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ARB #:

LBH ARB Application (version 7/1/2014)

LifeBridge Health Page 1 of 5

LIFEBRIDGE HEALTH

ADMINISTRATIVE REVIEW BOARD

APPLICATION FORM FOR UNFUNDED OR LBH-FUNDED RESEARCH

Please check at which of the following facilities you wish to conduct your research:

CourtlandGardensNursing & RehabilitationCenter

Levindale Hebrew

NorthwestHospitalCenter

SinaiHospital of Baltimore

Other:

Principal Investigator:

Co-Investigator: (faculty, student/resident/fellow/nurse)

Sponsoring Department:

LifeBridge Health Sponsor (Required for all research by non-LifeBridge Health investigators involving LifeBridge Health patients):

Project Title:

ResidentFellow Faculty Research Project

Anticipated Start Date: Anticipated End Date:

  1. This study can be categorized as (check all that apply):

Interventional (Treatment) StudyObservational Study

Survey or Questionnaire StudyMedical Records Review Only

  1. What is the primary purpose of the proposed research?
  1. How will this research contribute to improved clinical intervention, care, and/or patient outcomes?
  1. Are you planning on publishing this work? Yes No
  2. Is there any potential risk to the research subject for conducting the proposed research?

Yes No

If Yes, please explain below:

  1. Who is responsible for communicating with the Finance Department to update study information?
  1. Are any of the following ancillary departments involved in this study? Yes No

If yes, check the appropriate boxes:

NursingPathologyPharmacyRadiology

Other:

Please provide the documentation for the LBH funding arrangement that has been agreed upon. Also, please summarize costs in Section 11 of this application.

  1. Will procedures, tests, or drugs be performed or given which are beyond normal standard of care for patient involved in the research? Yes No Varies

If Yes, please provide the documentation from the providing department regarding the approved costs of the procedure/test. Please note the importance of making sure our Patient Accounting Department is provided with all the necessary information in a timely manner in order to ensure proper billing pertaining to this study.

  1. Will medical devices or durable medical equipment (DME) be used in this

Research? (i.e. stent, implant, disposals, etc.)Yes No

If yes, is the device/DME FDA approved for this protocol? Yes No Pending

Expected Approval Date

If yesor pending, give description of device or DME:

Will a LifeBridge Health facility be purchasing experimental drugs or devices?

Yes No

  1. Is home department providing support for statistical consultation? Yes No

If yes, estimated charges $

  1. Budget Breakdown:

Direct Costs:

Item
/ Justification / Budgeted
Principal Investigator/Clinic Staff
Administrative Salary Support
(Research Coordinator/Manager)
Institutional Review Board Fees
Subtotal
Overhead Costs / 30% of direct costs
Total Reimbursement of Direct Costs

Ancillary Costs:

Department
/ Procedure, Tests, Drugs, Equipment / Budgeted
Subtotal
Overhead Costs / 30% of ancillary costs
Reimbursement of Ancillary Costs

The signatures below imply review and approval of the application and attached budget.

______

Principal Investigator’s SignatureDate

Type or Print Principal Investigator’s Name

______

Department Administrator or Designee’s SignatureDate

Type or Print Department Administrator’s Name

______

Department Chairman’s SignatureDate

Type or Print Department Chairman’s Name

The following directors agree that the time allocated for services provided by their department for the above referenced protocol are appropriate:

______

Department Director or Designee’s SignatureDate

Type or Print Department Director’s Name and Department

______

Department Director or Designee’s SignatureDate

Type or Print Department Director’s Name and Department

______

Department Director or Designee’s SignatureDate

Type or Print Department Director’s Name and Department

If more Departments are involved, please add more signature lines.

LBH ARB Application (version 7/1/2014)