National Institutes of Health (NIH) Contents: What's New Proposal Guidance Budget Guidelines Compliance Award Guidance Subawards Prior Approvals Reporting Effort Reporting / Cost Share Record Retention Sponsor Resources Forms and Templates Archives What's New (also see Archives for more information) 3/10/21: NIH Requiring Login.gov Beginning this year, NIH will be requiring the use of Login.gov to access its systems. All users of any NIH system must transition to using Login.gov by September 15, 2021, however, NIH is encouraging users to create and begin using Login.gov now, before the mandatory September deadline. What do I have to do? To link your eRA Commons account: Select the login.gov option on the eRA Commons home screen Create a new account through Login.gov if you do not already have one; if you have one, log in to login.gov Once redirected back to Commons, you will complete a one-time process to associate your Commons ID to your Login.gov account Once associated, the next time you log into eRA Commons using login.gov, you will automatically be redirected to eRA Commons without having to log in again. 1/29/21: NIH Salary Cap Increase to $199,300 Per NIH notice NOT-OD-21-057, the Executive Level II salary rate has been increased to $199,300 effective January 3, 2021. The salary cap for AY faculty is $149,475 and the summer salary cap is $49,825. These new amounts may be used in budgets for upcoming proposal submissions. 1/27/21: Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2021 NIH recently published NOT-OD-21-049, which outlines FY21 annual stipend levels that apply to all individuals receiving support through NRSA institutional training grants or individual fellowships. The new rates are effective for all NRSA awards made on or after 10/1/2020. While stipends have increased for all, the institutional allowance remains the same. Please see the NOT for more information. Proposal Guidance Guidance on the requirements of your NIH proposal will be in the solicitation, and comprehensive instructions can be found in NIH’s General Application Guide. Note that FORMS-F is applicable for proposals due on or after May 25, 2020. NIH’s Annotated Form Set is another good resource that provides tips and business rules for completing NIH application forms. NIH's Submission Policies webpage provides links to common submission questions, such as: what happens with late applications, continuous submission rules, resubmission rules, deadlines on holidays/weekends, etc. OSP has created a checklist for FORMS-F NIH research proposals (e.g. R01, R21, R03) with guidance on what attachments are mandatory versus optional, as well as specifics on how to complete the proposal in Kuali Coeus (MSU’s proposal submission system). Proposal Tips Following is a list of some NIH proposal requirements (note, this is not a comprehensive list): Every MSU PD/PI must have an eRA Commons ID associated with MSU. If a PD/PI does not have an eRA Commons ID, or if their ID is not associated with MSU, please contact your OSP Proposal Team. NIH has a Multiple PI option that allows more than one PI to be included on an application. If this option is being pursued, a Multiple PI Leadership Plan must be attached to the proposal The PHS Human Subjects and Clinical Trials Form is required and can be challenging to complete. Please reference the FORMS-F PHS Human Subjects and Clinical Trial Information Guide for assistance with completing this form. NIH’s Annotated Forms or Walk-Through of the PHS Human Subjects & Clinical Trials Information Form video can also help. Single IRB – If the proposal includes subrecipients and human subjects will be involved at multiple-sites, a Single IRB plan will need to be included at Just-in-Time stage. To allow proper time, it is recommended to contact MSU HRPP at proposal stage for assistance with completing the plan, IRBReliance@ora.msu.edu. More information is provided in the Compliance section of this webpage. Prior approval is required from an NIH Program Officer if any budget period in a proposal includes $500,000 or more in direct costs, excluding consortium F&A. The approval must be indicated in a cover letter that is attached to the application. Biosketches are typically required for all Key Personnel and should follow NIH’s format. They are limited to five pages per person. The Personal Statement should only include up to four publications, and the Contributions to Science section should only include up to five contributions. The use of URLs outside of works cited, such as to include a full list of published work, is limited to Federal Government websites only; NIH suggests My Bibliography. Other Support forms are required at the Just-in-Time stage. For additional information on completing Other Support forms, see the Current and Pending/Other Support Requirements by Sponsor webpage and the template Other Support form. Annual and Project Based Conflict of Interest forms must be completed for all Key Personnel prior to proposal submission. For more information, see the Compliance section. Many proposal submissions follow NIH Standard Due Dates. Some investigators who participate in NIH review committees may have continuous submission eligibility, which allows them some flexibility with submission deadlines. The Assignment Request Form should be included with the proposal if the PI would like to recommend a particular