What is required for disclosures of PHI for research purposes?

For disclosures of Protected Health Information (PHI) for research purposes, it is necessary to have either informed consent from the individual or a waiver of authorization granted by an Institutional Review Board (IRB). Informed consent ensures that individuals understand the nature of the research, what their participation involves, and how their information will be used. This helps safeguard the rights and privacy of participants.

Alternatively, if obtaining informed consent is not feasible or could impede the research, the IRB can grant a waiver of authorization. The IRB evaluates the research's ethical implications and decides whether the potential benefits justify the need for using PHI without individual consent, ensuring that the rights of the individuals involved are still protected.

Other options do not meet the legal and ethical standards set forth by HIPAA regulations regarding research. Since family consent, verbal agreement, or public disclosure documents do not sufficiently protect individual privacy or ensure that individuals are fully informed about the use of their data, they are not adequate substitutes for the informed consent or IRB waiver necessary for disclosing PHI in research settings.