All agreement projects must be electronically submitted through myUABResearch. Funded projects include various types of research projects, both sponsor-initiated and investigator-initiated, in which an external (for-profit, non-profit, and federal) source will provide funding to perform a project. Agreement projects commonly consists of monetary funding and/or materials, products, drugs, devices, and other equipment necessary to perform a project. Agreement projects are funded through the submission and negotiation of an agreement or contract.
Agreement submissions to myUABResearch must include all applicable, required documents to ensure an accurate and efficient review. The documents required for any given submission depend upon the type of project to be reviewed. A listing of the required documents for each type of submission can be found in the OSP Required Documents Search Tool. A brief description of the required documents is also listed below.
If a submission to OSP is missing any required documents, all required documents should be submitted to myUABResearch as expeditiously as possible to ensure a timely routing and review of the submission.
Required Documents for Industry Funded Submissions
Jump to a Section
- Proposals
- Registry Studies
- Observational Studies
- Chart Reviews
- Research Agreements
- Services Agreements
- Data Use Agreements (DUA)
- Project Master Agreements (PMA)
- No Cost Extensions (NCE)
- Amendments
Proposals
myUABResearch Funding Proposal
Create a Funding Proposal in myUABResearch. The FP must be submitted simultaneously with the other required documents listed below. Please ensure the Funding Proposal is thoroughly completed and the information provided is as accurate as possible.
Statement/Scope of Work
The most current draft or final statement of work must be submitted to OSP in the myUABResearch Funding Proposal and is necessary for an accurate review of the proposal. Each project has unique components which must be addressed in the submission, and the statement of work is necessary for the officer or specialist to identify those components. The statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the submission and corresponding statement of work. The statement of work should be specific and detailed to enable the sponsor to fully understand the proposed work to be funded.
For Continuing Medical Education (CME) proposals, the statement of work or a description of the CME event, including the offered CME credit and supporting documentation, must be submitted through myUABResearch.
Budget
The most current draft of the budget must be submitted via the Funding Proposal. While the final budget is not necessary at the time of submission, it is necessary for inclusion into the final award. Thus, the final budget should be uploaded as soon as it is available. Please ensure the applicable Facilities and Administration (F&A) rate is included in the budget pursuant to the rate agreement or UAB policy.
Funding Announcement/Website
The funding announcement and/or website link must be submitted for all proposal submissions. This information must be included as either (1) an additional document in the Funding Proposal or (2) pasted into the additional comments section in the Funding Proposal. The funding announcement and website provide necessary information regarding a funding source’s requirements and guidelines for submitting the proposed project to the sponsor. The funding announcement and website also provide any terms and conditions that may be applicable to the receipt of awarded funds.
Miscellaneous Required Documents (if applicable)
For Continuing Medical Education (CME) proposals, the application or approval letter from CME must be uploaded as an additional document.
If applicable to the proposal, any additional sponsor-required documentation must be uploaded. Additionally, if applicable to the proposal, a statement of intent and/or cover letter must be uploaded.
Research Agreements/Services Agreements/Registry Studies/Observational Studies/Chart Reviews
Funding Proposal
Create a Funding Proposal in myUABResearch. The Funding Proposal is required for projects that receive funding or will involve cost-sharing. The Funding Proposal must be submitted simultaneously with the other required documents listed below. Please ensure the Funding Proposal is thoroughly completed and the information provided is as accurate as possible.
Sponsored Research Agreement
Create a Sponsored Research Agreement from Funding Proposal in myUABResearch. The Sponsored Research Agreement is required for projects that are awarded by the funding source requiring the execution of an agreement. Please ensure that the Sponsored Research Agreement is thoroughly completed and the information provided is as accurate as possible.
Protocol or Statement/Scope of Work
The final protocol or statement of work must be uploaded to myUABResearch and is necessary for an accurate review of the agreement. Each project has unique components which must be addressed in the agreement, and the protocol or statement of work is necessary for the officer or specialist to identify those components. The protocol or statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the agreement and corresponding protocol or statement of work. Further, submission of the final protocol or statement of work is necessary to enable the OSP officer or specialist to incorporate the document as an exhibit to the agreement.
The statement of work must be specific and detailed to include all deliverables, timeframes and milestones applicable to the project. Statements of work must also include a detailed payment schedule describing the means and frequency that payments will be issued, as well as to whom and to where payments will be received for the project. A template statement of work may be found here.
Informed Consent Form/HIPAA Authorization
The most current or final draft of the informed consent form must be uploaded to myUABResearch as an additional document in the Agreement submission. The informed consent has information related to risk, subject medical injury and use of personal health information that may correspond with language in the agreement and assists the officer or specialist with tailoring the terms of the agreement appropriately.
