IDeA Post Award Management Lisa Hildred Grants Management Specialist Grants Administration Branch National Institute of General Medical Sciences, NIH
Meet the Grants Management Team Christy Leake Sam Farrell Lisa Hildred Brian Iglesias Arina Kramer Courtney Tardd-Wright Emily Tran
IDeA Post Award Management IDeA Policy Reminders Cost Considerations Annual Performance Reporting Requirements Prior Approvals NIH Updates and Policy Reminders
IDeA Policy Reminders Funds awarded to an IDeA-eligible institution may not be transferred via subcontract to a consortium partner institution in a non-idea state. IDeA funds may be used in other IDeA and non-idea states for fee-forservice type of activities that include activities associated with collaborative projects, research education and training, sample and data analysis, workshops, etc. The PD(s)/PI(s) of IDeA awards may not receive research project support from any COBRE or INBRE program and may not use IDeA funds to supplement research activities within his/her laboratory. Junior investigators of COBRE or INBRE funded research projects or pilot projects may not receive simultaneous research support from more than one IDeA program or receive multiple research projects or pilot projects.
Selected items of Cost Honorarium unallowable when the primary intent is to confer distinction on, or to symbolize respect, esteem, or admiration for, the recipient of the honorarium; a payment for services rendered such as speakers fees is allowable Stipends only allowable on training grants; unallowable on IDeA grants; Compensation of Students is allowable Housing not allowable on NIH grants per diem for research participants as part of other expenses is allowable General Supplies Only costs directly related to the grant and/or project are allowable as direct costs; must be consistently treated and reasonable within organizational policy Meals/Food allowable in cases when they are an integral and necessary part of a meeting; must be consistently treated and reasonable within organizational policy Scholarships not allowable on NIH grants; Compensation for research experiences, Participation or Incentive costs is allowable
Post Award Requirements
Annual Performance Reporting Requirements Research Performance Progress Report (RPPR) Annual progress reports for non-snaps are due two months (60 days) prior to the anniversary date Failure to submit complete and timely progress reports may affect future funding to the organization Grantees may access a list of progress reports that are due using the Status page in era Commons, and selecting the Tab "List of Applications/Grants
Annual Performance Reporting Requirements Scientific Information Reporting System (SIRS) Inclusion Management System (IMS) data Inclusion Reports Submitted with the RPPR submission Progress Report Additional Materials (PRAM) Must be initiated by the Grants Management Specialist Allows additional information to be submitted via the era Commons If you need to submit an inclusion report after the RPPR is submitted, you must use the PRAM
Prior Approvals NIH Grants Policy Statement Sections 8.1 Changes in Project and Budget https://grants.nih.gov/grants/policy/nihgps/html5/section_8/8.1 _changes_in_project_and_budget.htm 8.1.2 Prior Approval Requirements https://grants.nih.gov/grants/policy/nihgps/html5/section_8/8.1 _changes_in_project_and_budget.htm#prior 8.1.3 Requests for Prior Approval https://grants.nih.gov/grants/policy/nihgps/html5/section_8/8.1 _changes_in_project_and_budget.htm#requests
Requests for Prior Approval Requests for actions that require prior approval must be submitted by an Authorized Organization Representative (AOR) to the NIGMS Grants Management Specialist and Program Officer no later than 30 days before the proposed change NIGMS tries to respond to all prior approval requests within 30 days of receiving all necessary information from the grantee
Prior Approvals The following are some Prior Approvals frequently requested for IDeA grants: Carryover of Unobligated Balances Change of Key Personnel Change of Scope Addition of new research projects and changes to currently approved research projects Addition of new pilot projects and changes to currently approved pilot projects
Carryover of Unobligated Balances IDeA grants do NOT have automatic carryover Prior approval is required to use unobligated funds from a previous budget period during the current budget period
Carryover Requests A carryover request should include the following: Explanation of why there is an unobligated balance Justification of why carryover funds are needed in the current year If the request will generate recurring costs in future years, an explanation of how costs will be supported without future use of unobligated balances or new supplemental funding Budget and justification pages (PHS398 or SF424), including any subcontract sites Calculation of F&A costs (checklist page of PHS398 or SF424) Appropriate Just In Time (JIT) documents (e.g., biosketches for new key personnel, other support, human subjects education certification) Equipment quotes, if appropriate
Reasons Why Carryover Requests are Delayed or Rejected: The prior year Federal Financial Report (FFR) has not been received and approved by NIH The request was not signed by or sent through an Authorized Organization Representative (AOR) Requested costs duplicate costs in the current year s award Unlikely that carryover funds can be spent in the budget period they are requested Unallowable costs were included Use of the carryover funds are not within the currently approved scope of the grant Carryover request does not reflect immediate needs No plan to support recurring costs in future years
Change of Key Personnel Prior approval is required for the following changes regarding the PI and any Key Personnel named on the Notice of Award: Reduction in effort of 25% or more of the originally approved effort level Reduction in effort that would bring the person below the required minimum effort level Removal from the grant Replacement/Addition of Key Personnel
