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 Last Modified: 10/11/03

The medical care of patients admitted to the UTMB GCRC is the primary responsibility of the physician investigator. The investigator must provide house staff coverage in case of an emergency.

Initiating a GCRC Study:

Once GCRC approval is granted, investigators are required to contact the Nurse Manager, Holly Paskell, RN @ X29542 to schedule a Study Initiation Meeting prior to the start of the research. The nursing, dietary, and laboratory staff should have sufficient advance notice concerning the investigator's requirements for patient care and conduct of the study. The Nurse Manager appoints a primary and secondary Protocol Nurse as a liaison to work with the investigator to schedule admissions and to plan flow sheets. Nursing staff must have physician orders prior to initiating clinical procedures. Advance personal communication with the proper GCRC personnel ensures optimal conduct of each research study. Additionally, it is important to schedule admissions as early as possible so that the Nurse Manager of the GCRC can provide proper staffing during times of heavy utilization.

Patient Recruitment:

The investigator is responsible for recruiting patients and securing their consent. A written informed consent must be obtained from the study subject and kept on file in the hospital chart. These informed consents satisfy NIH and OPRR guidelines for human subject research.

Informed Consent:

All subjects must give their written voluntary consent, unless IRB-approved exceptions apply. The investigator has the primary responsibility to have the Consent Form (or Assent Form) completed and signed before any research, inpatient admission or outpatient visit occurs. A copy of the consent form must be provided for each hospital admission. Should a volunteer be under legal age of consent, permission of parents or legal guardian must be obtained and an Assent Form signed. Children between ages 6-11 should give verbal consent. Those between 12-18 should sign the Assent Form.

The Consent (Assent) Form gives permission for the subject’s participation as a volunteer in a research study. The process of obtaining a valid Informed Consent requires that the investigator (or qualified designee) helps the subject to arrive at an adequate understanding of the planned procedure or study to which he/she is to be subjected. This must include any necessary appreciation of the hazards or inconveniences that may reasonably be expected. Once completed, the Consent (Assent) Form will be placed permanently in the patient's medical record for each GCRC admission, nursing must verify that a Consent (Assent) Form has been signed.

Patient Admissions:

Some of the criteria for admission is a subjects' suitability for participation in a research project and a willingness to become involved in the study as documented by a signed and witnessed Consent (Assent) Form, physician orders and medical coverage.

Scheduling of admissions is arranged by the investigator with the GCRC Nursing Department. Investigators are urged to schedule admissions as early as possible. This allows efficient use of the GCRC and its facilities by permitting prediction of workload. The investigator is responsible for notifying the subject of the admission date and providing necessary instructions to the subject. Transportation and parking expenses cannot be covered by the GCRC.

All inpatients will be admitted to the GCRC through the regular UTMB Hospital Admitting Office. The admitting procedures will be the same as for patients admitted to other floors of the Hospital. Outpatients will be registered directly at the UTMB GCRC.

The investigator must provide the following information on all inpatients and outpatients at the time of admission: full name, hospital number, gender, race, date of birth, social security number, and address.

Patient Care:

All details of the care of UTMB GCRC patients/subjects are the direct responsibility of the investigator, who writes or oversees admission work-ups, progress notes, and any other medical aspects of the project in compliance with UTMB’s Hospitals' standards. Although these duties may be delegated to other members of the investigative team, primary responsibility remains with the investigator. All physicians designated to write orders or admit patients must be clearly listed on the project protocol. The hospital record is to be kept in the same detail and with the same standards of excellence as that of any other patient. All patients admitted directly to the unit must have a complete working History and Physical in the record, within 24 hours of admission, and patients transferred from other services to the UTMB GCRC must have the appropriate transfer notes in the records.

When a patient is discharged from or transferred to another service, the investigator is responsible for the discharge summary and for signing the record. In addition to the usual information concerning the patient, the discharge summary must include the purpose of the study, the reasons for the inclusion of the particular patient, the procedures and investigations performed, the results of the study, if available, and any future plans which involve the patient.

Twenty-four hour, seven-day-a-week coverage for the clinical care of the patient must be provided by the investigator or his/her designee and the nursing staff must know whom to call at all times for the purpose of patient care.

Progress Reports:

Annually, investigators are expected to provide a listing of all presentations and publications relating wholly or partially to their UTMB GCRC research. Information on grant and contract funding (federal and non-federal) and highlights of their scientific research findings from the projects utilizing the UTMB GCRC resources are collected by the GCRC and submitted to the NIH for review. Publications, abstracts or presentations of research which utilize resources in any way must be asterisked. These will be included in the GCRC Annual Report.