Budget
The most current draft of the budget must be uploaded to myUABResearch via the Funding Proposal for all projects that will receive monetary funding. While the final budget is not necessary at the onset of the negotiation, it is necessary for final processing of the award. Thus, the final budget should be uploaded as soon as it is available. Please ensure the applicable Facilities and Administration (F&A) rate is included in the budget pursuant to the rate agreement or UAB policy.
Budgets are not required for non-sponsored funded projects. Non-sponsor funded projects include projects in which an external industry source provides only product, material, and/or equipment, including drug(s) and/or device(s), for the performance of a project and does not provide any monetary funding. Additionally, Facilities and Administration (F&A) rates and costs are not applicable to projects that will not receive monetary funding from an external industry source.
Contract/Agreement
The OSP officer or specialist will need an unlocked, editable copy of the agreement (including applicable exhibits, attachments, appendices, etc.), in Word version or format, which must be included with a submission to OSP. The Principal Investigator (PI) and the corresponding department should review the agreement prior to submission to OSP and provide any comments or areas of concern in an email or memorandum to your assigned OSP officer or specialist. Please do not make edits or comments in the agreement provided by the sponsor.
Hospital Letter of Agreement
(Medical Device Trials Only)
A Hospital Letter of Agreement must be uploaded to myUABResearch in the additional documents under the Agreement submission for Category B device trials only. Because these letters often take time to receive, it is recommended the Principal Investigator (PI) begin this process upon or before submission to myUABResearch. The Clinical Billing Review (CBR) unit will assist in determining whether a Hospital Letter of Agreement is necessary.
Data Use Agreements/Project Master Agreements/No-Cost Extensions
UAB Expedited Checklist
Please see our dedicated DUA page.
Contract/Agreement
The OSP officer or specialist will need an unlocked, editable copy of the agreement (including applicable exhibits, attachments, appendices, etc.), in Word version or format, which must be included with a submission to OSP. The Principal Investigator (PI) and the corresponding department should review the agreement prior to submission to OSP and provide any comments or areas of concern in an email or memorandum to your assigned OSP officer or specialist. Please do not make edits or comments in the agreement provided by the sponsor.
Statement/Scope of Work (Data Use Agreements Only)
For Data Use Agreements (DUA) only, the final detailed statement of work must be submitted to OSP myUABResearch and is necessary for an accurate review of the agreement. Each project has unique components that must be addressed in the agreement, and the statement of work is necessary for the officer or specialist to identify those components. The statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the agreement and corresponding statement of work. Further, submission of the final statement of work is necessary to enable the OSP officer or specialist to incorporate the document as an exhibit to the agreement.
The statement of work must be specific and detailed to include all deliverables (what data is being shared, who is receiving the data, and how the data will be used), timeframes, and milestones applicable to the project. A template statement of work may be found here.
Contract Language
Unlocked Word Version of the Agreement
All industry agreements (including applicable exhibits, attachments, appendices, etc.) provided to UAB must be in the form of an unlocked and editable Microsoft Word document. Because UAB has multiple levels of internal review that may include privileged communications that are not shared with external parties, UAB will not participate in contract negotiations if a template is provided in a locked or otherwise uneditable format.
Please be assured that UAB: (1) will not make edits without both parties being made aware of any such changes; (2) will track all edits in “track changes” mode; and (3) will provide a redlined copy reflective of any and all changes made. UAB’s integrity is of the utmost importance in all contractual negotiations.
Study Start-Up Fees
Study start-up fees are non-refundable and due upon (1) full execution of the agreement and (2) confirmation of IRB and/or other regulatory approval(s) (as applicable). Site initiation may not be a trigger for payment of start-up fees because doing so places UAB at risk of not recovering its start-up expenses in the event a sponsor decides not to initiate UAB as a site. Without site initiation, a sponsor would have no obligation to pay start-up costs incurred by UAB, which would equate to UAB subsidizing a sponsor’s research, as most start-up activities have occurred before the site initiation. As a non-profit public entity of the State of Alabama, UAB is prohibited from subsidizing a for-profit entity’s research.
Existence of an Agreement Cannot Be Confidential
While UAB can agree to keep certain terms and conditions of an agreement confidential, UAB cannot accept contract language that requires the existence of an agreement to remain confidential. As a non-profit public entity, UAB is subject to the State of Alabama’s Public Records Laws and could be required to disclose certain information relating to the agreement, such as the existence of the agreement, the sponsor’s name, the investigator’s name, the total funding amount received, the title of project, and the project period. UAB’s position is that confidential information owned by a third party is protected from disclosure pursuant to public policy exemptions, and UAB will use its best efforts to protect a sponsor’s confidential information from disclosure as appropriate under the law.
