Uitgelicht en gespot op internet (week 10, 2022)
Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet. Er zijn ook weer nieuwe bijeenkomsten en publieke consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Algemene verordening gegevensbescherming (AVG), Data sharing, Privacy
- Spain: Spanish Data Protection Authority approves the first industry code of conduct to enable compliance of clinical research and pharmacovigilance with the GDPR (10-03-2022). Global Compliance News.
- Respect, justice and learning are limited when patients are deidentified data subjects (04-03-2022). Learning Health Systems.
- Navigating Clinical and Business Ethics While Sharing Patient Data. JAMA. Published online February 25, 2022.
- Legal study on Government access to data in third countries (08-11-2021). EDPB.
Centrale Commissie Mensgebonden Onderzoek (CCMO), Clinical Trials Regulation (CTR)
- Model protocol samenvatting (Nederlands), vs 2.0, d.d. 7 March 2022
- Model protocol samenvatting (Engels), vs 2.0, d.d. 7 March 2022
Clinical trials
- Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing (09-03-2022). Therapeutic Innovation & Regulatory Science.
- FDA Commissioner Califf and the Potential of RWE in Clinical Trials (07-03-2022). BioSpace.
- Cell & Gene Therapy Fueled Large Surge in Clinical Holds Last Year (07-03-2022). WCG CenterWatch.
- CNS Trials Look to Decentralized Methods to Help Solve Enrollment Challenges (07-03-2022). WCG CenterWatch.
- Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020 (02-03-2022). Therapeutic Innovation & Regulatory Science.
- 2021’s top 10 clinical trial flops (01-03-2022). Fierce Biotech.
- WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations (28-02-2022). Vaccine.
- Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community (31-01-2022). Journal of Clinical and Translational Science.
Commissie Genetische Modificatie (COGEM)
ELSI Servicedesk
Enrollment, Inclusiviteit, Diversiteit, Representativiteit
- Dermatology Trials Still Lack Diversity Despite Decade of Inclusion Efforts (07-03-2022). WCG CenterWatch.
- Adoption of Health Literacy Best Practices to Enhance Clinical Research and Community Participation: Proceedings of a Workshop—in Brief. National Academies of Sciences, Engineering, and Medicine.
- What Should Engagement in Health Research Look Like? Perspectives from People with Lived Experience, Members of the Public, and Engagement Managers (04-03-2022). Cambridge Quarterly of Healthcare Ethics.
- Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients’ and public attitudes (03-03-2022). Journal of Comparative Effectiveness Research.
Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)
Medicines and Healthcare products Regulatory Agency (MHRA)
Oekraïne, Rusland, Oorlog
- Kennisinstellingen NL schorten samenwerking met Rusland en Belarus op (04-03-2022). NFU.
- Umc’s schorten samenwerkingen met Russische en Belarussische instellingen op (07-03-2022). Skipr.
Paul Janssen Futurelab Leiden
Proefschriften
Research Data Nederland (RDNL)
University of Calgary
US Food and Drug Administration (FDA)
- FDA Commits to Accelerating and Improving Cancer Research, Issuing Trio of Final Guidances (07-03-2022). WCG CenterWatch.
- Remote inspections prompt drop in data integrity citations in FY2021 (11-03-2022). Regulatory Focus.
ZonMw
Overige berichten
- Weekend reads: Journals’ Russia bans; a chronic fatigue syndrome retraction; a Twitter retraction notice feature? (12-03-2022). Retraction Watch.
- Methodological advances in the design of peptide-based vaccines (10-03-2022). Drug Discovery Today.
- Pandemic publishing: rethinking editorial ethics during COVID (08-03-2022). London School of Economics and Political Science.
- Erasmus MC richt DARWIN EU® Coördinatiecentrum op voor Europees Geneesmiddelenbureau (07-03-2022). Amazing Erasmus MC.
- Visualization formats of patient-reported outcome measures in clinical practice: a systematic review about preferences and interpretation accuracy (03-03-2022). Journal of Patient-Reported Outcomes.
- Academic Misconduct in Higher Education: Beyond Student Cheating (01-01-2022). Academic Integrity in Canada.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties