Policies and Guidance

Policy Statement
All HMS and HSDM proposals/applications and institutionally authorized progress reports (“sponsored submissions”) must be received by the Office of Research Administration (ORA) via the Grants Management Application Suite (GMAS) at least five (5) full business days prior to the sponsor’s due date. The GMAS request must be locked and routed with PI and departmental signatures completed and all relevant documents uploaded. Proposal components must be in final form with the exception of the research plan (also referred to as the research strategy, statement of work (SOW), technical narrative, project description, etc.), which may be submitted in near-final form to meet the 5-day deadline. Near-final means that the draft must be developed to the degree that no further changes would occur to the research design, project concept, collaborators, inclusion of human/animal subjects, and other aspects that impact the budget and administrative components of the application. The final, submission-ready research plan is due to ORA no later than two (2) full business days before the sponsor’s due date. 

Proposals that do not meet the submission deadlines of 5 business days for all budgetary and administrative components with a near-final research plan, and 2 business days for the final research plan, will not be reviewed or authorized for submission.

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HMS Contacts and Subject Matter Experts: ORA Pre-Award Team Members

Policy Statement

Academic Service Centers are units within Harvard departments or centers that charge for goods or services that directly support the research or academic mission of the University and recover costs through charges to internal and external users. All Academic Service Centers are expected to recover no more than the aggregate costs of their operations through charges to users. All Academic Service Centers must be able to demonstrate compliance with federal requirements, and cannot use fee structures that discriminate against federal and other funding sources.

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Policy Statement

Harvard University requires that faculty and staff authorizing expenditures on federal awards comply with the federal requirement that administrative or clerical salaries should only be directly charged if they meet all required criteria.  This policy provides guidance on administrative and clerical personnel that specifically support, and are integral to, achieving the scientific aims and objectives of the federally funded projects. Note that technical-salaried employees performing scientific or technical work necessary to meet the goals of the project (e.g., research assistants) are excluded from this policy.

Policy Statement

Advance accounts, also known as "at risk" accounts, provide Principal Investigators with an opportunity to initiate sponsored research projects and begin incurring associated expenses prior to institutional acceptance of an award by the HMS Office of Research Administration. Advance accounts allow PI's and departments to record and track expenditures and eliminate the need to charge other unrelated accounts.

Administrators can request to create an active account string for a sponsored project prior to institutional award acceptance to allow project charges to be incurred at the requesting department’s own financial risk, in accordance with University policy. This guidance summarizes some key information to be aware of when requesting an advance (“at risk”) account.

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Office of the IACUC
A variety of research activities at Harvard Medical School involve animals. Extensive effort is made to provide excellent care for animals used in research, and to minimize procedures that have potential for discomfort, distress or pain.

The Institutional Animal Care and Use Committee (IACUC) oversees the responsible use of animals in research and instructional activities. The IACUC reviews protocols, reviews the animal care and use program, and monitors the animal facilities to ensure compliance with standards and regulatory requirements.

The Office of Biological Safety facilitates the Committee on Microbiological Safety (COMS). COMS is a standing faculty committee that reviews all research involving recombinant DNA as well as work involving biohazards at Harvard and its 16 affiliated institutions. The Office provides the administrative support for the Committee and the technical review of COMS applications. The Office also supports the biosafety programs at these institutions by providing additional risk assessment as well as establishing policies and procedures.

Visit the website to access COMS Policy Manual.

This policy establishes the proper methods to account for facilities and equipment, including capitalization, depreciation, disposals and impairments, and various funding sources. For details on capital equipment on sponsored research projects refer to the University's Financial Management of Property 

Policy Statement
As the recipient of sponsored funding from federal and non-federal sources, the University is required to provide accurate, timely, and complete disclosure of financial information, as required by each sponsored award. The timely recording of financial transactions to sponsored awards is critically important, especially as an award’s end date approaches, since it is the basis for financial reporting, cash collection, and sponsor closeout requirements. The Closeout & Reporting Policy for Sponsored Awards establishes the framework for administering the timelines to manage the sponsor’s financial deadlines and non-financial reports.

Harvard University Faculty of Medicine may from time to time apply for and/or receive funding through various outside grant awards for their Research, for example grants from government awarding agencies, research foundations, and private companies.  The following requirements apply to Sponsored Research, including at the time an application for funding is made to an awarding agency, for example the National Institutes of Health (NIH).  These requirements are in addition to the rules set forth in the Faculty of Medicine Policy on Conflicts of Interest and Commitment (Faculty COI Policy) and apply to all Investigators, as defined below, in a Research project for which an application for funding has been made through and/or granted to Harvard Medical School (HMS). 

