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Post-Trial Obligations in the Declaration of Helsinki 2013, 1st Revision
DOI: 10.17160/josha.2.7.73
This presentation by Dr. Mastroleo is Revision 1 of the previously published version of September 6, 2015 (DOI: 10.17160/josha.2.6.65) Dr. Ignacio Mastroleo works on human health research ethics. Since Feb 2015 he is a member of the Post-Trial Responsibilities Workgroup of the Multi-Regional Clinical Trial (MRCT) Center, at Harvard University. He has a PhD in Philosophy from the University of Buenos Aires and Assistant Researcher at CONICET (National Scientific and Technical Research Council of Argentina) working at the Bioethics Program of FLACSO Argentina with his advisor, Dr. Florencia Luna. He was member of the research ethics committee at the Oncology Institute of the University of Buenos Aires.
JOSHA - Table of Contents Volume 2 Issue 6
DOI: 10.17160/josha.2.6.72
We are happy to present to you the Table of Contents for the next issue 2.6, with a number of articles and presentations by “bright minds at work”. Two artists are sharing their work and ideas with us, Jürgen Meyer-Isenmann with art on leather and wood, artistically transforming part of our industrial history. Dörte Oppermann presents a wonderful, unique description of her dreams in a series of poems and impressive paintings. A fascinating reading list on The Bayes Approach in Medical Statistics by Gerhard Nehmiz addresses the most important literature on the impact of Bayes' theorem on design and analysis of clinical trials. In probability theory and statistics, Bayes' theorem (alternatively Bayes' law or Bayes' rule, see also Wikipedia)) describes the probability of an event, based on conditions that might be related to the event.
The Bayes Approach in Medical Statistics
DOI: 10.17160/josha.2.6.68
Dr. Gerhard Nehmiz, Biberach, Germany, presents four reading lists on the Bayes approach in Medical Statistics - (1) References that had, from his subjective point view, historically the highest impact on the subject, (2) References that had the highest influence on his own thinking about the subject, (3) References to start with for a person with mathematical background, and (4) References to start with for a person with a medical or biological background. G.N. was born in 1955. He achieved the diploma in Mathematics in 1981 and the doctorate in Biostatistics in 1988. He is working as a biometrician for Boehringer Ingelheim since 1986. The main areas of his expertise include: Phase I trials in general, phase II and III trials in cardiovascular indications and hepatitis C. His special interest is project planning (extrapolation, optimization) based on uncertain knowledge. G.N. is married and has 3 adult children. Contact: gerhard.nehmiz.ext@boehringer-ingelheim.com
Post-Trial Obligations in the Declaration of Helsinki 2013
DOI: 10.17160/josha.2.6.65
Dr. Ignacio Mastroleo works on human health research ethics. Since Feb 2015 he is a member of the Post-Trial Responsibilities Workgroup of the Multi-Regional Clinical Trial (MRCT) Center, at Harvard University. He has a PhD in Philosophy from the University of Buenos Aires and Assistant Researcher at CONICET (National Scientific and Technical Research Council of Argentina) working at the Bioethics Program of FLACSO Argentina with his advisor, Dr. Florencia Luna. He was member of the research ethics committee at the Oncology Institute of the University of Buenos Aires. Last year he was awarded the Caroline Miles Scholarship of the Ethox Centre, Oxford University, UK and The Manuel Velasco Suarez Award for Excellence in Bioethics, by the Pan American Health Organization (PAHO) and the PAHO Foundation. In this presentation Dr. Mastroleone addresses the obligations of reserachers and clinicians after the formal clinical trial is completed.
Informed Consent in Genomic Research: The Iterative Feedback Model
DOI: 10.17160/josha.2.6.64
Recently, there has been a discussion on the best way to implement informed consent for the disclosure of incidental findings in research using whole genome sequencing (WGS)/whole exome sequencing (WES) procedures. Appelbaum et al. (2014:29) present four different “prototypical models” for the return of incidental findings, drawing on a literature review on return of incidental findings, a survey of a large number of genomic researchers and in-depth interviews with researchers and genomic research participants. I agree with Appelbaum et al. (2014) that consent models could be evaluated with the ethical criterion of “consistency with researchers’ ethical obligations” which is based on the ethical principles “respect for persons, beneficence, and justice” stated in the Belmont Report (1979). However, I propose to draw a different conclusion than Appelbaum et al. from this ethical evaluation. Appelbaum et al.
