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I @ oFtuiopr DE UrUROrr Europ€a, LDdty Sedes - r\/o Ptoyislonal Edition ADDITIONAL PROTOCOL TO THE CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE CONGERNING BIOMEOICAL RESEARCH Slrasbourg, 30 June 2OO4 The membd Sleles to rhi. ',the other stetes end lhe European communily torlb Prot€clion of Huimn REhts and Dignily ot Adaitiin"i "ign"tori". rt'i nun a.,"!*riffi - logy tld Modlcm€ (hercnafler refefted to ;s ;the ' " colvenlton-), Considering lnal tjie a.m of the Councll-or, E urope i5 ie echievem€nt ot greater unity belween iis members and that ohe of the nEthods bv r pursued is lhe ;ahtenanc; and turlhe' aim reahsaton ot hurhan dghts and rundaftentat ir,?*i?ir6 ' Consdering that _o.ing" the denlity ol ati h"-in other iights and f Anide is lo prolect lhe dignily End iminalion' respGct for their lnlegrli and tundarn€nt";t of biokrgy and medicine. consrdcring rhat progress in rn€dr-r Snd brorogicd aci.nces, rn partclJrar sdvances obi6rned lhrough, bom€drc€l research. contnbutes to $ving hves - ,, eni ingoung quamy 6nir" - Conscous ot lhe fect lhsl th€ edvan.2nEnt ot biorEdicat science and practice is dependent on fnowledge and dtscovery s/hich neclssitates reseerch on huo.l bcings. Slressing thel suc}l res€arch is oi6n tsansdisciphnary ati inremationali Taking inlo accounl naljonel and lntemstonsl rroibadonet slendsrds in lhe lield ot biomedtcaT research end the previous work ot lhe Com.nittee ol Mnists'! and the Parliameniary fusombly ot lhe councitofEurope in this fietdi Convinced that bomedrcel research that is contrary be canied out to tuman dignily End human rights shoutd never Stressing the pararhount concem to be rhe proteclron orfie human being partEipating in research: Atlirming that partcular Drotection 6hat Ibe given to hman beings who may be vulnerabie in lhe context ol re6earchi R6.Ognrsrng thal every pe60n has e nghr ro accepr or rcfuse ro undergo bromedicar researcn and tiel no one shoutd b€ forc€d to undergo Buch res€arcn Resotving to lake such measures ss er. ,'gr,t" -a r'*i ii,"" ,jiii",,ffi;;:il'#A#,f.T:::.',"5 seresuard human disnnv and the tundamentar Heve agr€ed as lollows .f:ffJ,'il* Arllcle I - Obleci end purpGe Parties io lhis protocot lha orotec, fl €veryone. *nhout discriminaton, resoect to, *,1-e- lgniiy end denlity ol ar nLman berngs and gue.anlee ,"s",0 ro "ny,","",ir, Alltcte 2 - Scope inu;ffi ift"JiffiH;#."s^"|:il: fl[" #il:ff,dofl;leme;Errreodoms wrrh i;r"" olll;5to'""0' "o'ers the tull rsnge of rosearch acltvilies in the heaflh ri6rd tnvotving inrorventons on :* "n,il:""|;"Jffi' o*s not spplv to reao.rch on embryos ih v/r/D rt does .ppry to .eBearch on roetuses 3 I ri Forlhe pueoses ol his protocol, the tem -intervention, includes; a phFlcsl lnlervonlion, end sny olher lnle.vontion ln so ,ar as it concemed A(lcle 3 - Prirhicy ot the huhan betng tnvofues a risk to tie psychotogicat heanh of the p€6on """""Hi]"T"L"" The nterests and wefare ol the hutu .interest otsociety ' -' "'E-"ur"dn being parlic'peling in research shatl prevail over or screic--"- lhe sote Anlcle 4 - G6nerrtrule Research sha b€ carned out treetv s provrsions ersu ^s rhe p;;di;;il;;'#j'bbJ:"'J lo lh€ prov'siotrs ol rh,s Prolocol and rhe other tesar Artlcle 5 - Abronce