Presentation on theme: "Frank Urso Executive Director of Research Administration"— Presentation transcript:
1 Responsible Conduct of Research Grant Writing, Budgeting and Management Frank UrsoExecutive Director of Research AdministrationHarvard School of Public HealthFebruary 14, 2014IntroductionRoleWhat our office doesSome statistics
2 Research Partnership Sponsor Applicant Peer ReviewProject ManagementProgram AdministrationPrinciple InvestigatorDepartmentCentral AdministrationThis model applies to Federal and non-federal awards.In the case of federal awardsFor Federal research our decentralized university centered model for basic research has been very successfulUniversities provide structure, resources, training and developmentThe federal government enjoys a competitive leveraged model for fulfilling its research agendaIN ALL CASES EXCHANGE OF VALUE
3 Award LifecycleProposal DevelopmentHU Review& SubmissionThrough Award Set-UpAward ManagementAward CloseoutProposal development happens in departmentsSubmission through set-up in spaManagement in departmentsCloseout through OSPGrant Managers and other Dept staff can help you navigate the system
4 A Principal Investigator (PI) Is… An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible and accountable to the grantee and NIH for the proper conduct of the project or activity. NIH Grants Policy Statement 10/11 On research projects, the PI is usually a faculty member.Grantee is the funding institute.PI Eligibility policy4
5 Ethical Considerations GOOD SCIENCEThe scientific research enterprise is built on a foundation of trustScientists trust reported results are validSociety trusts that scientists act honestly and without biasSTEWARDSHIP-Responsible Resource ManagementConducting research is a privilegeRegulatory oversight: human and animal subjects, environmental concernsPublic and or charitable fundsPis are trusted by sponsors and their home institutions to conduct good science &Responsibly manage resources
6 Responsibilities6Principal Investigators are in charge of technical and financial aspects of projectsPIs should work with administrators to help:Prepare and submit proposals with achievable scope and accurate budgetsSubmit technical reports on timeFollow federal cost principles
7 Grant ProposalsResponsible conduct of research begins at the proposal stage and the Principal Investigator is ultimately responsible for all aspects of the proposal as submitted to the granting agency or organization.Accuracy of the proposal is paramount to a successful and compliant research award.Scope of WorkBudgetCollaborators:Subcontractors, Consultants and Service AgreementsThree major components of proposals: SCOPE, BUDGET, COLLABORATORS
8 Grant ProposalsProposals are reviewed for overall impact and influence over the research fields involved.Research Misconduct can occur if there is fabrication or falsification in grant proposals.Do not provide embellished or misleading information in the scope of work, CV or other agency-required documentation.There is a line between touting your expertise and experience, and exaggerating them – don’t cross itFor help with grant development consider using ORSD editorial or peer review servicesACCURACY is PARAMOUNT
9 Basics of Effective Proposals DOCUMENTATION and TIMELINESSClear languageList full names/titles prior to abbreviatingPresentation is importantFollow instructions and guidanceCultivate relationships and communication - with all stakeholdersSpend appropriately and to whatever extent possible according to planTransparency
11 Extra Prep Time Needed For… 11Collaborations with other departments or institutionsLarge, complicated projectsNewsworthy projectsComplex compliance issues (PAs, FCOI, Provost review)
12 Proposal Submission12Work with your grant administrator to create the best proposal possibleSend proposal for SPA review 10 days prior to sponsor due date (submission deadlines vary by school)Proposals are ultimately submitted via one of the university Sponsored Program OfficesHSPH SPAHMS SPAUniversity OSPProposal submission cannot be guaranteed if university review begins later than 5 business days prior to sponsor due date
13 Choosing your Collaborators 13When a Harvard collaborator is not available there are several options for establishing relationships with collaborators.During proposal development, discuss the collaboration you have in mind with your departmental administrator to determine whether the relationship is a subaward or a vendor procurement/purchased services transaction.The terms and conditions governing the relationship will differ whether it is with a subrecipient or with a vendor furnishing goods and/or services.At the same time, the Principal Investigator should assess the potential Collaborator’s ability to perform the work successfully based on:Expertise and past performanceTechnical/financial resourcesProposed scope of workThere are financial, operational, risk and compliance ramifications to your choices
14 Cost of Doing Research14Direct Costs + Indirect Costs = Project CostsAlso referred to as:-IDC-Overhead-F&ADirect Costs: Expenses that are specifically associated with a particular sponsored award and/or can be directly assigned to that award with a high degree of accuracyIndirect Costs: Expenses that cannot be specifically identified with a particular project or activity.
