Transcript Document
Introduction to Pre-Award Partners Research Management June 2011 © Partners HealthCare System, Inc., 2011 Don’t Mess with your Grants Administrators ! PI Topics of Discussion – Grant Lifecycle – Research Management Pre-Award Office Structure – Research Institutions – Sponsor and Proposal Types • Common Sponsors • Types of Grant and Cooperative Agreement Announcements • Types of Applications Topics of Discussion – Electronic Research Administration • • • • InfoEd PD Grants.gov NIH eRA Commons NSF FastLane, Proposal Central and other Foundation Websites – Proposal Process • • • • • Creation and Submission Process Partners Internal Documents PI and Institution Approvals SF424 R & R Internal Grant Review and Approval Deadlines Topics of Discussion – Required Compliance Approvals • IACUC • IRB • Possible Additional Approvals – ESCRO – Biohazards/Recombinant DNA – Export Controls • Common Points of Negotiation – Proposal Budgets • • • • • • Allowability, Allocability and Reasonableness Effort Modular budgets F&A Costs MTDC Calculation Cost Sharing Topics of Discussion – After the Proposal has been Submitted • NIH Review • Just-in-Time Requests • Progress Reports – Deliverables • Other Support Grant Lifecycle Proposal Development (PD) More Money! Locate Funding & Complete Proposal Package Institutional Review Record Creation (PT) Proposal Submission and/or Signature Approval Close-outs and Sponsor Reports Just-in-Time submission Progress Report review & Submission Tracking and Accounting Contracts Incurring Costs and Purchasing Negotiate & execute incoming & outgoing subcontract & contract agreements Account set up Prior Approval requests Pre-Award Office Structure • • • The Pre-Award Office is part of the Office of Research Management Pre-Award Roles: – Grant Administrator I, Grant Administrator II, Senior Grant Administrator, PreAward Manager and Director The Pre-Award Office is responsible for the following steps in the Grant Lifecycle: – Review proposal guidelines (PA, RFA, RFP, BAA. foundations) to ensure that, if awarded, the terms and conditions are in compliance with Partners policy and to ensure the proposal is submitted in compliance with Sponsor specifications – Review the proposal, budgets, and supporting documentation – Ensure proper institutional sign-offs on proposals, as well as other commitments (commitments of space, resources, specialized facilities or equipment, level of effort, cost sharing, etc.) – Review Draft InfoEd PD record/application, approve Final record to convert to PT and complete/review the record for accuracy – Review and submit Just-In-Time (JIT) submissions – Review and submit Progress Reports – Provide technical guidance to PI and Department Grant Administrators Pre-Award Team • McLean info to be inserted Research Institutions • Partners is composed of multiple legal entities, each with their own Federal Identification Number and accounts. A few of them are represented here. • • Partners entities also work with organizations that are not part of the Partners HealthCare System, but they collaborate closely on research. Grants may be awarded to a Partners entity as the prime recipient and then a portion of the research may be subcontracted out to an affiliate or another institution to complete under the terms of a subcontract. For example, MGH may be the prime and DFCI the subcontract, as shown here. • Both the prime recipient and the subcontractor must adhere to Sponsor guidelines Partners HealthCare Mass General Hospital Spauldin g Rehab Dana Farber Cancer Institute Brigham and Women’s Hospital McLean Hospital Harvard Medical School Broad Institute Common Sponsors and Funding Organizations • • Federal Sponsors – Department of Health and Human Services (DHHS) • National Institutes of Health (NIH) – 27 Institutes and Centers within the NIH » National Cancer Institute (NCI) » National Center for Research Resources (NCRR) – National Science Foundation (NSF) – Department of Defense (DOD) – National Aeronautics and Space Administration (NASA) Non-Federal Organizations – American Heart Association – American Cancer Society – Robert Wood Johnson Foundation – Pew Charitable Trust – John D. & Catherine T. MacArthur Foundation – Burroughs Wellcome Fund Department of Health and Human Services National Institutes of Health National Cancer Institute Types of Grant and Cooperative Agreement Announcements – Parent Announcements – All electronic grant applications must be submitted in response to a Funding Opportunity Announcement (FOA). Provides guidance regarding the application process. – Program Announcements (PA) – A formal statement about a new or ongoing extramural activity of mechanism. Most PAs have a standing submission date. – Requests for Applications (RFA) – A formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. Will specify the amount of funding available, number of awards to be made and the specific application date. Includes detailed and specific information regarding how to apply. – Broad Agency Announcements (BAA) - Is a competitive solicitation procedure used to obtain proposals for basic and applied research from a federal agency. A BAA will also specify the general terms and conditions under which an award may be made. – Request for Quotations (RFQ) - Is also a competitive solicitation procedure. A request for quotation (RFQ) is a document that an organization submits to one or more potential suppliers eliciting quotations for a specific service or product. Typically, an RFQ seeks an itemized list of prices for something that is well-defined and quantifiable, such as lab tests. – Request for Proposals (RFP) - is a formal statement that invites grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. The RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, and the application receipt date(s). Types of Applications • • • • • • • Competing Applications – New or resubmitted applications that must undergo initial peer review. Competitive Renewal - An application requiring competitive peer review and Institute/Center action to continue beyond the current competitive segment. Administrative Supplement - Monies added to a grant without peer review to pay for items within the scope of an award but unforeseen when a grant application was submitted. Resubmitted Application - Unfunded application that has been resubmitted for consideration. NIH allows only one resubmission. Non-Competing Continuation – A year of continued support for a funded grant. Progress reports for continued support do not undergo peer review but are administratively reviewed by the Institute/Center and receive an award based on prior award commitments. No-Cost Extension – Request for additional time beyond the years previously awarded. Modification - Change Order or Supplemental Agreement not meeting the requirements for a renewal as shown above; however, alters or amends one or more provisions of an existing contract (i.e., extensions of less than six months, overhead adjustments and/or obligation of additional funds with or without extending the contract). Electronic Research Administration Most sponsors have moved to electronic submission formats to reduce the administrative burden and accelerate the proposal process. • InfoEd Proposal Development (PD) • • • Grants.gov (multiple Government funding sources) • • • • • FastLane is an interactive real-time system used by the NSF https://www.fastlane.nsf.gov/fastlane.jsp ProposalCENTRAL • • • Web interface where NIH and the grantee community are able conduct extramural research administration business electronically New department users and Investigators must contact their GA to establish an account https://commons.era.nih.gov NSF FastLane • • • Grants.gov is a central storehouse for over 1000 grant programs and approximately $400 billion in annual awards. This is our main electronic submission environment http://www.grants.gov/index.jsp NIH eRA Commons • • InfoEd PD is the internal mechanism to create and submit grant proposals http://www.infoed.partners.org proposalCENTRAL is an e-grantmaking Website used by many Foundations, including the American Cancer Society https://proposalcentral.altum.com/ Foundation Websites • • Some foundations such as Susan G. Komen Foundation and American Heart Association have their own grant submission sites Proposal Process Proposal Creation and Submission Process • Step One: Identification of Funding Opportunities – Search for funding opportunities - Principal Investigator (PI) and Department Administrator (DA) • Step Two: Proposal Preparation – Develop proposal (narrative, budget, key personnel) - PI and DA – Submit to RM via InfoEd PD or eSubmission Grant Portal = PCS, COIs, Budget Template, Proposal • Step Three: Proposal Review and Approval – Proposal requires technical/scientific review and approval from the Division and/or Department Chief (cost sharing, budget, science review) – Institutional review and approval from Research Management • Step Four: Proposal Submission – Proposal is submitted electronically/signed by Research Management Pre-Award GA or mailed to Sponsor - PI/Department Partners Internal Proposal Documents ― Partners Proposal Coversheet • Internal form that provides a snapshot of application information and conveys the required hospital approvals and assurances for submission • NOTE: if your department is not submitting applications via InfoEd PD, the paper signed PCS must accompany the proposal ― COI(s) • Required for all (BWH/MGH) Key Personnel • Required annually for all awards (except Industry and sundry) • Will become electronic in September 2011 ― Statement of Intent/Statement of Work • Required for subcontracts ― Agency Guidelines • Research Management requires Sponsor guidelines in order to begin the review process ― Cost Share Forms • Partners requires internal approval for all proposed cost sharing Approvals • There are typically three levels of approval needed for submission of applications: Principal Investigator, Department/Division Chief and Research Management • In some cases, there may be four levels of approval required: Principal Investigator, Division Chief, Department of Medicine Chief, and Research Management • Department approvals (PCS) are obtained electronically via InfoEd PD routing: – PI and Chief electronic signatures are required for all applications Approvals – PI Signature • • Why is the PI signature on the PCS a critical piece of information? – The assurance includes the following certifications: (1) that the information submitted