The principles of medical ethics
and medical research
O s p rinc íp io s d a é tic a mé d ic a
e d a p e sq uisa mé d ic a
1 Cen tre for Social Eth ics & Policy, Un iversity of M an ch ester. Hu m an ities Bu ild in g Ox ford Road M an ch ester M 13 9PL M an ch ester, En glan d . joh n .m .h arris@m an .ac.u k
Joh n Harris 1
Abst ract In th is p ap er I d iscu ss th e ap p lication of th e p rin cip les of m ed ical eth ics an d of m ed -ica l resea rch t o t h e ca se of ch ild ren a n d ot h ers w h ose con sen t t o t rea t m en t a n d t o resea rch is p roblem atic. Pu blic h ealth d ep en d s su bstan tially on th e p ossibility of on goin g research in to all con d ition s w h ich affect th e h ealth of th e p eop le. Con strain ts on th is research are th erefore a p u b-lic h ealth issu e. Moreover an d m ore im p ortan tly th e p ossibility of p red ictive testin g an d in d eed of screen in g for h ealth -relevan t con d ition s is an im p ortan t p u blic h ealth tool, an d lim itation s on th e u se of th is tool are of great sign ifican ce to p u blic h ealth m ed icin e. Havin g con sid ered th e p articu lar p roblem s created by research an d p red ictive testin g on ch ild ren for late-on set con d i-tion s I go on to d iscu ss research on th ose w h ose con sen t is p roblem atic m ore gen erally. I con clu d e w ith rad ical recom m en d ation s for th e reform of Th e Declaration of Helsin k i an d of th e In tern a-t ion a l Ea-t h ics Gu id elin es for Biom ed ica l Resea rch In v olv in g Hu m a n Su b jeca-t s, p rep a red by a-t h e
Co u n cil fo r In t e r n a t io n a l Orga n iza t io n s o f Me d ica l Scie n ce s(CIOM S).
Key words Bioeth ics; Research ; Pu blic Health
Resumo N esse artigo, d iscu to a ap licação d os p rin cíp ios d e ética m éd ica e d a p esqu isa m éd ica ao caso d e crian ças e ou tros cu jo con sen tim en to a tratam en to e p esqu isa é p roblem ático. A saú d e p ú blica d ep en d e su bstan cialm en te d a p ossibilid ad e d a con tin u id ad e d e p esqu isas d irigid as a tod as as con d ições qu e afetam a saú d e d a p op u lação. Restrições n essas p esqu isas são, p ortan to, u m a qu estão d e saú d e p ú blica. Além d isso, e m ais im p ortan te, testagen s p red itivas e, esp ecialm en te, screen in g p ara con d ições relevan tes (p ara) à saú d e con stitu eecialm se eecialm valiosos in stru ecialm en -tos d e saú d e p ú blica. Lim itações n o u so d esses in stru m en -tos são d a m aior sign ificân cia à m ed i-cin a ligad a à saú d e p ú blica. Levan d o em con sid eração os p roblem as p articu lares criad os p ela p esqu isa e testagem p red itiva p ara crian ças n o qu e se refere a con d ições qu e se m an ifestam tar-d ia m en t e, p rossigo tar-d iscu t in tar-d o in v est iga ções n a qu eles cu jo con sen t im en t o é p roblem á t ico em term os m ais gerais. Con clu o com recom en d ações rad icais p ara a reform a d a Declaração d e Helsin k i e d as Orien tações Éticas In tern acion ais p ara Pesqu isa Biom éd ica En volven d o Su jeitos Hu -m an os, p rep arad as p elo Co u n cil fo r In t e r n a t io n a l Orga n iza t io n s o f Me d ica l Scie n ce s (CIOM S).
Introduction
On e o f t h e p ro b le m s t h a t h a s p re o ccu p ie d m e re c e n t ly is t h a t o f fo r m u la t in g e t h ic a l p r in c i-p le s a i-p i-p ro i-p r ia t e t o t e st in g a n d sc re e n in g fo r la te-on set d isea se. As a m em b er of th e recen tly e st a b lish e d Un it e d Kin gd o m Ad viso r y Co m m it t e e o n Ge n e t ic Te st in g (ACGT ) a n d in p a r -t icu la r o f i-t s wo rkin g p a r -t y o n Ge n e -t ic Te s-t in g fo r La t e On se t Diso rd e rs, I h a ve b e e n p a rt icu -la r in t e re st e d in t h e q u e st io n o f t h e a p p ro p r i-a ten ess o f testin g ch ild ren , o r testin g p ren i-a ti-a l-ly fo r la te-o n set co n d itio n s.
Th e re se e m s t o b e a n o r t h o d o xy a ga in st testin g ch ild ren wh ich p erh ap s n eed s som e fu r-th er reflectio n .
In t h is p a p e r I will a t t e m p t t wo t a sks. Th e fir st is t o sa y so m e t h in g ve r y b r ie f a b o u t t h e d ile m m a s o f t e st in g a n d scre e n in g a s t h e y a p -p ly t o t e st in g c h ild re n fo r la t e o r ‘la t e r’ o n se t c o n d it io n s. I sh a ll t h e n , in t h e m a in p a r t o f wh a t I h a ve t o sa y, t r y t o a d d re ss t h e ve r y ge n -e ra l issu -e o f t h -e -e t h ics o f r-e s-e a rch o n ch ild r-e n a n d o t h e r s wh o e it h e r c a n n o t give a u t h e n t ic co n se n t o r wh o se co n se n t t o re se a rch m a y b e p rob lem a tic.
Should Children be tested for late-onset conditions?
If we a sk wh e t h e r o r n o t it is le git im a t e t o t e st ch ild re n fo r la t e -o n se t co n d it io n s, t h e re se e m to b e p owerfu l a rgu m en ts o n b o th sid es.