Change of Key Personnel A request for changes to key personnel must include: The reason for the request (leaving/joining/replacing) Justification for selection of the person Level of effort and duties to be performed Explanation of any changes to the budget or scope of the grant Biographical sketch for new person Updated other support for new person Human subjects education if person is involved in the design and conduct of human subjects work
Change of Scope A change of scope requires prior approval Potential indicators of a change in scope: Change in the specific aims approved at the time of award Change from the approved involvement of human subjects Change from the approved use of live vertebrate animals Substitution of one animal model for another Shifting research emphasis from one disease area to another Applying a new technology; i.e., changing assays from those approved to a different type of assay Transfer of performance of substantive programmatic work to a third party Change in other senior/key personnel not specifically named in the NoA Significant rebudgeting of 25% or more in a single direct cost budget category Purchase of a unit of equipment exceeding $25,000
IDeA Research and Pilot Projects Official approval from NIGMS is required prior to the commencement of any new research project or pilot project COBRE I and II : research and pilot projects COBRE III and IDeA-CTR : pilot projects only INBRE : research and pilot projects
Addition of Research Projects COBRE I and II Prior to the commencement of any new research project, the following documentation must be submitted to NIGMS staff: Research project proposal. Using PHS398 forms and instructions, only the following sections have to be submitted: Face Page Project Summary (Page 2) Research Strategy Section External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the research project Biographical Sketch of Research Project PI Updated other support of Research Project PI Detailed Budget with justification Checklist Format Page with F&A cost breakdown IRB approval, human subjects education certification, and Targeted/Planned Enrollment Table (if applicable) IACUC approval and Vertebrate Animal Section (if applicable) Terms of the NoA
Addition of Pilot Projects COBRE I, II, III, and IDeA-CTR Prior to the commencement of any pilot project, the following documentation must be submitted to NIGMS staff per NOT-GM-14-111 (http://grants.nih.gov/grants/guide/notice-files/not-gm-14-111.html): Pilot project proposal. Using PHS398 forms and instructions, only the following sections have to be submitted: Face Page Project Summary (Page 2) Research Strategy Section External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the pilot project. IRB approval, human subjects education certification, and Targeted/Planned Enrollment Table (if applicable) IACUC approval and Vertebrate Animal Section (if applicable) Terms of the NoA
Addition of Research and Pilot Projects - INBRE Prior to the commencement of any developmental research project and pilot project, the following documentation must be submitted to NIGMS staff: Developmental Research Project/Pilot Project proposal. Using PHS398 forms and instructions, only the following sections have to be submitted: Face Page Project Summary (Page 2) Research Strategy Section External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the developmental research project/pilot project. IRB approval, human subjects education certification, and Targeted/Planned Enrollment Table (if applicable) IACUC approval and Vertebrate Animal Section (if applicable) Terms of the NoA
Changes of Human Subjects and Vertebrate Animals Involvement Changes of human and vertebrate animal involvement require prior approval For IDeA grants, changes to human subjects and vertebrate animals involvement are usually due to research and pilot projects The required prior approval items for both human subjects and vertebrate animals are submitted as part of the prior approval request for research and pilot projects
When Prior Approval is Not Needed NIH prior approval is not required for certain budget and project changes, unless the incurrence of costs is associated with or is considered to be a change in scope. Incur pre-award costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award. Recipients may incur pre-award costs before the beginning date of a non-competing continuation award without regard to the time parameters stated above. Initiate a one-time extension of the final budget period of a previously approved project period without additional funds (a.k.a First No-Cost Extension) Rebudget among budget categories Rebudget between direct and F&A costs
When Prior Approval is Not Needed Level of Effort Changes The personnel are not named on the Notice of Award The personnel are not required to maintain a minimum level of effort (e.g. Pilot Project PIs) The departure or addition of personnel does not result in a change of scope
If you aren t sure if prior approval is needed Check the NIH Grants Policy Statement on Prior Approvals for guidance Ask your Sponsored Programs Office / AOR Ask your Program Officer Ask your Grants Management Specialist
NIH Updates & Policy Reminders
Grant Closeout Requirements NIH GPS 8.6 Closeout: Recipients must submit all closeout documents within 120 calendar days of the end of the period of performance (project period) Final Research Performance Progress Report (F-RPPR) Final Invention Statement and Certification (FIS) Final Federal Financial Report (FFR) HHS policy requirement - Unilateral closeout of awards if the following final reports are not timely and acceptable. Other enforcement actions, such as withholding of further awards, can also be taken.
