1 The NIH Grants Policy Statement (NIHGPS) © Partners HealthCare System, Inc., 2011.

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The NIH Grants Policy Statement (NIHGPS)

© Partners HealthCare System, Inc., 2011

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What is the NIHGPS?

• The NIHGPS is a single document reference source (for all NIH Grantees) containing all of the policy requirements that serve as the terms and conditions of NIH grant awards.

• It is also designed to be a useful reference point for information about NIH staff, its organization and the NIH grants process.

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Why is the GPS Important?• SECTION III – TERMS AND CONDITIONS – 1R01NIDDKXXXXX-01• This award is based on the application submitted to, and as approved by,

NIH on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following:

• a. The grant program legislation and program regulation cited in this Notice of Award.

• b. Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriations acts.

• c. 45 CFR Part 74 or 45 CFR Part 92 as applicable.• d. The NIH Grants Policy Statement, including addenda in effect as of

the beginning date of the budget period.• e. This award notice, INCLUDING THE TERMS AND CONDITIONS

CITED BELOW.

• See NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above.

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Important update!

• The NIH released a revised Grants Policy Statement on October 15, 2010.

• The revision applies to all grants and cooperative agreements with a budget period start date on or after October 1, 2010.

• This revision will supersede the 12/03 version of the GPS as a term and condition of award.

• However, the 12/03 GPS will continue to be applicable for all NIH grants and cooperative agreements with budget periods that began between 12/1/03 and 9/30/2010.

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More on the October 1, 2010 Update

• This revision is an update to the 2003 publication.

• It incorporates several new and modified requirements.

• It clarifies and emphasizes policies that require increased attention by grantees.

• Most of the changes have been previously introduced and published as NIH Guide Notices.

• Glossary and acronyms lists have been updated to include new terminology introduced since last revision i.e.; “applicable clinical trial” which ties to the ClinicalTrials.gov registry requirement.

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How is the NIHGPS structured?• The NIHGPS has three main parts:

1. Part I. NIH Grants – General InformationThis section contains a glossary defining all commonly used terms and abbreviations; a description of NIH and its relationships to other entities within DHHS; an overview of responsibilities and the grant application/review process; and explains the resources available regarding the NIH grants process.

2. Part II. Terms and Conditions of NIH Grant AwardsThis section includes the terms and conditions generally applicable to NIH grant awards. Also specifies the terms and conditions as they apply to specific types of grants, grantees – including activities that differ from, supplement or elaborate on the standard terms and conditions (ie. Construction grants, research training grants, grants to foreign entities, grants to federal or for-profit entities, and research patient care activities).

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More on how the NIHGPS is structured Part III. NIH Points of ContactThis section contains a listing of pertinent office and officials of NIH along with their addresses and phone numbers. This listing includes the Centers and Institutes.

• GPS Part I: General Information

• The NIHGPS was originally published with an effective date of October 1, 1998. It has since been revised twice and now has an effective date of October 1, 2010 however the December 1, 2003 version will remain in effect until the awards subject to have cycled out and termed.

• The 10/1/2010 NIHGPS applies to all new NIH grants and cooperative agreements with a budget period start date beginning on or after 10/1/2010 and all prior awards that are amended to incorporate the new version.

• The Office of Policy for Extramural Research Administration (OPERA) develops and maintains the NIHGPS.

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More on how the NIHGPS is structured GPS Part I

• OPERA will announce changes to statutes, regulations, or policies that will take effect prior to the next revision of the GPS in the NIH Guide for Grants and Contracts.

• All NIH Grantees are responsible for monitoring and reviewing the NIH Guide for Grants and Contracts which is available on the NIH home page at http://grants.nih.gov/grants/guide/index.html

• All NIH Grantees are expected to watch for changes and implement them, as appropriate, upon posting in the NIH Guide for Grants and Contracts.

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NIH as a Grant-Making Organization – GPS Part I

• NIH’s mission is to improve human health by increasing scientific knowledge related to disease and health.

• This mission is accomplished through the conduct and support of biomedical and behavioral research, research training, research infrastructure and communications.

• NIH is an organizational component of the Department of Health and Human Services (DHHS).

• DHHS develops, issues and maintains the regulations that govern the Departments grants process. Among these are the regulations that implement the OMB Circular A-110.

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More on NIH as a Grant-Making Organization – GPS Part I

• These regulations are then codified (arranged into an organized system or code) at 45 CFR Part 74.

• They provide the framework for the terms and conditions of NIH awards as specified in Part II of the NIHGPS.

• NIH is organized into Institutes and Centers, each with its own missions, functions, appropriations and statutory authorities.

