Related Experiment Video
Updated: May 10, 2026

Microbiota Analysis Using Two-step PCR and Next-generation 16S rRNA Gene Sequencing
Published on: October 15, 2019
Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human
Diane E Hoffmann1, J Dennis Fortenberry, Jacques Ravel
1University of Maryland School of Law.
Abstract:
This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a "reference catalogue" of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.
Related Concept Videos
Introduction to the Human Microbiota
Development of Human Microbiota
Applications of Molecular Taxonomy
Evolution of New Traits in Microbes
Evolution of Microbial Genome
Evolutionary Processes in Microbes

