of an IGNITE project.

Diversity Initiatives

Q: Do diversity initiatives include disability in addition to race, ethnicity, socioeconomic status, etc.?
A: Yes, these initiatives include disability. For further information, you can consult the Notice of NIH’s Interest in Diversity.

 

 

 

October 14, 2021 - Clinical Phased Mechanisms

In this webinar, Dr. Maryanne Pelleymounter (NINDS) provided an overview of the R61/R33 Clinical Phased Grant Mechanism for exploratory and developmental research activities, with an explanation of milestones and tips for applying and transitioning. Then, Dr. Lanay Mudd (NCCIH) gave an overview of the Clinical UH3/UH3 (Cooperative Agreement) Grant Mechanism, which included explanations of milestones, transitions, and terms and conditions for the award. Finally, Dr. Michelle Jones-London (NINDS) spoke about the workforce diversity grant mechanisms.

 

Question and Answer Summary: October 14, 2021, Webinar 7 - Clinical Phased Mechanisms

General

Q: Are small businesses eligible to apply for R61/R33 or U mechanism awards?
A: Small businesses are generally eligible for both R61/R33 grants and U awards. Please check the specific Funding Opportunity Announcement (FOA) for eligibility requirements before submitting your application.

Q: How much pilot data and extramural funding should I have before I apply for NCCIH funding?
A: Unfortunately, no answer would apply universally. You should contact relevant Program Officers for individualized advice.

Q: I am a clinical researcher. Which grants would my research be eligible for?
A: Clinical researchers are eligible for any grant mechanism from NIH that does not prohibit clinical trials. You should select an FOA that applies to the phase of research on which you are working. Please note that the FOAs discussed during this webinar applied to phased research. Clinical researchers should review K-awards.

R61/R33

Q: PAR-19-315 is biomarker focused. Are there similar R61/R33 programs focused on pain therapeutics development—either pharmacological or non-pharmacological?
A: There are early-stage therapeutic development PARs; IGNITE, discussed during the September webinar, is one example. The NIH HEAL Initiative has programs intended for early pain therapeutics development, which were also discussed during the September webinar. You should also explore NIH’s grants website to obtain more information.

Q: I aim to obtain funding for pilot studies. How would I decide between R61/R33 and R34?
A: The R61/R33 award is intended to facilitate exploratory research that then phases into validation studies; it has distinct projects in each phase. You should always review the specific FOA. NCCIH regularly uses R34 to support feasibility pilot studies. R34 is not a phased mechanism and includes 3 years of funding for a limited research project.

Q: Is the R61/R33 funding mechanism appropriate for early-stage investigators (ESIs)?
A: The level of funding through the R61 portion does not remove ESI status; however, if you progress to the R33 phase of the award, you will lose ESI status for future applications. If you still hold a postdoctoral fellowship, you should consider K-mechanisms (discussed in the June webinar), which may be more appropriate mechanisms with which to begin your independent research career. Some NIH Institutes and Centers (ICs) have specific mechanisms for beginning researchers—for example, NIDA’s START fund is intended for researchers beginning their independent research careers.

Q: Why does the new clinical R61/R33 FOA show only a single submission due date?
A: Unfortunately, no answer would apply universally. We generally post FOAs to target specific subfields; however, if you miss the deadline for a relevant FOA, other funding options will likely be applicable. You should contact relevant Program Officers for individualized advice.

Diversity

Q: Are ESIs more competitive for research supplements to promote diversity in health-related research?
A:  Each IC has its own priorities, and you should discuss this concern with the relevant Program Officer for the given parent award. In general, NIH is interested in funding researchers with a commitment to a research career with a specific timeline and plans for how the Diversity Supplement experience will transition them to later career stages.

Q: When applying for diversity supplements, should I consider any factors unrelated the candidate?
A: You should consider the product that you will achieve through your research funded by the Diversity Supplement, which depends on your career stage.