within the application is true, complete and accurate to the best of the PI's knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties; (3) that the PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded; (4) that the PI has reviewed all subcontracts to ensure budgetary compliance and that the subcontract is able to competently complete the required technical and administrative tasks for successful completion of the project; (5) that the PI acknowledges scientific and financial oversight of the study; and (6) that the PI attests that sub-recipient technical progress has been monitored by regular communication with the sub-recipient PI, monitoring receipt of technical reports for timeliness and content, and communicating with Research Management if changes need to be made to the SOW, reporting requirements, or budgets. – Partners must collect and retain a signature and date for each submitted application. This assurance must be available to the Federal or sponsoring agency upon request. When multiple PIs are proposed on an application, signed assurances must be retained for all named PIs. Institutional Signatures and Sponsor Deadlines • Institutional Signature – – – – – • Required for all submissions Awards are issued in the name of the INSTITUTION, not the researcher Legally binding to the Institution Acceptance of terms - may involve technology transfer, intellectual property Commitment to any cost sharing contained in the proposal Sponsor Deadlines – – Sponsor deadlines are set by the sponsor and will be listed in the proposal guidelines (RFA, PA, RFP, BAA, foundations) NIH expects that grant applications will be submitted on time. Late applications are generally not accepted. In rare cases, late applications will be accepted but only when accompanied by a cover letter that details compelling reasons for the delay. The PI would need to contact his/her Program Officer. SF424 R&R ― The Standard form used by most Government funding sources, such as NIH, Department of Defense (DOD), and Agency for Healthcare Research and Quality (AHRQ). ― Form Sections - SF424 - Project/Performance Site Location(s) - RESEARCH & RELATED Other Project Information - RESEARCH & RELATED Senior/Key Person Profile - PHS 398 Cover Page Supplement - PHS 398 Research Plan - PHS 398 Checklist - PHS 398 Cover Letter - PHS 398 Modular Budget - or - Research & Related Budget - R&R Subaward Budget Attachment(s) Form (if sub out) Internal Grant Review and Approval Deadlines • • Deadlines for DRAFT Submissions 10 business days before Sponsor deadline • The grant application and required internal documents must be submitted to Research Management by uploading to InfoEd PD or the secure website at http://insight.partners.org/documentsubmission/. • InfoEd PD: All internal documents (PCS, COI) must be included, and administrative portions of the grant should be complete. Draft routing should be planned so the record is available for the GA to begin reviewing 10 days before the due date. • If your department is not using InfoEd PD, the application and all required documents should be uploaded to the Insight Portal 10 days before the due date. • Research Management comments will be communicated to the PI and/or Departmental Administrator within 5 business days of receipt. • • Deadline for FINAL submissions 5 business days before Sponsor deadline • Administrative corrections should be completed and the Final application record available for review. Upon confirmation from the Department Administrator or PI, the application will be submitted. Required Compliance Approvals IACUC IRB ESCRO Biohazards Recombinant DNA Export Controls IACUC – Institutional Animal Care and Use Committee • The IACUC Review board assures that type and number of animals requested in a protocol are appropriate and that the Investigators and other laboratory personnel complete the federally mandated training for the care and use of laboratory animals. • The IACUC oversees the facilities and monitors all activities to assure that animals are treated humanely and with proper care, and that the animal care facility is in compliance with all relevant government laws, regulations and policies. • Please refer to: Guide for the Care and Use of Laboratory Animals: Eighth Edition http://www.nap.edu/catalog/12910.html • The IACUC approval should be listed as “Pending” on an application when it is initially submitted. If a Just-in-Time (JIT) requests IACUC approval, then it is submitted with other JIT requested elements. • Investigators must submit an IACUC protocol approval request for all new awards even if similar work has already received IACUC approval or the PI can request a modification to an already approved protocol to have the new award and users listed. IRB – Institutional Review Board • • The Institutional Review Board for the Use of Human Subjects reviews protocols and grant applications for research that involves human subjects Training and certification of study staff (CITI quiz and certification) is required prior to being allowed to work with human subjects or human related data: http://healthcare.partners.org/phsirb/education.htm • IRB review and approval is required for all research using humans as part of the research – May be documented as “Pending” when a