- What is the NTRR?
- What is the vision for the NTRR?
- What is the purpose of the NTRR?
- What type of data will be included in the NTRR?
- How does the NTRR differ from the National Trauma Data Bank (NTDB)?
- How does the NTRR differ from a hospital trauma registry?
- How does the NTRR dovetail with the National Trauma Research Action Plan (NTRAP)?
- Why should I share my data?
- What are the benefits of a research repository?
- What other research repositories exist?
- Who controls access to and what are the criteria for access to the NTRR?
- What are the expectations for investigators seeking access to NTRR data?
- What security measures are in place to protect data uploaded to the NTRR?
- Will NTRR requests require IRB approval as do NIH data repositories?
The National Trauma Research Repository (NTRR) is a Department of Defense-funded, cloud-based data repository for clinical trauma research data that supports national trauma research efforts. Investigators are encouraged to upload their data resulting from clinical trauma research. Users access the NTRR through web-based applications developed jointly with the National Institutes of Health – Center for Information Technology. The system allows researchers to share data sets and to access shared data sets for secondary analyses.
The NTRR will be a key piece of the national research infrastructure being developed to support the trauma research environment. The National Trauma Institute envisions a vast repository offering thousands of data points from hundreds of studies, which investigators can query for their own research. A robust research infrastructure will support trauma investigators in competing for federal research dollars.
The purpose of the NTRR is to advance trauma-related research by providing the infrastructure that enables investigators to access and use clinical research data that has not previously been available. Like other research data repositories, the NTRR will:
The creation of a national repository for trauma clinical research data that makes data available for continuing use is a cost-effective solution to the lingering challenge of funding trauma research.
Data stored in a fully developed and robust NTRR will cover the entire continuum of care, including injury prevention, point of injury, en route care, all phases of hospital care, and finally, rehabilitation/outcomes. This will be the central repository for clinical data resulting from both military and civilian federally funded trauma research.
The National Trauma Data Bank® (NTDB) is the largest aggregation of trauma registry data ever assembled. The goal of the NTDB is to inform the medical community, the public, and decision makers about a wide variety of issues that characterize the current state of care for injured persons. The difference between the NTRR and the NTDB is that NTDB data can be used for research, but the data were not collected for a research study. There are many additional variables collected by researchers conducting a study that are not included in the medical records typically uploaded into the NTDB. The NTRR will include all the additional variables that were collected in the course of research studies. Additionally, the NTRR will include multidisciplinary research studies that include orthopedics, neurotrauma, pediatrics, geriatrics, burns, and others.
Hospital trauma registries include de-identified information from medical records along with additional trauma information. Hospital registries do not include any additional data that is collected for a research study. The NTRR will include scrubbed, high-fidelity data with well-identified elements, uploaded from completed clinical trials.
The authors of the NASEM Report on a National Trauma Care System issued 11 recommendations including establishment of a National Trauma Research Action Plan and creation of a data collection system for real-time data entry, validation, and analyses of multi-site studies—which the NTRR achieves. Once the infrastructure exists to support investigators in their work, the priorities identified in the National Trauma Research Action Plan may be much more achievable, and the ultimate goal—zero preventable deaths—reachable. Read an article published in the Journal of Trauma on implementation of the National Trauma Research Action Plan.
Most federal funding sources require data sharing for funded research (e.g., NIH, DoD, NSF). Additionally, in a 2017 American Medical Association Journal editorial, the International Committee of Medical Journal Editors (ICMJE) argued that “there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.” Committed to this idea, the ICMJE now requires that manuscripts submitted to ICMJE journals reporting results of clinical trials must contain a data sharing statement; and that clinical trials enrolling participants on or after January 1, 2019 must include a data sharing plan in their registration.
Investigators receive scholarly credit for sharing their data through the linkage to the original study’s Digital Object Identifier (DOI); they may also discover collaborations with new investigations. When investigators contribute and use data in the NTRR, they follow best practices for data stewardship--read our article in Trauma Surgery and Acute Care Open about the current data sharing landscape.
