D2.4 - STRONG AYA ethics report, with interim reports following ethics workshops

1 A new, in e disciplina y, mul i- s akeholde Eu opean ne wo k o imp o e heal hca e se ices, esea ch and ou comes o Adolescen s and Young Adul s wi h cance . STRONG-AYA – No. 101057482 – D2.4 2 Deli e able Repo WP2– Go e nance, Da a Secu i y and E hics Deli e able D2.4 STRONG AYA e hics epo , wi h in e im epo s ollowing e hics wo kshops Due da e o deli e able: 30/09/2024 Ac ual submission da e: 15/05/2025 P ojec : STRONG-AYA Lead Con ibu o S ephane Lejeune (EORTC) Email s ephane.lejeune@eo c.o g O he Con ibu o s Emails Due da e 30 09 2024 Deli e y da e 15 05 2025 Deli e able ype R Dissemina ion le el PU Desc ip ion o Wo k Ve sion Da e Final e sion o epo a e app o al o ERAB V1.0 30/04/2025 STRONG-AYA – No. 101057482 – D2.4 3 Desc ip ion: STRONG-AYA E hics epo , wi h in e im epo s ollowing E hics wo kshops (yea 1) Publishable summa y (max ½ page) This deli e able is he epo o he second mee ing (4 Ma ch 2025) o he STRONG-AYA E hics and Regula o y Ad iso y Boa d (ERAB). The ERAB aims o p o ide he conso ium wi h an independen iew on he e hics and legal challenges as well as he mi iga ion ac ions planned o al eady implemen ed by he conso ium. The ERAB is composed o ou independen expe s in e hics and/o legal aspec s. The ERAB mee s each yea oge he wi h conso ium ep esen a i es. This epo has been app o ed by he ou independen expe s and by he p ojec ep esen a i es who a ended he mee ing. STRONG-AYA – No. 101057482 – D2.4 4 1 Table o Con en s PUBLISHABLE SUMMARY (MAX ½ PAGE) .................................................................................................................... 3 1 TABLE OF CONTENTS .......................................................................................................................................... 4 2 DEFINITIONS....................................................................................................................................................... 5 3 ABBREVIATIONS ................................................................................................................................................. 6 4 INTRODUCTION .................................................................................................................................................. 7 PROJECT BACKGROUND ........................................................................................................................................... 7 DELIVERABLE INTRODUCTION .................................................................................................................................... 8 5 RESULTS ......................................................................................................... ERROR! BOOKMARK NOT DEFINED. 6 CONCLUSION .................................................................................................. ERROR! BOOKMARK NOT DEFINED. 7 REPOSITORY FOR PRIMARY DATA (ANNEX) .................................................... ERROR! BOOKMARK NOT DEFINED. STRONG-AYA – No. 101057482 – D2.4 5 2 De ini ions STRONG AYA conso ium membe s a e e e ed o as ollowing wi hin his ex : 1. NKI-AVL – S ich ing he Nede lands Kanke Ins i uu – An oni an Leeuwenhoek Ziekenhuis (NL) 2. YCE – You h Cance Eu ope (RO) 3. INT – Fondazione IRCCS Ins i u o Nazionale dei Tumo i (IT) 4. FFUND – FFUND BV (NL) 5. CLB – Cen e de Lu e Con e le Cance Leon Be a d (FR) 6. ECO – Eu opean Cance O ganisa ion (BE) 7. UNIMAAS – Uni e si ei Maas ich (NL) 8. IKNL – S ich ing In eg aal Kanke cen um Nede land (NL) 9. EORTC – Eu opean O ganisa ion o Resea