Publications Policy

Date Approved: June 21, 2023

Date of Last Update: December 1, 2023

Version: 4.1

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Purpose

The PRIMED Publications Policy is intended to create transparency, foster collaboration, and ensure timely sharing of proposals and products within the PRIMED Consortium (hence, “Consortium”). The Policy aims to streamline processes for single-site activities while also encouraging multi-site collaboration and contribution wherever possible. Opportunities for early-stage investigators are also emphasized. The Policy was initially drafted by the PRIMED Executive Committee with guidance and ultimate approval from the PRIMED Steering Committee.

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Scope

This Policy applies to any scientific work carried out by PRIMED investigators under the auspices of their PRIMED funding and that is central to the scientific mission of PRIMED (i.e. fitting within the aims of the PRIMED grants). Scientific work carried out by PRIMED investigators that is making use of PRIMED resources (e.g. AnVIL resources, software tools and workflows, individual- or summary-level datasets, PRS models) is also within scope. Here, “PRIMED investigator” is equivalent to “PRIMED member” (see Related policies for membership definitions). Note it is expected that any work that cites one or more PRIMED grants (e.g. in an Acknowledgements or Funding section) is within scope.

This Policy does not apply to the following activities:

• Proposals, manuscripts, and abstracts from non-PRIMED investigators.
• Proposals, manuscripts, and abstracts led by non-PRIMED investigators for which one or more PRIMED investigators provide consultation and input that does not use data from or leverage their position in PRIMED.

However, if a PRIMED investigator’s contributions to an external paper substantially leverage the investigator’s role in PRIMED, e.g. through specific Working Group participation or data access, then the activity is within scope.

PRIMED investigators collaborating on proposals, manuscripts, and abstracts must assume responsibility for following PRIMED’s publications procedures and identify a point person to check that appropriate procedures have been followed.

Should there be uncertainty about whether the Policy applies, the investigator is encouraged to contact the PRIMED Publications Committee.

Notably, it is also incumbent upon PRIMED investigators to be aware of and follow policies beyond the scope of this Publications Policy. For example, the National Institutes of Health Genomic Data Sharing Policy, dbGaP policies, the Genomic Data User Code of Conduct, other consortium- or study-specific policies, and any other local or institution-specific policies. PRIMED investigators are also responsible for following other relevant PRIMED policies (see Related policies below) and to ensure that proposed work complies with the data use limitations and informed consents of the contributing study/cohort data.

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Publication priorities

Priority will be given to proposals that address the original aims of the applications funded in the PRIMED Consortium. Other single- or multi-site proposals (see Definitions) will also be reviewed. Multi-site proposals that maximize the value of the Consortium as a whole are strongly encouraged.

Working Groups should involve all members—particularly early-stage investigators—as early as possible in analyses, and provide opportunities for them to take active leadership and/or other contributing roles that merit authorship.

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Publications Committee

The PRIMED Publications Committee has the following roles:

• Revises and updates this Publications Policy as needed. As with other PRIMED policies:
  • Minor updates (i.e. wording changes, clarifications on existing policy elements) can be made without Steering Committee approval
  • Major updates, which substantively change or extend the policy, require Steering Committee approval
• Solicits and reviews updates on paper proposals
• Reviews multi-site paper proposals and recommends approval to the Steering Committee or requests revision from the submitter
• Reviews single-site paper proposals to assess if they are appropriate to become multi-site proposals 
• Adjudicates and resolves potential conflict or overlap among proposals, optionally in consultation with the Executive Committee
• Serves as PRIMED liaison to Publications Committees from other consortia

The Publications Committee comprises two voting members from each Study Site, CC, and the NIH program office. Each group can vote to approve or require revision on any given multi-site proposal. The Executive Committee will name co-chairs to the Publications Committee, to serve between one and two year terms each (staggered to allow overlap with incoming and outgoing chairs).

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Paper proposals

Paper proposals are required for both single-site and multi-site manuscripts. Proposals should be submitted as early as possible once the work is conceived to enable transparency, tracking, and the participation of additional sites and authors as appropriate.

Proposal submission and review

Proposals are submitted via an online form maintained by the Coordinating Center (CC) on the internal PRIMED Consortium website. The form contains basic information such as title, hypotheses, lead author(s), Working Groups involved, and datasets and phenotypes to be included. Upon submission, proposal forms will be viewable by all Consortium members on the internal website, including while they are under Publications review. Any disagreements between the Publications Committee or Steering Committee and the submitting author will be referred to the Executive Committee for resolution, whose decisions will be final.

