ARCHIVED - NIH Grants Policy Statement (10/03)
NIH Grants Policy Statement(12/03)
Part II: Terms and Conditions of NIH Grant Awards
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities -- File 4 of 5
*Several NIH ICs use only one or two of the receipt dates for Kirschstein-NRSA institutional research training grant applications. Applicants are encouraged to confirm the application receipt dates by calling the appropriate IC or checking the NIH-wide program announcement for institutional research training grants at http://grants.nih.gov/training/nrsa.htm.
Modular applications and awards employ a simplified process for developing and reviewing application budgets, documenting approved budgets, and making post-award budgetary changes.
Modular procedures are required to be used for new, competing continuation, and revised (amended) applications as well as for competing supplements for individual research project grants (R01), small grants (R03), exploratory/development grants (R21), and Academic Research Enhancement Awards (R15) that request up to a total of $250,000 of direct costs per year, regardless of whether the application is an investigator-initiated application or is one submitted in response to a PA/RFA. Modular procedures also apply to SBIR and STTR Phase I grants (R43 and R41) that request up to a total of $100,000 (direct and F&A costs and fee).
Instructions for specific grant mechanisms other than the R01 and guidelines for IC programs may indicate a particular number or range of modules allowed. In addition, an IC may, at its discretion, specify in an RFA that the modular application requirements apply to applications for amounts in excess of the modular ceiling.
Modular applications and awards also are subject to other simplified procedures, specifically just-in-time requirements and SNAP.
Modular applications are submitted on the PHS 398, with the following modifications.
Modular applications request direct cost funding in modules of $25,000, up to the ceiling amount (i.e., $250,000 for each year of support under covered mechanisms other than SBIR/STTR Phase I grants and $100,000 for SBIR/STTR Phase I grants) plus applicable F&A costs. The modules should be a reasonable estimate of allowable, allocable, and reasonable costs for the proposed project, since only limited budget information is required for submission of a modular application, the standard application budget forms are not used. Applicants must submit budget information in accordance with the Modular Budget Format Page included in the PHS 398 application instructions. Sample modular application budget pages are available at http://grants.nih.gov/grants/funding/modular/modular.htm.
The modular budget is accompanied by a narrative for all personnel by position, role, and percent level of effort. This includes consultants and any “to be appointed” positions. No individual salary information should be provided. Applicants must use the current salary cap when determining the number of modules (see “Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages”). Given the ability to rebudget and to carry forward unobligated balances, funds generally should be available to cover any modest increase in the statutorily imposed salary cap.
As appropriate, the narrative also must address consortium/contractual costs (including applicable F&A costs) rounded to the nearest $1,000. The narrative should list the individuals and organizations with whom consortium or contractual arrangements have been (or will be) made, the percent of effort of key personnel and their role on the project, and indicate whether the collaborating organization is foreign or domestic.
A typical modular application will request the same number of modules for each year; however, well-justified modular increments (up to the specified modular ceiling) or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested at the outset. For example, a major equipment purchase in the first year may justify a higher overall budget in that year, but not necessarily in succeeding years. There is no provision for escalation in future years. NIH requires additional narrative budget justification if there is a variation in the number of modules requested from year to year.
The application checklist must be completed and submitted with the application. The checklist should include F&A costs calculated at the current negotiated rate, less exclusions, for the initial budget period and all future budget periods covered by the application.
The modular application instructions require only limited budgetary information. Therefore, applications not complying with those instructions will not be accepted for review and will be returned to the applicant by CSR as non-compliant applications.
An application will be considered non-compliant if one or more of the following occurs:
l The direct cost budget is not in modules of $25,000 for each year of support requested.
l A detailed itemized categorical budget is provided.
l The budget narrative justification includes an itemized justification for one or more of the following: equipment, travel, supplies, other expenses, etc., but the number of modules requested for each year is the same, or the information is not intended to explain the request for a different number of modules for one or more years.
A returned application, if revised and resubmitted to NIH in a timely manner, may remain in the review cycle for which it was originally submitted.
SRGs evaluate the budget on the basis of a general, expert estimate of the total effort and resources required to carry out the proposed research. If the SRG recommends an adjustment in the project budget, the recommended adjustment will be in terms of an entire module.
