Best Practices in Funding Extramural Research
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Making Funding Decisions

Moving Applications from Review to Approval

IMPAC II: Technology for Administering Grants

Making Funding Decisions

Funding Processes

Special Funding Mechanisms

Co-Funding Applications

Moving Applications from Review to Approval

The process through which applications progress from review to approval for funding depends on several factors. These factors include:

  • The funding mechanism under which the application was submitted or to which it is assigned.

  • The research priorities specified in the NCI funding plan.

  • Where the application falls with respect to the NCI payline.

  • The priority score assigned to the application in the peer review process.

The process by which priority scores are assigned is described in Voting on Applications.

Funding Categories and Funding Mechanisms

The NCI budget specifies expenditures in nine funding categories, six of which involve issuing grants to support research or to support activities related to research (e.g., training, construction of research facilities). Each year, about 65% of the NCI budget is used for grants to support these activities.

A funding mechanism is a particular kind of grant. Funding mechanisms vary in terms of the kind of work they support, eligibility criteria, the size of the grant that can be issued, review procedures, and the procedures used to determine whether grants will be awarded.

The six funding categories and the funding mechanisms within each category are:

  • Construction (C06).

    Construction grants support the creation of state-of-the-art cancer research laboratories and clinics for basic and applied research.

  • Training (F31-F36 & T32/T35/T36).

    The National Research Service Awards (NRSAs) provide long-term, stable support for the training of scientists and research clinicians.

  • Cancer prevention and control.

    The Office of the Director (OD), the Division of Cancer Control and Population Sciences (DCCPS), and the Division of Cancer Prevention (DCP) support research on methods of cancer prevention through grants, contracts, and in-house research.

  • Cancer Centers (P30/P20/U54) and Specialized Programs of Research Excellence (SPORE) (P50).

    Funds for cancer centers and SPOREs support diverse research approaches to the problem of cancer, incorporating all applicable disciplines.

  • Research project grants (RPGs).

    RPGs are awards given in response to investigator-initiated applications for research funds. Most grants issued by NCI are RPGs. Expenditures for these grants constitute 45-50% of the NCI budget.

    The specific kinds of RPGs are:

    - Traditional (R01)

    - Program Projects (P01)

    - MERIT Awards (R37)

    - RFAs (R01, U01)

    - Cooperative Agreements (U01 not responsive to RFA)

    - Shannon Awards (R55)

    - Small Grants (R03)

    - Exploratory/Developmental Grants (R21/R33)

    - SBIR/STTR Grants (R43/R44 & R41/R42)

  • Other research grants (non-RPGs).

This category includes the Research Career Program and other special programs. They include:

- Career Program

- RCDA (K04)

- Clinical Oncology (K12)

- Physician Investigator (K11)

- Preventive Oncology (K07)

- Clinical Investigator (K08)

- Temin Awards (K01)

- Cancer Education Program (R25)

- Clinical Cooperative Groups (U10)

- Scientific Evaluation (U09)

- Resource Grants (R24/U24)

- Conference Grants (R13)

- Exploratory Grants/Cooperative Agreements (U56)

Through the Comprehensive Minority Biomedical Program (S06), applicants may seek any RPG or non-RPG grant.

Assigning Applications to New Funding Mechanisms

An application submitted under one funding mechanism may, during the funding process, be assigned to another.

Typically, such reassignments occur when an application not funded under one mechanism is assigned to another. For instance, an investigator-initiated application not funded as an R01 may be funded as a Shannon Award.

Or, if the research plan presented in an unsolicited application indicates that NCI staff will play a substantial role in the proposed work, the award may be converted from a grant to a cooperative agreement. In such cases, grants funded under the R01 mechanism would be converted to U01s, and grants funded under the P01 mechanism would be converted to U19s. For more information about this process, see Converting Grants to Cooperative Agreements.

The NCI Funding Plan and Payline

Each year, the NCI Executive Committee (EC), which is made up of the Director of NCI and NCI Division Directors, develops NCI’s funding plan and specifies the payline.

  • The funding plan is a set of priorities for research project grants (RPGs).

    In developing the funding plan, the EC determines how to allocate NCI extramural research funds to achieve scientific goals.

  • The payline is a cut-off point.

    The level of the payline is determined by the NCI budget and its funding plan. Applications with priority scores or percentiles within the payline are likely to be funded. Applications with priority scores beyond the payline are not likely to be funded.

The funding plan and the payline for the coming fiscal year are established after an appropriation is signed into law—usually in October—but may be revised subsequently in response to changes in the budget, changes in research priorities or the quality of grants submitted during a particular round of submissions.

For information about current paylines, see http://camp.nci.nih.gov/admin/oem/efdb/paylines-fy01.html.

Funding decisions with regard to applications submitted in response to RFAs are based on the development of a funding plan that is specific to the initiative. For information about how applications submitted in response to RFAs are selected for funding see, Selecting Applications for Funding: Applications Submitted in Response to NCI Initiatives.

For information about other mechanisms that do not involve a payline, see Funding Mechanisms with No Payline.

Skipping Applications

After the peer review process—whether for investigator-initiated applications or applications submitted in response to NCI initiatives—a ranking list of approved applications, ordered by priority scores, is created. In most instances, applications are selected for funding in the order of their appearance on the ranking list.

In some cases, however, applications may be skipped for programmatic or budgetary reasons. For instance, if it is determined that there is substantial scientific overlap between an application being considered for funding and an already funded project, skipping the newer application may be warranted. Skips must be approved by the branch chief and the division director.

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IMPAC II: Technology for Administering Grants

IMPAC II is an electronic database that is used to track applications as they move through the funding process.

