Ethical Guidelines, Federal Regulations and State Statutes
Developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II, the code was the first major international document to provide guidelines on research ethics. It made voluntary consent a requirement in clinical research studies, emphasizing that consent can be voluntary only if participants are able to consent; they are free from coercion (i.e., outside pressure); and they comprehend the risks and benefits involved. The code also states that researchers should minimize risk and harm, make sure risks do not significantly outweigh potential benefits, use appropriate study designs and guarantee participants′ freedom to withdraw at any time.
At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction between medical care that directly benefits the patient and research that might -- or might not -- provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo), 1983 (Venice), 1989 (Hong Kong), 1996 (Somerset West, Republic of South Africa) and 2000 (Edinburgh).
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research: respect for persons, beneficence and justice. The Belmont Report explains how these principles apply to research practices. In response to the report, both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration revised their regulations on research studies that involve people.
Federalwide Assurance - The federal policy (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. The assurance formalizes the institution's commitment to protect human subjects. UC Merced's Federalwide Assurance number is 00005105. It remains in effect unless otherwise notified. Click on the link above for the current FWA expiration date.
- 21 CFR Part 50 Human Subjects Protections (informed consent) and Additional Safeguards for Children in Clinical Investigations describes the informed-consent requirements that apply to all clinical investigations regulated by the FDA under the Federal Food, Drug and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including drugs for human use, medical devices for human use, biological products for human use and electronic products.
- 21 CFR Part 56 Institutional Review Boards contains the general standards for the composition operation, and responsibility of an institutional review board (IRB) that reviews clinical investigations regulated by the FDA, as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including drugs for human use, medical devices for human use, biological products for human use and electronic products.
- 21 CFR Part 312 Investigational New Drug Application contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the FDA of investigational new drug applications (INDs). An IND exempts an investigational drug from the premarketing-approval requirements that are otherwise applicable, and allows lawful shipment for the purpose of conducting clinical investigations of that drug.
- 21 CFR Part 812 Investigational Device Exemptions provides procedures for the conduct of clinical investigations of devices. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.
California Legislative Information – search for California legislation regarding research with human subjects.
The following California Statutes apply to human subjects research activities.
California Health and Safety Code
- 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.
- The 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. This chapter also describes the hierarchy of surrogate decision makers who are able to provide informed consent for individuals who are unable to consent in emergency room and non-emergency room environments.
- 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 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 before administering any experimental drug. Parental or legal guardian consent (permission) is required and minor consent (assent) is required for children 7 years old or older.
- Communicable Disease Prevention and Control Act (sections 120500-120605): Healthcare providers who diagnose or treat patients for venereal diseases (i.e., syphilis, gonorrhea, chancroid, lymphopathia venereum, granuloma inguinale and chlamydia) must report such cases to the California 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.
- 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.
- Embryos for Research (sections 124320-125300): A physician and surgeon or other healthcare provider delivering fertility treatment shall provide his or her patient with timely, relevant and appropriate information to allow the patient 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.
- Assisted Oocyte Production (sections 125330-125355): Before 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.
California 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.
California Welfare and Institution 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.
California 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.
California 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).
OTHER USEFUL REFERENCES
- National Institutes of Health (NIH)
- Guidelines On Women And Minorities as Subjects in Clinical Research
- Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page
- Inclusion of Children as Participants in Research – Policy Implementation
- Office for Civil Rights (OCR)
- HIPAA – National Standards to Protect the Privacy of Personal Health Information
- ICH Good Clinical Practices (GCP): This is a link to the FDA division responsible for overseeing Good Clinical Practice (GCP). GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
- International Conference on Harmonisation (ICH): This website offers access to all guidance documents produced by ICH.
- Council For International Organizations of Medical Sciences: The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernment, nonprofit organization established jointly by WHO and UNESCO in 1949.
- World Medical Association: The World Medical Association (WMA) is an international organization representing physicians. The organization was created to ensure the independence of physicians, and to work for the highest possible standards of ethical behavior and care by physicians, at all times.