This section highlights what has to happen for proposals to be submitted at GW, who has responsibility for various approvals, and what is being approved when reviews of proposals and signatures are provided. As explained in this section, the routing and submission of all proposals require, at a minimum, that they be accompanied by an internal Routing Form www.gwu.edu/~research/forms/routingform.pdf, and a Financial Interest Disclosure Form http://www.gwu.edu/~research/forms/Conflict%20of%20interest.pdf. Additionally, many proposals will have one or more special factors requiring additional information, forms and levels of approval. These special factors include: proposals involving: two or more Principal Investigators or faculty from different GW organizations, cost sharing, additional facilities, clinical trials, hazardous materials, or other compliance matters such as human subjects, lab animals, or research involving radiation or rDNA. Many of these matters will have been addressed in pre-proposal planning and in proposal development. This section covers the process of submitting these assembled materials, forms and approved documents to enable a timely and successful proposal submission.
This Section will include:
10.1.1. Routing Sheet
In most cases, investigators will only need to complete the Proposal Routing and Approval Form and Financial Interest Disclosure Form. In some instances, additional forms described in 10.2, will need to accompany the proposal.
The “Proposal Routing and Approval Form” must be completed by the Principal Investigator for all proposals or applications of any kind submitted to outside sponsors that may result in a grant, contract, or other agreement with the University. Should the Principal Investigator include a Subrecipient’s proposal (a third-party organization performing a portion of the GW work scope), please review the requirements in Section 8.1.6. A new form is required each time a proposal is submitted, including, but not limited to, non-competing continuations, supplements, and revised budgets (only if revision results in significantly greater cost sharing or new cost sharing that was not in the original submission). The form is for internal use only. For additional information, instructions on completing the Proposal Routing and Approval Form, are available online www.gwu.edu/~research/forms/routingform.pdf or in Appendix E. Additionally, Principal Investigators may consult the appropriate RSC. For a list of RSCs and their contact information, check the OCRO web page: http://www.gwu.edu/~research/orsstaffing.htm. The Routing Form is available in two formats:
10.1.2. Financial Interest Disclosure Form
A “Financial Interest and Disclosure Form” must be completed and submitted by the Principal Investigator and all key participants and/or persons named in a sponsored research proposal with signatures from their departments and schools. These forms must be submitted concurrently with the proposal submission form(s) whether or not there is a disclosure to report. These forms are in addition to the annual conflict of interest disclosure forms that are required for all faculty. The forms are available in the following formats:
10.2. ADDITIONAL PROPOSAL APPROVAL FORMS
In addition to the mandatory proposal forms indicated above, additional approvals and/or forms may be required as follows:
Following are explanations and/or links to appropriate additional processing requirements.
10.2.1. Additional Investigator Information and Approval Form
Investigators should use the additional Investigator Information form when more than one Principal Investigator and three Co-Principal Investigators are involved OR when GW faculty collaborate from other schools.
10.2.2. Cost Sharing and Facilities Requirements Approval Form
Mandatory and Committed Cost Sharing should be disclosed during the OCRO proposal review process by utilizing GWU’s Cost Sharing and Facilities Approval form provided below. This form should contain the appropriate departmental/school signatures. This form is completed by the Principal Investigator when any cost sharing (either direct-cost cost sharing, F&A (indirect)-cost cost sharing, or both) is proposed OR when additional space is requested but not covered by the sponsor's budget OR when renovation of facilities is required and not covered by the sponsor's budget. For proposals submitted by or including Medical Center personnel that require cost sharing, the cost sharing component is approved by the AVPHR along with approving the proposal for further processing.
10.2.3. Allocation-Multiple Investigators and/or Units
This form is used use when more than one individual/University unit is involved in the program to indicate allocation of recognition for the research effort.
10.2.4. Clinical Trials/Hazardous Materials
For information regarding Clinical Research and/or Medical Billings, Principal Investigators should review Chapter VII, Research Supplements, Section 22, Clinical Research and/or Medical Billings and/or consult the appropriate RSC for forms and procedures.
10.2.5. Compliance Matters or Forms
All of the following compliance areas are managed by the Medical Center Office of Health Research, Compliance, and Technology Transfer (OHRCTT).
10.3. SPONSOR FORMS
Most of the forms required by federal sponsors and several other sponsors can be found at the following sites:
10.4. ELECTRONIC PROPOSAL SUBMISSION
More sponsors (federal and non-federal) are moving towards electronic grant submissions. The National Science Foundation (NSF) uses their Fastlane application and has been doing so for a number of years. If you plan on applying for NSF funding please work with your Research Service Coordinator (RSC) who is an expert with NSF Fastlane.