After the peer review process, DEA sends PDs a paylist, which is a list of all the applications assigned to their program areas that fall within the payline. PDs must enter identifying information about each of these applications into IMPAC II. This record then becomes the repository of all information about an application as it moves through the approval process.

Applications with priority scores that fall outside the payline are entered into IMPAC II as determinations are made about whether to fund them through procedures other than the expedited funding process or the regular process.

Several computer applications have been designed to track funding decisions in the IMPAC II database. Collectively, these applications are known as the Grants Reporting and Information Tracking System (GRITS).

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Making Funding Decisions

After applications have been reviewed, NCI staff must decide which applications to fund and how to fund them. Because funding decisions involve these two determinations, they are not straightforward, dichotomous "yea or nay" choices. Instead, the funding process should be seen as contingent and iterative.

  • The funding process is contingent in that whether and how applications will be funded depends on several factors.

    Most obviously, funding decisions depend on the priority score assigned to the application in the peer review process, but other factors also enter into the process. For instance, some funding decisions are based, at least in part, on characteristics of the applicant. One must be a distinguished senior investigator to be considered for a MERIT award, and one must be a new investigator to be considered for a *R01 award.

  • The funding process is iterative in that applications not funded in an initial pass through the funding process may be reconsidered for funding through another process.

    For instance, an unamended investigator-initiated application whose priority score falls outside the payline established for funding applications for the regular process (but within specified limits) may be considered for funding through the accelerated executive review process.

Operating effectively in the grant-making arena requires understanding the processes, and the relationship between those processes, through which funding decisions are made.

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Funding Processes

Figure 1 shows how investigator-initiated applications move into and through the funding process. This diagrams illustrates the contingent, iterative character of funding decisions.

The outcome of initial funding decisions depends, first, on whether the application falls within the payline. If the priority score assigned to the application is such that it falls beyond the payline, it can enter a new round of decision-making where it is again considered for funding.

For investigator-initiated applications, there are two alternative procedures through which an application might be funded—the accelerated executive review process and the exception process—as well as several special kinds of awards.

Figure 1. Funding Decision Processes: Investigator-Initiated Applications


Figure 2 shows how applications submitted in response to NCI initiatives move into and through the funding process. Funding decisions are based on priority scores, type of research proposed, and available funding. If the application is not funded through the regular process, it may be considered for funding through the exception process.

Figure 2. Funding Decision Processes: Applications Submitted in Response to NCI Initiatives

 

For investigator-initiated applications, the most frequently used funding processes are:

  • The expedited Board concurrence and early award process (known as the expedited process).

  • The regular process.

  • The accelerated executive review process.

  • The exceptions process.

For applications submitted in response to NCI initiatives, the two most frequently used funding processes are:

  • The regular process.

  • The exceptions process.

Further, both investigator-initiated applications and applications submitted in response to NCI initiatives may be funded through:

  • The end-of-year funding process.

Each of these processes is explained in the following section.

The Expedited Approval Process

 

Certain applications whose priority scores fall within the payline may be eligible for funding through the expedited NCAB approval process. Eligibility requirements are specified in the section below.

For budgetary or programmatic reasons, it may be necessary or desirable to skip applications whose priority scores are within the payline. Any skips must be justified in the I2E database.

Awards issued through the expedited approval process can generally be paid 3-5 months sooner than awards issued through the regular process.

In most cases, the NCAB must approve applications for funding. NCAB approval for applications funded through the expedited Board concurrence and early approval process (i.e., the expedited process) is obtained electronically, rather than by presenting applications for approval at an NCAB meeting. Using the expedited approval process, awards can be issued within 7-9 months of submission, rather than in 10-12 months as is the case for applications funded through the regular process.

This section describes:

  • The kinds of grants that are eligible for expedited approval.

  • The process of selecting applications for funding.

  • The process of creating the paylist.

Eligibility Requirements for the Expedited Process

The expedited approval process may be used to fund:

  • Unsolicited Type 1 and Type 2 R01s.

  • Exploratory/Developmental Grants (R21).

  • Small Grants, i.e., grants for less than $50,000 in direct costs issued under the R03 mechanism

The expedited process may not be used to fund:

  • Foreign applications or domestic applications with a foreign component.

  • Applications for which the SRG identified concerns about the protection of human subjects, the welfare of laboratory animals, or biohazards.

These applications must be called to the attention of the NCAB. For information about processing foreign grants and applications about which members of the SRG expressed concerns, see Processing Foreign Applications and Identifying Applications That Must Be Reported to the NCAB.

Selecting Applications for Funding through the Expedited Process

After receiving the list of eligible applications from DEA, the PD must:

1. Identify applications that are not eligible for the expedited funding process.

2. Select applications for funding.

In most instances, applications are selected in straight priority score order. However, PDs may skip applications that already receive support from other sources, or for other programmatic reasons.

Creating the Paylist for Expedited Funding

For each application that falls within the payline, the PD must:

1. Indicate whether the application has been selected for pay.

Using the GRITS paylist module, select "Yes" or "No" under "Intent to Pay." If the application is not selected for pay (i.e., is skipped), use the drop-down menu under "Comments" to enter the reason for the exclusion.

Skips must be justified in the GRITS form. To learn which NCI official must approve skips, see the Grants Administration Branch (GAB) Levels of Authority document at http://camp.nci.nih.gov/admin/grants/loaindex.htm.

2. Assign basic and applied research (B/A) codes, designate applications that are AIDS-related, and assign patient-oriented research (POR) codes.