Following peer review, for applications being considered for award, the IC will request from the applicant information about “Other Support” and, as applicable, human subjects, animal subjects, and education in the protection of human research participants. Additional budget information will be requested before award only under special circumstances.
NIH will attempt to make awards at or close to the level of total direct costs recommended by the SRG, taking other support into account. In unusual situations, an IC may have to reduce the funding amount to accommodate the IC’s cost management plan.
The award budget will be a noncategorical budget specifying approved total direct costs and F&A costs, if applicable.
In accordance with the applicable cost principles and other cost policies included in Subpart A of this part, grantees are required to allocate and account for costs related to their awards by category within their organizational accounting system.
Modular awards are subject to expanded authorities and SNAP.
Grantees may request administrative supplements as under nonmodular awards.
NIH supports scientific meetings, conferences, and workshops (hereafter “conferences”) that are relevant to its scientific mission and to public health under the R13 and U13 activity codes. NIH’s support of conferences is contingent on the interests and priorities of the individual ICs. Most ICs provide conference support although their budget guidelines may vary. Prior approval is required before submission of an application for conference support. Therefore, potential applicants must contact the funding IC for specific information as well as to ensure compliance with submission requirements. Applications for conference support must be submitted based on the published receipt dates. NIH will not make an award unless it can be issued before the conference’s start date.
This section applies to grants that support domestic and international conferences. If a policy is not addressed in this section, the Subpart A coverage applies.
Questions concerning the allowability of conference activity under research grants should be directed to the GMO.
Scientific Meeting (Conference). A gathering, symposium, seminar, workshop, or any other organized, formal event where people assemble to coordinate, exchange, and disseminate information or to explore or clarify a defined subject, problem, or area of knowledge.
International Conference. A scientific meeting so designated by its sponsor or one to which open invitations are issued on an equal basis to potential participants in two or more countries other than the United States or Canada. The meeting may be held in any country, including the United States.
Domestic Conference. A scientific meeting held in the United States or Canada primarily for U.S. or U.S.-Canadian participation (even if foreign speakers are invited).
Domestic institutions or organizations, including established scientific or professional societies, are eligible to apply for conference support. Both domestic and international conferences may be supported; however, an international conference can be supported only through the U.S. representative organization of an established international scientific or professional society. An individual is not eligible to receive a grant in support of a conference.
The PHS 398 is to be completed by an organization seeking NIH conference support. Supplemental application instructions for conference grants are available at the Kiosk for Conference Grants at http://grants.nih.gov/grants/funding/r13/index.htm.
Public Policy Requirements and Objectives
In addition to any applicable public policy requirements and objectives specified in Subpart A, conference grant applicants must comply with the Guidelines on the Inclusion of Women, Minorities, and Persons with Disabilities in NIH Supported Conference Grants (available through the NIH website at http://grants.nih.gov/grants/policy/policy.htm. Appropriate representation of women, individuals who are members of racial/ethnic minority groups, people with disabilities, and other individuals who have been traditionally underrepresented in science must be included in all aspects of planning, organization, and implementation of NIH-sponsored or -supported meetings. “Appropriate representation” is based on the availability of scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, NIH will not make an award until the applicant has submitted acceptable documentation of its compliance.
Applications for conference grants will be reviewed for programmatic relevance and for merit as described in the conference grant PA (http://www.niehs.nih.gov/dert/programs/conferen.htm).
Depending on IC policy, applications for conference grants also may be reviewed by the IC’s National Advisory Council or Board.
Grants or cooperative agreements may be used to provide conference support. A cooperative agreement may be awarded if the NIH awarding office determines that it needs to have substantial involvement in the planning and conduct of a conference.
Grant funds may not be used to provide general support for international conferences held in the United States or Canada. Grant funds may be awarded to support only specific aspects of such conferences. An example would be a selected symposium, panel, or workshop, including the costs of planning and travel of U.S. participants.
Awards in support of a single conference will be made for a project period commensurate with the time involved in planning and conducting the conference and post-conference follow-up, usually 1 year. A conference grant made to a permanently sponsoring organization for conferences held annually or biennially on a recurring topic may be awarded for up to a total of 5 years and will be funded annually, based on the availability of funds. Continued funding beyond the first year will be contingent on a report of satisfactory progress submitted in accordance with SNAP instructions. A change in conference focus requires NIH awarding office prior approval.
The following highlights allowable and unallowable costs under conference grants. No costs other than those specified in this subsection as allowable, including any qualifications on their allowability, are permitted under conference grants.
Conference Services. Grant funds may be used for necessary recording of proceedings, simultaneous translation, and subsequent transcriptions.
Consultant Services. Grant funds may be used to pay consultant fees, including travel and supporting costs (per diem or, where applicable, subsistence).
Equipment Rental. Grant funds may be used for the rental of necessary equipment.
Federal Employees. See “Grants to Federal Institutions and Payments to (or on Behalf of) Federal Employees under Grants.”
Meals. When certain meals are an integral and necessary part of a conference (i.e., a working meal where business is transacted), grant funds may be used for such meals, as qualified under “Travel” in this subsection.
Publication Costs. When grant funds are awarded to pay for either the entire or partial cost of publication of proceedings or a book or pamphlet, allowable costs include special plates, charts, diagrams, printing, distribution, mailing, postage, and general handling, unless otherwise specified at the time the grant is awarded.
Registration Fees. Grant funds may be used for registration fees paid by the grantee to other organizations on behalf of attendees, provided such fees cover only those allowable costs properly chargeable to the grant.
Salaries. In accordance with the policy of the grantee organization, grant funds may be used for all or part of the salaries of professional personnel, clerical assistants, editorial assistants, and other non-professional staff in proportion to the time or effort directly related to the conference.
Speakers Fees. Speakers’ fees for services rendered are allowable.
Supplies. Grant funds may be used for the purchase of supplies for the conference if the supplies are received and used during the budget period.
Travel. Funds may be used for the travel of staff, speakers, participants, and attendees, if identified in the application and approved at the time of award. Travel expenses for employees of the grantee organization are governed by the grantee’s travel policies, consistently applied regardless of the source of funds.
Any U.S. foreign travel restrictions that are in effect at the time of the award will be followed, such as
l limitations or restrictions on countries to which travel will be supported or
l budgetary or other limitations on availability of funds for foreign travel.
Proposed per diem or subsistence allowances must be reasonable and limited to the days of attendance at the conference plus the actual travel time to reach the conference location by the most direct route. Local mileage costs only may be paid for local participants. Where meals and/or lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem or subsistence allowance must take this into consideration.
Transportation costs for attendees and participants at the conference may not exceed coach class fares. In all cases, U.S. flag carriers will be used where possible (see “Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Travel”).
A&R. Not allowable.
Entertainment and Personal Expenses. Costs of amusement, diversion, social activities, ceremonials, and related incidental costs, such as bar charges, tips, personal telephone calls, and laundry charges of participants or guests, are unallowable. However, meals may be allowable as provided under “Allowable Costs—Meals” in this subsection.
Equipment Purchase. Grant funds may not be used for the purchase of equipment.
F&A Costs. Not allowable.
Honoraria. Honoraria or other payments given for the purpose of conferring distinction or to symbolize respect, esteem, or admiration may not be paid from grant funds.
Local Participants’ Expenses. With the exception of local mileage as indicated under “Allowable Costs—Travel” in this subsection, grant funds may not be used to pay per diem or expenses for local participants in the conference.
Membership Dues. Not allowable.
Research Patient Care. Not allowable.
Intellectual Property: Publications, Copyright, and Public Disclosure
If the grantee publishes material developed in whole or in part with NIH funds, the material may be distributed free of charge. If the grantee organization charges for the material, the sales proceeds are considered program income, and must be accounted for as specified in the NGA and reported on the FSR (see “Reporting and Record Retention” in this subsection).
Unless otherwise provided in the terms and conditions of the award, the grantee is free to arrange for copyright of any publication resulting from an NIH-supported conference. However, any such copyrighted publication shall be subject to a nonexclusive, irrevocable, royalty-free license to the Federal government to reproduce, translate, publish, and dispose of the material and to authorize others to use the work for government purposes. Copyright does not extend to any materials prepared by Federal employees as part of their official duties.
The grantee is cautioned to remind conference participants that any presentation or discussion constitutes public disclosure of information. Any such public disclosure would create a bar and seriously impact the degree to which any intellectual property rights could be protected.
Grantees are responsible for submitting the following reports to the NIH awarding office upon completion or termination of a grant in support of a conference.
