NA-ACCORD PROPOSAL DEVELOPMENT & PUBLICATION POLICY
The NA-ACCORD welcomes all who are interested to participate in research.
If you are interested in collaborating with us, please review our Collaboration Polices below and our brief description of the collaboration process then download a Concept Sheet template.
Links to key sections:
I. PROPOSAL DEVELOPMENT
The policies in this section have been developed to ensure that these important multi-center research findings from the NA-ACCORD are developed collaboratively, efficiently, and fairly. Additionally, it is the purpose of this policy to ensure an efficient, fair, and coordinated collaboration with other outside investigators or other cohort studies on all research questions deemed appropriate for joint analysis.
To address our scientific agenda, the pooling and harmonizing of high-quality and timely data from established cohorts to create a sufficiently large and up-to-date data set is required. This endeavor will create an understandable tension between the aspirations of investigators involved with individual cohorts and those of the collaborations as a whole. Issues naturally will arise concerning ownership of data, report writing, publication, and attribution. Therefore, the following principles will guide our scientific agenda.
- Ownership of individual cohort data remains with the contributing cohort. As an entity, the NA-ACCORD will not own any data.
- Data transmitted to and residing at the Data Management Core (DMC) or the Epidemiology /Biostatistics Core (EBC) will be a ‘limited dataset’ as defined by HIPAA criteria.
- An individual cohort can choose to withhold their cohort’s data from participation in any scientific aim or sub-aim.
- All cohorts will have input and one vote in the Steering Committee (SC) irrespective of contributing data to a specific scientific aim or question.
- Collaborating cohorts commit themselves to supplying data elements as specified by the DMC and EBC and in a timely manner.
- Data transmitted to the DMC by an individual participating cohort will be updated annually and used only to address specific scientific questions approved by the SC. The data will not be used for unrelated questions without the express permission of that cohort.
- After a scientific question has been addressed (e.g., analysis, generation of final reports and manuscripts), the programming code that gave rise to the findings for that question will be archived at the EBC.
The research proposal and publication policy is designed to address all investigations that may use data compiled in this study as outlined in the NA-ACCORD research agenda. Several categories of investigations are described below. The bases for determination of these definitions will, over time, fall to the Executive Committee (EC).
- Primary Investigations are those utilizing NA-ACCORD data management and analytical resources to address research questions relating to the NA-ACCORD Specific Aims. These investigations and publications will have highest priority for study resources.
- Secondary Investigations are those that rely upon NA-ACCORD data but are not directly related to the NA-ACCORD Specific Aims. Multi-regional IeDEA collaborations fall into this category. NA-ACCORD investigators may also propose such investigations on their or their consortium's behalf.
- Collaborative Investigations are those research efforts involving collaboration with groups external to NA-ACCORD and IeDEA that are designed to accomplish study objectives specified as core in the study protocol.
The NA-ACCORD EC and AC are responsible for overseeing specific written and oral communications concerning core hypotheses/research questions for publication and presentation at scientific meetings. Research questions of primary interest are those that are part of NA-ACCORD Specific Aims. Submissions dealing with these primary hypotheses will have priority over secondary submissions, both in terms of timing and in use of study resources for data analysis.
- Submission of Proposals. Any investigator who can be reasonably expected to be able to conduct the proposed work is eligible to submit a concept proposal to NA-ACCORD. This includes, but is not limited to, researchers at NA-ACCORD sites, members of NA-ACCORD Scientific Working Groups (SWGs), and funding entities. Investigators who do not fulfill this definition can submit proposals, but should do so in collaboration with an NA-ACCORD investigator (liaison) that has the responsibility of assisting the lead investigators in shepherding the CS through the NA-ACCORD proposal development process.
Proposals must be drafted using the Concept Sheet (CS) template and should be sent via email to the Administrative Core (AC) following instructions provided in the CS template. The AC will work with CS lead investigators and the EBC to ensure the goals of the proposal are feasible with NA-ACCORD data. If the CS is relevant to one or more NA-ACCORD SWGs, the CS will be reviewed by those SWGs prior to moving on to the next steps in the CS review process.