3. Obtain updated information about other support from the applicant.

4. Fill in the green sheet, which is required to authorize GAB to pay the grant.

5. Send the application and the green sheet to GAB.

For information about updating an applicant’s other support and the steps required to complete the green sheet, see Completing Green Sheets.

The Regular Process

 

The regular process is used for applications submitted in response to NCI initiatives, for applications submitted under the P01, P30, P50/P20 mechanism, for foreign applications and for applications that involve concerns raised by the SRG.

In some cases, it may be necessary or desirable to skip eligible applications. To determine when it is appropriate to skip an application, see The Skip Process.

The regular process is used to fund both investigator-initiated applications and applications for grants or cooperative agreements submitted in response to NCI initiatives. However, the procedures for creating a list of to-be-funded applications that has been approved by senior NCI staff depend on whether the application was initiated by the investigator or submitted in response to an NCI initiative. Thus, they are discussed separately below.

Selecting Applications for Funding: Investigator-Initiated Applications

After receiving the paylist of eligible applications from EFDB, the PD must select applications for funding.

In most instances, applications are selected in straight priority score order. However, PDs may skip applications that already receive support from other sources or for other programmatic reasons.

Selecting Applications for Funding: Applications Submitted in Response to NCI Initiatives

Applications for grants and cooperative agreements submitted in response to NCI initiatives are reviewed by ad hoc groups of NCI peer reviewers. The group reviews the applications, assigns priority scores, and specifies budget recommendations.

After these deliberations, PDs devise a funding plan based on priority scores and on the amount of money set aside to pay applications submitted in response to the initiative.

In most cases, applications are paid based on priority scores until the funds set aside for the initiative are exhausted.

There are, however, some alternatives to this procedure. NCI staff may decide to:

  • Pay none of the grants because all applications received poor priority scores.

  • Pay grants based on a sliding scale.

    Grants with top priority scores would receive full funding, and grants with lower priority scores would receive a percentage of the recommended amount. This strategy may be used when the budgets for applications that received high priority scores exceed the amount of money available under the initiative.

  • Skip certain applications whose priority scores are within the payline.

  • Set the payline at or near an application to be skipped and fund applications with lower priority scores as exceptions.

The completed funding plan must then be reviewed by the division director. Grants are not awarded until after they have been approved by the NCAB.

Creating a Paylist for Funding through the Regular Process

For each application that falls within the payline, the PD must:

1. Indicate whether the application is being selected for pay.

2. Assign basic and applied research (B/A) codes, designate applications that are AIDS-related, and assign patient-oriented research (POR) codes.

3. Indicate whether the application is to be skipped.

Skips must be justified in the GRITS form. To learn which NCI official must approve skips, see the GAB Levels of Authority document at http://camp.nci.nih.gov/admin/grants/loaindex.htm.

Obtaining Approval of the Paylist for Applications Funded through the Regular Process

The approval process consists of these steps:

1. The branch chief recommends the paylist (created in GRITS by the PD) for approval by the division approving official (DAO), which is usually the division director.

2. After the branch chief approves the paylist, the system automatically generates email to the DAO indicating that the paylist is ready for division approval.

3. For RPGs, financial analysts certify that funds are available to pay the grants and send the approved paylist to GAB. For NRSAs, CORE/SPORE and other non-standard grant programs, the Extramural Financial Data Branch (EFDB) certifies that funds are available to pay the grants. For RFAs and other division-controlled programs, the ARC manager may certify that funds are available.

4. The PD completes a green sheet for each grant that is approved for funding on the paylist.

Note that completing the green sheet will likely require obtaining information about other support from the investigator, and may involve discussions on other topics as well. For information about the steps required to complete the green sheet, see Completing Green Sheets.

5. GAB approves the paylist.

The Accelerated Executive Review (AER) Process

 

The accelerated executive review (AER) process may be used to fund applications whose priority scores are just beyond the payline.

The accelerated executive review (AER) process may be used to fund applications whose priority scores are just beyond the payline. Unamended investigator-initiated applications may be considered for awards through this process if they:

  • Propose basic research and received priority scores that are no more than five percentage points beyond the payline in the peer review process.

  • Propose patient-oriented research and received priority scores that are no more than ten percentage points beyond the payline.

Note that the policy establishing the number of percentage points that defines eligibility for accelerated executive review is established by the Executive Committee and may be adjusted each year.

This process requires that the applicant submit an abbreviated response to the critiques of peer reviewers. This response is reviewed by program staff and, finally, by the NCI Executive Committee.

Selecting Applications for Funding through the AER Process

To fund applications through the AER process, the PD must:

1. Contact the applicant, explain the AER process, and invite him or her to submit an AER request.

A sample letter containing instructions for the applicant, is available at http://deaintranet.nci.nih.gov/.

Follow-up discussions by telephone or email are both permissible and desirable. The PD should advise the applicant as to how the request might be made more competitive

2. Determine whether to recommend that the AER request be funded and prepare a GRITS form to communicate this judgment to the EC.

3. Submit the AER request to the branch chief and division director, along with a written recommendation indicating whether the application should be funded.

Obtaining Approval to Fund an Application through the AER Processs

In determining whether to recommend the grant for funding:

1. The branch chief and division director evaluate the application. If they approve the application for funding, it is forwarded, along with the PD’s written recommendation, through the division director to the Executive Committee.

2.The Executive Committee decides whether to fund the application.

If the Executive Committee decides to fund the application, the approval form is forwarded to EFDB and GAB and an informational copy is sent to the PD.

Note that completing the green sheet will likely require obtaining information about other support from the investigator, and may involve discussions on other topics as well. For information about filling in green sheets, see Completing Green Sheets.

