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Health-related innovation in biotechnology requires anticipating potential bioethical implications. In this article, we present a strategy to embed ethics in a group of early-stage researchers performing research in gene therapy and regenerative medicine in the laboratory phase. We conducted a series of focus group meetings with early-stage researchers who work in biotechnology laboratories. The objective was to reflect on the bioethical challenges of their own work and to promote the integration of research ethics with laboratory practice. The activity was assessed with questionnaires completed by the researchers before and after the meetings, and the analyses of the focus groups' content. As a result of the focus group series, all participants changed their perspectives about ethical issues regarding their planned research, developed the ability to reflect and debate on research ethics and had increased awareness of ethical issues in their own research activities. Half of them made changes in their research work. The study provides a concrete strategy to embed ethics and to strengthen responsibility in laboratory research. It is a strategy that allows to perform ethics reflection "on site" and in "real time" and complements the classic strategy of ethics assessment of the research protocol before starting the research procedure. [ABSTRACT FROM AUTHOR]

In this article, we explore ethical issues of Deaf people's engagement in research. To focus on the perspectives of Deaf people, we investigated existing qualitative and mixed methods research within a qualitative evidence synthesis. Our synthesis is based on a systematic database search (Scopus, PubMed) and reference check of included papers which resulted in 27 eligible papers. We analyzed the data using thematic synthesis and developed 5 analytical themes. The results present research as a struggle for Deaf people and emphasize the need for changes regarding recognition of Deaf research in a cross-cultural context, maintaining equal and partner relations, and provision of accessible communication. Our research contributes to understanding what the ethical inclusion of Deaf people in research implies. It may also support the development of evidence-based normative recommendations and scientific cooperation between Deaf and hearing people. [ABSTRACT FROM AUTHOR]

Background Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials. Methods and findings Our protocol was prospectively registered in PROSPERO (CRD42015015961). We systematically searched Embase and PubMed for solid and hematological malignancy Phase I pediatric trials published between 1 January 2004 and 1 March 2015. We included pediatric cancer Phase I studies, defined as 'small sample size, non-randomized, dose escalation studies that defined the recommended dose for subsequent study of a new drug in each schedule tested.' We measured risk using grade 3, 4, and 5 (fatal) drug-related adverse events (AEs) and benefit using objective response rates. When possible, data were meta-analyzed. We identified 170 studies meeting our eligibility criteria, accounting for 4,604 patients. The pooled overall objective response rate was 10.29% (95% CI 8.33% to 12.25%), and was lower in solid tumors, 3.17% (95% CI 2.62% to 3.72%), compared with hematological malignancies, 27.90% (95% CI 20.53% to 35.27%); p < 0.001. The overall fatal (grade 5) AE rate was 2.09% (95% CI 1.45% to 2.72%). Across the 4,604 evaluated patients, there were 4,675 grade 3 and 4 drug-related AEs, with an average grade 3/4 AE rate per person equal to 1.32. Our study had the following limitations: trials included in our review were heterogeneous (to minimize heterogeneity, we separated types of therapy and cancer types), and we relied on published data only and encountered challenges with the quality of reporting. Conclusions Our meta-analysis suggests that, on the whole, AE and response rates in pediatric Phase I trials are similar to those in adult Phase I trials. Our findings provide an empirical basis for the refinement and review of pediatric Phase I trials, and for communication about their risk and benefit., Author(s): Marcin Waligora 1, Malgorzata M. Bala 2,*, Magdalena Koperny 1,3, Mateusz T. Wasylewski 1, Karolina Strzebonska 1, Rafal R. Jaeschke 4, Agnieszka Wozniak 5, Jan Piasecki 1, Agnieszka Sliwka [...]