Protocol Review Process
Internal Review, Expert Peer Review, & Public Comment
Last updated
Regen Registry Handbook
Internal Review, Expert Peer Review, & Public Comment
Last updated
The protocol review process consists of four stages:
Initial Review of Concept Note/Draft and Acceptance into the Review Process
(4 weeks)
(approx. 3-6 months)
(14 - 30 days)
Each stage is described below. The length of time to complete the expert peer review depends on availability and response time of expert peer reviewers as well as the amount of comments to address and number of review cycles needed for the methodology review lead to approve the methodology.
In order to implement an effective and efficient review process we encourage protocl developers to submit high quality protocols for review. Regen Registry will do an initial review and assessment of the protocol to determine if it is ready to proceed with the review process of if it needs additional work before engaging in that process. The Regen Registry will provide suggestions for improvement at this stage if is determined that the protocol requires more work before proceeding to the nest stage of the Review Process.
The intent of the internal review is to ensure that the protocol adheres to the requirements outlined in this Handbook and Guide and that the quality of the protocol framework is sufficient to warrant review by expert peers.
Regen Registry aims to complete the internal review in less than four weeks. If the protocol still requires updating, it will be returned to protocol developers with feedback on how to improve it. Otherwise, the methodology review lead will approve the methodology to proceed to the Expert Peer Review stage.
The Expert Peer Review will focus on ensuring that the proposed protocol is scientifically robust and likely to produce the expected outlined results. Regen Registry will hire a minimum of two peers from the expert community that have sufficient expertise to evaluate the proposed protocol. We may use the list of potential expert peer reviewers submitted with the protocol and will identify additional reviewers at the discretion of the protocol review lead. This selection process can take a few weeks to accomplish. More information about the process that reviewers will follow can be found in the section below. When the protocol review lead is satisfied that the protocol is acceptable the protocol developer will be notified and the final phase will begin.
We will be using a single-blind review process where the names of the protocol developers are known throughout the process but the expert peer reviewers remain anonymous until review have been completed. At that time the expert peer reviewers have the option of being listed as reviewers on the protocol listing.
Once a reviewer accepts to review a protocol they will have four weeks to provide feedback. In some cases more time will be allotted to accommodate reviewer scheduling constraints.
Expert Peer Reviewers will fill in a Revision Report with suggested comments. This report if passed to the protocol developer by the protocol review lead.
The protocol developer is required to address each comment and provided a tracked changes new version of the protocol along with responses to each comment in the Revision Report so that the expert peer reviewer may check that each of their comments were addressed in a complete manner. If necessary, the protocol review lead will request additional feedback to clarify expert peer reviewer feedback that is not clear or is contradictory.
Once the expert peer reviewer has completed the reponses check the protocol review lead will decide if the protocol needs to go out for a second (or more) round of expert peer review to resolve any comments. If it goes out for review again, an effort will be made to use the same reviewers (if they formerly accepted to review future versions) or new reviewers will need to be found. If new reviewers are used, they will be made aware this is a revised methodology and they will need to have access to the revisions and past comments.
The task of a reviewer is to provide critical feedback to the protocol developer to help them improve the protocol. The reviewer should consider themselves an ally of the protocol developers.
The protocol review lead will contact potential reviewers until a minimum of two people commit to review the methodology. When a potential expert peer reviewer is contacted they will be offered a stipend to complete a review at the discretion of the protocol review lead.
If a review cannot be submitted within the three week time period, the expert peer reviewer should contact the protocol review lead as early as possible to request an extension.
The review should provide feedback on the validity of the protocol. Specifically it should address the following:
Is the protocol clearly written with adequate detail for implementation?
Is the underlying foundation of the protocol clear?
Is the protocol feasible?
Will the proposed protocol achieve the defined results?
Are the sampling and measurement protocols robust?
Are there any alternative or additional steps that should be considered?
Any additional questions noted by the protocol review lead
Is governance and stakeholder engagement clearly outlined?
In addition to review comments, the expert peer reviewer should also indicate if they are willing to review a future version of the protocol and if they want to be named in the review.
After the 14 day Public Comment period, the protocol review lead will compile comments and synthesize them before sending them to the protocol developer. If there are major concerns that cannot be confidently resolved within Regen Registry, input from the expert community will be requested. Also, some clarification might be requested from the commenters when necessary by the protocol review lead.
After a protocol has successfully completed the Expert Peer Review process it will advance to the final Public Comment stage. Comments about the protocol will be solicited from the general public for a period of 14 days. The public commenting period will be announced on and Regen Network Development (RND) typical social media platforms (ie and ).
Protocols open to Public Comment are posted on the page. Comments can be made through the Public Comment link found on the posting page. People submitting comments directly will have the option to remain anonymous (the default option) or they can request to have their name attached to the comments.
Comments should be constructive and developed with the intent of improving the protocol and in the spirit of an ally with the protocol developer. The points noted in the section can be used to guide the types of comments we are looking for.
The protocol developer will have six weeks to respond to the synthesized comments and return the revised protocol, along with responses to feedback, to the protocol review lead. The internal Regen Registry team will review the changes and decide if the protocol is sufficient to be accepted into the , or if more work is required. If more work is required, the protocol review lead will request the protocol developer to make specific changes and resubmit to the internal team.