Uitgelicht en gespot op internet (week 27, 2021)
Hierbij een nieuw overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet. Heeft u zelf iets gespot geef het gerust aan mij door via het contact formulier.
Vergeet niet om ook de bijgewerkte ‘Events‘ pagina en de ‘Consultations‘-pagina te raadplegen.
Artificial Intelligence
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Dutch Oncology Research Platform (DORP)
European Data Protection Board (EDPB)
- EDPB adopts Guidelines on Codes of Conduct as a tool for transfers, final versions of the Guidelines on Virtual Voice Assistants & the Guidelines on the concepts of Controller & Processor, disbands TikTok Taskforce & discusses topics for its first coordin (8 juli 2021).
- Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data (18 juni 2021).
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- 9th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published (1 juli 2021).
- ENCePP Guide on Methodological Standards in Pharmacoepidemiology, Revision 9, dated July 2021.
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
- Oproep aan alle sponsors om de resultaten van klinische proeven te publiceren (8 juli 2021).
- Het FAGG organiseert twee infosessies over de nieuwe verordening voor klinische proeven (CTR) (6 juli 2021).
Integraal Kankercentrum Nederland (IKNL)
Medicines and Healthcare products Regulatory Agency (MHRA)
- Guidance: Importing investigational medicinal products into Great Britain from approved countries (bijgewerkt 7 juli 2021). New guidance on authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries.
- Guidance: Clinical trials for medicines: manage your authorisation, report safety issues (bijgewerkt 6 juli 2021). Added guidance on how to increase transparency when presenting safety information in the Development Safety Update Report (DSUR).
- MHRA releases guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports (6 juli 2021).
Nanomedicines
Publications, Reporting guidelines
- Debate on missing trial results heats up in Europe (juli 2021). TranspariMED.
- Onvoldoende aandacht voor geslacht in studies naar covid-19 (7 juli 2021). Medisch Contact.
- Beware performative reproducibility (6 juli 2021). Nature.
- Altmetric Score Has a Stronger Relationship With Article Citations Than Journal Impact Factor and Open Access Status: A Cross-Sectional Analysis of 4,022 Sports Science Articles (1 juli 2021). Journal of Orthopaedic & Sports Physical Therapy.
- What difference might retractions make? An estimate of the potential epistemic cost of retractions on meta-analyses (1 juli 2021). Accountability in Research.
- ROSES-S: Statement from the World Health Organization on the reporting of seroepidemiologic studies for SARS-CoV-2 (26 juni 2021). Influenza and Other Respiratory Viruses.
- Initial evidence of research quality of registered reports compared with the standard publishing model (24 juni 2021). Nature Human Behavior.
- New Classification for the Reporting of Complications in Retinal Detachment Surgical Trials (24 juni 2021). JAMA Ophthalmology.
Research integrity
- Time to assume that health research is fraudulent until proven otherwise? (5 juli 2021). BMJ Opinion.
- Landmark research integrity survey finds questionable practices are surprisingly common (7 juli 2021). Science.
- Prevalence of questionable research practices, research misconduct and their potential explanatory factors: a survey among academic researchers in The Netherlands (6 juli 2021). MetaArXiv.
- Prevalence of responsible research practices and their potential explanatory factors: a survey among academic researchers in The Netherlands (6 juli 2021). MetaArXiv.
- Netherlands Code of Conduct for Research Integrity (2018).
- KNAW; NFU; NWO; TO2-federatie; Vereniging Hogescholen; VSNU (2018): Nederlandse gedragscode wetenschappelijke integriteit. DANS.
- Largest ever research integrity survey flounders as universities refuse to cooperate (25 november 2021). Science.
U.S. Food and Drug Administration (FDA)
Overige
- Weekend reads: How many scientists commit misconduct?; science ‘moved beyond peer review during the pandemic’; Juul pays for entire journal issue (10 juli 2021). Retraction Watch.
- Research Note: Individual participant data (IPD) meta-analysis (juli 2021). Journal of Physiotherapy.
- Patient advocacy groups and innovators must partner to advance new treatments (6 juli 2021). STAT.
- Geen onderzoek maar wel handig om te weten: Off-label voorschrijven verplicht vastleggen in het patiëntendossier? (6 juli 2021). NTvG.
- Recognizing the ethical implications of stem cell research: A call for broadening the scope (1 juli 2021). Stem Cell Reports.
- Ethics of HIV cure research: an unfinished agenda. BMC Med Ethics 22, 83 (2021).
- Empowering clinical research in a decentralized world (1 juli 2021). npj Digital Medicine.
- How a Sharp-Eyed Scientist Became Biology’s Image Detective (23 juni 2021). The New Yorker.
- TransCelerate BioPharma & CDISC Collaborate On SAE Data Collection Standard (22 juni 2021). Clinical Leader.
- Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates. (7 mei 2021). Therapeutic innovation & regulatory science, 1–7. Advance online publication.
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