Genome Sequencing in Cancer Research and Therapy
DOI: 10.17160/josha.2.6.63
Stefan Fröhling has a long-standing interest in identifying genetic abnormalities that define disease subgroups and treatment outcome in patients with acute myeloid leukemia. Furthermore, he works to identify new cancer drug targets through a better understanding of the functional dependencies of hematologic and solid-organ malignancies, and to bring targeted approaches and molecularly based patient stratification to clinical trials and patient treatment broadly across tumor types.
The Scientific, Social and Ethical Aspects of Prolonging Human Life
DOI: 10.17160/josha.2.6.62
Professor Borner is a leading scientist in the field of apoptosis research. His career and activities include the following stations: 2014-present Director of the International Master Program in Medical and Biological Sciences (IMBS) between the Universities of Buenos Aires and Freiburg 2013-present Professor and Tutor in Biology, Psychology and Environmental Sciences for the Business and Administration study track of the California Miramar University (CMU) in Nairobi, Kenya (50% lectures, 50% online/e-learning tutoring).
Science, Ethics and Society: Introduction
DOI: 10.17160/josha.2.6.61
Roland Mertelsmann is a haematologist and oncologist and was professor and chairman at the Freiburg University Medical Center, Department of Oncology and Hematology. Amongst others, Roland Mertelsmann is known for his scientific work in the fields of hematology, oncology and stem cell transplantation. He started his career as a medical student at the Universities of Göttingen, Hamburg and the King’s College School of Medicine, London. After his graduation at the University of Hamburg, he contributed to the isolation of the blood stimulating growth factor G-SCF during his work in Hematology and Clinical Oncology at Memorial Sloan-Kettering Cancer Center in New York. In 1985, he returned to Germany and became professor and head of the Department for Hematology and Oncology at the University of Mainz and since 1989 at the University of Freiburg. In 1994 he founded the philanthropic Biothera Foundation, which supports education, research and training in the Biomedical Sciences.
International Congress of Translational Medicine- Announcement: Buenos Aires, Argentina, Nov 24-25, 2015
DOI: 10.17160/josha.2.6.60
The Faculty of Pharmacy and Biochemistry (Facultad de Farmacia y Bioquímica) of the Universidad de Buenos Aires (UBA) hosts the second International Congress of Translational Medicine on November 24th and 25th . The event will be under the auspices of the German and Swiss Embassies in Buenos Aires. The International Congress will be held in the context of the International Master Program in Biomedical Sciences (IMBS) Cooperation, a German-Argentine Study Program at the Universities Freiburg and Buenos Aires which is currently being extended to the University of Montevideo, Uruguay. The Program was launched in 2008 and has already paved the way for many students who joined academic and professional careers after completing the Master Program. A broad range of topics in the fields of Molecular Biology and Medicine as well as Microsystems and Bioethics will be covered by the two day congress and communicated in oral and poster presentations. Dr.
IMBS Class 2016-18: Inscription Open
DOI: 10.17160/josha.2.6.59
In 2008 the International Master in Biomedical Sciences (IMBS) was established as a joint program between the Faculty of Medicine of the Albert Ludwigs University of Freiburg (ALU) and the Faculties of Medicine and Pharmacy and Biochemistry of the University of Buenos Aires (UBA) in Argentina. The aim of this program is to provide scientific knowledge and state-of-the-art experimental experience to current and emerging biomedical research areas with a focus on translational research and development. It is also meant to foster teaching and research cooperation between the two Universities and to contribute to cultural exchange on the master, PhD and professor level. The program was implemented in a specific agreement co-signed by the Rectors of the two Universities in 2008. Moreover, the cooperation was strengthened by the UBA visit of the Minister President of Baden-Württemberg Kretschmann in 2011 when another agreement was signed.