Chapter 3: Introduction

ACHRE Report

Part I

Chapter 3

Introduction

The Development of Human Subject Research Policy at DHEW

The Development of Requirements for Human Subject Research in Other Federal Agencies

Supreme Court Dissents Invoke the Nuremberg Code: CIA and DOD Human Subjects Research Scandals

Chapter 3: Introduction

The year 1974 marks the upper bound for the period of the Advisory Committee's historical investigation. That year two landmark events in the history of government policy on research involving human subjects took place: the promulgation by the Department of Health, Education, and Welfare (DHEW) of comprehensive regulations for oversight of human subject research and passage by Congress of the National Research Act. The DHEW regulations set rules for oversight of human subject research supported by the single largest funding source for such research, and the National Research Act authorized the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (also known as the National Commission), which was charged with examining the conduct of research involving human subjects. In the years following 1974, many of the rules promulgated by DHEW were subsequently adopted by various other government agencies, culminating in governmentwide regulations under the Common Rule in 1991.[1]

In the first part of this chapter, we trace the developments in the 1960s and early 1970s that influenced and led up to the DHEW regulations and the National Research Act. These developments included congressional hearings on the practices of the drug industry and the thalidomide tragedy, critical scholarly writings, interim policies at DHEW, public outcry over controversial cases of medical research, and the congressional hearings these cases occasioned. People were surprised and shocked to learn about practices and behaviors they knew to be wrong. While the ethical principles such practices violated may not have been well articulated specific to the enterprise of human research, they were part of individuals' moral consciousness. The history of these events has been well told before, and we only summarize it here, drawing heavily on the previous work of other authors.[2]

The 1974 regulations were promulgated by DHEW and applied only to that agency. Likewise, the National Research Act authorized the establishment of the National Commission and directed it to make recommendations to the secretary of DHEW. In the latter part of this chapter, we review developments in policies governing human research during this period in agencies other than DHEW. This is a history that has received comparatively little scholarly attention.

In the 1970s, just as DHEW was moving ahead with broad new regulations, scandal rocked the Department of Defense and the CIA. It was revealed that, with cooperation from university researchers, these agencies had engaged in secret experimentation on military and civilian subjects without their knowledge, sometimes with tragic results.[3] The discovery of the existence of these secret programs led to further congressional investigations and to a 1975 Department of the Army review of the effectiveness of the 1953 Secretary of Defense Wilson memorandum adopting the Nuremberg Code. This Army review led to the eventual declassification of the Wilson memorandum, which had been Top Secret upon its issuance and remained classified until 1975. It also led, much later, to litigation in which justices of the U.S. Supreme Court for the first time commented on the applicability of the Nuremberg Code to actions undertaken by the U.S. government.[4] The chapter concludes with a discussion of these important events.