The National Institutes of Health are slowly transitioning their grant programs to electronic submissions through Grants.gov. Below is information you will need to know in order to successfully submit grant applications through Grants.gov.
NIH is transitioning from the PHS 398 form to the Standard Form 424 Research and Related (R&R) and agency specific forms. All applications to NIH via Grants.gov will be required to be submitted on a SF424 (R&R) form by October 2007, thereby providing a consistent electronic submission process through Grants.gov to NIH. Phase-in for certain programs have begun now and will be indicated on the Funding Opportunity (FO) downloaded from the Grants.gov site.
What is Grants.gov?
Grants.gov (http://www.Grants.gov/) has been designated by the Office of Management and Budget as the single access point for all grant programs offered by 26 Federal grant-making agencies.
Once a grant mechanism “goes electronic” on the transition submission date, most applications (new, revised, competing) must use the SF424(R&R) form and be submitted electronically through Grants.gov. Paper applications will not be accepted after the transition date for a grant mechanism. Please note however, that a hard copy of the proposal with the Office of the Chief Research Officer (OCRO) proposal routing form is still required. OCRO requires that all proposals using Grants.gov be submitted at least 7 days in advance of the FO deadline.
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"Grants.gov allows organizations to electronically find and apply for competitive grant opportunities from all Federal grant-making agencies. Grants.gov is THE single access point for over 1000 grant programs offered by the 26 Federal grant-making agencies. The US Department of Health and Human Services is proud to be the managing partner for Grants.gov, an initiative that will have an unparalleled impact on the grant community." -- (http://Grants.gov/, 9/26/05)
What is the timeline of changes to the family of SF-424 forms?
For a complete list of the all grant programs please follow the following link:
http://era.nih.gov/ElectronicReceipt/files/Electronic_receipt_timeline_Ext.pdf
Who does what?
GW is currently registered on Grants.gov. However, all participating PI’s submitting to NIH must also be registered by the OCRO through eRA Commons, https://commons.era.nih.gov/commons/ prior to proposal submission. eRA Commons allows Principal Investigators to review the current status of all their grant applications and detailed information associated with their grants. It is important to note that individual investigators DO NOT need to be registered in Grants.gov, only eRA Commons.
In order for PI’s to be able to access eRA Commons the following applies:
Please contact Hal Gollos at hgollos@gwu.edu or at x4-0896 to request registration.
How do I access Grants.gov to find new opportunities, download application packages, develop and submit proposals?
Once you are registered as a PI at GW, you will currently need to download PureEdge Viewer http://www.grants.gov/resources/download_software.jsp#pureedge (Windows), a small, free program which will allow you to access, complete and submit applications electronically and securely on Grants.gov. A tutorial on how to do this can be found on our website at www.gwu.edu/~research/files/PureEdgeDwnld.EXE
Grants.gov and NIH are partnering to provide free access to Citrix servers for Non-Windows users (e.g. Macintosh users).
How to submit grants via Grants.gov?
There are five basic steps to submitting grants through Grants.gov. They are:
For an overview of these five steps go to this link and print out the summary sheet:
http://www.gwu.edu/~research/files/Grants_gov_Guide.pdf
Step 1 – Getting Started and Setting up Your Computer:
Step 2 – Locating the Grant Application Package:
Step 3 – Complete the Grant Application Package:
Step 4 – Routing the Grant Application Package:
Step 5 – Submitting the Grant Application Package Electronically:
Please keep up-to-date with the latest Research Administration Training Tips on the ORT&C’s webpage at www.gwu.edu/~research/traininginfo.htm.
11.1. REVIEW OF PROPOSALS
All proposals for external funding must be reviewed and approved by the authorized institutional officials before they can be submitted to sponsors.
Review of proposals at the department chair/director and dean level considers the academic appropriateness, as well as certain fiscal considerations (e.g., cost sharing of department/school funds, use of department/school resources, commitment of faculty effort, responsibility to absorb the cost of over-expenditures of grant funds).
Institutional review considers, among other issues: personnel commitments; salary arrangements; requirements for equipment, special facilities, and space; verification of costs (including fringe benefits); appropriateness of the budget to the work proposed and allowability of costs; availability and approval of matching costs or cost sharing proposed; and consistency with institutional and sponsor policies.