 

 

 

December 9, 2021 - NIH Staff roles in the process and high-level overview of before and after grant submission

In this webinar, Dr. Inna Belfer (NCCIH) discussed how to reach out to Program Officers (POs) before submitting a grant application, and what to expect from POs. Next, Dr. Michelle Timmerman (CSR) presented on the receipt and referral process for grant submissions and the institute/center assignment process. Additionally, Dr. Jasenka Borzan (NIMH) explained the key concepts, processes, and tools related to the scientific review process at NIH, such as types of Funding Opportunity Announcements (FOAs) and review criteria. Finally, Dr. Mark Egli (NIAAA) presented on understanding priority scores, and the next steps after application review.

 

Question and Answer Summary: December 9, 2021, Webinar 8 - Clinical Phased Mechanisms

General

Q: How do I know what sorts of projects NIH seeks to fund?
A: Funding Opportunity Announcements (FOAs) for all Institutes and Centers (ICs) describe the types of research projects that align with the current mission of each IC.

Q: Should the principal investigator (PI) suggest scientific review groups in the application cover letter?
A: No, suggestions for study sections should be provided on the Assignment Request Form (ARF). If it appears in the cover letter, the suggestion may be overlooked because it is misplaced.

Q: How long in advance of a submission date should I contact a Program Officer (PO) to obtain advice for my grant application?
A: It is never too early to contact a PO for advice on your grant application; however, it can be too late. You should contact a PO at least 1 month prior to your intended submission date in order to successfully incorporate the advice provided into your application.

Q: Are applications by New Investigators (NIs) who are not Early Stage Investigators (ESIs) reviewed with applications from ESIs at the beginning of a grant review session?
A: Applications from ESIs and NIs are generally reviewed together, but they are not always reviewed at the beginning of a session; however, that practice is common among Scientific Review Officers.

Q: Should I communicate to the reviewers that I spoke with NIH prior to submitting my application?
A: Include in the ARF the name of the PO with whom you spoke.

Q: In what ways can PO help me improve my grant application?
A: As one example, the PO may provide suggestions about repackaging your specific aims, to increase your chance of receiving funding.

Resubmission

Q: When meeting with a PO to prepare for resubmitting my application, should I provide the PO with the summary statement from the reviewing committee and my specific aims?
A: Most likely, the PO will already have access to the summary statement on a secure platform, so this answer ultimately depends on PO preference. You should communicate to the PO that you would like to discuss next steps for your grant application, including a possible resubmission.

Q: How should I approach resubmitting my application if the reviewers’ levels of enthusiasm about my initial submission varied greatly?
A: Generally, enthusiasm levels depend on similarity to existing bodies of work and the match with IC mission. However, reviewers may have differences of opinion, in which case a PI should provide a point-by-point response to the critique, discuss the program’s priorities with a PO, and ask the PO for suggestions about the best way to adjust experiments to address the reviewers’ concerns.

Q: How soon after I receive feedback on my initial application should I contact a PO?
A: You are always welcome to contact POs. However, it will be more helpful for you to wait until you have received your summary statement so that you have more specific questions to address.

Q: What sort of feedback should I take as a signal to not resubmit?
A: Don’t give up. The POs are available to help you improve your application, even after its rejection.

 

January 13, 2022 - Preparing, Writing, and Submitting an NIH Grant Application

In this webinar, Dr. Jennifer Haythornthwaite (John Hopkins University) discussed how to prepare and submit successful grants at NIH, particularly for early-stage investigators applying to R21 and R01 grants. She focused on identifying and developing a research idea, how and why to create a timeline, the iterative process of grant applications (with emphasis on the Aims Page) and the following application sections: significance, innovation, approach, and human subjects. She also gave advice related to methodology, feedback, and resubmitting applications. Then, Dr. Ericka Boone briefly presented on the Loan Repayment Program (LRP). 

