Institute for Community Health Policies, as adapted from:
The Detroit Community-Academic Prevention Research Center, the Michigan Center for
the Environment and Children’s Health, the North Carolina Community-Based Public
Health Initiative and the Harvard Medical School Faculty Policies on Integrity in
Science.
Introduction
The intent of this document is to outline
policies regarding data ownership, access to data, authorship, data confidentiality,
and data dissemination. Given that in each project, the Institute for Community
Health (ICH) will have differing roles (i.e. project evaluation vs. serving as the
lead on a federal grant) and will have different collaborators (schools, health
departments, university researchers etc.), these policies are meant to serve only
as a guide. For each project, it will be necessary for ICH and community/university
partners to draft a memorandum of understanding regarding each project area, when
appropriate, early on in the process. A project-specific working group should then
be assembled to facilitate ongoing discussion of issues as they arise. The Joint
Public Health Board may also be used as a forum in which to discuss policy-related
issues.
Data ownership
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.
All authors must state that they have made substantial contributions to each of
the following 3 activities (adapted from the International Committee of Medical
Journal Editors). Contributions can be in oral or written form:
Conception and design, or analysis and interpretation, or both.
Drafting the article or revising it critically for important intellectual
content
Approval of the final version to be published
Criteria for first authorship include:
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.
The first author is ultimately accountable for the information presented.
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.
Regardless of whether community partners qualify as co-authors, they will
review drafts of the manuscript and will have input about the presentation and
interpretation of data.
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
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.