Interim and Final Progress Reports NOT-OD-17-022: The Final Research Performance Progress Report (F-RPPR) has replaced the Final Progress Report (FPR) for closeout The general format is the same as the interim/annual RPPR Recipients are required to report on Project Outcomes Due dates have not changed NOT-OD-17-037: Implementation of the Interim-RPPR while a Renewal Application is Under Consideration - Effective 02/09/2017 If the recipient organization has submitted a renewal application on or before the date by which a Final-RPPR would be required for the current competitive segment, then submission of an Interim-RPPR via era Commons is required no later than 120 calendar days from the period of performance end date If the renewal application is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the renewal application is not funded, the Interim-RPPR will be treated by NIH staff as the institution's Final-RPPR.
NIH Forms NIH transitioned to FORMS-D Grant Application Forms in May 2016 NOT-OD-16-084 includes a summary of the changes NOT-OD-17-062: New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018 Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms Expansion and use of discrete form fields for clinical trial information Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms Application guides for FORMS-E application packages will be posted to the How to Apply - Application Guide page no later than 10/25/2017 v COBRE Phase I applications due date: January 24, 2018 v INBRE due date applications due date: March 27, 2018
Clinical Trials NOT-OD-16-148: Expects all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials be trained in Good Clinical Practice (GCP) Effective 01/01/2017 NOT-OD-16-149: Expects all NIH-funded clinical trials are registered and that results are submitted to ClinicalTrials.gov whether or not subject to FDAAA Applies to grants, contracts, and intramural clinical trials submitted on or after 01/18/2017 NOT-OD-16-094: Single Institutional Review Board for Multi-Site Research. Applicants will be expected to include a plan for the use of an sirb in grant applications submitted to the NIH for due dates on or after 1/25/2018. NOT-OD-17-043: All grant applications with plans to conduct clinical trials must be submitted in response to an FOA which specifically states that clinical trials are allowed Effective 01/25/2018 New and reissued FOAs expected to be updated fall 2017
Stay Informed Through outreach & education (formal & informal) Through training within your own institution Utilize era Commons New & revised policies announced through NIH GUIDE Notices (sign-up for the listserv; NIGMS Feedback Loop, NIH Extramural Nexus, OER Blog posts) The Notice of Grant Award (reference terms and conditions of award) Through Your GMS! Communicate early and often
Questions? NIGMS GAB CRCB Team Christy Leake Christy.Leake@nih.gov GAB CRCB Team Leader Specialists IDeA State Assignments Arina Kramer Arina.Kramer@nih.gov Kentucky, New Hampshire, Oklahoma, South Dakota Brian Iglesias Brian.Iglesias@nih.gov Alaska, Arkansas, North Dakota, Rhode Island Courtney Tardd-Wright Courtney.Tardd- Wright@nih.gov Nebraska, New Mexico, West Virginia, Wyoming Emily Tran Emily.Tran@nih.gov Delaware, Kansas, Mississippi, Vermont Lisa Hildred Lisa.Hildred@nih.gov Hawaii, Idaho, Nevada, South Carolina Samantha Farrell Samantha.Farrell@nih.gov Maine, Montana, Louisiana, Puerto Rico