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Nr. 70
5 november 2018

Beste abonnee,

Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 5 november 2018, met de laatste ontwikkelingen rond medisch-wetenschappelijk onderzoek met mensen, nieuwe wetgeving en gereviseerde richtlijnen.

Met vriendelijke groet,

Vincent Bontrop

www.bontrop.com

Link met mij via LinkedIn.

Inhoudsopgave

• Vernieuwde CCMO website gelanceerd
• Uitgelicht: Clinical trial results reporting
• Uitgelicht: Algemene verordening gegevensbescherming (GDPR), privacy, genetische data
• Meer nieuws, oa. ACRP, Brexit, EUPATI, EMA
• Bijeenkomsten
• Publieke consultaties

• Nieuwsbrief doorsturen
• Voorkeuren aanpassen
• Abonneren op deze nieuwsbrief
• Eerder verschenen uitgaven

• Contactgegevens

Vernieuwde CCMO website gelanceerd

De Centrale Commissie Mensgebonden Onderzoek heeft op 5 november 2018 haar vernieuwde website gelanceerd.

Ga naar CCMO website

Ga naar nieuwsbericht nieuwe website (5 november 2018)

Uitgelicht: Clinical trial results reporting

• Sponsors ‘still have further to go’ as 50% of trials go unreported: Report (31 oktober 2018). Outsourcing Pharma.
• Failing to publish data from clinical trials presents risk to human health (30 oktober 2018). The Science and Technology Committee.
• House of Commons Science and Technology Committee Research integrity: clinical trials transparency (30 oktober 2018).
• Half of Clinical Trials Fail to Publish Results, UK Report Finds (30 oktober 2018). Regulatory Focus.
• MPs propose fines for universities that fail to report trials. The Higher Education.
• Statement in response to ‘Failing to publish data from clinical trials presents risk to human health’ (Science and Technology Select Committee) (29 oktober 2018).
• Tell the FDA to identify and punish law breakers (26 oktober 2018). All Trials.

Uitgelicht: Algemene verordening gegevensbescherming (GDPR), privacy, genetische data

• Comparative analysis reveals a diverse international regulatory landscape for genetic data (2 november 2018). GA4GH.
• Deployment of service providers and the GDPR (november 2018). Reuschlaw.
• To Whom Does the GDPR Apply? (1 november 2018). GA4GH
• Antwoord op vragen van de leden Kuiken en Buitenweg over het bericht ‘bedrijven die DNA-materiaal van hun cliënten met anderen delen’ (31 oktober 2018)
• GDPR and Research – An Overview for Researchers. UK Research and Innovation.
• A systematic literature review of individuals’ perspectives on privacy and genetic information in the United States. PLOS ONE 13(10): e0204417
  
  • Treating ‘genetic privacy’ like it’s just one thing keeps us from understanding people’s concerns (31 oktober 2018). The Verge.
  • Review reveals ambiguous understanding of genetic privacy in US study participants (31 oktober 2018). EurekAlert.
• Jennifer Viberg Johansson (2018): Individual Genetic Research Results – Uncertainties, Conceptions, and Preferences, Uppsala: Acta Universitatis Upsaliensis.
  
  • Genetic risk: Should researchers let people know? (24 september 2018). The Ethics Blog.
• Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation (2018) 26 European Journal of Human Genetics 149–156.
• Are ‘pseudonymised’ data always personal data? Implications of the GDPR for administrative data research in the UK (2018) 34 Computer Law & Security Review 222–233.
• International data-sharing norms: from the OECD to the General Data Protection Regulation (GDPR) (2018) Human Genetics.
• Genetic data and the research exemption: is the GDPR going too far? (2017) 7 International Data Privacy Law 137–146.

Meer nieuws

Association of Clinical Research Professionals

• ACRP to Develop Principal Investigator Competence Standards (31 oktober 2018).
• Court Rejects Demand for Stronger Informed Consent Provisions (30 oktober 2018).

Brexit

• The Netherlands — More Than Just The New Home Of The EMA (1 november 2018). Life Science Leader.
• Brexit Boggles UK Trials (22 oktober 2018). CenterWatch.

Clinical Trials on Hold

• FDA Inspection Finds Minnesota Hospital Violated Informed Consent, IRB Rules (29 oktober 2018). Regulatory Focus.
• ER patients given ketamine, other powerful drugs in clinical trials without their consent, FDA finds (29 oktober 2018). STAT.
• Ketamine trial suspended following concerns around informed consent (30 oktober 2018). Outsourcing Pharma.
• US government halts heart stem-cell study (29 oktober 2018). Nature.
• Heart failure study paused over concerns about disputed cell therapy papers (29 oktober 2018). STAT.

European Patients Academy on Therapeutic Innovation

• The European Patients Academy on Therapeutic Innovation (EUPATI) Guidelines on Patient Involvement in Research in Development. Frontiers.

