mcourtot
commented
3 years ago After many discussion by email, f2f and in TCs it was established that none of the current participants and contributors to DUO have a use case for using GRU-CC. A pointer to the consent codes paper is not a use case, as per our governance policy, for terms we consider datasets to which the terms would apply and a representative of the project requesting the change, for example un deprecating the GRU-CC term. Unless a clear use case is being brough forward this ticket will be closed in 2 weeks.
Text below cited from https://doi.org/10.1371/journal.pgen.1005772
Research and clinical care A major issue we sought to address is that of dataset generation and use in both research and clinical contexts. An example of this is sharing either anonymized or coded patient information to find similar cases elsewhere among colleagues around the world. A goal of the Global Alliance Matchmaker Exchange (MME) project is to facilitate the use of coded patient information to enable discovery and, ultimately, clinical care.
In general terms, the need for consent to data sharing for either clinical care or research is usually dependent on the context in which data are collected and/or produced and shared, and on the balance between potential benefits and the probability of occurrence and seriousness of potential harm introduced by sharing possibly re-identifying information. Sharing within professional clinical networks is very important and often necessary for providing the best clinical care for patients. Nevertheless, broader accessibility and use of clinical datasets is potentially of great value to both scientific research and the clinical care it supports. As we foresee more clinical datasets being used in research in the future, we sought to identify any data use conditions that could specifically arise when seeking consent to data sharing for research purposes in a clinical setting, and we consulted researchers with experience in a clinical setting to this end. None were identified, which is, perhaps, not surprising, as many Database of Genotypes and Phenotypes (dbGaP) datasets, upon which much of the documentation we used was based, while considered typical research datasets, were partially generated in the clinic and include, for example, patient information about disease status.
Furthermore, when it is based on current standards of clinical practice, the sharing of clinical genomic datasets in support of clinical care may sometimes rely on presumed (or implied) consent—for example, for the use of data derived from residual medical samples [8]. We also sought to clarify if additional data use conditions would result from relying on presumed consent to clinical care. While we considered including a “clinical use only” category, this ultimately seemed unsatisfactory, as it would result in a silo of data with unclear permissions, whereas sufficient protection of clinical data could be achieved with the “health/medical/biomedical research and clinical care” or “disease-specific research and clinical care” data use Categories, along with the “collaboration required” data use Requirement for more complex data sharing agreements.
Conversely, it was important to consider the use of research datasets in the clinic. We expanded standard “research use” categories to “research and clinical care” in general terms with the understanding that, due to data quality and the likely consent situation, most of the time, research data would not be used directly in clinical decision-making (by researchers, clinicians, or others) or to provide research participants with their genetic information. If an obligation to share genetic data with research participants exists—and this may increasingly appear—it could be included under the “collaboration required” data use Requirement, which we imagine would be used to regroup different kinds of collaborative requirements (e.g., return of results, co-publication), though some of them might not be based on consent. As a separate matter, data quality, which may be of clinical grade, should be conveyed to data users. Defining data use Categories as for use in research and clinical care is, therefore, meant to reflect the pervasive contribution of scientific and medical research to inform clinical care, albeit in a somewhat indirect fashion for now. Along with this, a “research use only” IIry data use Category was included, as a safeguard if participants were given assurances about limitations as to research use of data. Finally, it is important to address concerns about inclusion of research datasets in databases that may affect commercial services available to participants [9] through legal and other protections.
MME provides a good example of the overlap between research and clinical care uses of data. Patient data (typically phenotype and candidate genes from genomic analyses), which may have been collected in either a research or clinical care setting, are submitted during a broad query of networked databases. The goal is to find "matches" that may build evidence for implicating a new genetic cause of a disease phenotype. In this setting, both clinical care and research are facilitated, and the need for consent, either for clinical care or for research, is dependent on the detail and type of data shared [10].
As we enter the era of "learning healthcare," where every clinical encounter contributes to research, and research is being applied in real time to clinical care (e.g., for clinical sequencing or clinical trial entry in cancer treatment), we expect to see an ever greater blurring of research and clinical care boundaries.