Authorship
General Guidelines:
In recognition of collaborators time and effort contributing cases to the Pediatric Covid-19 U.S. Registry, the leadership team will strive to be as inclusive as possible, while always adhering to the current International Committee of Medical Journal Editors (ICMJE) recommendations.
Per the ICMJE recommendations, authorship will be based on the following criteria:
Authorship is restricted to those centers contributing cases and/or individuals providing significant support to the published work as described above.
The study leadership team reserves the right to make final decisions regarding study authorship.
Authorship Order
For centers contributing cases, authorship order will be based on number of cases submitted.
Acknowledgement
All contributing centers and contributors will receive acknowledgement in all publications utilizing the data from this registry.
In recognition of collaborators time and effort contributing cases to the Pediatric Covid-19 U.S. Registry, the leadership team will strive to be as inclusive as possible, while always adhering to the current International Committee of Medical Journal Editors (ICMJE) recommendations.
Per the ICMJE recommendations, authorship will be based on the following criteria:
- Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
- Drafting the work or revising it critically for important intellectual content; AND
- Final approval of the version to be published; AND
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”
Authorship is restricted to those centers contributing cases and/or individuals providing significant support to the published work as described above.
The study leadership team reserves the right to make final decisions regarding study authorship.
Authorship Order
For centers contributing cases, authorship order will be based on number of cases submitted.
Acknowledgement
All contributing centers and contributors will receive acknowledgement in all publications utilizing the data from this registry.
DATA Transfer AGREEMENT (dTa)
As a coordinating center we do not require Data Transfer Agreements to participate in the Pediatric Covid-19 Registry. We understand that some institutions require a DTA to participate in the registry, and have made a template available under study documents for your usage.
Research proposals
Requests for De-Identified Case-Level Data Policy:
Overview:
Requests for use of Pediatric COVID-19 U.S. Pediatric Registry data for the purposes of research must be submitted using the Research Proposal Form by the principal investigator of the project or their designee. Registry data may only be used for the research purposes described on the form.
Requirements:
Proposal Review Procedure:
Requests for research studies, presentation, publications and pilot studies go through a review process prior to approval. This process includes several steps:
1. Review by the Registry Coordinating Center (RCC) team. The RCC team will conduct an administrative review of each proposal, which includes reviewing the proposal for completeness and clarity. The RCC will contact the researcher with any questions or requests for additional information to ensure the proposal is complete before it is reviewed by the Registry Leadership Committee.
2. Review by the Registry Leadership Committee (RLC). After the RCC team review is complete, the proposal will be scheduled for review by the RLC. The RLC will review proposals based on the following criteria:
After the RLC has reviewed the proposal, the RCC staff will contact the proposal requestor with results of the review.
3. If a proposal is approved, the RCC team will work with the researcher to finalize the variable list, IRB approvals, secure data transfer, timeline, citation of the registry in subsequent published work, acknowledgements, and plan for reporting publications and conference presentations.
The RLC and RCC reserve the right to update the Requests for De-Identfied Case-Level Data Policy and requirements as needed.
Overview:
Requests for use of Pediatric COVID-19 U.S. Pediatric Registry data for the purposes of research must be submitted using the Research Proposal Form by the principal investigator of the project or their designee. Registry data may only be used for the research purposes described on the form.
Requirements:
- The Pediatric COVID-19 Registry requires trainees, fellows, and/or students to have a mentor assigned to the project to provide guidance and support as needed.
- Prior to data being released, the researcher will be required to demonstrate that their proposal has scientific merit and institutional IRB approval and documentation (or documentation of IRB review waiver). The researcher must also provide any documentation of subsequent annual renewals or modification reviews completed by their local IRB.
- Researcher will NOT re-release data or use the data for any projects other than the registry approved proposal.
- Due to current capacity limitations, the coordinating center cannot provide statistical support for proposed research.
- All abstracts and manuscripts must be reviewed by the coordinating center prior to presentation or publication.
Proposal Review Procedure:
Requests for research studies, presentation, publications and pilot studies go through a review process prior to approval. This process includes several steps:
1. Review by the Registry Coordinating Center (RCC) team. The RCC team will conduct an administrative review of each proposal, which includes reviewing the proposal for completeness and clarity. The RCC will contact the researcher with any questions or requests for additional information to ensure the proposal is complete before it is reviewed by the Registry Leadership Committee.
2. Review by the Registry Leadership Committee (RLC). After the RCC team review is complete, the proposal will be scheduled for review by the RLC. The RLC will review proposals based on the following criteria:
- The request is feasible given the data available in the registry.
- The study design, scientific merit and rigor are in accordance with the registry intent.
- The research proposal is not too similar to the planned/published registry manuscripts as well as previously under review or approved proposals. If two proposals are similar, the RLC will encourage collaboration between groups submitting similar proposals.
After the RLC has reviewed the proposal, the RCC staff will contact the proposal requestor with results of the review.
3. If a proposal is approved, the RCC team will work with the researcher to finalize the variable list, IRB approvals, secure data transfer, timeline, citation of the registry in subsequent published work, acknowledgements, and plan for reporting publications and conference presentations.
The RLC and RCC reserve the right to update the Requests for De-Identfied Case-Level Data Policy and requirements as needed.