• Safe Harbor for Preclinical Use of Patented Inventions in Drug Research and Development: Merck KGaA v. Integra Lifesciences I, Ltd.

      OpenCRS (Library of Congress. Congressional Research Service, 2005-10-07)
      In Merck KGaA v. Integra Lifesciences I, Ltd., __ U.S. __, 125 S. Ct. 2372 (2005), the United States Supreme Court unanimously held that the preclinical use of patented inventions in drug research is exempted from patent infringement claims by the "safe harbor" provision of the Patent Act, 35 U.S.C. Section 271(e)(1). (Merck KGaA is a German company unaffiliated with the U.S.-based pharmaceutical company Merck & Co.) This decision potentially may help expedite the development of new medical treatments and lower the cost of some drugs for consumers. In 2003, the U.S. Court of Appeals for the Federal Circuit had narrowly construed the safe harbor provision as protecting only clinical research activities that produce information for submission to the Food and Drug Administration (FDA) in the regulatory process. In vacating that decision, the U.S. Supreme Court ruled that the exemption applies to all uses of patented inventions that are "reasonably related" to the process of developing any information for FDA submission. The Court explained that, under certain conditions, the safe harbor provision is even "sufficiently broad" to protect the use of patented compounds in experiments that are not ultimately submitted to the FDA or drug experiments that are not ultimately the subject of an FDA submission. Finally, the scope of the exemption is not limited only to preclinical studies pertaining to a drug's safety in humans, but also includes preclinical data regarding a drug's efficacy, mechanism of action, pharmacokinetics, and pharmacology. However, the Court cautioned that the exemption does not reach all experimental activity that at some point, however attenuated, may lead to an FDA approval process. For example, the safe harbor provision does not embrace basic scientific research performed on a patented compound without the intent to develop a particular drug or without a reasonable belief that the compound will cause a particular physiological effect that the researcher desires. In addition, because the matter was not at issue in the case, the Court expressly declined to decide whether or to what extent the exemption applies to patented "research tools" that are often used to facilitate general research in developing compounds for FDA submissions.
    • Safeguarding children's rights in psychopharmacological research: ethical and legal issues

      Kölch, Michael; Ludolph, Andrea G; Plener, Paul L; Fangerau, Heiner; Vitiello, Benedetto; Fegert, Joerg M (2010)
      Research on psychopharmacological treatment in children and adolescents is the subject of ongoing ethical discussion, as minors with mental disorders constitute a vulnerable patient group. Considering the important legislative changes in pediatric research over the past decade in both the US and Western Europe, there is a need to review recent developments in this area.
    • Safeguarding research ethics must be key to our work, particularly when we aim to create external impacts on politics and society

      Tarr, Jen (Blog post from London School of Economics & Political Science, 2012-02-08)
      The recent court case involving Boston College researchers illustrates the flimsiness of assurances of anonymity given by academic researchers. In its aftermath, Jen Tarr writes that we must consider the possible applications of our research from an early stage and be open with those participating in good faith.
    • Safeguards in the use of DNA databanks in genomic research

      Taub, Sara; Morin, Karine; Sade, Robert M.; Spillman, Monique A. (2011-07-12)
    • Safeguards in the use of DNA databanks in genomic research

      Taub, Sara; Morin, Karine; Sade, Robert M.; Spillman, Monique A. (2011-07-12)
    • SafePub: A Truthful Data Anonymization Algorithm With Strong Privacy Guarantees

      Bild Raffael; Kuhn Klaus A.; Prasser Fabian (Sciendo, 2018-01-01)
      Methods for privacy-preserving data publishing and analysis trade off privacy risks for individuals against the quality of output data. In this article, we present a data publishing algorithm that satisfies the differential privacy model. The transformations performed are truthful, which means that the algorithm does not perturb input data or generate synthetic output data. Instead, records are randomly drawn from the input dataset and the uniqueness of their features is reduced. This also offers an intuitive notion of privacy protection. Moreover, the approach is generic, as it can be parameterized with different objective functions to optimize its output towards different applications. We show this by integrating six well-known data quality models. We present an extensive analytical and experimental evaluation and a comparison with prior work. The results show that our algorithm is the first practical implementation of the described approach and that it can be used with reasonable privacy parameters resulting in high degrees of protection. Moreover, when parameterizing the generic method with an objective function quantifying the suitability of data for building statistical classifiers, we measured prediction accuracies that compare very well with results obtained using state-of-the-art differentially private classification algorithms.
    • SafePub: A Truthful Data Anonymization Algorithm With Strong Privacy Guarantees