ch and T ea men o Cance AISBL (BE) 10. IGR – Ins i u Gus a e Roussy (FR) 11. MSCNRIO – Na odowy Ins y u Onkologii im. Ma ii Sklodowskiej-Cu ie – Pans wowy Ins y u Badawczy (Ma ie Sklodowska-Cu ie Na ional Resea ch Ins i u e o Oncology) (PL) 12. UOM – Uni e si y o Manches e (UK) 13. UOL – Uni e si y o Leeds (UK) 14. LTHT – Leeds Teaching Hospi als Na ional Heal h Se ice T us (UL) 15. SOUTHAMPTON – Uni e si y o Sou hamp on (UK) • G an Ag eemen (including i s annexes and amendmen s): he ag eemen signed be ween he bene icia ies o he HORIZON Resea ch and Inno a ions Ac ions (he ea e e e ed o as Ho izon) and he Eu opean Heal h and Digi al Execu i e Agency (he ea e e e ed o as HADEA) o he unde aking o he STRONG AYA p ojec (G an Ag eemen no. 101057482). • Bene icia y: Signa o ies o he G an Ag eemen • Associa ed Pa ne : En i ies which pa icipa e in he ac ion bu wi hou he igh o cha ge cos s o claim con ibu ions. • P ojec : he sum o all ac i i ies ca ied ou in he amewo k o he G an Ag eemen . • Conso ium: he STRONG AYA conso ium, including all he a o emen ioned pa ne s. • Conso ium Ag eemen : The ag eemen made be ween STRONG AYA membe s o he implemen a ion and execu ion o he ac ion ou lined in he G an Ag eemen . The ag eemen shall no a ec he pa ies’ obliga ions o HADEA on behal o he Eu opean Union, and/o o one ano he a ising om he G an Ag eemen . STRONG-AYA – No. 101057482 – D2.4 6 3 Abb e ia ions Ac onym/Abb e ia ion Meaning HCP Heal h Ca e P o ide PRO Pa ien Repo ed Ou come PROM Pa ien Repo ed Ou come Measu e COS Co e Ou come Se WP Wo k Package WPL Wo k Package Lead(s) WP1 Wo k Package 1 (De elopmen Co e Ou come Se AYA wi h cance & da a collec ion) WP2 Wo k Package 2 (Go e nance, Da a Secu i y and E hics) WP3 Wo k Package 3 (In as uc u e and In e ope abili y) WP4 Wo k Package 4 (Ope a ion o STRONG AYA ecosys ems, s akeholde and pa ien in ol emen , dissemina ion, exploi a ion, communica ion) WP5 Wo k Package 5 (Scien i ic coo dina ion and p ojec managemen ) KPI Key Pe o mance Indica o OA Open Access PAB Pa ien Ad iso y Boa d EC Eu opean Commission HADEA Eu opean Heal h and Digi al Execu i e Agency SC S ee ing Commi ee MT Managemen Team ERAB E hics and Regula o y Ad iso y Commi ee STRONG-AYA – No. 101057482 – D2.4 7 4 In oduc ion P ojec backg ound Cance a adolescen and young adul (AYA) age (15-39 a p ima y diagnosis) is a e. Howe e , his a i y does no e lec he signi ican pe sonal and socie al cos s o cance in his popula ion, as e lec ed in he po en ial yea s o li e los o sa ed, he dec eased p oduc i i y and quali y-o -li e due o he impac o he disease du ing o ma i e yea s, and he long- e m complica ions o disabili ies1. AYAs wi h cance o m a unique g oup; hey ace age-speci ic issues (e.g. In e ili y, unemploymen , inancial p oblems) and dec eased quali y o li e due o cance and i s ea men . Unlike dedica ed heal hca e and ials o paedia ic cance pa ien s, AYA-speci ic heal hca e se ices a e sca ce and a y ac oss Eu ope. AYAs who a e a he co e o socie y and he economy need access o age-app op ia e and high-quali y heal hca e. The STRONG-AYA p ojec aims o ackle he unde ep esen a ion o AYA’s expe iences and ou comes when na iga ing he heal hca e sys em and in clinical ca e by de eloping na ional in as uc u es o ou come da a managemen and clinical decision-making wi hin a pan-Eu opean ecosys em and es ablishing communica ion eedback o AYAs wi h cance and he heal hca e sys ems. This will be key o imp o ing heal hca e se ices, esea ch, ou comes and policies o AYAs and o ul ima ely be e cance ca e o his pa ien g oup. The p ojec b ings oge he an in e na ional mul i-disciplina y conso ium (academic/ esea ch, clinical, s akeholde and pa ien o ganisa ions) ac oss se en Eu opean coun ies. Building on p e ious ini ia i es, a STRONG-AYA da a ecosys em will be se up o alue-based ca e, esea ch and policy o AYA wi h cance by: 1. De eloping a Co e Ou come Se (COS) speci ically o AYAs wi h cance , ia a pa icipa i e consensus p ocess de ining mos impo an aspec s o hose di ec ly a ec ed by AYA cance , including pa ien s and heal hca e p o essionals. 