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Publications Policy

Date Approved: March 16, 2022
Date of Last Update: March 16, 2022
Version: 1.0

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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 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. Here, “PRIMED investigator” is equivalent to “PRIMED member” (see Related policies for membership definitions).

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 and Presentations (P&P) 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 and Presentations (P&P) Committee

The PRIMED Publications and Presentations (P&P) 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 or disapproval to the Steering Committee
  • 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 P&P Committees from other consortia

The P&P Committee comprises two representatives (one primary and one alternate, which can rotate) from each Study Site, CC, and the NIH program office. Each group (each Study Site, CC, and NIH program office) will have one vote. The Executive Committee will name co-chairs to the P&P 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.

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), 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 P&P review. Any disagreements between the P&P 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 P&P 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 P&P Committee, with the Steering Committee given an opportunity to raise any concerns or additional comments.
    • Members of the P&P Committee will review the proposal for completeness and non-overlap with existing proposals. The P&P review and comment period will last two weeks. 
    • The P&P Committee will recommend either “approve” or “disapprove,” based on the members’ consensus. Disapproved proposals can be revised and resubmitted for a second round of review by the P&P.
    • Proposals that are recommended for approval by the P&P 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.
  • 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.

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.

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

Each proposal typically will focus on one phenotype or one specific hypothesis / analysis. In all cases, each proposal should result in one manuscript. Omnibus proposals that encompass many phenotypes and many analyses or those that are anticipated to result in several manuscripts are discouraged, and proposers will be asked to break down proposals into components.

The P&P Committee will periodically review and request updates on proposals. Proposals with no progress for a six month period, 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 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. The CC maintains a list of members of the banner on the Consortium website. For manuscripts deriving from PRIMED Working Groups, it is at the discretion of the Working Group to determine if a banner authorship for the Working Group is appropriate.

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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.

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.

Manuscript acknowledgements sections should include PRIMED grant numbers.

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, 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.

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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

V1.0 - Initial Policy

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