• Proposals for single-site manuscripts will be submitted with no further approval required in order to move forward (i.e. “registry”).
  • The Publications Committee can recommend that a registered single-site proposal be re-submitted as a multi-site proposal; however, the lead author is not required to follow the recommendation.
• Proposals for multi-site manuscripts will be submitted and then recommended for approval by the Publications Committee, with the Steering Committee given an opportunity to raise any concerns or additional comments.
  • Members of the Publications Committee will review the proposal for completeness and non-overlap with existing proposals. The Publications review and comment period will last two weeks. 
  • The Publications Committee will recommend either “approve” or “needs revision,” based on the members’ votes. Voting procedures are detailed separately in the Committee charter.
  • Proposals that are recommended for approval by the Publications Committee will be available for review and comment by the Steering Committee for an additional week.
    • Absent any concerns raised by the Steering Committee during this one week period, the proposal will be approved.
    • Any comments or concerns from the Steering Committee will be communicated back to the Publications Committee for further discussion.
  • Proposals that need revision can be revised and resubmitted for a second round of review by the Publications Committee. 
• Proposals involving an external collaboration are routed to the Executive Committee (EC) at the same time as the Publications Committee (see Figure A1 in the Appendix).
  • Here, “external collaboration” is meant to capture collaboration with another consortium or network (e.g., eMERGE), versus the inclusion of one or few co-authors with specific technical or other subject matter expertise relevant to the project who are not members of PRIMED.
    • Collaborations included as part of original grant proposals are also not considered “external” for the purposes of this Policy. 
  • During the two week review period of the Publications Committee, the EC reviews and schedules a presentation by the proposer to the Steering Committee (SC). 
  • If the Publications Committee requests revisions on the proposal, the presentation to the SC and the SC vote is postponed.
  • The presentation to SC is to minimally cover:
    • A brief description of the project including what gap it is addressing, who is involved, what resources would be needed (e.g. data, AnVIL), and expected products.
    • How the proposal aligns with PRIMED program objectives and what is the mutual benefit to the external collaborators (e.g. eMERGE)
    • How the collaboration would be structured, e.g. what PRIMED and eMERGE working groups are involved; where is the work being organized, discussed, and reported on?
  • The expectation is that SC members have read the submitted proposal form prior to the SC presentation and vote.
  • Following the presentation, the SC votes whether to approve the proposal or request revision.
• Once approved or registered as appropriate, proposals may be updated by the lead author(s) if needed. Major updates that substantively change the scientific scope or aims of the proposal will require re-review and approval.

Working Group involvement

PRIMED investigators are strongly encouraged to develop proposals within the context of a PRIMED Working Group, where co-chairs and other members can assist in developing the scientific content and identifying contributing groups and co-authors. Investigators are also strongly encouraged to discuss and refine their plans with the Population Descriptors and SEIPR WGs prior to submission; if consultation does not occur prior to submission, it should follow closely after submission. 

Proposals involving an external collaboration are required to have a designated host WG or sub-WG, selected based on thematic alignment. The host WG/sub-WG will not necessarily be responsible for organizing or leading the paper/project, but will provide a venue for brief progress updates, both in meetings, as appropriate, and via written monthly WG reports.

Proposals should provide leadership opportunities for early-stage investigators and foster multi-site collaboration wherever possible.

In all cases, each proposal should result in one manuscript. Omnibus proposals that are anticipated to result in several manuscripts are discouraged, and proposers will be asked to break down proposals into components. 

Proposal updates

Major status updates of proposals will be solicited annually (pre-print, publication, or no longer active), with the option for proposers to provide those updates at any time via the internal website. The Publications Committee may also request additional updates on proposals at its discretion. Proposals with no progress, particularly those that are causing delay of other projects led by early-stage investigators, may be subject to review and re-assignment of the proposal, restructuring of the writing group, or other actions.

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Collaboration and authorship

Facilitating cross-Consortium collaboration is a key element of the PRIMED Consortium and this Publications Policy. PRIMED investigators that can meet standard authorship criteria (see ICMJE standards) should be able to join as co-authors on any multi-site manuscript. Authorship should be discussed early in the process to enable substantive contribution and fairness in representation across Sites. Lead authors are encouraged to contact Site PIs, the CC, and the NIH program office to discuss contributions and authorship, ideally before multi-site proposal submission or soon after proposal approval.