For single conferences, a final report of the conference must be submitted to the NIH awarding office within 90 days after the end of the project period. The report must include the following:
l Grant number
l Title, date, and place of the conference
l Name of the person shown on the application as the conference director, PI, or PD
l Name of the organization that conducted the conference
l A list of the individuals, and their organizational affiliations, who participated as speakers or discussants in the formally planned sessions of the meeting
l A summary of topics discussed/conclusions.
Under multiple-year awards, i.e., ones that support more than one conference, NIH requires an annual progress report that contains a description of specific plans for the next budget period, in similar detail and format as for a single conference. The annual progress report must be submitted at least 6 months before the next scheduled conference. The final progress report should be submitted within 90 days after the end of the project period.
With the approval of the NIH awarding office, copies of proceedings or publications resulting from the conference(s) may be substituted for the final report, provided that they contain the information specified for inclusion in the final report.
An FSR is required from the grantee within 90 days after the end of the project period. Records of expenditures and any program income generated must be maintained in accordance with the provisions of 45 CFR 74.53 or 92.42 (see “Administrative Requirements—Monitoring—Record Retention and Access”).
This section includes the requirements for an applicant/grantee under consortium agreements in which the grantee collaborates with one or more other organizations in carrying out the grant-supported research. The grantee, as the direct and primary recipient of NIH grant funds, is accountable to NIH for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the grantee, as specified in the NIHGPS. In general, the requirements that apply to the grantee, including the intellectual property requirements in Subpart A and the program income requirements of the award, also apply to consortium participant(s). Exceptions are noted in this section. The grantee is responsible for including the applicable requirements of the NIHGPS in its agreements with collaborating organizations (see “Written Agreement” in this section).
Under grants that include consortium agreements:
l The award will be made to a single grantee with a single PI, even though one or more organizations other than the grantee will carry out portions of the planned programmatic activity.
l The grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties.
Applicants are expected to detail their proposed collaborations as part of the grant application. If the application is approved as submitted, no further approval is required unless, during performance, the grantee plans to undertake additional or alternative collaborations that would constitute a change in the scope of the approved project (see “Administrative Requirements—Changes in Project and Budget”). Applicants for STTR grants should follow the specific requirements for research collaboration established for that program (see “Grants to For-Profit Organizations”).
The following information must be provided to NIH as part of a competing application that proposes consortium arrangements:
l A list of all proposed performance sites, including those of the applicant organization and the consortium participant(s); and
l Complete application budget pages (for the first year and each future year of support requested) for each consortium participant, unless the application is for a modular award (see “Modular Applications and Awards”).
The signature of the AOO on the application signifies that the applicant organization and all proposed consortium participants understand and agree with the following statement:
“The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the NIH consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.”
NIH may request additional information before award and may place a special condition(s) on the award.
The following highlights several areas within the consortium relationship that the grantee needs to address with the consortium participant to ensure compliance with NIH requirements. The requirement for a written agreement addressing these and other areas is specified in this section.
Public Policy Requirements and Objectives
The grantee is responsible for determining whether a consortium participant, including foreign consortium participants under domestic or foreign grants, has filed assurances with NIH that would cover its activities within the consortium and, if not, for ensuring that any required assurances or certifications are submitted to NIH. See “Public Policy Requirements and Objectives” for the full statement of these requirements and their applicability to consortium participants.
The grantee is responsible for ensuring that all sites engaged in human subjects research have an appropriate OHRP-approved assurance and IRB approval of the research consistent with 45 CFR Part 46, and for complying with NIH prior-approval requirements related to the addition of sites not included in the approved application (see “Administrative Requirements—Changes in Project and Budget”). The list of organizations with approved assurances is available at the OHRP website: http://www.hhs.gov/ohrp.
The grantee also must ensure that all sites engaged in research involving the use of live, vertebrate animals have an appropriate animal welfare assurance. If collaborating institutions have full PHS Assurances, they may exercise discretion in determining which IACUC reviews research protocols and under which institutional animal welfare program the research will be performed. If an IACUC defers protocol review to another IACUC, then documentation of the review should be maintained by both committees. Similarly, an IACUC should be advised about any significant questions or issues raised during a semiannual program inspection of a facility housing a research activity for which that IACUC bears some responsibility or exposure.