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The application and review process

• Eligibility – in general, awards can be made to entities that are domestic or foreign, public or private, non-profit or profit.– When considering eligibility; check on both entity and individuals– Special criteria for applicant eligibility or requirements re; PI and other

staff will be covered in the program solicitation/guideline or other publically available documents

– For specifics regarding fellow and trainee eligibility, see Part II

• Types of awards - Financial assistance instruments – Grants are used for both investigator-initiated and targeted research– Cooperative agreements are used when NIH expects to be substantially

involved in carrying out the project

• Types of applications – 5 types of applications are used and the first four are considered “competing”

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– Type l New application not currently receiving NIH support– Type 2 Competing continuation is a request for funding to

renew a project period that would otherwise expire– Type 3 Competing supplemental application is used to request

the expansion of the project’s approved scope of work– Revised (Amended) application is an unfunded application

that has been modified based on initial peer review feedback and is being resubmitted for consideration (can only be done once)

– Type 5 Non-competing grant progress report – a progress report and request for funding of a non-competing continuation award for second or subsequent budget periods with an approved competitive segment

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– Types of Funding Opportunities

• Most are considered “unsolicited” applications which are reviewed in three cycles per year

• Any application requesting $500,000 or more in direct costs in any year of an unsolicited application carries the requirement of institute or center prior approval. This must be done no later than 6 weeks prior to submission and must be documented in the application cover letter. (RFA submissions not subject to this requirement)

• Program Announcements (PA’s) can be used to announce all support mechanisms except construction awards. Applications submitted in response are considered unsolicited and follow the common receipt deadlines.

• Request for Applications (RFA’s) are more targeted and solicit applications in well defined scientific areas for a one-time competition.

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– The signature of the Authorized Organizational Officer (AOO) certifies that the organization will comply with all applicable assurances and certifications referenced in the application.

– It additionally certifies that the grantee will be accountable for the appropriate use of any funds awarded and for the performance of the scope of work.

– “Even if the application is not awarded, the applicant may be subject to penalties if the information contained in or submitted as part of an application, including its certification and assurances, is found to be false, fictitious, or fraudulent.”

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– The Peer Review Process• Based on two sequential levels of review

• Initial review is done by the scientific review group – they are determining the scientific merit of the application

• The next level is the National Advisory Council/Board review which reviews for scientific and technical merit as well as relevance to the IC’s programs and priorities

• Upon completion of the initial review, the PI will receive a copy of the summary statement and will be advised whether the application has been recommended for further consideration by the Council

• If initial review and Council recommendations are favorable, the IC Director or designee then has the authority to make a final award determination

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– Additional Review Criteria

• Alignment with NIH’s funding principles

• Review of the project budget

• Assessment of the applicant’s management systems

• Determination of applicant eligibility

• Compliance with public policy requirements

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GPS Part IITerms and Conditions

• Part II, Subpart A starts out with an overview of the pre-award process including Just In Time, Funding Principles, Eligibility, and Cost Analysis.

• Overview of Terms and Conditions is reviewed in detail and includes all types of NIH awards.

• Public Policy requirements are explained in Part II. These are requirements that are based on social, economic, or other objectives or considerations that may be attached to the expenditure of Federal funds.

• The Public Policy requirements set the standards for high ethical, health, and safety standards in the conduct of the research funded and the expenditure of public funds.

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GPS Part II -Terms and Conditions

• This is a partial list of Public Policy requirements:– Debarment and Suspension– Drug-Free Workplace– Lobbying– Financial Conflict of Interest– Research Misconduct– Nondelinquency on Federal Debt– Human Embryonic Stem Cell Research– Human Subjects– Vertebrate Animals– Age Discrimination– Civil Rights– Sex Discrimination– Handicapped Individuals

– The GPS includes a detailed grid of Public Policy Requirements which is followed by in-depth descriptions of each PPR.

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GPS Part II –Just-in-Time (JIT) Procedures • Common JIT Attributes:

– Institution Review Board (IRB) approval– Certification for Key Personnel to verify that they have completed an

educational program in the protection of human subjects– IACUC (Institutional Animal Care & Use Committee) approval – Current Other Support – list funding for each person considered Key

Personnel for the project. Address how you would resolve any budgetary, scientific or effort overlap if this proposal is funded.

– Budget Breakdown/Budget Justification, only as requested

– The other support and Human subjects education information should be submitted within two weeks of receiving the JIT request.

– IRB or IACUC approval are understood to take longer and may be submitted later, at the earliest date that they become available.

– All of the JIT information can be submitted via eCommons using the Just in Time feature found in the “status” section. If submitting via eCommons, all information must be submitted at one time.

– 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.

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GPS Part II –Just-in-Time (JIT) Procedures • Other Support - Includes all financial resources, whether Federal, non-

Federal, 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.

• Information on Other SupportInformation 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 percent, is not permitted.

