Question

HIPAA's relatively new data-focused protections, which took effect starting in 2003, supplement Common Rule and FDA protections; they are not a replacement. Institutional Review Board (IRB) protocol reviews using Common Rule and FDA criteria remain as before, including aspects related to data protection. IRBs may have the responsibility for addressing HIPAA's additional requirements in their reviews when those apply; or some responsibilities may be given to another kind of body that HIPAA permits (a Privacy Board) or to an institutional official that HIPAA requires (a privacy officer). These federal standards complement states' and accreditation bodies' requirements.

a) True
b) False

Answer 1

HIPAA's data protections supplement the Common Rule and FDA protections and are not replacements, requiring IRBs or other bodies to consider additional HIPAA requirements during reviews.

Step-by-step explanation:

The statement that HIPAA's data-focused protections, which started in 2003, supplement but do not replace Common Rule and FDA protections is true. These protections require that Institutional Review Boards (IRBs) or other designated bodies such as a Privacy Board or a privacy officer to address HIPAA requirements in their reviews. The IRB reviews research proposals to ensure that they are ethical and protect the safety and privacy of human participants in accordance with federal regulations, which complement state laws and accreditation requirements.