The PRIMED Consortium banner author will only include PRIMED core members and is used to acknowledge individuals who contributed to the overall conduct of PRIMED but do not otherwise meet criteria for byline authorship for a given manuscript. PRIMED Principal Investigators (for Study Sites and the CC) and Program Directors (for NIH) determine who of the core members affiliated with their group should be on the banner author list and communicate that list (along with any update or changes) to the CC. Working Group and sub-Working Group chairs (past and current) are included in the banner. The CC maintains a list of members of the banner on the Consortium website. The Consortium banner author should be included on any publication that makes use of Consortium products or resources (e.g. AnVIL workspaces, harmonized datasets, etc.). 

For manuscripts deriving from PRIMED Working Groups, the inclusion and composition of a Working Group banner author is at the discretion of the Working Group.

The Acknowledgements section can be used to recognize individual contributors who do not meet ICMJE standards for byline authorship (see specifically ICMJE guidance on Non-Author Contributors); contributors named in the Acknowledgements section may also be members of the Consortium banner author.

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Abstracts

All accepted PRIMED conference abstracts should be submitted via an online form on the internal PRIMED Consortium website, maintained by the Coordinating Center (CC), for tracking and transparency. Abstract information can be submitted to PRIMED after acceptance to a conference but should ideally be submitted prior to presentation. Other types of PRIMED conference presentations (e.g. invited sessions, panel discussions) should also be registered with the PRIMED CC.

No approvals are required, but PRIMED investigators are encouraged to communicate within Working Groups when planning abstracts to enable collaboration and co-authorship.

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Manuscripts

Each manuscript in PRIMED must be the result of a registered single-site proposal or an approved multi-site proposal. Other types of Consortium manuscripts (e.g., commentaries, perspectives, marker papers) may originate in the Steering or Executive Committees; paper proposals should also be submitted for such manuscripts to enable tracking and transparency. 

It is the responsibility of lead author(s) to follow journal policies and any additional study- or consortium-specific policies (i.e. for datasets used) when preparing and submitting a manuscript for publication or pre-print. 

Internal NIH review is required for manuscripts with one or more listed NIH authors and/or when requested by NIH program staff. Manuscript abstracts should be provided to the NIH PRIMED Program Director at least 10 calendar days in advance of journal submission. In the event that internal NIH review would delay submission, the NIH program staff will be removed from the listed authors.

Manuscript acknowledgements sections should include PRIMED grant numbers for those Study Sites relevant to the publication, as well as the Coordinating Center (CC) when appropriate. Any Study Sites that contributed data, participated in the conception or implementation of analyses, or participated in manuscript preparation should be acknowledged. When data or resources provided or hosted (including on AnVIL) by the CC have been used, it should be acknowledged; there is a general expectation that the CC will be acknowledged on all multi-site manuscripts. Please see the example acknowledgements statement and grant numbers table. 

A complete list of PRIMED publications and pre-prints will be maintained by the CC on the public-facing Consortium website. Once published or pre-printed, the lead author will notify the CC via a form on the internal website, providing a PubMed ID and/or DOI, so that the Consortium website can be updated. 

All PRIMED publications shall be deposited in PubMed Central, in accordance with the NIH Public Access Policy; submission to preprint servers is acceptable.

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Related policies

• PRIMED Core Membership Policy
• PRIMED Affiliate Membership Policy
• (to come) PRIMED Data Sharing Policy

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Definitions

Single-site proposal or manuscript: a proposal or manuscript with authors from a single PRIMED Study Site or CC

Multi-site proposal or manuscript: a proposal or manuscript with authors from multiple PRIMED Study Site and/or CC

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Change log

• V4.1 - Adding minor clarification that work citing one or more PRIMED grants is within scope of the policy.
• V4.0 - 
  • Major: Per Publications Committee charter update to V2.0, each group should submit one vote when reviewing paper proposals. Approved by PRIMED Steering Committee on June 21, 2023.
  • Minor: adding a figure illustrating the review process for proposals involving an external collaboration
• V3.1 - Added subheaders and text formatting within “Paper proposals” section
• V3.0 - 
  • Major: Adding additional review and approval processes for proposals involving an external collaboration. Selection of host WG required for proposals with external collaboration. Approved by SC on June 21, 2023
  • Minor: Emphasizing WG involvement and consultation early in proposal development, in particular with the SEIPR and Population Descriptors WGs.
• V2.2 - Noting that WG and sub-WG chairs are included on the Consortium banner; adding information about NIH review of manuscript abstracts
• V2.1 - clarification to Scope section, guidance on non-author contributions, and moving example acknowledgements text to a dedicated webpage
• V2.0 - updates from Publications Committee meetings, July 1, 2022, August 5, 2022, and September 2, 2022
• V1.0 - Initial Policy. Approved by SC on March 16, 2022.

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Appendix

 

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