Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

Overview

The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes. Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent. ...

Background: Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment. Objectives: Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols. Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values. Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions. Eligibility: Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP. Design: This protocol is not a research study of an investigational drug or device. Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols. In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions. Tissues and biological fluids that are obtained during the screening process will be stored. Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.