proposal is initially submitted. The approval will be requested at Just-in-Time. • HIPAA (Health Insurance Portability and Accountability Act of 1996) – Patient education on privacy/ access to medical records/ use of records for research purposes • • The Partners Human Research Committee (PHRC) reviews all human subject protocols for Partners PIs: http://healthcare.partners.org/phsirb/ New research awards must undergo IRB review even if similar work has already received IRB approval or the PI can request a modification to an already approved protocol to have the new award and users listed. Possible Additional Approvals • • • Human Embryonic Stem Cells (ESCRO) – Research involving human embryonic stem cells requires ESCRO approval http://healthcare.partners.org/phsirb/guidance.htm Biohazards – Biosafety committee approval is required for research using hazard chemicals or agents BWH Biosafety Officer - Ted Myatt, ScD [email protected] 617-964-8550 Environmental Health and Safety Office at MGH http://intranet.massgeneral.org/ehs/ehs_home.htm • Recombinant DNA (rDNA) – Approval is required for research involving the transfer of rDNA work. • Export Controls – Research involving the export of materials or technology to certain foreign countries may be restricted by Federal regulations. The Institutional Research Compliance Office can assist in the event special licensing is required http://resadmin.partners.org/RM_Home/Documents/RMPolicies/ExportControlPolicy.pdf Common Points of Negotiation • When a solicitation specifies the terms and conditions of award (e.g., a federal RFP or BAA), Research Management reviews the terms prior to the submission of the proposal to ensure that the institution is able to comply. If terms are found to be unacceptable, an Exception letter to the problematic terms must be included at time of proposal submission. • Some Common Points of Negotiation are: – Award Amounts – Payment Terms and Schedule – Mandatory Cost Sharing – Rights to any resulting intellectual property that may arise from the work – Restrictions to the Investigators ability to freely publish and share the results – Additional Negotiation during Award Acceptance process • Partners Customary Contract terms can be found on the RM intranet: http://phsresearchintranet.partners.org/PHS_ResearchMgmt/documents/Terms&Condit ions.pdf Proposal Budgets Allowability, Allocability, Reasonableness Effort Modular Budgets F&A Calculation MTDC Cost Sharing Allowability, Allocability and Reasonableness • Certain conditions must be met for a potential budget line item to be included in the proposal budget. Each budget line item must be: • Allowable - eligible for reimbursement – Pursuant to Federal or Sponsor Guidelines – Sample budget items that are not permitted on Federal Grants: – Alcoholic beverages and other entertainment costs – General or University-related marketing activities – Lobbying of Government Officials – Fund raising costs • Allocable - able to be applied to a specific cost category – Incurred solely to advance the work under the sponsored agreement; – Benefits both the sponsored agreement and other work of the institution in proportions that can be approximated through use of reasonable methods – Necessary to the overall operation of the institution and, in light of the principles provided in the OMB Circulars, is deemed to be assignable in part to sponsored projects • Reasonable– Costs must be reasonable to the project What is Effort? • Effort is measured in “person months” and Is the metric for expressing the effort (amount of time) PI(s), faculty and other senior personnel devote to a specific project. • Effort is reported on the All Personnel Report and is part of the NonCompeting Continuation Progress Report (PHS 2590). • The PD/PI(s) is always reported, regardless of their level of effort. Report other personnel who participated in the project during the current budget period (period for which the report covers) for one person month or more, regardless of compensation, salary, affiliation or Senior/Key status. Modular Budgets • For certain grant mechanisms, NIH provides the opportunity to apply for funding under a less stringent set of budget guidelines in order to reduce the administrative burden on both the Grantee and Sponsor • Modular budgets require less detail in the proposal budget and accounting – Direct costs must be $250,000 or less per year – Budget is requested in $25,000 increments – Budget Justification should only include Personnel, Consortium Justification, and justification of any unusual expense that requires additional $25,000 modules in any year • http://grants.nih.gov/grants/funding/modular/modular.htm F&A (Facilities and Administrative) Costs • F&A costs are expenses incurred for common or joint activities – cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. – Examples: Building maintenance costs, electricity, phone charges • F&A costs are applied to direct costs, excluding equipment, subcontracts greater than first $25,000, patient care costs, alteration and renovations, and animal expenses (please refer to individual Institutional Rate Agreement). • Each Partners entity negotiates a multi-year agreement of predetermined F&A rates with DHHS each year. The current applicable