      Bild Raffael; Kuhn Klaus A.; Prasser Fabian (Sciendo, 2018-01-01)
      Methods for privacy-preserving data publishing and analysis trade off privacy risks for individuals against the quality of output data. In this article, we present a data publishing algorithm that satisfies the differential privacy model. The transformations performed are truthful, which means that the algorithm does not perturb input data or generate synthetic output data. Instead, records are randomly drawn from the input dataset and the uniqueness of their features is reduced. This also offers an intuitive notion of privacy protection. Moreover, the approach is generic, as it can be parameterized with different objective functions to optimize its output towards different applications. We show this by integrating six well-known data quality models. We present an extensive analytical and experimental evaluation and a comparison with prior work. The results show that our algorithm is the first practical implementation of the described approach and that it can be used with reasonable privacy parameters resulting in high degrees of protection. Moreover, when parameterizing the generic method with an objective function quantifying the suitability of data for building statistical classifiers, we measured prediction accuracies that compare very well with results obtained using state-of-the-art differentially private classification algorithms.
    • Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research

      Schmidt, Matthias H. (Schulich Scholars, 2012-07-12)
      Specialized and uptodate knowledge is required to identify and manage the risks associated with advanced biomedical research Additional complexities need to be considered when the research involves infants or young children In this article we focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps With an eye to assisting institutional review boards and researchers we consider strategies for the management of these risks and formulate key questions aimed at exposing hidden hazards Institutional review boards should ask these questions and researchers should bear them in mind as they develop research protocols
    • Safety of elastography applied to the placenta: be careful with ultrasound radiation force

      Imagerie et cerveau ; Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM); GREMAN (matériaux, microélectronique, acoustique et nanotechnologies) (GREMAN - UMR 7347) ; Université de Tours-Institut National des Sciences Appliquées - Centre Val de Loire (INSA CVL) ; Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS); Simon, Emmanuel,; Callé, Samuel (HAL CCSD, 2017)
      International audience
    • SAMOREGULACIJA TRŽIŠNOG KOMUNICIRANJA U HRVATSKOJ NA PRIMJERU TELEKOMUNIKACIJSKE INDUSTRIJE

      Fraculj, Mario; Družijanić, Marta (Visoko učilište Algebra.Algebra University College., 2020-03-10)
      Cilj ovog završnog rada je istražiti opće znanje i zapažanje ljudi o moralno dvojbenim oglasnim porukama. U prvom, teorijskom dijelu rada objašnjeni su neki od najčešćih pojmova u marketingu, oglašavanju i tržišnom komuniciranju. Također, obrazložen je regulacijski i samoregulacijski sustav u Hrvatskoj te svrha njihova postojanja. Naime, oglasne poruke dio su naše svakodnevice, ali mnogi potrošači nisu svjesni njihovog utjecaja na kreiranje odluke o kupnji ili u nekim slučajevima, štetnog utjecaja na društvo, a posebice na djecu i mlade. Također, analizirani su stvarni primjeri neetičnog oglašavanja iz telekomunikacijske industrije te zaključci Suda časti o istim. Spomenuti primjeri korišteni su u svrhu praktičnog dijela završnog rada, točnije u svrhu istraživanja stavova potrošača o neetičnim oglasnim porukama.
    • Samples and data accessibility in research biobanks. An explorative survey

      Capocasa, Marco; Anagnostou, Paolo; D'Abramo, Flavio; Matteucci, Giulia; Dominici, Valentina; Bisol, Giovanni Destro; Rufo, Fabrizio (PeerJ Inc., 2016)
      Biobanks, which contain human biological samples and/or data, provide a crucial contribution to the progress of biomedical research. However, the effective and efficient use of biobank resources depends on their accessibility. In fact, making bio-resources promptly accessible to everybody may increase the benefits for society. Furthermore, optimizing their use and ensuring their quality will promote scientific creativity and, in general, contribute to the progress of bio-medical research. Although this has become a rather common belief, several laboratories are still secretive and continue to withhold samples and data. In this study, we conducted a questionnairebased survey in order to investigate sample and data accessibility in research biobanks operating all over the world. The survey involved a total of 46 biobanks. Most of them gave permission to access their samples (95.7%) and data (85.4%), but free and unconditioned accessibility seemed not to be common practice. The analysis of the guidelines regarding the accessibility to resources of the biobanks that responded to the survey highlights three issues: (i) the request for applicants to explain what they would like to do with the resources requested; (ii) the role of funding, public or private, in the establishment of fruitful collaborations between biobanks and research labs; (iii) the request of co-authorship in order to give access to their data. These results suggest that economic and academic aspects are involved in determining the extent of sample and data sharing stored in biobanks. As a second step of this study, we investigated the reasons behind the high diversity of requirements to access biobank resources. The analysis of informative answers suggested that the different modalities of resource accessibility seem to be largely influenced by both social context and legislation of the countries where the biobanks operate.