Codes of Ethics

Since World War II there have been three major "Codes of Ethics" that apply directly to research involving human subjects. These codes are listed below. They are based on general principles of ethics that most people agree are very important to keep in mind at all times in doing research that involves people.

  1. The Nuremberg Code: This code of ethics was written as a result of the Trials of War Criminals right after World War II. It was written in response to the terrible things that Nazi doctors did to other people during the war. The doctors claimed that what they did was o.k. because it was research. The Nuremberg Code responds to this by giving guidelines for how people should do research so that human subjects are respected.
  2. World Medical Association Declaration of Helsinki: Adopted in 1964, this statement also gives guidelines for anyone who wants to do research that involves human beings.
  3. The Belmont Report: This 1979 report was written by the 'National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research'. The report talks about the boundaries between medical practice and research, basic ethical principles (see below), and what these principles mean when you apply them to human subject research.

  4. There are three important ones in particular for talking about research with human subjects. Here are some very basic definitions:

Other Resources:
Beecher Article (NEJM)

CIOMS Ethical Guidelines (WMA)
Code of Federal Regulations (HHS, Protection of Human Subjects)
Common Rule
The Presidential Commission for the Study of Bioethical Issues
Office of Biotechnology Activities (NIH)

Educational Resources for Human Subjects Protections, Scientific Integrity, and the Responsible Conduct of Research:
HHS, NHLBI, NIH: Who Needs Human Subject Protections Training?
Collaborative Institutional Training Initiative (Registration Required)
NCI: Human Participant Protections Education for Research Teams (Registration Required)
UCLA: Stanley G. Korenman book: Teaching the Responsible Conduct of Research
AAAS / NAS: Scientific Integrity Program
UTMB CRC CREO: Tools and Techniques for Clinical Research: Ethics Module
UTMB Data & Safety Monitoring Planning Computer-Based Course

Government Resources and Federal Regulations:
Institutional Review Board Guidebook
NIH Common Fund
Clinical Trials.gov
RegSource Regulatory Page
HHS Code of Federal Regulations: Browser
HHS Code of Federal Regulations: Protection of Human Subjects
HHS: Office for Human Research Protections
HHS: Office of Research Integrity
HHS: HIPAA regulations
FDA: Regulations Related to Good Clinical Practice
FDA: Protection of Human Subjects
FDA: Good Clinical Practice in FDA-Regulated Clinical Trials
FDA: Guidance for Institutional Review Boards and Clinical Investigators
NIH: Bioethics Resources on the Web
NIH: Office of Human Subjects Research
NIH: HIPAA regulations
NIH: Office of Biotechnology Activities - Recombinant DNA and Gene Transfer