Where required, compliance review by the appropriate committee (human subjects, animal research, etc.) should either precede institutional review, occur simultaneously or be completed and documented as soon thereafter as possible.
Proposals should be submitted to the RSC with sufficient lead time to allow the Office of the Chief Research Officer (OCRO) to review the proposal, notify the Principal Investigator of any issues to be resolved, obtain institutional endorsement, and prepare the submission prior to the deadline. Submitting a proposal less than five business days before the deadline may not leave sufficient time for institutional review, preventing proposal submission
The University may choose not to accept awards in cases where proposals have been submitted without institutional authorization.
11.2. OBTAINING INSTITUTIONAL APPROVAL FOR PROPOSAL SUBMISSION
11.2.1. Proposal Processing Levels
For purposes of review and signature approval, and pursuant to the University’s general signature policy, Signing Contracts and Agreements, http://my.gwu.edu/files/policies/SigningofContractsandAgreements1.pdf, proposals are signed at the level of the Managing Director except for those requiring approval by the Chief Research Officer.
11.2.2. CRO Signature and Approval
Proposals that meet the criteria below are processed as follows: 1) the Chief Research Officer is notified by the Pre-award Specialist when such a proposal is identified; and 2) the Chief Research Officer, following consultation with the Managing Director, Research Support & Analysis, is responsible for signing the proposal or determining that it is not appropriate for submission.
Criteria currently requiring CRO Signature and Approval: Any proposal or award that:
In addition, specific proposals or proposals from a particular Center or Unit may be designated as requiring CRO approval on an ad-hoc basis. For any proposal that may involve significant unmitigated risk, e.g., work being conducted in a country with a Department of State Travel Advisory, the Investigator should inform the RSC who will confer with the Managing Director to enable further guidance to be provided.
11.2.3.Managing Director Signature and Approval
All other proposals not requiring CRO signature and approval are signed by the Managing Director, Research Support and Analysis, who may also sign proposals requiring CRO approval in the event of the unavailability of the CRO. Similarly, the Managing Director, Research Services & Operations may sign proposals in the absence of the CRO and the Managing Director, Research Support & Analysis.
11.2.4. Routing of Proposals for Signature Within the OCRO
When a proposal is subject to a Request for Proposal (RFP), the RSC promptly routes information regarding the proposal (e.g., the RFP) to the Pre-award Specialist and the Contracts Manager for feedback and actions required (e.g., exceptions, Principal Investigator input) to resolve any problematic terms and conditions. Proposals for signature by the Managing Director are routed from the RSC to the Pre-Award Specialist for review. If there are issues or problems, the Pre-Award Specialist will solicit advice from the Managing Director, Research Support and Analysis. Following this review and any necessary changes, the proposal is routed to the Managing Director, Research Support and Analysis for signature, or, If CRO signature is required, for review and forwarding to the CRO for signature.
11.3. PROPOSAL REVIEW STEPS - ROLES AND RESPONSIBILITIES
11.3.1. Principal Investigator
Steps that the Principal Investigator should have been taken already, or that need to be taken by the Principal Investigator when preparing a proposal for submission, are presented in the following Checklist:
Click here to use the fillable pdf version of the PI Steps for Proposal Development Checklist.
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Proposal Submission Roles and Responsibilities (continued)
11.3.2. Department Chair/Director
For further information, see: The Chair’s Roles and Responsibilities for Oversight of Sponsored programs at GW, especially “Reviewing Routing Sheets and Proposals.”
11.3.3. Dean
11.3.4. Other Reviews
11.3.5. RSC
11.3.6. Pre-Award Specialist
11.3.8. Chief Research Officer
*When all signatures are obtained, the Principal Investigator is called to pick up the proposal for transmission to the sponsor. In some cases, and when the RSC has received the proposal well in advance of the deadline, the investigator may request that it be transmitted by the RSC. Submission arrangements should be decided when the proposal is first brought to the RSC.
To further assist the Principal Investigator and others to prepare for and address proposal submission requirements, and to understand what happens after proposal submission to the OCRO, the following checklist of what the RSC will be reviewing and what happens once submitted for review is provided as a guideline.
If the preliminary/pre-proposal effort has been followed, the proposal development work has been completed, and the steps to obtain proposal approval are understood, completing this final checklist of activities as provided here should enable the Principal Investigator to verify that the proposal is ready for formal proposal submission and final approval.