Against
1) Ma n y a d u lt s re fu se t e st in g a n d t h is is so m e e vid e n ce a s t o t h e like ly ch o ice s o f ch il-d ren wh en th ey b eco m e co m p eten t.
2) Te st in g c h ild re n p re e m p t s t h e ir a u -ton om ou s d ecision .
3) Th e re a re im p o r t a n t in su ra n ce a n d e m -p loym e n t c o n se q u e n c e s o f t e st in g wh ic h a re a d ve rse t o t h e in d ivid u a l t e st e d . Th e se a re n o t o f c o u r se a n a rgu m e n t a ga in st t e st in g p er se b u t so lo n g a s t h e y re m a in t r u e t h e y m u st b e ta ken in to a cco u n t.
4) Ch ild re n m a y grow u p wit h a se n se o f a b ligh t e d e xist e n ce a n d d e p r iva t io n re la t ive t o th eir frien d s a n d p eers.
For
1) A cle a r re su lt e n a b le s ra t io n a l p la n n in g for a p rob ab ly sh orter life. Deferred gratification m a y b e le ss a p p e a lin g a s m a y d e cisio n s wh ich p resu p p o se a n o rm a l life sp a n .
2) Pre ve n t ive st ra t e gie s m a y b e p o ssib le wh ic h wo u ld n o t b e t h o u gh t o f wit h o u t c le a r kn owle d ge o f t h e co n d it io n (p o ssib le p re ve n -tive m a stecto m y, fo r exa m p le).
3) Re p ro d u c t ive p la n n in g b e c o m e s p o ssi-b le, e it h e r t o h a ve a n e a r ly fa m ily wit h e a r ly p re n a t a l t e st in g fo r ge n e t ic d ise a se s o r t o d e -cid e n o t to h a ve a fa m ily.
A policy proposal
Th e Un it e d Kin gd o m Gove r n m e n t Ad viso r y Co m m itte e o n Ge n e tic Te stin g h a s p ro d u ce d a c o n su lt a t io n d o c u m e n t wh ic h a d d re sse s t h e p o lic y q u e st io n s ra ise d b y su c h d ile m m a s. I m u st stre ss th a t th e se a re su gge stio n s fo r co n -su lta tion p u rp oses a n d a re by n o m ea n s settled p o licy p ro p o sa ls. Howe ve r, t h e y a re, I b e lie ve, o f c o n sid e ra b le in t e re st a s o n e p o ssib le wa y fo r wa rd . Be low I re p ro d u ce p a ge s 22 a n d 23 o f th is d ocu m en t. I m u st em p h a size th a t th is d oc-u m e n t is fo r c o n soc-u lt a t io n p oc-u r p o se s o n ly a n d h a s n o o fficia l sta n d in g.
• “Presym p tom atic Gen etic Testin g of you n g
ch ildren for late-on set disorders:
a )‘Over th e cou n ter’ gen etic testin g of ch il-dren is n ot appropriate.
Th is w as th e con clu sion of th e com m ittee’s previou s report an d w e con tin u e to en dorse th is ap p roach . Th e issu es in volved m ay be com p lex an d th ey requ ire profession al in volvem en t.
b )An y requ est from a person or person s w ith
p aren tal resp on sibility to p rofession als, for presym ptom atic gen etic testin g of a you n g ch ild u n able to give con sen t, sh ou ld be fu lly discu ssed in con text of th e particu lar fam ily situ ation , th e n atu re of th e d isord er, th e p ossible m ed ical or oth er ben efits, an d th e im p lication s of testin g for th e ch ild an d fam ily.
Requ ests for su ch testin g are frequ en tly p art of a m ore gen eral n eed for in form ation an d re-qu ire fu ll an d sen sitive d iscu ssion w ith a p ro-fession al w h o can p rovid e th is; th ey sh ou ld n ot be sim p ly accep ted or d eclin ed on grou n d of gen eral p olicy. If a ch ild is to be tested th en th e con sen t to be given for th e test by th e p erson or p erson s w ith p aren tal resp on sibility sh ou ld be on th e basis th at it is in th e ch ild’s best in terest.
c) “Presym p tom atic testin g of you n g ch il-d ren for il-d isoril-d ers n ot cu rren tly in flu en ceil-d by th erap y, an d w h ere on set is n orm ally in ad u lt life, is n ot recom m en d ed , th ou gh th ere m ay be special situ ation s th at are exception s to th is”.
es-p ecially sin ce it is k n ow n th at a con sid erable proportion of adu lts m ay declin e testin g in su ch a situ ation . Th is h as also been th e con clu sion of oth er bodies, su ch as th e Clin ical Gen etics w ork -in g grou p rep ort, th e Gen etics In terest Grou p an d th e U S Task force on Gen etic Testin g. Th e situ ation for a p articu lar d isord er w ill requ ire reassessm en t in th e ligh t of advan ces in th erapy.
d )W h ere gen etic tests are bein g u sed d
iag-n ostically iiag-n th e coiag-n text of a ch ild w ith a fam ily h istory of a late-on set disorder sh ow in g clin ical featu res, it is essen tial th at th ese clin ical fea-tu res are relevan t to th e n afea-tu re of th e fam ily dis-order.
Gen etic testin g is in creasin gly p art of d iag-n osis iiag-n p ed iatric p ractice. W h ere a late-oiag-n set d isord er m ay occasion ally occu r in ch ild h ood , th ere is th e risk th at in a ch ild w ith sym p tom s, th ese m igh t be u n related to th e d isord er in th e fam ily; th is w ou ld give a real risk of in adverten t detection of th e gen e bein g presen t, w ith seriou s im p lication s for later life. M an y clin ician s d o n ot at presen t recogn ize th is poten tially dan ger-ou s situ ation .
