NA-ACCORD PROPOSAL DEVELOPMENT & PUBLICATION POLICY
The NA-ACCORD welcomes all who are interested to participate in research.
I. PROPOSAL DEVELOPMENT
The policies in this section have been developed to ensure that these important multi-center research findings from the NA-ACCORD be 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 participate or not 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.
- By agreeing to participate in a scientific project, participants 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 question 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 data for that question will be archived at the EBC. The SC and individual cohorts would have to approve any additional uses of these data.
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), a subcommittee of the Steering Committee (SC).
1. Primary Investigations are those utilizing NA-ACCORD data management and analytical resources to address research questions relating to NA-ACCORD Specific Aims. As shared data, these investigations and publications will have highest priority for study resources.
2. Secondary Investigations are those that rely upon data compiled by the DMC but are unrelated to study-wide hypotheses. NA-ACCORD investigators may propose such investigations on their or their consortium's behalf.
3. Collaborative Investigations are those research efforts involving collaboration with groups external to NA-ACCORD that are designed to accomplish study objectives specified as core in the study protocol. The major source of Collaborative Investigations will be the other regional IeDEA awardees. As specified in the IeDEA RFA, an international Steering Committee will identify questions and issues of importance that require the participation of multiple international cohort collaborations.
C. Primary Investigations
The NA-ACCORD Executive Committee (EC) is 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, funding entities, and biotech and pharmaceutical companies. Investigators who do not fulfill this definition can submit proposals, but should do so in collaboration with an NA-ACCORD investigator. Investigators should normally develop ideas in conjunction with an established NA-ACCORD Working Group. Proposals should be sent electronically to the Administrative Core (AC) to the attention of the NA-ACCORD Project Manager for posting and review. Outside investigators (those not directly supported by NA-ACCORD funding) should name an NA-ACCORD contact person who will have the responsibility to ensure the lead investigator has had the opportunity to share his/her ideas with appropriate Working Groups. The proposal will use the Concept Sheet (CS) Proposal Form.
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 imprimatur 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. All proposals from non-NIH funded investigators including investigators from biotech and pharmaceutical companies will also be examined during the review process by the EC to ascertain feasibility, establish prioritization and provide specific advice on the use of NIH resources so they are directed to the highest priority scientific questions.
The AC will circulate the submitted CS to the EC for approval to post to the forum. The EC will determine if the proposal is appropriate for NA-ACCORD consideration. Following EC approval to post, the CS will be added to the ‘Submitted Concept Sheets’ section of the forum and the SC will be invited to submit votes and comments. A targeted end date for voting will be set for two weeks after initial posting. 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 NA-ACCORD should allocate resources for the proposed research, 2) their cohort wishes to contribute data to the research and 3) recommend cohort representative(s) to be part of the Writing Group (WrG) abstracts, presentations, reports and manuscripts resulting from 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.
Once a majority of votes from collaborating cohorts have been received, the AC will summarize all votes and comments received and circulate the summary to the EC to formalize the outcome of forum voting. Following EC review, the AC will notify the CS lead investigator of the voting outcome. Author(s) of the CS must acknowledge, in writing, receipt of voting outcome. If comments from the SC necessitate revision of the CS, then the authors must go through all of the steps outlined above until approval is granted by SC. Once the proposal is accepted, the AC will facilitate discussions between CS investigators, WrG members, and appropriate Working Groups.
If overlapping proposals are received, the EC will present the overlapping issues to the SC and invite suggestions as to how they may be combined and re-submitted as one proposal, how they may be revised and re-submitted as two non-overlapping proposals, or to choose the proposal with the greatest overall merit.
Each step in the review and approval process of submitted research proposals is tracked via the NA-ACCORD Administrative website. In addition to the status of submitted research proposals, all associated documentation for the CS is available for download and review, such as a copy of the CS, summary of SC votes received, as well as abstracts and manuscripts resulting from the CS.
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 CS review process. WrG chairs have primary responsibility for completion of the analyses and preparation of the publication.
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 below for authorship policies)
- Determining and obtaining consensus on authorship order (for the writing committee)
- Coordinating with AC and study statisticians to ensure that data analyses are distributed to WrG members in a timely fashion
- Notifying the EC of significant problems or delays in completion of analyses or writing of drafts, or the need for changes in authorship
Data and Analysis Requests. Once a project is approved, the WrG chair will communicate with EBC and DMC to start collaboration in a study protocol that will detail the study design, creation of analytical data sets, and data analysis. Analyses will be conducted by the EBC, except where approval is given by the SC that analysis can be conducted by another entity (e.g., the Writing Group chair’s home institution). In this situation, the EBC will transmit the approved data to the institution conducting the analysis along with the necessary coding and formatting instructions. It is recognized that site-specific Data Transfer Agreements (DTA) may preclude data transfer from the EBC except with modification of the DTA. An exception to this policy is that no direct data transfer will be done to a biotech, pharmaceutical or other commercial entity.
It is anticipated that, during the analysis phase, EBC team members will primarily and intensively communicate with the WrG chair (and perhaps a few others). The WrG chair is responsible for updating other members of the writing committee, participating working groups and the EC.
Specimen Repository Requests. If repository specimens are required, the AC will facilitate discussions between writing committee, the Specimen Repository Working Group (SRWG) and representatives of cohorts that will contribute specimens to the investigation. Together, they will identify the specimens available for testing, determine the logistics for specimen delivery, and oversee the implementation of proper QA procedures. The SRWG and AC will work together to ensure that each cohort contributing specimens has proper approval from their IRB to do so.