If the Executive Committee decides not to fund the application, it is returned to the PD. The PD then notifies the applicant—by telephone, email or US Mail—that the application will not be funded through the AER process. The PD must inform the applicant that a negative funding decision does not preclude submitting a revised application through normal channels.

PDs may submit applications that were not funded through the AER process for funding under the exception process.

The Exception Process

 

The exception process is used to fund applications whose priority scores were beyond the payline and not funded through the accelerated executive review process. It is also used to process applications submitted under or assigned to other special funding mechanisms.

Several times each year, NCI staff meet with their division directors to consider applications for funding through the exception process. Through this process, NCI allocates funds to:

  • Fund investigator-initiated applications that have not received funding through either the regular process or the AER process.

  • Fund applications submitted in response to NCI initiatives that received priority scores outside the payline or to fund applications that were not funded after the initial review because the funds set aside for the initiative were exhausted.

Under EC policies, certain kinds of applications are given high priorities in the exception process. These priorities include:

  • Supporting research in certain disease areas (e.g., AIDS-related malignancies and breast, ovarian, prostate, head and neck, and brain cancers).

  • Supporting research that aims to address health disparities.

  • Supporting applications submitted in response to PAs or RFAs for which no set-aside funds were available.

  • Supporting new investigators.

The exceptions process is also used to:

  • Fund applications submitted under mechanisms that do not involve a payline or funding plan, e.g., the R/U 24 and R13 mechanisms. See Funding Mechanisms with No Payline.

  • Restore funds in instances where project budgets were cut in previous decision processes. See Responding to Appeals.

  • Provide administrative supplements for unanticipated expenses that arise during the life of a grant. See Administrative Supplements.

  • Provide interim support for previously-funded applicants to insure that significant research continues while the applicant competes for new funding. See Interim Support.

  • Provide phase-out support when investigators need additional time and resources to finish an already-funded project. See Phase-Out Support.

  • Provide small grants to support activities (e.g., collecting feasibility data) that would permit investigators to compete successfully for funds issued through the regular process. See Shannon Awards.

Procedures and timetables for considering awards to be issued through the exceptions process vary across NCI divisions. For information about the exception process within a particular division, see the relevant section below.

DCB Exception Process

In the Division of Cancer Biology (DCB), three two-day exceptions meetings are held each year. To prepare for exceptions meetings, staff members within the branches discuss applications whose priority scores were beyond the payline and decide which applications to put forward for funding.

One week before the meeting, staff members begin to assemble the information required to review the applications put forward for exception funding. To assemble this information:

1. PDs send summary statements for applications proposed for exception funding and draft versions of the exceptions form to the Special Assistant to the Director of DCB.

In determining which applications to put forward, PDs must assess the relative merits of applications, consider the needs of particular investigators in relation to the programmatic goals of the Institute and the funds available. PDs are expected to make sound scientific judgments as to why particular applications should be funded, and must be prepared to present their views effectively to other PDs and senior division staff.

To strengthen their arguments, PDs may request that applicants submit responses to summary statements, additional data collected during the interval between the SRG meeting and exceptions meeting, and copies of new publications. Applicants may also be asked to provide statements to justify budget requests.

2. Senior staff review the summary statements and exceptions forms and assign members of the program staff as reviewers for each application.

3. The Special Assistant to the Director prepares and distributes copies of the summary statements and forms to reviewers.

On the first day of the exceptions meeting, PDs describe the research proposed in each of the applications put forward for exception funding and present a brief rationale as to why the application should be funded.

After these discussions, a table is generated in which all the applications to be considered for funding are listed. The table includes columns for the priority rankings assigned by the PD, reasons to fund the application, and votes.

On the second day of the exceptions meeting, members of the Senior Advisory Group discuss budget parameters and rank the applications put forward for exception funding. These rankings are communicated back to the branch chiefs and put forward as recommendations to the Director of DCB.

After the meeting:

1. The branch chiefs forward approved exceptions packages to the Deputy Director.

2. The Deputy Director obtains signatures from the Director and from the manager of the Administrative Resource Center (ARC).

3. The ARC manager makes copies of exceptions packages containing the summary statements and exceptions forms for ARC files and returns originals to the Special Assistant to the Director.

4. The Special Assistant to the Director prepares a funding memo and, for applications selected for funding, attaches the original exception forms to the memo, and makes three copies of the package containing the memo and the exception forms.

5. The Special Assistant sends:

- The original package to GAB.

- A copy of the entire package to EFDB.

- A copy of the entire package to the DCB/OD to be retained in the DCB files.

- A copy of the funding memo to the branch chiefs and the manager of ARC.

- A copy of the signed exception forms to the appropriate PD.

DCTD Exception Process

DCTB exceptions meetings are held three times each year. To prepare for exceptions meetings, staff members within the branches discuss applications whose priority scores were beyond the payline and decide which applications to put forward for funding.

One week before the meeting:

1. PDs send summary statements of applications to be put forward for exception funding to a program analyst in the DCTD ARC.

2. The program analyst prepares a spreadsheet listing the requests for exception funding by:

- Funding mechanism.

- Reason for the exception request.

- Amount requested.

- PD’s name and affiliation (i.e., program and branch).

Four days before the meeting, the program analyst sends the spreadsheet, along with copies of the GRITS forms and summary statements to:

  • The Director of DCTD.

  • The Deputy Director of DCTD.

  • All PDs.

At the meeting, budget parameters are discussed, after which PDs present the applications they are recommending for exception funding, along with any modifications to the GRITS form. After each presentation, the application is discussed. Anyone present may ask questions and present points of view. The Director sorts applications into three categories: approved, not approved, or deferred for further consideration.