• Budgetary overlapBudgetary 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 overlapCommitment overlap occurs when a person’s time commitment exceeds 100 percent, whether or not salary support is requested in the application.

• Scientific overlap occurs when: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.

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GPS Part II –Just-in-Time (JIT) Procedures

• Resolution of OverlapResolution of Overlap - - Resolution of overlap occurs at the time of award in conjunction with applicant 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."

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What else is found in Part II?

• The Notice of Grant Award is overviewed, including payment information and cost principles.

• The Cost Principles address four tests that NIH follows to determine the allowability of costs:

1. Reasonableness – a cost can be considered reasonable if the goods and services acquired or applied and the associated dollar amount reflect the action that a prudent person would have taken when the decision to incur the cost was made.

2. Allocability – when a cost is incurred solely in order to advance work under the grant, benefits both the grant and other institutional work, or is necessary to the overall operation of the organization and can be assigned at least in part to the grant.

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The four cost principles test used by NIH, cont.

3. Consistency – costs are treated consistently for all work of the organization under similar circumstances, regardless of the source of funding, so as to avoid duplicate charges. Directs as direct costs, indirects consistently applied as indirects.

4. Conformance – an allowability test. Conformance with limitations and exclusions as contained in the terms and conditions of award.

– These tests apply regardless of whether the particular category of cost is one specified in the cost principles or one governed by the other terms and conditions of award.

– Tests apply regardless of treatment as direct or indirect costs.

– The fact that a proposed cost is awarded as requested by an applicant does NOT indicate a determination of allowability.

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Selected Items of Cost – GPS Part II

• If a cost is allowable, it is allocable as either a direct or indirect (F&A) cost, depending on the Grantee’s accounting system.

• The GPS lists selected items of cost and indicates if the item is allowable as a direct or indirect cost. While this list is not inclusive, it is a very helpful tool when working on specific items of cost in reviewing budgets or expenses incurred.

• Tip – you will also find lists of selected items of cost in the Hospital Cost Principles and in OMB Circular A-21 – Section J when looking for same or similar items of cost for determination of allowability.

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Administrative Requirements – GPS Part II

• In this subsection, the NIH reviews:– Changes in Project and Budget (expanded authorities, prior approval

requirements and requests for prior approval)

– Availability of Research Results (rights in data, sharing of unique research resources, inventions and patents)

– Management systems and procedures (financial management system standards, program income, property management system standards and procurement systems and requirements)

– Monitoring (reporting, record retention and access and audit)

– Enforcement actions (modification of terms, suspension, termination, withholding of funds, recovery of funds, debt collection and other actions)

– Closeout

– Grants appeals procedures

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Expanded Authorities - The operating authorities provided to grantees under certain research grant mechanisms that waive the requirement for NIH prior approval for specified actions. These authorities are inherent in each award granted by the NIH, unless otherwise specified

– 90 days Pre-Award90 days Pre-Award - The federal government has authorized Institutions to approve pre-Award spending up to 90 days prior to the start date of the anticipated award.

– Re-budgetingRe-budgeting – The federal Government allows for the re-budgeting of funds up to 25% of the total approved budget except for the following items: direct costs moved to indirect costs or vice versa, training or fellowship costs

– Carry-OverCarry-Over - Unexpended funds are carried over from one budget period to the next without prior approval

– Time ExtensionTime Extension – The institution may apply for one time extension of up to one year in the final year of a grant.

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Administrative Requirements – GPS Part IIPrior Approval RequestsAll requests that require prior NIH approval must be made in writing (e-mail is acceptable) to the Grants Management Officer at least 30 days before the proposed change. The request must be endorsed by the Authorized Organization Representative.

Failure to obtain required prior approval from the appropriate NIH awarding office may result in the disallowance of costs, termination of the award, or other enforcement action within the NIH’s authority.

E-mail requests must be clearly identified as prior-approval requests, must reflect the complete grant number in the subject line, and should be sent by the AOO to the GMO that signed the NGA. (E-mail addresses for NIH staff can be obtained from the NIH Directory and E-Mail Forwarding Services at http://directory.nih.gov)

E-mail requests must include the name of the grantee, the name of the initiating PI, the PI’s telephone number, fax number, and e-mail address, and comparable identifying information for the AOO.

If the entire message of the request cannot be included in the body of the e-mail, the request should be submitted to NIH in hard copy.

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ActionsActions requiring NIH prior approval: requiring NIH prior approval:

• Rebudgeting that would exceed 25 percent of the total approved budget for a budget period. If rebudgeting would not meet this threshold but would result in a change in scope. Any single A&R project exceeding $300,000.

• Capital expenditures (construction, land, or building acquisition). All instances when purchase proposed; any proposal to convey, transfer, assign, mortgage, lease, or in any other manner encumber real property acquired with NIH grant funds.

