SECTIONS 111515-111545 - California Statutes

HEALTH AND SAFETY CODE

SECTION 111515-111545

111515. As used in this article, "experimental drug" means any of
the following:
A drug intended for investigational use under Section 111595.

111520. No person shall prescribe or knowingly administer an
experimental drug to another person in violation of this article.

111525. Prior to prescribing or administering an experimental drug,
consent to the use of the drug shall be obtained in the method and
manner specified in Chapter 1.3 (commencing with Section 24170) of
Division 20.

111530. (a) Notwithstanding the provisions of Section 24175, if the
subject is a minor, consent shall be provided by a parent or
guardian of the subject and shall also be provided by the subject if
the subject is seven years of age or older.
(b) Consent given pursuant to this section shall only be for the
prescribing or administering of an experimental drug that is related
to maintaining or improving the health of the subject or related to
obtaining information about a pathological condition of the subject.

111535. Consent given pursuant to Section 111525 may be revoked at
any time by either verbal or written communication to the
practitioner supervising the administration of the experimental drug.

111540. Prior to administering an experimental drug, the
experimental activity as a whole, including the consent procedures
required by Section 111525, shall be reviewed and approved by a
committee for the protection of human subjects that is acceptable, as
determined by the department. A committee for the protection of
human subjects that operates under a general or special assurance
approved by the federal Department of Health, Education, and Welfare
pursuant to Part 46 of Title 45 of the Code of Federal Regulations
shall be an acceptable committee for purposes of this section. A copy
of the consent procedures approved by a committee for the protection
of human subjects shall be filed with the department prior to the
commencement of the experiment.

111545. A person having an ownership interest in a skilled nursing
facility or intermediate care facility, as those terms are defined in
Section 1250, may not prescribe an experimental drug for a patient
in the facility.