After the meeting:

1. The Director signs exception forms for approved requests and notifies PDs of final decisions through the program analyst.

2. The program analyst prepares a funding memo specifying the list of approved exceptions request and forwards the memo, along with the signed exception forms, to GAB and EFDB.

In some cases, P01s submitted for exception funding must undergo a second review. Applications for which exception funding would be drawn from the RPG pool must be discussed by the Extramural Division Directors (EDDs) and the EC. P01s for which exception funds would be drawn from division funds do not require further discussion.

DCP Exception Process

To prepare for exceptions meetings, staff members within the branches discuss applications whose priority scores were beyond the payline and decide which applications to put forward for funding.

One week before the meeting of the DCP Coordinating Unit, PDs provide the Director with an exception form and a copy of the summary statement for all applications to be put forward for exception funding.

The Secretary to the Director prepares and distributes copies of the exception package to the members of the Coordinating Unit for review.

DCCPS Exception Process

DCCPS considers applications for exception funding four times each year. PDs submit exception requests to the DAO for approval.

For additional information about exception funding in DCCPS, see "SOPs and Policies" at http://camp.nci.nih.gov/dccps.

The End-of-Year Funding Process

At the end of the fiscal year, all grants and cooperative agreements can be considered for additional funding. Applications are nominated for end-of-year funding by PDs.

In many cases, requests for end-of-year funding involve grants that do not have out-year obligations (i.e., they are not funded for the coming fiscal year). Examples of such grants include one-year administrative supplements and funds awarded for the support of scientific conferences.

In some instances, however, the end-of-year process is used to fund applications that received outstanding scores in the peer review process. By funding applications through this process, NCI ensures that high-quality research enterprises will not be disrupted by a gap between the end of one award period and the beginning of another.

The steps for obtaining approval to fund applications through the end-of-year process are as follows.

1. The PD creates a request in GRITS (using the supplement module or the exception module as appropriate) for each application that he or she wants to nominate for funding.

2. The division director either approves or does not approve submitting the application to EDD.

3. The lists of approved applications from all NCI divisions are combined by EFDB and EDD prioritizes them for funding.

4. EFDB coordinates with GAB to assure that awards are issued according to the priority list and the amount of funds available.

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Special Funding Mechanisms

Several special funding mechanisms are available to fund applications submitted by certain investigators or to fund particular kinds of research. These mechanisms include:

  • MERIT Awards

  • Shannon Awards

  • New Investigator Awards (*R01s)

MERIT Awards

MERIT awards (MERIT stands for Method to Extend Research in Time.) are issued to investigators who have demonstrated superior competence and outstanding productivity during their previous research experience.

Nominations for MERIT awards are made when an application is being considered for funding. If the nomination is approved, the recipient will be funded for the period specified in the application and, in addition, will have the opportunity to apply for one to five years of additional funding without submitting a new application for peer review.

Thus, MERIT awards provide distinguished investigators with long-term, stable support to foster their continued creativity.

Selection Criteria for Merit Awards

The following criteria are used to select nominees for MERIT awards.

  • The candidate must be the principal investigator (PI) on an unamended competing continuation (Type 2) R01 application that has been supported by NCI for at least seven years.

  • The current application must have been assigned a priority score within the 5th percentile and must have been approved by the NCAB for five years of additional support.

  • The current application should represent the PI's principal area of research and should be in an area of special scientific importance or promise.

  • The candidate PI must be an established scientist, at the leading edge in the proposed research area as indicated by a continuous record of publications in the highest quality journals for that field.

Obtaining Approval to Fund a MERIT Award

Candidates for MERIT awards may be nominated by members of the NCI staff or, in theory, by members of the NCAB.

To obtain approval to issue a MERIT award, the PD must:

1. Identify a potential nominee for a MERIT award and, if required, discusses the nominee with division management.

2. Assemble a nomination package containing the GRITS MERIT form and summary statement. This package is called a special actions package.

3. Submit the package, through the division director, to the Executive Committee for approval.

If the Executive Committee does not approve the nomination, the application is returned to the stream of competing applications and submitted to the NCAB for approval as an R01.

If the Executive Committee approves the nomination, the application is discussed in a pre-Board meeting convened by the Director of DEA. The PD is responsible for making any changes to the application package recommended in this meeting and for ensuring that it is submitted to DEA so that it can be considered by the NCAB.

If the NCAB does not approve the nomination, the application will be funded as an R01.

If the NCAB approves the nomination, the PD must carry out the administrative steps required to process the MERIT award process.

Processing Approved Nominations for MERIT Awards

After the NCAB has approved the nomination of a candidate for a MERIT award:

1. The PD prepares a nomination letter and obtains the signature of the division director.

2. Within two weeks of NCAB approval, the division director signs and distributes the nomination letter.

If the nominee turns down the nomination, the application is funded as an R01.

If the nominee accepts the nomination, he or she must send an acceptance letter signed by an institutional business official to the PD. Upon receiving the acceptance letter, the PD sends a copy of the letter to GAB, and GAB converts the R01 award to an R37 award.

Applying for MERIT Award Extensions

Receiving a MERIT award does not mean that the period of a grant will automatically be extended when the original grant expires. Instead, the applicant must apply for the extension by submitting:

  • A progress report.

  • A brief description of the research planned for the period of the extension.

  • A list of publications and presentations during the period of the MERIT award.

This application is then reviewed within the division and by the Executive Committee and must be approved by the NCAB.

Reviewing Applications for MERIT Award Extensions

MERIT extensions may be approved for one to five years, depending on the degree to which the awardee and the research demonstrate continuing scientific promise, originality, and productivity.