institute or center that they would like their proposal to be reviewed by. This form is included as a User Attached Form in the KC Proposal Development Document. The “Equipment” attachment is a required form for most research proposals. It should list the major items of equipment already available for the project with the pertinent capabilities. Submission System Most NIH proposals are submitted using the System-to-System (S2S) feature in Kuali Coeus (KC). For assistance with completing NIH S2S research proposals, use the NIH FORMS-F checklist. There are some NIH proposals that currently cannot be submitted using KC. They are: Proposals with multiple projects/cores Training Grants Proposals with budgeting requirements that cannot be accomplished in the KC Budget Module (this scenario requires OSP’s approval to proceed with another submission system) If the proposal cannot be submitted in KC using S2S, it can be submitted in ASSIST, which is NIH’s submission system, or Grants.gov’s Workspace. After submission, the proposal may be reviewed in eRA Commons. The PD/PI is encouraged to log in to eRA Commons to ensure the final proposal is accurate and correct. If there are any issues that need to be addressed or any attachments that need to be updated, please work with your proposal team to submit a changed/corrected proposal within two business days of original submission and prior to the proposal deadline. Supplement applications may be submitted via KC or eRA Commons. If the supplement can be submitted in eRA Commons, refer to the eRA Commons Administrative Supplement Module User Guide. Please work with your proposal team to determine the best method for submission. Just in Time NIH sends automated JIT emails to the PD/PI(s) for any proposal receiving an impact score of 30 or less, regardless of the Institute/Center’s payline. The automated JIT email includes requests for updated Other Support and certifications such as IRB approval. You do not need to respond to this automated request. You may wish to provide JIT materials at this time if your application scored within the Institute/Center’s payline and you wish to provide materials to help speed NIH review; additional materials may be requested later. After the automated JIT request, the PD/PI may receive a personalized JIT email from a NIH Grants Management Specialist (GMS) that may include requests for updated Other Support, confirmation of MSU’s current F&A rate agreement, and other materials specific to the application such as IACUC approval, IRB approval, human subjects education certificates or a Single IRB plan. The GMS will typically provide a deadline for JIT submission, and unless otherwise noted, these materials should be submitted using the JIT module in eRA Commons. You must respond to this request in order to be considered for funding. Please work with your proposal team to coordinate JIT submission. Budget Guidelines The guidelines listed here are generally applicable to this sponsor. Please refer to the solicitation for any deviation to standard guidelines or specific requirements for a program. Personnel Salary Salaries should be based on KC values unless a known increase/decrease is expected, for example due to a change in title/rank; the salary cap may be used when using a module budget or if there is a budget ceiling, otherwise NIH advises that the full salary be used; FY21 salary cap is $199,300 (AN)/ $149,475 (AY) / $49,825 (Summer); salaries are usually escalated in the out years using 2-3% inflation Fringe Fringe should be based on KC values; the fringe rate at the level of the salary cap may be used Research Associate (Post Doc) Salary Salaries should be based on KC values if a current employee; the current (2020) NIH minimum salary for a Post Doc is $52,704(AN) Research Associate (Post Doc) Fringe Fringe should be based on KC values; Post Docs are eligible for retirement in the 4th year of employment or if they participated in a retirement plan at a previous employer that made employer contributions. Please contact HR for more information. Graduate Student Stipend Stipend amounts should be based on standard/published college/department levels or HR levels Graduate Student Fringe Appropriate health benefits should be applied based on the current Grad Fringe Chart; 7.65% for summer hourly work Undergraduate Labor Usually based on hourly rates; see HR standard rates Undergraduate Fringe Fringe of 7.65% applied during the summer; fringe only applied during AY if student is not expected to be enrolled full time Administrative Staff Allowable per UG if justified and integral to the project; salaries and fringes should be based on KC values Equipment Allowable items ordinarily will be limited to research equipment not already available for the conduct of the work; quotes must be provided to the sponsor for equipment proposals Participant Support Costs Only allowable when specifically identified in the FOA Patient Care Costs Routine services provided by hospitals to research participants are allowable; OSP recommends the PI/research administrator contact CTSI to develop a billing grid; rebudgeting to or from patient care costs may be considered a change in scope and requires prior approval Travel Domestic Includes U.S, Canada, Mexico, and U.S. possessions; justification should include the purpose of travel, destination, dates of travel (if known) or