ot attemaUves "o""t"#jll'"n on human belngs may onty be urdedak.n it rherc is no artehativ€ of compsrubre Artlclo 6 - RtStB and b€nents I - Reseerch shalt not involve nsl(s and b urdens to the human t)€ing dtspropoationat€ lo its pol6ntial Denefits. Artlcle 7 - Approyat Research lhay ontv be und.rr,kc^ Ener rndependenr resoarch, and murtidisclpft;;, ;mr;fi;;]i".]iIJ; ;ri;;;il: as be€n ap?oved by lhe competenr bocry essmenl or the ihporlance of the aim of Arlicb A- Sctentiflc qu.Ity iu<tffied, m€€tg€nBlty accepGd crit€ria of sci€nt{lc quat,ty and 'proressronar f ff oE'rrernl ano-!r""o"ii.'i"j""iiii'"rp".*i"" "r .":r:.Tll.ll Artlcle 9- tndep.ndent .rsmtn.Uon by.n eUtcs commlt& ,. Every research proEcl shall be submlied for indepertnt exemtnetton of its ethicat €cceplabitly io en ethics commirlee Such pro,ects shal be suumneo o inqenienr any resesrch acl,vty is tolake ptsoe. ex-#i"*"i,i."i.i1i","rn rt"n sciptinery oraminaton o,ltE ethhlt aceptEbit,ty of fhe research projecl s, Eaioty snd wel+eing ot rrsearcr partcipintsi iire issl-ssment ot tne en approprjate range ot cfrtise and erpeaence aOetr.raiety refleaing 3, Theetl cscomm ee sh6 produc€ en oplnion @ntalttE loasonslorls conclusion Artlcle l0 - tndepond€nc. otth€ ethtcG committe. 1 Parlies to this Protoco, 6hall Iake rEesures to sssur! he rndependence ol lhe ethtcs comm lee Thal body shattnot be subject lo undue oxlemarnnu€nces 2-_ , Members ot the ethics comhiliee shall decJaro all ciElmstanc€s lh6t mighl_ tead *to a conitcl ot Inlerest Shoutd such conflEts anse, those invotved staltnot partoate rn thai re,i; -* A cle lt - lnlomadon forthe athics commtttee 1 Atl lntormaion whrch is necessarv for ttre ethical assesarienl of the resesrch proJect shall be given tnwritten lom lo the ethEs committoe 2. ln partcular, tnformatjon pp€aldir lo thE Protocot shal be Drovaded, in so ,Er ss il is relsvant tor the resea rEy be ahended by ihe comm;nee sel up bv Article 32 olthe convonuon by a Artlcle l2 - Undue tnfluencc The ethics comlnittee must be 6atisfed-that no.undue hluence, includhg thet of a financiat nalure, witt be €xerted on porsons to panErDste in rgsearcn. tn ttris ospea, panrc_ur"liriii.ti.,r"-r m g,*" t" wlnerable or dependenl peBons CHAPTER IV lnfo7ma0on and conrnt Artlc16 13 - lntorma on lor aessrrch pertictpents I. The persons being asked to partcipele in a reseercn tom This inlormaton shalt be doojmented FDiect shatt be given edequal6 intomal,on in a comprcherstbte ?: H: ;;i; the overal ptan snd the possibte dsks and benefis ",trle 6rhics comr lree adror" i"r^j "si"i ot the io, *n""n, ,o concerned shall be specficallv infonned, accord,ng ro lne IJJ::"1$'iii*::,:lt lo',yj;" ot,n" procedures invorved, in padicurar, detEirs or any burden lr olavajlable pr€ventive, rtiagnostic iir ol the arEngements torrospondjng snd lherapeulic procedures: lo adverce I olarrangements ro ensure ,"ao* ror or lhe concems of research p€fticipanrsj rnr"," ,*tuunts fl il:rliffir. ", "**" " ,,"_,." *o*"i ,: ,," of ihe aarangemBnts forf€ir compensa{on in the ffi:::ffil" _""",1.,";" ," cas€ ofdamegei $.",#":,?t"i:l ',:*""' tunher uses, hcludins comrneroar us€s, onhe research resuls, dara or viri 3. olthe source offunding ofth6 reseerch project. tn edddion, the Dersons beih6 .a!