Why is a signed informed consent form recommended for SARS-CoV testing?

A signed consent form is recommended because neither the RT-PCR test nor the EIA test has been licensed by FDA and the RT-PCR test is being used under an FDA-approved investigational device exemption (IDE). In addition, consent is required to store specimen remainders for future investigations. Why are there two different consent forms, one for RT-PCR and one for EIA?

Two forms are required because of differing IRB review requirements; CDC’s IRB reviewed and approved two separate protocols. What happens if I submit specimens for testing without a signed consent form? Because of the potentially serious public health impact of SARS-CoV transmission, specimens that are received by a state or local public health laboratory without a signed consent form will still be tested.

What is the patient information sheet, and when do I use it? The patient information sheet/consent for long-term specimen storage will be sent to the physician along with the patient’s test results. The physician ... more.

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