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Collaborations: Guidance on Conflict Management Considerations 

Policy Statement

This policy establishes a process for approving and managing service or consulting agreements that faculty undertake under the auspices of Harvard University, meaning Harvard would be the contracting party.  These are agreements under which faculty are obligated to provide specified services or “deliverables” and that do not fall squarely within the traditional framework of research or teaching activities.   While these agreements may have research or scholarly benefits, those are a secondary aspect, not the primary purpose of the activity.  The terms “service agreement” or “consulting agreement” are intended to be descriptive; such agreements could have many different labels or titles.

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Policy Statement

Harvard University has established the following policy for the management of cost sharing to comply with the requirements of the Office of Management and Budget (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (“Uniform Guidance”) and federal agency policies and procedures.  Additionally, any non-federal sponsor cost share requires similar diligence to recognize the commitment and maintain appropriate documentation which provides evidence of a cost sharing commitment. Therefore, all committed cost sharing is subject to this policy.

Cost sharing is any project cost that is not reimbursed by the sponsor to support the scope of work defined by the federal or non-federal sponsored award.  Cost sharing, also known as matching, is funded by Harvard or a third-party, which is generally a non-federal resource. 

Harvard strongly discourages cost sharing, unless such a commitment is required by the federal or non-federal sponsor. All committed cost sharing must be tracked and may require reporting.

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Policy Statement

Harvard University has established the following policy for the processing of cost transfers to comply with the requirements of Office of Management and Budget (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (“Uniform Guidance”) and federal agency policies and procedures. For the purposes of this policy, a cost transfer (CT) is a transfer of an expense onto a federally-funded sponsored award previously recorded elsewhere on Harvard's General Ledger (GL) and identified by Harvard as requiring institutional approval before it can be posted to the GL.

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Cost Transfer Preparer and Approver Checklist

Harvard University requires all individuals who receive federal sponsored funding to comply with University policies and sponsoring agency regulations regarding the proposing, charging, and reporting of effort on those awards.

University faculty and staff are expected to charge their time to sponsored awards commensurate with the committed effort expended on all activities they perform.  Payroll charges to sponsored awards, and cost sharing recorded for faculty and staff, serve as the initial data points for the University’s effort reporting system.

University Effort Reporting Policy (Owner - OSP)

HMS-HSDM Faculty Effort on Sponsored Awards (Max. & Min.) Policy (Owner - ORA)

Visit the University's Environmental Health & Safety website for resources, tools and training requirements.

The purpose of this guidance is to guide the establishment and oversight of internal grant programs funded by donor gifts or grants specifically in support of a particular area of inquiry or specific aims. The guidance applies to situations where a competitive selection process will be used to select award recipients and the terms of the award are memorialized in an award letter. 

GUIDANCE STATEMENT

The Office of Research Compliance within the Office of the Vice Provost for Research oversees Harvard University’s compliance with U.S. export control laws and regulations and maintains and updates the University-wide Export Compliance Manual and a website with information and guidance regarding export requirements. In addition, each school has an individual designated as the point of contact regarding export control matters within the school.

If you are planning to export materials, equipment or technology abroad, to engage in research that may be controlled, to engage in international collaborations with foreign persons, or have any other questions about the application of export controls to activities in which you are involved, consult the Office of the Vice Provost for Research website or contact your school’s representative on the Export Control Council or the University’s Chief Compliance Officer. 

For HMS international collaboration related questions or activities where you are unsure if there may be an export control or research security related concern, contact the HMS ORA Research Security Team.

OVPR Website

EXPORT LICENSE REVIEW AND APPROVAL

HMS has developed a tool by which the appropriate HMS and University offices and officials would be notified of a faculty member’s departure. This process is intended to assist departing faculty, as well as HMS/University Departments and Offices, to be in compliance with state, federal, and University guidelines, providing an efficient and effective means to close out projects and resources associated with sponsored research and ensure a smooth transition for student advisees and staff.

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Review the Faculty Disclosure Guidance posted to the Harvard OVPR website. 

Per the IRS, a fellowship is an amount paid to or allowed for the benefit of an individual to aid in the pursuit of that individual’s own study or research. At Harvard, we use the term "fellowships" to refer to a host of payments: awards, stipends, grants, and allowances. Fellowships are generally gross income to the recipient, unless they are qualified payments for required tuition and fees for a degree program. Visit the Financial Policy website for additional information.

PIs and administrators must prepare accurate, detailed proposal budgets, and include costs associated with the fixed price sponsored award to fully capture all resources necessary for the work performed on the project. If the project is performed at a cost below the awarded amount, the residual balance must be treated in accordance with the terms and conditions of the award and/or the sponsor’s written policies relating to disposition of residual balances.

