See Notice NOT-OD-21-170, April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-GM-20-041. An ESI, or Early Stage Investigator, is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post See more tips for avoiding common errors. 3. WebOctober 7, 2019 - Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing Investigators' Research Award (MIRA) for Early Stage Investigators (R35 - Trending Young in New and Early Stage Investigator MIRA A proposed Clinical Trial application may include study designs, methods, and interventions that are not by themselves innovative but address important questions or unmet needs. A letter from the subcontract PD/PI should be included making it clear why he/she cannot participate in collaborative research with the PD/PI without support from the MIRA. NIGMS strongly encourages potential applicants to contact Scientific/Research Staff at least 6 weeks prior to submission for advice on the suitability of the proposed research for NIGMS. Any costs incurred before receipt of the NoA are at the recipient's risk. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantees business official. Changes in the distribution over time of research topics studied by NIGMS MIRA vs. traditional grantees. See Notice NOT-OD-23-148; August 5, 2022 - Implementation Research involving human subjects is permitted in the MIRA program. ClinicalTrials.gov: If an award provides for one or more clinical trials. 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). For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53. The Concept to Clinic: Commercializing Innovation Education Program is designed to help current BRAIN-funded investigators from a research institution or early-stage start-up better understand how to take their innovative technology and apply it to an unmet market need. How will successful completion of the research change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed? This initiative is not subject to intergovernmental review. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Jarrod French, PhD The Hormel Institute MIRA Awards Reflect Innovation of UConn Scientists. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. New Investigator All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). For the purpose of this FOA, a program of research is a collection of projects in the investigator's lab that are relevant to the mission of NIGMS. Subject to the eligibility criteria below, any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. PHS Human Subjects and Clinical Trials Information. For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? Additional Information on Eligibility, Section I. 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. All PD(s)/PI(s) must have an eRA Commons account. As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for Requested Salary and $0 for Fringe Benefits. National Institute of General Medical Sciences (NIGMS) Provide the total consortium/subaward costs for each budget period listing the total direct costs and indirect (F&A) costs separately. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. An application does not need to be strong in all categories to be judged likely to have major scientific impact. See Section III of this FOA for information on registration requirements. SF424(R&R) Project/Performance Site Locations. Applicants should directly address the rationale, underlying the balance of effort and the resources dedicated to each activity, and how the activities are distinct or complementary. The Maximizing Investigators' Research Award (MIRA) under this FOA is a grant to provide support for a program of research in an early stage investigator's laboratory that falls within the mission of NIGMS. Other than years when equipment is requested, it is expected that the annual direct costs will remain constant in all years. What do I need to know to start the process? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? For this FOA, do not suggest a Scientific Review Group because applications will be reviewed by Special Emphasis Panels. In addition, for applications involving clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information, or potential to advance scientific knowledge or clinical practice? For this FOA: Will creative strategies be employed as needed and appropriate to address the research questions posed? Are potential ethical issues adequately addressed? 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. An Early Stage Investigator (ESI) is a Program Director/Principal Investigator (PD/PI) who meets the following qualifications: Completed terminal research degree or end of post-graduate clinical training, whichever date is WebEarly stage investigators should apply through PAR-23-145 . For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy, or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors, or health care policy? Applications that do not comply with these instructions may be delayed or not accepted for review. In assessing the effectiveness of its research investments, NIH may request information from databases, PD/PIs, and from participants themselves. This document should serve both the needs of the public and the needs of the reviewers for an introduction to the research plan. MIRA Welcome Letter MIRA for Established and New Investigators (EIs and NIs) See below for MIRA for Early Glossary | BRAIN Initiative Is there a plan to obtain required study agent(s)? Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Is the prior research that serves as the key support for the proposed project rigorous? For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. Is there a logical plan for sustained progress across a research program for the five-year award period? 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 his/her total research effort to this award, inclusive of his/her combined research effort at all institutions where he/she holds an appointment (including foreign institutions). Services, National Institutes of Health: As part of the scientific peer review, all applications: Cooperative Agreement Terms and Conditions of Award. July 1, 2020 - Notice of Pre-Application Webinar for PAR-20-017. 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). Dr. Jessica L. Rouge Note that preliminary data are neither expected nor required, and PD/PIs may wish to indicate this prominently in the Research Strategy. F&A base: Also use the Budget Justification to explain any exclusions applied to the F&A base calculation.