Application for Research

Transcription

1 Application for Research All research conducted within the Brooks Rehabilitation system or any entity or facility bearing the Brooks name, including the Brooks Rehabilitation Clinical Research Center, must have final written approval from the Brooks Local Scientific Advisory Committee, and documented Institutional Review Board (IRB) approval before the project may be initiated. All Brooks research policies may be accessed at For consultation or questions regarding the Brooks Clinical Research Center or the Application process: Floris F. Singletary, M.S., CCC-SLP Research Manager Brooks Rehabilitation Clinical Research Center 3901 University Blvd South, Suite 101 Jacksonville FL The following Required documents should be submitted electronically to Floris Singletary at Application for Research A: Project Information B: Resource Request C: Project Funding and Proposed Site Budget Protocol Informed Consent(s), if available Curriculum Vitae of Principal Investigator (if not previously submitted) IRB approval letter, if available A. Project Information Title of Project: IRB To be Used: (include full name and contact information) Principal Investigator: PI Contact Information: Institutional Affiliation Phone: Fax: Mailing Address: Co-PI/Co-Investigator(s):

2 Co-PI Contact Information: Phone: Fax: Mailing Address: Other Key Research Personnel: Purpose of Study: (may copy and paste from protocol) Brief Study Description: (may copy and paste from protocol brief paragraph only, do not insert the entire protocol) Target Recruitment Population: (fully describe) How many Subjects do you intend to enroll at this site: Subjects to be recruited from: (check all that apply) Patients from Brooks Rehabilitation facilities: (please specify below) Inpatient hospital Outpatient clinics (specify clinic locations) Home Health agency Skilled Nursing Unit or Facility (specify locations) Other (specify) Base) Clinical Research Center (including query of the Brooks Registry and/or Data Age, Race, Gender: Jacksonville community at large Other specific location(s): (specify)

3 Inclusive Diagnosis Group(s): Please list specific inclusion/exclusion criteria: Describe methods and how participants will be recruited for this project: Specify names of all research personnel who will be IRB-authorized to obtain informed consent: Part B: Resource Request Note: It is assumed that all resources needed to conduct the study will be provided by PI and Grant unless otherwise specifically indicated. Specify if you need us to provide study personnel or project staffing: Let us know if you need personnel support from us and please specify proposed % effort (FTE, number of hours needed), time frame needed, whether needed full time, part time, or PRN. Site Investigator (Principal Investigator, Co-Investigator) Study Physician Recruitment Specialist Research Assistant Clinical Research Coordinator Research Nurse (ARNP, RN, LPN) Licensed Therapist (PT, OT, SLP) Brooks Rehabilitation Clinical Employee Support: (RN, PT, OT, SLP, etc): (please specify) Data Coordinator Phlebotomist/Laboratory Technician Specify ALL Location(s) where study activities will be conducted: Brooks Rehabilitation: Inpatient hospital Outpatient clinics (specify clinic locations) Home Health agency Skilled Nursing Unit or Facility (specify locations) Other (specify)

4 Brooks Rehabilitation Clinical Research Center Other space: (specify) Specify if you need us to provide any EQUIPMENT: Diagnostic: Intervention: Specialized: Biological Laboratory: Specify if you need us to provide other ancillary services: (which may be contracted and/or coordinated from external sources: e.g. Memorial Hospital, Quest Diagnostic Laboratories): Pharmacy and Investigational Drug Services Clinical Laboratory Services (clinical test results, safety labs) Radiology Services Part C: Project Funding and Proposed Site Budget Source of Funding: Expected Funding Amount: Proposed Time Frames for Funding: Grant Submission Due Date: Anticipated Funding Date: IRB Submission Proposed Date: Participant Enrollment and Study Start Date: Study End Date: Proposed Budget: Please include or attach your proposed study budget and applicable spreadsheets. Study Budget Rates For assistance with specific rates or costs, please consult with Holly Morris, Research Director.

5 Personnel Rates (approximate salary rates with fringe benefits): Research Scientist/Investigator: Variable, call for specific rates Recruitment Specialist: $500/per month (5% effort) Research Assistant: $22/hour Clinical Research Coordinator: $30/hour Research Nurse (RN): $35/hour Licensed Therapist (PT, OT, SLP): $55/hour Brooks Rehabilitation Clinical Employee Rate: Variable, call for specific rates Data Coordinator: $22/hour Research Services: Brooks Active Recruitment Registry and Data Base Query $200 Recruitment Advertising: Variable, depending on needs Phlebotomy Services: $50 per draw Laboratory Processing, Storage and Shipping: Variable, depending on needs Ancillary Services: Variable, depending on needs Other Study Budget Considerations: Study initiation of the project and specific protocol training time (describe and estimate amount of time required) Any anticipated ongoing training needs, e.g WOC training, human subject protections Central IRB costs Statistician Consultation & Data Analysis Site monitoring visits Travel expense (staff or participant) Subject reimbursement (if applicable) Special equipment purchase and/or supplies needed for the project Indirect Cost: Additional 25% of Total Site Budget, where allowable.