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The "Common Rule"

NIJ policy provides for the protection of the privacy and wellbeing of individuals who are participants in NIJ research studies under two different, but philosophically related, sets of regulations.

One of these policies covering the protection of human subjects used in research was adopted by 17 Federal agencies, including the Department of Justice (DOJ), in 1991. These policies are referred to as the "Common Rule" or Subpart A and can be found in 28 CFR Part 46. The Common Rule establishes the core procedures for human research subject protections, which include informed consent and review by an Institutional Review Board (IRB). U.S. Department of Health and Human Services (HHS) regulations include Subparts B, C, and D, which provide additional protections for certain vulnerable populations including pregnant women, incarcerated persons, and children. Like most other Federal agencies, DOJ did not adopt Subparts B through D; nevertheless, we remain ethically concerned about these populations when included as study subjects.

The Common Rule represents the culmination of more than 40 years of development and discussion on the underlying ethical principles and guidelines for conducting research using human subjects, beginning with the Nuremberg Code in 1947. Through the years, several international and national commissions have contributed valuable concepts and approaches to the protection of human research subjects. One of these, the Belmont Report, published in 1978, described the three ethical principles on which the procedural requirements of the Common Rule are based. These principles are respect for persons, beneficence, and justice.

Respect for persons includes the recognition of personal dignity and autonomy, and provides the need to obtain voluntary, informed consent prior to conducting research involving human subjects. Beneficence encompasses an obligation to protect individuals from harm and to maximize possible benefits and minimize harm; this principle provides the basis for risk/benefit assessment. Justice deals with the fair distribution of the benefits and risks of the research and establishes the requirement that the selection of subjects be fair. (Note that these principles are consistent with the goals of the Privacy Protection provisions.) The IRB process was established as an integral requirement of the Common Rule for the purposes of reviewing the informed consent process; reviewing the balance of the risks to the subject with the benefits to either the subject or society at large; and ensuring the equitable selection of subjects. An IRB must carry out these duties based on a thorough assessment of all aspects of the research design and systematic consideration of alternatives.

Date Published: November 19, 2007