An Institutional Review Board (IRB) is a committee formally designated to review and monitor research involving human subjects. Its purpose is to protect the rights and welfare of individuals who participate in research studies. IRBs ensure that research is conducted ethically, adhering to established guidelines and regulations. This oversight helps maintain public trust in scientific endeavors and safeguards participants from potential harm.
The Ethical Catalyst: From Atrocities to Awareness
The necessity for formal ethical oversight in human research emerged from historical instances of severe misconduct. Following World War II, the Nuremberg Medical Trials exposed horrific experiments conducted by Nazi physicians on concentration camp prisoners. These trials highlighted a profound disregard for human dignity and the absence of consent. The verdict in 1947 led to the creation of the Nuremberg Code, a foundational document outlining ten principles for ethical human experimentation.
The Nuremberg Code emphasized voluntary informed consent, meaning participants must freely agree to participate after understanding the research. It stipulated that experiments should yield fruitful results for society, avoid unnecessary suffering, and be conducted by qualified individuals. The Code further established that the degree of risk should never exceed humanitarian importance, and participants should be able to withdraw at any time. These principles marked a shift towards valuing the autonomy and well-being of research subjects.
Decades later, revelations of the Tuskegee Syphilis Study in the United States further underscored the need for ethical safeguards. This study, conducted by the U.S. Public Health Service from 1932 to 1972, involved 600 impoverished African-American men, 399 of whom had latent syphilis. Researchers observed the natural progression of untreated syphilis, deliberately withholding effective treatment, even after penicillin became widely available in the late 1940s. Participants were not informed of their diagnosis and were misled about the study, which resulted in severe health complications, transmissions to wives, and congenital syphilis in children. The study’s exposure in 1972 sparked public outrage and highlighted a breach of ethical standards, particularly regarding informed consent and the protection of vulnerable populations.
Laying the Groundwork: Key Principles and Reports
The global medical community began formalizing ethical guidelines in response to past abuses, leading to influential documents that shaped modern human subject protection.
The World Medical Association adopted the Declaration of Helsinki in 1964, a statement of ethical principles for medical research involving human participants. This declaration is regarded as a foundational document in human research ethics. It emphasizes that the well-being of the individual research participant must take precedence over the interests of science and society.
A revision in 1975 expanded the Declaration of Helsinki to include the requirement for oversight by an independent committee. These international guidelines underscored the growing consensus that research protocols needed external, impartial review.
In the United States, direct legislative action followed the exposure of the Tuskegee study. The National Research Act of 1974 was enacted, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This Commission was tasked with identifying ethical principles for human subject research and developing guidelines to ensure ethical conduct. The Act mandated that institutions receiving federal research funds establish Institutional Review Boards (IRBs) to review human subjects research.
The Commission’s work culminated in the Belmont Report, published in 1979. This report articulated three core ethical principles for human subject research: Respect for Persons, Beneficence, and Justice.
Respect for Persons acknowledges individual autonomy and the need to protect those with diminished autonomy, emphasizing voluntary informed consent. Beneficence requires researchers to maximize benefits and minimize potential harms to participants. Justice ensures that the burdens and benefits of research are distributed fairly across populations, preventing the exploitation of vulnerable groups. These principles became the ethical foundation for all subsequent U.S. regulations concerning human subject protection.
The Birth of the IRB System
While ethical considerations for human experimentation existed in earlier forms, the formal establishment and widespread mandate of Institutional Review Boards occurred in the mid-1970s in the United States. The passage of the National Research Act in July 1974 marked the legislative turning point. This Act specifically required institutions seeking federal funding for biomedical or behavioral research involving human subjects to establish an IRB. This statutory requirement cemented the IRB’s role as an oversight body.
Prior to this, some institutions had required review panels for clinical research projects. However, these early requirements were not consistently enforced or universally applied. The National Research Act formalized and expanded these review processes, making them a legal prerequisite for federally funded research.
Following the Act, regulations for the protection of human subjects were published in 1974 by the Department of Health, Education, and Welfare. These regulations explicitly introduced the term “institutional review board” and established specific procedures for their review. Subpart A, often referred to as “the Common Rule,” was published in 1991. The Common Rule codified basic provisions for IRBs, informed consent, and assurances of compliance, further standardizing ethical review across government-funded research. This period in the 1970s represents the institutionalization of IRBs as a mandatory part of the research landscape in the U.S.
IRBs Today: Upholding Ethical Research
Today, Institutional Review Boards remain central to safeguarding human participants in research. They continue to review proposed research protocols to ensure studies are ethically sound, scientifically valid, and that potential risks to participants are minimized. IRBs assess whether the benefits of the research outweigh the risks and confirm that informed consent processes are thorough and transparent.
These boards also monitor ongoing research for ethical compliance and participant safety, with the authority to require modifications or even disapprove studies if ethical concerns arise. This oversight helps maintain public trust in scientific research and prevents a return to the unethical practices of the past. IRBs ensure that scientific advancement proceeds responsibly while prioritizing the rights and welfare of every individual involved.