Dr. Reynolds is coauthor of revised ARRIVE 2.0 guidelines for preclinical research

Penny Reynolds, PhD

After four years of extensive work by an international panel of experts that included Assistant Professor of Anesthesiology Penny S. Reynolds, PhD, the updated and revised ARRIVE 2.0 (Animal Research: Reporting In Vivo Experiments) guidelines have been published on July 14 in the journal PLOS Biology.

Dr. Reynolds is the only representative from a U.S. academic institution and one of only three U.S. members of the working group.

ARRIVE 2.0 are international consensus best-practice reporting guidelines that enable investigators to identify the minimum information that must be reported to enable assessment of research reliability, validity, and reproducibility. Similar in intent to the CONSORT (Consolidated Standards of Reporting Trials) guidelines for human clinical trials, ARRIVE 2.0 has two goals: to facilitate complete and transparent reporting of preclinical research methods and results and to facilitate study planning and design before experiments are performed.

ARRIVE 2.0 is a comprehensive set of recommendations that will assist investigators with complying with the National Institutes of Health standards for grant applications and publications, as well as manuscript reporting standards for over 1,000 journals.

The ARRIVE guidelines were first released in 2010 by NC3Rs, a UK-based scientific organization. The ARRIVE 2.0 guidelines have been updated to reflect current evidence-based best practice and extensively revised and reorganized to simplify their use. The updated guidelines consist of a 21-item checklist and companion Explanation and Elaboration (E&E) document. The “ARRIVE Essential 10” items are the indispensable minimum that must be reported to assess reproducibility and validity. The “Recommended Set” provides context for the specific study; they are not necessarily optional, but they provide important information for assessing the internal and external validity of the study and for welfare and ethical oversight.

The E&E document serves as a “user’s manual,” providing for each item a detailed description of its meaning, details to be reported, the rationale for inclusion, and published examples of good reporting. Incorrect or inappropriate study designs and statistical analyses contribute to the large proportion of results from animal-based studies that fail to translate to humans; therefore, the guidelines are accompanied by expanded and revised descriptions of statistical design concepts and a glossary of terms.

The ARRIVE 2.0 guidelines and the E&E documentation are the result of an extensive multiyear international collaboration among academics, industry personnel, preclinical investigators, statisticians, journal editors, and funding agency representatives, as well as the external research community. The guidelines underwent multiple internal and external revisions, the latter consisting of Delphi exercises with expert stakeholders from 19 countries, as well as road-testing with an international test group of preclinical investigators.

Dr. Reynolds was invited to participate in the project in 2017 and was an active member of the international working group. “I am immensely proud of having been able to contribute to this monumental project,” she said.

In addition to the PLOS Biology release, ARRIVE 2.0 was published simultaneously in the journals BMC Veterinary Research, BMJ Open Science, the British Journal of Pharmacology, the Journal of Cerebral Blood Flow and Metabolism, Experimental Physiology, and the Journal of Physiology. More information and supplementary resources can be found on the ARRIVE 2.0 website.