DS007 - Access to the TBIMS Module Project Datasets

DS007	Access to TBIMS Module Project Datasets
Review Committee: Research	Start Date: 6/17/2024
Attachments: None	Last Revised Date:
Forms: DS007F - TBIMS Module Project Notification Form and DUA	Last Reviewed Date:

Introduction:

The National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) supports the collection of data from participants in the Traumatic Brain Injury Model Systems (TBIMS) Program, a collaboration of institutions across the country collecting data for research on outcomes after a traumatic brain injury (TBI). The result of this collaboration is a unique well-characterized population of subjects with uniformly collected data. One of the major components of the TBIMS program is a standardized National Database (NDB) for innovative collection, processing, storage and analyses of data relevant to TBI treatment and outcomes. The TBIMS NDB contains information on cases treated within any TBIMS center funded since 1987, which are located around the United States.

In 2001, the TBIMS program reduced the number of variables in the core NDB and implemented Module Projects. Modules are time limited studies involving more than one TBIMS Center and are generally observational in nature focused on a specific aspect of TBI. These studies generally start at the beginning of each new 5-year TBIMS grant cycle and are intended to conclude prior to the end of the same grant cycle.

The TBIMS Centers Program has a responsibility to the public in general, and to the scientific community in particular, to encourage scientific use of the TBIMS National Database (NDB) and Archived Module Datasets as rapidly as possible, subject to appropriate terms and conditions. This document outlines the policies for data access, use, and publication/presentation for those who desire to use the Archived Module Datasets.

Purpose:

To define the process by which the scientific community and the general public can gain access to the TBIMS Archived Module Datasets.

Scope:

1. All staff, students, and other related personnel involved in the NIDILRR-funded TBIMS Centers who wish to use data from the TBIMS Archived Module Datasets;

1. Previously funded TBIMS Centers that are currently funded as TBIMS Longitudinal Follow-Up Centers;

2. Non-TBIMS entities that have been designated as formal collaborators per SOP DS004 Policy and Procedure for Collaborative Relationships between TBIMS and Non-TBIMS Entities;

3. All staff, students, and other related personnel at an institution that has a NIDILRR-funded TBIMS Center or Follow-up Center, but not involved in the TBIMS Center or Follow-up Center at that institution who wish to use data from the Archived Module Datasets; this would include previously funded TBIMS Centers that are no longer funded and no longer collecting follow-up data for the TBIMS NDB; and

4. The scientific community at large and the general public.

Responsibilities:

All TBIMS, TBIMS Follow-up Centers, the TBIMS National Data and Statistical Center (NDSC), the larger scientific community, and the general public will abide by this procedure.

Management and Disposition of Module Data:

1. Module data will remain under the control of the Module Principal Investigator (MPI) throughout the study.

2. Once the Module is complete, the MPI, site Project Director (PD) (if different from the MPI), and the module lead institution will identify a responsible party who will retain a copy of the module data and serve as steward of data archiving and sharing for the module. In the MPI leaves the institution, retires, or is no longer able to serve as the responsible party, a new responsible party will be identified by the MPI, PD, and/or lead institution. Henceforth this SOP uses the term “responsible party” to refer to the MPI and/or designee who is responsible for module data.

3. The module data will remain in the possession of the responsible party at the institution funded by NIDILRR for the study.

4. Modules that involve TBIMS NDB participants and include TBIMS NDB variables/data will be archived and can be shared with the Module data and the TBIMS NDB data included.

5. Historically, the TBIMS National Data and Statistical Center (NDSC), which houses the TBIMS NDB also manages and provides analytic support for some Modules.

   1. If the NDSC provides data management, once data collection is complete and data have been cleaned, the NDSC will send the final dataset and any related documentation to the responsible party to begin analysis.

   2. If the NDSC has also provided analytic support, once the study is complete, the NDSC will send the final dataset and any related documentation to the responsible party at the studies host institution.

6. Beginning with the 2022-2027 TBIMS grant cycle, the funded institution is required by NIDILRR to archive their module datasets 90 days after the end of the grant funding, and recommend using the Inter-University Consortium for Political and Social Research (ICPSR). Therefore, the Module datasets from the 2022-2027 TBIMS grant cycle will be available via ICPSR or other designated data repository.