15 Cost Principles: Direct vs. Indirect Cost Direct CostsExpenses that are specifically associated with a particular sponsored award and/or can be directly assigned to that award with a high degree of accuracyIndirect Costs (Facilities & Administrative (F&A))Expenses that cannot be specifically identified with a particular project or activity. “Overhead costs are administration, buildings, utilities, research infrastructure, and other expenses necessary for the operation of the University.”
16 Cost PrinciplesHarvard and its Principal Investigators are jointly responsible for managing sponsored funds in accordance with the cost principles set forth in OMB Circular A-21.For a cost to be allowable under OMB Circular A-21,it must be reasonable, allocable, and consistently treated.A cost is reasonable if it is necessary for the performance of the specific award and would have been incurred by a “prudent person” for the particular goods or services obtained.A cost is allocable if its benefit, either in whole or in part, to the specific sponsored award can be demonstrated.A cost is consistently treated if it is always institutionally treated as either a direct cost of research or an indirect (Facilities and Administrative; F&A) cost of research when incurred for the same purpose in like circumstances.
17 Costs Normally Considered F&A 17administrative & clerical salaries & fringebooks & subscriptionsconference feeshazardous waste disposalmembership duesoffice suppliespersonal computerspostage & shippingproposal preparationsoftware- generaltelephone & fax service (basic costs)Auditors look at these closely and regularly – any idea as to why these aren’t directly charged?administrative costs – could be used for any reasonhard to specifically identifyindirect costs pays for libraries – so sponsored awards shouldn’t pay for books and subscriptions
18 OMB Circulars A-21 and A-110Principles for Determining Costs Applicable to Grants, Contracts, and Other Agreements with Educational Institutions (OMB Circular A-21) provides:the principles governing reimbursement of research costs for grants made to colleges and universities.These principles define those costs that are allowable and allocable to the federal government, and those that are notGrants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (OMB Circular A-110) provides:the administrative rules for managing grants responsibly, including procuring goods and services, managing equipment, financial and non-financial reporting, record retention, etc.These apply to federal grants
19 Budget Estimate the project costs accurately. Don't overstate or understate your expensesThe budget should be complete and fully-loadedInclude all the costs of personnel, equipment, supplies, and activities required for the projectUse the correct F & A rate – on-campus v. off-campus (see policy)Expenditures must be allowable, appropriate, and reasonable in accordance with applicable cost principles.Actual expenses must then match up to the budget proposed, or permissions must be obtained from your grant officer for budget variances.Ask for what you need to complete the project with excellence – Three sites versus two example
20 Salary Charges to a Grant and Time and Effort Reporting Grant Proposals must contain an accurate representation of the time commitment of the Principal Investigator and all Key Personnel.Later significant deviations (i.e., 25 percent or greater time and effort reduction) must be approved by funder.Salary and Wages charged to an award must be both reasonable and for actual work performed on the project.Time and effort reports are required to be completed at periodic intervals by employee or supervisor, and must be accurate and signed (Monthly for staff, annual for faculty).For Federal grants, costs of administrative or clerical staff must be treated as a F & A Cost, and not a direct costIn other words, departmental administrators cannot ordinarily be listed as Key Personnel and directly charged to your grant.
21 Proposal Budgets PIs should work with their grant manager 21PIs should work with their grant managerFederal sponsors require the use of federal cost principlesFor non-federal grants, HSPH provides an non-federal budget template
22 Compliance For Federal Grants: For Non-Federal Grants Congress Passes LawsAgencies publish regulationsHarvard Establishes PoliciesSponsors issue terms and conditionsFor Non-Federal GrantsCan be financial( eg: Cost allowability, effort, etc)&non-financial(eg:Human subjects protection, COI, Export Control)Compliance is financial and non-financialNon-financial examples: Human Subjects ProtectionUse of Animals in ResearchConflict of InterestExport ControlsFinancial examples…Allowability of CostsCost principlesAgency policyAward terms and conditionsInstitutional PolicyEffort reporting/certificationCost transfersCost sharing
23 University Policies and Practices Financial Conflict of InterestIP OwnershipOTDPA AgreementUniversity ReviewUCIPSProvost CriteriaThese add time to the review and submission process !
24 Lesson: DO NOT SIGN ANYTHING WITHOUT INSTITUTIONAL REVIEW ! When Things Go Wrong…In the news…Yale (7.6M)– 2006; Cost accounting and effort reportingStanford v Roche ($M’s) – 2011; PI signed a confidentiality agreement when working in a corporate lab assigning rights to IP to the companyFCOI – Institutional responsibility is greatly increased, disclosure threshold lowered to $5,000UFlorida (192K) – 2011; Prematurely destroyed records, possibly falsified OT hours and questionable chargesIn our own backyard…Reading NGAsCarry ForwardsBilling termsSub recipientsLesson: DO NOT SIGN ANYTHING WITHOUT INSTITUTIONAL REVIEW !
