HRA Responsibilities for Grant Administration
This announcement serves to clarify which types of sponsored projects shall be negotiated and administered by USC Health Research Association, Inc. (HRA) and which types of sponsored projects shall be negotiated and administered by USC Department of Contracts and Grants (DCG).
Health Research Association (HRA)
- HRA is authorized to negotiate and administer Industry-sponsored human clinical-trials* provided there is no Federal sponsor for the industry funds.
- HRA may not negotiate or administer agreements that do not involve human subjects (e.g. animal studies), regardless of sponsor.
- HRA may not negotiate or administer any projects involving a federal sponsor.
Department of Contracts & Grants (DCG)
- DCG is authorized to negotiate and administer all Federal grants and contracts, federal subcontracts, state, local and foundation agreements, as well as industry sponsored non-human subjects research.
DCG or HRA
- Industry-sponsored human studies (non-clinical trials), such as testing of industry developed diagnostic software, equipment, etc. may be negotiated by HRA (with the relevant Dean’s written approval) or DCG.
- All human studies involving patient care require a budget and coverage analysis from the Clinical Trials Analysis Budget and Billing (CTABB) unit regardless of whether the study is administered by HRA or DCG. Examples of patient care costs that would trigger a CTABB analysis include: inpatient and outpatient hospital services, professional services provided by a clinician, radiology services such as x-rays or scans, laboratory services, or any other clinical or diagnostic testing. CTABB will analyze the protocol to determine the patient care costs that can be charged to an insurance company, a sponsor or other source of funding.
USC Stevens Center for Innovation
- All Material Transfer Agreements (MTA) that are not already covered by Clinical Trial agreements are administered by USC Stevens.
By clarifying which sponsored projects are administered by administrative unit, we hope to achieve administrative consistency in procedures and communication for PI’s and sponsors.
*A Clinical Trial is a phased biomedical research study using human volunteers, designed to answer safety and efficacy questions about biologicals, devices, pharmaceuticals, new therapies or new ways of using known treatments.
National Institutes for Health Definition of Clinical Trial:
A biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Clinical trials of an experimental drug, treatment, device, or intervention may proceed through four phases:
- Phase I. Testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
- Phase II. Study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
- Phase III. Study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
- Phase IV. Studies done after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.