Unit
- Historical context: The Nuremberg Code of 1947 arose from Nazi experimentation, establishing the principle of voluntary consent in human subjects research. This foundational document mandated that participants must be fully informed of risks and benefits and freely agree to participation without coercion.
- Declaration of Helsinki: Adopted by the World Medical Association in 1964, this set of ethical principles expanded on the Nuremberg Code by requiring review by an independent committee for all human research. It emphasized the primacy of participant well-being over societal benefit.
- Belmont Report: Published in 1979 by the U.S. National Commission, the report identified three core principles: respect for persons (autonomy), beneficence (maximize benefits and minimize harms), and justice (fair distribution of research burdens and benefits). These principles guide IRB review today.
- Tuskegee Syphilis Study: This infamous study (1932-1972) involved observing untreated syphilis in African American men without their informed consent, leading to severe harm. Its exposure catalyzed the U.S. National Research Act of 1974, which established the IRB system.
- Common Rule: The Federal Policy for the Protection of Human Subjects (the Common Rule) was adopted by multiple U.S. agencies in 1991, standardizing requirements for IRB review, informed consent, and documentation across federally funded research.
- Role of the IRB: An IRB is an independent review body that evaluates research protocols to ensure ethical standards and regulatory compliance before studies commence. It protects participant rights, safety, and welfare through prospective review and ongoing oversight.
- Key milestones: Between 1974 and 2000, regulatory refinements included the addition of vulnerable population protections (children, prisoners, pregnant women) and expanded definitions of minimal risk. These changes aimed to close gaps in participant safety.
- International impact: The principles and structures of U.S. IRB regulations have influenced research ethics frameworks globally, including the International Conference on Harmonisation Good Clinical Practice (ICH GCP) and national guidelines in many countries.
- Vulnerable populations: Federal regulations mandate additional safeguards for vulnerable populations, including children, prisoners, pregnant women, neonates, and individuals with cognitive impairments. These protections often require parental permission, participant assent, and justification for including these groups, ensuring that their rights and welfare are specially safeguarded throughout the research lifecycle.
- Informed consent process: The informed consent process is foundational to ethical research and is a process, not merely a document. It involves providing potential subjects with comprehensible information about the research purpose, procedures, risks, benefits, and alternatives, allowing adequate time for questions and discussion to ensure understanding and voluntary participation.
- Expedited review: This streamlined review mechanism applies to research that presents no more than minimal risk and fits specific regulatory categories, such as blood collection or noninvasive imaging. Conducted by the IRB chair or a designated experienced reviewer, it allows efficient approval without requiring a meeting of the full board.
- Continuing review: IRBs conduct continuing review at intervals determined by the board, at least annually, to ensure active protocols remain compliant with ethical standards and regulations. The review evaluates progress reports, adverse events, and protocol modifications, verifying that the research continues to adequately protect participant rights and welfare.
Scope of Practice
Role: IRB Administrator
Within scope:
- Facilitating initial review assignments based on risk level and reviewer expertise.
- Maintaining minutes, correspondence, and records of IRB meetings and decisions.
- Guiding investigators on submission procedures and regulatory documentation.
Outside scope:
- Making independent ethical determinations on research protocols.
- Interpreting clinical data or medical outcomes to assess risks.
- Approving protocol modifications without full board consultation.
Terminology
- Human subject
- A living individual about whom an investigator obtains data
Quick Revision
- Review the key concepts covered in The Birth of Bioethics and the IRB System.
- Apply these principles in practical working contexts.
- Connect this material to the wider module objectives.