• Gen etic testin g for late-on set d isord ers in adolescen ts:
Requ ests from ad olescen ts th em selves re-gardin g presym ptom atic gen etic testin g for late-on set disorders deserve fu ll an d sen sitive discu s-sion , tak in g in to accou n t th e in d ivid u al an d th eir fam ily. If th e ad olescen t is com p eten t to give con sen t bu t th ere are n ot clear ben efits of testin g, w e w ou ld recom m en d th at id eally test-in g be d eferred u n til th e age of m ajority is reach ed . How ever, th e com p eten t ad olescen t is en titled to m ak e a p erson al d ecision on th is m atter after a fu ll discu ssion an d exploration of th e issu es.
Adolescen ts w ill vary greatly as to th eir em otion al an d m en tal m atu rity in relaotion to com -p lex issu es for later life. Cu rren t ex -p erien ce is th at su ch requ ests are few bu t th at th ey n eed fu ll d iscu ssion w ith an ex p erien ced p erson . Preg-n aPreg-n cy cou ld be a special situ atioPreg-n w h ere testiPreg-n g n eeds to be con sidered.
In som e late-on set d isord ers, e.g. fam ilial ad en om atou s p olyp osis, for w h ich treatm en t m igh t be p ossible or for w h ich screen in g m igh t detect th e con dition at an early en ou gh stage for treatm en t to be effective, th ere is good reason to con sid er early testin g of ad olescen ts. In con d i-tion s su ch as fam ilial card iom yop ath y, w h ere th ere m ay be a fam ily h istory of su dden death in you n g fam ily m em bers, th ere m ay be ben efit in carryin g ou t p red ictive testin g in ch ild ren an d ad olescen ts. Th e situ ation for each d isord er re-qu ires carefu l con sideration (Ad viso r y Co m m i-tee o n Gen etic Testin g, 1997)
We h a ve re vie we d so m e o f t h e p a r t ic u la r p ro b le m s ra ise d b y t e st in g c h ild re n fo r la t e r o n se t d ise a se s a n d e xa m in e d o n e p o ssib le se t o f p o licy re co m m e n d a tio n s to co p e with th e se d iffic u lt ie s. Fo r t h e re m a in d e r o f t h is p a p e r I will n ow t u r n m o re ge n e ra lly t o t h e e t h ic s o f t re a t m e n t a n d re se a rc h o n t h o se wh o se c o n -sen t is p rob lem a tic a n d I will, I h op e, ch a llen ge wh a t I h a ve com e to rega rd a s a p ern iciou s a n d u n su sta in a b le o rth o d oxy (Ha rris, 1997).
Problematic consent to treatment
We will b e gin b y co n sid e r in g t h e ca se o f m e d ica l tre a tm e n t o f th o se wh o se co n se n t is p ro b le m a t ic a n d t h e n m ove o n t o t h e issu e o f re -sea rch . Th ere is a con tin u u m b etween th ese d im e n sio n s o f c o n se n t wh ic h will, I h o p e, b e -com e obviou s.
Be ca u se t h e re a re so m a n y ca se s in h e a lt h c a re p ra c t ic e wh ic h n e c e ssit a t e t o u c h in g p a -t ie n -t s in c irc u m s-t a n c e s wh e re -t h e ir c o n se n -t c a n n o t b e o b t a in e d a n d wh e re kn owle d ge o f t h e ir wish e s is a b se n t , t h e la w h a s c o n t r ive d va r io u s fic t io n a l c o n se n t s t o p ro t e c t we ll in t e n t io n e d p ra c t it io n e r s fro m t h e gu ilt o f u n la wfu l co n d u ct. Th e m o ra l n ecessity o f o b ta in -in g a va lid co n se n t wh e re th is ca n b e o b ta -in e d d o e s n o t re q u ire fu r t h e r d iscu ssio n . To vio la t e th e b o d ily in te grity o f p e rso n s wh o re je ct su ch viola tion is a form of tyra n n y a n d sh ou ld b e a c-ce p t e d a n d t re a t e d a s su ch . We m u st h owe ve r lo o k m o re clo sely a t th o se ca ses wh ere co n sen t o r its refu sa l is p ro b lem a tic, a n d a t th e fictio n -a lized co n sen ts th -a t -a re o ften m -a n u f-a ctu red in th ese circu m sta n ces.
Th e re a re a n u m b e r o f in st a n c e s in h e a lt h ca re wh ere th e p a tien t’s co n sen t is a p p ea led to a n d u se d , wh e re a c t u a l c o n se n t is u n o b t a in a b le. Th ese a re circu m sta n ces in wh ich th e p a -tien t is eith er u n con sciou s or u n a b le to p rocess t h e in fo r m a t io n re q u ire d t o give a va lid c o n -se n t , o r is t e m p o ra rily o r p e rm a n e n t ly la ckin g th e re le va n t ca p a city to co n se n t. In su ch ca se s t e r m s like ‘p ro xy c o n se n t’, ‘su b st it u t e d ju d g-m e n t’, ‘p re su g-m e d co n se n t’ o r e ve n ‘re t ro sp e ct ive co n se n ct’ a re u se d ct o ju sct ify ct re a ct in g a p a -tien t.