• Change of scope

• Changes in status of key personnel (Withdrawal from the project; absence for any continuous period of 3 months or more; reduction of time devoted to project by 25 percent or more from level in approved application)

• Change of grantee organization

• Carryover of unobligated balances (If the NGA indicates that the grantee does not have the authority to automatically carry over balances)

• Deviation from award terms and conditions (Includes undertaking any activities disapproved or restricted as a condition of the award)

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More actionsMore actions requiring NIH prior approval: requiring NIH prior approval:

• Foreign component added to a grant to a domestic organization

• Need for additional NIH funding (Including extension of a final budget period of a project period with additional funds)

• Pre-award costs (If more than 90 days before effective date of the initial budget period of a new or competing continuation award)

• Retention of research grant funds when the award is K series award

• Second no-cost extension or extension greater than 12 months

• Transfer of funds between construction and non-construction work

• Transferring amounts from trainee costs

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Administrative Requirements – GPS Part II– Availability of Research Results

– It is the NIH policy that the results and accomplishments of the activities that it funds should be made available to the public.

– If the outcomes result in inventions, the provisions of the Bayh-Dole Act apply.

– Grantees own the rights of data resulting from a grant supported project.

– Publications can be copyrighted without NIH approval.

– NIH must be given a royalty free, nonexclusive license for the Federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for Federal purposes.

– Grantees must include an acknowledgement of NIH grant support and a disclaimer on each publication.

– Grantees must adhere to the NIH Public Access Policy.

– Research Data and Unique Research Resources must be subject to timely release and sharing. NIH considers this sharing an important means to enhance the value of NIH sponsored research.

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Bayh-Dole Act Provisions (not part of the GPS but compliance with this is referenced)

Bayh-Dole states:• The grantee is obligated to have written agreements with its faculty and

technical staff requiring disclosure and assignment of inventions. • The grantee has an obligation to disclose each new invention to the

federal funding agency within two months after the inventor discloses it in writing to the grantee entity.

• The decision whether or not to retain title to the invention must be made within two years after disclosing the invention to the agency.

• Upon election of title, the grantee must file a patent application within one year

• Grantees must include within the specification of the patent a notification of government support of the invention and government rights in the invention.

• If the grantee elects to retain title, the grantee must provide the government with a non-exclusive, non-transferable, irrevocable, paid-up right to practice or have practiced the invention on behalf of the U.S. throughout the world.

• The grantee must submit periodic reports regarding the utilization of the invention as requested by the funding agency, but no more often than annually.

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Bayh-Dole Act Provisions, continued

• Any company holding an exclusive license to a patent that involves sales of a product in the United States must substantially manufacture the product in the U.S.

• In their marketing of an invention, grantees must give preference to small business firms (fewer than 500 employees), provided such firms have the resources and capability for bringing the invention to practical application. However, if a large company has also provided research support that led to the invention, that company may be awarded the license.

• Grantees may not assign their ownership of inventions to third parties, except to patent management organizations.

• Grantees must share with the inventor(s) a portion of any revenue received from licensing the invention. Any remaining revenue, after expenses, must be used to support scientific research or education.

• Government retains “march in rights”

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– Management systems and procedures• Grantee organizations are expected to have systems, policies, and

procedures in place by which they manage funds and activities.• Systems must be consistently applied regardless of source of funds.• Grantee organization culture must be committed to compliance by

having clearly delineated roles and responsibilities of programmatic and administrative staff; written policies and procedures; training; management and other internal controls; performance assessment; and information sharing.

• Funds must be used appropriately, documented and safeguarded.

• Internal controls must be in place that provide for appropriate monitoring of accounts to ensure that obligations and expenditures are reasonable, allowable and allocable. They must also be able to identify large unobligated balances, accelerated expenditures, inappropriate cost transfers and other inappropriate obligation and expenditure of funds. (The InSight Fund Statement facilitates compliance with this requirement).

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Administrative Requirements – GPS Part IIAdhering to the Reporting RequirementsAdhering to the Reporting RequirementsNIH requires that grantees periodically submit reports. For all of the reports identified in the Notice of Award, remember that they are due at specific times during the life cycle of a grant award. It is important that all reports are accurate, complete, and submitted on time.

Progress ReportsProgress Reports (A Pre-Award task)Progress reports are usually required annually as part of the non-competing continuation award process. The “Grant Progress Report” (PHS 2590) or equivalent documentation must be submitted to (and approved by) the NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment).

Invention ReportsInvention ReportsRegulations require that grantee organizations report all inventions to the awarding agency (see NIH Grants Policy Statement), as well as include an acknowledgement of federal support in any patents. Grantee organizations are expected to use the Web-based Interagency Edison system (iEdison). NIH funding recipients are expected to use this system to comply with the Bayh-Dole Act (P.L. 96-517) and related intellectual property reporting requirements. The Research Ventures and Licensing Office will file the reports in iEdison for all Partners inventions.

