These sealed envelopes, in addition to the aforementioned information, MUST have the university's name, the PI's name, the protocol number and title, and MUST be marked CONFIDENTIAL.

Should the need arise to notify research subjects of additional information that has come to light about the study drug or device, the CPHS must approve the mechanism for such notification and specifically require that it be channeled through the original PI or the patient's attending physician.

This procedure has been used successfully in the past and preserves the confidentiality of the subject/patient as well as the relationship between the physician/investigator and the subject/patient.