Common Rule
Overview
The Common Rule, formally known as the Federal Policy for the Protection of Human Subjects, is a United States federal policy that provides guidelines for the ethical conduct of research involving human subjects. The policy was first published in 1991 and has been revised several times since then, most recently in 2018. The Common Rule applies to all federally funded research involving human subjects, and many private institutions have also chosen to adopt it.
History
The origins of the Common Rule can be traced back to the aftermath of World War II, when the Nuremberg Trials revealed horrific instances of human experimentation conducted without the subjects' consent. In response to these revelations, the Nuremberg Code was established in 1947, setting forth ten principles for the ethical conduct of research involving human subjects. The Nuremberg Code served as the foundation for many subsequent ethical guidelines, including the Declaration of Helsinki and the Belmont Report, both of which influenced the development of the Common Rule.
Principles
The Common Rule is based on three fundamental ethical principles outlined in the Belmont Report: respect for persons, beneficence, and justice.
Respect for Persons
This principle requires that individuals be treated as autonomous agents and that persons with diminished autonomy be provided with additional protections. In the context of the Common Rule, this principle is operationalized through the requirement of informed consent. Researchers must provide potential subjects with all the information necessary to make an informed decision about participation, including details about the study's purpose, procedures, risks, benefits, and alternatives.
Beneficence
Beneficence involves the obligation to maximize possible benefits and minimize possible harms. Researchers are required to design their studies in a way that ensures the benefits outweigh the risks. This principle is implemented through the process of risk-benefit analysis, which is conducted by an Institutional Review Board (IRB) before a study can be approved.
Justice
The principle of justice requires that the benefits and burdens of research be distributed fairly. In practice, this means that researchers should not select subjects solely because of their easy availability, compromised position, or manipulability.
Requirements
The Common Rule sets forth several requirements for the conduct of research involving human subjects. These requirements include, but are not limited to, the following:
Institutional Review Board (IRB)
All research covered by the Common Rule must be reviewed and approved by an IRB before it can commence. The IRB is responsible for ensuring that all research complies with the ethical principles and requirements outlined in the Common Rule.
Informed Consent
Informed consent is a key requirement of the Common Rule. Researchers must obtain and document the informed consent of each subject or the subject's legally authorized representative.
Continuing Review
The Common Rule requires that ongoing research be subject to continuing review by an IRB. This review must occur at least annually and must ensure that the research continues to meet the requirements of the Common Rule.
Revisions
The Common Rule has been revised several times since its initial publication in 1991. The most significant revisions occurred in 2018 and included changes to the requirements for informed consent, IRB review, and the definition of research.
Impact
The Common Rule has had a significant impact on the conduct of research involving human subjects in the United States. It has established a national standard for the protection of human subjects and has influenced the development of similar policies in other countries.
Criticisms
Despite its widespread adoption and influence, the Common Rule has been subject to several criticisms. Some critics argue that the policy is overly bureaucratic and hinders valuable research. Others contend that the Common Rule does not adequately protect vulnerable populations or address emerging ethical issues in research.