Committee for the Protection of Human Subjects.

(a)

To access confidential data under Section 97394 or 97398, it is required that the Committee for the Protection of Human Subjects approve the data applicant's project pursuant to subdivision (t) of Section 1798.24 of the Civil Code.

(b)

The applicant may seek the approval of the Committee for the Protection of Human Subjects before or concurrently with its data application to the Department.