This section establishes the title of the chapter as the 'Protection of Human Subjects in Medical Experimentation Act.' It essentially names the act, setting the groundwork for rules and protections concerning people involved in medical experiments.

This section emphasizes that while medical experimentation on humans is crucial for progress, it must be conducted with respect for human life and the individual's right to control their body. It acknowledges influential ethical guidelines like the Nuremberg Code and the Declaration of Helsinki, which are not legally enforceable. The law highlights the necessity of safeguarding the rights of research participants against unauthorized or harmful experiments.

The aim is to establish minimum legal protections for individuals in California involved in medical research and to impose penalties on those who violate these protections.

This law outlines the rights of people participating in medical experiments, known as the 'experimental subject’s bill of rights.' Participants must be informed of the experiment’s purpose and procedures, any risks and discomforts, and potential benefits. They should also know about alternative procedures and post-experiment treatments. Individuals are entitled to ask questions, withdraw consent at any time, and receive a signed consent form. Consent must be given freely, without pressure or deceit.

This law defines "informed consent" as permission given for a medical experiment after meeting several requirements. These include providing the experimental subject's bill of rights, a signed consent form, and thorough information about the experiment's details, risks, and benefits. The subject must be fully informed in a language they understand and know they can withdraw at any time without repercussions. The information must also cover who is conducting the experiment, who funds it, and any significant financial interests involved. Consent must be freely given without any pressure or deceit.

This section defines what qualifies as a "medical experiment" under the law. It includes any procedure that involves cutting, penetrating, or damaging human tissues, using drugs, devices, radiation, heat, cold, or biological substances, which isn't meant to benefit the individual’s health. It also covers testing unapproved drugs or devices and withholding medical treatment unless it's for the person's health benefit.

This law states that you must get informed consent from a person before they can be part of a medical experiment. If the person is under a conservatorship, the consent process depends on whether they have been deemed able to make medical decisions for themselves. This is explained in sections of the Probate Code. If the person has a conservator, sometimes the conservator can give consent instead.

For adults who are gravely disabled and under a conservatorship, they must give consent themselves unless their conservator is authorized to make medical decisions for them, as stated in certain sections of the Welfare and Institutions Code. For adults with developmental disabilities who can't give consent and don't have a conservator, consent must be obtained as per the Welfare and Institutions Code guidelines.

Additionally, when someone other than the person themselves gives consent, it must be for experiments that improve health or provide information about medical conditions.

This law outlines the responsibilities and liabilities of those conducting medical experiments in California, particularly around obtaining informed consent from participants. If a person negligently fails to secure informed consent, they may owe up to $10,000 in damages, with a minimum of $500. Willful failure to obtain consent can result in up to $25,000 in damages, with a minimum of $1,000. If this willful failure exposes a participant to serious risk, it can lead to misdemeanor charges with potential jail time or fines up to $50,000. Pharmaceutical company representatives who knowingly conceal risks can also face similar punishments. Each violation of these rules is treated as a separate offense. Attempts to waive these rights are void, and this law does not restrict other modes of legal recovery for damages.

This law states that the rules in this chapter are to be used alongside, not replace, the existing rules found in two other parts of California law. These parts include certain sections of health and safety regulations and part of the penal code related to the management of hazardous substances or similar issues.

This law explains when medical experimental treatments that might benefit patients in life-threatening emergencies can bypass certain regulations. It applies only if several strict conditions are met. These conditions include following federal safety procedures, recognizing the emergency nature of the condition, and acknowledging that the patient cannot give consent due to their condition. The law also requires attempts to contact a legally authorized representative for consent. Moreover, scientific studies supporting the treatment's potential benefits must exist, and an institutional review board must approve consent procedures. Finally, community consultation and transparent communication about the research are necessary, along with oversight by an independent committee.

The law clarifies these exceptions without exempting any party from other legal obligations, like acting responsibly and without negligence.

This section outlines exceptions and requirements for conducting medical experiments involving participants with cognitive impairments or serious conditions. It specifies when informed consent is needed, especially if participants can't consent themselves. In such cases, a surrogate decisionmaker, like a spouse or adult child, can provide consent, following a specific priority order. If multiple surrogates exist, anyone's refusal to consent prevails. In an emergency room, similar rules apply but with fewer surrogate options. Surrogate decisions must consider the participant's wishes or best interests. Consent providers cannot be financially compensated, and federal rules on informed consent must be followed.

This law states that the rules in this chapter don't apply when a pharmacist gives out medication based on a doctor's prescription.

This law states that if an adult is in a terminal condition and has created a directive to withhold or withdraw life-sustaining treatments, this chapter does not apply to them. Furthermore, if there is any conflict, the Probate Code's rules on the matter will take precedence over this chapter.