estimated number of days, and the number of individuals for each trip International Includes any destination not considered domestic; justification should include the purpose of travel, destination, dates of travel (if known) or estimated number of days, and the number of individuals for each trip Other Direct Costs Communications Allowable if not otherwise treated as F&A costs; should be allocable to the project Computer Services/ADP MSU services should be based on the established computer service rates (Financial Analysis approved rates); quotes or other justification for how rate was determined are helpful Conferences Allowable under R13 and U13 activity codes for most Institutes and Centers (IC’s); budget guidelines vary by IC; prior approval is required before submission of an application for conference support; for generally allowable/unallowable costs see NIH Grants Policy Statement, Section 14.10 Consultant Services Justification should include: services performed, total number of days, travel costs, total estimated costs, names and organizational affiliations other than those involved in a consortium agreement, consulting physicians in connection with patient care, persons to serve on external monitoring boards or advisory committees Equipment/Facility Rental Allowable to the extent rates are reasonable Event Registration Fees Allowable for symposiums/seminars if necessary to accomplish project objectives Genomic Arrays Allowable; genomic array costs in excess of $50,000 in a budget period should be excluded from the MTDC base for determining F&A; see NIH Grants Policy Statement, Section 7.4 Graduate Student Tuition & Fees Should match the graduate student tuition chart unless applying to a fellowship solicitation; tuition should be prorated based on project dates; KC will apply appropriate inflation Honoraria Unallowable; speaker's fees or other payments for services are allowable Human Fetal Tissue If the project includes the use of Human Fetal Tissue, choose the Object Code Name “Human Fetal Tissue Costs” under Other Direct Incentives Allowable; incentive should not be so great as to coerce or unduly influence participation in the project IRB/IACUC Fees Effective January 25, 2018, costs associated with Single IRB (sIRB) review may be charged as direct costs, provided costs are well-justified and consistently treated (details and scenarios). Please contact MSU HRPP for more guidance on the sIRB policy. Non-sIRB and IACUC fees are not allowable as direct costs. Materials & Supplies Justification should include general categories including an amount for each category; categories with amounts less than $1,000 are not required to be itemized. If animal purchase and care is budgeted, the price per animal, number/type of animals, and per diem rates should be included in the justification. For Modular Budgets, OSP may request additional justification if this line item is 25% or more of TDC. Meals/Refreshments Allowable for subjects or patients in study where specifically approved as part of the project activity; alcohol is unallowable unless within the scope of an approved research project; meals for conferences/meetings for which the primary purpose is technical dissemination are not allowable Publication/Dissemination Allowable Service Charges/CORE Services Must be based on Financial Analysis approved rates; quotes or other justification for how service rate was determined are helpful Subaward Subaward budget, justification, scope of work, and commitment form must be on file internally; foreign subawards are restricted to 8% F&A; consortium justification will need to be submitted with proposal, whether detailed or modular Visa Fees Generally allowable as a recruiting cost on an NIH grant Contingency /Misc. Unallowable F&A NICRA rates should be used based on project nature unless otherwise limited by the solicitation Cost Share Only include cost share if required in the solicitation. Voluntary committed cost share should be documented in the Custom Data tab in KC. NIH Modular Budget Establishes $25,000 increments in which direct costs must be requested up to a maximum of $250,000 direct costs per year (excluding any consortium F&A costs). Modular budgets are required for new, renewal, and resubmission applications for the following types of applications: Research Project Grants Program (R01/U01) Small Grant Program (R03) Exploratory/Development Research Grant Award (R21/UH2) Clinical Trial Planning Grant Program (R34/U34) Academic Research Enhancement Awards (R15/UA5) If the direct costs (excluding consortium F&A costs) exceed $250,000 in any given year, a detailed budget must be submitted. For instructions on how to create a modular budget in the KC Budget Module, see the Creating a Modular Budget job aid. Additional Budget Resources Allowability of Costs/Activities R&R FORMS-F Budget Form Guide FORMS-F Modular Budget Form Guide Compliance Conflicts of Interest (COI) Annual and project-based disclosures are required for any key person prior to submission of an NIH application. This includes the PD/PI(s), Co-Investigator(s), key person(s), and any consultant named on the Senior/Key Person Profile form. MSU employees should complete their disclosures in KC. Anyone listed with the Other Significant Contributor role typically does not need to complete a COI disclosure. Key Persons under a subaward may be covered by their