ACHRE Report

Part III

Chapter 14


The Federal Policy for Human Subject Protections (The Common Rule)

Research Involving Ionizing Radiation

Scope of Programs of Research Involving Human Subjects

Administravtive Structures and Procedures for Research Oversight

Federal Responses to Violations of Human Subjects Protections

Protections for Human Subjects in Classified Research


Chapter 14: Introduction

Each year many thousands of people participate in biomedical and behavioral research projects conducted, sponsored, or regulated by federal agencies. The federal government invests roughly $3.5 billion annually in research that involves human subjects.[1] The Committee wanted to establish what the federal government currently does to protect the rights and interests of these subjects. The answers to this question all emanate from a seminal event in the history of human subjects research, the adoption of what is widely known as the "Common Rule."

A single, general set of regulatory provisions governing human subjects protections was adopted by sixteen federal departments and agencies[2] in 1991; the Common Rule specifies how research that involves human subjects is to be conducted and reviewed, including specific rules for obtaining informed consent.[3] The Common Rule was developed in response to recommendations made by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1981 calling for the adoption by all federal agencies of Department of Health and Human Services regulations then in effect for the protection of human subjects of research.[4] In mid-1982 the President's science adviser, the head of the Office of Science and Technology Policy (OSTP), appointed an ad hoc committee that included the federal departments and agencies engaged in research involving human subjects to address these recommendations.[5] Nine years later, the Common Rule was the result of this committee's efforts.

History of the Common Rule Since 1974[a]


Title II of the National Research Act (P.L. 93-348)

Required codification of DHEW policy in regulations, imposed a moratorium on federally funded fetal research, and established requirements for IRB review of all human subjects research at any institution receiving DHEW funding.

DHEW regulations for the protection of human research subjects, 45 C.F.R. 46

Established IRB review procedures in accordance with Title II. Later in the same year DHEW published regulations providing additional protections for pregnant women and fetuses.


National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Issued reports and recommendations on fetal research; on research involving prisoners, psychosurgery, children, and the mentally infirm; on IRBs and informed consent; and, in The Belmont Report, discussed criteria for distinguishing research from the practice of medicine and ethical principles underlying the protection of subjects.


Revised DHEW regulations governing protections for pregnant women, fetuses, in vitro fertilization (subpart B of 45 C.F.R. 46), and prisoners (subpart C) published


President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

Charged with, among other responsibilities, reviewing federal policies governing human subjects research and determining how well those policies were being carried out. Recommended that all federal agencies adopt the DHHS (a successor agency to DHEW) regulations for the protection of human subjects (1981).


DHHS published a revision of 45 C.F.R. 46, responding to recommendations of the National Commission

The revision set out in greater specificity IRB responsibilities and the procedures IRBs were to follow.

FDA regulations at 21 C.F.R. 50, governing informed consent procedures, and at 21 C.F.R. 56, governing IRBs, revised to correspond to DHHS regulations to the extent allowed by FDA's statute


President's Science Adviser, Office of Science and Technology Policy (OSTP), appointed an interagency committee to develop a common federal policy for the protection of human research subjects


DHHS regulation governing protections afforded children in research (subpart D of 45 C.F.R. 46) published


Proposed common federal policy for the protection of human research subjects published


Final common federal policy published on June 18, codified in the regulations of fifteen federal agencies and adopted by the CIA under executive order.

This common policy, known as "the Common Rule," is identical to the basic DHHS policy for the protection of research subjects, 45 C.F.R. 46, subpart A. Other sections of the DHHS regulation provide additional protections for pregnant women, fetuses, in vitro fertilization (subpart B), prisoners (subpart C), and children (subpart D). Several agencies have adopted these additional provisions as administrative guidelines. The FDA made conforming changes in its informed consent and IRB regulations.

a . For a brief history of federal protections for human subjects prior to 1974, see chapter 3.

The promulgation of the Common Rule was a significant achievement. The ability of the Common Rule to protect the rights and interests of human subjects is, however, at least partially dependent on how the departments and agencies to which the Common Rule applies implement and oversee its provisions. As a foundation for the Advisory Committee's recommendations concerning contemporary policies and practices regarding human subjects, we asked the sixteen federal agencies and departments that conduct human subjects research to provide us with information on the relevant policies and practices currently in place. In this brief descriptive overview, we focus on six agencies within the scope of the Advisory Committee's charter: the Department of Defense (DOD), Department of Energy (DOE), Department of Health and Human Services (DHHS), Department of Veterans Affairs (VA), National Aeronautics and Space Administration (NASA), and the Central Intelligence Agency (CIA). (Information on the ten other agencies covered by the Common Rule is provided in a supplemental volume to this report.)

The following sections briefly describe the institutional structures, review mechanisms, and policies prescribed by the Common Rule and the variety of ways in which federal agencies attempt to ensure that human subjects are adequately protected in the conduct of research. The chapter closes with a review of an issue of particular importance to the Advisory Committee--the status of protections for human subjects of classified research.[6]

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