Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

Environmental Health Perspectives
Lynn S McCartyEllen M Mihaich

Abstract

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establi...Continue Reading

References

Mar 9, 1990·JAMA : the Journal of the American Medical Association·D F Horrobin
Mar 9, 1990·JAMA : the Journal of the American Medical Association·D A Kronick
Mar 9, 1990·JAMA : the Journal of the American Medical Association·J C Burnham
Mar 7, 1985·The New England Journal of Medicine·J C Bailar, K Patterson
Feb 1, 1997·Regulatory Toxicology and Pharmacology : RTP·H J KlimischU Tillmann
Sep 30, 1999·Environmental Health Perspectives·J W CrissmanR R Miller
Feb 13, 2001·Trends in Pharmacological Sciences·D F Horrobin
Feb 24, 2001·Quality Assurance : QA·A R BattermanF W Whiteman
Feb 24, 2001·Quality Assurance : QA·L S Birnbaum, B T Culpepper
Jun 1, 2002·JAMA : the Journal of the American Medical Association·Tom JeffersonFrank Davidoff
Jul 9, 2005·Environmental Health Perspectives·Jennifer Beth SassDavid Wallinga
Feb 3, 2006·Environmental Health Perspectives·Craig S Barrow, James W Conrad
Apr 28, 2006·Integrated Environmental Assessment and Management·Dustin A HobbsScott J Markich
Mar 3, 2007·Regulatory Toxicology and Pharmacology : RTP·Christopher J Borgert
Jan 17, 2008·Environmental Health Perspectives·Leslie I Boden, David Ozonoff
Jan 17, 2008·Environmental Health Perspectives·Carol J Henry, James W Conrad
Mar 7, 2008·Regulatory Toxicology and Pharmacology : RTP·P M ForristalL S McCarty
Apr 26, 2008·Diabetes, Obesity & Metabolism·Kasper AaboeJens Juul Holst
Feb 25, 2009·Regulatory Toxicology and Pharmacology : RTP·Gio Batta Gori
May 30, 2009·Toxicology Letters·Klaus SchneiderSebastian Hoffmann
Jan 6, 2010·Environmental Health Perspectives·Richard A BeckerRobert E Brackett
Jan 12, 2010·Acta Psychiatrica Scandinavica·Povl Munk-JørgensenRasmus W Licht
Feb 4, 2010·Environmental Health Perspectives·Frederick S vom Saal, John Peterson Myers
Mar 25, 2010·JAMA : the Journal of the American Medical Association·Catherine D DeAngelis, Phil B Fontanarosa
Apr 7, 2010·Toxicological Sciences : an Official Journal of the Society of Toxicology·Jay SchreiderMichelle R Embry
Jan 22, 2011·Regulatory Toxicology and Pharmacology : RTP·Christopher J BorgertRichard A Becker
Feb 26, 2011·Journal of Pharmacology & Pharmacotherapeutics·Carol KilkennyDouglas G Altman
Aug 2, 2011·Regulatory Toxicology and Pharmacology : RTP·Christopher J BorgertRichard A Becker
Nov 9, 2011·International Journal of Obesity : Journal of the International Association for the Study of Obesity·K A KaiserD B Allison

❮ Previous
Next ❯

Citations

Sep 23, 2014·Current Opinion in Pharmacology·Anna BeroniusChristina Rudén
May 16, 2013·Accountability in Research·David B Resnik, Kevin C Elliott
Aug 2, 2015·Reproductive Toxicology·Jerrold J HeindelThaddeus T Schug
Feb 11, 2014·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Christopher J BorgertAbraham Tobia
Dec 19, 2015·American Journal of Industrial Medicine·Laetitia RollinJean-Francois Gehanno
Oct 25, 2013·Risk Analysis : an Official Publication of the Society for Risk Analysis·Brian H MacGillivray
Mar 29, 2016·Integrated Environmental Assessment and Management·Lynn S McCarty, Christopher J Borgert
Aug 6, 2014·Integrated Environmental Assessment and Management·Richard A BrainDwayne Rj Moore
Nov 7, 2014·Critical Reviews in Toxicology·Glen J Van Der KraakKeith R Solomon
Apr 10, 2013·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·Susan ShelnuttWilliam Allaben
May 13, 2014·Regulatory Toxicology and Pharmacology : RTP·Ann de Peyster, Ellen Mihaich
Oct 3, 2014·Accountability in Research·Jaime A Teixeira da Silva, Judit Dobránszki
May 22, 2016·Toxicological Sciences : an Official Journal of the Society of Toxicology·Christopher J BorgertKun Don Yi
Dec 16, 2016·Integrated Environmental Assessment and Management·Ellen M MihaichKeith Solomon
Nov 25, 2016·Environmental Toxicology and Chemistry·Jeffrey C Wolf, Gerd Maack
Nov 22, 2016·Integrated Environmental Assessment and Management·Caroline MoermondHolly Zahner
Oct 12, 2013·PLoS Biology·Jonathan A EisenCameron Neylon

❮ Previous
Next ❯

Software Mentioned

WoE
GLP

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Kennedy Institute of Ethics Journal
Heather Douglas
Birth Defects Research. Part B, Developmental and Reproductive Toxicology
Robert E ChapinSusan R Woskie
JAMA : the Journal of the American Medical Association
Justin E BekelmanCary P Gross
Journal of Toxicology and Environmental Health. Part B, Critical Reviews
Keith R Solomon, Dean G Thompson
© 2022 Meta ULC. All rights reserved