institutions PHS-compliant COI policy. This will be noted on the subrecipient commitment form. If the subrecipient does not have a compliant policy and agrees to follow MSU’s policy, each key person will need to complete a Conflict of Interest Disclosure Form prior to submission. Non-MSU consultants named as key persons will also need to complete a Conflict of Interest Disclosure Form prior to submission. If awarded, all key personnel must maintain updated annual COI disclosures, and they must have up-to-date Conflict of Interest training (this includes non-MSU key personnel who are following MSU’s COI policy). Human Subjects / IRB Below are resources to assist faculty with making NIH Human Subjects determinations. Decision Tool: Am I Doing Human Subjects Research? – Decision tree to help determine if you’re doing human subjects research Human Subjects Research Infographic – One page infographic with examples of human subjects research Exempt Human Subjects Research Infographic – One page infographic explaining the human subject exemptions NIH Annotated Forms (PHS Human Subjects and Clinical Trials Information form starts on page 11 for FORMS-E and page 31 for FORMS-F) – provides NIH guidance on how to complete the fields within the PHS Human Subjects and Clinical Trials Information Form. Including the Study Record and Planned/Cumulative enrollment form. Single IRB - Proposals submitted after 1/25/2018, fall under NIH’s Single IRB Policy. This requires additional steps to be taken at the proposal stage. Below is specific information related to the new policy. Which proposals will be impacted? According to the NIH FAQ’s, “The NIH single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.” If my proposal is subject to the NIH Single IRB policy, what do I need to do prior to proposal submission? Contact the IRB office, IRBReliance@ora.msu.edu, for assistance with completing the IRB plan. The plan describes the use of a single IRB that would be selected to serve as the IRB of record for all study sites. This plan must be submitted with the proposal. Where Can I Find More Information? To learn more, please visit the MSU HRPP website at https://hrpp.msu.edu/help/reliance/nih-sirb.html and the NIH Single IRB website at https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm. IRB approval is not required at the proposal stage, but will be requested at the Just-in-Time stage. A delay in IRB approval could delay the award being received or account setup. Animal Subjects / (IACUC) If animal subjects are being used, IACUC approval is not required at the proposal stage, but will be requested at the JIT stage. A delay in IACUC approval could delay the award being received or account setup. NIH Policies on Harassment NIH requires institutions to report changes in a principal investigator or other senior key person's status during an investigation of alleged sexual misconduct. For additional information, visit the NIH section of the Resources Related to Harassment Notification Requirements webpage. Responsible Conduct of Research Please see Responsible Conduct of Research – Training Requirements by Agency for information on NIH compliance requirements. Award Guidance NIH is a signatory to the FDP Phase VI Agreement, therefore, their award terms are usually standard. The Uniform Guide regulations at 2 CFR 200 govern funding. The solicitation is typically referenced in the Notice of Award and the terms of the solicitation also apply. Projects are incrementally funded, and future funding is subject to the availability of funds and satisfactory progress of the project. The NIH award will usually include an estimated amount to be awarded in future years. There can be spending restrictions that must be removed prior to initiation of research and typically an unobligated balance may be carried over into the next budget period without prior approval. Subawards Required Documents At the time of proposal submission, the detailed budget, justification, scope of work, and signed subrecipient commitment form are required. Drafting Subawards NIH participates in the Federal Demonstration Partnership (FDP). Subawards issued under a Prime agreement from an FDP-participating Federal Agency are drafted by Contract and Grant Administration (CGA), unless the subrecipient is a for-profit entity or a national lab, in which case the subaward is drafted by the Office of Sponsored Programs (OSP). Prior Approvals Required Prior Approvals NIH requires prior approvals for several actions, including no cost extensions, changes in scope, administrative/clerical staff not budgeted, reduction of PI effort by 25% or more, adding a foreign component, and pre-award costs more than 90 days before the effective date of the initial budget period. A full list of required prior approvals can be found in the NIH Grants Policy Statement. Submission System The following prior approvals can be submitted in eRA Commons: No Cost Extension (NCE): Contact CGA Awards Group Carryover Request: Contact CGA Awards Group Change of PD/PI Request: Contact CGA Awards Group for already established awards, Contact OSP Proposal Team for pending applications Prior approvals submitted in eRA Commons need to be initiated by the Signing Officer (CGA) for submission. Please refer to the eRA Commons User Guide for directions for submitting each type of prior approval. For all other prior approvals, please