To be approved for the MERIT extension, applicants must meet the following criteria.

  • A proposed MERIT extension must be a logical continuation of the current award.

  • Applicants for MERIT extensions who propose new, unrelated lines of research or significant changes in their own level of effort or that of key personnel must be advised to submit a regular Type 2 R01 competing application.

  • Progress made by the applicant during the current award period must demonstrate continued leadership in the field. The research proposed for the extension period must be at the cutting edge of the discipline, in an area of continued importance to the NCI mission and goals.

The process for reviewing applications for extensions of MERIT awards is as follows.

1. The PD and a Grants Management Specialist (GMS) review the application.

If the application is not approved, the PD notifies the applicant by letter and recommends that the application be resubmitted as an R01.

If the application is approved, the PD writes a recommendation for the extension and submits the recommendation, along with the summary statement, to the division director and the Executive Committee.

2. The Executive Committee reviews the application.

If the application is not approved by the Executive Committee, the PD notifies the applicant by letter and recommends that the application be resubmitted as an R01.

If the application is approved by the Executive Committee, the application is discussed in a pre-Board meeting convened by the Director of DEA. The PD is responsible for making any changes to the application package recommended in this meeting and for ensuring that it is submitted to DEA so that it can be considered by the NCAB.

3. The NCAB reviews the application.

If the application is not approved by the NCAB, the PD notifies the applicant by letter and recommends that the application be resubmitted as an R01.

If the application is approved by the NCAB, the PD sends an approval extension letter to the applicant.

When the application for a MERIT extension has been approved at all three levels, GAB negotiates the specific conditions of the award with the applicant and his or her institution.

Shannon Awards

The Shannon Award is designated as an R55 and is designed to provide a total of $100,000 of support ($80,000 in direct costs, $20,000 in indirect costs) over a single budget period of up to two years. Applications that received priority scores that fell beyond the payline and were not funded through the accelerated executive review or exception processes may be considered for Shannon Awards.

The Shannon Award provides applicants with a small amount of support to complete studies that might allow them to compete successfully for funds issued through the regular process. Shannon Awards are not intended to sustain or continue a current project. Appropriate uses of a Shannon Award include:

  • Testing the feasibility of innovative approaches.

  • Developing tests and refining research techniques.

  • Performing secondary analyses of available data sets.

  • Conducting discrete projects to demonstrate research capabilities.

Eligibility Criteria for Shannon Awards

To be considered for a Shannon Award, an application must be nominated by NCI program staff. After each of the three annual review cycles, Shannon Award nominations are reviewed by NCI division staff. The funds for Shannon Awards are drawn from the division’s exceptions pool. An application is eligible for a Shannon Award if:

  • The application was submitted under the R01 (either new or competing continuation) or the R03 funding mechanism.

  • The application received a priority score that was beyond the payline but above the 50th percentile, or a raw score above 250.

  • The applicant does not already have Public Health System (PHS) research support that totals more than $300,000 in direct costs.

Although amended applications may be considered for Shannon Awards, preference is given to unamended (A1) applications. If an amended (A2) application is nominated for a Shannon Award, the nomination package should specify why the amended application should be considered.

Selecting Applications for Shannon Awards

In selecting applications for Shannon Awards, priority should be given to:

  • New investigators or investigators who have not yet established significant research programs.

  • Senior investigators who are entering new research areas.

  • Investigators who are women, members of minority groups, disabled, or members of other disadvantaged groups.

  • Applicants who are proposing high-risk projects.

Funding Applications as Shannon Awards

The procedures for funding applications as Shannon Awards are as follows:

1. The PD identifies a candidate for whom a Shannon Award would be appropriate.

If necessary, the PD may contact the applicant for additional information before proceeding with the award process.

2. The PD prepares an exception in GRITS.

3. The PD prepares and submits a nomination package for the division exceptions meeting.

During the exceptions meeting, the PD must be prepared to justify the nomination to other members of the Division program staff.

4. The Division Director selects applications for receipt of a Shannon Award.

5. ARC staff in the Office of the Division Director will send approval forms identifying applications that have been selected for Shannon Awards to EFDB and GAB.

6. The PD notifies the applicant that the Shannon Award has been approved.

7. The applicant submits a letter of acceptance Co-signed by the appropriate institutional official.

8. GAB negotiates the specific conditions of the award with the applicant and his or her institution.

New Investigator Awards (*R01s)

Each fiscal year, NCI attempts to increase the success rate of new investigators by allocating funds to divisions to support *R01 (pronounced star R01) awards. Divisions may not use funds specifically set aside for *R01s for any purpose other than funding applications submitted by new investigators. They may, however, allocate additional funds for *R01 awards from their discretionary budgets.

If an application submitted by a new investigator is not funded through the regular process, it may be funded as a *R01 application. Applications that are eligible for *R01s must be identified as such when presented to the DAO. (New investigators identify themselves by checking the "New Investigator" box in Item 3 on the PHS 398 application form.) Use of *R01 funds must be approved by the relevant division director.

Applications from new investigators that are not approved for *R01 awards may be submitted for funding through the accelerated executive review or exception process.

Funding Mechanisms with No Payline (R24/U24 and R13)

There are several NCI funding mechanisms that do not have a payline. These mechanisms include R24/U24, which are used to fund resource grants, and R13s, which are used to fund conferences.

Funds used to pay grants or cooperative agreements under these mechanisms may be drawn from the non-RPG pool, from funds set aside to issue awards through the exception process, or from divisional discretionary funds.