25 Subrecipient Monitoring Subrecipient Monitoring is the process of providing oversight on subawards throughout their lifecycle.At the proposal stage, the Principal Investigator is responsible for choosing an appropriate collaborator as well as:Obtaining the appropriate information prior to submitting the proposal (statement of intent, accurate budget, statement of work)Reviewing appropriateness of subawardeeExecuting an agreement consistent with federal requirements (Note: Drafted, Reviewed and signed by SPA)Acquiring all required representations, certifications, and assurances (e.g., human subject assurance).
26 Subrecipient Monitoring The federal regulations that describe subrecipient monitoring are general, but contain the following core elements of compliance:Advising subrecipients of all applicable federal laws and regulations, and all appropriate flow-down provisions from the prime agreementThe routine receipt and review of Technical Performance ReportsThe routine Review of Expenses-to-BudgetThe periodic performance of On-site Visits, or regular contact, if necessaryThe option to perform "audits" if necessaryReview of A-133 audit reports filed by subrecipients and any audit findingsReview of corrective actions cited by subrecipients in response to their audit findingsConsideration of sanctions on subrecipients in cases of continued inability or unwillingness to have required audits or to correct non-compliant actions
27 Subrecipient Monitoring Principal Investigators are responsible for the overall monitoring of the subrecipients including if:Subrecipient has performed the research in accordance with the Statement of WorkSubrecipient is continuing to meet compliance requirementsSubrecipient is meeting reporting requirementsSubrecipient is requesting reasonable expendituresMonitoring can be through reporting, regular contact and communication and detailed invoice review
28 Rights to Research Data Research Data are critical to protecting intellectual propertyObtaining patentsEnforcing patentsGovernment has right to inspect those data and research materials whose collection and analysis government has fundedDisclosure and dissemination of Research Data is critical for University reputation and assures future research support.
29 Research Data Ownership and Use Harvard retains ownership of all research data and materials, but researchers have rights to use the data and materials, publish their findings, and retain copyrightHarvard does not ordinarily perform “classified research” or accept any significant restrictions on publication of research results (such as confidentiality)
30 Harvard Principles for Access to and Retention of Research Data and Materials 1. Harvard researchers and staff should have systems or practices for maintaining the essential Research Records that they create in order to be able reasonably to support research findings, justify the uses of research funds and resources, and protect any resulting intellectual property. In determining which records are essential, Harvard researchers and staff should use prudence and reasoned judgment and may seek to refer to the prevailing standards in their relevant academic or professional disciplines. In general, researchers and staff should keep those records that will document research findings and justify the uses of research funds and other resources.2. Research Records should be retained, generally, for a period of no fewer than seven (7) years after the end of a research project or activity.1 For this purpose, a research project or activity should be regarded as having ended after (a) final reporting to the research sponsor, (b) final financial close-out of a sponsored research award, or (c) final publication of research results, whichever is later.3. As needed, researchers and staff must make Research Records available to the University so that it may respond to federal audits or other official requests, respond to subpoenas or other document demands, and conduct other internal and external oversight activities.
31 Harvard Principles for Access to and Retention of Research Data and Materials 4. The record keeping systems or practices used by Harvard researchers and staff should allow unmediated access by the University to the Research Records over their entire retention period. Such systems include, but are not necessarily limited to, electronic systems owned by the University or those located on the physical premises of the University. To the extent that use of University computing or other electronic systems for these purposes is not reasonably possible or is not preferred (e.g., research conducted off-site, electronic records that are required to be stored on non-Harvard servers, research conducted in collaboration with researchers whose primary affiliation is not Harvard), Harvard researchers and staff should assure that, if needed by the University for oversight purposes, such Research Records are readily available to the University.5. The record keeping systems or practices used by Harvard researchers and staff should be designed to include the retention of important written correspondence (including mail and electronic mail, and copies of reports, analyses and progress reports) related to their research. The scope of the correspondence that should be retained should be sufficient to enable an independent party reviewing that correspondence to identify and understand primary findings, major events, and major strategic decisions or judgments made in the course of that research.6. Harvard researchers and staff should be mindful that for research that has led to major academic findings or major scientific discoveries, a wider and more inclusive set of Research Records should likely be maintained, for historical purposes and for the protection of intellectual property.
32 HSPH Research Administration Support Proposal review and submission - SPAFunding opportunities, Research Oversight, ORARC , IACUC, & Award Administration – ORSD, OERWebsite:Frank Urso Executive Director for Research Administration