Final Invention StatementFinal Invention StatementWhen a grant is completed and no more funding is provided, or when a grant is transferred from one institution to another, a Final Invention Statement and Certification (HHS 568) is one of the required forms submitted to the NIH. For grants that are closing out, the Final Invention Statement and Certification can be submitted along with the other required closeout documents through the eRA Commons.

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CloseoutCloseoutNIH closes out a grant as soon as possible after expiration if the grant will not be extended of if continued funding is not provided.

Closeout includes ensuring timely submission of all required reports and adjustments for amounts due the grantee or NIH. Closeout of a grant does not automatically cancel any requirements for property accountability, record retention, or financial accountability.

Following closeout, the grantee remains obligated to return funds due as a result of later refunds, corrections, or other transactions, and the federal government may recover amounts based on the results of an audit covering any part of the period of grant support.

Required closeout reports include:Required closeout reports include: • Final FSR • Final progress report • Final Invention Statement and Certification • Final population tracking data when applicable • These reports are due within 90 days of the end of grant support. Failure to submit timely and

accurate final reports may affect future funding to the organization or awards with the same PD/PI.

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Record RetentionRecord Retention

Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted.

For awards issued under the SNAP authorities, the three-year retention period is calculated from the date the FSR is submitted for the entire competitive segment.

Closeout may also affect the time period for retention of records by the grantee, because the three-year record retention period begins with the submission of the final FSR.

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Monitoring an AwardMonitoring an AwardAll Grantees are responsible for managing the day-to-day operations of their grant. To fulfill your role in regard to the stewardship of federal funds, you need to monitor the grants on your assigned workload once the account is set up and activated. This active monitoring is accomplished through review of accounts This active monitoring is accomplished through review of accounts and expenses, correspondence with subcontractors (as applicable), requests to the and expenses, correspondence with subcontractors (as applicable), requests to the Sponsor and the justification for each prior approval request made, audit reports, site Sponsor and the justification for each prior approval request made, audit reports, site visits, and other information that may be available. visits, and other information that may be available.

Monitoring ExpendituresMonitoring ExpendituresAll Grantees are required to have financial systems in place to monitor their grant expenditures. A good steward will monitor expenditures under individual grants within each budget period and within the overall project period. The funding that NIH provides for each budget period is based on an assessment of the effort to be performed during that period and the grantee’s associated budget, including the availability of “un-obligated” balances. Although NIH allows its grantees flexibilities with respect to re-budgeting (see “Administrative Requirements – Changes in Project and Budget” in the NIH Grants Policy Statement), NIH expects the rate and types of expenditures to be consistent with the approved project and budget and may question or restrict expenditures that appear inconsistent with these expectations.

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Enforcement Actions:– If a grantee materially fails to comply with the terms and

conditions of award, the NIH may; • Modify the terms and conditions of award• Debarment or suspension actions• Temporarily withhold payments pending corrective action• Disallow all or part of the costs of the activity or action found

not in compliance• Wholly or partially suspend or terminate the current award• Withhold further awards for the project or program• Take other remedies that may be legally available such as

civil action

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GPS Part II, Subpart B• Subpart B covers the terms and conditions for specific types of

grants, grantees and activities:– Construction grants

– Ruth L. Kirschstein National Research Service Awards (individual awards, institutional awards and payback information)

– Modular applications and awards

– Conference grants

– Consortium agreements

– Grants to foreign institutions, international organizations and domestic grants with foreign components

– Grants to federal institutions and payments to federal employees (includes information on VA affiliations)

– Grants to for-profit organizations

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GPS Part II, Subpart BResearch Patient Care Costs. The costs of routine and ancillary services provided by hospitals to individuals participating in research programs. The costs of these services normally are assigned to specific research projects through the development and application of research patient care rates or amounts (hereafter “rates”). Research patient care costs do not include: (1) the otherwise allowable items of personal expense reimbursement, such as patient travel or subsistence, consulting physician fees, or any other direct payments related to all classes of individuals, including inpatients, outpatients, subjects, volunteers, and donors, (2) costs of ancillary tests performed in facilities outside the hospital on a fee-for-service basis (e.g., in an independent, privately owned laboratory) or in an affiliated medical school/university based on an organizational fee schedule, or (3) the data management or statistical analysis of clinical research results.

• NIH provides funds for research patient care costs under grants. Research patients may receive routine services as inpatients or ancillary services as either inpatient or outpatient subjects/volunteers.

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GPS Part II, Subpart B• If the patient is receiving service or care that neither differs from usual

patient care nor results in expenses greater than those that would have been incurred if the study had not existed, then the patient is considered to be hospitalized for usual care purposes and the grant will not support the costs.

