Evidence map›Paper›PMID 23802897›Full record

ArticleThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2013

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 Dennis Fortenberry, Jacques Ravel

Abstract read
In one paragraph

Article in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2015
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Diane E HoffmannUniversity of Maryland School of Law.
J Dennis Fortenberry
Jacques Ravel

Funding

Federal Regulation of Probiotics: An Analysis of Existing Regulatory FrameworkR01HG005171 · NHGRI · UNIVERSITY OF MARYLAND BALTIMORE · PI HOFFMANN, DIANE E. · 2009 to 2011
$531k
NHGRI NIH HHS R01 HG005171
6 · The paper itself

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.

Indexed as

MetagenomeHuman ExperimentationHumansNational Institutes of Health (U.S.)Patient SelectionResearch SubjectsSocial StigmaUnited States

Identifiers

PMID23802897
PMCPMC5761648

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.