Publications by authors named "P Kleist"
Article Synopsis
- Ethics review looks at whether research involving people is fair and safe, and an Ethics Review Committee (ERC) checks this.
- There is a debate about if ERCs are still good at their job, especially with the rise of big data research.
- The article points out both the ongoing issues with ERCs and new problems caused by big data, and suggests changes to make ERCs better at overseeing research.
On 19 February 2019 the severance of a 110kW cable caused an extensive electrical power cut in the Treptow-Köpenick district of Berlin. Subsequently, ca. 30,000 households were without electricity and ca.
View Article and Find Full Text PDFGene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the patients. The combination of an exceptionally large single payment and the life-long clinical follow-up needed for understanding the long-term benefits and safety of gene therapy, represent new types of scientific, financial, social and ethical challenges for the pharmaceutical industry, regulators and society. With special consideration of the uniqueness and importance of gene therapy, the authors propose a three points plan for a close cooperation between the pharmaceutical industry and society to develop orphan gene therapy.
View Article and Find Full Text PDFArticle Synopsis
- The expansion of data-driven research in the 21st century has identified gaps in the existing ethical frameworks for research, particularly in the use of secondary data.
- The World Medical Association's Declaration of Helsinki, which outlines ethical principles for medical research, was last updated in 2013, and the Declaration of Taipei was introduced in 2016 to address health databases and biobanks.
- The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine recommends enhancing the connection between these two declarations to better support data-driven research and protect participants' rights.