Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015




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1.6 Inventions and Patents


NIH Grants Policy and Federal law require NIH recipient organizations to promptly report all inventions that are either conceived or first actually reduced to practice using NIH funding. Invention reporting compliance is described at http://www.iedison.gov. Grantees are encouraged to submit reports electronically using Interagency Edison (http://www.iedison.gov). Information from these reports is retained by the NIH as confidential and submission does not constitute any public disclosure. Failure to report as described at 37 CFR Section 401.14 is a violation of 35 U.S.C. 202 and may result in loss of the rights of the recipient organization. Inquiries or correspondence should be directed to Division of Extramural Inventions and Technology Resources, Office of Policy for Extramural Research Administration, OER, NIH, 6705 Rockledge Dr., Suite 310, MSC 7980, Bethesda, MD 20892-7980, Telephone: (301) 435-1986.

1.7 Just-In-Time Policy


Several elements of an application are not required at the time the application is submitted. Instead, this information is requested later in the review cycle (i.e., “Just-in-Time”) to minimize burden to institutions and to ensure that the information is current. The information eligible for Just-in-Time submission includes:

  • Current Other Support (not generally required for Fellowship applicants): See Part II Section 5.4 IRB Approval. See 1.8 Other Support policy information below. Use the sample format provided on the Other Support Format Page (MS WORD or PDF). For all senior/key personnel, provide details on adjustment of any budgetary, scientific, or effort overlap if the application is funded.

    For Career Development Award applicants, information on all active support for the candidate, mentor(s), co-mentor(s), and senior/key personnel may be requested by the awarding component prior to award.



  • Certifications:

  • If human subjects are involved, provide the Federalwide Assurance number (if not previously provided) and the Certification of IRB Review and Approval of the research proposed in the application, and any IRB imposed changes. Pending or out-of-date approvals cannot be accepted. IRB approval must be dated within the last year to be valid. See Part II.5.4 IRB Approval.

  • If live vertebrate animals are involved, provide the Animal Welfare Assurance number of the applicant organization (if not previously provided), date of IACUC approval of the research proposed in the application, and any IACUC-imposed changes. Pending or out-of-date approvals cannot be accepted. IACUC approval must have been granted within three years to be valid. See 2.2 Vertebrate Animals.

  • Human Embryonic Stem Cells (hESCs): If the proposed project involves hESCs and the applicant did not identify an hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line(s) may be submitted as an “Other Upload” file.

  • Other Information Requested by the Awarding IC: Additional JIT information (i.e., revised budgets, changes to the human subjects, or vertebrate animal sections of the application) may be requested by NIH Institutes and/or Centers on a case-by-case basis. These should be submitted as an “Other Upload” file.

  • Human Subjects Education: For applications that propose human subjects research, certification that each person identified as senior/key personnel involved in the design or conduct of research involving human subjects has completed an educational program in the protection of human subjects. See Required Education in the Protection of Human Research Participants in Part II, 5.5.

Applicants are advised to submit Just-in-Time information only when requested by the awarding component. Guidance for submitting this information will be provided at the time of the request. Alternatively, this information may be submitted using the Just-In-Time feature of the eRA Commons found in the Status section. For information on the Commons see: https://commons.era.nih.gov/ commons/index.jsp.

NIH grant applicants are responsible for verifying the accuracy and validity of all information submitted through the Just-in-Time process and for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up to the time of award.


1.8 Other Support


Do not submit information on Other Support with the application beyond that required in the biographical sketch. See 1.7 Just-in-Time Policy.

Information on Other Support is required for all applications that are to receive grant awards, except Program Directors, training faculty and other individuals involved in the oversight of training grants. NIH will request complete and up to date information from applicants at an appropriate time after peer review. The Institute/Center scientific program and grants management staff will review this information prior to award.

Do not confuse Research Support with Other Support, they are distinctly different. As part of the biosketch section of the application, Research Support highlights your accomplishments, and those of your colleagues, as scientists. This information will be used by the reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualification of the research team. In contrast, Other Support information is required for all applications that are selected to receive grant awards and includes detailed financial information. NIH staff will request complete and up-to-date “other support” information after peer review. This information will be used to check that the proposed research is not already funded through other sources.

Other Support Policy


Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts are not included.

Information 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 (i.e., 12 person months), is not permitted. The goals in identifying and eliminating overlap are to ensure that sufficient and appropriate levels of effort are committed to the project; that there is no duplication of funding for scientific aims, specific budgetary items, or an individual’s level of effort; and that only funds necessary to the conduct of the approved project are included in the award.

Budgetary 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 overlap occurs when a person’s time commitment exceeds 100 percent (i.e., 12 person months), whether or not salary support is requested in the application. While information on other support is only requested for senior/key personnel (excluding consultants), no individuals on the project may have commitments in excess of 100 percent or 12 person months.

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. Potential scientific overlap is to be addressed by the SRG only by its identification in an Administrative Note in the Summary Statement.

Resolution of Overlap. Resolution of overlap occurs at the time of award in conjunction with applicant institution officials, the PD/PI, and awarding agency staff.

Other Support Information


Information on Other Support should be submitted ONLY when requested by the NIH Institute/Center (IC).

There is no form page for Other Support. Follow the sample format provided below. The sample is intended to provide guidance regarding the type and extent of information requested.