Investigators must have independent funding to conduct a study that utilizes the specimens from collaborating cohorts. It is possible that data analyses being done at an entity other than the EBC may need independent funding, since the NA-ACCORD is not able to provide contractual funds to conduct analyses outside of the EBC.
D. Secondary Investigations
Secondary investigations refer to proposals with aims that are part of, but not directly related to, the primary hypotheses of the NA-ACCORD study. While the primary hypotheses shall have priority in terms of data analysis, proposals to study other scientific questions using NA-ACCORD data are encouraged. NA-ACCORD members may propose such studies on their own behalf or on behalf of other qualified investigators from their own or other institutions.
Secondary investigations must go through the same approval and development processes outlined above for primary investigations. SC review of such plans should assure that the study will not interfere, compete, or conflict with the conduct of the primary investigations in process at that time.
Cohort-specific studies that use NA-ACCORD resources must also be reviewed and approved by the SC. Cohort-specific proposals must have the approval of the principal investigator of the cohort(s) at the time of submission of the concept sheet.
Final abstracts, presentations, and publications of secondary studies must also be approved by the SC before any presentation to a formal scientific meeting or prior to submission for publication. These requests will follow the same approval process as outlined above, and will be accomplished in a timely fashion. The review will focus on the accuracy of the description of the methods and on the conclusions as consistent with the spirit of the NA-ACCORD.
E. Collaborative Investigations
The initial process for development and implementation of collaborative proposals involving external groups will be the same as with primary and secondary investigations in that a CS must be submitted to the AC and reviewed by the EC prior to posting to the forum for SC approval.
The AC will be responsible for initiating and facilitating discussions between NA-ACCORD WrG members and all parties contributing to the CS, as well as updating all members of the SC on the status of the joint proposal.
Many of collaborative projects with external groups will be investigations that are part of the IeDEA international collaboration. The Principal Investigator of NA-ACCORD is a member of the Steering Committee of the IeDEA. It is expected that the details of conducting joint IeDEA analyses, writing of manuscripts and publication will be decided by that committee and communicated to the NA-ACCORD SC via the AC.
II. PUBLICATION POLICY
Final abstracts, manuscripts, and presentations must be reviewed and approved by the SC before any presentation to a formal 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.
Co-author(s) must participate in the writing and/or review process in a timely manner. Once the manuscript has been approved by ALL co-authors, it should be submitted electronically to the AC using the Manuscript Submittal Form available on the Administrative website or by contacting the Project Manager. Manuscripts submitted with incomplete or outdated submittal forms will be returned to the submitting author for correction. Manuscripts will be circulated for SC review and comments. Co-authors are strongly encouraged to provide comments on circulated manuscripts. If a co-author does not participate, he or she may be removed from the manuscript at the discretion of the EC and WrG chair. If a co-author disagrees with a manuscript, 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.
The AC will update the WrG on comments and suggested revisions posted to the forum and track revised versions of the manuscript, which will be posted to the forum as they become available. This information, including associated documents, will also be posted to the relevant CS section of the Administrative website
A manuscript can not be submitted 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 on the status of the submission. This information will be posted to the administrative website. Once the manuscript is accepted for publication a copy will be distributed to the SC and a link to the manuscript will be posted to the Administrative website.
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. These requests will be processed and posted by the AC.
When submitting drafts of abstracts and presentations, the following information must be included: name and dates of conference, submission deadline, abstract title, and co-authors. The abstracts and presentations will be posted to the NA-ACCORD forum. SC members will be notified of the posting via e-mail and will have at least one week to provide comments, recommend acceptance, acceptance with revisions, or rejection. 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 posting to the Administrative website. In addition, the WrG chair will forward adjudication results to the AC for distribution to the SC and posting to the Administrative website.
All manuscripts and abstracts will acknowledge that the data were collected through the NA-ACCORD and credit all collaborating cohorts and institutions (NA-ACCORD representatives, AC, DMC, EBC and the NIH). The authorship byline should include “for the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of the International Epidemiologic Databases to Evaluate AIDS (IeDEA).”
The criteria for authorship should be determined in line with the Uniform Requirements for Manuscripts (URM) issued by the International Committee of Medical Journal Editors (ICMJE):
- Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;
- Drafting the article or revising it critically for important intellectual content;
- Final approval of the version to be published; and
- All contributors who do not meet the criteria for authorship listed above should be listed in an acknowledgements
Additional details can be found at www.icmje.org
At least one representative of each collaborating cohort will be offered the opportunity to participate in the WrG at the time of CS review and will have to sign off on their level of contribution before a resulting manuscript can be submitted to a journal. All co-authors are expected to make substantive contributions based on the criteria for authorship listed above. Other co-investigators who make substantive contributions to the publication according to the same criteria and who are approved by the WrG chair should also be included as co-authors. Primary authorship shall be fairly distributed among each of the collaborating cohorts; this distribution shall be monitored and promoted by the EC. Disagreements or problems with individual author participation should initially be addressed to the writing committee chair. If this fails, formal grievances regarding credit or authorship shall be directed to the EC.
For manuscripts or for abstracts which have a restriction on the number masthead authors, the priority authorship would be (1) investigators working directly on the project; (2) investigators wishing to be part of the WG from among cohorts that contribute data; (3) investigators wishing to be part of the WG 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”. If group (1) is larger than the allowed number of masthead authors, then the WrG chair will be responsible for final selection of authorship.