Provisio n fo r th ese so rts o f ‘co n sen ts’ is en -d o r se -d b y m o st o f t h e le a -d in g in t e r n a t io n a l p ro to co ls o n resea rch . Fo r exa m p le, th e Decla -ra t io n o f He lsin ki p rovid e s t h a t “W h ere p h
o f gu id e lin e s in t h is fie ld a re t h e In t e r n a t io n a l Et h ics Gu id e lin e s fo r Bio m e d ica l Re se a rch In volvin g Hu m an Su b jects, p rep ared by th e Cou n -cil fo r In t e r n a t io n a l Orga n iza t io n s o f Me d ica l Scie n ce s (CIOMS) in co lla b o ra t io n wit h t h e World Health Organ ization (WHO). Th eir Gu id e-lin e 1 states: “…in th e case of an in dividu al w h o is n ot cap able of givin g in form ed con sen t, th e proxy con sen t of a properly au th orized represen
-tative”m u st be obtain ed”(CIOMS/ WHO, 1993).
However, n o t o n ly a re th ese a ll fictio n s, b u t t h e y t o t a lly fa il t o b e ju st ifica t io n s fo r t re a t in g th e p a tien t in p a rticu la r wa ys.
Here o f co u rse we sh a ll b e a d va n cin g a th e-sis t h a t r u n s c o u n t e r t o m u c h c o n t e m p o ra r y th in kin g on con sen t wh ich seem s a t h om e with a t t r ib u t in g co n se n t t o in d ivid u a ls wh o a re t o ta lly u n a wa re th a t th ey a re su p p osed to b e con se n t in g o r we re u n a wa re a t t h e t im e t h e c o n -sen t is op era tive (a s in th e ca se of retrosp ective con sen t).
Th e re a so n wh y it is r igh t t o d o wh a t p re -su m ed co n sen t o r -su b stitu ted ju d gm en t seem s t o su gge st in t h e se c a se s is sim p ly b e c a u se t re a t in g t h e p a t ie n t in t h e p ro p o se d wa ys is in h is b est in terests a n d to fa il to trea t h im wo u ld b e d e lib e ra te ly to h a rm h im . It is th e p rin cip le t h a t we sh o u ld d o n o h a rm t h a t ju st ifie s t re a t in g th e p a tien t in p a rticu la r wa ys. Th e ju stifica t io n fo r t re a t m e n t is n o t t h a t t h e p a t ie n t co n -se n t e d , n o r t h a t h e wo u ld h a ve, n o r t h a t it is sa fe to p resu m e th a t h e wou ld h a ve, n or th a t h e will wh e n h e re ga in s co n scio u sn e ss o r co m p e -ten ce, b u t sim p ly th a t it is th e righ t th in g to d o, a n d it is r igh t p re cise ly becau seit is in h is b e st in t e re st s. Th a t it is t h e ‘b e st in t e re st s’ t e st t h a t is o p era tive is sh own by th e fa ct th a t we d o n o t p re su m e co n se n t t o t h in gs t h a t a re n o t in t h e p a t ie n t’s b e st in t e re st s, e ve n wh e re it is c le a r t h a t h e wo u ld h a ve c o n se n t e d . We d o n o t in -fu se kn own h eavy sm okers with cigarette sm oke wh ile t h e y a re u n c o n sc io u s e ve n wh e re it is re a so n a b le t o su p p o se t h e y wo u ld h a ve c o n -sen ted , a n d p a tien ts a re o ften d en ied a ccess to a lc o h o lic b e ve ra ge s o r c iga re t t e s, e ve n wh e n th ey sp ecifica lly req u est th em .
It is wid ely h eld th a t n ot on ly sh ou ld we n ot h a r m p e o p le wh o d o n o t wa n t t o b e h a r m e d , we a lso sh o u ld n o t h a r m e ve n t h o se wh o d o wa n t t o b e h a r m e d , a n d t h a t t h is is su ffic ie n t re a so n n o t t o wit h h o ld t re a t m e n t t h e a b se n ce o f wh ich wo u ld h a rm . Th is ra ise s t h e q u e st io n o f t h e r igh t t o h a r m o n e se lf, wh ic h I h a ve n o sp a ce to d iscu ss fu rth er h ere.
Not on ly d o we n ot n eed th e con cep t of im -p lie d o r a ssu m e d o r -p roxy co n se n t , b e ca u se it lit e ra lly d o e s n o t wo rk; we d o n o t n e e d it b e -c a u se it m isle a d s u s a s t o t h e -c h a ra -c t e r a n d
m ea n in g o f o u r a ctio n s. Th e n in eteen th cen tu -r y En glish p h ilo so p h e -r Je -re m y Be n t h a n wa s r igh t ly sca t h in g o f fict io n a l co n se n t s wh e n h e re m a rke d : “In En glish law, fiction is a syp h ilis, w h ich ru n s in every vein , an d carries in to every p art of th e system th e p rin cip le of rotten n ess... Fiction of u se to ju stice? Exactly as sw in dlin g is to trade... It affords presu m ptive an d con clu sive eviden ce of m oral tu rpitu de in th ose by w h om it w as in ven ted an d first em p loyed .”(Be n t h a n , a p u d Stein er, 1994: 258).
So wh ere, in m ed ica l con texts, we a ct in th e b e st in t e re st s o f p a t ie n t s wh o ca n n o t co n se n t , we d o so, I su gge st , b e ca u se we r igh t ly b e lie ve we sh o u ld n o t h a r m t h o se in o u r ca re a n d n o t b e ca u se so m e irre le va n t p e rso n o r th e la w h a s co n stru cted a co n sen t. Th is d o es n o t o f co u rse h elp with th e vexed p rob lem of wh o is a n d wh o is n o t c o m p e t e n t t o c o n se n t , b u t it d o e s e x-p la in t h e ju st ific a t io n fo r in t e r ve n in g in t h e live s o f t h o se we a re sa t isfie d a re n o t a b le t o give t h e co n se n t s t h a t wo u ld o t h e r wise b e re -q u ired .
If t h e t re a t m e n t o f t h o se wh o se co n se n t is im p a ire d is p ro b le m a t ic, a n d d e cisio n s t o d isch a rge t h e m fro m ca re e q u a lly so, wh a t o f re -sea rch ?
