Useful Documents

Internal Documents

Research Packet Information (PDF) (DOC): a summary and clarification of the full Academic Memorandum on Ethical Principles and Review Procedures for Human Participants in Research (last revised on 8/6/2001)

Academic Memorandum on Ethical Principles and Review Procedures for Human Participants in Research (PDF): a document containing the policies and procedures that govern activities involving research with humans conducted by faculty, students, academic affairs or student life staff, or outside investigators at Elon University.

External Documents

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This document provides the philosophical underpinnings for current Federal laws governing research involving human subjects. The NIH embraces The Belmont Report and holds IRP investigators responsible for conducting their research actvities in keeping with its principles and guidelines. The Belmont Report establishes three fundamental ethical principles that are relevant to all research involving human subjects: Respect for Persons, Beneficence, and Justice. (April 18, 1979)

Title 45 Code of Federal Regulations, Part 46, Protection of Human Subjects (45 CFR Part 46), embodies the ethical principles of The Belmont Report. These regulations apply to all research involving human subjects conducted or supported by the Intramural Research Program (IRP) of the NIH, including involvement by intramural investigators in collaborative activities off the NIH campus. Such activities include "hands-on" involvement with patients or subjects and also indirect involvement, such as analyses of data or human samples (e.g., blood or tissue).

45 CFR Part 46 is not a set of rules that can be applied rigidly to make determinations of whether a proposed research activity is ethically "right" or "wrong." Rather, these regulations provide a framework in which investigators and others can ensure that serious efforts have been made to protect the rights and welfare of research subjects. (Revised June 18, 1991)

Most of documents have been geared to medical research, so they were often not applicable to research in social and behavioral science. Nowadays, researchers are seeing a new movement that tries to provide a clearer guideline for social and behavioral scientists. One memorandum from the Social and Behavioral Sciences Working Group of the National Human Research Protection Advisory Committee issued a memorandum on "public use data files," "risk and harm" and "third parties" on July 25, 2001. This memorandum is available in pdf format, too.