Ethical Principles Guiding Biomedical Research

Three Initiatives That Followed the National Research Act of 1974

Oct 21, 2009

The National Research Act (1974) set forth ethical principles for research on human subjects. Three additional initiatives followed to put those principles into practice.

One consequence of the U.S. 1974 National Research Act was the requirement that any institution seeking Federal research funding had to create Institutional Review Boards (IRBs). IRBs were needed to evaluate the process by which research subjects were selected, to assure that the risks of research were minimized, to assess risks of research against potential benefits, and to verify that informed consent was obtained and documented. Nevertheless, three other initiatives were needed to put these principles into practice.

The Vancouver Group Expands into Ethical Issues

In 1978, the International Committee of Medical Journal Editors (ICMJE) met in Vancouver, Canada, to establish uniform requirements for formatting manuscripts that were intended for publication in scientific journals. The Vancouver Group, as it soon came to be called, gradually expanded its focus to examine other ethical issues beyond those set forth in its Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication.

There are nine sections in the Uniform Requirements. Section II (“Ethical Considerations in the Conduct and Reporting of Research”) is the most relevant section for ethics, as it focuses on six important issues related to clinical research:

Peer review involves the evaluation of research by fellow scientists. If potential conflicts of interest (by both the reviewer and the experimenter) were avoided, then the integrity and independence of the peer evaluation would be safeguarded. Furthermore, in order to protect the confidentiality of patient data, all personal information that could identify a patient was to be removed prior to publication.

All authors had to insert a declaration in their manuscripts assuring that the research procedures followed were in accord “with the ethical standards of the responsible committee on human experimentation (institutional and national).” A similar assurance had to be given for all research on animals.

The International Conference on Harmonisation Coordinates Global Policy

Following the outbreak of the AIDS epidemic during the 1980s, more and more clinical trials were being conducted in different countries around the world. In order to simplify global clinical research procedures, the ICH attempted to find a common ground for new drug approval by establishing guidelines for safety, quality, and drug effectiveness.

After six years of effort, the ICH initiative led to the release of The Guideline for Good Clinical Practice (GCP), which set forth basic standards for clinical research in places such as the EU, the United States, Canada, Japan, and Australia. The GCP glossary not only describes ethical research, but also defines terms relevant to clinical research, such as blinding, protocol, vulnerable subjects, and randomization.

The 'Common Rule' Sets Guidelines for Funding Research

On June 18, 1991, the U.S. Government adopted a Federal Policy for the Protection of Human Subjects, otherwise known as the ‘Common Rule.’ This policy put all Federally-funded research under a single set of guidelines for all 16 qualifying Federal agencies.

In addition to establishing an IRB, any institution seeking Federal funding had to provide assurances that the institution was complying with all known Federal regulations, including adherence to the principles of informed consent. The Common Rule has four subparts, with each part offering protection to the following groups:

The Common Rule is typically referenced as 46 CFR 45. This means that it is found in Part 46 (Protection of Human Subjects) within the Code of Federal Regulations (CFR) at Title 45 (Public Welfare). Subpart A is the Basic Health & Human Service (HHS) Policy for Protection of Human Research Subjects.

Summary

The discovery of ongoing research abuses such as the Tuskegee Study of Untreated Syphilis in 1972 contributed to public outrage and the demand that something be done to stop unethical conduct. Unfortunately, even the initiation of these three reforms have done little to curb research abuses on human subjects.

Federal Policy for the Protection of Human Subjects. 1991. “The Common Rule.” 46 CFR 45.

Fischer BA. 2006. A summary of important documents in the field of research ethics. Schizophrenia Bulletin. 32(1):69-80.

International Committee of Medical Journal Editors (ICMJE). 2007 (October). Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Philadelphia, PA: American College of Physicians.

The copyright of the article Ethical Principles Guiding Biomedical Research in Bioethics is owned by Jeffrey Willett. Permission to republish Ethical Principles Guiding Biomedical Research in print or online must be granted by the author in writing.