While a clinical trial is research, it is also health care as defined in § 160.103, and the information generated in the course of the trial would be protected health information. In § 164.514(b)(iv), we are proposing that a researcher/provider could deny a request for inspection and copying of the clinical trial record if the trial is still in progress, and the subject-patient had agreed to the denial of access in conjunction with the subject’s consent to participate in the trial. The IRB or privacy board would determine whether such waiver of access to information is appropriate, as part of its review of the research protocol. In the rare instances in which individuals are enrolled in trials without consent (such as those permitted under FDA regulations, at 21 CFR 50.23), the covered entity could deny access to information during the course of the trial even without advance subject consent.
Clinical trials are often masked – the subjects do not know the identity of the medication they are taking, or of other elements of their record while the trial is in progress. The research design precludes their seeing their own records and continuing in the trial. Thus it is appropriate for the patient to waive the right to see the record while the trial is in progress. This understanding would be an element of the patient's consent to participate in the trial; if the consent signed by the patient did not include this fact, the patient would have the normal right to see the record. In all cases, the subject would have the right to see the record after the trial is completed.
As with all grounds for denial of access, denial would not be required under these circumstances. We would expect all researchers to maintain a high level of ethical consideration for the welfare of trial participants and provide access where appropriate. For example, if a participant has a severe adverse reaction, disclosure of information during the course of the trial may be necessary to give the participant adequate information for proper treatment decisions.