Click here to use the fillable pdf version of the Proposal Submission Checklist.
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There are restrictions on pre-award spending that derive from the sponsor and the University. Because it is important that all charges to a sponsored program be properly allocated to that program, it is important to get advance approval before spending any money against an anticipated award. Some sponsors who may allow some level of pre-award spending with permission impose cut-off dates before which pre-award spending will not be allowable.
Similarly, the University imposes restrictions on pre-award spending and requires that any such spending be done with prior approval and in a manner that enables a proper accounting of the costs. A formal review and approval process is required to obtain such approval to proceed..
12.1.1. Administrative Establishment of Award
In some cases a Principal Investigator may want to establish an award in the financial system that has yet to be received from the sponsor. In most cases, the Principal Investigator has received confirmation from a program officer that the award is forthcoming, but the Principal Investigator wishes to begin work and charge expenses. A Principal Investigator may also already have an award, but is awaiting a continuation to the award. In this case also, the Principal Investigator has received some type of indication from the sponsor that an award will be made some time in the future. In these types of cases, with appropriate department approvals, the Principal Investigator may request that an award be administratively established or funded.
12.1.2. Requests for Pre-Award Expenditure or Commitment Approvals
An “Administrative Establishment,” is a process in which the University sets up an award in the financial system before the official notice of award is received in order to allow the work to begin. The RSC guides and assists the Principal Investigator and others involved in the process in obtaining appropriate reviews and approvals before submitting such requests for OCRO final approval and authorization of an Administrative Award Setup. Administrative Establishments can only be done:
12.1.2.1. Administrative Establishment/Funding Process: An Administrative Establishment is initiated when the Principal Investigator requests an Administrative Establishment from his/her OCRO RSC. A memorandum is generated for review and approval by the department Chair and/or Dean. The Chair and/or Dean assess the risks to the department/school. Approval of the request by the Chair or Dean includes an acknowledgement that in the event the sponsor does not provide the anticipated funding, any costs incurred under the Administrative Establishment will be charged to the department. Following review by the RSC, the request is forwarded to the Contracts Manager for assessment and review of critical elements. Upon satisfactory review, the request is forwarded to the Managing Director, Research Support and Analysis for approval. Once approved, the RSC sets up the award as an Administrative Establishment in the financial system for a period of up to 90 days. If the award is not forthcoming, then at least two-weeks before the expiration of the Administrative Establishment period, the Principal Investigator should discuss the matter with the Chair and/or Dean and determine whether to recommend that the Administrative Establishment be extended for an additional period. Should an extension be desired, requests for existing Administrative Establishments must be processed and approved through same process as the originating Administrative Establishment.
The Office of the Chief Research Officer is responsible for negotiating grants, contracts and cooperative agreements on behalf of the University. Within the OCRO, the responsibility for negotiating these awards is assigned to the Contracts Managers. There is a Contracts Manager for University awards, and a Contracts Manager for Medical Center awards including clinical trials agreements with pharmaceutical companies. These Contracts Managers work closely with the Principal Investigators, as well as the RSCs, experts in the Office of Health Research Compliance and Technology Transfer, Risk Management, the General Counsel’s Office and others involved in the proposal to verify that the University’s interests are protected. Because of the complexity of many of these agreements and the potential risks to the University, it is critically important that any negotiation of sponsored program agreements be done by the authorized individuals in the OCRO.
13.2. CUSTOMARY UNIVERSITY AWARD REQUIREMENTS
All research agreements must be signed by an authorized representative of the University. To advise Principal Investigators of certain basic principles that govern the University’s involvement in sponsored research and to avoid unnecessary delays in processing and negotiating agreements, the following summary of customary University Award provisions is provided in this section.
13.2.1. Budget Considerations
The Contracts Manager will compare the awarded budget to the proposed budget and the Principal Investigator will be advised of any significant differences. In some cases, a revised budget or scope of work may be necessary to reflect the awarded budget.
13.2.2. Publication Rights
In furthering its mission of pursuing traditional principles of education and research, The George Washington University encourages free and open dissemination of scholarly work through publication. A Publication is defined as a manuscript, abstract, or presentation regardless of the form in which it is recorded or compiled, submitted for distribution to a journal, editor, meeting, seminar, classroom or similar scientific forum. All research must be undertaken with the clear understanding that the investigators concerned have the full right to publish and present any results obtained by them, subject only to established safeguards for the protection or privacy or confidentiality of personal data, or industry sponsors’ proprietary confidential information for optimal protection of industry sponsors’ intellectual property.
