Investigators in the process of preparing grant applications or initiating contracts may find the following information helpful.
Due to the unique nature of studies involving human subjects, all clinical research projects at Seattle Children’s Research Institute require protocol review by the Office of Sponsored Research's (OSR) clinical research budget analysts (CRBAs). The CRBAs work with investigators and their staff to identify research-related vs. standard-of-care service pricing, identify resource availability, prepare study budgets and ensure clinical research billing compliance.
Steps to prepare grant applications
- Notify your designated grant and contract administrator (GCA) of an upcoming submission no later than 10 business days before the proposal due date. If submitting a new NIH grant or competing renewal, please give at least six to eight weeks notice of the submission deadline. This will provide adequate time to coordinate with subcontract sites, route internal documents and ensure a timely submission.
- Email a copy of the protocol or research plan to your GCA and the clinical research budget analysts (CRBAs).
- After CRBA review, the budget is forwarded to your GCA. The GCA will enter the budget into the sponsor format and complete any further budget development as needed.
- You will work with your CGA to complete all required applications documents. Your GCA will initiate any outgoing subcontracts and complete research institute sign-off for necessary forms (e.g., OSR-10).
- The OSR reviews application forms and the OSR-10 form to ensure compliance with sponsor guidelines and research institute policies.
- Once approved, the grant is submitted, and confirmation of submission is sent to the principal investigator (PI).
Children’s investigators are often invited by colleagues to participate in ongoing or proposed research projects. If you plan to engage in a research project with a collaborating institution, please contact your GCA to initiate a subcontract application.
Required subcontract components
- Budget justification
- Scope of work
- Updated NIH biosketch
- Resource page
- Letter of intent
An industry agreement defines the contractual relationship between an industry entity and Seattle Children’s Research Institute for the performance or financial support of a clinical study. Industry agreements specify each party's rights and responsibilities and include financial terms, including the budget and payment schedule by which the industry entity will pay the research institute for conducting the study.
OSR is the authorized agent for negotiating industry agreements on behalf of the research institute. It acts as a liaison between industry and principal investigators to ensure such agreements are consistent with research institute policies. Clinical studies conducted under an industry agreement may be either industry-initiated or investigator-initiated and may be negotiated either directly with industry or with a contract research organization (CRO) representing a sponsor. Principal investigators may be asked to countersign an agreement indicating that they have read and understood its terms, but are not authorized to independently negotiate agreements on behalf of the research institute.
Steps to initiating a contract
- Notify your GCA of pending contract(s), concurrently informing OSR Research Contracts and
CRBAs and including a project protocol for pricing of clinical billable events and a Contract Initiation Request Form (OSR-10) (DOC).
- CRBAs work with the study team to complete a financial responsibility analysis and develop a budget based on the project protocol. PI approval of the budget is required prior to contract negotiation by OSR.
- As negotiations near completion, OSR requests an OSR-10 form from the GCA indicating institutional approvals for the project.
- OSR negotiates the budget and contract terms, confirms institutional approvals and obtains the required signatures for contract execution.
- OSR processes an activity set-up request to be submitted to the Office of Research Finance for entry into Lawson.
- Upon full execution of the contract, OSR forwards a copy of the signed agreement, final budget, OSR-10 form and Activity Set-Up Request Form to the GCA.
Facilities and Administration Costs (Indirect Costs)
Facilities and Administration (F and A) costs, also known as indirect costs, are basic expenses associated with maintaining research infrastructure. F and A rates are based on the research institute's actual operating costs and are calculated based on federal guidelines on a regular basis. The research institute's rates are reviewed by and negotiated with the Department of Health and Human Services
For questions you might have about F and A costs, see F and A Costs Frequently Asked Questions.