Question and Answer Summary: January 13, 2022, Webinar 9 - Preparing, Writing, and Submitting an NIH Grant Application

General

Q: Do I need a specific degree type to be considered a PI for a grant?
A: Degrees required for PI status are generally decided by the Institute or Center (IC) in accordance with Funding Opportunity requirements. Eligibility criteria will always be stated in Funding Opportunity Announcements (FOAs).

Q: What are good strategies for developing inter-institutional collaborations?
A: Your professional society presents a good opportunity to meet scientists with similar research interests. In addition, you can use the NIH RePORTER’s Matchmaker function to find potential collaborators based on their expertise.

Q: Can I apply any time within the stated window on a grant?
A: Yes, you may apply any time from the date the IC begins to accept applications to the deadline for applications.

Q: In each of these webinars, NIH mentions programs that specifically support pain intervention development. What are those programs?
A: A series of NIH programs are directed to different stages of pain therapeutic development. Within the Helping End Addiction Long-term (HEAL) Initiative, you can apply for a U19 at the initial translational stage, a UG3/UH3 therapeutic development with clinical trial optional, a pre-clinical screening platform program, and EPPIC-Net. Within the Blueprint Neurotherapeutics Network, you can apply for programs targeted to small molecules, biologics, and medical devices.

Q: Are applications for supplements structured the same as applications for original grants? When should I contact the PO about supplements?
A: Please communicate with POs listed in supplement notices with your draft ideas or specific aims as soon as possible so that they can guide you through the application process and assess the mission fit.

Q: How should my specific aims be connected to each other?
A: Your specific aims should not depend on each other—that is, the pursuit of one aim should not depend on whether another aim achieved the expected results. However, the aims should be integrated so that the entire application appears as a single unit. Your application should provide clear reasoning for why your aims work together so that they don’t seem too independent.

Q: Where can I learn how to improve my grant writing skills?
A: You should watch this webinar. If applicable, you should consult with your institution’s grant writing program. You can find valuable online sources, such as BioScience Writers, Monte and Libby (2018), Liu et al. (2016), Inouye and Fiellin (2005), and this guide from NIAID. In addition, you could develop groups for grant writing improvement, by following the methods outlined in Botham et al. (2020) or a variant of a Writer Accountability Group. You can find information about NIH grants through the NIH guide and the About Grants page. You can also review funded grants, such as these R01s from NIAID.

Q: How do the general grant writing guidelines extend to training grants?
A: Most of the guidelines also apply to training grants. However, you should be especially attentive to the training plan and the mentor section, and the mentor you’ve chosen is just as important as the trainee.

Q: How do the general grant writing grant guidelines extend to SBIR/STTR (R41/R43) grants?
A: Most of the guidelines also apply to R41/R43 grants.

Q: At what point in the process should I contact a PO?
A: Please contact a PO at any point in the process. You can share ideas or your specific aims page. Contact a PO even if you don’t know which funding opportunity or grant mechanism is most appropriate for your project.

Resubmission

Q: How should I approach resubmission if one reviewer was very positive, and another is very negative?
A: The best strategy for this situation is to provide point-by-point responses to reviewers’ critiques. You should discuss the matter with the relevant PO and highlight the most important comments in your Summary page when resubmitting your application.

Q:  Is it better for me to resubmit my application with a summary statement addressing the review or to submit a new application that has been modified based on the review?
A: Your strategy should depend on how extensive the critique is. You should carefully read the review sheets and talk with the PO, especially if they were present for the review.

Q: How should I structure my introduction page when resubmitting my application (e.g., by reviewer, by section of grant)? If I received many comments, how do I use my one page efficiently?
A: Generally, you will combine individual comments into categories and provide a brief response with references to changes made. Good introductions are challenging to write, so involve your mentors and colleagues and allow yourself the time necessary to write it well.