- Review and Approval of Proposals. The review process seeks to ensure that approved proposals are a) scientifically sound; b) methodologically viable; c) feasible within the limits of NA-ACCORD resources; and d) not duplicative of ongoing efforts. Any approved study carries the endorsement of the NA-ACCORD and its parent, IeDEA, and therefore, implies a certain level of quality. As such, only those proposals possessing the highest scientific merit should be approved.
After the CS investigators receive and respond to comments from the relevant NA-ACCORD SWGs, the AC will circulate the submitted CS to the EC for approval. All proposals, including investigators from biotech and pharmaceutical companies, will be examined during the review by the EC to confirm feasibility, establish prioritization, and provide specific advice on the use of resources so they are directed to the highest priority scientific questions.
Following EC approval, the CS will be forwarded to the SC for review and feedback. A targeted end date for SC review and approval will be set for two weeks after the review request is sent to the SC. If needed, this deadline will be extended to accommodate cohorts who need more time for the CS to pass through approval processes of their cohort. Each cohort must decide through its own established procedures whether 1) they agree that the proposal is scientifically sound and the NA-ACCORD should allocate resources (via data sharing or EBC analyses) for the proposed research, 2) their cohort wishes to contribute their data to the proposed research aims, and 3) recommend cohort representative(s) to be part of the Writing Group (WrG) associated with the CS. If an individual cohort does not participate, it will continue to maintain input on the SC regarding the science relevant to that proposal.
Following the SC review, the AC will summarize all comments received and circulate the summary to the CS leads to formalize the outcome of the SC review. The authors must either respond satisfactorily to comments without need for a revised protocol or re-submit a revised version of the CS to the SC for approval. This process may be repeated as necessary until approval is granted by the SC. Once the proposal is accepted, the AC will facilitate discussions between CS investigators, the EBC, WrG members, and appropriate SWGs. Subsequent amendments to the proposed aims in the CS require review by relevant SWGs and SC. CS leads should contact the AC for assistance with this process.
If overlapping proposals are received, the EC will present the overlapping issues to the CS leads of the overlapping projects and invite suggestions as to how the issues of overlap may be remedied. This may include (but is not limited to) revising and re-submitting one of the overlapping proposals to remove issues of overlap or combining the aims into a single proposal that is submitted for review as an amended CS.
Each step in the review and approval process of submitted research proposals is tracked by the NA-ACCORD AC.
D. Formation of Writing Groups.
The investigator who submits the approved CS will be chair of the writing group (WrG) for that proposal unless they indicate someone else. Additional WrG members will be recommended by each of the collaborating cohorts during the SC review process. WrG chairs have primary responsibility for completion of the analyses and preparation of the publication. A group email address specific to the WrG will be set up by the AC to facilitate communication among WrG members. As membership in the WrG is open during the course of the analyses and through the manuscript approvals process, the AC will manage the WrG-specific e-mail address to ensure it accurately reflects all members.
The investigator who submits the approved CS will be chair of the writing group (WrG) for that proposal unless they indicate someone else. Additional WrG members will be recommended by each of the collaborating cohorts during the SC review process. WrG chairs have primary responsibility for completion of the analyses and preparation of the publication. A group email address specific to the WrG will be set up by the AC to facilitate communication among WrG members. As membership in the WrG is open during the course of the analyses and through the manuscript approvals process, the AC will manage the WrG-specific e-mail address to ensure it accurately reflects all members.
Specific tasks of the writing chair include:
- Establish and maintain, with assistance from AC, effective communication and collaboration with all members of the WrG (see authorship policies listed above)
- Determining and obtaining consensus on authorship order
- Coordinating with AC to ensure that data analyses are distributed to WrG members in a timely fashion
- Notifying the AC of significant problems or delays in completion of analyses or writing of drafts, or the need for changes in authorship
E. Data and Analysis Requests.
Once the project is approved, analyses will be conducted by either the EBC or the CS leads (via data sharing to the CS leads), depending on details provided in the approved CS. The AC will facilitate communication between the CS lead investigator(s) and the EBC to finalize details of the study design, create an analytic data sets, and move forward with data analysis or data sharing. For NA-ACCORD data sharing, the SC will note approval of sharing their cohort’s data through the CS review process. There must be a Data Use Agreement (DUA) in place between NA-ACCORD and the entity receiving the data. Data used for analyses will be limited to cohorts who have approved use of their data for the aims outlined in the associated CS. After all approvals are in place, the EBC will share the data with the CS leads.