contact the CGA Awards Group at firstname.lastname@example.org. Reporting * All final reports are due 120 days after the award end date and are submitted through eRA Commons Progress/ Technical Report Submitted in eRA Commons Also called a non-competing continuation application Initiates additional year of funding to be received Contains scientific and administrative information SNAP Research Performance Progress Reports (RPPRs) are due annually 45 days prior to current budget period end date Non-SNAP RPPRs are due approximately 60 days before the next budget period start date. Final/Interim Progress Report Located in Requires Closeout Section of eRA Commons (not RPPR tab) Similar to annual/interim report, but requires section I, Outcomes, to be completed. Financial Reports Submitted in eRA Commons Final Financial Report Other Reports Final Invention Statement Research Performance Progress Report Information RPPR instruction Guide Effort Reporting / Cost Share Effort is set up for PI/Co- PI and key personnel listed in the NoA. The Salary Cap for 2020 is $197,300 for AN Faculty and $147,975 for AY Faculty. See the following for current and prior year salary cap amounts: Salary Cap Effort Reporting MSU effort reporting overview and FAQ’s can be found on the Sponsored Program Administration website at the following link: https://www.cga.msu.edu/PL/Effort/EffortReportingTools.aspx Effort reporting instructions can also be located on the Sponsored Program Administration website: https://www.cga.msu.edu/PL/Portal/231/EffortReportingInstructionsEffortAdministrators For additional questions and information, please contact the CGA Effort Reporting inbox at, email@example.com Cost Share Information on cost share can be found on the Sponsored Program Administration website at the following link: https://www.cga.msu.edu/PL/Portal/249/CostSharePolicy In cases where salaried cost share has been committed, MSU uses the effort reporting system for tracking and documentation. Non-salary cost share is documented through PI certified operating statements. Record Retention Record retention is three years from submission of the final financial report. Sponsor Resources NIH Grants Policy Statement Proposal Application Guides NIH Standard Due Dates ASSIST User Guide NIH Annotated Forms NIH Submission Policies Decision Tool for Human Subjects Research NIH RePORTER – Identify I/C’s and funding priorities; search for previous awards Forms and Templates Grants.gov Form Screenshots (FORMS-F) PHS Forms Biographical Sketch Templates Other Support Template—Version adapted by OSP 1/10/2020 Harassment and Discrimination Protections Letter for T-Series Proposals User Attached Forms for Proposals NIH Relinquishing Statement Archives Expired items from the Current Events section 2020 News - expand to see all 11/17/20: NIH Implementation of the Revised Federal-wide Research Terms and Conditions On November 17, NIH issued NOT-OD-21-029, which includes information on NIH’s implementation of the recent revisions to 2 CFR §200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) effective November 12, 2020. There are no significant changes, but NIH encourages the review of updated documents. Please see the NOT for more information. 10/29/20: Final NIH Policy for Data Management and Sharing NIH issued NOT-OD-21-013 as the final NIH policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This outlines the type of data included and clarifies expectations for data sharing. Please see the NOT for more information. 9/16/20: Reminder—NIH Policy on Use of Hypertext in NIH Grant Applications NOT-OD-20-174 reminds applicants of NIH’s policy on the use of hypertext (e.g., hyperlinks and URLs) in applications. No change has been made to the policy; this is simply a reminder of the information in the NIH SF424 R&R Application Guide. Please review guidance and remember that in general, the use of hyperlinks and URLs are only allowed when specifically noted in a funding opportunity. 8/11/2020: Temporary Extension of Eligibility for the NIH K99/R00 Pathway to Independence Award During the COVID-19 Pandemic On August 11, 2020, NIH issued NOT-OD-20-158 to extend the eligibility for K99/R00 applications by about 8 months. Normally, individuals must not have more than four years of postdoctoral research experience; NIH will be allowing up to a two-receipt cycle extension from the time period covered by the June/July 2020 due dates through the February/March 2021 due dates. Please see the NOT for more information. 5/22/2020: Reissue of Parent Announcements for Certain FOAs Currently Underway NOT-OD-20-110 was released on May 22, 2020 with a list of Funding Opportunity Announcements (FOAs) currently being updated for reissue, anticipated to be reissued by June 25; these are for supplemental and change in organization announcements. In the interim: If the current FOA has FORMS-E and FORMS-F packages available, use FORMS-F If the current FOA has only FORMS-E, continue to use FORMS-E Please see the NOT for more information. 