APPENDIX D
Human Subject Research Policy For Medical Experiments: California Requirements
Certain medical experiments are subject to California's Protection of Human Subjects in Medical Experimentation Act (California Health and Safety Code § 24170 et seq.).
This Act applies if the proposed experiment involves:
1.The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of such subject or otherwise directly benefiting such subject;
2.The investigational use of a drug or device;
3.Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of such subject.
If the experiment falls within one of these categories, the following additional requirements must be satisfied:
1.The subject must be provided with an Experimental Subject's Bill of Rights (see attached);
2.The subject (or appropriate conservator/guardian) must provide written, dated, informed consent:
- The consent form must be in a language in which the subject (or appropriate conservator/guardian) is fluent;
- The consent form pursuant to California Health & Safety Code §§ 2412724175 is similar to the general consent form for research on human subjects. However, California statute requires that the following statement be included on the form:
"I have received a copy ofthe Experimental Subject's Bill of Rights which I have read and understand."
- See attached draft consent form listing information which must be provided to all potential subjects.
- Who may give informed consent?
- The person to be subjected to the medical experiment may give informed consent.
- If the medical experiment is related to maintaining or improving the health of the human subject or related to obtaining information about a pathological condition of the human subject then the following may give informed consent:
If a person is under a conservatorship of the person or of the person and estate, informed consent for a medical experiment involving such person shall be obtained:
1.As provided in § 2354 of the Probate Code if the person has not been adjudicated to lack the capacity to give informed consent for medical treatment.
2.As provided in § 2355 of the Probate Code if the person has been adjudicated to lack the capacity to give informed consent for medical treatment.