2. Implemen ing he COS ac oss se e al na ional Eu opean heal hca e sys ems. Da a will be collec ed a local le el and will hen be included in a da a in eg a ion pla o m. An o e all ecosys em amewo k o da a analy ics and ou pu will be c ea ed suppo ing ede a ed analyses and he c ea ion o epo s ac oss clinical and pa ien - epo ed da a and making na ional eposi o ies o (pa ien - epo ed) heal h da a, a ailable o indi idual pa ien s, pa ien o ganisa ions, egula o y au ho i ies, as well as he pa ien s’ heal h ca e p o ide s o in o m clinical decision-making. The i e esul ing na ional ecosys ems will be connec ed o each o he in o he pan-Eu opean ecosys em using a ede a ed app oach also u ilizing he o e all ecosys em amewo k. 3. Dissemina ing he COS o a wide ange o local as well as pan-Eu opean s akeholde s, in pa icula by de eloping analy ical ools o p ocess and p esen pa ien ou come da a and es ablish eedback loops ha in o m pa ien s and clinicians. Implemen ing hese p ojec objec i es a e i e wo k packages wi hin he STRONG-AYA p ojec : • WP1: De elopmen Co e Ou come Se AYA wi h cance and Da a Collec ion (Lead: SOUTHAMPTON) • WP2: Go e nance, Da a Secu i y and E hics (Lead: EORTC) • WP3: In as uc u e and In e ope abili y (Lead: UNIMAAS) • WP4: Ope a ion o STRONG-AYA ecosys ems, S akeholde and Pa ien in ol emen , Dissemina ion, Exploi a ion, Communica ion (Lead: E.C.O.) • WP5: Scien i ic Coo dina ion and P ojec Managemen (Lead: NKI) 1 S oneham SJ. AYA su i o ship: The nex challenge. Cance 2020; 126: 2116-2119. STRONG-AYA – No. 101057482 – D2.4 8 STRONG-AYA will enable AYA ca e and esea ch o bene i om collec ion and pooling o pa ien - cen e ed da a and collabo a ion among all s akeholde s: pa ien s, heal hca e p o essionals, scien is s, and policymake s. Mo e widely, he p ojec will le e age he ne wo k o in e es ed o ganisa ions and ne wo ks es ablished unde STRONG-AYA o long- e m s eng hened p omo ion o he necessa y implemen a ion o specialis AYA cance se ices ac oss Eu ope. This will ul ima ely b ing no el insigh s in o AYA cance ca e, esea ch and policy, con ibu ing o he long- e m imp o emen o ou comes o people wi h AYA cance . Deli e able in oduc ion This deli e able is he epo o he i s mee ing (3 d No 2023) o he STRONG-AYA E hics and Regula o y Ad iso y Boa d (ERAB). The ERAB aims o p o ide he conso ium wi h an independen iew on he e hics and legal challenges as well as he mi iga ion ac ions planned o al eady implemen ed by he conso ium. The ERAB is composed o ou independen expe s in e hics and/o legal aspec s. The ERAB mee s each yea oge he wi h conso ium ep esen a i es. This epo has been app o ed by he ou independen expe s and by he p ojec ep esen a i es who a ended he mee ing. 5 STRONG AYA E hics and Regula o y Ad iso y Boa d (ERAB) – Repo o he second mee ing ( i ual), 4 Ma ch 2025 Pa icipan s • ERAB membe s o F ancesco Ta a, UK o F ancis P. C awley, BE o Ma hias B aun, DE o San a Slokenbe g, SE • Conso ium membe s o Da ian Meacham, UNIMAAS o Flo a Lysen, UNIMASS o Leona d Wee, UNIMAAS o Ma ine Jacquemin, UNIMAAS o Simone Hanebaum, NKI o S ephane Lejeune, EORTC Agenda - Discussion on he ollow-up o ERAB’ ecommenda ions. - The use o dynamic