Please contact the Booth Family Center for Special Collections for assistance with accessing these materials.

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

Collection

Identifier: BRL-001

The collection documents 43 meetings of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research held between 1974 and 1978 and includes briefing books, subject files, and transcripts from these meetings.

An index of subjects and their corresponding meeting and box numbers is available in an earlier version of this guide, which is available here: https://repository.library.georgetown.edu/handle/10822/559326.

Dates

1974 - 1978

Creator

United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Organization)

Conditions Governing Access

Materials are open without restrictions.

Conditions Governing Use

Researchers are solely responsible for determining the copyright status of the materials being used, establishing who the copyright owner is, locating the copyright owner, and obtaining permission for intended use.

Extent

12.5 Cubic Feet (in 33 manuscript boxes)

Additional Description

Overview

The collection documents 43 meetings of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research held between 1974 and 1978 and includes briefing books, subject files, and transcripts from these meetings. The Executive’s Branch of the Department of Health, Education, and Welfare established the group in 1974 and it is considered one of the first modern bioethics commissions.

Historical Note

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS) was established on July 12, 1974, under Title II of Public Law 93-348, the “National Research Service Reward Act of 1974”, to develop guidelines which should be followed in biomedical and behavioral research involving human subjects and to make recommendations to the Secretary of the Department of Health, Education, and Welfare.

The commission was composed of eleven members appointed by the Secretary on December 1, 1974. The Chairman of the Commission, Kenneth J. Ryan, M.D., was selected by the Commission from among its members. Meetings were held approximately once a month and were open to the public except when determined otherwise by the Secretary of the Department of Health, Education, and Welfare. Subject to the specific provision of Title II, Part A, of Public Law 93-348, this Commission was established in accordance with and was governed by the provisions of Public Law 92-463 which set forth standards for the formulation and use of advisory committees. Public Law 94-573 extended the Commission for one year with the same mandate. This extension enabled the Commission to devote additional time and effort to certain duties and to develop some new projects that resulted in a more comprehensive Commission response to its mandate.

In accordance with Public Law 93-348, the Commission was given a mandate to investigate and study research involving the living fetus and to recommend whether and under what circumstances such research should be conducted or supported by the Department of Health, Education, and Welfare. During the first year of its monthly meetings this subject dominated other issues. The use of psychosurgery was another issue which the Commission examined and deliberated on during the first two years of its meetings.

The legislative mandate also directed the Commission to make recommendations to Congress regarding the protection of human subjects in research not subject to regulation by the Department of Health, Education, and Welfare. Classes of research subjects that received the Commission’s particular attention included children, prisoners and the institutionalized mentally infirm. The Commission's recommendations on these topics were the product of almost two years of data gathering and deliberations. An additional aspect examined by the Commission was research that is conducted or supported by other federal agencies. In relation to this, the staff compiled an up-to-date survey of the policies and procedures of other federal agencies. Upon completion, this provided a basis for the Commission’s consideration of government-wide Protections.

Several other topics of study identified in the Commission's mandate under Public Law 93-348 were the following: disclosure of research information; ethical principles and guidelines (Belmont document); Institutional Review Boards and protection of the Department of Health, Education, and Welfare health care recipients. In addition, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was directed to conduct a "special study" of the ethical, social and legal implications for public policy of advances in biomedical and behavioral research and technology. The extension of its Charter gave the Commission the time it required to consider the reports and public opinion polls on these issues.

The Commission also supported activities and studies undertaken in particular areas that were encompassed by the special study, especially recombinant DNA research. Since the Commission's mandate included "any. . . matter pertaining to the protection of human subjects of biomedical and behavioral research" there were other topics to which the Commission also turned its attention. Other areas examined by the Commission included the problems of confidentiality and privacy, compensation, human experimentation, informed consent, sterilization, the swine flu vaccine and role of assessment of risk/benefit criteria.

In September 1978 the Commission published three reports, including the Belmont Report, which draws a close to the Commissions’ publications. In total twelve studies and reports would be published. The Belmont Report(occasionally referred to as the Belmont Document in the collected materials) is widely considered to be the defining document produced by the Commission. Its recommendations would go on to form the basis of many Federal regulations concerned with the protection of human subjects.

The Commission's Charter officially expired in October of 1978 with the dismissal of staff and closure of the office.

A detailed chronology of the Commission is available in an earlier version of this guide, which is available here: https://repository.library.georgetown.edu/handle/10822/559326.

Arrangement

The collection is organized into the following series:

Series 1: Briefing Books

Series 2: Subject Files

Series 3: Transcripts

Series 4: Summary Minutes

Immediate Source of Acquisition

Gift of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, sometime before 1986.

Existence and Location of Copies

Portions of this collection have been digitized and are available via the Bioethics Research Library's Flickr. Additionally, a selection of reports produced by the Commission and meeting transcripts are available in DigitalGeorgetown's U.S. Bioethics Commissions Archival Collection.

Related Materials

The Barbara F. Mishkin Papers (BRL-030) and Robert M. Veatch Papers (BRL-018) include records related to the National Commission.

Processing Information

The collection was processed by Ariella Barrett in August 1989. Laura Shanner authored the original chronology at that time. The guide to the collection was updated and expanded by Laura Ruth Barry and Charles N. Norton in August 2012. John Zarrillo imported the collection's inventory into ArchivesSpace and updated the guide to the collection for DACS-compliance in June 2020. In August 2020 the collection was surveyed. Although no material was removed from the collection during the survey, the extent of the collection was reduced from 33 boxes to 31 boxes after materials were rearranged to better fit their containers. In December 2020 meeting summaries (Accession 026) were processed and added to the collection. In March 2022, additional subject files which had been found unprocessed were added to the collection.

Storage Location: This collection is held in offsite storage.

Subjects

Related Names

Creator

United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Organization)

Finding Aid & Administrative Information

Title: Guide to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Records
Status: completed
Author: Ariella Barrett, Laura Ruth Barry, Anita Nolan, Charles N. Norton, Laura Shanner, and John Zarrillo
Date: June 2020
Description rules: Describing Archives: A Content Standard
Language of description: Finding aid written in English

Revision Statements

2012-08: The guide to the collection was updated and expanded by Laura Ruth Barry and Charles N. Norton.
2020-06: John Zarrillo imported the collection's inventory into ArchivesSpace and updated the guide to the collection for DACS-compliance.
2020-08: The collection's extent was updated by John Zarrillo.
2022-03: Additional subject files added to the collection by John Zarrillo.