StATS: Withholding Personal Health Information from a patient (June 20, 2006)

An interesting discussion on the IRBForum related to a statement in an informed consent document that informed the patient that PHI (Personal Health Information) would be withheld from the patient during the course of the research study. This comment was apparently based on 45 CFR 164.524(a)(2)(iii)

An individual's access to protected health information created or obtained by a covered health care provider in the course of research that includes treatment may be temporarily suspended for as long as the research is in progress, provided that the individual has agreed to the denial of access when consenting to participate in the research that includes treatment, and the covered health care provider has informed the individual that the right of access will be reinstated upon completion of the research.

A couple of people pointed out that the PHI being withheld was only information specific to the research study. If you did not withhold this information, you would lose the benefits of blinding.

There probably needs to be some common sense exceptions. If a patient has to undergo an emergency operation unrelated to the research study, then perhaps some of the PHI relating to the research study might be needed (e.g., was the drug being given a placebo or the active drug which has a known tendency to reduce clotting).

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Privacy in research.