Responsible Conduct of Research Grant Writing, Budgeting and Management Frank Urso Executive Director of Research Administration Harvard School of Public Health February 14, 2014 Introduction Role What our office does Some statistics

Research Partnership Sponsor Applicant Peer Review Project Management Program Administration Principle Investigator Department Central Administration This model applies to Federal and non-federal awards. In the case of federal awards For Federal research our decentralized university centered model for basic research has been very successful Universities provide structure, resources, training and development The federal government enjoys a competitive leveraged model for fulfilling its research agenda IN ALL CASES EXCHANGE OF VALUE

Award Lifecycle Proposal Development HU Review & Submission Through Award Set-Up Award Management Award Closeout Proposal development happens in departments Submission through set-up in spa Management in departments Closeout through OSP Grant Managers and other Dept staff can help you navigate the system

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 http://grants.nih.gov/grants/policy/multi_pi/faq.htm#2952 On research projects, the PI is usually a faculty member. Grantee is the funding institute. PI Eligibility policy 4

Ethical Considerations GOOD SCIENCE The scientific research enterprise is built on a foundation of trust Scientists trust reported results are valid Society trusts that scientists act honestly and without bias STEWARDSHIP-Responsible Resource Management Conducting research is a privilege Regulatory oversight: human and animal subjects, environmental concerns Public and or charitable funds Pis are trusted by sponsors and their home institutions to conduct good science & Responsibly manage resources

Responsibilities 6 Principal Investigators are in charge of technical and financial aspects of projects PIs should work with administrators to help: Prepare and submit proposals with achievable scope and accurate budgets Submit technical reports on time Follow federal cost principles

Grant Proposals Responsible 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 Work Budget Collaborators: Subcontractors, Consultants and Service Agreements Three major components of proposals: SCOPE, BUDGET, COLLABORATORS

Grant Proposals Proposals 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 it For help with grant development consider using ORSD editorial or peer review services ACCURACY is PARAMOUNT

Basics of Effective Proposals DOCUMENTATION and TIMELINESS Clear language List full names/titles prior to abbreviating Presentation is important Follow instructions and guidance Cultivate relationships and communication - with all stakeholders Spend appropriately and to whatever extent possible according to plan Transparency

Recent Notice to SPH Investigators

Extra Prep Time Needed For… 11 Collaborations with other departments or institutions Large, complicated projects Newsworthy projects Complex compliance issues (PAs, FCOI, Provost review)

Proposal Submission 12 Work with your grant administrator to create the best proposal possible Send 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 Offices HSPH SPA HMS SPA University OSP Proposal submission cannot be guaranteed if university review begins later than 5 business days prior to sponsor due date

Choosing your Collaborators 13 When 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 performance Technical/financial resources Proposed scope of work There are financial, operational, risk and compliance ramifications to your choices

Cost of Doing Research 14 Direct Costs + Indirect Costs ----------------------- = Project Costs Also referred to as: -IDC -Overhead -F&A Direct 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 accuracy Indirect Costs: Expenses that cannot be specifically identified with a particular project or activity.

Cost Principles: Direct vs. Indirect Cost Direct 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 accuracy Indirect 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.”

Cost Principles Harvard 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.

Costs Normally Considered F&A 17 administrative & clerical salaries & fringe books & subscriptions conference fees hazardous waste disposal membership dues office supplies personal computers postage & shipping proposal preparation software- general telephone & 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 reason hard to specifically identify indirect costs pays for libraries – so sponsored awards shouldn’t pay for books and subscriptions

OMB Circulars A-21 and A-110 Principles 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 not Grants 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

Budget Estimate the project costs accurately. Don't overstate or understate your expenses The budget should be complete and fully-loaded Include all the costs of personnel, equipment, supplies, and activities required for the project Use 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

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 cost In other words, departmental administrators cannot ordinarily be listed as Key Personnel and directly charged to your grant.

Proposal Budgets PIs should work with their grant manager 21 PIs should work with their grant manager Federal sponsors require the use of federal cost principles For non-federal grants, HSPH provides an non-federal budget template

Compliance For Federal Grants: For Non-Federal Grants Congress Passes Laws Agencies publish regulations Harvard Establishes Policies Sponsors issue terms and conditions For Non-Federal Grants Can be financial( eg: Cost allowability, effort, etc) & non-financial(eg:Human subjects protection, COI, Export Control) Compliance is financial and non-financial Non-financial examples: Human Subjects Protection Use of Animals in Research Conflict of Interest Export Controls Financial examples…Allowability of Costs Cost principles Agency policy Award terms and conditions Institutional Policy Effort reporting/certification Cost transfers Cost sharing

University Policies and Practices Financial Conflict of Interest IP Ownership OTD PA Agreement University Review UCIPS Provost Criteria These add time to the review and submission process !

Lesson: DO NOT SIGN ANYTHING WITHOUT INSTITUTIONAL REVIEW ! When Things Go Wrong… In the news… Yale (7.6M)– 2006; Cost accounting and effort reporting Stanford v Roche ($M’s) – 2011; PI signed a confidentiality agreement when working in a corporate lab assigning rights to IP to the company FCOI – Institutional responsibility is greatly increased, disclosure threshold lowered to $5,000 UFlorida (192K) – 2011; Prematurely destroyed records, possibly falsified OT hours and questionable charges In our own backyard… Reading NGAs Carry Forwards Billing terms Sub recipients Lesson: DO NOT SIGN ANYTHING WITHOUT INSTITUTIONAL REVIEW !

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 subawardee Executing 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).

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 agreement The routine receipt and review of Technical Performance Reports The routine Review of Expenses-to-Budget The periodic performance of On-site Visits, or regular contact, if necessary The option to perform "audits" if necessary Review of A-133 audit reports filed by subrecipients and any audit findings Review of corrective actions cited by subrecipients in response to their audit findings Consideration of sanctions on subrecipients in cases of continued inability or unwillingness to have required audits or to correct non-compliant actions

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 Work Subrecipient is continuing to meet compliance requirements Subrecipient is meeting reporting requirements Subrecipient is requesting reasonable expenditures Monitoring can be through reporting, regular contact and communication and detailed invoice review

Rights to Research Data Research Data are critical to protecting intellectual property Obtaining patents Enforcing patents Government has right to inspect those data and research materials whose collection and analysis government has funded Disclosure and dissemination of Research Data is critical for University reputation and assures future research support.

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 copyright Harvard does not ordinarily perform “classified research” or accept any significant restrictions on publication of research results (such as confidentiality)

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.

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.

HSPH Research Administration Support Proposal review and submission - SPA Funding opportunities, Research Oversight, ORARC , IACUC, & Award Administration – ORSD, OER Website: http://hlcra.harvard.edu Frank Urso Executive Director for Research Administration furso@hsph.harvard.edu