Inflammation and the Host Response to Injury Research Program 1U54GM62119
Guidelines for the Release of Program Data
INTRODUCTION
Guiding Principle. The goal of the Large-Scale Collaborative Research Program is the rapid and
complete dissemination of all of its products to the scientific community and to the general public, while
assuring protection of research subject confidentiality, and recognizing the academic and scientific
contributions of the participating investigators, and the financial commitment of the United States Public
Health Services. To assure that the results of the program (the “Product”) are of maximal usefulness to
the scientific community at large, and to the public in general, the product is released within six weeks
upon its scientific validation, annotation and certification, as determined by the Steering Committee.
The Data Access Subcommittee of the Glue Grant Steering Committee recognizes that the rapid
dissemination of the patient data, particularly clinical, genetic and gene expression data poses unique
technological and ethical concerns that are not directly pertinent to the dissemination of methodologies,
standard operating protocols, and even the animal research data. In particular, the Subcommittee is
concerned that patient confidentiality must be preserved at all costs, and that the participating
investigators, particularly the clinical scientists contributing patient data, have the opportunity to explore
the clinical databases as they develop, and to receive appropriate academic recognition for their efforts.
The Subcommittee also recognizes that implementation of these guidelines is not currently possible,
because the technological tools are not currently available (databases, etc.). The Subcommittee also
recognizes that the implementation of this process requires three discrete steps:
1) Consensus regarding the overall goals and principals guiding the release of Program
generated data;
2) Establishment of guidelines for the Consortium Membership Program, and Data/Materials
Distribution Agreements; and
3) Development of the technological tools for the actual transfer of the data to investigators.
Nevertheless, the Subcommittee believes that deriving consensus on the overall principle that will guide
the release of the Program data, and identification of the critical requirements for Consortium Membership
and Distribution agreement would be of great value to the Program and the Steering Committee.
It should be noted that these issues have been raised and addressed by other large-scale collaborative
research programs. Specifically, the current language of the Membership and Distribution Agreement
was acquired from a similar agreement produced by the Framingham Heart Study. The Framingham
Heart Study is a contract between the National Heart, Lung and Blood Institute and Boston University to
manage the groundbreaking epidemiological study of heart disease, now in its fifth decade. Several
issues raised by our Large-Scale Collaborative Research Program have been recognized and addressed
by this highly successful NIH-funded program.
RECOMMENDATIONS
The following recommendations (in italics) have been taken directly from the NIGMS Specific Terms and
Conditions statement dated October 4, 2001 provided to the principal investigator at the time of the
award.
“The principles governing the sharing of research results will be (1)
nonexclusive access, (2) timely and responsible release, and (3) reasonable
accommodation. To implement these principles, the PI, working with the
Steering Committee and the NIGMS program director, will develop any
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operating rules and guidelines that are needed beyond those specified in the
competing application or agreed upon at the time of award. The milestones and
management should reflect an appropriate balance between responsible
validation and a prompt timetable for evaluation and release. In seeking this
equitable balance, protection of individual human subjects (i.e., confidentiality)
is the prime consideration, followed by the goals of the project and the interests
of the field and the community as a whole (as opposed to individuals.”
All products of the research (clinical, physiological, genetic, genomic, proteomic, animal and
methodological information, including raw data from microarray readouts, 2-D gels, sequencing and
sequence searches, and other sources that generate multiple observations, as well as methodologies and
standard operating procedures) related to the overall databases will be released to Participating
Investigators and Consortium Members within six weeks of being “validated”, “annotated” and “certified”.
Proprietary items with direct commercial value, such as the source code for the trauma related database,
laboratory information management system, clinical data collection system, unique computational models,
novel reagents, and methodologies, will be released simultaneously upon publication in peer-reviewed
journals, or the issuance of a patent (intellectual property).
“Schedule B (Release with Publication). Schedule B applies to results that are
to be released in conjunction with publication. Many activities in this project will
fall into this schedule. This schedule includes:
First applications of new concepts or other novel results where there has been
a significant investment of time and/or creative effort.