-, tr"I,lili;#j[["i;""ffi,i*-[},ult[ ilxr',j*[ft","x Articte 14_ Conlant w may Articte 19, consent the_provrsions ot boli Chapter m€nted crnssnt of the perGonV and Such i;-., j*;11:1,3ffi:Hiitl"l*:Jg;:ffi,""J::?:?t*i##i;::11f,i,,1",t1,i1*i[:"0"_, ii"* '"Hi-li"",r?I"',:H,ilit:l"J;"*J".,r:"r""g:nned or r"."onSlL"t"af ".,"",,.n artlcte 15 - prot.cuon ol pe.lons ir r, the results ollhe r€se3rch have research of @mparable v t1e caeacitv to @nsenr to.""""..r, to rese5rch msy be underraken th6 polontiatlo poduce reatand efiectveness ct rhe person undergo,ng resoarch hassnn't flt "on".nt sharr be in not abte to consert to hglearch J;r"",^X"",ir"iiln"lL#"i'J:LTlt:ut I rl consenr ,s rn doubr, sranee;nrs onry , s, the direct ben€lll to hts or h6r be canied oul on individusls heelh; capable of grving consent; ;;; # .;';;'.i,:T'f;i filnT #H"1, :',:',:":',1T"i,,,1': :H"i:,:":?:"fr: the person concemed does nol obiect polen auho lhe to i lhe researctt undeEtieMing capEble ofcon or affltcted wilh h€ research has not lhe such r€seerch mav bE iv, and v above, a;d to scienlilic of resulls category g""f#:l*:l*?,:J]: ' qnimar r,den rD, rhe individue, concemed, snd sny ffiffi:l"j_:I n6ns ottie relarci 6ha[ not be us€d lo |evetoi risk or buden lustrty an tnqeased 3. Pani regB , refusat to_ give edhori{on or the w hdrawst of aulhoflsation dbanvtonn ol dlscrihinaEn egahsiihe person concemed, lo in padicutar Aitlc16't6-tntomrzflon p.torto arrthori.edon 1. Those being ssked to euthorisr Dart ro,ecl sharr b€ siven aoeq,areinro.m"r,oi,ia;il;ffi;,;#"ff1"T*"#"i:,'1"il::"#:h 3. The lntormation shal atso be oovided to the lndMdrC concerned, unless this p€rson is not in a slaie lo receive the nfolmation A(icl6 l7 - Research wlth minlmat rtEk .nd hlntm.t burder 1. plotocot it is deemed that tE research b€ars a minthal dst d, having he intervenrion. n is,ro be *ri,i.in.Ii,iili,.noo ad on the heelth olthe persm "p.a"Jil"ili concerned resar. r","o ![gnr a 2 . I is deemed th6t it bears s minimat burden i, it i3 to b l:m.eorary and very shght for the person conc€meo. ll:rt h person onjoying rhe sp€crar co-nnoence ot itre person c_oncemea al the Xll:l CHAPTER VI Speclljc altu.tionr Aruclo 18 - R6..rch durtng pEgn.nc, or brt .f€odtng 1. a woman $rticn dr ,*-""ni,iil,illi jii,ffiTH.gL:ffi #ffi :tsTlrHf#*,tr?tT.ll,.ffi i Res€erch on pregnant lhe rcs6arch has the srn ol contributing-to lhe benef I ro othet wonEn in ret.Uon ro rerodurrion ii iil a€search ofcomparable effrcliveness ultimate,attainmeat of resutls capable o, or to .dr", minimat buden I":: contering "rd;.;Gil;;i;;[;". ca nnotbe cariedoul on women who the researdr entaits onty minirmt risk End "Tff are nol pregnanti 1""""ff#:,Hff:"1"':iffffjli,ll " o'"'"n'ed'|ns woman, panicurarcare sha, be raken to avoic eny Article 19 - Re!6rich on person. tn €mcrg€ncy clhtc. t ! itua ons :.",r"Ji,"",""#r:X""g"li#;:"yj$i:l *o und€r which prc."clive sdditionar conditions, resesrch i. ill s person ls notin s slete to give consent, because o! lhe Uryency of the and sduatbn :i[i::lru.g"hl;'g,'"",m#gri?; ""iT.li;I'#lmI;]:it; 2 The law shaU iflclude the toltowing I f,n"rlffi,ot -tott"o," effecliveness cennor b€ caried our on p€rcons n non-emergency specfic conditions] :H,JrT$?rf:'g*#iJ,lllof 'no"n"*"" ir has been approved lp€crncary ror