rates are available on the Partners intranet site. • Partners policy requires that the full negotiated F&A rate be used for all Sponsors (Federal, Foundation, and Industry). An exception is made for foundations, non-profit sponsors and government agencies with explicit, published policies limiting F&A recovery to a lesser amount. This will be specified in the proposal guidelines or online at the sponsor’s website. Any other exceptions to the Partners F&A policy require the approval of the institution's Sr. Vice President for Research. http://phsresearchintranet.partners.org/PHS_ResearchMgmt/documents/RMPolicies/F&ACostsPolicy.pdf MTDC Calculation • • • Modified Total Direct Costs (MTDC) – Common Base method for calculating the F&A Amount on a proposal MTDC = all direct costs minus exclusions Example: – Salaries $50,000 – Equipment $25,000 – Supplies $5,000 – Subcontract $35,000 – F&A rate = 77% – Direct Costs = ? – MTDC = ? – F&A costs = ? – Total Budget Requested = ? Example - MTDC • Example: – Salaries $50,000 – Equipment $25,000 – Supplies $5,000 – Subcontract $35,000 – Direct Costs = $115,000 – MTDC = $80,000 (excluded equipment and $10,000 of subcontract costs) – F&A costs = $60,000 (77% F&A multiplied by $80,000 MTDC = $61,600 F&A costs) – Total Budget Requested = ($115,000 + $61,600 = $176,600) Cost Sharing – Mandatory = required by sponsor – approved by Director of Pre-Award – Voluntary committed = offered by grantee – Approved by BWH/MGH Sr. Vice President What kind of cost sharing is required? – Matching - Cost sharing where the institution will match the financial value of the sponsor’s grant to help fund that specific project – In-Kind - Cost sharing where costs are borne by an external organization, for example when individuals at another organization volunteer their time. • Many institutions, including Partners, have policies limiting voluntary cost sharing. For this reason, Departmental and Research Management approval of all cost sharing is required at the time of proposal. – Determining a source of secondary funding can delay the proposal process – Correct signatures/approvals ensure that voluntary cost sharing is not inadvertently written into the proposal and that any voluntary cost sharing that cannot be eliminated is minimized. After the Proposal has been Submitted NIH Review Just-in-Time Requests Progress Reports Grants process at a glance - NIH Planning: Applicant should start early, collect preliminary data, and establish internal deadlines. Writing: Applicant often begins writing application several months prior to application due date. Submitting: Applicant organization submits application to NIH Receipts and Referral: Months 1-3 Application arrives at Center for Scientific Review (CSR). (Applications compliant with NIH policies are assigned for review and funding consideration.) CSR assigns application to an NIH Institute/Center (IC) and a Scientific Review Group (SRG). Scientific Review Officer (SRO) assigns applications to reviewers and readers. Grants process at a glance, cont’ Peer Review: Months 4-8 Initial Level of Review: SRG members review and evaluate applications for scientific merit. Priority Scores: Available to PD/PIs on eRA Commons. Summary Statement: Available to PD/PIs on eRA Commons. Award: Months 9-10 Pre-Award Process: IC grants management staff conducts final administrative review and negotiates award. Notification of Award: IC issues Notice of Award (NoA) Congratulations! Project period officially begins! Second Level of Review: Advisory council/board reviews applications. You submitted a proposal, so what do you do now… • Once an application has been submitted, Grants.gov sends a series of status email notifications. The RM GA will confirm the success of the submission. If, there are Errors, the GA will work with the Department Administrator and PI to correct and resubmit the application. If the application has received an AN# and has no Errors, then it has been successfully submitted. • PIs are responsible for checking the submission status. If it is successful, they should review the application in eRA Commons to make sure the attachments appear correctly. You submitted a proposal, so what do you do now..., • Login to Grants.gov eCommons: • Click the Status tab and select the eApplication status. Within the eApplication search screen you will have several options (e.g., search by “PI Name”, search by “GRANTxxxxxxxx” etc.). Once your selection criteria is entered, click on the Search button on the bottom of the screen. • Find the application (match the application criteria, i.e. date submitted, title, etc.) that shows “eSubmission Error” in the Application Status. Click the link on the Application ID to see specific error/warning messages. • View the list of Errors/Warnings. Warnings may be fixed at the applicant’s discretion but do not require action for the application to proceed. Errors must be corrected by the due date of the grant before the application can proceed. Just-In-Time Requests • Just-In-Time (JIT) – Supporting information requested by the sponsor and submitted by Research Management before possible funding • Should only be submitted if requested by Grant Specialist. NIH eRA Commons records often show JIT link, which does not necessarily