The procedures for issuing R24/U24 awards are:

1. The PD submits a completed GRITS exception form to the division director for approval.\

2. The division director submits applications to the Deputy Director for Extramural Sciences who usually includes them on the EDD agenda.

If approved by the Deputy Director, the list of approved R24/U24 applications is published on the EFDB website.

The procedures for issuing R13 awards are:

1. The PD submits a completed GRITS form to division director for approval.

2. The division director forwards the approved application to the ARC manager.

3. The ARC manager certifies that discretionary funds to pay the grant are available.

Before the date of the conference, the signed GRITS form must be submitted to GAB for funding and to EFDB for tracking. DHHS policy prohibits issuing awards under the R13 mechanism if the conference has already taken place.

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Co-Funding Applications

Co-funded applications are applications for which NCI provides part of the funds required to issue the award and the remainder of the funds are provided by another governmental or private organization.

Most NCI co-funding agreements involve other NIH Institutes or Centers (IC), but occasionally applications are co-funded by NCI and another governmental organization. NCI may co-fund applications with private organizations, but has not done so. If desirable opportunities for co-funding awards arise, PDs should consult senior GAB staff members about how to proceed.

The policies and procedures governing co-funded awards depend on the amount of the award. For detailed information about co-funding policies, see http://deaintranet.nci.nih.gov/ncipolicy/cofunding.htm. For information about obtaining approval for co-funding agreements, see the Levels of Authority document at http://camp.nci.nih.gov/admin/grants/loaindex.htm.

Roles and Responsibilities in Co-Funding Agreements

The IC that initiates the agreement is called the administering or primary funding agent, and the other IC is called the participating or secondary funding agent. The administering IC initiates the agreement and issues the Notice of Grant Award (NGA) to the applicant.

In establishing co-funding agreements, the ICs agree to fund awards at specific levels. Any changes in the proportion of the award contributed by each of the co-funders or any changes in common accounting numbers (CANs) require the agreement of both parties. Such agreements must be established at least one month before an award is issued.

A grants management contact prepares a Notification of Co-Funding Commitment and is responsible for obligating IC funds and seeking approval from the relevant GMO. The administering IC prepares all worksheets throughout the life of the grant based on the costs stated in the Notification of Co-Funding Commitment. Future-year facilities and administrative costs are to be calculated using the rate in effect when the award was issued.

The administering IC maintains the Notification of Co-Funding Commitment in its files. A copy of the award notice for each year of support, the yearly progress report, and any publications are to be forwarded to the grants management specialist who prepares the Notification of Co-Funding Commitment.

Co-Funding with NCI as the Primary Assignment

An NCI division may be the administering IC in a co-funding agreement with:

  • Another NCI division.

  • Another NIH IC.

  • An NIH office.

  • Other federal agencies.

As noted previously, NCI may establish co-funding agreements with private organizations but has not, to date, done so.

Co-Funding across NCI Divisions

Co-funding agreements between NCI divisions offer a means of extending the resources of each of the participating divisions. By co-funding applications, divisions are able to use their resources to support a larger and more diverse set of applications than they would be able to support independently.

Co-funding agreements are used to fund:

  • Applications submitted in response to an initiative.

    To establish such an agreement, the PD must:

1. Indicate in the funding plan that another division is co-funding the application.

2. Obtain the approval of the Director of the second division.

3. Ensure that the ARC manager of the second division certifies that funds are available to pay the grant.

  • Exception requests.

    In such instances, the PD must specify the amount to be contributed by each division in the GRITS form.

  • Initiatives requesting supplemental applications to existing grants or cooperative agreements.

    In such instances, a funding plan is devised by the program or division soliciting the supplemental applications.

Co-Funding with Other NIH Institutes or Centers

Co-funding arrangements with other ICs are often used to fund R13 applications, but applications submitted under other funding mechanisms can also be funded in this way.

To establish a co-funding agreement with another IC, the PD:

1. Determines the amount to be contributed by the second IC by consulting with the PD in that IC.

2. Identifies a contact person on the grants management staff (GMs) at the second IC.

3. Submits the information regarding the co-funding agreement and the grants management contact to the NCI GMS.

NCI GMS requests a GMS worksheet from the second IC. This worksheet must include a CAN number. The GMS then issues the award.

To co-fund applications submitted under other funding mechanisms, an intra-agency agreement may have to be signed. Consult the Levels of Authority document at http://camp.nci.nih.gov/admin/grants/loaindex.html.

Co-Funding Special Initiatives with NIH Offices

Several NIH offices provide resources for supplements to existing grants or co-funding new or continuing applications. These offices include:

  • The Office of Research on Minority Health (ORMH).

  • The Office of Special Populations Research (OSPR).

  • The Office of Research on Women’s Health (ORWH).

  • The Office of Dietary Supplements (ODS).

  • The Office of Behavioral and Social Sciences Research (OBSSR).

These special initiatives are typically offered once each year.

Office of Research on Minority Health

Dr. John Ruffin, Director

Phone: 301-402-1366

The Office of Research on Minority Health leads the federal effort at NIH in stimulating new research ideas for improving the health status of minority Americans. The Office promotes programs aimed at increasing the participation of underrepresented minorities in all aspects of biomedical and behavioral research.

Contact Information:

Office of Research on Minority Health
6707 Democracy Boulevard
Suite 800
MSC 5465
Bethesda, MD 20892-5466
Phone 301-402-1366
Fax: 301-480-4049

http://www1.od.nih.gov/ORMH/main.html

NCI Office of Special Populations Research

The NCI Office of Special Populations Research shares the goals of the Office of Research on Minority Health and works with NCI program staff to support these goals through the grants issued by NCI.