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HMS Fixed Price Award Residual Balance Transfer Guidance 
Per University guidance effective July 1, 2021, the Fixed Price Residual Balance Form is required for any sponsored award with a remaining balance of $250.00 or more at award end. Balances of $10,000 or more require a Balance Justification, PI signature, and OSP signature. Balances below $250 or interest-only transfers do not require a form. All forms should be routed to the ORA Research Finance Office for approval. The residual balance will be split between direct and indirect costs at the negotiated indirect cost rate. In the event the indirect cost rate is 0%, HMS will apply our school’s IDC policy. Any interest earned can be retained by the department. Contact Sheila Doyle with questions. 

Policy Statement

The University must manage all funds received in accordance with applicable federal, state, and local laws, and with the specific terms and conditions of any gift, grant or contract. The University’s approval, negotiation and agreement processes and mechanisms, accounting, budget practices, oversight, and compliance practices differ depending on whether funds received are categorized as a gift or as a sponsored award.

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HMS-HSDM Gift vs Sponsored Award Determination Chart

Refer to policy and practices for assigning a Harvard Sponsored Role to an individual through HUIT Identity and Access Management (IAM).

The University has rules regarding the use of Harvard Names and Insignias. Also refer to the Medical School's supplemental policy and process for review and approval of the use of the Harvard name at Harvard Medical School and Harvard School of Dental Medicine.

The Office of Regulatory Affairs and Research Compliance (ORARC) is a comprehensive administrative office designed to review, approve, assist, and oversee all human research projects conducted by faculty, staff, and students across the Harvard Longwood Medical Area (LMA) Schools, including Harvard Medical School, Harvard School of Dental Medicine, and Harvard T.H. Chan School of Public Health. Our mission is to protect the rights and welfare of subjects involved in human research and to provide high-level education and human research support to our research community. OHRA is comprised of two units: IRB Operations and the Quality Improvement Program(QIP).

Refer to the HMS Low IDC Policy and the below resources for calculating and submitting proposals subject to the Low IDC Policy. Please direct all questions to your ORA Pre-Award Representative. 

Low IDC Policy Tool for A02 Applications

Low IDC Policy Tool for A03 Applications

Refer to the Statement of Policy in Regard to Intellectual Property (IP Policy), available on the Office of Technology Development (OTD) Website.

Harvard University’s Office of Treasury Management (OTM)’s interest policy is to annually credit interest to Non-Federal Awards (“NE”) and Non-Federal Sponsored Grants (“NG”). 

Refer to the OSP website for policy and procedure information.

The International Project Planning Considerations document provides faculty and administrators with clear, simple guideposts for international projects, including the policies, guides and contacts at Harvard to learn more.

Harvard’s Global Support Services is also available to provide tools and guidance on international business operations.

Go to Harvard Strategic Procurement's website

Refer to guidance when determining the responsible parties for coordinating the review and signature of research-related agreements at Harvard. To the extent an agreement type listed herein arises outside of the research context, the named parties may still be consulted for guidance. Please note that, pursuant to University policy, certain agreement types mandate review by additional stakeholders within the University (e.g. review by the Office of the Vice Provost for International Affairs is required for all agreements with foreign sovereign governments). In addition to any such required review, the responsible parties shall consult with the appropriate offices within the University, including the Office of General Counsel and the Office of the Vice Provost for Research, on an as needed basis to ensure the terms and scope of all agreements align with the University’s mission and applicable policies.

Information and resources for the updated NIH Other Support and Biosketch requirements have been posted to the Harvard OVPR Faculty Disclosure for Federal Funding Agencies webpage. 

Check the NSF current and pending support website for information on NSF-Approved Formats for Current and Pending Support.

NSF requires information on all current and pending support for ongoing projects and proposals. Detailed information about the content is available in the Proposal and Award Policies and Procedures Guide (PAPPG), Chapter, II.C.2.h.

A table entitled, NSF Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Current and Pending Support, has been developed to provide helpful reference information regarding pre-award and post-award disclosure information in the biographical sketch and current and pending support proposal sections. The table identifies where these disclosures must be provided in proposals as well as in project reports. A set of FAQs related to current and pending support also is available.

Refer the the Human Resources site for information

Policy Statement

The President and Fellows of Harvard College adopted the Statement of Policy in Regard to Intellectual Property, on February 4, 2008. The Policy as it may be amended from time to time, applies to all members of the University and visitors who perform research in Harvard facilities. Also, Federal policy requires the University to obtain written agreements from anyone performing research under a federally sponsored program regarding their obligations for reporting and assignment of inventions.