• When the research extends the period of hospitalization beyond that ordinarily required for usual care, or imposes procedures, tests or services beyond usual care, whether in an inpatient or outpatient setting, the grant may pay the additional costs.

• Patient care costs for individuals who are receiving accepted treatment according to standard regimens would not ordinarily be acceptable charges to an NIH grant.

• Similarly, in certain kinds of clinical trials where accepted treatments are compared against new therapies, research patient care costs generally may be charged to a grant only insofar as they are measurements or services above and beyond those that constitute usual patient care and are specified by the study protocol.

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GPS Part II, Subpart B• NIH funds may be used to pay all costs (whether usual care costs or research

care costs) for the entire period of hospitalization or research tests or services for individuals who would not have been hospitalized or received such tests or services except for their participation in the research study.

• Research patient care costs, whether expressed as a rate or an amount, shall be computed in an amount consistent with the principles and procedures used by the Medicare program for determining the portion of Medicare reimbursement based on reasonable costs.

• Separate cost centers must be established for each discrete bed unit for purposes of allocating or distributing allowable routine costs to the discrete unit.

• F&A costs should not be paid on any cost component representing the cost of research patient care activities.

• Research patient care rates (routine and ancillary) include F&A costs related to “hospital-type” employees (nurses, medical technicians, and similar personnel) supported as a direct cost under a grant. Therefore, to preclude over-recoveries of costs similar to these F&A costs, salaries and wages of all “hospital-type” employees working on the grant must be excluded from the S&W base used to claim F&A costs. Related fringe benefits also should be excluded if such costs are part of the S&W base.

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So, Back to What’s New in the 10/1/10 revision

• New in Part I (page 30) a section on eRA Commons. Includes a short overview and registration instructions, including a section on Postdocs. User guides and FAQ’s http://era.nih.gov/commons/index.cfm.

• Part I, section 2.3.7 now includes an overview of all policies affecting applications i.e.; consortium/contractual F&A excluded from direct cost limitation, prior approval for requests of $500k or more in directs, resubmission of unfunded RFA applications…

• 2.5.2 Details the process for submitting Revised Project Summary/Abstracts, Specific Aims, and/or Public Health Relevance Statement when requested as part of the pre-award process.

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Modified Application Submission Policy for NIH Appointees

• The new policy applies to R01, R21, and R34 applications that would normally be received on standard submission dates.

• The applicant PD/PI has been serving as:– Appointed members of NIH chartered study sections– NIH Boards of Scientific Counselors– NIH Program Advisory Committee or– Peer reviewers who have served as regular or temporary

members six times in 18 months

• The new policy now allows for applications to be submitted as soon as they are fully developed and they will be reviewed no later than 120 days after receipt.

• See 2.3.9.3 for additional information and specifics for multiple PD/PI applications.

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PD/PI, Applicant and Sponsor Assurance

• The applicant organization is required to secure and retain a unique signature and dated assurance from the PD/PI for each submitted application, prior to submitting an application to the NIH. We do this via the Partners Proposal Cover Sheet.

• For individual Fellowship applications, this assurance requirement applies to the individual fellow and the sponsor. Such an assurance must include at least the follow certifications: (1) that the information submitted within the application is true, complete and accurate to the best of the Fellow’s and Sponsor’s knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the Fellow and Sponsor to criminal, civil, or administrative penalties; (3) that the Sponsor will provide appropriate training, adequate facilities, and supervision if a grant is awarded as a result of the application; (4) that the Fellow has read the Ruth L. Kirschstein National Research Service Award Payback and will abide by the Assurance if an award is made; and (5) that the award will not support residency training.

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Post Submission of Additional Grant Application Materials

• “Adding materials to reviewer workload may be counterproductive, so applicants should carefully consider the need to send post-submission materials. For materials that are submitted after the initial grant application submission but prior to initial peer review, NIH will only accept such materials resulting from unforeseen administrative issues. This policy does not modify the Just-in-Time requirements or any other requests for additional information after the initial peer review.”

• Please see 2.3.7.7 for detailed information regarding acceptable materials, limitations, exclusions and process

• “The opportunity to submit additional materials should not be a means of circumventing submission deadlines, page limitations, or content requirements and should not substantially enhance, alter or add to the originally submitted application.”

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What Else is New?

• More in-depth overview of the peer review process including scientific and technical merit review criteria as well as additional items considered but not scored individually. See section 2.4 for specifics. Good information for first time NIH applicants and Beginning Investigators.

• The Just-in Time section has been expanded to provide much more detail regarding the process and the information requested at the JIT stage. See section 2.5.1 for specifics.

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Federal-wide Standard Terms and Conditions for Research Grants

• To create greater consistency in the administration of Federal research awards, all Federal research agencies now utilize a standard core set of administrative terms and conditions on research and research-related awards that are subject to OMB Circular A-110 (2 CFR part 215), to the extent practicable.

• The Government-wide core set of administrative requirements and other pertinent documents are posted at: http://www.nsf.gov/bfa/dias/policy/rtc/index.jsp.

• Grantees are encouraged to review the companion documents which include a Prior Approval Matrix, National Policy Requirement Matrix, Subaward Requirement Matrix, and Agency-Specific Requirements.

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New Additions to the Public Policy Section

• The Public Policy and Appropriation Mandates section has been expanded by the addition of new policies and has been improved by clarifying the intent of some of the existing provisions.

Examples of new additions:• ClinicalTrials.gov requirement – The FDA Amendment Act

(FDAAA) mandates registration and results reporting of applicable clinical trials (interventional studies with 1 or more sites in the US) in the ClinicalTrials.gov registry.

• Federal Funding Accountability and Transparency Act (FFATA) - full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000

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New Additions to the Public Policy Section, con’t

4.1.11 is an overview of the Fly America Act • The Fly America Act (49 U.S.C. 40118) generally provides that

foreign air travel funded by Federal government money may only be conducted on flag air carriers.

• A "U.S. flag air carrier" is an air carrier that holds a certificate under 49 U.S.C. 41102 but does not include a foreign air carrier operating under a permit.

• There are limited circumstances under which use of a foreign-flag air carrier is permissible. – Airline "Open Skies" Agreements – Involuntary Rerouting – Travel To and From the U.S. – Travel Between Points Outside the U.S

Short Distance Travel

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New Additions to the Public Policy Section, con’t

• Trafficking in Persons – take it literally (forced labor, sex acts – when award is in effect) Full text of the award term is provided at 2 CFR part 175.15

• Federal Information Security Management Act (FISMA) - All information systems, electronic or hard copy which contain federal data need to be protected from unauthorized access. This also applies to information associated with NIH grants and contracts. The applicability of FISMA to NIH grantees applies only when grantees collect, store, process, transmit or use information on behalf of HHS or any of its component organizations.

• Text Messaging While Driving - NIH encourages grantees to consider new rules and programs, reevaluate existing programs to prohibit text messaging while driving, and conduct education, awareness, and other outreach for employees about the risks associated with texting while driving.

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Protecting Sensitive Data and Information Used in Research (a bit more on FISMA - section 4.1.9)

• New section that implements policy previously announced as a Guide Notice

• Reminds recipients that protecting sensitive and confidential data is part of being a good steward

• Recommends not storing personally identifiable, sensitive or confidential information on portable electronic devices

• When used, they should be encrypted– Have you complied with the internal mandate to have hand held

devices and laptops encrypted?

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4.1.20 National Environmental Policy Act

• All NIH grants, whether or not they include construction or major A&R activities, are subject to the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended.

• This Act requires Federal agencies to consider the reasonably foreseeable environmental consequences of all grant-supported activities.

• As part of NIH's implementation of this Act, grantees are required to promptly notify NIH of any reasonably foreseeable impacts on the environment from grant-supported activities, or certify that no such impacts will arise upon receipt of a grant award.

• In addition, NIH has determined that most NIH research grants are not expected to individually or cumulatively have a significant effect on the environment unless any part of the proposed research and/or project includes any of the categorical exclusions listed in section 4.1.20

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Additional Sections Where Changes Have Been Made

• Significant changes have been made to the sections on Human Stem Cell Research, Select Agent Research and Financial Conflict of Interest.

• Details regarding the changes start in section 4.1.13. This is a must read section for anyone involved in the above types of research projects.

• The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (September 2009 or latest revision) apply to all research projects that involve recombinant DNA and are conducted at or sponsored by an organization that receives NIH support for recombinant DNA research. A copy of the NIH Guidelines is available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.

• The NIH Guidelines apply to both basic and clinical research studies. Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines.

• Failure to comply with these requirements may result in suspension or termination of an award for recombinant DNA research at the organization, or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization.

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Senior/Key Personnel Clarification

• The Notice of Award section now states that the NoA will include “Name(s) of Senior/key personnel that are subject to NIH prior approval requirements if a significant change in level of effort occurs”.

• Under Prior Approvals, this is now restated “The grantee is required to submit a prior approval request to the GMO if the PD/PI or other senior/key personnel specifically named in the NoA will…”.

• “The requirement to obtain NIH prior approval for a change in status pertains only to those personnel NIH designates in the NoA regardless of whether the applicant organization designates others as senior/key personnel for its own purposes.”

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Selected Items of Cost Chart (section 7.10 - example of change)

Equipment:• Allowable for purchase of new, used, or replacement equipment as

a direct cost or as part of F&A costs, depending on the intended use of the equipment. NIH prior approval may be required as specified in Administrative Requirements—Changes in Project and Budget.

