OSR-1 Instructions

last updated 03/23/10

Sponsor Deadline: Indicate the deadline and time published by the sponsoring agency. Also indicate whether the deadline refers to a receipt date (the agency must receive the proposal by that date) or a postmark (the proposal must be postmarked by that date). Note: In some instances, only a postmark of the U.S. Postal Service is considered a postmark. For confirmation or clarification, contact the agency.

Investigator Information
Project Information
Personnel
Budget
Commitments
Human Subject Information
Endorsements
Mailing and Pick-Up Information

Requested Pick-up Date: Date on which the investigator or staff request pick-up of the proposal from OSR. OSR should receive a proposal at least five working days prior to an agency deadline. If a proposal is received fewer than five working days before that deadline, the level of review may not be as thorough and the principal investigator will be responsible for mailing.

Investigator Information:

Contact Principal Investigator/Faculty Advisor: A Contact Principal Investigator/Faculty Advisor must be a faculty member. Individuals with other appointments, such as visiting scholars, should contact the appropriate OSR director at 847/491-3003 or 312/503-7955 well in advance of the deadline to determine if a proposal can be submitted.

Please note that "contact principal investigator" is a new term developed by federal agencies for use in the event a project has multiple principal investigators. You can read more about the National Institute of Health's tentative implementation plan to recognize multiple principal investigators at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-055.html.

Fellow: Fellows cannot be principal investigators. Proposals for fellows must be sponsored by a faculty member.

School/Center, Department/Center, Section/Program: To more accurately track project activity, fill in as many spaces as relevant. If the grant is to be shared by more than one unit, list the units involved on a continuation page.

Project Location: Indicate the buildings and rooms of the project activity (e.g., labs). Shared facilities need not be listed unless they are the primary site of work. For a multi-investigator project, list the building and rooms for all participants on a continuation page.

Project Information:

Project Title: Continuing, revised, and supplemental applications should have the same title as the previous grant or application.

Sponsor: Name of the agency/ organization receiving support from the Originating sponsor and providing some of that support to Northwestern for its participation in the project.

Originating Sponsor: Name of the agency/organization providing support for the project.

Sponsor Contact: Name of someone in the agency or subcontract from organization (see above) who can provide information if needed, or someone you have been in contact with about this application.

Proposal Type:

New: A proposal with a unique workscope and budget that has not been submitted to the sponsor previously; may be a multiyear project and budget.

Continuation: Request for continued support from a sponsor for a previously awarded project that is currently under way. Such a request is generally contingent on the investigator making satisfactory progress and the sponsor having funds available to meet its initial estimate of outyear funding.

Competing Renewal: A proposal to continue support of a project beyond the initial commitment made when the award was issued. A renewal generally requires submission of a new proposal to the sponsor and usually requires competitive review.

Supplement: A request for an increase in the amount of funding and possibly an extension of time for an existing project.

Revised Application: Resubmission of a proposal that has undergone revision in response to comments from the sponsor and will undergo competitive review or be reconsidered for funding.

Preliminary proposal: A preliminary proposal which is sometimes required to be submitted specific programs/sponsors and typically outlines the overall project, includes minimal (if any) budget information, and requires institutional endorsement.

Non-funded Negotiations: A proposal that fits the category of a Material Transfer Agreement (MTA) or Confidential Disclosure Agreement (CDA) and will not result in funding.

Solicitation Request: If available, give the Request for Proposal (RFP) or Request for Application (RFA) number, provided by some agencies when issuing a solicitation.

ARRA: Is this proposal being submitted in response to the American Reinvestment and Recovery Act (ARRA) of 2009?

Budget:

Project Institution #: If this project is a continuation or competitive renewal, give the InfoEd Institution number.

Facilities and Administration Costs: Fill in the percentage. For questions regarding the rate and base, consult the OSR staff or see F&A Rates.

Cost Rate Used: Indicate on the OSR-1, by letter, which base type was used.