European Medicines Agency

• Reflection paper on the use of extrapolation in the development of medicines for paediatrics (Final, 7 oktober 2018).
• EMA’s Rasi on Genome Editing: Time to Move Forward (30 oktober 2018). Regulatory Focus.

NHS Health Research Authority

• Supporting commercial contract research in the NHS (30 oktober 2018).
• Applicants and reviewers welcome the introduction of a UK-wide standardised review process for research involving ionising radiation (29 oktober 2018).

Uitgelicht

• Single-molecule magnet controversy highlights transparency problems with U.K. research integrity system? (2 november 2018). Chemical & Engineering News.
• Understanding Experimental Controls  (2 november 2018). The Scholary Kitchen.
• Establishing the Effectiveness of Procedural InterventionsThe Limited Role of Randomized Trials. JAMA. Published online November 01, 2018.
• Can I have an SPC for my drug-device combination? (1 november 2018). Fieldfisher.
• Current and Future Landscape of Nutritional Epidemiologic Research. JAMA. Published online October 31, 2018.
• CRISPR is supposed to be easy. Try explaining it to a gaggle of beginner biohackers (31 oktober 2018). STAT.
• Why a Helium Leak Disabled Every iPhone in a Medical Facility (30 oktober 2018). Motherboard.
• The “regression to the mean project:” What researchers should know about a mistake many make (30 oktober 2018). Retraction Watch.
• Update on the European MDR and IVDR (30 oktober 2018). BioSlice Blog.
• What should journals do to promote transparent and responsible research? (29 oktober 2018). Elsevier Connect.
• Enrollment challenges in multicenter, international studies: The example of the GAS trial (29 oktober 2018). Paediatric Anaesthesia
• Surrogate Endpoints Table: FDA Seeks Feedback (29 oktober 2018). Regulatory Focus.
• Confused by Nutrition Research? Sloppy Science May Be to Blame (29 oktober 2018). The New York Times.
• Conflicts of Interests, Authors, and JournalsNew Challenges for a Persistent Problem. JAMA. Published online October 26, 2018.
• Should Failure to Disclose Significant Financial Conflicts of Interest Be Considered Research Misconduct?. JAMA. Published online October 26, 2018.
• How much do phase III trials cost?. Nature Reviews Drug Discovery volume 17, page 777 (2018).
• CDRH Works on Clinical Objectivity in Patient-Reported Outcomes (26 oktober 2018). Regulatory Focus.
• Translating genotype data of 44,000 biobank participants into clinical pharmacogenetic recommendations: challenges and solutions. Genetics in Medicine (2018).
• “Responsible Research With Urban American Indians and Alaska Natives”, American Journal of Public Health , no.  (25 oktober 2018): pp. e1-e4.
• Report on the Metrodora Multi-Stakeholder Meeting of 16th May in Brussels 'Meaningful engagement of women in HIV treatment research'
• Clinical trials in France: improved designation process of the competent ethical committees (CPPs) (24 oktober 2018). Bird & Bird.
• How the CIOMS guidelines contribute to fair inclusion of pregnant women in research (20 oktober 2018). Bioethics.
• Ethical Considerations for Unblinding a Participant’s Assignment to Interpret a Resolved Adverse Event (19 oktober 2018), The American Journal of Bioethics.

8 november 2018 - Cursus kwalitatief onderzoek

Locatie: Heerlen

Alleen beschikbaar voor medewerkers het Zuyderland

Lees verder via LinkedIn

30 november 2018 - Haags Congres Bureau & Vide: Nieuwspoort Seminar - Toezicht in Transitie 2018. Perspectieven op toezicht

Locatie: Den Haag

Lees verder

6 december 2018 - Understanding Society Conference: Combining Biological and Social Data

Locatie: Londen

Lees verder

5 februari 2019 - NVFG: Symposium "EMA in Nederland: Impact en nieuwe mogelijkheden!" *updated*

Locatie: Amsterdam

Nog geen programma beschikbaar.

Inschrijven vanaf 15 november 2018

Lees verder

FDA: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA

• Download Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA

Consultatie loopt tot 20 november 2018 (11:59 PM ET)

Lees verder

Voor meer bijeenkomsten en lopende publieke consultaties:

• Supplement 'Bijeenkomsten & Consultaties' - november 2018

In de eerste week van december zal er weer een nieuw overzicht van bijeenkomsten & consultaties worden verstuurd naar de abonnees die zich hebben aangemeld voor het supplement 'Bijeenkomsten & Consultaties'.

Bent u abonnee van de nieuwsbrief en ontvangt u het maandelijkse supplement met bijeenkomsten en consultaties nog niet? Klik dan hier om uw voorkeuren aan te passen (en vink het maandelijkse supplement aan).

Heeft u een vraag of een verzoek?  U kunt mij bereiken door te antwoorden op deze e-mail, via het contactformulier op de website, of door een e-mail te sturen naar: info@bontrop.com

Copyright © Vincent Bontrop, All rights reserved.

Contactgegevens:
Hopakker - 3514 BZ Utrecht - Netherlands

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