mean proposal will be awarded or requires JIT • Common JIT requests: – Active IRB approval – Active IACUC approval – Certification for Key Personnel to verify that they have completed an educational program on the protection of human subjects (CITI certification) – Current Other Support – list Active and Pending funding for each person considered Key Personnel for the project. Address how any budgetary, scientific or effort overlap will be resolved if proposal is funded. – Other items: Revised budget and/or budget justification Just-In-Time Requests, cont. – Information should generally be submitted within two weeks of receiving the JIT request or by the requested due date on email request. – If IRB or IACUC approval is not approved by JIT, they may be submitted to the sponsor as soon as they are approved, but the award will have restrictions in these areas. The approval process should be started by the PI if he/she received a fundable score. – All of the JIT information can be submitted via eRA Commons using the Just-in-Time feature found in the Status section. – All Just-in-Time submissions must be countersigned by an Authorized Institutional Official. – Just-In-Time requests are NOT a Notice of Award. They are an indicator of a possible award. Progress Reports Progress Reports • • • • Most progress reports are required annually by the sponsor Most NIH progress reports qualify for eSNAP - Electronic Streamlined Noncompeting Award Process For paper Progress Reports: use Grant Progress Report form (PHS 2590) and mail signed progress report directly to the awarding office To determine when a progress report is due, there are several tools available: • eRA Commons Status • Electronic Notifications: The PI receives an email 60 days before the scheduled due date. In the event a progress report is not submitted on time, a reminder email is sent to the PI • Progress Report due dates are set up in the InfoEd system under the Deliverable tab Progress Reports, (cont) eSNAP submissions: • Electronic progress reports must be submitted at least 45 days before the beginning date of the next budget period and are reviewed and submitted by the Pre-Award Grants Administrator Paper submissions of the PHS 2590: • Non eSNAP progress reports require paper submission. Complete the PHS 2590 progress report forms. The report should be ready to mail at least 60 days before the beginning date of the next budget period and is mailed by the PI or DA Non-Competing Grant Progress Reports, (cont) Components of an eSNAP, electronic submission: • Face Page – PI contact info, Signing Official contact info, compliance areas, Institutional info, performance site(s), Invention/Patent info and Organizational Certification with SO signature. Do not complete sections 8a and 8b. • Progress Report Summary - Were there changes from the proposed use of human subjects, animals, select agents or multiple PI Leadership plans? The Progress Report should be a brief presentation of the accomplishments on the research project during the reporting period, in language understandable to a biomedical scientist who may not be a specialist in the project's research field. Areas to be covered include; Specific Aims, Studies and Results - describe the studies directed toward specific aims during the current budget year and the positive and negative results obtained. Significance - emphasize the significance of the findings to the scientific field and their potential impact on health. Plans - summarize plans to address the Specific Aims during the next year of support. Include any important modifications to the original plans. Address any changes involving research using human embryonic stem cells, human subjects, and/or vertebrate animals. Tables and figures that summarize key accomplishments are not counted in the twopage limit. • All Personnel Report – include everyone who has dedicated more than 1 month effort: name, degree, last four digits of Social Security number, role on project for the current budget period, effort on project for current budget period. Progress Reports, (cont) Components of an eSNAP, electronic submission: • Checklist Page – Complete only if there is a change in Project/Performance site(s) that will affect facilities and administrative costs and/or if program income is anticipated. If program income is anticipated, the Checklist should reflect the amount and source(s) • 3 eSNAP Questions 1. Has there been a change in the other support of senior/key personnel since the last reporting period? Specific information is to be provided only if active support has changed. If a previously active grant has terminated and/or if a previously pending grant is now active, include Other Support information 2. Will there be, in the next budget period, a significant change in the level of effort for the PD/PI(s) or other senior/key personnel designated on the Notice of Award from what was approved for this project? A significant change in level of effort is defined in Federal regulations as a 25% reduction in time devoted to the project. If yes, explain. If no, question must be answered as “no” 3. Is it anticipated that an estimated unobligated balance (including prior year carryover) will be greater than 25 percent of the current year's total