7. For Modules conducted in the TBIMS 2017-2022 grant cycle for which the NDSC provided data management, the NDSC will retain a copy of the module dataset and be responsible for archiving and sharing that dataset with permission from the MPI using the procedures below, if the responsible party has accepted this offer. For those particular modules, the NDSC will be responsible for fulfilling any data requests. For all 2017-2022 modules for which the responsible party declines NDSC archiving and data sharing support, and for those that did not receive data management support from the NDSC, the responsible party will retain the dataset and be responsible for archiving and sharing the dataset.

8. For Modules conducted in the TBIMS 2012-2017 grant cycle for which the NDSC provided data management, the NDSC is contacting the MPIs/lead institutions to designate a responsible party and determine where to send the final datasets and documentation, and requesting if they want the NDSC to retain a copy of the module dataset. The designated responsible party will be responsible for fulfilling any data requests.

9. For all other Modules, the responsible party will be responsible for fulfilling any data requests.

10. DS007 - TBIMS Module Project Notification Form and DUA has been developed to facilitate the process of requesting and sharing module datasets and can be used for any data request regardless of who holds the data. For those responsible parties that hold their module data, their institution may or may not allow the use of the DUA portion of DS007F, and may require the use of their own institutional DUA.

11. Whoever is responsible for archiving the Module dataset must request a persistent identifier number (DOI) (see OP006 – Branding and Authorship Policy) that should be part of the documentation associated with the dataset. That DOI will become part of the citation for the module dataset to be used in publications using that dataset.

12. Module data will remain under the control of the responsible party for one year after completion of data collection and creation of an analytic database for the project. This will allow ample time for analyses and preparation of planned manuscripts. After the one-year period, anyone may request the data for additional analysis and dissemination using the procedure described below. In special circumstances, the responsible party may request an extension of the one-year period if approved by the appropriate NIDILRR Project Officer and the TBIMS Project Directors.

13. Notifications of requests to use Archived Module Datasets for anything other than the originally intended study analyses must be submitted using the procedures below. If the NDSC receives a completed DS007 - TBIMS Module Project Notification Form and DUA to release a Module Study Dataset prior to archiving, this request will be forwarded to the responsible party for consideration.

Procedure for Internal Requests:

This section addresses the use of the Archived Module Datasets by TBIMS users (defined as #1, #2 and #3 under Scope above).

Policy

The TBIMS are committed to encouraging the productive and scientifically responsible use of the Archived Module Datasets in a timely and effective manner to answer appropriate research questions. The policy includes the following requirements:

1. An analysis may be proposed through the Notification listserv by a funded TBIMS Center, a TBIMS Longitudinal Follow-up Center, or a Non-TBIMS entity that has been designated as a formal collaborator per SOP DS004. Non-TBIMS entities that do not have the designation of formal collaborators may collaborate on proposed projects at the invitation of the Module Project PI (PPI) (i.e., the lead of the notification/request for module data) from a TBIMS Center, a TBIMS Longitudinal Center or an entity with a formal collaboration. The procedure detailed below is designed primarily for notification purposes and to allow other Centers to collaborate if desired or needed. It is not necessary to solicit additional Centers beyond three to collaborate on the project.

5. When there are fewer than three collaborating Centers, the process is designed to solicit additional collaborators to promote an equitable representation of the Centers contributing to the TBIMS NDB. However, all collaborators must intend and be able to play a substantial role in creating the end product, contributing skills, knowledge and/or insights that complement those of the original proposer(s).

6. When a PPI or co-investigator on a proposed project leaves the original institution, they may continue involvement in the project, at the discretion of the TBIMS Project Director(s) of the lead site, and assuming both the original and new institution have sufficient funding and resources available to complete the project. It is the responsibility of the PPI to ensure data use agreements (DUA) are established with their new institution, if needed.

7. The posting of an updated notification after the process of scrutiny of the idea for duplication of other efforts gives the PPI and their team of collaborators a three-year term during which they can work to perform the analysis and reporting proposed. A major purpose of the Notification listserv is to ensure that others within and outside the TBIMS are not allowed to propose or perform analyses that are considered largely overlapping.

8. Anyone receiving an Archived Module Dataset will need to complete a DUA. Internal collaborators, whether PPI or other internal researcher, who receive an Archived Module Dataset data must abide by the terms of DS007F - TBIMS Module Project Notification Form and DUA. Any external collaborator listed on the notification who receives Archived Module Dataset data must sign DS007F - TBIMS Module Datasets Request and Data Use Agreement which has been marked up to refer to the Archived Module Dataset received. Institutional DUAs must be established if required by any collaborating institution(s) that will have access to the data.

