Investigators who join the Pediatric Brain Injury Research Network: (1) do so without any actual or implied commitment of funding support from the network itself; (2) in the absence of contractual, funded, research relationships, are free to leave the network at any time; (3) must agree to abide by the terms of this Network Governance Agreement; (4) must obtain IRB approval prior to onset of local research activities; and (5) must commit to capture complete data regarding every hospitalized child meeting study inclusion criteria.
A single PediBIRN investigator from every participating site: (1) will serve as the site Principle Investigator (site PI), responsible for all local PediBIRN research activities, investigators, and the integrity and completeness of on-site data capture; and (2) can be appointed to the network’s Executive Committee.
The Network Coordinator will: (1) coordinate and direct the activities of the Pediatric Brain Injury Research Network; (2) maintain and improve the PediBIRN website, its data capture software, and its data management capabilities; (3) monitor and assure the integrity and completeness of data capture at every participating site; (4) post periodic reports on the PediBIRN website to update network investigators and study PIs regarding the status of pooled data capture; and (5) clean, organize and release data to study PIs when appropriate and required for data analysis; and (6) direct the network’s Executive Committee.
PediBIRN investigators who contribute actively to the network’s pooled data: (1) will retain unlimited access to the data collected at their site; (2) can include that site-specific data in any presentation or manuscript without prior approval of the network; (3) can request participation in the authorship of any manuscript that required analysis of the network’s pooled data, if data from his/her site were used; and (4) can submit a written proposal(s) to direct a new network research study, based upon a novel analysis of the network’s pooled data.
PediBIRN investigators whose research proposals are approved by the network’s Executive Committee: (1) will be designated the study Principle Investigator (study PI) of the new, approved, network research study; (2) will assume primary responsibility for data analyses required to complete his/her approved network research study; and (3) will assume primary responsibility for authorship of manuscripts that derive directly from his/her approved network research study.
Study PIs with primary responsibility for authorship of a manuscript: (1) will require that named authors participate actively in manuscript writing, editing and/or re-writing; (2) must approve each contributing author prior to his/her participation in manuscript preparation; (3) will have the right to limit the total number of authors; (4) will determine the position or order of authors’ names on the manuscript, based upon each author’s specific contribution to writing, editing and/or re-writing; (5) will forward a final draft of the manuscript to the Network Coordinator prior to submitting the manuscript for publication; and (6) will allow 2 full weeks to receive feedback from the network’s Executive Committee, before deeming lack of feedback to imply network endorsement of the manuscript.
Any manuscript endorsed by the network’s Executive Committee and submitted for publication: (1) must include written acknowledgment of PediBIRN affiliation, in a format to be specified by the network’s Executive Committee; (2) must include the phrase “for the PediBIRN investigators” or “and the PediBIRN investigators” at the end of the list of named authors; and (3) must include a boilerplate acknowledgment of up to 3 network investigators at each participating site.
The network’s Executive Committee will review, provide feedback, receive and review revision(s), and thereafter vote to (either) endorse or not endorse: (1) final drafts of PediBIRN manuscripts to be submitted for publication; (2) network investigator proposals for new network research studies; (3) study PI requests for modification(s) or expansion of an approved network research study; and (4) network investigator requests to replace a site PI, a study PI, or the Network Coordinator. Endorsement by the Executive Committee will require a simple majority vote.
The network’s Executive Committee will consider and/or arbitrate any and all requests, queries, or disputes regarding: (1) authorship of manuscripts that required analysis of the network’s pooled data; (2) oral presentations that present analysis of the network’s pooled data; (3) the scope and/or limits of an approved network research study; (4) prospective research definitions and/or criteria to be adopted by the entire network; and/or (5) editing or expansion of the core data set represented in the network’s standardized, online data forms. Decisions by the Executive Committee will require a simple majority vote.