approved budget? If yes, provide an explanation which should include why there is a significant balance and how it will be spent if carried forward into the next budget period Progress Reports, (cont) Components of the PHS 2590 (non-eSNAP, paper submissions): • Face Page – PI contact info, Signing Official contact info, compliance areas, Institutional info, performance site(s), Invention/Patent info and Organizational Certification with SO signature • Detailed budget for the next budget period - Itemize the direct costs requested for the next budget period by budget categories. Use the recommended direct cost shown on the spreadsheet included with the Notice of Award issued in the competitive year as the guide for developing the line item annual budget • Budget Justification page – provide a detailed budget justification for the line items and amounts that represent a significant change (>25%) from what was originally requested for funding • Biographical Sketch - required for new senior/key personnel and/or new other significant contributors who will be working on the project in the requested budget period Progress Reports, (cont) Components of the PHS 2590, cont: • Progress Report Summary - same as for eSNAP submissions. • Checklist page – was there any Program Income? List current F&A date, Statement regarding Assurances/Certifications. • All Personnel Report – name, degree, last four digits of Social Security number, role on project for the current budget period, effort on project for current budget period. Other Support NIH definition of Other Support - Includes all financial resources, whether Federal, nonFederal, commercial or organizational, available in direct support of an individual’s research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. Other support does not include training awards, prizes, or gifts • • • • Do not submit information on Other Support with the application beyond that required in the biographical sketch. If this information is included at the time of application, processing may be delayed or the application may be returned to the applicant without review Don’t confuse “Research Support” with “Other Support.” Though they sound similar, these parts of the application are very different. As part of the bio sketch section of the application “Research Support” highlights your accomplishments, and those of your colleagues, as scientists. It is used by reviewers for the “investigator” review criterion. In contrast, “Other Support” information is required for all applications that are selected to receive grant awards. NIH staff will request current “Other Support” information after peer review. This information will be used to verify that the proposed research has not already been Federally-funded Information on Other Support assists awarding agency staff in the identification and resolution of potential overlap of support. Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100% is not permitted Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salary) are requested in an application but are already provided for by another source Commitment overlap occurs when a person’s time commitment exceeds 100% whether or not salary support is requested in the application Other Support Cont: • Scientific overlap occurs when - (1) substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration, or (2) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of the funding source • Resolution of Overlap - Resolution of overlap occurs at the time of award in conjunction with institution officials, the principal investigator, and awarding agency staff Information on active and pending Other Support is required for Key Personnel, excluding consultants For individuals with no active or pending support, indicate “None” Neither the application under consideration nor the current PHS award for this project should be listed as Other Support Do not include Other Support for individuals listed as "Other Significant Contributors" unless their involvement has changed so that they now meet the definition of "key personnel" Other Support Components of Other Support Submission: • • Project Number: If applicable, include a code or identifier for the project Source: Identify the agency, institute, foundation, or other organization that is providing the support • Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or subcontract • • • • Dates of Approved/Proposed Project: Indicate the inclusive dates of the project as approved/proposed. For example, in the case of NIH support, provide the dates of the approved/proposed competitive segment Annual Direct Costs: In the case of an active project, provide the current year’s direct cost budget. For a pending project, provide the proposed direct cost budget for the initial budget period Level of Effort: For an active project, provide the level of actual effort (even if unsalaried) for the current budget period. For a pending project, indicate the level of effort as proposed for the initial budget period Overlap: After listing all support, summarize for each individual any potential overlap with the active or pending projects and this application in terms of the science, budget, or an individual’s committed effort Questions? © Partners HealthCare System, Inc., 2011