Notification Process

1. As early as possible in the research process, the PPI must send an email notification of the project to the TBIMS Notification Listserv at tbimsnoti@lists.service.ohio-state.edu. The email must include a completed and signed DS007F - TBIMS Module Project Notification Form and DUA.

9. The notification must occur as early as possible in the research process in order to facilitate involvement by interested collaborators and to allow for a check for duplication of projects. This should occur at the time of the initial planning process when an idea and methodology are being generated and before actual analyses are performed.

Collaboration

1. Other Centers that are interested in collaborating on the project have 10 working days in which to contact the PPI and express the desire to collaborate. Those wishing to participate must suggest meaningful input they could offer to the project. This policy encourages collaboration, while acknowledging projects must be manageable. While every TBIMS investigator has a stake in using the Archived Module Datasets, there are limited opportunities on a manuscript for substantial contribution to conception, design, analysis, interpretation, and writing. Anyone volunteering to collaborate should critically consider her/his potential contributions and intent to follow through. People offering collaboration should provide very specific information about the additional expertise they offer and the roles they are willing to serve on the project. The PPI can facilitate this process by specifying gaps that may remain in the study team (e.g., expertise or specific roles). The PPI has the right to accept or decline the participation of interested researchers based on her/his judgment as to whether the contributions of each will meet the needs of the project and will not be duplicative of skills and other resources already in place. It will be the responsibility of the proposing center and the other interested parties to work out a satisfactory arrangement. If such an arrangement cannot be made, the matter must be referred to the Chair of the TBIMS Research Committee who will then take the issue to the Committee for resolution. However, it is assumed that reasonable efforts will be made to foster a collaboration of at least three Centers on the project, and for each researcher involved being able to contribute in such a way and extent that per the existing guidelines, he/she is entitled to authorship. PPIs are encouraged to review the TBIMS authorship policy (SOP OP006 Branding and Authorship Policy) at the time of notification, early in the project development, and again at the time of manuscript preparation to encourage adherence and create opportunities, and to renegotiate authorship as needed.

10. If fewer than three Centers express interest and a good effort has been made to recruit the recommended number of Centers, it is permissible to move forward with the project after the 10-day notification period has ended.

11. It is not necessary for the PPI to accept additional collaborators once three Centers are involved, if the PPI deems the additional involvement unnecessary to the project. Thus, if at any time during the 10-working day notification period, a total of three or more Centers have agreed to collaborate on the project, the project can move forward without further delay.

12. It is assumed that non-response by a center within 10 days indicates that the project may proceed without that center’s participation or claim that the project duplicates an existing project that was properly announced through the notification process.

13. At the end of the 10-day notification period, the PPI must post an updated notification with the updated list of collaborators to the Notification Listserv at tbimsnoti@lists.service.ohio-state.edu.

Notification Registry

1. The NDSC will maintain a list of projects submitted through the notification process and will make it available on the members’ side of the NDSC website at www.tbindsc.org under “Members” and then “Notifications,” which is on the left side of the page.

14. The PPI is responsible for notifying the TBIMS NDSC of any updates to the project. Updates will need to be made at the end of the 10-day notification process and then annually, at a minimum. Annual updates must list all collaborators, and an indication of the development phase of the project as well as the titles of and other key information on any abstracts and manuscripts that have been submitted since the last update. If updates are not received by the NDSC by the anniversary of the original posting, NDSC will send out one request to supply it. If the PPI is affiliated with a funded TBIMS center, the center Project Director (PD) will be copied on this correspondence to provide additional visibility and opportunity to solicit an update. If the notification PPI does not supply an update within 14 days of receiving the reminder, NDSC will refer the matter to the Research Committee. The Research Committee will review nonresponsive notifications at least twice annually. The Committee may decide to void the notification, which would make the topic area available for analysis by another group.

15. The NDSC will prepare a listing of all notifications including the latest update twice a year, in time for inclusion in the binder of the biannual TBIMS Project Directors’ meeting. The Research Committee will review a list of expired and nonresponsive notifications at its meeting, and make decisions in accordance with this SOP to address non-reporting and/or notification expiration.

