Browsing by Subject "Harmonization"

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  • CTR-TBI Investigators Participants; Timmers, Marjolein; van Dijck, Jeroen T. J. M.; van Wijk, Roel P. J.; Kompanje, Erwin J. O.; Palotie, Aarno; Piippo-Karjalainen, Anna; Pirinen, Matti; Posti, Jussi P.; Raj, Rahul; Tenovuo, Olli; Ripatti, Samuli (2020)
    Background The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
  • Zupancic, Neza; Havu, Katri Annikki (2017)
    This comment article discusses the Unfair Commercial Practices Directive in the context of pre-installed software. Moreover, the text analyses the interface between consumer and competition law as regards issues pertaining to tied-in software. The article presents critical remarks on the separate nature of the enforcement systems of EU consumer and competition law.
  • van Vliet-Ostaptchouk, Jana V.; Nuotio, Marja-Liisa; Slagter, Sandra N.; Doiron, Dany; Fischer, Krista; Foco, Luisa; Gaye, Amadou; Gogele, Martin; Heier, Margit; Hiekkalinna, Tero; Joensuu, Anni; Newby, Christopher; Pang, Chao; Partinen, Eemil; Reischl, Eva; Schwienbacher, Christine; Tammesoo, Mari-Liis; Swertz, Morris A.; Burton, Paul; Ferretti, Vincent; Fortier, Isabel; Giepmans, Lisette; Harris, Jennifer R.; Hillege, Hans L.; Holmen, Jostein; Jula, Antti; Kootstra-Ros, Jenny E.; Kvaloy, Kirsti; Holmen, Turid Lingaas; Maunitso, Satu; Metspalu, Andres; Midthjell, Kristian; Murtagh, Madeleine J.; Peters, Annette; Pramstaller, Peter P.; Saaristo, Timo; Salomaa, Veikko; Stolk, Ronald P.; Uusitupa, Matti; Van der Harst, Pim; Van der Klauw, Melanie M.; Waldenberger, Melanie; Perola, Markus; Wolffenbuttel, Bruce H. R. (2014)