The clinical trials informed consent includes:

• The reason for the clinical study
• Who is eligible to take part in the clinical study
• What is known about the study treatment
• Possible risks and benefits to study participation
• Other treatment options for the specific cancer
• The design of the clinical trial
• The type and frequency of required tests and visits to the doctor
• Responsibility for the costs of the study
• Responsibility for the costs if a patient needs care as a result of the clinical trial
• Who will have access to the patient’s medical record and what will be done to protect the privacy of that record
• Patients rights in the study
• Contact information for both the principle investigator, the clinical trials research nurse, and the Sandhills Multi-Institutional Review Board

The clinical trials research nurse will review the informed consent with the patient as well as explain the study’s purpose, procedures, risks and benefits so that the patient understands the plan and can decide whether to participate.

Patients are welcome to take the informed consent home to discuss with friends or family members. If the patient decides to participate in the clinical trial, he or she signs the informed consent form as well as the HIPPA form. This form releases the physician and hospital to provide required medical information to the statistical and medical functions of the study organizers.

The Clinical Trials Office of FirstHealth Moore Regional Hospital and the Sandhills Multi-Institutional Review Board try to keep personal medical information private. The Food and Drug Administration and the sponsors of the clinical studies will review your medical record to collect data and to see that the research is being done safely and correctly.

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