AOP Review and Endorsement

Overview

Scientific peer review and subsequent endorsement by OECD working parties can be important to establishing the scientific credibility of an AOP and its suitability for fit-for-purpose application.

This page provides information on the Three Step AOP Review process, and current Paths to AOP Review and Endorsement.

AOP Development and Review Process (general)

Figure 1.  Key steps in the AOP development and review process.

1. Assembly:  Develop your content in the AOP-Wiki following guidance in the AOP Developer’s Handbook.
   1. It is recommended that developers engage a “coach” early in the AOP development process to help ensure their compliance with the handbook as the AOP is being developed, to avoid rejection at the compliance check stage. For assistance identifying a coach, contact aopwiki@googlegroups.com and include information about the content/subject matter of your AOP.
2. Compliance Check: A coach, journal editor, or review manager (see paths below) will go through a check-list to make sure that content in the AOP-Wiki has been developed in a manner consistent with the AOP Developer’s Handbook, and will certify that to be the case, before the AOP can proceed to scientific peer review.
3. Scientific Review: Scientific peer-review of AOPs is conducted by subject matter experts with the guidance of review manager or editor with expertise in the AOP framework.
   1. Review must follow guidance and principles laid out in OECD Guidance Document No. 344: Guidance Document for the Scientific Review of Adverse Outcome Pathways.
   2. Review must be independent:  The editor/review manager and reviewers should not be part of the AOP development team or have close affiliation with the developer(s) or have conflicts of interest with the developer(s). Individuals that served as coaches for the AOP’s development should not be included on the scientific review team.
   3. Review must be transparent:  Identities of the reviewers, and a compilation of their review comments and the author’s responses to those review comments will be published.
   4. Review must include subject matter expertise necessary to cover the full scope of the AOP and address the following charge questions:
      1. Does the AOP incorporate relevant scientific literature and evidence?
      2. Does the scientific content of the AOP reflect current scientific knowledge on this specific topic?
      3. Considering the weight-of-evidence for each KER and the AOP as a whole, is the weight-of-evidence judgement/scoring well described and justified based on the evidence presented.
   5. Scientific peer review must be completed before an AOP can be considered for endorsement by OECD working parties.
4. Endorsement: Endorsement is a formal process whereby an AOP that has undergone scientific peer review is circulated to the OECD Working Party on Hazard Assessment (WPHA), Working Party of the National Coordinators of the Test Guidelines Program (WNT) or other relevant OECD working parties for their consideration and comment.
   1. The endorsement process may involve receiving additional comments from OECD member countries and subsequent revisions to the peer-reviewed AOP.
   2. If approved for endorsement, a snap-shot of the approved version of the AOP will be published on the OECD public website on the OECD Series on Adverse Outcome Pathways.
   3. Endorsement is regarded as an indication that relevant OECD working parties (to be listed in a declaration) express confidence in the scientific review process that the AOP has undergone and accept the recommendation of the OECD Advisory Group on Emerging Science for Chemicals Assessment (ESCA) that the AOP be disseminated publicly via the OECD series. Endorsement does not necessarily indicate that the AOP is considered a tool for direct regulatory application.
   4. Endorsement is an optional process. AOPs that are peer-reviewed but not endorsed will still be available and viewable in the AOP-Wiki, but will not be published in the OECD Series on Adverse Outcome Pathways.

Paths to Review and Endorsement

Figure 2. Established paths to AOP peer review and endorsement

1. OECD Workplan Path
   1. AOP-relevant projects can be proposed by scientists from OECD member countries for potential inclusion on the AOP Development Workplan. To have a project considered, authors should complete the form to submit an AOP project proposal.
   2. Proposals are reviewed bi-annually by the OECD ESCA.
   3. If accepted onto the workplan, the OECD Secretariat will assist in identifying a coach that can answer questions about the AOP framework, provide clarifications regarding the guidance in the AOP developer’s handbook, and conduct the compliance check required before an AOP can proceed to peer-review.
   4. When an AOP on the OECD workplan has completed the Compliance Check and is ready for Scientific Peer Review, OECD ESCA will issue a call to OECD member countries and relevant advisory groups to try to identify a review manager willing to organize a peer review in accordance with the OECD Guidance Document No. 344: Guidance Document for the scientific review of Adverse Outcome Pathways.
   5. Once scientific peer review and any associated revisions are completed, the OECD secretariat will submit the reviewed AOP to relevant working parties for consideration for endorsement.
   6. If endorsed, the AOP will be published in the OECD Series on Adverse Outcome Pathways.
2. Partner Journals Path
   1. The OECD has developed a cooperation (formalized via a memorandum of understanding) with multiple scientific journals for the review and publication of AOPs.
   2. This path involves developing an AOP in the AOP-Wiki and a companion summary journal article to be submitted to a partner journal.
   3. AOP developers on this path have the option to engage a coach to assist in understanding how to structure their information and evidence in the AOP-Wiki. If a coach is desired, please contact aopwiki@googlegroups.com to request a coach.
   4. Upon submission of the journal article with companion AOP in the AOP-Wiki, the journal editor will perform the compliance check and declaration that the AOP-Wiki content has been developed in accordance with the developer’s handbook (or will return the submission to the authors for revision).
   5. Once a compliance check has been completed, the journal editor will invite subject matter experts to perform the scientific peer review and manage the review process in accordance with the OECD Guidance Document No. 344: Guidance Document for the scientific review of Adverse Outcome Pathways.
   6. After review comments are received and any revisions made, the journal editor will accept or reject the AOP and its companion journal article for publication in the partner journal.
   7. At the discretion of the Authors, an AOP accepted for publication by a partner journal can be submitted to the OECD ESCA to be considered for endorsement. At this point, the OECD secretariat manages the endorsement process as described for the OECD workplan path above.  Note, consideration for endorsement may involve addressing additional comments from OECD member countries and expert groups which may also entail further revision of the AOP that was already accepted by the journal.
   8. If endorsed, the updated version of the AOP (revised based on any additional comments received during the endorsement process) will be published in the OECD Series on Adverse Outcome Pathways.

HELP

If neither of the Paths to Review and Endorsement described above seem appropriate for your AOP or you have questions regarding the Review and Endorsement process, please contact aopwiki@googlegroups.com or post your question(s) to the AOP Forum.