View/Read:

• GCRC Application Instructions

• DSMP

• GCRC Notices

Download:

• Protocol PHS 398 Template

• Resource Request Form (GCRC Application Packet and Instruction)

Link to:

• NIH Biosketch Form

• IRB Human Subjects Training

• IRB Forms

• Other Useful Links

 Last Modified: 10/11/03

To use the resources of the GCRC you must prepare an application packet. Whether you use this comprehensive packet or individual links to the six components, all six items must be included in the GCRC submitted application. Incomplete application submissions may be returned without review.

Submit electronic completed packet documents to ebruiz@utmb.edu

1. Protocol - The GCRC Protocol should follow the PHS 398 grant application format. If another format is required by a granting agency that format may be acceptable if all the required information is included in the protocol or as an attachment, including Layman’s Abstract, a Human Subjects Section in the PHS398 format (link) and a Data and Safety Monitoring Plan.

2. Attachment I-Resource Request Form-This form requests information that the GCRC requires for setting up a study and for annual reporting to the NIH. (Click on Resource Request Form under Download)

3. Attachment II-Consent forms-A current copy of the IRB approved and stamped consent form must be on file at the GCRC before study subjects can be seen on the GCRC.

4. Attachment III-Biosketch-A current biosketch is required for the PI and all UTMB co-investigators.

5. Attachment IV-IRB Form #2-and all IRB correspondence to date

6. Attachment V-Cover Memo-The memo should state whether the study is externally funded and the source of such funding. If the study is not funded, investigators should discuss the potential use of the data generated through the use of the GCRC in applying for external funding, and the likelihood of the study culminating in a successful extramural grant application.

The GCRC Protocol should follow the PHS 398 grant application format. The following is a template to assist you (Click here). If another format is required by a granting agency that format may be acceptable if all the required information is included in the protocol or as an attachment, including

• Layman’s Abstract,

• a Human Subjects Section in the PHS 398 format and

• a Data and Safety Monitoring Plan.

The PHS 398 grant application instructions can be found at: http://grants.nih.gov/grants/funding/phs398/phs398.html

A detailed outline of the resources needed to complete your protocol.

Consent forms or assent forms for children subject’s parents/guardians prepared for IRB review, (or already approved by the IRB) should accompany all GCRC protocol submissions. The template for a sample consent form required by the IRB can be accessed at: http://research.utmb.edu/irb/irbm74.doc.

A current copy of the IRB approved and stamped consent form must be on file at the GCRC before study subjects can be seen on the GCRC. Please list the types of consent forms and the current IRB Approval status:

A current biosketch is required for the PI and all others from UTMB listed as co-investigators. These must be in the 4-page PHS 398 format that includes information about all grant funding. Please remember to include the following information when listing support from funding agencies:

1. Title of protocol
2. Principal Investigator
3. Source of support
4. Award number
5. Dates of project
6. Both Direct and Indirect costs for the current award period
7. % effort associated with the project

Download relevant sections at: http://grants.nih.gov/grants/funding/phs398/phs398.html 

Form #2 and any other IRB forms appropriate to the study (such as forms for inclusion of children, prisoners, and pregnant women). These forms can be accessed at: http://research.utmb.edu/irb/forms.shtm 

Sample

Don W. Powell, M.D.
Director
General Clinical Research Center
RE: Protocol Submission: “Protocol Title”

Dear Dr. Powell:

Enclosed please find the above-mentioned protocol, for which we are requesting GCRC approval and the use of GCRC facilities and funding. There is no current external funding for this study (only departmental funds). We believe that the proposed research offers great potential for generating data that can be used to apply for future external funding. In fact, this study will be one of the cornerstones in an application for NIH grants planned to be submitted within a year from today.

Please note that this protocol has been previously approved by the IRB; enclosed please find all correspondence between our office and the IRB.

Sincerely,