pa ien consen in STRONG-AYA. - The use o he Public VaLUe Assessmen TOol (PLUTO) ool in STRONG-AYA. Key poin s o discussion - Commen s and ques ions on he ollow-up documen epo ing eedback om pa ne s on he ERAB ecommenda ions (mee ing No 2023). o To make su e ha AYA pa icipan s a e well in o med abou he p ojec and hei igh s p o ec ed. STRONG-AYA – No. 101057482 – D2.4 9  Pa ne s con ibu ing wi h da a ha e o a i y ag eemen ha includes he obliga ion o in o m pa icipan s and o p o ec hei igh s. In o ma ion abou he use o he da a is a ailable om he p ojec websi e. Communica ion campaign and s akeholde in ol emen ac i i ies will ake place.  Was consen used as legal base and child igh conside ed? Legal base depends on he coun y. Legi ima e in e es was used in mos o he coun y.  The websi e was de eloped in co-c ea ion wi h pa ien s. The e will be a FAQ sec ion on he use o he da a and alignmen wi h child igh s con en ion. o Wha a e he accep able pu poses o using he da a con ibu ed o he p ojec ?  Accep able pu poses a e limi ed o esea ch and educa ion. P ojec esul s including clinical p edic ion model a e no alida ed o o he use. I is no cu en ly planned o do such alida ion. The e will be a disclaime on he p ojec websi e.  I was cla i ied ha he ci cula ed documen wi h eedback o ERAB is o p ojec in e nal use only.  Any public p ojec s a emen e.g. on he p ojec websi e should be wo ded ca e ully o a oid con usion o con adic ion ega ding he accep able pu poses o use.  The conso ium will no ha e he au ho i y o p e en unau ho ized use o p ojec esul s e.g. o clinical decision. Howe e , he use o he p ojec da a will be con olled I.e. analysis will ha e o be app o ed be o e being un in he sys em.  We need o di e en ia e how we concei e he scope o he p ojec and how o communica e i o pa ien s which should be ca e ully done.  Pa ne s need o check wha is w i en on he websi e o make su e we a e no aising un ealis ic expec a ion om pa ien s o in con adic ion wi h p ojec ules on he use o p ojec esul s. We mus be clea , in elligible o lay people and a oid any misma ch. o How pa ne s de ine he di e en ypes o esea ch ques ions, and which ypes o use s can access o he esul s o such ques ions?  A conso ium p ocess will de ine who can ask which ype o esea ch ques ion (simple desc ip i e analysis e sus sophis ica ed analysis), who can code he ques ion and who can access o he esul s. The ede a ed model will in ol e di e en le els o con ol and igh s g anula i y. o How o discuss accep able ade-o wi h pa ien s?  How ade-o s a e app oached in he p ojec was explained. Pa ne s asked o pa ien s wha hey ind impo an and wha a e hei p e e ences on how o be in o med. Pa ne s a e e iewing he li e a u e which is complemen ed wi h consul a ions wi h pa ien s in a co-design app oach.  Do we implemen collabo a ion be ween he di e en p ojec boa ds: scien i ic, e hical and pa ien s? Good poin e en i he in o ma ion is ci cula ed al eady amongs he whole conso ium bu we could make i deepe .  Which opics could bene i om such c oss- e iliza ion? Any p ac ical/ope a ional opic could bene i . - Dynamic pa ien consen . o How such concep could be implemen ed in STRONG-AYA? This is a way o use o mo e pa icipa o y and g anula app oach as compa ed o b oad consen o seconda y use o he da a. o Dynamic consen allows pa ien o decide which p ojec ime span hei consen is co e ing and o which esea ch ques ion. o Dynamic consen will no p eplace he classical “s a ic” consen bu add a laye allowing pa ien o decide which da a could be used o which usage and by who. o The p ojec could p o ide he igh si ua ion in which dynamic consen could be implemen ed.