ern€rsency :iJr3:f"t prevlouslv expressed obJections of rhe person known to rhe rcse€rcher shsrr De ;",,", :"1T11; 5fl:i:i,J,'"il lf"ffii'ff :""":Tarch projecr o' r, app,,ceb,e, lherr panicrpatron in rhe re Dossibre. Consent o, aL"on.ii,ri ioi leo particrpalion shall be requeste possrore """iiX"i'rns A(icle 20 - ReB€€rch on poEons deprtved ot Ibe.ty frffif;Xfi3#?I:fd*f"",fi# "?tff;[*i[it" "#lf3;,11?,ti],iti ilEr,,?:XiTf ;1.: I r€searci ol @mparebte eflecttueness carnol be caFied out without - - -. . - .--- *' rle partcrpetion o, ii Lbeiy d peasons deprived the raseerch hss the arm ofcontriMino _k) lhe ullirule atlaindlerit ofresuns capable ot aonlbmng tC) persofis depnved benefit oftibertyi l[ the research enla.ls onty minimatisk and minhatbuden CHAPTER VII Safety .nd 3upeivisjon Article 2t - Minimtlaflon of rtsk and burden 1 Ail reasonable meesures shall be taken to ensure safely and lo minimise research participants nsk and burden for lhe RBearc_h may only be cani6d out underthe 6up€rvEot o, a ctinlcat pmfessionel who possesses lhe ? necessary qualific€uons and €xgcdence, Arllclo 22 -Aasesshsnt ot health ttatu! I The rcseercher sha tate e[ nec€ssrv steps lo ass€sth6 siate of heallh of human berngs prior 10 to ensure thar rt'oi" ino"""J J"'iJ" ffi:I"#';::,Jl#**"h 2 'tr ^ "i i"'pla"]i"iilii" " "p"""r;" Wllue research is underlaten on Dfisons ln the rproductjve Etege ot then lives, padicular *. cr""nioi riir"r'" pr"g;"r,lio rh" h""t,n consideralron shal be g en tothe possrbte adwrs" irp""r ol an embryo,loetus o. child Arucle ,(l - t{on-lntcafaa€nco wtt r nccaasrry clinlcat nol delav nor lnteryrtons particiPants deprive of rDdicallv nec€ssary prevenrive, diasnost. or l"rrr"I:t1'"'"i:[J 2. ln rcs€arch essooated witi prevention, diagnosls d trestment parttcipanls * **'*' assigned to control groups shell b6 assur€d of poven m€thods ol p.ev6nt-on. Oiag.Ets or ireitl;;;i* 3 The ure of placebo is D€rmirsible wh.Ie there are m helhods ol proven Gflectiv€ness, wirldlEwet or wlthhotding ot such rErhods does not pres"nt an -acceprrOt.,iii;;;u;;;-*" or where A.tlcle 24 - Ncw devolopmlnt 1., ,_Pe ies to this protocolsha[ leke meesures lo ensurelrlllhe research projed is re-examrned iflhis |6jusufied tn the tight ot sc€ntrijc devetopmenls or events edsi.tg h the couIse oitnZ-,ll9J",i,i " 2 i The purpose ofihe re-examlnalion is lo estabtish whetlE the research needs lo be di6conlinued or i, chaflges b lhe research project ii iii 3 research lo conlinue are necessary tor lhe research panicipanrs, or epprrcabre ther represer{atiEa, need ro be intomed orthe deveropmenls sddrtionat consenr or authorisstion lor particrpation is reqrired Any new intormatior rclevanr to thFir .alicipaton shal b clnveyed to lh6 research parlicipants, or, rlspplicable, to thelr Ep.rsentatves, in s trmely mann€r. 4. . prciect, The competenl body shalt be htormed O{ the reasons br sny premstur€ lenhioalion of e research CHAPTER VIII Conflden slty.nd nghtlo lntonn. on A.tlcl6 25 - Confid€nltalty t. Any information of a personet nature coltected durlng tiomedrcal research shsl as "-" *be constdered con,identhtsnd tr€ated eccord,ng to the rutes relarrng ro he piiecron oipri;; H" talshal pr:tect agahrt happroptute drsctosure of.ny other intonnelon retat6d to a res6arch lhet