Evidence map›Paper›PMID 20637931›Full record

ArticleNursing outlook

Changes in the institutional review board submission process for multicenter research over 6 years.

Monika Pogorzelska, Patricia W Stone, Elizabeth Gross Cohn, Elaine Larson

Abstract read
In one paragraph

Article in Nursing outlook. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Trial
  2. Article
  3. The IRB structure and medical research reform.Clinical and translational medicine · 2018
    Article
  4. Article
  5. Article
  6. Article
  7. Improving the Proficiency of Research Consent Administrators.Clinical and translational science · 2015
    Article
  8. Article
  9. Article
  10. Article
  11. 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

4 authors.

Monika PogorzelskaColumbia University School of Nursing, Columbia University, New York, NY 10032, USA. mp2422@columbia.edu
Patricia W Stone
Elizabeth Gross Cohn
Elaine Larson

Funding

Prevention of Nosocomial Infections and Cost-Effectiveness Refined (P-NICER)R01NR010107 · NINR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI STONE, PATRICIA W. · 2007 to 2012
$3.2M
Research: Antimicrobial Resistance (RMI)P20RR020616 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LARSON, ELAINE LUCILLE · 2004 to 2006
$1.7M
NCRR NIH HHS P20 RR020616NCRR NIH HHS P20RR020616NINR NIH HHS R01 NR010107NINR NIH HHS R01NR010107
6 · The paper itself

Abstract

Although collaborative research across sites is essential to increase the statistical power and generalizability of research findings, the need to undergo multiple institutional review board (IRB) reviews is a challenge. The purposes of this paper are to describe changes in the IRB submission process in 2 national multisite studies before and after the implementation of the Health Information Portability and Accountability Act (HIPAA) Privacy rule (2002 and 2008) and to discuss implications for policy and practice related to human subjects research. In the second study, there was a shorter mean approval time and reduced variability in the decision about the level of review, the mean number of pages per application doubled, and an increased proportion of IRBs required conflict of interest and data use agreements. Possible approaches to further enhance the efficiency and streamlining of the research review process are suggested.

Indexed as

Human ExperimentationMulticenter Studies as TopicAnalysis of VarianceChi-Square DistributionConflict of InterestData CollectionData Interpretation, StatisticalEfficiency, OrganizationalEthics Committees, ResearchGovernment RegulationHealth Insurance Portability and Accountability ActHumansInformed ConsentNursing ResearchOrganizational InnovationOrganizational Objectives

Identifiers

PMID20637931
PMCPMC2917109

What OpenQuestion holds

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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.