4/8/2020: National Cancer Institute Minimum Effort Levels On April 8, 2020, the National Cancer Institute (NCI) issued NOT-CA-20-047, which sets minimum levels of effort to be eligible for NCI funding through R01, U01, P01, and R21 grant mechanisms. This policy applies to those individuals listed as PI, Project Leaders on multi-project grants, and Core Leaders. Please see the NOT for more information. NIH eRA Systems will be unavailable April 17 to April 20 NIH is planning to migrate modules and data to the Amazon Web Services cloud. This is expected to begin 8 a.m. ET on Friday, April 17, ending 8 p.m. ET on Monday, April 20. All eRA modules (eRA Commons, ASSIST, IAR, iEdison, etc.) as well as informational websites (era.nih.gov, etc.) will be unavailable during this time, and any affected due dates will be extended. 2/7/2020: FY 2020 Ruth L. Kirschstein National Research Service Award (NRSA) Budgetary Levels NIH recently published NOT-OD-20-070, which outlines FY20 annual stipend levels that apply to all individuals receiving support through NRSA institutional training grants or individual fellowships. The new rates are effective for all NRSA awards made on or after 10/1/2019. For the Institutional Allowance, while the predoctoral trainees and fellows allowance remains the same, the allowance for postdoctoral trainees and fellows has been increased. Please see the NOT for more information. 2/5/2020: NIH Salary Cap Updated Per NIH notice NOT-OD-20-065, released February 5, the Executive Level II salary rate has been increased to $197,300 effective January 5, 2020. The salary cap for AY faculty is $147,975 and summer salary cap is $49,325. These new amounts may be used in budgets for upcoming proposal submissions. 1/24/2020: NIH Issued a Notice of an Update of NIH Continuous Submission Policy On January 24, 2020, NIH issued a Notice of the NIH Continuous Submission Policy: Change in Submission Deadlines and End of Recent Substantial Service Option. NIH is discontinuing the practice of the one-year continuous submission status for reviewers with recent substantial review service. This does not affect reviewers who are currently eligible through Recent Substantial Service or those who earn eligibility through Recent Substantial Service from January 1, 2019 through June 30, 2020. See NOT-OD-20-060 for full information on this update. 2019 News - expand to see all 12/10/19: NIH Released the FY 2020 Grants Policy Statement (GPS) The FY 2020 Grants Policy Statement (GPS), released December 10, 2019, applies to all NIH grants and cooperative agreements with budget periods beginning October 1, 2019 or after. Awards prior to this date will follow the previous version of the GPS. Please see the Summary of Significant Changes, as well as NOT-OD-20-043 and the NIH GPS for more information. Please note, NIH included changes to the Other Support section of the GPS, however, they did not indicate these changes within the Summary of Significant Changes. For up-to-date information on NIH’s requirements for Other Support please see our Current and Pending / Other Support Requirements by Sponsor webpage. 7/10/2019: NIH Issued a Notice on Other Support, Foreign Components and Financial Conflicts of Interest On July 10, 2019, NIH issued a Notice on Other Support, Foreign Components and Financial Conflicts of Interest with the purpose of improving grant application transparency and protecting the integrity of biomedical research. Although the notice is written as a reminder, we believe there are changes to current practice when preparing Other Support Forms. For additional details, please read the announcement that was sent to MSU Faculty participating in NIH research and view the Notice. 7/10/2019: NIH Issued a Notice on ORCID iDs In October 2019, ORCID iDs will be required during the appointment process for trainees, scholars, and participants supported by institutional training grants, career development awards, and research education awards that require appointments through the xTrain system. Beginning with proposal receipt dates on or after January 25, 2020 ORCID iD’s will be enforced at the time of application for fellowship and career development awards. ORCID iD’s are digital identifiers that can be used to connect researchers with their contributions to science. Click here, for instructions on how to link an ORCID iD to an eRA Commons profile. To view the full NIH notice, see NOT-OD-19-109. 2018 News - expand to see all 10/1/2018: NIH Released the FY 2019 Grants Policy Statement (GPS) The FY 2019 Grants Policy Statement applies to all NIH grants and cooperative agreements beginning 10/1/2018 or later. Awards made prior to 10/1/2018 will still be subject to previous versions of the GPS. A full summary of the significant changes to the GPS is published online. Please refer to NOT-OD-19-021 and the NIH GPS for more information. 11/7/2018: New Requirement for NIH Training Grants NIH recently issued notice NOT-OD-19-029, adding a requirement that Training Grant applications include a signed letter of institutional commitment addressing three specific areas related to harassment and discrimination protections. This required letter must be included in applications submitted for due dates on or after January 25, 2019. A template letter can be found on the Sponsored Programs Website in the Forms & Templates/Proposal section. The letter must be sent to Academic Human Resources, firstname.lastname@example.org, for institutional signature. 