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Background: The secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions (e.g., in Europe), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities., Methods: A working group of the national Medical Informatics Initiative in Germany conducted a requirements analysis and developed a GDPR-compliant broad consent standard. The development included consensus procedures within the Medical Informatics Initiative, a documented consultation process with all relevant stakeholder groups and authorities, and the ultimate submission for approval via the national data protection authorities., Results: This paper presents the broad consent text together with a guidance document on mandatory safeguards for broad consent implementation. The mandatory safeguards comprise i) independent review of individual research projects, ii) organizational measures to protect patients from involuntary disclosure of protected information, and iii) comprehensive information for patients and public transparency. This paper further describes the key issues discussed with the relevant authorities, especially the position on additional or alternative consent approaches such as dynamic consent., Discussion: Both the resulting broad consent text and the national consensus process are relevant for similar activities internationally. A key challenge of aligning consent documents with the various stakeholders was explaining and justifying the decision to use broad consent and the decision against using alternative models such as dynamic consent. Public transparency for all secondary use projects and their results emerged as a key factor in this justification. While currently largely limited to academic medicine in Germany, the first steps for extending this broad consent approach to wider areas of application, including smaller institutions and medical practices, are currently under consideration., (Copyright © 2022. Published by Elsevier Inc.)

To ensure good performance of pathogen inactivation with the INTERCEPT blood system, specific target requirements must be met for platelet dose, volume, plasma content and residual red blood cells (RBCs) prior to photochemical treatment (PCT). A two-arm in vitro study was conducted to compare quality parameters of pooled platelet concentrates (PCs), either treated (test units) or nontreated (control units). PCs meeting European requirements were evaluated with reference to their compliance with INTERCEPT guard bands. Of 50 PCs (25 tests and 25 controls) meeting European quality requirements, 24% (three test and three controls units) did not reach INTERCEPT requirements, particularly in terms of sufficient volumes and RBC contamination. The buffy-coat optimization procedure assessed prior to this study ensured plasma contents well within target limits of 30 to 45%. Due to PCT-related in-process loss of 11% in volume (34.38 +/- 3.94) and in platelet dose (0.41 +/- 0.14), the mean platelet dose was significantly (P < 0.001) lower in test units: 3.1 +/- 0.3 versus 3.6 +/- 0.4 x 10(11). After treatment, six of the overall 25 test units (25%) would not have met the European guideline for platelet dose (3.0 x 10(11)). Before implementation of techniques for pathogen reduction, each centre should optimize processing steps during a validation procedure to ensure PC complying with INTERCEPT targets before and European targets after treatment. Besides buffy-coat optimization for sufficient plasma reduction, centrifugation profiles need to be optimized as well to prevent PC with low volumes and, in particular, with higher than acceptable RBC contamination.

Articles published in five prominent personality journals for the three-year period 1993-1995 were reviewed in order to identify recent trends in personality research. Each article was assessed in terms of research methodology and content area. Research methodology has changed very little, the exceptions being a shift away from laboratory settings and a greater use of nonuniversity participants. Results for content demonstrate that over time certain topics emerge and fade from popularity. Current popular topics include traits, emotion/motivation, and health psychology. The general lack of advancement in methodology is discussed, and the current "hot topics" in content area are compared with those of the past. In addition, some comparisons are made between current personality research in North America versus research in Europe.