A. Modified Total Direct Costs (MTDC) - Standard: For most standard research projects; follows University rate agreement for exclusions. Modified Total Direct Cost (MTDC) is defined as Total Direct Costs (TDC) less the following: capital equipment, tuition and stipends, the amount of each subcontract exceeding the first $25,000, space rental, hospital medical expense, and telecommunications.
B. Total Direct Costs: For drug studies sponsored by industry and projects not receiving full overhead.
C. Total Costs: When the base is the total amount budgeted.
D. MTDC - Direct Costs less Tuition Only: For NIH training grants
E. MTDC - Split Rate: For projects with on- and off-campus modules
F. MTDC - Standard less Participant Support Costs: For some NSF projects
G. MTDC - Stipend and Institutional Allowance Only: For NRSA projects
H. MTDC - Stipend Only: For NSF REUs
I. MTDC - Direct Costs less Equipment Only: (Use for American Cancer Society applications)
J. MTDC - Salaries and Wages Only
K. MTDC - Salary and Fringe Benefits Only
L. Fixed Administrative Fee
M. No Indirect Costs Allowed by Sponsor: Rate always equals 0%
N. Rate Base Other than Listed

Personnel:

Personnel Chart: List of all faculty and key personnel on the project and their Employee ID #'s. Key personnel include the contact principal investigator/faculty advisor, co-investigators (might include research associates, postdoctoral fellows, but generally not graduate students), and any other persons who are responsible for the design, conduct, or reporting of research, educational, or service activities funded--or proposed for funding--by an external sponsor. For each individual, also list their appointment type (9, 11, 12 months), Department /Center, VA appointment info (if applicable), and percent effort (charged and/or cost shared for the academic year and/or summer).
It is important that the proposed and correct amount of effort be recorded on the OSR-1 form as this data will flow from the OSR database into the Committed Effort Management system, https://ersweb.itcs.northwestern.edu/GenericERS/ .

Please note that the percent summer salary to be charged to a project is calculated based on the total amount of time available during the summer (or research quarter) period. For example, a faculty member with a 9-month appointment generally has 3 months available. If the PI plans to charge 1 summer month to a sponsored project, s/he will have 33% summer effort (1/3). At the time of effort certification, if the faculty member only worked 2 months during the summer, of which 1 month was charged to this sponsored project, then the effort commitment for this project will be recorded as 50%; where the effort base is the actual number of summer months paid.

Commitments:

1. PI Eligibility: Any individual who holds one of the following positions can be identified as a principal investigator (PI) and submit proposals to external sponsors:

o tenure-track faculty (full, associate, and assistant professors)
o nontenure-track research faculty (full, associate, and assistant professors)
o nontenure-track clinical faculty (full, associate, and assistant professors)
o instructors
o adjunct faculty
o emeritus faculty
o librarians
o curators

On a case-by-case basis, an individual who holds one of the following positions can be identified as a PI upon approval from the vice president for research:
o visiting faculty
o visiting scholars

In general, research associates may not serve as PIs, but may seek approval from the vice president for research. Postdoctoral fellows and research assistants (graduate students) may not serve as PIs.

2. Matching Funds/Cost Sharing: Some grant programs require funds raised from other sources to match the level of support provided by the sponsor. Financial commitments must be obtained prior to submitting the proposal for review. If the final distribution of matching funds/cost sharing is not known at the time of submission, it must be known soon after. Some schools require completion of matching fund negotiations prior to submission of a proposal. Principal investigators should refer to the Cost Sharing/ Matching Policy (1/8/96) and speak to their dean and department chair before approaching the central administration with requests for matching funds/cost sharing. Requests to the Office for Research should be directed to the Office for Research Planning, Finance and Communications at 847/491-2101. Questions or concerns can be directed to the OSR staff that serve your unit or department.

3. Tuition: To be RAS eligible, the project must recover indirect costs at the full applicable federally or nonfederally negotiated rate. Any other tuition support, such as selected fellowships, requires evidence of the prior approval of The Graduate School.

4. McGaw Medical Center/Other Institutions: This information is required to ensure that appropriate interinstitutional guidelines, procedures, and policies are adhered to.

5. Subcontracts: Proposals that include subcontracts to other organizations working under Northwestern University direction require a letter of intent, a statement of work, and an approved budget endorsed by the subcontractor's authorized official before the proposal is sent to the sponsor.

6. Space: If additional space or renovation is needed, your department chair, center director, or dean may require an explanation.

7. Computer Space: If a computer cluster will be purchased, space will need to be identified and discussed with the appropriate Dean's office.

8. Consulting: Faculty members and departments frequently engage individuals as independent contractors/consultants to provide services for a variety of University programs. Northwestern faculty and staff typically should not be paid as consultants on Northwestern projects. OMB Circular A-21 limits payments to internal institutional consultants. Any consulting arrangements with the sponsor may have an impact on Northwestern intellectual property, or may indicate a possible perceived conflict of interest. See the Faculty Conflict of Commitment and Conflict of Interest policy (http://www.research.northwestern.edu/research/policies/facultyConflict.html)

9. Conflict of Interest: Principal investigators and all key project personnel must submit an annual OSR-100 form for all NIH, NSF, and American Heart Association, and all industry sponsored clinical trial applications. Applications will not be approved until the OSR-100 form is submitted. Check “Yes” to indicate that all forms are present. The Policy on Conflict of Interest for Sponsored Programs Supported by the Department of Health and Human Services or National Science Foundation is available on the OSR web site. In addition to the conflict of interest policy mentioned, faculty must also file an annual disclosure form for the conflict of interest policy published by the Provost's Office.

10. Human Subjects: Investigators are reminded that Institutional Review Board (IRB) approval must be obtained prior to initiation of any research activity that involves human subjects unless declared exempt by theIRB. The schedule for meetings is available by contacting the IRB at 312/503-9338 or 847/467-1723, or can be found on the IRB homepage. Forms and instructions on their use are available from the IRB, located on the Chicago campus on the 7th floor of 710 North Lake Shore Drive and on the Evanston campus on the 6th floor of the Hogan building.

11. Stem Cells: Indicate whether the research involves the collection, derivation, or use of human stem cells. If the research involves the use of human embryonic stem cells and applying to a federal sponsor, funding is available only for research using those lines included on the NIH Human Embryonic Stem Cell Registry.

12. Animal Use: All animal review forms should be submitted directly to the Animal Care and Use Committee (ACUC). The schedule for ACUC meetings is available by contacting the ACUC at 312/503-9339, or on-line at the ACUC homepage. The ACUC is located on the Chicago campus in on the 7th floor of 710 North Lake Shore Drive.

13. Safety Documentation: A Safety Plan is required for all laboratories. Laboratories using human blood and other potentially infectious human materials must also have an Exposure Control Plan. Use of hazardous chemicals creates obligations under the Hazard Communication Program. Contact the Office for Research Safety (ORS) for appropriate forms and to discuss and resolve compliance issues. The Evanston office is located in Room NG71, Technological Institute, 2145 Sheridan Road, phone 847/491-5581. The Chicago office is located in Room B106, Ward Building, 303 East Chicago Avenue, phone 312/503-8300.

14. Recombinant DNA and Ionizing Radiation: Registration is required if recombinant DNA technology is utilized. Use of radioactive materials must be approved by the Radiation Safety Committee, and all radiation workers must register with the Office for Research Safety (ORS). For information on these matters, contact ORS at the locations and phone numbers in #7 above.

15. Patents, Intellectual Property: University inventors are urged to contact the Technology Transfer Program (TTP) as soon as a potentially patentable discovery is made to determine a strategy for the protection of intellectual property. To discuss questions about intellectual property, call TTP at 847/491-3005. In addition, the PI should indicate whether any inventions or patent applications related to the proposal have been disclosed to TTP. If so, please state whether the research requires the use of compounds or materials form non-Northwestern sources, and whether the research has been part of any current or past industry collaboration.

16. Other Commitments: Check Yes if there are any additional commitments of departmental, center, or University resources in the proposal that are not disclosed in the OSR-1 form.

Human Subject Information (FAQ's):

Q4- Which category describes your research?

Outcomes or Health Services, Therapeutic Invention ,Patient Oriented Research, or Epidemiological or Behavioral Studies

Q5 - Which category describes your Patient Oriented Research on 4, what type?

Clinical Trial, Mechanism of Human Disease, or Development of New Technologies

Budget Information

Per Patient Allocation: Cumulative total of cost components that support patient-related tests, procedures, etc. - including personnel and supplies. Subcontracted personnel costs should also be factored into the per patient allocation and should include salaries and benefits at the employer's established rates plus the employer's facilities and administrative costs. All of these subcontractor costs should be included in the per patient allocation direct cost category and NU's facilities and administrative costs at 26% should be calculated against the total.