16. Three years after the date of data receipt of the initial updated notification, the privileges afforded by the notification system and DUA automatically expire. Data will not be further analyzed and new results will not be shared/presented/submitted for publication under an expired notification. The original proposer has the option to submit a written request to the Research Committee Chair, at least two months before the expiration date, explaining the circumstances that prevented or will prevent achieving the original objectives within the three-year period. Upon consideration of this explanation, the Research Committee may grant a one-year extension of the approved three-year term. If the extension is not granted, the original proposer must submit a new notification in order to continue work on the project.

Duplicate Studies

1. If a project posted to the notification listserv bears substantial resemblance to one which was previously posted, the PPI of the earlier project must notify the PPI who has just posted the new project which is perceived to be duplicative. The two PPIs must attempt to come to an agreement that avoids duplication of research. Such an agreement may involve (a) the second PPI and/or collaborators joining as collaborators on the first study; (b) the aims and methods of one or both studies being changed to avoid duplication if both studies proceed; or (c) the second study being discontinued as duplicative. The study that was first posted to the notification listserv must be given priority in this decision. The nature of the agreement may depend on the status of each research project at the time when the duplication is noted and the specific interests of both PPIs. If a satisfactory agreement cannot be reached between the PPIs, the Chair of the TBIMS Research Committee will be notified so that he/she may help resolve the issue. The Chair of the TBIMS Research Committee will assess the situation, communicate with the PPIs, and consult with the full Research Committee if warranted.

Objections

1. Objections to the use of data as proposed in a notification must be sent by email to the originating author within 10 working days of the notification, together with a rationale and constructive suggestions for resolving duplication or partial overlap. If the matter cannot be resolved, it will be referred to the Chair of the TBIMS Research Committee who will then take the issue to the Research Committee for recommendations. This recommendation will then be forwarded to the TBIMS Project Directors for vote and resolution.

Data Sets, Publications, & Presentations

1. Center identity must always be treated as masked in internal reports and in publications, unless all Centers involved give written prior approval for identification of their Center.

17. All those who, after the initial notification or at a later time, were accepted as collaborators must be offered an opportunity to be co-authors, unless either they left the group using written notice to the PPI, or repeated non-participation in meetings and other activities clearly indicates a lack of interest in further participation. In order to be included in published manuscripts, all authors must have provided meaningful input, and satisfy all other criteria for authorship specified in the standards of the American Psychological Association or the International Committee of Medical Journal Editors.

18. Notification must have occurred prior to submission of an abstract, presentation, or manuscript. Authors of manuscripts or abstracts submitted for presentation or publication without prior notification and all other requirements of this policy will be asked to withdraw them from review, unless their analysis is based on similar data available to the scientific community at large.

Studies Originating in TBIMS Committees

1. All research studies utilizing an Archived Module Dataset that are proposed by a TBIMS Committee must be posted through the notification process detailed above.

Grant-funded studies Using TBIMS Data

1. Studies involving the Archived Module Datasets which are proposed in new TBIMS Centers’ grant applications submitted to NIDILRR must follow the notification process immediately post funding notification. This applies regardless of the number of Centers involved. If duplicate studies are posted, resolution must be sought per the procedures discussed above.

19. If seeking funding for a project that involves use of the Archived Module Datasets from an agency or program other than the NIDILRR TBIMS Centers Program, the PPI must comply with the notification process before submission for such funding.

Unusual Situations

It is expected that users of the Archived Module Datasets will follow this policy and procedure and the applicable Data Use Agreement.

1. Failure to Follow the Data Use Agreement. If users inadvertently violate the DUA, corrective action must be taken as soon as the infractions are discovered. If users willfully violate the DUA, NIDILRR and/or the NDSC and the MPI will revoke current and future access to the Archived Module Datasets.

20. Fraudulent Use of Data. If the TBIMS Research Committee, the NDSC or the MPI discover an attempt to publish data obtained fraudulently or become aware of any breach of the DUA, immediate steps will be taken to secure the breach or end the violation. This may include discontinuing the user’s data access and/or reporting the violation, and reporting scientific misconduct to the violator’s institution and/or relevant professional organizations and/or scientific institutions.

Grievances

Any grievances must be made to the NIDILRR TBIMS Centers Program Manager.

References:

None

History:

Date	Action
6/17/2024	New SOP was developed specifically for accessing and using Archived Module Datasets.

Review schedule:

At least every 5 years.