TY  - JOUR
AB  - With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic.
AU  - Tilch, K.*
AU  - Hopff, S.M.*
AU  - Appel, K.*
AU  - Kraus, M.
AU  - Lorenz-Depiereux, B.
AU  - Pilgram, L.*
AU  - Anton, G.
AU  - Berger, S.*
AU  - Geißler, R.*
AU  - Haas, K.*
AU  - Illig, T.*
AU  - Krefting, D.*
AU  - Lorbeer, R.*
AU  - Mitrov, L.*
AU  - Muenchhoff, M.*
AU  - Nauck, M.*
AU  - Pley, C.*
AU  - Reese, J.P.*
AU  - Rieg, S.*
AU  - Scherer, M.*
AU  - Stecher, M.*
AU  - Stellbrink, C.*
AU  - Valentin, H.*
AU  - Winter, C.*
AU  - Witzenrath, M.*
AU  - Vehreschild, J.J.*
C1  - 68644
C2  - 54847
CY  - Campus, 4 Crinan St, London N1 9xw, England
TI  - Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany.
JO  - BMC Med. Ethics
VL  - 24
IS  - 1
PB  - Bmc
PY  - 2023
ER  - 

TY  - JOUR
AB  - Skin affections after sulfur mustard (SM) exposure include erythema, blister formation and severe inflammation. An antidote or specific therapy does not exist. Anti-inflammatory compounds as well as substances counteracting SM-induced cell death are under investigation. In this study, we investigated the benzylisoquinoline alkaloide berberine (BER), a metabolite in plants like berberis vulgaris, which is used as herbal pharmaceutical in Asian countries, against SM toxicity using a well-established in vitro approach. Keratinocyte (HaCaT) mono-cultures (MoC) or HaCaT/THP-1 co-cultures (CoC) were challenged with 100, 200 or 300 mM SM for 1 h. Post-exposure, both MoC and CoC were treated with 10, 30 or 50 mu M BER for 24 h. At that time, supernatants were collected and analyzed both for interleukine (IL) 6 and 8 levels and for content of adenylate-kinase (AK) as surrogate marker for cell necrosis. Cells were lysed and nucleosome formation as marker for late apoptosis was assessed. In parallel, AK in cells was determined for normalization purposes. BER treatment did not influence necrosis, but significantly decreased apoptosis. Anti-inflammatory effects were moderate, but also significant, primarily in CoC. Overall, BER has protective effects against SM toxicity in vitro. Whether this holds true should be evaluated in future in vivo studies.
AU  - Rogowski, W.H.
C1  - 53711
C2  - 44981
CY  - Elsevier House, Brookvale Plaza, East Park Shannon, Co, Clare, 00000, Ireland
TI  - Evaluation as institution: A contractarian argument for needs-based economic evaluation.
JO  - BMC Med. Ethics
VL  - 19
IS  - 1
PB  - Elsevier Ireland Ltd
PY  - 2018
ER  - 

TY  - JOUR
AB  - ACKGROUND: Recently, individualized or personalized medicine (PM) has become a buzz word in the academic as well as public debate surrounding health care. However, PM lacks a clear definition and is open to interpretation. This conceptual vagueness complicates public discourse on chances, risks and limits of PM. Furthermore, stakeholders might use it to further their respective interests and preferences. For these reasons it is important to have a shared understanding of PM. In this paper, we present a sufficiently precise as well as adequate definition of PM with the potential of wide acceptance. METHODS: For this purpose, in a first step a systematic literature review was conducted to understand how PM is actually used in scientific practice. PubMed was searched using the keywords "individualized medicine", "individualised medicine", "personalized medicine" and "personalised medicine" connected by the Boolean operator OR. A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing the search terms in title or abstract were screened for definitions. Definitions were extracted; according to the means/ends distinction their elements were assigned to the corresponding category. To reduce complexity of the resulting list, summary categories were developed inductively from the data using thematic analysis. In a second step, six well-known criteria for adequate definitions were applied to these categories to derive a so-called precising definition. RESULTS: We identified 2457 articles containing the terms PM in title or abstract. Of those 683 contained a definition of PM and were thus included in our review. 1459 ends and 1025 means were found in the definitions. From these we derived the precising definition: PM seeks to improve stratification and timing of health care by utilizing biological information and biomarkers on the level of molecular disease pathways, genetics, proteomics as well as metabolomics. CONCLUSIONS: Our definition includes the aspects that are specific for developments labeled as PM while, on the other hand, recognizing the limits of these developments. Furthermore, it is supported by the quantitative analysis of PM definitions in the literature, which suggests that it it is widely acceptable and thus has the potential to avoid the above mentioned issues.
AU  - Schleidgen, S.*
AU  - Klingler, C.*
AU  - Bertram, T.*
AU  - Rogowski, W.H.
AU  - Marckmann, G.*
C1  - 29080
C2  - 33153
TI  - What is personalized medicine: Sharpening a vague term based on a systematic literature review.
JO  - BMC Med. Ethics
VL  - 14
IS  - 1
PB  - Biomed Central Ltd
PY  - 2013
ER  - 

TY  - JOUR
AB  - Large-scale genetic data sets are frequently shared with other research groups and even released on the Internet to allow for secondary analysis. Study participants are usually not informed about such data sharing because data sets are assumed to be anonymous after stripping off personal identifiers. DISCUSSION: The assumption of anonymity of genetic data sets, however, is tenuous because genetic data are intrinsically self-identifying. Two types of re-identification are possible: the "Netflix" type and the "profiling" type. The "Netflix" type needs another small genetic data set, usually with less than 100 SNPs but including a personal identifier. This second data set might originate from another clinical examination, a study of leftover samples or forensic testing. When merged to the primary, unidentified set it will re-identify all samples of that individual.Even with no second data set at hand, a "profiling" strategy can be developed to extract as much information as possible from a sample collection. Starting with the identification of ethnic subgroups along with predictions of body characteristics and diseases, the asthma kids case as a real-life example is used to illustrate that approach. SUMMARY: Depending on the degree of supplemental information, there is a good chance that at least a few individuals can be identified from an anonymized data set. Any re-identification, however, may potentially harm study participants because it will release individual genetic disease risks to the public.
AU  - Wjst, M.
C1  - 5027
C2  - 27830
TI  - Caught you: Threats to confidentiality due to the public release of large-scale genetic data sets.
JO  - BMC Med. Ethics
VL  - 11
IS  - 1
PB  - BioMed Central
PY  - 2010
ER  -