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What are the reporting requirements for screening tests?

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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

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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