• Office equipment (copiers, laptops, desktop computers, personal handheld computers, fax machines, scanners, etc.) that is used for general office purposes (rather than justified as a specific research purpose) are not allowable as direct costs; they are allowable as an F&A cost.

• Funds provided under a conference grant may not be used to purchase equipment.

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8.2 Availability of Research Results

Added new sections:

• NIH Public Access Policy – clarifying that NIH funded PIs are required by Federal law to submit to PMC

• Sharing Model Organisms – clarifying that the expectation of sharing applies to all applications where the development of model organisms is anticipated, regardless of funding amount

• Policy for Genome-Wide Association Studies (GWAS) clarifying that all applications, regardless of amount requested, that propose a GWAS are expected to provide a plan for submission of GWAS data to the NIH designated GWAS data repository or provide an appropriate explanation why submission to the repository is not possible

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8.4.1 Reporting

• More detail provided regarding reporting requirements

• All SNAP progress reports must be submitted electronically

• New section added (8.4.1.4.4) Recipient Reporting of Subrecipient Data and Executive Compensation Information for Federal Funding and Accountability and Transparency Act (FFATA).– Details the new requirement to report on

subawards/subcontracts/consortiums equal to or greater than $25,000. This includes awards that are initially below $25,000 but subsequent grant modifications result in an award equal to or greater than $25,000.

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More on FFATA and Subaward Reporting Requirements

• Applies regardless of award type.

• The new subaward reporting system (fsrs.gov) will serve as the collection point for data that will be displayed on USASpending.gov

• Grantees are required to register with FSRS, collect the necessary data from subawardees, and file subaward reports by the end of the month following the month in which the prime grantee awards any subaward greater than $25,000.

• Please see 8.4.1.4.4 for specific data elements collected

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Subpart B – Terms and Conditions of Specific Types of Awards

New sections:

• Multiple Program Director/Principal Investigator Applications and Awards covering eligibility, application specifics and post award administration

• 11.3.3.5 explains the Responsible Conduct of Research training requirement

• Training grant section expanded to include a lot more detail regarding application, appointment, award administration and close out

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More on Subpart B – Terms and Conditions of Specific Types of Awards

New section on Career Development Awards: • Provides a detailed overview of overall program and each of the

different types of K awards

• Each overview includes individual and institutional eligibility criteria as well as citizenship and appointment requirements

• Application requirements and review criteria

• Allowable/unallowable costs for K awards

• Level of effort and temporary adjustments

• Concurrent support

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Chapter 11 Revisions – NRSA Awards

*Note – this section underwent extensive changes and should be reviewed by all working on training grants and fellowships.Some of the highlights include:

• Clarified language regarding citizenship and degree requirements• Reiterates mandate that went into effect 8/8/09 requiring all

submissions go electronically via Grants.gov; reference letters go separately via eCommons; resubmissions must include an introduction addressing review criteria; 5 review criteria described and scored individually

• Clarification of period of support – “No individual may receive more than 5 years of aggregate Kirschstein-NRSA support at the predoctoral level and 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of Kirschstein-NRSA support from institutional research training grants and individual fellowships.”– Any exception to the maximum period of support requires a waiver

from the NIH awarding IC based on review of a justification from the individual and sponsoring institution.

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Chapter 11 Revisions – NRSA Awards, con’t

• Clarification of full time – “Full-time is generally defined as devoting at least 40 hours per week to research training activities or as specified by the sponsoring institution in accordance with its own policies.”

• Reiterates requirement to use xTrain effective January 1, 2011

• Section on allowable costs for training and fellowship awards clarified (tuition and fees, employee benefits, institutional allowance…)

• Termination notices must be completed within 30 days, even if the trainee is not available to sign

• Added a new parental leave policy - Trainees may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child when individuals in comparable training positions at the grantee organization have access to this level of paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave must be approved by the Training PD/PI.

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Chapter 19 – Research Patient Care Costs

Added new section; 19.6 Post-Award Requirements

• Post-award rebudgeting into or out of the patient care costs category is likely to be considered a change in scope and require prior approval of the NIH awarding IC (see Administrative Requirements—Prior Approval Requirements—Change in Scope in IIA).

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Questions?

http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm

http://grants1.nih.gov/grants/policy/nihgps_2010/index.htm

http://grants1.nih.gov/grants/guide/index.html

Robin Cyr [email protected]

© Partners HealthCare System, Inc., 2011

1 The NIH Grants Policy Statement (NIHGPS) © Partners HealthCare System, Inc., 2011.

Documents

Transcript of 1 The NIH Grants Policy Statement (NIHGPS) © Partners HealthCare System, Inc., 2011.