Ethical Guidelines, Regulations and Statutes

Ethical Guidelines

 

Nuremberg Code

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 that risks do not significantly outweigh potential benefits, use appropriate study designs, and guarantee participants′ freedom to withdraw at any time.

Declaration of Helsinki

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 may or may not provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo, Japan), 1983 (Venice, Italy), 1989 (Hong Kong), 1996 (Somerset West, Republic of South Africa) and 2000 (Edinburgh, Scotland).

Belmont Report

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.

UCI agrees to uphold the ethical principles of the Belmont Report. UCI will apply DHHS regulations to all federally-funded proposed research involving human participants. Commensurate protections are in place for all other human subject research conducted at or under the jurisdiction of UCI.

Federal Regulations

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. UCI's Federalwide Assurance (FWA# 00004071) was approved on January 31, 2003 and remains in effect unless otherwise notified.

IRBs reviewing clinical investigations involving Food and Drug Administration (FDA) regulated products are required to register with the FDA. The FDA requirement operates in coordination with the Office for Human Research Protections (OHRP), which already requires registration of IRBs reviewing federally-supported research. IRB registration does not represent accreditation or certification by the FDA or OHRP. The agencies do not provide certificates confirming IRB registration. UCI's Institutional Review Boards (IRBs) are registered with the FDA in compliance with this new rule. UCI's IRB Organization Number is IORG 0000236. See the IRB Roster Listings to view each IRB's registration number and the list of IRB members.

Office of Human Research Protection (OHRP)

  • 45 CFR Part 46 (aka "The Common Rule")
    Revised in 2018, this is the basic Health and Human Services (HHS) policy for the protection of human subjects - required for all federally funded proposed research involving human participants. Commensurate protections are in place for all other human subject research conducted at or under the jurisdiction of UCI.

Food and Drug Administration (FDA)

  • 21 CFR Part 50 Human Subjects Protections (Informed Consent) and Additional Safeguards for Children in Clinical Investigations
    This part 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 Food and Drug Administration, 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
    This part contains the general standards for the composition operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration 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
    This part 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
    This part 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.

International Research Considerations

  • OHRP Compilation of International Issues
  • 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, non–government, non–profit 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.
  • International Association of Bioethics
    The International Association of Bioethics aims to be truly international, linking all those working in bioethics and related fields, facilitating mutual contacts, and encouraging the discussion of cross–cultural aspects of bioethics.