Question

HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization—or with a waiver, alteration, or exception determination from an IRB or Privacy Board. However, remember that you generally cannot proceed on your own without some approval from an IRB, Privacy Board, or other designated governing entity.

a) True
b) False

Answer 1

The statement is true. HHS guidelines state that patient authorization or approval from an IRB or Privacy Board is required for the use or disclosure of PHI in retrospective research studies. It is generally necessary to obtain approval from an IRB, Privacy Board, or other governing entity before proceeding.

Step-by-step explanation:

True. The U.S. Department of Health and Human Services (HHS) requires that the use or disclosure of Protected Health Information (PHI) for retrospective research studies can only be done with patient authorization or with a waiver, alteration, or exception determination from an Institutional Review Board (IRB) or Privacy Board. It is generally not allowed to proceed with retrospective research studies without some approval from an IRB, Privacy Board, or other governing entity.