Research on children or on cognitively impaired subjects
Th e re is o f c o u r se n o t h in g sp e c ia l a b o u t re se a rc h o n c o gn it ive ly im p a ire d e ld e r ly su b -je ct s. Co gn it ive im p a irm e n t is o n ly sign ifica n t in t h is c o n t e xt in so fa r a s it a lso in vo lve s im -p a ir m e n t o f a u t o n o m y a n d t h e e ld e rly a re n o t im p o r t a n t ly d iffe re n t fro m o t h e r a ge gro u p s fro m t h e p o in t o f vie w o f c o n se n t (H ir sc h & Ha rris, 1988).
o n . Id e n t ifyin g p rim aryin t e n t is h a rd ly m o re h e lp fu l b e c a u se it e it h e r re lie s o n a d e gre e o f se lfa wa re n e ss th a t fe w ca n a ch ie ve, o r, it sim -p ly st i-p u la t e s o n e o f m a n y -p o ssib le o r a c t u a l in t e n t io n s a s p a ra m o u n t fo r t h e p u r p o se s o f b r in gin g t h e a c t ivit y in t o a n a p p ro p r ia t e o r p erm itted ca tego r y.
Th is d oes n ot m ea n th a t th ere is n o d istin ct io n ct o b e d ra wn b e ct we e n re se a rch a n d ct h e ra -p y, b u t ra t h e r t h a t t h e d ist in c t io n c a n n o t b e d ra wn su fficien tly clea rly to su sta in cla im s th a t t h e ra p y is ju st ifie d wh e re a s re se a rc h is n o t . Th is is p erh a p s less worryin g th a n m igh t a t first a p p e a r. Fir st ly t h e wo rk su p p o se d ly d o n e b y t h e d ist in ct io n b e t we e n re se a rch a n d t h e ra p y m igh t a s e a sily b e a c c o m p lish e d b y c o n c e n t ra t in g o n t h e d e gre e o f a d va n t a ge t o t h e p a -tien t. We co u ld sa y th a t in ter ven tio n s, wh eth er m o t iva t e d b y re se a rch o r t h e ra p e u t ic im p e ra t ive s, a re p e r m issib le if e it h e r t h e p a t ie n t a c -c e p t s a n d -c o n se n t s t o t h e in t e r ve n t io n s, o r, wh e re co n se n t is u n o b t a in a b le, t h a t t h e in t e r-ve n t io n s a re t h e b e st a va ila b le t re a t m e n t fo r th e p a tien t, wh eth er or n ot th ey a lso con stitu te resea rch .
Howe ve r, it is wo r t h p u r su in g t h e d ist in c -tio n b etween th era p eu tic a n d n o n -th era p eu tic re se a rch a b it fu r t h e r, b e ca u se, in so fa r a s it is c o h e re n t , it re lie s o n a su sp ic io u sly n a r row vie w a b o u t t h e d e fin it io n o f ‘t h e ra p e u t ic’ a n d a lso a b o u t wh a t is, in fa c t , in e ve r y p a t ie n t’s b est in terests.
Th e fo llowin g two cla im s a re o ften m a d e in th is con text:
1) Th e p a tien t’s in terests a re p a ra m o u n t. 2) Th a t re se a rc h o n p a t ie n t s wh o c a n n o t co n sen t fo r th em selves m u st b e eith er:
i) Th era p eu tic or
ii) In th e p a tien t’s own in terests orof p oten -tia l b en efit fo r th e p a tien t h erself or
iii) If n o t d ire ctly fo r th e b e n e fit o f th e p a rticu la r p a tien t in q u estio n , a t lea st fo r th e b en -e fit o f t h -e c a t -e go r y o f p a t i-e n t s t o wh ic h t h -e su b je ct b e lo n gs, so th a t fo r e xa m p le, if th e p a -t ie n -t is su ffe r in g fro m Li- Fra u m e n i d ise a se, t h e n re se a rc h will o n ly b e ju st ifie d if t h e re -se a rc h will b e o f b e n e fit if n o t t o t h e p a t ie n t h im self, a t lea st to o th er Li-Fra u m en i victim s. Ne it h e r cla im se e m s su st a in a b le a n d sin ce th e cla im s a re often rep ea ted , it is worth ta kin g a m o m en t to see wh y th is is so.
Th e p a t ie n t’s in t e re st s c a n n o t b e p a ra -m ou n t for th e si-m p le a n d su fficien t rea son th a t b e in g o r b e co m in g a p a t ie n t is n o t t h e so r t o f t h in g t h a t c o u ld c o n c e iva b ly in c re a se e it h e r yo u r righ ts o r yo u r m o ra l cla im s. All p eo p le a re m o ra lly im p o rta n t a n d with re sp e ct to o n e a n -o t h e r e a ch h a s a cla im t -o e q u a l c-o n sid e ra t i-o n .
No on e h a s a cla im to overrid in g con sid era tion . To sa y t h a t t h e p a t ie n t’s in t e re st s a re p a ra -m o u n t, if it -m ea n s a n yth in g, -m u st b e seen a s a wa y o f rea ssertin g th a t h ea lth p ro fessio n a ls a re c o n c e r n e d p r im a r ily fo r t h e p a t ie n t s in t h e ir c a re a n d m a y h a ve sp e c ia l c o n t ra c t u a l d u t ie s t o t h e m . Howe ve r a s a ge n e ra l re m a rk a b o u t t h e o b liga t io n s o f t h e h e a lt h ca re syst e m o r o f so ciety it is n o t su sta in a b le.
