3) Overview of Future Research Plans. 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. 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. Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75and 2 CFR Part 200. Generally, summary statements will be available no later than 30 days before Council. Given that the MIRA is meant to provide support for a research program within the NIGMS mission in a PDs/PIs laboratory, and may include multiple projects on disparate topics, there is no obligation for the PD/PI to present a single unifying theme. For the purpose of the STAR Program, NIAMS defines these investigators as those who have successfully renewed a first NIAMS-supported R01 which was received no earlier than 2009 with Early Stage Investigator (ESI) status. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398). Additionally, a signed letter from the institution's Authorized Organizational Representative (AOR) stipulating to the following points will be required as just-in-time information after review for applications being considering for funding: The PD/PI will devote at least 51% of their total research effort to this award, inclusive of their combined research effort at all institutions where they hold an appointment (including foreign institutions). The application budget cannot exceed a maximum direct cost of $70,000; applicable F & A (indirect) cost can also be requested. In addition to research designed to answer scientific questions and generate new ideas and hypotheses, the development of technology and computational approaches are supported. 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. This new all-time high level of support for ESIs represents a 7.2% increase over FY 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. NIH sets target numbers for funding early-stage R01 investigators. The total research effort should include the PD/PI's combined research effort at all institutions where the PD/PI holds an appointment, should be expressed in person-months, and should not include time expended toward teaching or administration not directly related to the PD's/PI's research, and/or clinical duties. While NIDDK often makes administrative reductions in grant duration, applications from ESIs that fall within the payline are usually awarded the full requested duration. Date 06/2024. Women, individuals from underrepresented racial and ethnic groups, from disadvantaged backgrounds, or with disabilities (NOT-OD-22-019) are always encouraged to apply for NIH support. NI R01 applications will be clustered together for review within a meeting. Resolving Overlap with Other NIGMS Research Grants During the Award Process. 5. Requires M.D. Consortium Justification: Consortium/Contractual Arrangements are not anticipated in most cases and must be extremely well justified. Does the application propose to use existing available resources, as applicable? 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. Budget details for mentored candidates in the NIH intramural program will be negotiated with the sponsoring laboratory and will be consistent with offers to scientists in comparable positions. Description of any planned partnerships that may enhance geographic and regional diversity. Only one award per eligible investigator may be considered for this special payline. 21. At least 40% of the research project is to be conducted by the small business concern, and at least 30% of the work is to be conducted by the single, partnering research institution. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 5 years of support. Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed program? NIAMS has 2 receipt dates for this program: May 1st and Nov 1st. 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 For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding? To support a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach. eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues), Finding Help Online:https://www.era.nih.gov/need-help(preferred method of contact) NINDS will fund additional R01 applications from Early Stage Investigators with scores beyond the percentile payline with the aim of supporting these early career scientists at a success rate equivalent to that of established investigators submitting new R01 applications. The following will be considered in making funding decisions: 3. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes. Although only UH2 awardees are generally eligible to apply for UH3 support, specific program initiatives may establish eligibility criteria under which applications could be accepted from applicants demonstrating progress equivalent to that expected under UH2. Has the PD/PI presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 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. An Early Stage Investigator (ESI) is a New Investigator who is within 10 years of completing the terminal research degree or within 10 years of completing medical residency or equivalent. WebEarly Steps Assistant Program Manager, Professional Development. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. In Section C: Equipment Description, enter budget request for equipment. For Budget Type select Project. A separate budget form for any Subaward/Consortium is not required for this NOFO. Budget justification. Applicants must include NOT-OD-23-031 in box 4b of the SF424 R&R form. Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Preliminary dataare not required and justification for the proposed work may be provided through literature citations, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow. So R01s from experienced investigators or experience PIs are discussed separately as a cluster or a group. ORWH works in partnership with the NIH Institutes as well as the Food and Drug Administration (FDA) to ensure that women's health research is part of the scientific framework at NIH and throughout the scientific community. Based in part on his own career experiences, he frequently advocated for an NIH mechanism by which an early-stage investigator could receive support for a project unrelated to his or her area of postdoctoral study. Note that the goals of the program of research supported by the MIRA are broader than the specific aims of a single project and should be appropriately described. The NIGMS Maximizing Investigators' Research Award (MIRA) provides support for the NIGMS-relevant program of research in an investigator's laboratory. ESIs are new investigators who are within 10 years of completing either their terminal research degree or their medical residency (whichever is later) at the time they apply for R01 grants. CSRs primary role is to handle the receipt and review of ~ 75% of the grant applications that NIH receives. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. The payline for ESI applications is typically more generous than the regular payline for established investigators (see NIDDK Funding Policy). Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). ESIs are new investigators who are within 10 years of completing either their terminal research degree or their medical residency (whichever is later) at the time they apply for R01 grants. Award Administration Information, Maximizing Investigators' Research Award (MIRA), https://braininitiative.nih.gov/about/pedp-key-elements-and-examples, NIH Directors Transformative Research Award (TRA), Research Supplements to Promote Diversity in Health-Related Research, Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, Administrative Supplements for Equipment Purchases, MIRA for Established and New Investigators, NIH Policy on Late Submission of Grant Applications, NATO Commercial and Government Entity (NCAGE) Code, Guidelines for the Review of Human Subjects, Guidelines for the Review of Inclusion in Clinical Research, Worksheet for Review of the Vertebrate Animals Section, Award Conditions and Information for NIH Grants, https://grants.nih.gov/policy/clinical-trials/reporting/index.htm, http://grants.nih.gov/grants/policy/hs/data_safety.htm, NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General, Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, Federal wide Research Terms and Conditions, Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment, HHS Assurance of Compliance form (HHS 690), https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html, https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html, https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html, https://www.hhs.gov/civil-rights/for-individuals/disability/index.html, https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html, https://grants.nih.gov/grants/policy/harassment.htm, https://www.hhs.gov/conscience/conscience-protections/index.html, https://www.hhs.gov/conscience/religious-freedom/index.html, https://www.hhs.gov/ocr/about-us/contact-us/index.html, Research Performance Progress Report (RPPR). This activity code is used in lieu of the UH2 activity code when larger budgets and/or project periods are required to establish feasibility for the project. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov. Dr. Stephen I. Katz directed the National Institute of Arthritis and Musculoskeletal and Skin Diseases from August 1995 until his death in December 2018. Content and Form of Application Submission. In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. The NIAMS uses a variety of funding types, or mechanisms, to support research at other institutions, organizations, and facilities. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and the National Institute of General Medical Sciences. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official. In FY21, NIH supported 1,513 new ESIs as first-time PIs on R01-equivalent awards. Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers. Please turn on JavaScript and try again. Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? At least 6 months of support must be remaining on the grant at the start of the supplement award. 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. Renewals: ESI MIRA recipients will be eligible to renew their MIRAs through MIRA NOFOs not limited to ESIs, e.g., through PAR-22-180 and reissuances of it. Institutional Commitment to Candidate's Research Career Development attachment (1-page limit): When multiple years are involved, recipients will be required to submit theResearch Performance Progress Report (RPPR)annually and financial statements as required in theNIH Grants Policy Statement. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. NIH uses success rates as a metric for describing the likelihood of a project getting funded. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html. NIAMS strongly encourages the PI of the parent research grant to contact both the scientific contact listed in this table and the NIAMS Program Officer of that grant. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. Larger award amount than the current average NIGMS R01 award to ESIs. A committee of NIAMS program and grants management staff will review requests submitted to NIAMS. Extension Request Process PDs/PIs who submitted a MIRA application in previous years and are still eligible for this NOFO (i.e., retain their ESI status) are welcome to apply, but must submit a New application because Resubmission applications are not allowed. Because the MIRA is intended to support a significant and ambitious program of research, the PD/PI is required to devote at least 51% of their total research effort to this award. These costs may be reimbursed only to the extent considered allowable pre-award costs. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. PA-21-021: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp Clinical Trial Not Allowed), PA-18-837: Administrative Supplements to Promote Diversity in Research and Development Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed), Diversity Supplement Program GuidelinesRe-Entry Supplements Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials are also not permitted. 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. to Grants.gov and. All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. Summary statements for new investigator R01 applications are prioritized, and when possible, released before summary statements for other applications reviewed in the same meeting. 3. NIAMS accepts and reviews applications on a continuous basis between October 1 and May 31. If an application for renewal of the MIRA is unsuccessful, the grant will terminate at the end of its approved project period. The institution and PD/PI are aware of and accept that other NIGMS research awards, except as allowed in Section I, must be relinquished, and pending NIGMS research applications withdrawn, as a condition of receiving a MIRA. April Hearron. Where possible, applicant(s) should align their description with these required elements within the research strategy section. Activation of the independent award phase is administrative, and is contingent upon the investigator securing an independent research position. The NIAMS welcomes applications to the NIH Loan Repayment Program. The supplement may be used to support additional personnel, computational services, supplies and equipment that will promote the continuity of the career development research project during a period in which the PD/PI experiences critical life events which have the potential to impact research progress or potential productivity. If this letter is not included, the application will be considered incomplete and will not be reviewed.This information could include start-up packages and other institutional research support, space available to the PD/PI, salary support commitment for the PD/PI, skills and career development opportunities for the PD/PI, mentoring during the promotion and tenure process, and career advancement prospects for non-tenure track applicants. The types of research programs we support are differentiated by NIH activity codes (e.g., R01, R43, etc.). NIs and ESIs are strongly encouraged to contact their program director to discuss the decision of when to resubmit a revised application.
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