Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to: For further information on the PEDP, please seehttps://braininitiative.nih.gov/about/pedp-key-elements-and-examples. 5. Projects that propose the novel application of methods, technologies, or conceptual approaches from outside biomedical science to a research problem in the NIAMS mission area. Contact: Xibin WangApplications Due: Standard dates Additional Information: Office of Extramural Research: Small Business Innovation Research (SBIR) and Small Business Technology (STTR) Programs, Small Business Innovation Research (SBIR) Program. Only those application types listed here are allowed for this NOFO. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following: We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Enhance investigators' ability to move into research areas that are distinct from those of their postdoctoral mentors by not requiring or expecting preliminary data, which could lead to new scientific discoveries. WebThe Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project in an area of science that represents a change in research direction for an early Date 06/2024. Has the PD/PI presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Because most institutions expect some commitment from investigators to administrative, teaching, and/or clinical duties, any salary support for the PD/PI charged to the grant should generally be less than 51% of the PD/PI's annual salary and should in no case be more than the actual research effort the PD/PI will devote to the grant. PHS Human Subjects and Clinical Trials Information. Institutions will be required to relinquish their interests in current NIGMS-funded research grants and withdraw pending applications where the MIRA investigator is listed as the PD/PI or multi-PD/PI. The NIAMS funds the following types of grants: Research Grants As applicable for the proposed research program, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? For this NOFO, the "program of research" is defined as a collection of projects in an investigator's laboratory that are within the mission of NIGMS. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Submission ofother research grant applications (e.g., R15, R16, R21) within NIGMS mission is not allowed while an ESI MIRA application is pending review* at the same time, with the following exceptions: Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance of the ESI MIRA become ineligible to receive the award. Resource-Related Research ProjectsCooperative Agreements. Do they have appropriate experience and training? For Established Investigator or New Investigator MIRA applications, it is NOT okay to have similar ReWARD application under review at the same time. All recipients of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. Only single PD/PI applications are allowed. If a special payline award is made to an eligible investigator any other eligible applications from that investigator SF424(R&R) Project/Performance Site Locations. Eligible candidates will have no more than 4 years of postdoctoral research at the time of application (initial or amended). Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance of the ESI MIRA become ineligible to receive the award. For support to develop and/or implement a program as it relates to a category in one or more of the areas of education, information, training, technical assistance, coordination, or evaluation. Description of any planned partnerships that may enhance geographic and regional diversity. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. These costs may be reimbursed only to the extent considered allowable pre-award costs. Is there evidence that the research program will evolve appropriately as the work is performed? We are particularly interested in applications from physician-scientists. U.S. citizenship or permanent resident status is required.Duration: Up to 6 yearsCommitment: Full-time research fellowshipProvisions:NRSA Stipends, Tuition/Fees, and Institutional AllowanceApplications Due: Standard dates, Predoctoral Individual National Research Service Award, To provide predoctoral support of research leading to the Ph.D. or equivalent research degree for individuals to extend their potential for a career in research in arthritis, muscle, bone, musculoskeletal, and/or skin diseases. For this particular announcement, note the following: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. After the PD/PI's ESI eligibility has expired, they may be eligible to apply to the MIRA for Established and New Investigators as a new investigator. Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Applicants must complete all required registrations before the application due date. To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project? Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Transfer of a MIRA to a foreign institution will not be allowed. The following will be considered in making funding decisions: 3. MERIT Award The Limited Competition: Small Grant Program for NIAMS K01, K08, K23, and K25 Recipients (R03) is intended to enhance the capability of NIAMS-supported K awardees to conduct research as they complete their transition to fully independent investigator status.Duration: No more than 2 years, not renewable.Budget Cap: Multi-year funds up to $100,000 direct costs for entire project periodApplication Due Dates: June 20, 2022; October 19, 2022; February 21, 2023; June 19, 2023; October 19, 2023; February 20, 2024; June 19, 2024; October 21, 2024; February 19, 2025. If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH Grants Policy Statement. Projects of limited time and scope that do not meet these characteristics of innovative, ground-breaking research should consider applying for a small Research Project Grant (Parent R01). WebNIA New and Early Stage Investigators A New Investigator (NI) is an investigator who has not yet competed successfully for a substantial, independent NIH research award, such as In support of this, the nominal payline for first competitive renewal applications for R01 awards to researchers who were ESIs when they competed for the initial NIDDK Type 1 R01 award is typically more generous than the regular payline for established investigators (see NIDDK Funding Policy). All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. The Pathway to Independence Award is uniquely designed to facilitate the transition of outstanding postdoctoral candidates from mentored to independent research positions. is acting as the primary caregiver for an ailing spouse, child, partner or a member of the immediate family. NIAMS accepts applications in response to PA-16-161"NIH Exploratory/Developmental Research Grant Program (Parent R21)" proposing studies related to arthritis, musculoskeletal or skin diseases or disorders. This new all-time high level of support for ESIs represents a 7.2% increase over FY Investigators with K awards from NIGMS will be required to relinquish the K award prior to the start date of the MIRA. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Conditionfor Recipient Integrity and Performance Matters. Once an R01 has been renewed, it is no longer considered an Early Stage Investigator award. All current NIGMS research grants except those listed in the bulleted list in the "Overlap During Peer Review" section above will be terminated upon the issuance of a new MIRA grant. Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? These provide support for an investigator to collect key preliminary data in order to submit an improved revised R01 application, but you should understand that NIDDK has only enough funds to make very few of these awards. Applications are reviewed in study sections (Scientific Review Group, SRG). These scientifically meritorious projects should demonstrate an essential element of unity and interdependence. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Subscriptions Funding Trends & Support of Guiding Principles - NIDDK If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Investigators and teams composed of researchers at different career stages. NINDS no longer accepts applications to the Stephen I. Katz Early Stage Investigator Research Project Grant Program. SBIR/STTR: FAQ Page NIH NOFOs outline intended research goals and objectives. NIGMS staff will verify that the MIRA research effort requirement is met by using theOther supportdocumentation and will exclude support for which the purpose is education, training or enhancing workforce diversity. Preparing NIH Grant Proposals Types of Funding Mechanisms (Activity Codes) | NIAMS At least 6 months of support must be remaining on the grant at the start of the supplement award. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO. Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds. All instructions in the SF424 (R&R) Application Guide must be followed. For Established Investigator or New Investigator MIRA applications, it is NOT okay to have similar ReWARD application under review at the same time. Your First R01 Grant Application Relevance of the proposed research to NIGMS priorities. For Early Stage Investigator MIRA applications it is okay to have a similar ReWARD application under review at the same time, but only one application will be funded. Resolving Overlap with Other NIGMS Research Grants During the Award Process. In FY 2009, NIH announced a new policy involving the identification of early stage investigators (ESIs). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. PDs/PIs who are currentlyNew Investigatorsproposing research within the scientific mission of NIGMS are not eligible for this NOFO and should apply instead through PAR-22-180or its subsequent reissuance. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to: If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. By virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would overlap with the MIRA. NIAID Paylines Addition of a foreign component requires NIGMS' prior approval. So R01s from experienced investigators or experience PIs are discussed separately as a cluster or a group. Supplement requests should be submitted electronically. The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative. nih Institutional letter of commitment that includes details of resources and mentoring to be made available to the applicant to ensure strong productivity on the parent grant. No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix. NIGMS strongly encourages potential applicants to confer with the program officer managing awards in their specific research area at least 6 weeks prior to submission for advice on the suitability of the proposed research for NIGMS. Substantial Federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of award. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. Eligibility Information contains information about registration. Funds are expected to be awarded by July 1st and Jan 1st, respectively. And then very importantly on at the on-site meeting, grants are clustered. Note: NIH will consider a request to extend the period of your ESI status if there has been a lapse in your post-degree training. Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research. In FY 2009, NIH announced a new policy involving the identification of early stage investigators (ESIs). Exploratory/Developmental Cooperative Agreement Phase I, Exploratory/Developmental Cooperative Agreement Phase II. A strong biomedical research community conducting NIAMS mission-relevant research is a prerequisite for establishment of a Resource-based Center. Will creative strategies be employed as needed and appropriate to address the research questions posed? While NIDDK often makes administrative reductions in grant duration, applications from ESIs that fall within the payline are usually awarded the full requested duration. Each research project is usually under the leadership of an established investigator in an area representing his/her special interest and competencies. EarlySteps Provider Specialist. Similarly, early career stage applicants may not have yet published independently as senior or corresponding authors, and the absence of these publications should not be viewed as a weakness. Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance Administrative supplements must support the scope of the original project and provide support during the period of critical life event. WebYes, ESIs that are awarded a grant under this FOA will lose their ESI status, because it is an R01 award. The application budget cannot exceed a maximum direct cost of $70,000; applicable F&A (indirect) cost can also be requested. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). For Early Stage Investigator MIRA applications it is okay to have a similar ReWARD application under review at the same time, but only one application will be funded. The R33 Phase will provide up to 1 additional year of support to further validate and explore the innovative concept. This grant supports the administrative planning and development of a clinical trial implementation cooperative agreement (U01). Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Read about our outreach programs and publications. Grants supporting resources for the research community (e.g., R24); Collaborative Program Grant for Multidisciplinary Teams grants**; Biomedical Technology Optimization and Dissemination Center (BTOD) grants***; Grants supporting training, workforce development, or diversity building; Public/State Controlled Institutions of Higher Education, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education), For-Profit Organizations (Other than Small Businesses), Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), Eligible Agencies of the Federal Government, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations. NIA New and Early Stage Investigators - National Institute on Aging 3. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. Letters of support from collaborators must be limited to 1 page each, must not include attached Biographical Sketches, and should not circumvent page limitations by includingfigures and data. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The same UEI must be used for all registrations, as well as on the grant application. Answers to Frequently Asked Questions about ESI MIRA PAR-23-145 Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. Do not repeat material adequately covered in the Biosketch. Clinical research must be completely within the context of the NIGMS clinical areas (anesthesiology, perioperative pain, clinical pharmacology, sepsis, injury and critical illness, wound healing, innate immunity and inflammation). For assistance with application submission, contact the Application Submission Contacts in Section VII. This site is protected by reCAPTCHA and the GooglePrivacy Policyand Terms of Serviceapply. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Program Directors/Principal Investigators (PD(s)/PI(s)). Figure 2: Award This FOA will not support core centers (or activities within centers) focused on the generation of biological or genetic data or the development of novel technologies for such generation.Duration: 5 yearsBudget Cap: $500,000 direct costsFAQS: NIAMS Core Centers for Clinical Research (CCCR) - FAQsContact: NIAMS Centers Program, To promote translational research through a multidisciplinary approach on a disease specific theme. Contributions to Science: This section of the biosketch should emphasize contributions over the past five years. NIs and ESIs are strongly encouraged to contact their program director to discuss the decision of when to resubmit a revised application. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. Provide the Budget Period Start Date and End Date. Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Notice of Early Expiration of RFA-HG-21-041 "New This attachment should be titled Plan for Enhancing Diverse Perspectives.. To support follow-on awards to small businesses for technology development, testing, evaluation, and commercialization assistance for SBIR or STTR Phase II technologies or for awards to small businesses to support the progress of research, research and development, and commercialization conducted under the SBIR or STTR programs to Phase III. Candidates must have completed their specialty and, if applicable, subspecialty training prior to receiving an award.Duration: 3 to 5 yearsProvisions: Support is provided for salary up to $100,000 for a minimum 75% effort (with the exception of orthopaedic surgeons, who may devote a minimum of 50% effort*), fringe benefits, and other research expenses up to $30,000.Applications Due: Standard dates*Please see NOT-AR-16-012, Midcareer Investigator Award in Patient-Oriented Research, To support protected time for clinicians to allow them time for patient-oriented research and to act as mentors for beginning clinical investigators. The focus should be on the importance of the questions or challenges. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. A program to invite eligible institutions to submit a pre-application (also known as a white paper or prcis) to facilitate certain approaches or economies, such as reducing burden on the applicant community, for a funding opportunity. I am thrilled to announce that I have been awarded a new @NIDDKgov /@NIH Stephen I. Katz Early-Stage Investigator Research Project Grant-R01 providing $2.3 million in funding over five years to advance our research efforts NHGRI Program Contact: Lisa Chadwick RFA-HG-21-041 : New Investigators to Promote Workforce Diversity in Genomics, Bioinformatics or Bioengineering and Biomedical Imaging Research (R01, Clinical Trial Optional) Next Application Due Date: February 22, 2023 NHGRI Program Contact: Jyoti Dayal Eligibility: Do not include the number of person months or direct costs. Open Mike: Introducing the Stephen I. Katz Early Stage Investigator Research Grant Program. An official website of the United States government, NINDS No Longer Participates in the Katz Program. This may include development of technical expertise and administrative skills such as mentoring. After the award, research involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component would require prior approval by NIGMS staff according to existing policies and procedures. NIH uses success rates as a metric for describing the likelihood of a project getting funded. Obtaining an eRA Commons account can take up to 2 weeks. In Section F: Other Direct Costs, add a line item titled Requested Direct Costs and provide the total request for that budget period (up to $250,000). Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Organizations are not eligible to apply. Investigators NIGMS will accept MIRA applications with foreign collaborations but will only provide funding for a foreign consortium arrangement when the collaboration is essential to the PD's/PI's research program and represents a unique scientific opportunity that cannot be supported by the collaborator without MIRA funds. The National Institutes of Health (NIH) has recently posted guidance regarding administrative supplements. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicants integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships..