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Limitations on Biomedical and Behavioral Research Involving Prisoners: An Argument Supporting the Institute of Medicines Recommendations to Revise Regulations
INTRODUCTION In the conduct of scientific ese! ch in"o#"in$ hu%!n su&'ects( the %!inten!nce of ethic!# st!nd! ds !nd ) otoco#s is ! fund!%ent!# ) inci)#e* 1 This is )! ticu#! #+ t ue ,hen the hu%!n su&'ects ! e %e%&e s of ! dis!d"!nt!$ed $ ou)-fo e.!%)#e( ) isone s* A c itic!# ch!##en$e ,hen conductin$ ese! ch on ) ison )o)u#!tions is desi$nin$ ) otections th!t ! e s)ecific to these su&'ects( $i"en thei fund!%ent!# "u#ne !&i#it+( &ut !#so to ensu e th!t those ) otections ! e not so & o!d !s to effecti"e#+ ) ohi&it )! tici)!tion in %edic!# t i!#s( the e&+ e#i%in!tin$ ) isone s/ !ccess to the )otenti!# &enefits*2 The e h!s ce t!in#+ &een ! histo + of e.)#oit!tion in the conduct of %edic!# !nd &eh!"io !# ese! ch on ) isone s* 0u%!n1su&'ect ese! ch %ust %o"e fo ,! d( !nd in the ) isone )o)u#!tion( &eneficent ese! ch c!n !nd %ust &e conducted !cco din$ to f!i !nd ethic!# ) otoco#s* Indeed( 2%uch 3of4 hu%!n1su&'ect ese! ch h!s cont i&uted $ e!t#+ to hu%!n ,e##1&ein$ !nd h!s &een conducted !cco din$ to sound ethic!# st!nd! ds*53 Cu ent fede !# e$u#!tions( ) o%u#$!ted in 1678 &+ the De)! t%ent of 0e!#th( 9duc!tion !nd :e#f! e ;D09:<( st!te th!t ) isone s in the United St!tes %!+ )! tici)!te in fede !##+ fin!nced &io%edic!# !nd &eh!"io !# ese! ch so #on$ !s the 2e.)e i%ent )oses no %o e th!n =%ini%!#/ is>s to the su&'ects*54 2Mini%!# is>5 is defined !s 23 4is> of )h+sic!# o
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* ?9@@R9A B* CA0N( ANNA C* MASTROIANNI D ?9R9MA SUGARMAN( E9AOND CONS9NTF S99CING ?USTIC9 IN R9S9ARC0 2 ;1668<* 2 . Id. !t 3* 3 . Id. !t 112* 4 . I!n U &in!( Panel Suggests Using Inmates in Drug Trials( N*A* TIM9S( Au$* 13( 2006( G 1* The D09: ,!s #!te est uctu ed !s D00S* U*S* De)! t%ent of 0e!#th D 0u%!n Se "ices( 00S @ eHuent Iuestions 0o%e( htt)F//,,,*dhhs*$o"/f!H/inde.*ht%# ;se! ch 2Aou c!n "ie, @AIs &+ C!te$o +5 fo 2A&out 00S5J then c#ic> 2:h!t is the histo + of 00SK :hen did it $et st! tedK :h!t +e! s ,e e the %ost i%)o t!nt in its

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174 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 )s+cho#o$ic!# h! % th!t is no $ e!te in ) o&!&i#it+ !nd se"e it+ th!n th!t o din! i#+ encounte ed in the d!i#+ #i"es o in the outine %edic!#( dent!# o )s+cho#o$ic!# e.!%in!tions of he!#th+ )e sons*5 M On Au$ust 1( 2006( the Institute of Medicine/s Co%%ittee on 9thic!# Conside !tions fo Re"isions to the De)! t%ent of 0e!#th !nd 0u%!n Se "ices Re$u#!tions fo B otection of B isone s In"o#"ed in Rese! ch eco%%ended th!t the De)! t%ent of 0e!#th !nd 0u%!n Se "ices ;D00S< e"ise e$u#!tions &ec!use the+ se"e e#+ #i%it the in"o#"e%ent of ) isone s in &io%edic!# !nd &eh!"io !# ese! ch*6 This Note ,i## ! $ue th!t the Institute of Medicine/s eco%%end!tions( if i%)#e%ented( ,ou#d he#) ensu e th!t &io%edic!# !nd &eh!"io !# ese! ch in"o#"in$ ) isone s ,i## cont i&ute $ e!t#+ to hu%!n ,e#f! e &+ !##o,in$ ) isone s to )! tici)!te in ese! ch t i!#s th!t cou#d t e!t o e"en cu e thei %edic!# conditions* @u the %o e( this Note ,i## ! $ue th!t the eco%%end!tions ,ou#d s!fe$u! d ethic!# st!nd! ds !s the+ !))#+ to the ) ison )o)u#!tion &ec!use the+ enco%)!ss $ e!te ) otections fo ) isone )! tici)!nts th!n ! e e.tended &+ cu ent e$u#!tions* B! t I ,i## e.)#o e the de%o$ !)hics of cu ent ) ison )o)u#!tions !nd int oduce th ee h+)othetic!# ) isone s con"icted ,ith diffe ent sentences( inc! ce !ted !t diffe ent institutions in the United St!tes( !nd )#!$ued ,ith diffe ent %edic!# conditions* B! t II ,i## e.)#o e the histo + of &io%edic!# !nd &eh!"io !# ese! ch in"o#"in$ ) isone s in the United St!tes !nd cu ent e$u#!tions on this ) !ctice* B! t III ,i## ) esent cu ent e$u#!tions* B! t IL ,i## discuss the effect of cu ent e$u#!tions on ) isone s* B! t L ,i## int oduce the Institute of Medicine/s e)o t to the $o"e n%ent !nd discuss the effect th!t the eco%%ended e$u#!tions ,ou#d #i>e#+ h!"e on ) isone s &+ focusin$ on the h+)othetic!# ) isone s int oduced in B! t I* B! t LI ,i## discuss the constitution!#it+ of cu ent !nd eco%%ended e$u#!tions* This Note ,i## conc#ude ,ith !n e.!%in!tion of the &enefici!# effects th!t the eco%%ended e$u#!tions ,ou#d #i>e#+ h!"e on &oth ) isone s !nd societ+*

histo +K5 h+)e #in><* M * O@@IC9 @OR 0UMAN R9S9ARC0 BROT*( BROT9CTING 0UMAN SUE?9CTSF INSTITUTIONAN R9L* ED* GUID9EOOC( ch* 6( )t* 9( !t 1 ;Ro&in Ne"in Bens#! et !#* eds*( 2d ed* 1663<( htt)F//,,,*hhs*$o"/oh )/i &/i &Och!)te 6ii*ht%P$6 ;citin$ 4M C*@*R* G 46*102;i< ;200M<< 3he ein!fte O0RB4* 6 * U &in!( supra note 4J see als A##i!nce fo 0u%!n Rese! ch B otection( IOM Panel Re! mmends Using Pris n Inmates as "uinea Pigs in Drug Trials ( N*A* TIM9S( Au$* 13( 2006( a#aila$le at htt)F//,,,*!h )*o $/c%s/inde.2*)h)Ko)tionQco%OcontentDdoO)df Q1DidQ308*

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20084

%IOMEDICAL AND %E&AVIORAL RESEARC& I* T09 CURR9NT BRISON BOBUNATION

17M

A* De%o$ !)hics In its 2006 e)o t to the $o"e n%ent( the Institute of Medicine st!ted th!t the ) ison )o)u#!tion in the United St!tes h!s d !stic!##+ ch!n$ed o"e the #!st th ee dec!des*7 In the )!st thi t+ +e! s( the )o)u#!tion of ) isone s in the United St!tes h!s e.)!nded %o e th!n 4*M fo#d( co ection!# f!ci#ities ! e inc e!sin$#+ o"e c o,ded( !nd %o e of the count +/s dis!d"!nt!$ed )o)u#!tions- !ci!# %ino ities( ,o%en( )eo)#e ,ith %ent!# i##ness( !nd )eo)#e ,ith co%%unic!&#e dise!ses such !s hu%!n i%%unodeficienc+ "i us ;0IL</ !cHui ed i%%une deficienc+ s+nd o%e ;AIDS<( he)!titis C( !nd tu&e cu#osis-! e unde co ection!# su)e "ision* 8 The Institute !tt i&utes this st!tistic #! $e#+ to "i$o ous enfo ce%ent !nd sentencin$( notin$ th!t &et,een 1678 !nd 2004 the co ection!# )o)u#!tion in the United St!tes inc e!sed f o% 21*M %i##ion to !#%ost 7 %i##ion !s ! esu#t of tou$he sentencin$ #!,s !nd the ,! on d u$s*5 6 :hi#e the d!t! fo )e sons !ctu!##+ in ) isons !nd '!i#s is co%)! !&#e ;!n inc e!se f o% 24M4(444 to 2*1 %i##ion5<(10 the te % co ection!# )o)u#!tion e.tends &e+ond those ,ho ! e inc! ce !ted* 11 It enco%)!sses !## )o)u#!tions ,ho ! e unde co ection!# su)e "ision !nd in so%e ,!+ const !ined in thei #i&e ties(12 inc#udin$ those on ) o&!tion o )! o#e !nd those co%%itted to hos)it!#s o othe !#te n!ti"e institutions*13 Since 166M( the )o)u#!tion h!s dou&#ed fo those confined outside of ! '!i# f!ci#it+* 14 Tod!+( the e ! e %o e ,o%en !nd !ci!# %ino ities ente in$ the co ection!# s+ste%* 1M Eet,een 1680 !nd 1668( the nu%&e of fe%!#es in the co ection!# s+ste% inc e!sed f o% 13(400 to 84(400* 16 A#thou$h ! #! $e )e cent!$e of ,o%en in the co ection!# s+ste% ! e on ) o&!tion o )! o#e( the )o)u#!tion of inc! ce !ted fe%!#es $ e, &+ 134R &et,een 1660 !nd 2004*17 :ithin the co ection s+ste% the e is ! dis) o)o tion!te !%ount
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* INST* O@ M9D* O@ T09 NAT/N ACAD*( 9T0ICAN CONSID9RATIONS @OR R9S9ARC0 INLONLING BRISON9RS 1 ;N!, ence O* Gostin( No i L!nchie D And e, Bo)e eds*( 2006<( a#aila$le at htt)F//&oo>s*n!)*edu/o)en&oo>*)h)K eco dOidQ11662D)!$eQR1 3he ein!fte IOM4* 8 . Id. 6 . Id. !t 26* 10 . Id. 11 . Id. !t 30* 12 . Id. 13 . Id. ;e.)#!inin$ th!t !#te n!ti"e institutions inc#ude 2 estitution cente s( c!%)s( t e!t%ent f!ci#ities( !nd e#ect onic %onito in$ ) o$ !%s5<* 14 . Id. !t 32133* 1M . Id. !t 3M( 38* 16 . Id. !t 3M* 17 . Id. !t 36*

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176 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 of E#!c>s !nd 0is)!nics*18 2At %id+e! 2004( !n esti%!ted 12*6 )e cent of !## &#!c> %!#es( in thei #!te 20s ,e e in ) isons o '!i#s( co%)! ed ,ith 3*6 )e cent of his)!nic %!#es !nd 1*7 )e cent of ,hite %!#es*5 16 In %!n+ co ection!# f!ci#ities tod!+( the ) o"ision of he!#thc! e e%!ins su ) isin$#+ in!deHu!te*20 M!n+ co ection!# f!ci#ities #!c> the !&i#it+ to !dd ess conditions such !s di!&etes( h+)e tension( !nd !sth%!( !nd %!n+ h!"e not i%)#e%ented ) o$ !%s to !dd ess co%%unic!&#e dise!ses( ch onic dise!ses( o %ent!# i##ness*21 In so%e st!tes( inc#udin$ C!#ifo ni!( fede !# cou ts h!"e t!>en cont o# of such conditions* 2In ?u#+ 200M( ! fede !# 'ud$e o de ed th!t ! ecei"e t!>e cont o# of C!#ifo ni!/s ) ison he!#th c! e s+ste% !nd co ect ,h!t he c!##ed de)#o !&#e conditions th!t #ed to 64 unnecess! + in%!te de!ths e!ch +e! &ec!use of )oo %edic!# c! e*5 22 Si%i#! #+( in the 1680s( ) isone s in Southe n Michi$!n fi#ed ! #!,suit e$! din$ in!deHu!te he!#thc! e*23 As ! esu#t( ! fede !# 'ud$e too> cont o# of the ?!c>son Count+ ) ison( ! southe n Michi$!n Co ection!# Cente ( 24 ,he e ecent#+ ! t,ent+1one1+e! 1o#d %!n ,ho suffe ed f o% &i)o#! diso de ( de) ession( !nd !n.iet+ died of deh+d !tion* 2M 0is n!%e ,!s Ti%oth+ Soude s* 0e h!d &een )#!ced in so#it! + confine%ent &ec!use he too> ! sho,e ,ithout )e %ission*26 :hi#e in so#it! + confine%ent( he !tte%)ted to f#ood his ce##*27 As ! esu#t( the ,!te ,!s shut off in his ce## !nd he ,!s )ut in 2to) of &ed5 est !ints* 28 It ,!s #!te e"e!#ed th!t Soude s ,!s 2 est !ined fo st etches of 12 hou s( 16 hou s( !nd 17 hou s*526 Du in$ these )e iods of iso#!tion !nd est !int( the ) ison st!ff did not encou !$e Soude s to d in> ,!te *30 As ! esu#t( he died !t the !$e of t,ent+1one f o% deh+d !tion*31 Soude s h!d &een sentenced to se "e th ee to fi"e +e! s in the ?!c>son Count+ ) ison fo sho)#iftin$*32 0is %othe e)o ted th!t she #e! ned of his
18 16

. Id. !t 38* . Id. 20 . Id. !t M0* 21 . Id. !t M01M1* 22 . Id* !t M1* 23 . '( Minutes) T*e Deat* + Tim t*, S uders ;CES te#e"ision & o!dc!st !nd u)d!ted ?u#+ 17( 2007< ;t !nsc i)t<( htt)F//,,,*c&sne,s*co%/sto ies/2007/02/08/60%inutes/) int!&#e 2448074*sht%#* 24 . Id. 2M . Id. 26 . Id. 27 . Id. 28 . Id. 26 . Id. 30 . Id. 31 . Id. 32 . Id.

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 177 )s+cho#o$ic!# diso de 2#!te in his teen!$e +e! s*5 33 In e%iniscence( she e)o ted( 23i4t ,!s ?!nu! +( in the ,inte ti%e* And +ou >no,( he ,!s unnin$ ! ound outside ,ith his c#othes off( thin>in$ he ,!s ! >ni$ht( fi$htin$ d !$ons* Aou >no,( +ou #ose touch ,ith e!#it+*5 34 Soude s ,!s ne"e t e!ted fo his %ent!# i##ness ,hi#e in ) ison* 3M 9"en !fte st!&&in$ hi%se#f se"en ti%es in the sto%!ch( ! st!te )s+cho#o$ist s!id Soude s ,!s not %ent!##+ i## !nd ,!s %e e#+ t +in$ to %!ni)u#!te the st!ff*36 2Afte Soude s/ de!th( fede !# ?ud$e Rich! d 9ns#en( ,ho o"e sees the ) ison( , ote th!t in%!tes ! e e.)osed to !n =un!utho iSed de!th )en!#t+ !t the h!nds of ! c!##ous !nd d+sfunction!# he!#th c! e s+ste% th!t e$u#! #+ f!i#s to t e!t #ife1th e!tenin$ i##ness*/5 37 N!tion,ide( 2the e ! e 300(000 %ent!# )!tients &ehind &! s*538 In ) isons ,he e in%!tes do not h!"e !deHu!te he!#thc! e( the on#+ !ccess to t e!t%ent fo thei conditions %!+ &e ) o"ided &+ &io%edic!# o &eh!"io !# ese! ch t i!#s*36 0o,e"e ( %!n+ conce ns ! ise in the %!tte of ese! ch t i!#s usin$ ) isone su&'ects( inc#udin$ conce ns of coe cion( const !int( o e"en ,hethe ( &ec!use of )oo e!din$ !nd co%%unic!tions s>i##s( ! ) isone c!n e"en $i"e info %ed consent to )! t!>in$ in ese! ch* 40 Indeed( one of the ) edo%in!nt c iticis%s of the Institute of Medicine/s eco%%end!tions in"o#"es the %!tte of info %ed consent* The c iticis% ste%s f o% the &!sic ) e%ise th!t ese! che s c!nnot o&t!in info %ed consent f o% 2)eo)#e ,ho c!nnot %!>e thei o,n &!sic decisions !&out !n+thin$-food the+ ,i## e!t( c#othes the+ ,i## ,e! o ,hen the+ ,i## #e!"e*541 The Nu e%&e $ Code( fo %u#!ted !fte :o #d :! II !s ! esu#t of the Nu e%&e $ T i!#s( eHui es 2th!t the su&'ect =&e so situ!ted !s to &e !&#e to e.e cise f ee )o,e of choice( ,ithout the inte "ention of !n+ e#e%ent of fo ce( f !ud( deceit( du ess( o"e 1 e!chin$( o othe u#te io fo % of const !int o coe cion*/542 Asce t!inin$ ,hethe ! ) isone is e.e cisin$ ! f ee )o,e of choice is ! difficu#t t!s> fo ese! che s* M!n+ conditions ,ithin ! ) ison settin$ c!n !ffect ! ) isone /s !&i#it+ to $i"e f ee( info %ed consent( !nd not the #e!st of those %i$ht &e the in!deHu!c+ of ! cu ent he!#thc! e s+ste% to e!ch
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. Id. . Id. 3M . Id. 36 . Id. 37 . Id. 38 . Id. 36 * IOM( supra note 7( !t M1* 40 . Id. !t M8* 41 * Bostin$ of S! ! G!%& i## to Cente ,!tch C#inic!# T i!#s Tod!+( Pris ners As Stud, -V lunteers(. htt)F//,,,*c#inic!#t i!#stod!+*co%/cente ,!tchOc#inic!#Ot i!/2006/08/ ) isone sO !sO st*ht%# ;Au$* 17( 2006<* 42 * O0RB( supra note M( !t 1*