has been subm ned to a. eth,cs commiflee in compbncir " 3--.prqoct-. -Th.e. wftn lhrs -p.;; '_-*' Arucl€ 26 - Rlght to lntorm.tion I Research parttcipants shalt be entited- to tnow conlormrtv wtlh the provrsions otArtrcte looftn6 Lonvennon any inlorhaton co ecled on lheir heallh in 2. Olher personal informaiion collected to with rhe rawoarhe;ro1ed;;;;!,i,,;l#i;1"!',1r",:,;i"[?:,"",#iilifjX":?f to rhem in conrorr,ir/ Ar0cle 27 - Duty ot ca.e the ilt 1o quahty ot trfe of :[ffiri"a; Anlcle 28 - Av.[.biIV of rEsuns '1. On comptetion ot the leseerch, a reDor rne comperenl 2 1 or summary shEll b€ submited body. The conclusions ot fte rosearch shall 3 I1r,,,f,j""*", be made avallable to padicipants in reasonable shall take appropnete measur€s 10 make pubtic """""..n ,n lo lhe ethics cohmittee or time, on the resuls ot research tn .o,"Tff|t"1lJ" to t r proro"or Ardcle 29 -Rele.rch in State6 not p:Itie3 to this protocol direct Provisi of t1is this protocot ensure lilal, he prinopte oprlale fiEas ,n,n"r".".,.,,ntJ|flt*TJ" o,,n" ",o,o"o, Article 30 - tntrtngoment ofthe rtghts or prtnctptes Artlcl€ 3t - CompeNaflon lord.mage The pe6on who has suflared demaoe *-p"*"r,oi "."oJng io-ir'!.coffi#T"["pffif;il|;:J#fff!!l,l "**"h 3harr be eotided ro reir Artlcle 32 - Sancuons . Pertes 6hall provide lor eppropnele prDvrsron! contatned in rhts prorocot !anclions lo be applied in the evenl of inlringemed of lhe CHAPTER XI Rer.tron between thrs protocorana o*er provisions Articlo 33 - Relation betwean this protocoland As betwoel the parl,es the orov,siois addrt.onat artjct€s to the coFventjon. e;d a[ end re€xrmrnerion orthe prorocor lhe Convention Aflrctes.l to-32 of lhrs protocot sha be regaroed -o. the Drovrslons or lhe corventon shalr aopty accord,ngty as Articte 3/t - Wder prot€c on None of the provisions of thE prctocot .helt be inlaFted as Lmiting or oh€Mise affecting the possibility tor a Party to grant research particjpants e wider mirsure ot protec;on th3n is Errputaled in thrs Prolocol A.tlclo 35 - R..€x.mtnaton ot the protocot tn order to monilor scienllfc developmenls, lhe pnairl protocd shal be examined within the commiflee rer6red ro ln A(icre 32 of the convenrion no ratirtrr nve yeil rro; lhe €nrry nro force or this Prorocot and thereaffer et such interua ts 6s the Corhmiflee rn y -termi;e. CHAPTER XII Flnilclauaes ArUcle 36 -Stgn.tu.s.nd r. flctuon to Elitic€tion. "ct h has previousty n, acceptance or . o 6 v ardct€ 37- Entry Into torce . 1 This Protocot shatt enter inlo rorcr on the fi,"t dey of tE month iolto ng t'e expiration of a p€riod of rhree months after the date on whlch five srale', hcruirng .r iasl tour mem;er srsies of lhe c;uncir of Europe, have express€d rheir cons6d ro be bound by tha ftdocor in accordance wirh the provisions of Adde 35 2 lh respecl of any State which subsequ€nlly 6xpresscs ts cDnse lo be bound by it, the protoco shall enter rnlo iorce on tt|e irst day of the month lollowing th! cxpiration ol a period ol lhiee rnonths atter lhe date oflhe deposil of lhe instrumenl ofrstifcetion, scceplarEa orapproval A[icle 38 - Accesston 1 Alter the enlry into lorc€ ol lhis protoaol, eny State wtii has acceded to the Convention may atso acced€ to this Protocol 2 Acc€ssion shaltbe etfecled by he depostt with lhe