What are the reporting requirements for screening tests?

Certain clinical tests, such as for HIV infection, may have State requirements regarding:

• the information that must be provided to the participant,
• which organizations have access to the test results, and
• whether a positive result has to be reported to the health department.

Prospective subjects should be informed of any such requirements and how an unfavorable test result could affect employment or insurance before the test is conducted. The IRB may wish to confirm that such tests are required by the protocol of the study.

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