The University normally does not accept grants or contracts that impose restrictions on publication. In addition to other concerns, agreeing to restrictions on publication rights can also have the effect of setting aside the Fundamental Research Exclusion for export control purposes (see the University’s Policy Limiting Distribution and Sharing of Information, Technology and Commodities Both Internationally and Domestically - “Export” Control Policy and applicable export-control laws, http://my.gwu.edu/files/policies/ExportControlFINAL.pdf). Under rare circumstances, a sponsor may require or ask for restrictions on publication rights.In these cases, the Contracts Manager follows OCRO procedures for reviewing such requests for waiving publication rights to secure appropriate approval.
The University does permit sponsor review and comment of proposed publications to ensure that the proposed publication does not contain any proprietary or privileged material for the sponsor or other parties to the research endeavor, as well as to provide opportunities for evaluation of potentially patentable subject matter. Normally, sponsors are provided up to a 60 day review period in which to review draft publications or presentations in advance of their release in order to determine if such proposed publication contains confidential or proprietary information. For more information, please refer to the University’s Policies on Patents and Scholarly Work, http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf., and Copyrights, http://my.gwu.edu/files/policies/CopyrightPolicyFINAL.pdf.
13.2.3. Intellectual Property Provisions
As a condition of receiving awards, sponsors impose various requirements and duties on GW, including patent-related obligations. The University, through the Office of the Chief Research Officer, also seeks to verify that certain protections for the inventor and the University related to such rights are negotiated and included in such awards.
The OCRO, through the Contracts Managers, oversees the negotiation of agreements with third parties to sponsor research conducted by the University which may contain provisions governing intellectual property including patents. The University will not enter into such agreements if the provisions differ in any material way from University policy unless such deviating provisions are reviewed and approved by appropriate management and deemed acceptable in writing by the Principal Investigator for the program.
The Office of Health Research, Compliance, and Technology Transfer and the General Counsel’s Office are available to advise these Contracts Managers as well as faculty, staff, and students on intellectual property and patent questions, particularly as they relate to award negotiations and requirements. For further information, please refer to Section 20, Intellectual Property and Sponsored Research and the Policies cited therein.
13.2.4. Use of University Name
The George Washington University protects its good name and marks from improper or misleading use. In this regard, the University will not agree to provisions that appear to state or imply an endorsement of programs, products or services not directly associated with the University or appropriately licensed in writing and properly approved by an authorized representative of the University.
For further information, please refer to GW’s Licensing and Trademarks Program, http://gwired.gwu.edu/ltp/.
13.2.5. Sponsor Indemnification
As a non-profit institution, The George Washington University does not have the means to recover losses and therefore must insist on reducing all risks when participating in non-federally sponsored research. As such, The George Washington University endeavors to ensure that non-federal sponsors indemnify the University for claims arising from the sponsor’s negligence or willful misconduct.
For commercially-funded clinical drug or device trials, The George Washington University (and MFA, Inc. d/b/a The George Washington University Medical Faculty Associates, and District Hospital Partners, LP, d/b/a The George Washington University Hospital, as applicable) requires that sponsors provide an indemnification against any and all claims, costs or liabilities, for any loss, damage, personal injury, or loss of life that arises out of the performance of the clinical study.
13.2.6. Representations and Warranties
Except for certain standard representations and warranties required by federal sponsors, GW generally does not make any representations or warranties regarding the research activities it conducts or the results of any such research or activity.
13.2.7. Subawards/Subcontracts
The Office of the Chief Research Officer is responsible for negotiating subawards and subcontracts to its subrecipients. These subawards and subcontracts will include the University’s standard subcontract terms and conditions as well as any required sponsor flow-down provisions. Subrecipients must meet a variety of requirements regarding financial viability and accounting controls. The University also imposes a right to audit provision in its subcontracts.
13.2.8. Termination
The University should have the right to terminate the agreement for any reason. At a minimum, termination must be allowable in the event of necessity or the sponsor’s breach of the agreement. In the event of termination due to the sponsor’s breach, the sponsor must be obligated to pay for all work performed including any costs committed and to be incurred up to the time of termination.
13.3. LINKS TO FORMS OF STANDARD RESEARCH/SUBCONTRACT AGREEMENTS
Forms of Standard Research and Subcontract Agreements are available for information only on Appendix E. These forms should not be used without the specific involvement of and approval of the Office of the Chief Research Officer.