Max. # Patients: Maximum number of patients authorized for enrollment at Northwestern under this protocol.

Other Costs: Ancillary costs associated with the study but not included in the per patient allocation, such as advertising. Include associated facilities and administrative costs at 26% of the direct costs.

IRB Fee: Effective September 15, 2003, the IRB fee for new submissions increased from $1,800 to $2,000 and the fee for a periodic review increased from $400 to $500. These fees are charged to all clinical trials supported by commercial sponsors. In addition, the Feinberg School of Medicine requires that all industry-sponsored trials include a line item in the budget that reflects additional costs related to the preparatory work required prior to submission of a protocol to the IRB. As a result, a regulatory fee of $4,500 (representing the $2,000 IRB fee plus $2,500 for regulatory preparation) must be included with all industry-sponsored clinical trial budgets submitted to the Office for Sponsored Research, except for trials performed through the Robert H. Lurie Comprehensive Cancer Center. Those trials will continue to be subject to the Clinical Research Office's standard regulatory preparation fee. Facilities and administrative costs should not be assessed on this amount.More information is available at http://www.northwestern.edu/research/OPRS/irb/irbFees/.

Total: Total of per patient allocation X maximum number of patients, plus other costs + the IRB and regulatory fees. This amount includes both direct and applicable F&A costs as outlined above.

Budget Worksheet

IRB Fee Information

Clinical trials sponsored by industry must pay a $2,000 initial and $500 annual fee for IRB protocol review. Initial trials also incur a $2,500 regulatory preparation fee. Because this fee reimburses the University for costs associated with conducting the IRB review, it applies whether or not a contract is executed and/or patients are enrolled. A clinical trial sponsored project account (trial account) will be established by OSR and charged for the fee following receipt of OSR materials. Annual fees will be charged directly to the trial account. In the event the Sponsor does not reimburse the University for the IRB fee, the Principal Investigator and/or Department will be responsible for this amount. Investigators are responsible for including the IRB fee in their clinical trial budget.

Endorsements:

Northwestern University does not enter into agreements to conduct "secret" or "classified" research, nor does it agree to any requirements that restrict the freedom of a scholar to publish or disseminate findings. Each school has different policies on endorsements for the submission of research proposals. Check with your department chair and dean for the appropriate policies. Proposals will not be signed by OSR or sent to the sponsor until proper endorsement is received. For proposals that include more than one department or school, each department and school's policies apply. In general, center directors/deans require investigators' and chairs' signatures before they will sign. Obtaining endorsements can take time; please plan accordingly.

NIH PI and Fellow Certification Requirement: NIH no longer requires the signature of the PI or Fellow (for fellowship applications) and has removed these signatures from the face page. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-054.html; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-004.html). However, Northwestern is still required to obtain and retain a written assurance from the PI (and the Fellow on fellowship applications) prior to proposal submission. In the event a request for applications or program announcement allows for multiple PIs, all Northwestern PIs should sign and date the assurance. By endorsing, all NIH PI's and Fellows are meeting the agency compliance requirement as stated on the OSR-1 form in addition to the standard proposal endorsements.

NIH New Public Access Policy (PubMed Central): Recipients of funding from the National Institutes of Health (NIH) funding should be aware of a new reporting requirement (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) that is effective as of April 7, 2008. Principal investigators must ensure that electronic versions of any peer-reviewed manuscripts arising from NIH funding and accepted for publication after that date are deposited in PubMed Central (PMC), NIH's digital archive of biomedical and life sciences journal literature. Full text of the articles will then be made freely available to the public no later than 12 months after publication. The requirement applies to any NIH direct funding, including grants, contracts, training grants, subcontracts, etc. In addition, beginning May 25, 2008, anyone submitting an application, proposal, or progress report to NIH must include the PMC or NIH Manuscript Submission Reference Number when citing applicable articles that arise from their NIH-funded research.

Mailing and Pick-Up Information:

On request, OSR will assist with mailing proposals if they are submitted at least five business days before the sponsor's deadline.

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