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First applications of novel genetic, genomic, and proteomic screens
Novel reagents
First-of-kind methods and assays
Computational innovations, including new algorithms, for entering,
describing, organizing, processing, transforming, manipulating,
displaying, and communicating information. Languages and
compilers
Software (specifically including all source code)
Theoretical innovations: models, original mathematics
Schedule B Guidelines:
 Timetable for Release: Upon publication. If a situation arises where a
manuscript is delayed in the review process for greater than 6
months, the Steering Committee must be informed and render a
decision concerning release of results, balancing protection of the
investigators' interests and maintaining the intended spirit of the
release policy.
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Schedule B may be appropriate when: (a) external peer review is
advisable before release, (b) extensive or sophisticated
characterization is necessary, or (c) simultaneous publication is
necessary for the developers to receive due credit for original
concepts and/or creative effort they have expended in producing the
result.”
“After Publication. Once information or a resource is referenced in any research
article that draws conclusions from it, it must be immediately released to the
entire community with the only restrictions being those required to protect
human subjects.”
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1.1. Products of the research generated from defined experiments, such as those designed to
develop or refine standard operating procedures and methodologies will be released upon their
completion, as defined in Section 1 within six weeks of validation, annotation and certification.
Similarly, products of the research once applied systematically through the Program (such as
software programs, standard operating procedures and methodologies) will be released upon
their completion, as defined in Section 1 within six weeks of validation, annotation and
certification.
1.2. Products of the research generated from the defined human volunteer experiments, intended to
develop methodologies and standard operating protocols for subsequent studies in burn and
trauma patients, will be released upon their completion, as defined in Section 1 within six weeks
of validation, annotation and certification.
1.3. It is recognized that the clinical data obtained from the trauma and burn patients will be
generated throughout the course of the award, and represents a principal product of the
Program. Unlike products of the research that are generated in response to specific
experimental questions, the clinical data represents an ever growing and increasingly valuable
database without a finite beginning or end. In this context, it would not be desirable to withhold
the release of the data until the entry and analysis are complete. It is recommended that the
products of the research generated from the clinical studies in burn and trauma patients are
released upon their completion, as defined in Section 1 within six weeks of validation, annotation
and certification, with the limits identified in Sections 1.3.1 and 2.
1.3.1. It is recognized that as the clinical database increases in size, its value to the scientific
community also increases. Analysis of the database while it is limited in size is of reduced
value to the scientific community, and may lead to misinterpretation. The initial release of
data may be delayed until the number of patients has been determined by the Steering
Committee. Thereafter, the products of the research generated from the clinical studies in
burn and trauma patients will be released upon their completion, as defined in Section 1
within six weeks of validation, annotation and certification.
1.4. The validation, annotation and certification of data will not be used to impede the rapid and
complete dissemination of the products of the research.
2. Individuals will be provided free-of-charge and unfettered access to all of the products of the
research, as stipulated in Section 1. Access to the database, however, will be limited to those
individuals who have agreed to become Consortium Members. Consortium membership and full
execution of a “Distribution Agreement” will permit individuals to obtain access to all non-clinical data
and methodologies. Individuals who desire access to the clinical database will be required to submit
to the Steering Committee an application for Consortium Membership and to fully execute a “Clinical
Data/Materials Distribution Agreement”. The “Clinical/Data Materials Distribution Agreement”
contains additional protections to protect the confidentiality of clinical data and materials, which are
not relevant to individuals seeking only access to methodologies, standard operating protocols and
animal/experimental data. Consortium membership requires that the individuals and their institution
execute and adhere to the guidelines established under the “Distribution Agreement” and/or “Clinical
Materials Distribution Agreement”, which will establish the following:
2.1. Assure intellectual integrity and academic recognition. The “Distribution Agreement” will require
that individuals who seek access to the data submit, as part of their application, a research plan
that details the specific aims for the search of the data set, as well as a research plan. The
research plan should contain sufficient detail for the Steering Committee to evaluate the
following: (1) its overall goals; (2) the research plan and specific aims; and (3) the ultimate
disposition of the research (publication, grant submission). Individuals who obtain access to the
data set do so with the agreement to submit to the Steering Committee 30 days prior to
submission, any material for consideration of publication. In addition, the individuals agree to
acknowledge in those publications the primary source of the data set, as outlined in the
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Distribution Agreement.
