Research Grant Application Requirements

ST. JOSEPH MERCY HOSPITAL

Research Committee

Research Grant Application Requirements

Applications must be submitted electronically by close of business on the noted submission deadline date for the appropriate meeting. Late submissions will be reviewed at the next months meeting, based on the proposed meeting schedule.

The following documents must be included in the application package. (Templates for some of the documents can be found on the Research or IRB web page):

-Completed “Research Grant Application” with required Department signatures, as noted on the cover sheet. Note that any specific individual identified in the protocol should sign off on the application.

-Management support for any resources to be used on the project (i.e. staff time for data collection, etc.) should be documented through one of the following mechanisms:

A signed letter of support, or
Signature on the application cover page, or
Copy of email confirming management support

-External entities complete an external collaboration form, in addition to the documents listed here

-Completed appropriate Institutional Review Board (IRB) required protocol template

“Minimal Risk Template” or
“Clinical Trial Template”

-An informed consent form, if applicable (incorporate HIPPA language if applicable, or submit a stand alone HIPPA authorization form in addition to the informed consent)

-Any survey or data collection tools that will be used

-Any documents such as advertisements, recruiting information, informational brochures or anything to be seen or used by a potential research participant must be submitted.

-Verification of completed certificate of human subject protection training. SJMHS requires researchers to complete the “Clinical Researchers-Human Subject Research, Basic Course” provided by the CITI training program. CITI certification will need to be completed every four years.

-Verification of completed financial conflict of interest (FCOI) training and disclosure. FCOI disclosure needs to be completed every year, or if there is a new disclosure to report. Training is required every 4 years.

Research Committee approval must be obtained prior to submitting a new project application to the IRB office for consideration. Research Committee approval must be obtained in advance of IRB approval if restricted funding is required to support study operations, and SJMHS will be listed as the “study sponsor”on the IRB application.

St. Joseph Mercy Health System
Research Committee

Research Grant Application Cover Sheet

Title of Project:
Principal Investigator:
Position Title:
Department:
Phone Number:
Pager Number:
e-mail address
Inclusive Project Dates:
Total Budget Requested:
By signing below, each individual indicates that s/he accepts responsibility for conducting this project in accordance with SJMHS Policy, applicable regulatory requirements and to follow the protocol as written.
Signature of Principal Investigator, Co-Investigators, Sub-Investigators:
(1) ______
Typed Name Signature Department Date
(2) ______
Typed Name Signature Department Date
(3) ______
Typed Name Signature Department Date
(4) ______
Typed Name Signature Department Date
Signature of Departmental Chairpersonor designee (signing as awareness of the conduct of the study in their department):
______
Typed Name Signature Date

STUDYBUDGET JUSTIFICATION

Grantrequests will not be reviewed without the submission of a detailed budget, budget justification and study timeline. The budget worksheet should be completed as follows and accompanied by a detailed budget justification.

The following categories of costs are pre-specified:

Personnel Costs – All personnel should be list with their anticipated hours on the project regardless of whether a salary is requested. Explain in detail the role of each individual in the budget justification.

Consultant Costs – Provide names(s) and the organizational affiliation(s). The need and role for each consultant must be outlined in the budget justification, including the task to be completed.

Equipment – a limited amount of equipment may be requested if appropriate for accomplishing the objectives of the proposal. In the budget justification, state the use of the equipment separately and justify each item.

Supplies – Itemize supplies in separate categories, such as stamps, paper, etc.

Other Costs – Itemize costs for data processing, preparation of abstracts (posters) and manuscripts, travel to scientific meetings, etc. Patient costs such as travel, alterations and renovations, equipment maintenance, service contracts and IRB costs usually will not be funded.

Indirect costs – no indirect costs can be requested from the RC.

Expenditures – The PI is required to report final expenditures, on an annual basis and at time of study close out, on a line item basis corresponding to their approved budget. Over expenditures can occur on a line item provided the overall approved budget is not exceeded. All unexpended funds will be released within the restricted fund account and available for distribution by the RC. An extension of funding may be granted by the RC, provided a formal request is submitted with a revised budget and an explanation regarding the research activities to be undertaken during the requested extension period. This would require a Protocol Amendment.

PROPOSED GRANTBUDGET WORKSHEET

(Each category must be itemized.)

Title of Project: Date:

1. Personnel Costs:
Name / Anticipated Hours / Salary*
(hourly rate) / Fringe Benefits*
(26%) /

Total

2. Consultant Costs:
3. Equipment Costs:
4. Supply Costs:
5. Other Costs: (Preparation of abstracts and manuscripts; travel to scientific meetings, etc.)
TOTAL:

* Salary/Fringe costs not required for internal “in kind” resources.

Budget Justification:

Provide a narrative that fully supports and explains the basis for the information in the budget worksheet. For example, provide the names of the personnel that will be involved in the study, the names/fees associated with consultants, and the need for any supplies. Please provide a reasonable estimation of what your expenses are anticipated to be, with enough detail for reviewers to have a good understanding of the overall costs of the project. Ensure the following points are addressed in the budget justification:

Rationale for study costs and calculation justification
How the amount shown in the budget was arithmetically determined
What the specific item is (use of “miscellaneous” is unacceptable).

Research Committee Study Timeline Submission

Please list planned time intervals for key study milestones, with associated tasks and responsible party for completion. This timeline will be used for study evaluation at the time annual review. Additional study milestones may be added to this template as needed.

Critical Study Milestone #1:

Tasks Completed By (include estimate of “in kind” research department staff time):