Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project

Diane E. Hoffmann, J. Fortenberry, Jacques Ravel

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)454-469
Number of pages16
JournalJournal of Law, Medicine and Ethics
Volume41
Issue number2
DOIs
StatePublished - Jun 2013

Fingerprint

Microbiota
Human Body
Research
Patient Selection
Health

ASJC Scopus subject areas

  • Health Policy
  • Issues, ethics and legal aspects

Cite this

Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project. / Hoffmann, Diane E.; Fortenberry, J.; Ravel, Jacques.

In: Journal of Law, Medicine and Ethics, Vol. 41, No. 2, 06.2013, p. 454-469.

Research output: Contribution to journalArticle

@article{adaa6e12939f4f128789815359586f39,
title = "Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project",
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.",
author = "Hoffmann, {Diane E.} and J. Fortenberry and Jacques Ravel",
year = "2013",
month = "6",
doi = "10.1111/jlme.12055",
language = "English",
volume = "41",
pages = "454--469",
journal = "Journal of Law, Medicine and Ethics",
issn = "1073-1105",
publisher = "Wiley-Blackwell",
number = "2",

}

TY - JOUR

T1 - Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project

AU - Hoffmann, Diane E.

AU - Fortenberry, J.

AU - Ravel, Jacques

PY - 2013/6

Y1 - 2013/6

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84879708414&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879708414&partnerID=8YFLogxK

U2 - 10.1111/jlme.12055

DO - 10.1111/jlme.12055

M3 - Article

C2 - 23802897

AN - SCOPUS:84879708414

VL - 41

SP - 454

EP - 469

JO - Journal of Law, Medicine and Ethics

JF - Journal of Law, Medicine and Ethics

SN - 1073-1105

IS - 2

ER -