If information about the subject’s participation will be included as part of the VHA medical record that information must be given to the prospective subject as part of the informed consent process that information regarding study participation will be included in the medical record.

In instances where a written informed consent form is used, inclusion of a statement that the study has been issued a CoC is required.

Investigators should work with the research office in their facility to assure that when Veterans are enrolled in a study protected by a Certificate of Confidentiality, they are not simultaneously enrolled in other interventional studies unless it is absolutely clear that this enrollment does not raise safety issues.