Seqltary Generatollhe Councilof Europe ol an instarment of accession whlch shsll lake gffecil on the irst day of the monlh lolowing lhe expiratton ot a period ol lhr66 months anerlhe datr ofhs d6po nl. Artlclo 3S - Oenunct.tion \/ I Any Parly may et 6ny time denounce this proiocot t heans of a notificaton addressod to the Secretary General ol th€ Councilol Europe 2 Such denuncialion shall b€come ellective on lhe llrst dly of the month tolowing the expiration ot a Friod of three months aier the date of rec€ipt ofsuch nofficitiriby the Sesarary cenerar. Artcle 40 - Nollf icadons The S6cretary Genelal of the Councit of Europe shati notily the member SEtes of the Councit 01 Europe, the Europeen Communrty, any Signatory, any party ad ani other Stete whldr hes been invited lo eccode lo the Prclocolot: a b c d any signature. Ued€pos ofeny instrumenl of ralirication, a@eptence, epprovator accession, Eny date ofentry into torce ofthis protocotin accordance w(h A.ticles 37 and 38 any otheract, notillcalion orcommunicaton relating to this protocol a tn wilness whereoflhe undeEigned, b€ lhg duly sulhonsed therelo have signed this prorocol eq . The he cou erng ro any 6rngre of lhe :Jy[ App.ndL to th! Addtuohat prDtocot lnronnaflon to b6 glvan r",. rl Bionedic.t Relearch to radtics cornmitee *" J:1"#;1"1,::,1n" lollowing nems sha, be provided b rhe erhics cohminee, in so far as I is rerevani Dcrcrtpfl on ot tho proroct I lhe name ot lhe pdnclpet rlseer. appropriare. rne Jnrca)ii;.ffi;j:"r:,:"T]:#;ffi.,#ff#Hi"" th6 silh and justificeton,or rii rv v methods and proceorra" a compreh.nsive the res6 0"""d on thxesr srEre orscientific proJect m ! Iangusge, "r.*, or r" ,"' s stetemenr o, prevrous end condseerci or the research projecr ror app,o,at ano rciuri-iil;J?rT;,*::I""'dr essessmenr or justitication ,or invotving on humsn beings h the r6seardrlDjecli '" ffi:i[:: lTJt'"'""i?"ffi:li:il;j jlirjx?H,ffifon" viti reasons for lhe use or ;"at::;J,Hi" :J.lhec.ature ' :11i"','"',iJ;i"##:"11H';:""J;i";:,:*::liTif; xiv r,,. na.t"ic"tion in ,rre ,esea,ch lho absonce orcontmlgroupsi " ' ' ''' knowredgei stetstsl end orher an€ytcar "nro"r"o"* techniques; 'no'o'ng Parllclpanti, com6nt and lnrorrmfl vi researchers end, wh€re snd desre€ or rorese..bte .isks thal may be incuned rhroush ""-", ",,"",he res6arch pari.pants, ;E:l?T.T?,I3ffl'l1?H:::i;:.#,;1,8 -"rin'E'es rhat may heve consequences,o.he *i'flT"*'"'r::*T:'lfffi*fl,11::f,:a;;"";- **o ,"ro"ipare in the reseerch proiecr :fi'^'#::li*"ilHltf,r'"'i":""";T;:""fr"1ffiTl or, h r,,e ca.6 or persons :Jr":tffilf.l",::il:J:"r[f,J?[*"r3r;,:,*"1 rv itrlTgil':,T:::il9*'ifl"*l,Xlit.IJ,"T "ose nor abre to consenr. F,e*ons who wourd parricipare in B#j."tr1"3; fj,:f l1o ,,e present or OlherthtormaUon xvi xv deteils ol a paym€nts sod rewerds to br ,',f,;H:1fli",[*,f":i"H,."' '',,,,,:;:"'::;:]T":"::ffi1]l",",lrre inoepencent rvlii dalails ol aoy foreseen F,otefllial fu{her uses, inctuding commercia uses of lhe r6s6arch resllts, data or biolo!rca, malerialsi xix xr delails olEllother ethlcalissues, es perc€ived by the reseerchei delails otany insurance orindemndyto coverdamage arising an the context oflhe research prqect The elhics cofimtilee may r6quest additional lnlormaiion necessary tor evEluation of lhe research Projecl