Q: How should I handle suggestions that are not logistically or monetarily feasible?
A: You should write that you considered or investigated the option, determined you could not include it, and propose an alternate solution to address the concern. However, to determine that alternate solution you must first discern exactly the basis of the concern and why it arose.

Loan Repayment Programs

Q: When is the next application cycle for LRPs?
A: The next application cycle opens on September 1, 2022, and closes November 18, 2022.

Q: Can a research proposal for an LRP be similar to one that is already funded through a different mechanism (e.g., R21, R01)?
A: Yes. Because the LRP will not provide resources or funding for your research or salary, you can use the same project to apply for each.

Specific Programs

Q: Which Program Officer (PO) should I contact to learn about the IRACDA program?
A: The POs responsible for IRACDA are Dr. Edgardo Falcón-Morales and Dr. Shakira Nelson.

Q: I am active-duty military, a clinician, and a researcher. How can I best pursue research, especially if the research I want to pursue isn’t necessarily military-specific?
A: A good resource for you is the Pain Management Collaboratory, which is operated jointly by Veteran’s Affairs, the Department of Defense, and NIH. You can also access several research courses, trainings, and webinars through the National Capital Region Pain Initiative run out of Walter Reed National Military Medical Center. You may also wish to contact either the Defense and Veteran Center for Integrative Pain Management or the Uniformed Services University of the Health Sciences.

Q: I am a Canadian citizen. Can I apply for the NCCIH High Priority Pain Research as the PI?
A: The Notice relating to the NCCIH High Priority Pain Research covers a number of funding opportunities. For many of these, you would be eligible to apply as a PI, but you are encouraged to check each opportunity and contact the relevant PO directly.

Q: Do I need preliminary data to be competitive when applying for an R21 or an R03?
A: No, you typically do not need preliminary data for those grant mechanisms.

 

February 10, 2022 - Building a Budget

In this webinar, Dr. Kathleen Sluka (University of Iowa) discussed how to build a budget from the PI’s perspective, including how to manage a budget, tips for budgeting, and what to do when a budget gets cut. Then, Maggie Spencer (University of Iowa) provided the administrator perspective for how to prepare a budget for an NIH award. She covered what roles an administrator plays in the award process, how they can help with the proposal budget, where to find a research administrator, as well as tips for budget development and post-award administration. Next, Dr. Leslie Boggs (NCCIH) discussed the roles and responsibilities of Grants Management Specialists at NIH, as well as several grant-related concepts. Finally, James Washington (NINDS) provided an overview of helpful websites and resources related to grants policies, such as the NIH Grants Policy Statement (GPS), the NIH Guide for Grants and Funding, and biosketch information.

 

 

Question and Answer Summary: Webinar 10 - Building a Budget

General

Q: How do you create a budget buffer? Should I just budget for a higher cost than the actual cost for some budgeting  items?
A: Do not claim a higher cost just to have a buffer; that higher cost should be clearly justified. For example, in clinical trials, some screened participants will not be eligible for the trial or will not complete the trial, requiring additional recruitment and repeated experiments. As another example, your primary antibody may not work as expected and your backup antibody is more expensive; you should budget for the more expensive antibody.

When developing your budget for future years, remember that NIH does not escalate funds, which impacts your budget in two ways. First, if you know that certain expenses increase annually (e.g., animal care costs), you should budget for the future cost. Second, you must clearly reflect plans to increase personnel or travel costs in your budget justification; otherwise, grant management will assume that increased costs are an unjustified escalation of funds and will reduce them.

Q: Which costs do new investigators tend to over- or underbudget?
A: New investigators tend to make budgeting errors related to personnel time and effort. They may budget for too many or too few lab assistants. Underestimations or overlaps in effort are especially common in Just In Time (JIT) extensions or applications via eRA Commons. In addition, new investigators may not be familiar with the various roles that are required or helpful to a research program or project. 

