Uitgelicht en gespot op internet (week 18, 2022)
Ook deze week weer 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.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Algemene verordening gegevensbescherming, WGBO
- Privacy By Design as Anchor in a Value Network or Value Ecosystem (05-05-2022). Marlon Domingus, via LinkedIn.
- Nauwelijks bezwaar van SEH-patiënten tegen terugkoppeling medische gegevens (10-02-2022). NTvG.
Centrale Commissie Mensgebonden Onderzoek (CCMO), Patiënten participatie in klinisch onderzoek
Clinical trials, Decentralized clinical trials, Informed consent, Representativiteit, Results reporting
- The push for clinical trials 2.0 (04-05-2022). POLITICO.
- European institutions risk steep FDA fines over unreported clinical trial results (02-05-2022). TranspariMED.
- eConsent—The First Step to Enable Clinical Trial Access to Anyone, Anytime, Anyplace (02-05-2022). Applied Clinical Trials.
- Inadequate reporting quality of registered genome editing trials: an observational study (02-05-2022). BMC Medical Research Methodology.
- Substituting genetic ancestry for race in research? Not so fast (02-05-2022). STAT.
- The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors (27-04-2022). Trials.
- mRNA Clinical Trials: Key Regulatory Considerations (19-04-2022). Advarra.
- Informed Consent Writing Tip Sheet (14-04-2022). Advarra.
- A Look at the Processes Behind Clinical Endpoint and Event Adjudication (06-04-2022). Advarra.
Dutch Clinical Research Foundation (DCRF)
EFPIA, EFGCP, EUPATI: Good Lay Summary Practice
- Final report “Implementing “Good Lay Summary Practice” (GLSP Workshop, February 2022).
- Terugkijken: Good Lay Summary Practice Workshop Presentations (02-12-2021), via YouTube.
European Health Data Space
- European Health Union: A European Health Data Space for people and science (03-05-2022). Europese Commissie.
- The EU’s Data Act: data protection must prevail to empower data subjects (05-05-2022). EDPS.
- The European Health Data Space Proposal of the European Commission (05-05-2022). Bird & Bird.
- Nieuwe EU concept-verordening wijkt op meerdere punten af van de Wegiz (04-05-2022). Geranne Lautenbach, via LinkedIn.
- Commission proposes European Health Data Space to unlock research opportunities (04-05-2022). Regulatory Focus.
European Medicines Agency (EMA), Good Clinical Practice
- Updated – Good clinical practice (GCP) inspection procedures
- Regulatory and procedural guideline: Annex I to procedure for conducting GCP inspections requested by the CHMP: Investigator site (updated 05-05-2022).
- Regulatory and procedural guideline: Annex II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories (updated 05-05-2022).
- Regulatory and procedural guideline: Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO) (updated 05-05-2022).
- Regulatory and procedural guideline: Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents (updated 05-05-2022).
- Regulatory and procedural guideline: Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (updated 05-05-2022).
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Model-Informed Drug Development (MIDD) Discussion Group Guidance Roadmap (03-05-2022).
- ICH plans model-informed drug development guideline in 3-4 years (04-05-2022). Regulatory Focus.
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Nieuwsbrief voor Goede Onderzoekspraktijken
Research integrity
- Helft Nederlandse onderzoekers handelt soms bedenkelijk (22-04-2022). NTvG.
- Prevalence of responsible research practices among academics in The Netherlands [version 1; peer review: awaiting peer review]. F1000Research 2022, 11:471.
- Verlässliche Wissenschaft. Bedingungen, Analysen, Reflexionen (2022).
Swissmedic (Zwitserland)
Technische Universiteit Eindhoven
“At the TU/e, we strongly believe that excellent research can only be executed in an organization with excellent support. For this reason, we have established the Research Support Network. The Research Support Network is the TU/e knowledge network that supports researchers in developing and executing research projects in all project phases. The support is organized in two tiers around the researcher.”
US Food and Drug Administration (FDA)
- Newly added guidance documents
- Final – Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff (06-05-2022).
- Draft – Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies (04-05-2022).
- FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease (02-05-2022). Regulatory Focus.
Wet open overheid (Woo)
- Woo regelt recht op overheidsinformatie (01-05-2022). Ministerie BZK.
- Wet open overheid (Woo): Wanneer moet of mag de openbaarmaking van informatie al dan niet achterwege blijven? (04-05-2022). Van Benthem & Keulen.
Wet zeggenschap lichaamsmateriaal (WZL)
In het licht van het wetsvoorstel WZL een aantal interessante berichten met raakvlakken:
- Schritelijke vragen aan minister van VWS: Het bericht ‘China ziet DNA als natuurlijke hulpbron en bouwt aan enorme genendatabank’ (03-05-2022).
- Martini Ziekenhuis in cassatie tegen inzage OM in dossier (04-05-2022). Skipr.
Overige berichten
- Weekend reads: ‘The science crisis’; Peru president plagiarism probe; does a Nature cover help or hurt citations? (07-05-2022). Retraction Watch.
- Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency (06-05-2022). Front. Med.
- Researchers should be assessed on quality not quantity: here’s how (05-05-2022). The Conversation.
- The gene-edited pig heart given to a dying patient was infected with a pig virus (04-05-2022). MT Technology Review.
- Nieuwe golf cel- en gentherapieën onderweg (03-05-2022). Vereniging Innovatieve Geneesmiddelen.
- Rijnierse: ‘Dóórgaan met registreren aan de bron’ (03-05-2022). Vereniging Innovatieve Geneesmiddelen.
- Downstream retraction of preprinted research in the life and medical sciences (02-05-2022). PLOS ONE 17(5): e0267971.
- Another Firing Among Google’s A.I. Brain Trust, and More Discord (02-05-2022). The New York Times.
- 5 Considerations for Evaluating an eIRB System (27 april 2022). Advarra.
- The self-fulfilling prophecy of post-hoc power calculations (01-02-2022). Statistics and Research Design.