2.2. Assure institutional recognition. Individuals who seek access to the database will be required to
acknowledge the financial support of the National Institutes of General Medical Sciences, and
the funding instrument on all publications arising from the data set.
“With respect to the data set generated on human subjects, access by the
community (as defined in 4.1.2.4) may be limited. Data collected from human
subjects by the collaborative effort must be stripped of all personal identifiers,
but given the nature of the research, the extent of data from other sources
might make possible the individual identity of some subjects. To protect
confidentiality and privacy of these participants, the recipient who is granted
access to these data must become a Consortium Member and execute and
adhere to a Distribution Agreement, which will include a means to assure
protection for human subjects (for example, Institutional Review Board (IRB)
approval from his/her home institution). Failure to comply with this Distribution
Agreement could result in the loss of Consortium membership benefits and
denial of further access to the limited data set. Violation of confidentiality
requirements of this agreement may leave the requesting investigator liable to
legal action on the part of the study participants.”
2.3. Assure protection for human subjects. This process will be guaranteed by the requirement that
the individuals who seek access to the clinical database will have been granted from their home
institution, institutional review board (IRB) approval to receive the patient or volunteer data in a
manner consistent with protecting the confidentiality of the subjects. In the event that the
individual and his/her institution do not have an internal institutional review board or ethical
committee, the individual will be required to obtain institutional review board approval from an
independent IRB, such as the Western IRB (WIRB).
“To protect confidentiality and privacy of these participants, the recipient who is
granted access to these data must become a consortium member and execute
and adhere to a Distribution Agreement, which will include a means to assure
protection for human subjects (for example, Institutional Review Board (IRB)
approval from his home institution)”
2.3.1. The Steering Committee will require from the individual a copy of the approval letter from
the IRB, as well as a copy of the IRB application.
Prior to release of all products of the Large Scale Collaborative Research Program to Consortium
Members, the products will undergo “validation”, “annotation” and “certification”. Ultimately, final
certification of the product will be confirmed by the Steering Committee. Once the product has been
certified by the Steering Committee, it will be released to Consortium Members within six weeks.
3.1 Each of the individual Cores will be responsible for data and product validation. Validation refers
to an internal Core review of the product in terms of its correctness. Each of the individual Cores
will be responsible for the establishment of standard operating procedures for data and product
validation. This will be accomplished by drafting SOPs and designing experiments to test each
method used to generate data. Data will then be exchanged among core group members for
internal review. Once a method or SOP has been validated, the Core will then be responsible for
drafting a highly detailed report summarizing the findings. The report will then be submitted for
review by the Steering Committee, or its designated investigators.
Once a Method or SOP has been validated, the Core group will then be responsible for drafting a highly
detailed report summarizing the findings. The report will then be submitted for internal review by the
Steering Committee, or its designated investigators.
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3.2 Each of the individual Cores will be responsible for data and product annotation. Annotation
refers to an internal Core review in which the data or product are properly labeled, linked to the
appropriate standard operating procedure, reviewed for accuracy and completeness.
3.3 The appropriate Administrative Core or Information Dissemination and Data Coordination Core
(IDDC) members will be responsible for data and product certification. Members of the
Administrative or IDDC Cores, in consultation, with Core members that provided validation and
annotation, will certify the data and product validation and annotation.
“VALIDATE means to review for correctness, annotate, and certify. ANNOTATE means to label with
descriptions of the result, how it was obtained, and the checks that have been made upon it.
CERTIFICATION means confirmation by the designated responsible individuals that the result has been
reviewed and annotated correctly. RELEASE means to announce results to the public on the project web
site and share either non-exclusively (for results derived from animals) or as a limited data set (for results
derived from human subjects). LIMITED DATA SET is the information derived from human subjects,
whose privacy must be maintained absolutely.”
Prior to release of the product of the research, all of the clinical data will undergo "de-identification" as
required by Federal, State and local regulations to assure complete confidentiality of the data set. Data
collection and de-identification will be a two-tiered process overseen by the Steering Committee and
implemented by the IDDC Core. Data collection variables will be obtained by the individual clinical sites,
and will be undergo “de-identification” by the IDDC Core for both internal review, and for release to the
scientific community.
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