Contact Person: To Be Named
Executive Plaza South
6120 Executive Boulevard, Room 320
Bethesda, MD 20892
Phone 301-496-8589
Fax: 301-435-9225

http://ospr.nci.nih.gov/

Office of Research on Women’s Health

The Office of Research on Women’s Health (ORWH) serves as a focal point for women’s health research at NIH. ORWH promotes, stimulates, and supports efforts to improve the health of women through biomedical and behavioral research. ORWH works in partnership with the NIH ICs to ensure that women’s health research is part of the scientific framework at NIH and throughout the scientific community.

Contact Information:

Lisa Begg, PhD
Director of Research Programs
Building 1, Room 201
9000 Rockville Pike
Bethesda, MD 20892-0162
Phone: 301-402-1770
Fax: 301-402-1798

http://www4.od.nih.gov/orwh/

Office of Dietary Supplements

The Office of Dietary Supplements (ODs) supports research and disseminates research results in the area of dietary supplements. ODs also advises other federal agencies about the results of research on the use of dietary supplements.

Contact Information:

Office of Dietary Supplements
National Institutes of Health
Building 31, Room 1B25
31 Center Drive, MSC 2086
Bethesda, MD 20892-2086
Phone: 301-435-2920
Fax: 301-480-1845
Email:ODs@nih.gov

http://dietary-supplements.info.nih.gov/

Office of Behavioral and Social Sciences Research

Dr. Raynard Kington, Director

The mission of the Office of Behavioral and Social Sciences Research (OBSSR) is to stimulate behavioral and social sciences research throughout NIH and to integrate these areas of research more fully into others of the NIH health research enterprise, thereby improving our understanding, treatment, and prevention of disease.

Office of the Director
National Institutes of Health
Building 1, Room 326
1 Center Drive
Bethesda, MD 20892-0183
Voice: 301-402-1146
Fax: 301-402-1150

http://obssr.od.nih.gov/

Co-Funding with Other Federal Agencies

Establishing Co-funding agreements with grant-makers in other federal agencies usually requires an interagency agreement.

To establish a co-funding agreement with another federal agency, the PD:

1. Determines the amount to be contributed by the other agency by consulting with the PD in that agency. Identifies a contact person on the grants management staff at the other agency.

2. Prepares a written justification for the co-funding arrangement and submits it to the ARC manager for approval.

3. Submits the information regarding the co-funding agreement, including the signed justification and the grants management contact to the NCI GMs

The NCI GMS requests a GMS worksheet from the other agency. This worksheet must include a CAN number. GAB then issues the award.

Co-Funding with NCI as the Secondary Assignment

To establish co-funding arrangements with NCI as the secondary assignment, the grant that is to be co-funded must have been approved by the NCAB. Potential co-funding agreements must be established before the NCAB meeting to assure that the summary statement is included in the Board actions.

To establish a co-funding arrangement with NCI as the secondary assignment, the PD must:

1. Consult with the PD and the other Institute and with the applicant to ensure that both agree that a Co-funding arrangement is desirable and feasible.

2. Write a justification for the co-funding arrangement on a GRITS exception form and submit it to the division director.

3. Obtain certification from the ARC manager to ensure that funds are available to pay grants from division funds.

4. Submit the signed GRITS form to GAB.

5. Notify the PD in the primary IC that the application has been approved by both program staff and grants administration staff.

GAB staff inform grants management staff at the other Institute that the application has been approved and assign a CAN number. GAB staff may sign inter-Institute or intra-agency agreements.

Transferring Applications from Another Institute or Center

If NCI is interested in funding an application that has a primary assignment at another IC, the application can be transferred to NCI.

If the application does not already have a secondary assignment at NCI, obtaining a secondary assignment for the application will facilitate this transfer. If NCI has been designated as a secondary assignment for the application, the application will be included in the materials sent to members of the NCAB before their review meeting and can be approved in the en bloc vote.

To add NCI as a secondary assignment, the PD files a 901 form requesting the assignment. The 901 form must be signed by a branch chief and sent to the NCI Referral Office for processing.

If NCI already has a secondary assignment for the application and the priority score is within the NCI payline, RPG funds can be used to pay the grant. To transfer the application, the PD must:

1. Consult with the PD at the other Institute to ensure that a transfer is both feasible and desirable.

2. Obtain permission for the transfer from his or her branch chief or division director.

NCI RPG paylines may be more favorable to applicants than the paylines of other ICs. Thus, it is essential to control the number of applications reassigned to NCI. Program staff must ensure that the application is compatible with NCI’s funding plan and that the funds are available to pay the grant before a transfer can be accepted.

If the re-assignment to NCI is completed prior to NCAB concurrence review, the grant will appear on the relevant paylist. When the reassignment to NCI is completed after the NCAB meeting, the PD must use the division exception process to request division exception process to request division funding of the grant. The 901 form (see next step) should not be submitted until after the division director has made the commitment to pay such an application within the NCI payline for the relevant mechanism.

3. File a 901 form requesting the transfer.

The 901 form must be signed by the branch chief and sent to the NCI Referral Office for processing.

If NCI already has a secondary assignment for the application and the priority score is beyond the NCI payline, division-controlled funds can be used to pay the grant. To transfer the application, the PD must:

1. Consult with the PD at the other Institute to ensure that a transfer is both feasible and desirable.

2. Present the application for funding in the division’s exception process.

For more information about the exception process, see Funding Applications through the Exception Process.

If the application is approved for funding, the PD must file a 901 form requesting a transfer. The 901 form must be signed by the branch chief and sent to the NCI Referral Office for processing.

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