Research repositories and other data sharing instruments have been developed in other disciplines for some time, such as business and science (Open Science Framework). Medical researchers and funding sources are recognizing the benefits of data sharing and data repositories. In recent years, the medical research community has recognized the need to adopt this practice, established in other disciplines such as business and science. Examples of well-established medical research data repositories are:
FITBIR—Federal Interagency Traumatic Brain Injury Research Informatics System
FITBIR shares research data across the entire TBI research field and facilitates collaboration among laboratories and interconnectivity with other informatics platforms
ADNI—Alzheimer’s Disease Neuroimaging Initiative
Researchers are mandated to contribute standardized data to ADNI. More than 4,000 researchers have accessed ADNI data, resulting in more than 400 publications
NDAR--National Database for Autism Research
Begun in 2007 with support from five institutes at the NIH, NDAR promotes scientific collaboration and datasharing among autism spectrum disorder investigators. Its goal is to explore ways to aggregate and curate existing autism data in order to speed research on the causes and treatment of ASD.
NHLBI--National Heart, Lung and Blood Institute
NHLBI developed a data-sharing protocol focused on balancing the interests of study participants, investigators and the research community. It now includes data on more than 560,000 participants from 100 Institute-supported clinical trials and observational studies.
Access to the data housed in the National Trauma Research Repository is controlled through an application process. Access to data for research purposes is provided through the NTRR Data Access Subcommittee. Membership of this committee includes researchers and staff with expertise in the relevant scientific disciplines, research participant protection, and privacy. The NTRR Data Access Subcommittee reviews data access applications (which include an Investigator Information Form, a current biographical data sketch, institutional review board approval, a Data Access Request [see below] and a signed Data Use Certification) and makes a determination based on research institution affiliation and the scientific merit of the request. Investigators and institutions seeking data from the NTRR are expected to meet data security measures (such as physical security, information technology security, and user training).
- Use the data only for the approved research; if the Recipient Investigator wants to use the data to investigate additional research questions, a second data access request form must be submitted;
- Protect data confidentiality;
- Follow appropriate data security protections;
- Follow all applicable laws, regulations and local institutional policies and procedures for handling NTRR data;
- Do not attempt to identify individual participants from whom data within a dataset were obtained;
- Do not sell any of the data elements from datasets obtained from the NTRR;
- Do not share with individuals, other than those listed in the request, any of the data elements from datasets obtained from the NTRR;
- Agree to the list of approved research uses;
- Provide IRB approval memorandum and continuing reviews (if appropriate);
- Agree to report, in real time, violations of the NTRR Data Sharing Policy to the NTRR Executive Committee;
- Adhere to the NTRR Data Sharing Policy with regard to publication; and
- Provide annual progress reports on research using NTRR data.
NTRR is being developed under a memorandum of understanding between the National Trauma Institute and the NIH Center for Information Technology. The platform is the Biomedical Research Informatics Computing System (BRICS). This platform was used to build the Federal Interagency Traumatic Brain Injury Research (FITBIR) and six other NIH repositories. The NTRR platform is hosted in a secure Amazon Web Services (AWS) cloud environment conforming to standards set forth in the Federal Information Security Management Act (FISMA) providing a standardized approach for assessing, monitoring, securing and authorizing cloud computing products. Specific security controls in place for NTRR include:
- Application monitoring software and integrated cloud tools for operating system scanning
- SSL (Secure Sockets Layer), Data, Anti-Virus and Password encryption technology
- Security audits and inspections
Yes, all data requests will be accompanied by an institutional review board approval memo for the study described in the Data Access Request. The qualifications of the requesting researcher are evaluated as described above. The Data Access Certification addresses the limited use of the data for the specific study and best security practices the investigators are expected to follow. The contributed data sets will not contain potentially identifiable data. The contributing investigators will affirm this when they submit data to NTRR.