The COVID-19 pandemic has affected the world and caused a supply shortage of personal protection equipment, especially filtering facepiece respirators (FFP). This has increased the risk of many healthcare workers contracting SARS-CoV-2. Various strategies have been assessed to tackle these supply issues. In critical shortage scenarios, reusing single-use-designed respirators may be required. Thus, an easily applicable and reliable FFP2 (or alike) respirator decontamination method, allowing safe re-use of FFP2 respirators by healthcare personnel, has been developed and is presented in this study. A potent and gentle aerosolized hydrogen peroxide (12% wt) method was applied over 4 hr to decontaminate various brands of FFP2 respirators within a small common room, followed by adequate aeration and storage overnight. The microbial efficacy was tested on unused respirator pieces using spores of Geobacillus stearothermophilus. Further, decontamination effectiveness was tested on used respirators after one 12-hr shift by swabbing before and after the decontamination. The effects of up to ten decontamination cycles on the respirators\' functionality were evaluated using material properties, the structural integrity of the respirators, and fit tests with subjects. The suggested H2O2 decontamination procedure was proven to be (a) sufficiently potent (no microbial recovery, total inactivation of biological indicators as well as spore inoculum on critical respirator surfaces), (b) gentle as no significant damage to the respirator structural integrity and acceptable fit factors were observed, and (c) safe as no H2O2 residue were detected after the defined aeration and storage. Thus, this easy-to-implement and scalable method could overcome another severe respirator shortage, providing enough flexibility to draft safe, effective, and logistically simple crisis plans. However, as highlighted in this study, due to the wealth of design and material used in different models and brands of respirators, the decontamination process should be validated for each FFP respirator model before its field implementation.

Factor XI deficiency is a rare condition with an estimated prevalence of about one in one million and is more commonly seen in Ashkenazi Jews (8-9%) due to consanguinity. It occurs because of mutations in the factor XI gene (F11) on chromosome 4(4q35). Patients with this disorder may remain asymptomatic until they undergo any surgical procedure or delivery. The most common sites of bleeding include the oral cavity, pharynx, and genitourinary tract, where there is high fibrinolytic activity. Our patient was asymptomatic his whole life. He never had spontaneous bleeding or bruising; however, he had severe bleeding requiring multiple transfusions of fresh frozen plasma during and after surgeries.

China has achieved a dramatic development in scientific research over the last few decades. However, just like many other countries, it has also seen a surge of scientific misconducts. With its expansion of international publications, retractions due to suspected research misconduct are also on the rise. A transcultural case study was conducted by investigating the perception of research misbehaviors by Chinese researchers compared to their Belgian Flemish colleagues. The study was designed to find out variation in research practices in different countries and to see how research was shaped and influenced by cultural contexts. An online questionnaire was sent to 3,236 researchers by e-mails and it received a response rate of 13.09%. They were asked to score 32 research misbehaviors on a 5-point scale. The findings suggested that compared to Flemish respondents, the Chinese had a significantly higher acceptance toward most research misbehaviors. To be more specific, the Chinese respondents felt less unacceptable toward behaviors violating such values as honesty, fairness, and verifiability than the Flemish, while their perceptions of behaviors that violated such values as responsibility, objectivity, and truth were not different compared to the Flemish. This case study implies that the Chinese research community is in an urgent need of training in responsible conduct of research and strong as well as sound guidelines for responsible research practices in place.

OBJECTIVE: To improve on the efficiency of biomarker assay readiness, and for reliable biomarker data to support three drug programs, we implemented a fit-for-purpose approach, qualifying two biomarker assays and validating a third. Results/methodology: The qualification strategy and selection of experiments for two exploratory biomarkers (CXCL1, CCL19) was determined by the intended use of the biomarker data. The third biomarker, IL-6, was validated as the data would be used in monitoring patient safety during dose-escalation studies in a Phase I trial. All three assays passed a priori acceptance criteria.
CONCLUSIONS: These assays highlight strategies and methodologies for a fit-for-purpose approach. Minimum qualification, full qualification and validation were chosen and supported programs at different stages of drug development.