11/28/2018: NIH - New Parent Announcements (PA) NIH has released new parent announcements to account for new opportunities for basic experimental studies involving humans. The new opportunities still have a PA for “Clinical Trial Not Allowed”, but have broken up the clinical trial opportunity into two separate PA’s for “Basic Experimental Studies with Humans Required” and “Clinical Trial Required.” The PA’s that have been added for “Basic Experimental Studies with Humans Required” are for studies that meet the definition of basic research and are also subject to clinical trials policies based on NIH’s definition. Please review NIH’s Parent Announcement webpage to make sure you have the correct parent announcement for upcoming NIH proposal submissions. For additional information related to Basic Experimental Studies Involving Humans, see the following Open Mike blog: https://nexus.od.nih.gov/all/2018/11/28/new-funding-opportunities-for-basic-experimental-studies-involving-humans/. 2016 News - expand to see all November 29, 2016: Revised NIH Grants Policy Statement The National Institutes of health has released a revised version of their Revised NIH Grants Policy Statement for FY 2017. This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2016. This revision supersedes, in its entirety, the NIH Grants Policy Statement (October/November 2015) as a standard term and condition of award. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2016. NIH’s summary of significant changes can found at https://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2016.pdf. A general summary can be found on our website at SUMMARY of NIH Changes Effective January 2017. May 25, 2016: New NIH Forms D NIH is gearing up to start posting updated application forms (FORMS-D) to be used for due dates on or after May 25, 2016. The use of these updated application forms is a critical part of their implementation of Phase II of the 2016 policy changes outlined in NOT-OD-16-004. You’ll start seeing FORMS-D application packages hit the streets as early as mid-March. See link to sample annotated Form set D below! http://grants.nih.gov/grants/ElectronicReceipt/files/Annotated_Forms_General_FORMS-D.pdf February 18, 2016: NIH Rigor and Reproducibility: Use of Animals in Research This session discussed factors contributing to variability of data associated with animal studies and how investigators might approach the new NIH requirements with respect to explaining the conditions around which studies are conducted. Power Point Presentation Handout - General parameters to be considered for in vivo work January 25, 2016: NIH Significant Changes for Proposals Due on or after January 25, 2016 Research Strategy Attachment In the significance section, must now also address the following: “Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.” In the approach section, must now also address the following: "Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application." "If your study(s) involves human subjects, you are expected to explain how relevant biological variables are important to the proposed experimental design and analyses. The sections on the inclusion of Women and Minorities and Inclusion of Children can be used to expand your discussions on inclusion and justify the proposed proportions of individuals (such as males and females) in the sample." Authentication of Key Biological and/or Chemical Resources - New Attachment! This is a new attachment required on the SF 424 (R&R) Other Project Information Form, in the Other Attachments field. The single file should be named “Authentication of Key Resources Plan.” The attachment must, “Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.” NIH provides a caution that the information in this attachment must focus only on authentication and/or validation of key resources to be used in the study; all other methods and preliminary data must be included within the page limits of the research strategy. Applications identified as non-compliant with this limitation will be withdrawn from the review process. Vertebrate Animals The criteria has been changed as follows: "Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the “Research Strategy” section. Identify the species, strains, ages, sex, and total numbers of animals by species, to be used in the proposed work. If dogs or cats are proposed provide the source of the animals." "Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro).” "Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain, and injury." "Euthanasia: State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification." Definition of a Child The age of a child will be defined as individuals under 18 years old instead of 21 years old. Training Grant Applications There are also significant changes to the training grant application instructions. If you are aware of a training grant application being submitted, please make sure to review the new application instructions and contact your Proposal Team if you have any questions. Direct quotes were taken from the Updated SF424 (R&R) Application Guide January 7, 2016: Educational Session for faculty PowerPoint Presentation of the session Video presentation of the session Link to the FASEB article titled, "Studying both sexes: a guiding principle for biomedicine" The FASEB Journal article fj.15-279554. Published online October 29, 2015. Link to the Academy of Medical Sciences website where you can download the Symposium report dated October 2015 titled, "Reproducibility and reliability of biomedical research: improving research practice." Link to the NIH Rigor and Reproducibility website Website includes scenarios, training materials and FAQ's related to the upcoming application changes for rigor and reproducibility. FASEB Issues Recommendations on Reproducibility The Federation of American Societies for Experimental Biology (FASEB) issued a set of recommendations aimed to promote the reproducibility and transparency of biomedical and biological research. 