Each person performing research at Harvard should sign either the Harvard University Participation Agreement or the Harvard University Visitor Participation Agreement as applicable

Review the OVPR Policies & Guidance posted.

The policy establishes the criteria that allow individuals to serve as a Principal Investigator on sponsored programs submitted through Harvard Medical School (HMS). 

Please note that approvals of exceptions to the policy are granted for the specific project only, and do not apply to future sponsored projects. The individual seeking PI status (or their administrator) must submit a request for an exception to the policy each time they intend to submit a proposal for a new sponsored project.

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Harvard University requires that faculty, staff, researchers, students, or other individuals who plan for or purchase products, equipment, supplies, and services with University funds, base purchases on sound business practice, best value, accountability, and compliance with donor, sponsor and regulatory requirements.

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The Provost's Office aims to facilitate academic programs, projects and research at Harvard by providing clear criteria and procedures for University-level review of research proposals that pose management challenges and/or reputational risk and by providing reasonable review and oversight of major projects and programs. This process is intended to streamline the review process for PIs and administrators, improve management and administration, and reduce risks for program participants, for individual researchers, for Schools, and for Harvard as an institution. Refer to the Criteria and Procedures for Provost's Review of New Projects or Grants which describes the criteria that determine whether a proposal requires Provostial review.

The University may agree to provide sponsors with copies (or drafts) of articles, manuscripts or other written publications up to thirty (30) days in advance of submission for publication or up to thirty (30) days in advance of the anticipated publication date (including electronic publication). When necessary, an extension of an additional thirty (30) days is permitted. At the end of this period, submission or publication would proceed. The University may agree that sponsors will receive up to a thirty (30) day period to review material intended for public oral disclosure in venues such as scientific meetings, colloquia, or lectures at other institutions. When necessary, an extension of an additional thirty (30) days may be permitted. At the end of this period, public oral disclosure would proceed.

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Refer to the OVPR website for information on Harvard's Research Data Security Policy (HRDSP); General Data Protection Regulation (GDPR); Data Use Agreements (DUAs); and Research Records Retention.

For questions related to HMS research data policies and processes, contact the ORA Research Data Compliance Team.

Federal guidance regarding severance expenses comes from two primary sources: NIH Grants Policy Statement, Part II, Subpart A, Cost Considerations  and OMB Uniform Guidance, Subpart E §200.431

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This guidance is related to the charging of stipends to sponsored awards. Stipends are payments made to individuals for subsistence support or to defray expenses during a period of academic appointment. Stipend payments are not compensation for services rendered and, therefore, are not allowable on federal awards unless the purpose of the agreement is to provide training to selected participants and the charge is approved by the sponsoring agency (OMB Circular Uniform Guidance, Subpart E).

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Subrecipient monitoring is required by Harvard University’s Subrecipient Monitoring Policy and is an essential element of sponsored funding stewardship. All key stakeholders share this responsibility. The purpose of the Toolkit is to provide guidance and resources to assist with the monitoring process. 

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Contractor/Vendor vs. Subrecipient: Guidance on Appropriate Classification of Legal Relationships
Before entering into a relationship with another entity under a sponsored award in which the other entity will provide goods or services or substantive, programmatic work to Harvard as the prime recipient of funding, a determination must be made as to the nature of the legal relationship of Harvard and other entity, which in turn will determine the type of legal agreement required to document the relationship. This is a significant decision because it determines the allocation of responsibilities and influences the appropriate application of indirect cost rates. 

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The Harvard Analytics and Reporting Tool (HART) allows users to review summary level and detailed information of the reimbursements paid through Concur, to the Employees/Reimbursees, for a selected date or date range. Analysis and monitoring to ensure travel expenses are compliant with sponsored rules can also be performed by using this dashboard. Visit OSP website.

Policy Statement

Effective July 1, 2007, graduate tuition remission may be charged to research awards at Harvard as a non-overhead-bearing direct cost. Tuition remission is the payment of tuition expense as part of compensation to students performing necessary work on federal research awards [Office of Management and Budget Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR §200) ("Uniform Guidance")]. Unlike salaries and wages, tuition remission must be excluded from the application of indirect costs [Uniform Guidance §200.466]. Students whose work benefits research awards granted to Harvard University will be placed on payroll and their salaries will be charged in the payroll object code for “students in professional positions.” Remission for tuition and fees will be recorded as “graduate tuition and fees.” 

All compensation charged to federal research awards, whether it is paid as salaries and wages or as tuition remission, is subject to effort reporting. In order to meet this requirement without including tuition remission payments explicitly on salary certification forms, the allocation of tuition remission costs on research awards must match the distribution of work effort as reported through salary charges.

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