The grantee must include in consortium agreements the applicable government-wide cost principles and NIH cost policies described in “Cost Considerations” and, as appropriate, requirements related to allowable and unallowable costs in other sections of Subpart B. For example, a university grantee must flow down the cost principles of OMB Circular A-122 to a consortium participant that is a non-profit research organization. This includes the application of F&A rates in determining consortium budgets and the reimbursement of costs.
The grantee is responsible for obtaining NIH awarding office approval for any actions to be undertaken by consortium participants that require prior approval. Grantees may establish requirements for review of consortium participants’ activities consistent with those requirements and with any authorities provided to the grantee; however, a grantee may not provide any authority to a consortium participant that the grantee has not been provided under its NIH award.
Regardless of whether there is a change in scope, in all cases, if a grantee (or consortium participant) proposes the transfer of work to a foreign site, awarding office prior approval is required.
If the grantee provides exempt property to a consortium participant or authorizes a consortium participant to purchase property that would be considered exempt if acquired by the grantee, the grantee may vest title in the consortium participant upon transfer or purchase or may reserve the right to do so at a later time. The grantee also may establish its own use, disposition, and accountability requirements, provided they are consistent with the NIH right to transfer title (see “Administrative Requirements—Management Systems and Procedures—Property Management System Standards—Equipment and Supplies”).
If the grantee provides nonexempt property to a consortium participant or authorizes a consortium participant to purchase property that would be considered nonexempt if purchased by the grantee, title to such property must remain with the grantee or be vested in the grantee upon acquisition of the property. The grantee may establish use, accountability, and disposition requirements for the property, provided they are consistent with, and do not impair, the grantee’s ability to comply with the requirements of 45 CFR Part 74 or 45 CFR Part 92, as appropriate.
The grantee must require consortium participants to comply with the requirements of OMB Circular A-133 or 45 CFR 74.26(d), as applicable, for audit of NIH grant funds expended by consortium participants. A consortium participant also may be a direct NIH grantee or contractor or may be receiving funds only under the consortium agreement. Regardless, if a non-profit consortium participant meets the OMB Circular A-133 threshold criterion of aggregate annual expenditures of $500,000 or more under applicable Federal awards, the grantee must receive a copy of that organization’s A-133 audit and take appropriate action based on any findings that relate to the consortium agreement. If a consortium participant will not reach that expenditure threshold, the grantee is responsible for monitoring the organization’s activities to ensure compliance with NIH requirements. The grantee may not require a consortium participant to have an audit and charge the audit costs to NIH grant funds unless required or authorized by OMB Circular A-133 or 45 CFR 74.26(d).
The grantee must enter into a formal written agreement with each consortium participant that addresses the negotiated arrangements for meeting the scientific, administrative, financial, and reporting requirements of the grant, including those necessary to ensure compliance with all applicable Federal regulations and policies and facilitate a smoothly functioning collaborative venture. At a minimum, this agreement must include the following:
l Identification of the PI and individuals responsible for the research activity at each consortium participant along with their roles and responsibilities
l Procedures for directing and monitoring the research effort
l Procedures to be followed in reimbursing each consortium participant for its effort, including dollar ceiling, method and schedule of reimbursement, type of supporting documentation required, and procedures for review and approval of expenditures of grant funds at each organization
l If different from those of the grantee, a determination of policies to be followed in such areas as travel reimbursement and salaries and fringe benefits (the policies of the consortium participant may be used as long as they meet NIH requirements)
l Incorporation of applicable public policy requirements and provisions indicating the intent of each consortium participant to comply, including submission of applicable assurances and certifications (see “Public Policy Requirements and Objectives”)
l Whether the financial conflict of interest requirements of the collaborating organization or those of the grantee apply
l A provision addressing ownership and disposition of data produced under the consortium agreement
l A provision making the NIH data sharing and inventions and patent policy, including a requirement to report inventions to the grantee (see “Administrative Requirements—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources”), applicable to each consortium participant and its employees in order to ensure that the rights of the parties to the consortium agreement are protected and that the grantee can fulfill its responsibilities to NIH
l Provisions regarding property (other than intellectual property), program income, publications, reporting, and audit necessary for the grantee to fulfill its obligations to NIH.
GRANTS TO FOREIGN
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