Th e secon d cla im is eq u a lly p rob lem a tic. To a sse r t t h a t re se a rch m u st b e t h e ra p e u t ic o r in t h e p a t ie n t’s own in t e re st s is n o t p la u sib le wh en in terp reted a s con fin in g resea rch to work t h a t will b e n e fit p a rt icu la r p a t ie n t s d ire ct ly, in th e sen se th a t th ey will th em selves, so to sp ea k, ‘fe e l th e b e n e fit’, o r th a t it will se r ve th e ir co n -tin u in g in terests.
Let u s lo o k a t th e id ea o f wh a t is o r is n o t in so m e o n e’s in t e re st s fir st . We m u st b e wa r y o f b e in g t o o c o n se r va t ive a b o u t wh a t d o e s o r d o es n o t b en efit so m eo n e o r o f d efin in g so m e-on e’s in terests too n a rrowly. We a ll b en efit from livin g in a so cie ty in wh ich m e d ica l re se a rch is c a r r ie d o u t a n d wh ic h u t ilize s t h e b e n e fit s o f p a st re se a rc h . It is b o t h o f b e n e fit t o p a t ie n t s a n d it is in th eir in terests to b e p a tien ts in a so-c ie t y wh iso-c h p u r su e s a n d a so-c t ive ly a so-c so-c e p t s t h e b en efits o f resea rch a n d wh ere resea rch a n d its fr u it s a re give n a h igh p r io r it y. We a ll a ls o b en efit fro m th e kn owled ge th a t resea rch is o n -go in g, in t o d ise a se s o r co n d it io n s fro m wh ich we d o n ot cu rren tly su ffer b u t to wh ich we m a y su c c u m b . It m a ke s u s fe e l m o re se c u re a n d give s u s h o p e fo r t h e fu t u re, fo r o u rse lve s, o u r d e sce n d a n t s, a n d o t h e r s fo r wh o m we ca re. If th is is righ t, th e n I h a ve a stro n g ge n e ra l in te rest th at th ere b e research , an d in all wellfou n d -e d r-e s-e a rch ; n o t -e xclu d in g b u t n o t -e xclu siv-e ly, re se a rch o n m e a n d o n m y co n d it io n . All su ch resea rch is a lso of clea r b en efit to m e. A n a rrow in terp reta tio n o f th e req u irem en t th a t resea rch b e o f b e n e fit to th e su b je ct o f th e re se a rch is, I b e lie ve, p e r ve rse. If t h e cla im t h a t re se a rch o n su b je cts wh o ca n n o t co n se n t fo r th e m se lve s is ju st ifie d o n ly if n a r rowly t a rge t e d o n c o n d i-t io n s fro m wh ich i-t h o se su b je ci-t s cu rre n i-t ly su f-fer, a n d wh ich will likely b ea r fru it in tim e to b e o f d ire c t b e n e fit t o t h e m is t o b e su st a in e d , t h e n it re q u ire s se p a ra t e a rgu m e n t a n d su p -p o r t . Th e re is n o re a so n h owe ve r t o t a ke t h is n a rrow in terp reta tio n a s th e sta n d a rd o n e.
is-e a sis-e, Li- Fra u m is-e n i fo r is-e xa m p lis-e ? Su ris-e ly a n y m o ra l o b liga t io n I h a ve t o a cce p t r isk o r h a r m fo r t h e b e n e fit o f o t h e r s is n o t p la u sib ly c o n -fin ed to th o se o th ers wh o a re n a rrowly like m e. Th is is su re ly c lo se t o c la im in g t h a t re se a rc h sh o u ld b e c o n fin e d t o o t h e r s wh o a re ‘b la c k like m e’ or ‘En glish like m e’ or ‘God -fea rin g like m e’? Th e m o st a p p ro p r ia t e c a t e go r y is s u re ly ‘h u m a n like m e’.
Justice
Wh ere I b en efit from research b u t refu se to p ar-ticip ate in it I am clearly actin g u n fairly in som e se n se. I a m fre e rid in g o n t h e b a ck o f t h e co n -trib u tion of oth ers. Wh ile we m ay con clu d e th at p eo p le a re u ltim a tely en titled to a ct u n fa irly in t h is wa y if t h e y ch o o se, t h a t t h e y sh o u ld n o t n orm ally b e com p elled to con trib u te or p artici-p a t e, t h e re is n o re a so n t o artici-p re su m e t h a t t h o se wh o ca n n o t co n se n t wo u ld h a ve wish e d t o b e fre e rid e rs. In d e e d , a s we h a ve a rgu e d , t h e re is n o ju st ifica t io n fo r a n y p re su m p t io n s a b o u t th eir willin gn ess to con sen t or oth erwise, in th e a b sen ce o f clea r in d ica tio n s a b o u t th eir p refer-en ces. Wh at is clear, I b elieve, is th at th ere is n o b a sis fo r a n y p resu m p tio n th a t th o se wh o ca n -n o t co -n se-n t sh o u ld b e exclu d ed fro m resea rch , wh e th e r th a t re se a rch is ta rge te d o n th e ir co n -d it io n o r n o t . No r, o f co u rse, is t h e re a n y b a sis fo r t h e p re su m p t io n t h a t t h o se wh o ca n n o t co n se n t sh o u ld b e, so t o sa y, ‘p ro fe ssio n a l re se a rch su b je ct s’. Th e y sh o u ld n e it h e r b e a u t o m a t ica lly in clu d e d in re se a rch , p e r h a p s b e ca u se th ey h a p p en to b e rea d ily a va ila b le in in -stitu tio n s o r u n d er co n tin u in g ca re, n o r sh o u ld th ey b e a u to m a tica lly exclu d ed .
