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Federal and State Regulations

Federal Regulations


Organizational Chart of Federal Agencies/Offices Dealing with Human Subjects Protections
 

Federalwide Assurance

The Federal Policy 45 CFR 46 (Common Rule) for the protection of human subjects requires that each institution "engaged" in Federally-supported human subject research file an Assurance with the Office of Human Research Protections (OHRP). The Assurance formalizes the institution's commitment to protect human subjects. LMU's Federalwide Assurance (FWA# 4212) was approved February 8, 2008 and remains in effect until February 14, 2014.

 

Department of Health and Human Services (DHHS)

45 Code of Federal Regulations (CFR) Part 46 (aka "The Common Rule") 
• Subpart A:  General Categories 
Exempt Research Categories 
Expedited Review Categories 

Criteria for IRB Approval of Research 
General Requirements for Informed Consent 
Waiver of Elements of Informed Consent 
Waiver of Documentation of Informed Consent 

• Subpart B:  Pregnant Women, Human Fetuses & Neonates 
• Subpart C:  Prisoners in Biomedical and Behavioral Research 
• Subpart D:  Children as Research Subjects 

US Department of Education

State Regulations

California Legislative Information regarding research with human subjects. 
The following California Statutes apply to human subjects research activities.

CA Health and Safety Code

Protection of Human Subjects in Medical Experimentation Act (Sections 24170–24179.5):  Describes the informed consent process and requires that the "Experimental Subject's Bill of Rights" be provided to all research subjects in medical experiments.

Human Cloning (Sections 24185-24187):  No person shall clone a human being or engage in human reproductive cloning; no person shall purchase or sell an ovum, zygote, embryo, or fetus for the purpose of cloning a human being. 

Use of State Death Data Records (Sections 102231–102232):  IRB review is required for research using California-produced death data files containing personal identifying information (i.e., state issued death certificates and indices.) 

Experimental Use of Drugs and Consent for Minors Provision (Sections 111515–111545):  Minor consent is required prior to administering an experimental drug. Parental or legal guardian consent (permission) is required and minor consent (assent) is required for children 7 years of age or under.

Use of Opioid, Stimulant and Hallucinogenic Drugs in Research (Sections 11480-11481):  Proposed research projects involving certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II Controlled Substances, are to be reviewed and authorized by the Research Advisory Panel of California in the Attorney General’s Office.

Communicable Disease Prevention and Control Act (Sections 120500-120605):  Healthcare providers who diagnose or treat patients for venereal diseases (i.e. syphilis, gonorrhea, etc.) must report such cases to the CA Department of Health Services. 
Confidentiality of Research Records involving AIDS Patients (Sections 121075–121125):  Identifiable research records involving AIDS patients are confidential and may not be disclosed, except as provided in this statute.

Abortions and Use of Fetal Material (Sections 123420-123450):  Except in a medical emergency requiring immediate medical action, no abortion shall be performed upon a minor unless she first has given her written consent (assent) to the abortion and also has obtained the written consent (permission) of one of her parents or legal guardian.

Embryos for Research (Sections 124320-125300):  A physician and surgeon or other health care provider delivering fertility treatment shall provide his or her patient with timely, relevant, and appropriate information to allow the individual to make an informed and voluntary choice regarding the disposition of any human embryos remaining following the fertility treatment; covers consent requirements for donation of embryos for research.

Confidentiality of Records involving Hereditary Disorders (Section 124980):  All testing results and personal information from hereditary disorders programs obtained from any individual, or from specimens from any individual, shall be held confidential and be considered a confidential medical record except for information that the individual, parent, or guardian consents to be released. Data compiled for research purposes without reference to the identity of any individual requires IRB review and approval with a waiver of consent.

Assisted Oocyte Production (Sections 125330-125355):  Prior to obtaining informed consent from a subject for assisted oocyte production or any alternative method of ovarian retrieval on a subject for the purpose of procuring oocytes for research or the development of medical therapies, a physician and surgeon shall provide to the subject a standardized medically accurate written summary of health and consumer issues associated with AOP and any alternative methods of oocyte retrieval.

CA Civil Code

Committee for the Protection of Human Subjects (CPHS) of the California Health and Human Services Agency (CHHSA) and the California Information Practices Act, Civil Code, Section 1798.24 (SB 13):  For identifiable LMU data sent to Data Repositories under California Civil Code 1798.24, the Lead Researcher is responsible for complying with all applicable federal and state laws regarding the confidentiality of information (such as the California Information Practices Act).

Research funded by CHHSA or any of its departments must be sent to the CHHSA Committee for the Protection of Human Subjects for review. The CPHS serves as the IRB for the CHHSA. The CHHSA CPHS must also review when identifiable data held by LMU will be released or when identifiable data will be received from another state agency. Unless subjects have provided Informed Consent no more than 30 days before the disclosure, or in the time limit specified in the informed consent document, or another exception exists as outlined in the law, the release of identifiable information to or by LMU requires review by the CPHS of the CHHSA.

CA Family Code

Minor Consent (Sections 6920-6929):  Describes when minors may consent for themselves.
 
 Emancipated Minors (Sections 7000-7002; 7050-7052; 7110-7111; 7120-7123; 7130-7135; 7140-7143):  Defines an emancipated minor and rights of emancipated minors.

CA Welfare and Institutions Code

Elder Abuse and Dependent Adult Civil Protection Act (Sections 15600-15601; 15610-15610.65; 15630-15632; 15633-15637): Reporting of known or suspected cases of abuse of elders and dependent adults; defines mandatory and non-mandatory reporters.

CA Penal Code

Behavioral and Biomedical Research; Prisoners’ Rights as Research Subjects (Sections 3500; 3501-3509.5; 3515-3520; 3521-3523): Describes provisions and prohibitions for research, and the informed consent requirements for prisoners.

Child Abuse and Neglect Reporting Act (Sections 11164-11174.3): Reporting of known or suspected cases of abuse or neglected children; defines mandated reporters.

CA Education Code

Parental Consent for Children to Participate in Research (Section 51513): For K-12 students - tests, questionnaires, surveys, or examinations containing any questions about the pupil's or the pupil’s family’s personal beliefs or practices in sex, family life, morality, and religion require written parental consent (permission).