ADACC: Data Use, Publications, and Presentations Policy

Please note that the information provided below may be subject to change.

If you would like

Any member of the ADACC Steering Committee can serve as the lead author for an analysis or manuscript proposal. All proposals from external collaborators must have a sponsoring member of the Steering Committee who will work with the lead author as needed.

1. Publications, Presentations, and Analyses Originating from ADACC Steering Committee, Executive Committee, and Working Groups

Analysis, presentation, and manuscript ideas that are developed by the Steering Committee, Executive Committee, and Working Groups do not require formal review and approval prior to submission to the Data Coordinating Center for work to begin. However, all scientific presentations and publications given or published on behalf of the ADACC network should meet the following requirements:

At least one of the ADACC Network principal investigators should be included as an author on the publication or presentation (Michele Mielke, Nicole Fowler, Thomas Karikari, Jeff Williamson)
The opportunity to serve as an author on the publication should be extended to the NIH Scientific Officer (Marcel Salive)
The final version of the publication or presentation should be reviewed and approved by the ADACC Executive Committee
A statement acknowledging that “funding for the ADACC Network is supported by the National Institutes of Health/National Institute on Aging (U24AG082930). This material should not be interpreted as representing the official viewpoint of the US Department of Health and Human Services, the National Institutes of Health, or its represented agencies”

2. P&P Committee for External Collaborator Requests

a. Composition

The ADACC P&P Committee includes 6 rotating members of the ADACC Steering Committee who will serve as primary reviewers, representatives from the ADACC Data Coordinating Center, and at least one representative from the ADACC Executive Committee.
b. Meeting Schedule
The P&P Committee will meet at least monthly during Years 3-5.

3. Proposal Types
Any of the following proposal types that include use of ADACC data require review and approval from the P&P Committee:

• Manuscript – planned submission to peer-reviewed journal
• Abstract – summary of intended poster or short presentation for scientific conference/meeting
• Presentation – poster or slides for scientific conference/meeting • Funding Application
• Collaborative or Consortium Paper – manuscript using ADACC data in conjunction with data from one or more other study cohorts
• Thesis, Dissertation, or Academic Project

4. Proposal Development and Submission
All proposals must be reviewed and approved by the P&P Committee prior to development of an ADACC manuscript or other publication. A list of all ADACC publications, approved proposals and approved manuscripts to date is available on the website. Prospective authors should review this list before developing a proposal to avoid overlap. If overlap is identified, the prospective author may either drop the idea, contact the lead author of the initial proposal to determine if overlap can be avoided through selective data analysis and reporting, or discuss the possibility of joining the writing group should the lead author be in agreement. A summary of these discussions should be forwarded to the P&P Chair for final approval. In the event that overlap should be identified following a proposal’s approval from the P&P Committee, the authors may be asked to cease their writing or to work collaboratively.

To encourage timely completion of manuscripts, investigators are not allowed to lead more than 3 papers at one time. Petitions for exceptions to this rule may be sent to the P&P Chair and ADACC Executive Committee.

All proposals must contain the specific information outlined in the Manuscript Proposal Template (Appendix 1). All definitions, criteria and data to be used in the manuscript should be included in the proposal. Statistical power estimates should also be included whenever possible.

Prospective authors are encouraged to contact the biostatisticians in the ADACC Data
Coordinating Center during the proposal development process in order to enhance the quality of the analytical plan, assure sample size for statistical power, and to begin to formulate a thoughtful approach to data analysis.

All proposals should include pooled analysis of at least two of the observational or real-world cohorts. No requests to use data from only a single study or cohort will be considered. The ADACC Data Coordinating Center will not serve as a pass-through for access to data from individual cohorts.

Proposals are reviewed during P&P Committee monthly meetings and submissions of proposals to P&P for review should be done at least 10 days in advance of the meeting.

Upon receipt of a manuscript proposal, the proposal is added to the next P&P agenda. Two committee members will be assigned to review the proposal for scientific merit, analytic issues, policy issues, concerns regarding interpretation of findings, overlap with other ADACC papers, etc., using a standard review form. Assignments for reviewers are made based on manuscript focus, matched to reviewer expertise. At that time, the committee will decide on the recommended course of action. This includes: approved, approved with recommended changes, approved with required changes, revise and resubmit to primary reviewers, revise and resubmit (to full committee), and disapproved. Committee recommendations and reviews are provided to prospective authors within one week after the meeting in which the proposal was reviewed. If additional committee review is recommended, prospective authors should submit their revised proposals to the committee for a second review ideally within 3 months. If a proposal is designated for review to primary reviewers, those reviewers will be given 2 weeks to complete reviews.

Once a proposal has received committee approval, a writing group is formed, which includes the authors listed on the proposal and other investigators who are interested in participating and who have expertise in the proposal’s subject area. The writing group nomination process is described in section 5.

Once a proposal is submitted and approved by the P&P Committee, the authors are expected to submit the corresponding manuscript for Committee review within 6 months. Following manuscript approval, authors must submit the paper to a peer-reviewed journal for publication within 3 months.

5. Selection and Formation of Writing Groups

The authorship for most ADACC manuscripts is determined through the formal writing group selection process after a proposal is approved and listed for co-author nominations. Proposals are generally circulated to the ADACC Steering Committee and Working Groups within the 2 weeks following the P&P Committee’s approval of a proposal, with a 2-week nomination period. Within the 2-week period, ADACC Steering Committee members may nominate themselves or a qualified colleague to participate in a writing group. Nominations must be submitted electronically through REDCap. All investigators listed as authors on a proposal will be included in the writing group; they do not need to be formally nominated.

The following guidelines apply to writing group formation:

The P&P Committee does not restrict the number of authors per paper; however, investigators are encouraged to keep in mind the limitations established by their target journal.
Criteria for selection of writing group members will include level of expertise (related to the manuscript topic), support of authorship by early career scientists, balanced representation across participating institutions, and consideration of individual commitments to other ADACC writing group endeavors.
Sufficient ADACC Steering Committee members should be represented on manuscripts to reflect their scientific contribution to the project as well as expertise in the content area. If the number of nominees causes the total writing group membership to exceed a reasonable limit (typically 12-13 authors) the lead author may request to exclude a select number of nominees and may provide rationale for specific nominees to be excluded. Ultimately, the P&P Chair will make a final impartial selection to limit a writing group.