We h a ve b e e n t a lkin g ve r y ge n e ra lly o f co u r se a n d a ssu m in g a fa vo ra b le r isk/ b e n e fit b a la n ce fo r th e re se a rch su b je cts. Na m e ly th a t th e risks an d p ain , d iscom fort, or in con ven ien ce o f th e re se a rch a re m in im a l, a n d th e p ro je cte d b e n e fit s cle a r. Th e re is cle a r ly a t ra d e o ff b e t we e n r isks a n d b e n e fit s a n d a fa irly st e e p u p -wa rd cu rve wh ere we d em a n d th a t th e b en efits b e cle a r a n d u rge n t b e fo re we will a cce p t sig-n ifica sig-n t risks or p a isig-n , isig-n cosig-n vesig-n iesig-n ce, a sig-n d so osig-n fo r o u rselves. We sh o u ld su rely a p p ly th e sa m e sta n d a rd s to th o se wh o ca n n o t co n se n t. I ca n -n o t sa y a -n yt h i-n g u se fu l o r o r igi-n a l a b o u t t h is b a la n c e. Cle a r ly I will o n ly a c c e p t sign ific a n t r isk o f d e a t h fo r m yse lf if wit h o u t a c c e p t in g su ch risk t h e re is a n a lm o st ce rt a in ly a n d su b -st a n t ia lly wo rse o u t co m e fo r m yse lf o r t h o se I ca re a b ou t. However even h ere th e risks a re n ot p la u sib ly u n d e r t a ke n o n ly t o b e n e fit o n e se lf. Live kid n e y d o n o rs fo r e xa m p le cle a rly a cce p t
sign ifica n t r isks fo r o t h e rs a n d we u su a lly a p -p la u d th eir d ecisio n so to d o.
Th e re cle a rly is a n o b liga t io n (so m e t im e s) to m a ke sa crifices fo r th e co m m u n ity o r a n en -titlem en t o f th e co m m u n ity to go es so fa r a s to d e n y a u t o n o m y a n d vio la t e b o d ily in t e grit y in th e p u b lic in terest a n d th is o b liga tio n is reco g-n ized ig-n a g-n u m b er o f wa ys. Th e fo llowig-n g a rea s in wh ich th is is a lrea d y reco gn ized a n d a ccep ted to som e exten t will serve a s a rem in d er: con -tro l o f d a n gero u s d ru gs, co n -tro l o f ro a d tra ffic, va ccin a t io n , scre e n in g t e st s, b lo o d d o n a t io n , q u a r a n t in e fo r c o m m u n ic a b le d is e a s e , c o m p u lso ry m ilita ry service, d eten tio n u n d er m en -t a l h e a l-t h a c -t s , r e s -t r ic -t io n o n s e xu a l a c -t ivi-t ie s a n d p ro fe ssio n a l a civi-tiviivi-tie s o f H IV p o siivi-tive p e o p le . All t h e s e in vo lve s o m e d e n ia l o f a u -t o n o m y, so m e im p o si-t io n o f p u b lic s-t a n d a rd s e ve n wh ere co m p eten t in d ivid u a ls d o n o t co n -s e n t t o t h a t im p o -s it io n . H o we ve r t h e re a re cle a rly so m e e xce p t io n a l ca se s wh e re ove rr id -in g m o ra l co n sid era tio n s ta ke p reced en ce over a u to n o m y.
An exa m p le wh ich seem s to m e to illu stra te, a n d to a n exten t exp la in , ou r a ttitu d e to th e im -p o sit io n o f r isk in t h e -p u b lic in t e re st in vo lve s t h e fo llowin g st o r y. Im a gin e a n o ce a n lin e r o n a cr u ise. Th e ca p t a in re ce ive s a ra d io m e ssa ge th at th ere is an oth er sh ip in d istress som e m iles t o t h e n o r t h . Th e re a re t wo h u n d re d p e o p le a b o a rd t h is o t h e r sh ip a n d h is lin e r h a s o n e t h o u sa n d a b o a rd . His is t h e o n ly sh ip t h a t ca n e ffe c t t h e re sc u e b e fo re t h e st r ic ke n sh ip will fo u n d e r. He kn ows t h a t if h e d ive r t s in t o t h e st o rm h e will im p o se so m e risk o n h is p a sse n -gers a n d crew. Th ere will b e a sm a ll b u t sign ifi-ca n t risk of d ea th for a ll. Th e storm is a b a d on e b u t t h e m o d e r n lin e r sh o u ld b e a b le t o c o p e. Th e re is a gre a t e r, b u t st ill sm a ll, r isk o f d e a t h fo r a fe w o f h is p a sse n ge r s a n d c re w in t h e ro u gh a n d t u m b le o f t h e re sc u e. Fin a lly, b e c a u se t h e st o r m is se ve re, h e will a lm o st c e r t a in ly b e su b je ct in g h is m a n y e ld e r ly p a sse n -ge rs t o r isk o f m in o r in ju r ie s in t h e ro u gh se a s a n d certa in ly to d isco m fo rt, fea r, a n d in co n ve-n ieve-n ce. Sigve-n ifica ve-n tly, we d o ve-n’t h a ve to a sk wh a t h e sh o u ld d o. Th e c a p t a in kn ows h e m u st a t -t e m p -t -t h e re sc u e a n d su b je c -t h is p a sse n ge r s a n d cre w to th e a tte n d a n t risks a n d fe w wo u ld d isa gre e. He a lso kn ows t h a t h e ca n a n d m u st d o so with ou t a skin g for th e con sen t of h is p a s-se n ge r s a n d cre w, fo r t h e y wo u ld b e wro n g t o wit h h o ld t h e ir co n se n t a n d t h e ca p t a in wo u ld b e wro n g to a ct o n it.