Institution Questions

Q: How do Business Officials (BOs) and Signing Officials (SOs) differ?
A: An SO and a BO are very similar positions, and one person often assumes both roles. Both positions have signatory authority on behalf of a university.

Q: If I have a research appointment at a university as well as an appointment to the Veterans Administration or am active-duty military, do I need to budget differently than if I were only an academic researcher?
A: Yes; your effort cap and salary requirements may differ from those of a PI without these other professional responsibilities. You should speak with the grant office at your institution to receive assistance on navigating the multiple sets of rules that will affect your budgeting decisions.

Q: How does the standard cut from your institution differ from indirect costs?
A: The standard cut is the money your institution claims from your award before division of direct and indirect costs. Some institutions use a standard 10-15% cut, but other institutions will make decisions based on the line items in your budget.

 

 

Specific Grant Mechanisms or Budget Items

Q: How should I budget for clinician champions who are on the study team but are not necessarily co-investigators?
A: Clinician champions may receive a per salary charge or a flat fee for participation in the study, but they are identified only as champions at sites, clinician champions, or consultants in the budget justification.

Q: Guidelines state that under the Modified Total Direct Cost (MTDC) system, subrecipient costs cannot exceed $25,000 in indirect costs. However, you’ve said that I can claim 100% of  subrecipient costs in indirect costs if I instead use Total Direct Costs (TDC) and ask for only 40% in indirect costs. Is that correct?
A: Forty percent can be applied toward small businesses but you must use an applicable Facilities and Administrative Costs (F&A) rate at the time of award for the consortium. A modular budget includes a separate line item for indirect costs for consortiums, but they are reduced if the award is reduced. You should work closely with a grants management specialist when submitting the application, because this question is important to resolve prior to submission.

Q: If my estimated spending for a certain year exceeds the budget cap (e.g., due to significant batch assay costs), can I spread out the cost for budgeting purposes?
A: Whether you can carry cost into the following year depends on the grant mechanism. R01s and UM1s are among those awards that allow researchers to carry costs forward and reduce spending in the following year.

Q: Will NIH allow grantees to budget for childcare within grant awards, especially as it relates to traveling for conferences and disseminating research?
A: Currently, NRSAs for fellowships, postdocs, and training grant awards (e.g., T32, F31, F32) include budget items for childcare. Please note that many conferences independently provide childcare options.


March 10, 2022 - Programs to support technology development and SBIR

In this webinar, Dr. Craig Hopp (NCCIH) gave an overview of technology grants, explained several technology-related development projects currently funded by NIH, and highlighted several current funding opportunities for technology development (R21, R01, and Parent R01). Next, Stephanie Fertig (SEED) discussed development opportunities for small businesses at NIH. She explained the SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer) programs, which are focused on product development, as well as some resources available to applicants applying to SBIR and STTR grants. Next, Dr. Terez Shea-Donohue (NIDDK) described the scope of the Common Fund program, the goals of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) program, and several HEAL-related RFAs.

 

 

Question and Answer Summary: Webinar 11 - Programs to Support Technology Development and SBIR

General

Q: If a small business is defined as no more than 500 employees, what percentage of grants are awarded to businesses with fewer than 10 employees?
A: The majority of the small businesses we support have far fewer than 500 employees. NIH supports many businesses with fewer than 10 employees.

Q: Who determines what constitutes an allowable expense? For example, is clinical trial insurance allowable as a direct expense given that that cost would only be incurred with a grant award?
A: Allowable costs are defined in the
grant policy guidance. You should also refer to the Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Application Instructions, which include information specific to this grant mechanism (e.g., commercialization expenses). Please request further clarity from Program Officers when applying.

Please note that using grant money to buy liability insurance for participants is prohibited by the Antideficiency Act. NIH has previously had to reject applications from clinical centers that did not have their own insurance policy.

