Evidence map›Paper›PMID 30312589›Full record

ArticleChest2019

Implications of the Revised Common Rule for Human Participant Research.

Evan G DeRenzo, Joel Moss, Eric A Singer

Abstract read
In one paragraph

Article in Chest, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Review
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.

Evan G DeRenzoJohn J. Lynch Center for Bioethics, MedStar Washington Hospital Center, Washington, DC.
Joel MossPulmonary Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD.
Eric A SingerRutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ. Electronic address: eric.singer@rutgers.edu.

Funding

TRANSCRIPTIONAL PROFILINGP30CA072720 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI Tracie Saunders · 1997 to 2026
$94.5M
NCI NIH HHS P30 CA072720
6 · The paper itself

Abstract

This paper looks at the implications of changes to the regulatory governance of human participant research that can be expected with implementation of the Revised Common Rule (RCR). The RCR refers to revisions of the existing federal regulations that govern the performance of research involving human subjects (ie, clinical research) in the United States and, under certain circumstances, when such research is also performed outside the United States. The term "common" is included because it refers to the fact that these regulations, often referred to as Code of Federal Regulations 46, is the common denominator regulations agreed to across a wide swath of federal agencies.

Indexed as

Biomedical ResearchEthics Committees, ResearchHumansInformed ConsentNeeds AssessmentPolicy MakingResearch DesignResearch SubjectsUnited Statesbiospecimencapacityclinical researchcommon rulehuman participant researchhuman subject researchinformed consentinstitutional review boardresearch ethicsrevised common rule

Identifiers

PMID30312589
PMCPMC6363814

What OpenQuestion holds

Textmetadata
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.