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HomeHealth and Safety CodeDiv. 104Pt. 5Ch. 6Art. 4§ 111540 Committee Approval Required

§ 111540 Committee Approval Required

Health and Safety Code·California
AI Summary·Official Text·Key Terms·Related Statutes·References
AI SummaryVerified

§ 111540 Committee Approval Required

Key Takeaways

  • •Before giving someone an experimental drug, a special group must check and approve the whole experiment, including how they ask for permission.
  • •This special group must be approved by the government to make sure they do a good job protecting people.
  • •The way they ask for permission must be sent to the department before the experiment starts.

Example

A doctor wants to test a new medicine on people to see if it helps with headaches.

Before the doctor can start, a group of people who know about keeping patients safe must look at the plan. They check how the doctor will ask people if they want to try the new medicine. If the group says it’s okay, the doctor can start the test. The doctor must also send a copy of how they asked for permission to the government.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source
View on CA.gov

§ 111540 Committee Approval Required

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. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

Last verified: January 23, 2026

Key Terms

experimental drugconsent procedurescommittee for the protection of human subjectsfederal Department of Health, Education, and Welfare

Related Statutes

  • § 111515 Experimental Drug Definition
  • § 111520 Experimental Drug Restrictions
  • § 111525 Experimental Drug Consent
  • § 111530 Minor Experimental Drug Consent
  • § 111535 Revoking Experimental Drug Consent

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Health and Safety Code. Section 111540.
View Official Source