Q: Could you define “high impact” as opposed to “unmet medical need” for a small patient population?
A: High-impact research moves the field forward significantly. For example, an R01 grant includes an impact score that is based on approach, innovation, and investigator, among other components. Unmet clinical need describes a situation in which the field lacks an answer that is needed for a given patient population. For example,
Stimulating Peripheral Activity to Relieve Conditions (SPARC) patients receive FDA-approved vagal nerve stimulation, but the field lacks basic knowledge, such as safety parameters.

Q: It appears as though the SBIR grants through the Helping End Addiction Long-term (HEAL) Initiative can either require or forbid clinical trials. Can you clarify what that means?
A: Some program announcements, including those for
SBIR and STTR grants, allow, require, or forbid clinical trials. When applying, ensure that your project matches the FOA you are responding to. Also determine whether you are actually conducting a clinical trial as defined by NIH. NIH’s definition sometimes differs from FDA’s definition, so human subject research may or may not qualify. For NIH, the definition depends on interventions and biomedical outcomes of those interventions without regard to risk.

Q: Should I cite published research from NIH investigators in my application?
A: Your application would be unusual if it had no citations. Use existing research to justify the significance of your research and establish the feasibility of your approach.

Grant Review

Q: How can I become a grant reviewer?
A: Every standing study section requires two early career reviewers (ECRs), so we strongly encourage you to pursue this idea. To become an ECR, you must present evidence of independent research (e.g., first or last author publications) and 2 years of assistant professorship. Please review
detailed application instructions before submitting your application.

 

April 14, 2022 - CTSA and patient engagement studios

This webinar started with an overview of the CTSA (Clinical and Translational Science Awards) Program, presented by Dr. Michael Kurilla (NCATS). He outlined the programmatic focuses of CTSA and mechanisms to support program efforts, with several examples of current CTSA programs. Next, Dr. Jane Atkinson (NCATS) explained the Trial Innovation Network (TIN). She explained the three current awardees, the Trial Innovation Liaison Teams, how to get started by requesting a consultation, who should apply for TIN resources, and when investigators should apply to the TIN. Dr. Atkinson also explained the types of TIN support and resources that are available to investigators, and outlined some of the major contributions that the TIN has made, such as the establishment of IRBs and support of trans-NIH initiatives like HEAL. Finally, Dr. Joan Davis Nagel (NCATS) discussed the Recruitment Innovation Center (RIC) by explaining the overall goals of RIC and RIC's four major areas of work: recruitment and retention planning, informatics/cohort assessment, community engagement, and recruitment materials. She also highlighted some tools within RIC, such as eConsent, Community Engagement Studios, MyCap, and FasterTogether (a course).

 

 

Question and Answer Summary: Webinar 12 - CTSA and patient engagement studios

Q: How do I access the Faster Together course?
A: The Faster Together course is free and publicly available on
Coursera.

Q: If I have more than one recruitment site in my proposal, can I take advantage of the Trial Innovation Network (TIN)?
A: Yes, you may use TIN if your proposal includes more than one recruitment site.

Q: If I apply to Helping End Addiction Long-term (HEAL), can I get Institutional Review Board (IRB) assistance even before receiving an award?
A: You may request single IRB support from a TIN IRB, but the cost for the review must be included in your grant.

Q: How much would it cost to work with the TIN IRB?
A: The cost depends upon the IRB you select, the number of sites, the length of the trial, and the negotiations among the single IRB, your institution, and you.

Q: Trial Innovation Center (TIC) and Recruitment Innovation Center (RIC) awards are expiring soon. How does this expiration change the Clinical and Translational Science Awards (CTSAs)?
A: The TIN will continue, and the CTSA Funding Opportunity Announcement (FOA) still includes many resources that have proven valuable. NCATS aims to facilitate a seamless transition to TIN 2.0, but if you currently rely on a long-term resource provided by a TIN, then you may learn that the provider of that resource may change. A technical assistance webinar on May 13 will provide information to help you with this transition.