The following instructions should be followed in completing the information:


  • Information on active and pending Other Support is required for senior/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 “senior/key personnel.”

  • If the support is provided under a consortium/contractual arrangement or is part of a multiproject award, indicate the project number, PD/PI, and source for the overall project, and provide all other information for the subproject only.

Instructions for Selected Items


Project Number: If applicable, include a code or identifier for the project.

Source: Identify the agency, institute, foundation, or other organization that is providing the support. Include institutional, federal, public, and private sources of support.

Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or consortium/contractual arrangement.

Dates of Approved/Proposed Project: Indicate the inclusive dates of the project as approved/proposed. For example, in the case of NIH support, provide the dates of the approved/proposed competitive segment.

Annual Direct Costs: In the case of an active project, provide the current year’s direct cost budget. For a pending project, provide the proposed direct cost budget for the initial budget period.

Percent Effort/Person Months: For an active project, provide the level of actual effort in person months (even if unsalaried) for the current budget period. Person months should be classified as academic, calendar and/or summer. For a pending project, indicate the level of effort in person months as proposed for the initial budget period. In cases where an individual’s appointment is divided into academic and summer segments, indicate the proportion of each devoted to the project.

Overlap: After listing all support, summarize for each individual any potential overlap with the active or pending projects and this application in terms of the science, budget, or an individual’s committed effort.

Sample Format for Other Support


OTHER SUPPORT

Format

NAME OF INDIVIDUAL

ACTIVE/PENDING

Project Number (PD/PI)

Source


Title of Project (or Subproject)
The major goals of this project are…

Dates of Approved/Proposed Project

Annual Direct Costs




Person Months
(Cal/Acad/
Summer)


OVERLAP (summarized for each individual)

Samples

ANDERSON, R.R.



ACTIVE

2 R01 HL 00000-13 (Anderson) 3/1/1997 – 2/28/2002 3.60 calendar

NIH/NHLBI $186,529

Chloride and Sodium Transport in Airway Epithelial Cells

The major goals of this project are to define the biochemistry of chloride and sodium transport in airway epithelial cells and clone the gene(s) involved in transport.
5 R01 HL 00000-07 (Baker) 4/1/1994 – 3/31/2002 1.20 calendar

NIH/NHLBI $122,717

Ion Transport in Lungs

The major goal of this project is to study chloride and sodium transport in normal and diseased lungs.


R000 (Anderson) 9/1/1996 – 8/31/2002 1.20 calendar

Cystic Fibrosis Foundation $43,123

Gene Transfer of CFTR to the Airway Epithelium

The major goals of this project are to identify and isolate airway epithelium progenitor cells and express human CFTR in airway epithelial cells.


PENDING

DCB 950000 (Anderson) 12/01/2002 – 11/30/2004 2.40 calendar

National Science Foundation $82,163

Liposome Membrane Composition and Function

The major goals of this project are to define biochemical properties of liposome membrane components and maximize liposome uptake into cells.
OVERLAP

There is scientific overlap between aim 2 of NSF DCB 950000 and aim 4 of the application under consideration. If both are funded, the budgets will be adjusted appropriately in conjunction with agency staff.


RICHARDS, L.

NONE
HERNANDEZ, M.

ACTIVE

5 R01 CA 00000-07 (Hernandez) 4/1/1995 – 3/31/2002 3.60 academic

NIH/NCI $110,532

Gene Therapy for Small Cell Lung Carcinoma

The major goals of this project are to use viral strategies to express the normal p53 gene in human SCLC cell lines and to study the effect on growth and invasiveness of the lines.
5 P01 CA 00000-03 (Chen) 7/1/2000 – 6/30/2002 1.80 academic

NIH/NCI $104,428 (sub only) 3.00 summer

Mutations in p53 in Progression of Small Cell Lung Carcinoma

The major goals of this subproject are to define the p53 mutations in SCLC and their contribution to tumor progression and metastasis.


BE 00000 (Hernandez) 9/1/1996 – 8/31/2002 1.80 academic

American Cancer Society $86,732

P53 Mutations in Breast Cancer

The major goals of this project are to define the spectrum of p53 mutations in human breast cancer samples and correlate the results with clinical outcome.


OVERLAP

Potential commitment overlap for Dr. Hernandez between 5 R01 CA 00000-07 and the application under consideration. If the application under consideration is funded with Dr. Hernandez committed at 3.60 person months, Dr. Hernandez will request approval to reduce her months on the NCI grant.


BENNETT, P.

ACTIVE

Investigator Award (Bennett) 9/1/1999 – 8/31/2002 9.00 calendar

Howard Hughes Medical Institute $581,317

Gene Cloning and Targeting for Neurological Disease Genes

This award supports the PD/PI’s program to map and clone the gene(s) implicated in the development of Alzheimer’s disease and to target expression of the cloned gene(s) to relevant cells.
OVERLAP: None



Special Instructions for Joint University and Department of Veterans Affairs (VA) Appointments


Individuals with joint university and VA appointments may request the university’s share of their salary in proportion to the effort devoted to the research project. The individual’s salary with the university determines the base for computing that request. Signature by the Institutional official on the application certifies that: (1) the individual is applying as part of a joint appointment specified by a formal Memorandum of Understanding between the university and the VA; and (2) there is no possibility of dual compensation for the same work, or of an actual or apparent conflict of interest regarding such work. Additional information may be requested by the awarding component(s).

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