Prime Agreement as an Exhibit to an Incoming Subcontract
UAB cannot accept an incoming industry subcontract where the prime agreement between the sponsor-institution and funding source is included as an exhibit and/or attachment to, is referenced in, or is otherwise incorporated into the subcontract. UAB is not a party to the prime and, as such, will not accept responsibility for reviewing the terms of the prime in order to determine whether a provision is applicable to UAB’s conduct in the relevant study. Instead, UAB requires that any terms or conditions from the prime that are specifically applicable to UAB’s conduct of the study be included in the body of the subcontract provided by the sponsor-institution and that any language not applicable to UAB be removed from the subcontract agreement between UAB and the originating institution.
Non-Sponsor Funded Research
Overview
The term “Non-Sponsor Funded” Research is most often used to describe a research project in which a UAB researcher is collaborating with an external entity who is providing product, equipment, or materials in lieu of financial support (see criteria set forth below). Often, the external entity is directing or requesting that a research agreement be used, rather than a material transfer agreement (“MTA”), because of the level of anticipated collaboration or scope of the project. Non-sponsor funded research agreements necessitate negotiation of terms and conditions and are required to be handled by the Office of Sponsored Programs (OSP). The criteria of “Non-Sponsor Funded” Research Projects are set forth below, along with submission requirements. Please note that a cost-sharing commitment form is required for costs, such as effort and supplies, that are associated with the project but are not being charged to the project account.
“Non-Sponsor Funded” Research Project Criteria
- You are receiving a product, equipment or research material (cell lines, compounds, etc) from an external entity.
- The external entity supplying the product, equipment, or material is NOT providing you with any financial support to conduct the work.
- Any financial support used to conduct the work is provided from another unrestricted source. If the product, equipment or materials provided by the external entity will be used in a project funded by another award, please see below.
- The data you supply to the external entity is more than just a listing of the raw data, but includes analysis of the results.
- There is some level of collaboration on the research project, where you are not the sole determiner of how the donated item is used in the project but the external entity providing the item has some input into how the project is conducted.
- Some of the criteria alone or a combination of the criteria will eliminate the use of a material transfer agreement (MTA) or a data use agreement (DUA).
Submission Requirements
Please ensure that you provide the following documents/information when submitting a “Non-Sponsor Funded” Research Project to OSP:
- Create a Funding Proposal in myUABResearch. The Funding Proposal is required for projects that receive funding or will involve cost-sharing. The Funding Proposal must be submitted simultaneously with the other required documents listed below. Please ensure the Funding Proposal is thoroughly completed and the information provided is as accurate as possible.
- Create a Sponsored Research Agreement from Funding Proposal in myUABResearch. The Sponsored Research Agreement is required for projects that are awarded by the funding source requiring the execution of an agreement. Please ensure that the Sponsored Research Agreement is thoroughly completed and the information provided is as accurate as possible.
- A contract/agreement with the external entity providing the product/equipment/materials
- Scope of Work
- Budget
- Cost Sharing Form
Federal and Other Awards Involving “Non Sponsor Funded” Research
If you intend to use the product, equipment or material provided by an external entity in a research project which is funded by a federal award, the federal funding agency’s approval is required. Approval will be deemed to have been given by the federal funding agency if the use of the product, equipment or material is identified and commitment is provided in the proposal resulting in the award. Alternatively, approval may be given under separate cover (email or letter) by the funding agency Grants Management Specialist (GMS) or equivalent grants or contracts officer. Please note: approval from a Program Official is not sufficient. Please do not hesitate to contact your OSP Officer for assistance with obtaining needed approvals.
You should also notify the external entity providing the product, equipment or material that it will be used in a project that will be funded by the federal government. Some for profit companies do not want and will not agree to the use of their developmental materials in federally funded projects because of the march in rights the federal government may exercise and which are granted to it by virtue of the Bayh-Dole Act. Please contact your OSP officer, the UABRF or the Office of Counsel if you need information or assistance on this issue.
If you intend to use the product, equipment or material provided by an external entity in conjunction with a research project for which any other party is providing external funding, then all entities should be made aware of the involvement of the other parties and each party should consent in writing (email is acceptable) that they are willing for the research to proceed. As with federal awards, if the involvement of all of the parties is referenced in the scope of work then additional approvals may not be required.
On notice of approval, the product, equipment or material provided by the external entity is considered in-kind cost sharing. UAB’s in-kind cost sharing commitment form is required only if the award terms and conditions or funding agency determines or requires reporting of the in-kind cost sharing.