wh en con sid erin g th e eth ics of resea rch in volv-in g say, ch ild ren or cogn itively im p aired eld erly su b jects, th at d ifferen t p rin cip les sh ou ld ap p ly? Firstly, let’s ju st rem in d ou rselves wh at th ese p rin cip les a re, a n d th en go o n to see if th ey a re co n st ra in e d in a n y wa y b y t h e sit u a t io n o f p a tien ts wh o se co n sen t is p ro b lem a tic. Th e p rin cip le s in vo lve d a re a ll d im e n sio n s o f t h e p r in -cip le o f e q u a lity fro m wh ich o u r first p rin -cip le o f re se a rch e t h ics wa s d e r ive d . Th a t p r in cip le is, it will b e re m e m b e re d , th at each p erson is en titled to th e sam e con cern , resp ect, an d p ro-tection of society as is accorded to an y oth er per-son in th e com m u n ity.Th is p r in cip le re m in d s u s t h a t t h e p a sse n ge r s o n t h e st r ic ke n lin e r h a ve a s go o d a cla im t o o u r p ro t e ct io n a s a n y o t h e r p e r so n s, (a lt h o u gh t h e y m a y n o t b e fe l-low citize n s) a n d th a t wh ile we a re n o t o b lige d t o a ffo rd t h a t p ro t e c t io n a t a ll c o st s, we a re o b liged to a ct m o ra lly wh en th e co sts o f so d o -in g a re re a so n a b le give n t h e im p o r t a n c e o f wh a t is a t sta ke. I h o p e it is o bvio u s th a t if a ct-in g m ora lly were on ly ob liga tory wh en d oct-in g so wa s co st -fre e t o t h e a ge n t , m o ra lit y wo u ld n o t exist. It is n ot p la u sib le to b elieve th a t th e costs o f a ctin g m o ra lly fa ll o n ly o n th o se co m p e te n t to con sen t. So lon g as we en su re th at su ch costs d o n o t fa ll m ore h eavilyo n t h o se n o t c o m p e -t e n -t -t o c o n se n -t -t h a n o n o -t h e r s I c a n se e n o so u n d a rgu m e n t fo r e xe m p t in g t h e m fro m t h e d em an d s of m orality. Th ey m ay n ot b e accou n t-ablein la w, if t h e y d o wro n g, b u t t h e re is n o re a so n t o e n su re t h a t t h e y d o wro n g, b y e x-em p tin g th x-em fro m th eir m o ra l o b liga tio n s.
Th e fa ct th a t th e m o ra l o b liga tio n s in q u est io n a re n o est m a n d a est o r y, in est h a est co m p e est e n est in -d ivi-d u a ls m a y n o t, u su a lly, b e co erce-d in to fu l-fillin g t h e m , d o e s n o t se e m t o b e a re a so n fo r exem p tin g th ose n ot com p eten t to con sen t. We
d o n o t a llow ch ild ren , (o r we sh o u ld n o t) to d o wro n g b e c a u se so m e a d u lt s m a y fre e ly d o so. Howe ve r we c o n st ra in c h ild re n n o t o n ly b e -c a u se we a re, in p a r t , m o ra lly re sp o n sib le fo r th eir a ction s, b u t a lso b eca u se th is is p a rt of a n e d u c a t io n a l p ro c e ss. Th e r igh t p a ra lle l wit h a d u lt s wh o la c k c o m p e t e n c e m igh t b e t o in -c lu d e t h e m in re se a r-c h wh e n , a lt h o u gh n o t co m p e t e n t t o co n se n t o r re fu se, t h e y m a ke n o overt ob jection to in clu sion or com p lain t ab ou t it. Wh ere th ey d o ob ject or com p lain , we sh ou ld p erh ap s resp ect th at, alb eit in com p eten t, rejec-tio n o f th is p a rticu la r m o ra l o b liga rejec-tio n .
Dou b tless th is d efen se of th e id ea th at th ere ca n b e a n o b liga t io n t o p a rt icip a t e in re se a rch in c e r t a in c irc u m st a n c e s, wh e t h e r t h o se wh o p a r t ic ip a t e a re c a p a b le o f c o n se n t in g o r n o t , will st r ike so m e a s co n t rove rsia l. Th e p ro h ib i-tio n o f re se a rch o n th o se in ca p a b le o f co n se n t e xce p t wh e re th e re se a rch is in th e ir own th e r-a p e u t ic in t e re st is r-a p r in cip le fo u n d e d o n t h e h igh e st o f m o t ive s, t h a t o f t h e n e e d t o p ro t e ct th e vu ln era b le. However, th e sa m e m o tive a n i-m a tes th e p osition d efen d ed h ere. It is n ot on ly th e in com p eten t wh o a re vu ln era b le in th e req u isit e se n se. We a re a ll vu ln e ra b le u n le ss re -se a rch is p u rsu e d . Th e issu e is o n e o f b a la n ce. If resea rch ca n b e p u rsu ed with o u t reco u rse to th o se wh o se co n sen t is d u b io u s, th en so m u ch th e b etter. Th is sh ou ld b e ou r first ch oice. Howe vHowe r, if su ch a p ro h ib it io n jHowe o p a rd izHowe s o u r ca -p a c it y t o -p u r su e we ll- fo u n d e d re se a rc h t h e n p e r h a p s we sh o u ld re m e m b e r t h a t fre e -r id in g is n o t a n a t t ra ct ive p r in cip le ; n o r is it a m o ra l p r in c ip le. We sh o u ld n o t , a s I h a ve in d ic a t e d , a ssu m e t h a t t h o se in c o m p e t e n t t o c o n se n t wo u ld wish t o b e fre e r id e r s, n o r t h a t t h e y b e e xc lu d e d fro m d isc h a rgin g a n o b liga t io n o f go o d citizen sh ip wh ich we a ll sh a re.
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