Ownership and Access to Data   There should be an explicit agreement between ICH researchers and community and university partners with respect to ownership of the research data. The nature of the agreement will be determined on a project-by-project basis, as the community needs/requirements may differ (i.e. a school, a department of health and a coalition may require different agreements). This agreement should be made prior to the onset of the project and revisited during the project with the project-specific working group.

Jointly with community partners, the Executive Director of ICH will review any and all requests for use of ICH data and access to ICH data by members of a research team, outside agency, or other persons (e.g. for dissertations, presentations, etc). For situations in which ICH has access to data that is owned by another source (i.e. a school or health department), ICH will defer to data access policies documented previously in a memorandum of agreement.

For ICH data, any person who gains permission to use any portion of a data set and conducts statistical analyses independent of the work of the ICH staff must provide written documentation of study design and analysis plans (including statistical programs used, creation of new variables, data output, etc) to the Senior Epidemiologist on a mutually agreed to schedule, usually within 1 month of the activities conducted using the data. In circumstances where ICH has access to the data of another organization, ICH must consult with that organization in order to determine who will supervise data analysis.

When appropriate and feasible, analytic files of ICH data will be made available for public use. Analytic files will have subject identifiers removed, to ensure confidentiality. Suppression of cell sizes < 5 in reporting will be considered the general rule. However, any agreement requiring larger numbers for suppression will supercede this rule.

Publication of manuscripts/Authorship   Included in the ICH mission statement is publication of research findings and of processes involved in improving community health. Publication is an important by-product of the work that is done although it may not be the primary goal of the work. Early on in each project, it is necessary for ICH members to communicate these goals to community partners. Discussions should address whether community partners would be agreeable to publishing data that arises from its work with ICH, especially in the event that such data were unfavorable. Involvement of partners in the research and writing process should also be discussed explicitly. In addition, it should be determined who, regardless of authorship, will review a paper before it is submitted for publication. The results of these discussions, including the details and scope of the review process, should then be incorporated into a project-specific memorandum of understanding.

Only those actively participating in the work of the project will be eligible for authorship. Active participation

• Is defined as substantial intellectual contribution to the publication in question.
• May be measured directly by physical hours of input on acquisition, processing and interpreting of data.
• May be measured indirectly by time and energy spent supervising a junior researcher in the acquisition, processing and interpretation of data.
• May be a combination of direct and indirect input.

1. Conception and design, or analysis and interpretation, or both.
2. Drafting the article or revising it critically for important intellectual content
3. Approval of the final version to be published

• Writing the entire manuscript or conceptualizing the paper/outline and assigning co-authors responsibility for writing specified sections of the manuscript.
• Overseeing data analysis or doing the data analysis firsthand.
• Handling all communication with journals.

Order of Authors:

The lead author will be listed first, followed in order by descending level of contribution to the manuscript. The “senior author,” usually the Principal Investigator of the grant that primarily funded the project, may choose to be last author.

Community partners who may have less experience writing for publication will qualify as authors if, either individually with the lead author or with the writing team:

• They are involved with concept discussions about the paper or interpretation of findings.
• They review and make comments on at least one draft.
• They review the final version and give approval prior to publishing.

These authorship policies are consistent with those of Harvard Medical School.

Conflict of Interest:

All manuscript authors will be required to sign a disclosure form (Appendix, adapted from the New England Journal of Medicine) acknowledging any conflicts of interest, or appearances thereof.

Acknowledgements:

It is the intent of ICH to recognize contributions of individuals, community-based organizations or others that have made contributions to the work not qualifying for authorship. Acknowledgements:

• Will be more inclusive of contributions to the project versus the paper specifically.
• Can acknowledge individuals, community-based organizations, funding sources, coalitions or others.
• May consist of recognition of a study population (i.e. students and staff in a school department).

Persons or groups acknowledged in a manuscript will be requested to provide written permission to have their name listed in an acknowledgement statement.

All discussions about authorship/acknowledgements should occur early in the research process.

Data confidentiality / IRB policy  

ICH research projects will adhere to the human subjects review process standards and procedures set forth by Cambridge Health Alliance and any other appropriate IRB. In addition, the ICH will adhere to standards of school departments and community-based organizations, when appropriate.

All investigators and research associates need to be certified for human subjects work. At the very minimum, they must complete on-line certification, and possibly attend a one-day certification.

All persons who work with ICH data (including Visiting Scholars and graduate students) will be required to sign a Pledge of Confidentiality for Data Use (Appendix).

In general, ICH will not publicly report data with a cell size less than 5 subjects. Suppression of cell sizes < 5 in reporting will be considered the general rule to protect the confidentiality of subjects. However, any agreement requiring larger numbers for suppression will supersede this rule.

Memorandum of agreement for outside data users  

All persons who work with ICH data, but are not on the ICH staff, will need to sign a memorandum of agreement. Such persons will include graduate students, visiting scholars, and outside researchers. Each memorandum of agreement will be specific to the project and scholar. The memorandum of agreement will explicitly describe the identity and role of co-authors, and the manuscript review process.

In the case of graduate students working on a dissertation, there will be a process leading to a memorandum of agreement. An initial meeting with the student, his/her advisor, and ICH member will determine the nature of the collaboration. A member of the ICH will serve on the students’ dissertation committee. Regular meeting schedules will be determined and the project will be formulated. The student must submit a formal proposal to the ICH and appropriate partners for approval. The outcome of this process will be the development of a memorandum of agreement that will address issues of authorship (including the role of ICH and partners as co-author on papers), and will stipulate roles and responsibilities of the student and ICH. The memorandum of agreement will also address issues of data ownership, access to data, and data confidentiality.

Dissemination of findings  

For each project, there should be a joint planning process early on between researchers and community participants with respect to the dissemination of the research results. Dissemination may be in the form of academic publications, presentations, newsletters, and articles in the lay press.

Conference attendance: To the extent feasible, there should be at least one ICH and one community partner co-presenting research findings.