Grants & Contracts

The UH Clinical Research Center provides infrastructure, programmatic and administrative support for all research activities performed at University Hospitals and/or by UH medical and/or scientific staff. Through its Grants and Contracts Office, the UH Clinical Research Center provides administrative support for Principal Investigators. The Grants and Contracts Office within the UH Clinical Research Center will review protocols for the purposes of:

  • Ensuring coordination of a legal review. To protect the investigator and UH by verifying that the research agreement appropriately addresses legal issues, including indemnification provisions and defines the responsibilities of the investigator and UH
  • Ensuring that investigators follow fiscal guidelines. To verify that UH will receive adequate compensation for resources used during the investigation, including personnel, supplies, hospital services, and administrative and indirect costs; and
  • Ensuring regulatory compliance with research subject billing policies. To implement and verify compliance with clinical investigation accounting procedures, including procedures which ensure compliance with third party payer restrictions on patient billing involving investigational procedures, drugs, and devices

Health Care Finance Administration (HCFA) policies and the requirements of third party payers require this level of review. For example, some Investigational Device Exemptions (IDE) devices, as determined by HCFA, are chargeable under regulations promulgated in 1995. The Grants and Contracts Office maintains up to date information on these regulations and associated codes. Protocol review by the UH Clinical Research Center will help to ensure that programs are in place to bill appropriately, reduce hospital liability, and ensure that costs are appropriately budgeted.

This section of the web site contains information and materials intended to facilitate completion of the required review process. Individualized assistance is available by contacting the Grants and Contract Office directly.

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