NRPM: Standards for Privacy of Individually Identifiable Health Information. ii. Individual access to research information.

11/03/1999

The provisions of § 164.514 of this proposed rule, regarding individual access to records, would also apply where the research includes the delivery of health care. We are proposing an exception for clinical trials where the information was obtained by a covered provider in the course of a clinical trial, the individual has agreed to the denial of access when consenting to participate in the trial (if the individual’s consent to participate was obtained), and the trial is in still in progress.