Q: How is the TIN liaison team transitioning to the Hub liaison team for these new CTSA FOAs?
A: Liaison activities among the center grants will continue, but the grants teams will no longer be referred to as TIN liaison teams.

 

May 12, 2022 - NIH data policy and data harmonization

In this webinar, Taunton Pain (OSP) and Dr. Cindy Danielson (OER) spoke about the NIH data sharing policy. Pain covered the benefits of data sharing, how NIH’s data sharing policy is meant to address current problems with data accessibility, and the requirements of the policy. Danielson covered allowable costs for data management and sharing, and how data plans will be submitted and reviewed. Next, Dr. Julia Slutsman (OER) discussed NIH’s Genomic Data Sharing (GDS) policy, focusing on the goals and background of the policy, as well as its scope. Slutsman then discussed some of the specific requirements under the policy, such as institutional certifications, informed consent, and data access. Next, Dr. Jessica Mazerik (HEAL OD) presented on the HEAL Data Ecosystem as well as the HEAL Data Sharing Agreement. Mazerik explained how to build and implement a data plan for the sharing of underlying primary data, HEAL’s distributed approach for managing and sharing diverse data, and the goals of the HEAL data ecosystem. Finally, Dr. Laura Wander (NINDS) gave an overview of the HEAL Common Data Elements (CDE) program, including the rationale behind the program, how the HEAL CDE program established a core set of pain domains, and the future implications of the program.

 

Question and Answer Summary: Webinar 13 -NIH data policy and data harmonization 

Q: Who can access the HEAL Common Data Element (CDE) Box account?
A: Any HEAL Principal Investigator or their team can access the NIH HEAL CDE Box account.

Q: Where can I find information about NIH’s data sharing policies?
A: NIH has created a new Scientific Data Sharing website that you should reference.

Q: What do I need to know to successfully share data within HEAL?
A: You should use HEAL’s CDEs and follow its Data Ecosystem Guidelines and Resources.

Q: How can I protect human subject privacy when I’m sharing data, and what language should I use when I’m telling my subjects about the data and samples I’m sharing from them?
A: NIH recognizes that sharing human subject data and samples requires some care. We have recently released two draft resources on this topic that you can reference and comment on if you think they are incomplete.

June 9, 2022 - Clinical trial oversight

In this webinar, Dr. Codrin Lungu (NINDS) explained how NIH defines clinical trials (and resources to determine if something is a clinical trial), as well as funding mechanisms for clinical trials at NIH, and how the development process for clinical trial applications work. Additionally, Lungu covered several NINDS clinical trials networks, such as NeuroNEXT and provided some tips for success for clinical trial applications. Next, Michelle Culp (OSP) explained how to determine if a study meets the NIH definition of a clinical trial, as well as the importance of clinical trial oversight across the lifespan of a clinical trial (and the sources of oversight). Lastly, Dr. Barbara Karp provided an overview of the Early-Stage Pain Investigation Clinical Network (EPPIC-Net). Karp discussed the goals of the program, the program structure, and the application and review process.

 

 

Question and Answer Summary: Webinar 14 -Clinical Trial Oversight

Q: Are PhD students eligible to access the Early Phase Pain Investigation Clinical Network (EPICC-NET)?
A: Yes, PhD students are eligible to apply to use EPICC-NET. These applicants are most likely to succeed if they have support from their institution.

Q: Do any specific grant mechanisms exist for the development of biomarkers?
A: NINDS has an entire program dedicated to the development of biomarkers, which has its own associated funding mechanisms. The most recent request for applications dedicated to biomarker development associated with the Helping End Addiction Long-term (HEAL) Initiative is accepting applications through February 24, 2023. EPICC-NET also accepts applications for the development of biomarkers, provided they are connected to pain and HEAL.

Q: How can I improve my knowledge about clinical trial methodology?
A: You can use a reliable and recommended clinical trial methodology course, such as University of Michigan’s course.

 

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