WORKING GROUP 4: DIALOGUE AND INTERACTION WITH ETHICS COMMITTEES
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1 07June2018 WORKING GROUP 4: DIALOGUE AND INTERACTION WITH ETHICS COMMITTEES Pirkk Lepla Enpr-EMA Annual WS / Pirkk Lepla 1
2 WG4 re-rganizatin since 01Nv2017: Primary members -> drafting dcuments EnprEMA WG 4 - Ethics Pirkk Lepla, Chair (Finnish Investigatrs Netwrk fr Pediatric Medicines, Helsinki, Finland) Maxine Kindred, (Janssen Research & Develpment, Buckinghamshire, UK) Viviana Giannuzzi (Fndazine per la Ricerca Farmaclgica Gianni Benzi, Valenzan, Italy) Heidi Glsli (Osl University Hspital, NrPedMed, Osl, Nrway) Martine Dehlinger-Kremer (SynteractHCR Deutschland GmbH, Munich, Germany) Harris Dalrymple (PRA HealthSciences, Reading, UK Peter Sallabank (RegulinX, Surbitn, UK) David Neubauer (University Children s Hspital, Ljubljana, Slvenia) Geraldine Bylan (Irish Centre fr Fetal & Nenatal Translatinal Research, University Cllege Crk, Ireland) Jean Cnway (Irish Centre fr Fetal & Nenatal Translatinal Research, Paediatric Unit, Crk University Hspital, Crk, Ireland) C-members -> reviewing dcuments Christina Manfredi (CVBF-Cnsrzi per Valutazini Bilgiche e Farmaclgiche, Pavia, Italy) J Mendum (PRA HealthSciences, Reading, UK Diane Hffman (prev. Janssen Research & Develpment, US Retired!) 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 2
3 Rle: EnprEMA WG 4 - Ethics Develp pragmatic respnses t be implemented within six mnths (apprx.!); Examples f gd practice when ECs cnsider trials relating t children and yung peple Develp prpsals t disseminate examples f gd practice t ECs 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 3
4 Backgrund I 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 4
5 Backgrund II 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 5
6 Backgrund III 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 6
7 Enpr-EMA WG4 Task 3 3 rd Task: Original Plan: Partly harmnized cre IC / Assent template with standard language (English) Based n the fllwing backgrund facts: 1. New EU CT Reg. (impl.apprx.10/2018) will harmnise the clinical trial applicatin (CTA) prcess, but IC/Assent issues remain with each Member State. 2. There are nticeable differences between natinal IC and assent requirements in Eurpe due t natinal laws and regulatins (See: Tl Kit data) 3. These discrepancies can present challenges fr multicentre paediatric CTs 3. Deliverable: Original Plan Partly harmnized f Infrmed Cnsent / Assent template -dcument Based n identificatin f all similar elements acrss assents / cnsents f existing templates 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 7
8 Enpr-EMA WG4 Task 3 3. Task Part I -: Executed by a Mini-Grup f Cnsents Diane Hffman : Jhnsn & Jhnsn Pediatric Center f Excellence (Chair) Maxine Kindred : Jhnsn & Jhnsn Operatins (Operatinal prducer) Heidi Glsi : Osl University Hspital (supprt) J Mendum : CRO, PRA (supprt) 3.Deliverable Part I -: Cmparisn f Assents frm WHO, MCRN and Finland Identificatin f all similar elements acrss assents Prepared t include all elements Items included in the WHO template was added t the guidance as they were deemed imprtant t the assent - Guidance template prvided January Presented in Enpr-EMA Annual Wrkshp 16May Prepared the dcument fr the Review prcess 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 8
9 Enpr-EMA WG4 Task 3 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 9
10 Task 3. Assent / Cnsent Mdel template - includes instructins 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 10
11 Enpr-EMA WG4 Task 4 4. Task & Deliverable Mdified frm the rginal Task 3 plan: The Cnsent / Assent infrmatin as a Guidance Dcument fr all Enpr-EMA stakehlders t be placed publicly available n Enpr- EMA web-site (-> by 06/ 2018) -> NO TEMPLATES Prcess: Cmparisn f the review respnses with the EU Ethics Guideline (Revisin 1); published in Octber Crrecting the guidance accrding t Ethics guideline (R1)and CTR Preparing t include all imprtant elements frm eypagnet Reprt Finalize the frmat 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 11
12 Review prcess f the Guidance Dcument Drafting & Discussin ( s, TC) the frmat between; April 2017 April 2018 (Versins ) including: Eurpean Academy f Pediatrics Feedback; 29June2017 > EAP Ethics Wrking Grup Cmments Inclusin f eypagnet Reprt Feedback; January 2018 > Children s Vice Inclusin f revised EU Ethics Guideline (v.2.0); September 2017 > Ethical Prf Inclusin f legal EU dcuments: EU CTR (2014), EU GDPR (2018) > Legal Prf + Language Prf (English) 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 12
13 The cntents f the Guidance Dcument Intrductin + references 1 page - 3 figure-ptin s menu fr marking the need f inclusin f the infrmatin sectins in Tables 1 and 2. Table 1: General Infrmatin requirements fr Infrmed Cnsents & Assents (Agreements) 2 pages Table 2: Trial Specific Infrmatin fr Infrmed Cnsents & Assents (Agreements) 6 pages 25 infrmatin sectins Ttal f 9 pages. 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 13
14 Versin 3.0 f the Guidance Dcument (p.1.) 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 14
15 Additinal Task fr eypagnet WG4 asked YPAGs feedback abut 1) usefulness 2) functinality Of the WORD READIBILITY SCORING functin in rder t pre-read the assent / cnsent / inf-dcuments fr better understanding (t avid t cmplicate/nn-understandable wrds). Our recmmendatin is avid as much yu can use this technlgy, because nt has a EU backgrund and never will be a 100% substitute f the feedback that children and yung peple can prvide. If fr any type f interest, fr example the urgency t deliver a dcument, yu will explre the use f these type f tls, ur suggestin is t d study and cmpare the feedback that yu can achieve frm the tl and frm the YPAGs. Readability Scring functin in the English language versin f MS Wrd. The Flesch-Kincaid methd was devised in 1942; US centric tl. 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 15
16 Next steps New eypagnet TASK: Design 3-pages lng example assent / cnsent t prf it is pssible (frm cmplex and lng dcument) Needed fr Guideline t wrk in practice: users must believe the requirements are reasnable and realistic Finalizatin f the Guidance Dcument with the whle WG4 (acute new cmments included) Writing an article fr a paper (nt yet decided) 1. first placed t Enpr-EMA website 2. int the article with the cpyright mark; Eurpean Medicines Agency, Reprduced with permissin. 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 16
17 Enpr-EMA WG4 + EUREC New cllabratin started with EUREC- Eurpean Netwrk f Research Ethics Cmmittees EUREC presentatin in Enpr-EMA Annual WS, May st Enpr-EMA WG4 presentatin in EUREC meeting, 08Sep2016, Helsinki Enpr-EMA WG4 presentatin in EUREC-ANCEI Cngress in Barcelna,18May2017 Discussin, brainstrming TC, 03Oct st Meeting in Lndn 13 th Nvember 2017, EMA -> 4 Actin Pints fr further activities 07June2018 Enpr-EMA Annual WS / Pirkk Lepla 17
18 07June2018 THANK YOU! Enpr-EMA Annual WS / Pirkk Lepla 18
DIALOGUE AND INTERACTION WITH ETHICS COMMITTEES
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