II. PUBLICATION POLICY
Final abstracts, manuscripts, and presentations must be reviewed and approved by the SC before any presentation to a scientific meeting or prior to submission for publication. These requests will be expedited by AC based on deadline dates and must meet NA-ACCORD, IeDEA and NIH guidelines.
NA-ACCORD adheres to the ICMJE authorship guidelines, which are based on the following 4 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.
Additional details can be found at www.icmje.org
NA-ACCORD protocol does not automatically grant authorship with data use or appointment to a Writing Group (WrG). During the CS review process, we solicit WrG members from all collaborating cohorts, regardless of whether or not their data will be used. This is the first step in becoming a co-author. If someone is not part of the initial WrG, they still have the opportunity to become a co-author by providing substantive feedback during the SC review process prior to the scientific product being made public (e.g. prior to manuscript submission).
All co-authors are expected to make substantive contributions based on the criteria for authorship listed above at some point throughout the review process, and must participate in the writing and/or review process in a timely manner. If a co-author does not participate, he or she may be removed as a co-author at the discretion of the AC and WrG chair. If a co-author disagrees with a manuscript, abstract, presentation, or finds the data or analysis misleading, he/she must resolve these issues with the WrG or request to be removed as a co-author.
Primary authorship shall be fairly distributed among each of the collaborating cohorts; this distribution shall be monitored and promoted by the AC. Disagreements or problems with individual author participation should initially be addressed to the WrG chair. If this fails, formal grievances regarding credit or authorship shall be directed to the AC.
For manuscripts or abstracts which have a restriction on the number masthead authors, the priority authorship would be (1) investigators working directly on the project; (2) investigators who are part of the WrG from among cohorts that contribute data; (3) investigators who are part of the WrG from among cohorts that don't contribute data; (4) other cohort representatives. If the authorship restriction is less than the number of investigators from a priority group, then the masthead would include members from group (1) and state “for the NA-ACCORD of IeDEA”. If group (1) is larger than the allowed number of masthead authors, then the WrG chair will be responsible for final selection of authorship.
When a draft manuscript is ready for review, the WrG chair must submit the draft to the WrG for review and feedback. The WrG will have at least one week to review the manuscript and provide feedback. Contact the AC if assistance is needed with this step. Once the manuscript has been approved by the WrG, it is then submitted via email to the AC (naaccord@jhu.edu) for SC review.
The AC will make sure the WrG chair receives all comments and suggested revisions raised during SC review of the manuscript and will facilitate responding to SC reviewer comments. If significant changes are made to the manuscript following SC review, a revised version must be re-submitted to the SC for review and approval before the manuscript can be submitted to a journal.
A manuscript cannot be submitted to a journal until all co-authors have approved of the manuscript. The WrG chair will notify the AC when the manuscript has been submitted and continue to provide updates to the AC on the status of the submission. Once the manuscript is accepted for publication, a copy will be distributed to the WrG and co-authors.
Final abstracts and presentations must be submitted to the SC for review and approval at least one week prior to submission to a formal scientific meeting. The associated WrG should have reviewed the abstract or presentation prior to submitting to the SC for review.
When submitting drafts of abstracts and presentations for SC review, the following information must be included: name and dates of conference, submission deadline, abstract title, and co-authors. The AC will submit abstracts and presentations to the SC for review and they will have at least one week to review and provide feedback. The AC will provide the WrG chair with a summary of all comments received. The WrG chair will have the responsibility to review the final abstract to be sure it incorporates critical comments and send a copy of the final/submitted version to the AC for distribution to the WrG. In addition, the WrG chair will forward adjudication results to the AC for distribution to the SC and WrG.
Acknowledgement of funding sources and contributing cohorts is essential for all scientific products using NA-ACCORD data. All manuscripts, abstracts, and presentations will acknowledge that the data were collected through the NA-ACCORD and credit all collaborating cohorts using the NA-ACCORD acknowledgement template. The authorship byline should also include “for the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of the International epidemiology Databases to Evaluate AIDS (IeDEA).”