2015 News - expand to see all December 24, 2015: NIH Salary Cap Increase NIH salary cap increased to $185,100 effective January 10, 2016. More guidance when developing your NIH budget can be found at this link. 12/21/15 NIH has issued significant grant policy statement changes for 2016. 2/26/15 The DHHS/PHS Application Guide instructions related to "Submitting Subaward Budgets that are not Active for all Periods of the Prime Grant" found in section "4.8 Special Instructions for Preparing Applications with a Subaward/Consortium" has been revised and the section language has been replaced in its entirety; see NIH notice for details. 2/12/15 Future Year Commitments on FY 2015 New and Competing Renewal Awards: As in recent fiscal years (see NOT-OD-13-064), inflationary salary increases for future year commitments are no longer provided for all competing and non-competing research grant awards. This policy was established in 2012 under NIH notice NOT-OD-12-136 that states that a detailed budget can include salary cost-of-living/inflation increases; however, NIH will not award the salary increases due to NIH’s appropriated budget issues (starting in 2012 and continuing as a standing NIH policy). See NIH's FAQ for more information at http://grants.nih.gov/grants/financial/fiscal_policy_faq.htm#3411 2014 News - expand to see all 12/5/14 The National Institutes of Health has issued significant changes to its Biosketch requirements for all grant and cooperative agreement applications submitted for due dates on or after May 25, 2015. Use of the new format for proposals due before May 25, 2015 is highly encouraged. A very helpful NIH Biosketch Q&A webpage has been updated to explain this new requirement and can be found at this link. 12/30/14 Effective with all Kirschstein-NRSA awards made on or after October 1, 2014, the annual stipend levels* apply to all individuals receiving support through institutional research training grants or individual fellowships, including the Minority Access to Research Career (MARC) program for FY2015. *Level # Yr Experience AN Stipdend Level Monthly Stipend Level Freshman/Sophomore $8,640 $720 Junior/Senior $12,096 $1,008 Predoctoral All $22,920 $3,570 Postdoctoral 0 $42,840 $3,570 1 $44,556 $3,713 2 $46,344 $3,862 3 $48,192 $4,016 4 $50,112 $4,176 5 $52,116 $4,343 6 $54,216 $4,518 7 or more $56,376 $4,698 12/19/14 Contrary to the Uniform Guidance guidelines allowing a de minimis rate of 10% F&A, international subawards and educational grants have limited F&A rates. Foreign and international organizations are limited to 8% less equipment and other items normally treated as indirect costs (e.g. rent) (usually referred to as 8% of "modified total direct costs") subject to the following qualification: Foreign and international organizations may budget items normally treated as indirect costs as a direct cost if properly justified. NIH will evaluate these costs for allowability. Research Training and Education Grants (e.g. R25) and K Awards are limited to 8% less equipment, tuition and fees (and health insurance when awarded as part of tuition and fees), subawards in excess of $25,000, and items normally treated as indirect costs (usually referred to as 8% of "modified total direct costs"). 12/17/14 NIH has simplified it’s late application submission policy for applications submitted for due dates on or after January 25, 2015. Specifically, there is now a two week window of consideration after the application due date, during which time NIH might consider accepting a late application. This is a significant change from previous policy, which tied different late windows of consideration to different types of applications, and provided no late window of consideration for applications submitted to any RFA (Request for Applications) or PAR (Program Announcement) with special application due dates. See the notice for additional information. Examples of Reasons Why Late Applications Might Be Accepted: Death of an immediate family member of the PD/PI (or MPI). Sudden acute severe illness of the PD/PI (MPI) or immediate family member. Temporary or ad hoc service by a PD/PI on an NIH advisory group during the two months preceding or the two months following the application due date. Examples of qualifying service include participation in an NIH study section/special emphasis panel, NIH Board of Scientific Counselors, Program Advisory Committee, or an NIH Advisory Board/Council. Qualifying service does not include participation in NIH activities other than those involved in extramural/intramural peer review or NIH Advisory Council/Board service. Delays due to weather, natural disasters, or other emergencies, not to exceed the time the applicant organization is closed. For PD/PIs who are eligible for continuous submission (http://grants.nih.gov/grants/peer/continuous_submission.htm), the late application policy applies to activities not covered under the continuous submission policy (i.e., other than R01, R21, and R34 funding opportunities that use standard due dates).