National Autopsy Registry (NAREG)
The National Autopsy Registry (NAREG) emerged from the German Registry for COVID-19 Autopsies (DeRegCOVID), which was founded in April 2020 to centrally collect information on autopsies of COVID-19 deaths. DeRegCOVID has contributed significantly to the understanding of COVID and its consequences and has been recommended by international experts as a model infrastructure for Europe and the world. NAREG now collects information from autopsies of various diseases and no longer “only” on COVID-19 in order to provide a sustainable, flexible, generic and inclusive infrastructure or platform for research on information obtained from autopsies.
In NAREG, the basic data of an autopsy is recorded in a standardized form. The data is entered via a web browser in a central database, which is operated in the data center of the University Hospital RWTH Aachen under strict security precautions.
In addition to the basic data, information is also recorded on which tissue samples were collected during each autopsy. These samples were required for a more precise diagnosis of the causes of death and are subject to a statutory retention period of ten years. These samples remain in the respective centers and are not collected centrally.
Only a limited number of autopsies are performed at the individual centers. As a result, the centers only have a few case examples in their own case material for certain, particularly rare, diseases. By collecting these cases centrally, the number of cases can be increased in a multi-center approach and thus significantly more robust analyses can be carried out.
In addition, the registry promotes cooperation between doctors from the various centers and departments (pathology, neuropathology and forensic medicine with clinical disciplines such as intensive care medicine, etc.). In this way, new findings can be returned to clinical practice and applied to patients more quickly. The registry plays an important role as a central point of contact and as a link to transparently inform the public about these findings and successes.
The registry also fulfills other important tasks. For example, it supports the standardization of diagnostics to ensure consistent and comparable results. Long-term data storage allows retrospective analyses to be carried out and valuable insights to be gained from previous cases. It also contributes to quality assurance by allowing results to be compared between centers and promoting best practices. The registry also serves to train and educate medical professionals and provides a platform for interdisciplinary exchange.
If an autopsy center (this can be an institute of pathology at a university hospital, a non-university hospital or a private practice, but also an institute of forensic medicine at a university hospital together with the neighboring institute of neuropathology) has performed an autopsy and they are a center participating in NAREG, they can subsequently enter the data on the autopsy in the register.
The registry consists of various parts that can be presented like a questionnaire or a database. The mandatory part (core data set) consists of data that is requested for every autopsy case that is entered into the register. This includes, for example, the type of death or the age of the deceased. In addition, further data can be entered on a module-specific basis that is relevant to specific diseases. These are mapped in various modules in the registry. In the case of COVID-19, additional information would include, for example, the virus variants or vaccinations received.
New modules can be quickly integrated into the registry, allowing for the timely collection and analysis of data in response to emerging diseases. This contributes, for example, to proactive pandemic preparedness.
The standardization of data within the registry improves the possibilities for quality assurance and harmonization, not only within the centers, but also nationally.
Only centers that have received a positive vote for participation in the registry from the responsible ethics committee of the respective university or the state medical association can participate in the registry. All participating centers are accredited, highly experienced and often have organ-specific expertise (e.g. tissue-based pathogen detection or infection diagnostics from post-mortem tissue/blood; see also Services). Through their participation, they make a significant contribution to improving the data situation and to further scientific development. The success of the registry would not have been possible without the active participation and committed involvement of the individual centers.
Only data from autopsies performed in accordance with the legal requirements of the respective federal state may be recorded. Typically, consent for autopsy is available, most commonly granted through the approval of the next of kin.
Data from autopsies commissioned by public prosecutors (forensic autopsies) are currently not recorded in the register.
The autopsy data is entered into a central database located at the University Hospital RWTH Aachen by employees of the participating centers.
The data is recorded pseudonymously, i.e. the centers can trace the entered cases internally. For external parties, such as the registry management, their employees, the data center (University Hospital RWTH Aachen) and all participants in possible research projects, the data cannot be traced back to a person. Traceability remains necessary for the respective center so that they can reassign the samples to the registry data in the event of their own analyses or study inquiries.
The consent of relatives is not required to enter data into the register. The (health) data queried has been recorded during routine clinical anamnesis and diagnostics. The data collected in this way falls under the Health Data Use Act (GDNG) and may be further processed within healthcare facilities. In this context, the required balancing of individual rights against the public interest – specifically, the improvement of disease research – yields a decision in favor of the public interest. No objection can be raised in this matter.
The data entered into NAREG is used for research, pandemic preparation, quality assurance and improving medical care. Requests from researchers are divided into two separate processes depending on the type of need:
1. Requests for autopsy data: Researchers can submit requests to use autopsy data stored in NAREG. These requests are first checked centrally by the registry team for plausibility and feasibility. If the scientific question can be answered with the available data, the researchers are given access to the corresponding data sets in accordance with the applicable data protection regulations and guidelines.
2. Requests for autopsy biosamples: For requests involving the provision of autopsy biospecimens, the registry team first assesses the general plausibility and feasibility. Subsequently, a link is established between the requesting research team and the respective autopsy centers. The local autopsy centers, which secure the samples, carry out a detailed examination of the suitability and availability of the requested material for the specific scientific question. If the request is approved, they provide the requested material to the researchers.
The results of the studies obtained with data from NAREG are published in scientific publications. Previous publications are listed here and can also be found via search engines for medical and scientific publications, such as PubMed.
Sometimes journalists pick up on the results of these studies and report on them in articles, broadcasts or podcasts. Media reports about NAREG are listed here.
