Purpose
To ensure that all interventions performed in the Radiology Department as part of a human research protocol are conducted according to hospital/departmental and Institutional Review Board (IRB) guidelines. Interventions include, but are not limited to, radiological procedures, administration of investigational drugs, use of an investigational device, or specimen collection performed as part of a human research study protocol.

Policy
Prior to initiation of research procedures, all protocols involving the Department of Radiology will be reviewed by the Radiology Research Committee and/or Radiology Research Quality Assurance/Quality Improvement (QA/QI). A written agreement specifying who will perform each aspect of care for the research subject will be required prior to the initiation of any research procedures. Study-specific equipment, supplies, training, and staff will be provided by the referring department.

Each subject participating in a clinical research protocol which involves the UAMS Department of Radiology will receive treatment according to the procedures outlined in that protocol and this policy. All interventions will be documented as required by the study protocol, institution policy, and the relevant Standard Operating Procedures (SOPs).

Radiology personnel participating in the care of the research subject will have documented training regarding human subject protection, HIPAA, and protocol specific training. Trained study personnel will perform and document the research interventions according to hospital departmental policy and/or according to the research protocol guidelines. No treatment will be conducted without documentation of subject Informed Consent in the permanent record.

Responsibilities and Chain of Command
Principal Investigator: The Principal Investigator (PI) for each human research protocol will be responsible for ensuring that all interventions performed as part of a human research protocol are conducted according to hospital/departmental and IRB guidelines. While the PI’s designees may perform some tasks, the PI is ultimately responsible.

Radiology Staff Responsibilities: The Radiology Research Committee and/or Radiology Research QA/QI will review and approve all protocols involving the Department and provide a written agreement specifying which aspects of care will be provided by Radiology personnel. Trained Radiology personnel will be responsible for registering the subject for the radiologic procedure (in the study log book and in the hospital system), maintaining and documenting maintenance of Radiology equipment, performing the procedure, and maintaining the Radiology study binder for each protocol. The Radiology Chief Financial Officer will review and approve the research billing procedure for interventions performed by Radiology prior to the initiation of any research procedure.

Non-Radiology Staff Responsibilities: The Principal Investigator will provide designated study personnel trained in Human Subject Protection (HSP), HIPAA, and the specific protocol. Study personnel will provide all supplies and any additional equipment needed for the study and will inventory supplies with the Radiology personnel prior to the initiation of the study. If Radiology equipment is used, usage time will be approved by the manager for that area prior to the onset of the study. The study personnel provided by the Principal Investigator will accompany the subject through the procedure, providing documentation of signed, informed consent, eligibility, the procedures performed, and the subject’s response to the procedures. The study personnel will document the use of test articles as outlined by the protocol, applicable federal guidelines, state guidelines, and the IRB. Study personnel will provide and document discharge instructions. Copies will be left for the Radiology file. If the Principal Investigator for the study is a UAMS Radiologist, radiology personnel may be trained and designated as the study personnel and assume the responsibilities listed above. Otherwise, these responsibilities will be carried out by qualified non-radiology personnel.

Training
All radiology personnel participating in the care of the research subject will have a certificate of completion of the IRB Human Subject Protection training module dated within the past year, Health Insurance Portability and Accountability Act (HIPAA) for research training and protocol-specific training (written verification from the PI that the radiology staff member has received training in protocol procedures). Documentation of all research training will be kept in the 3 ring binder for that study. The designated study personnel will also have HSP, HIPAA, and protocol-specific training with documentation kept in the study binder. Each radiology staff member participating in the research protocol will provide a copy of his/her professional license to be kept in the study binder and sign the signature log kept in the study binder.

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