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178 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 th!t ) isone /s i%%edi!te %edic!# condition* If !ccess to %edic!# !ttention is 2%ini%!# o e"en none.istent( the #!c> of cont o# !##o,ed ) isone s !nd the desi e to o&t!in the !d"!nt!$es offe ed to those ,ho !$ ee to )! tici)!te %!+ ) ec#ude thei !&i#it+ to ,ei$h f!i #+ the is>s !nd &enefits in"o#"ed in )! tici)!tion*543 As B! t L of this Note ,i## discuss( the Institute of Medicine/s eco%%end!tions cou#d en!&#e ) isone s( inc#udin$ those ,ho cu ent#+ h!"e %ini%!# !ccess to he!#thc! e( to ) o"ide info %ed consent ) io to thei )! tici)!tion in &io%edic!# o &eh!"io !# ese! ch t i!#s* E* 0+)othetic!# B isone s @o )u )oses of distin$uishin$ cu ent e$u#!tions f o% the Institute of Medicine/s eco%%ended e$u#!tions( this Note ,i## int oduce the c!ses of th ee 2h+)othetic!#5 ) isone s* 9!ch of the ) isone s is in ! diffe ent situ!tion ,ithin the co ection!# s+ste%F inc! ce !tion( ) o&!tion( !nd co%%it%ent to !n !#te n!ti"e institution* The+ ! e con"icted of diffe ent c i%es( ! e se "in$ thei sentences in diffe ent ! e!s of the United St!tes( !nd ! e )#!$ued ,ith diffe ent %edic!# conditions* This Note ,i## efe to e!ch of the% th ou$hout to i##ust !te the effect th!t the cu ent !nd eco%%ended e$u#!tions h!"e !nd cou#d h!"e on thei )! tici)!tion in &io%edic!# !nd &eh!"io !# ese! ch* 1* ?!c> ?!c> is ! t,ent+1si.1+e! 1o#d 0is)!nic %!n* 0e d o))ed out of hi$h schoo# in the tenth $ !de !nd ne"e o&t!ined his G9D* 0e ,!s con"icted !nd inc! ce !ted in 200M fo !)in$ ! chi#d* Afte ! se.u!##+1d!n$e ous1 )e sons he! in$( ?!c> ,!s co%%itted to ! M!ss!chusetts ci"i# confine%ent f!ci#it+* :hi#e unde e"!#u!tion the e( ?!c> ,!s di!$nosed ,ith schiSo)h eni!*
SchiSo)h eni! is ! ch onic( se"e e( !nd dis!&#in$ & !in diso de * * * * Beo)#e ,ith schiSo)h eni! %!+ he! "oices othe )eo)#e don/t he! o the+ %!+ &e#ie"e th!t othe s ! e e!din$ thei %inds( cont o##in$ thei thou$hts( o )#ottin$ to h! % the%* These e.)e iences ! e te if+in$ !nd c!n c!use fe! fu#ness( ,ithd !,!#( o e.t e%e !$it!tion*44

SchiSo)h eni! c!n h!"e %!n+ s+%)to%s( inc#udin$ #oss of cont!ct ,ith e!#it+( h!##ucin!tions( de#usions( diso de ed thou$hts( %o"e%ent diso de s( !nd soci!# ,ithd !,!#*4M ?!c> f eHuent#+ e.)e iences h!##ucin!tions( diso de ed thou$hts( !nd soci!# ,ithd !,!#* 0e h!s ne"e )! tici)!ted in !n+ d u$ ese! ch t i!#s &ut
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Id. NAT/N INST* O@ M9NTAN 09ANT0( U*S* D9B/T O@ 09ANT0 D 0UMAN S9RL*( SC0ITOB0R9NIA 1 ;2007<( htt)F//,,,*ni%h*nih*$o"/he!#thinfo %!tion/schiSo)h eni!%enu* cf% 3he ein!fte NIM04* 4M . Id. !t 114*

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 176 h!s &eco%e inte ested in )! tici)!tin$ ,ith the ho)e of disco"e in$ ! t e!t%ent th!t ,i## he#) hi% co)e ,ith his %ent!# i##ness* 2* Ei## Ei## is ! fift+1one1+e! 1o#d ,hite %!#e* 0e $ !du!ted f o% hi$h schoo# !nd i%%edi!te#+ &e$!n ,o >in$ fo his f!the ( ,ho o,ned ! ch!in of con"enience sto esJ ,hen his f!the )!ssed !,!+( Ei## too> o"e the f!%i#+ &usiness* In 2004( ,hi#e Ei## ,!s d i"in$ ho%e unde the inf#uence of !#coho#( he #ost cont o# of his c! ( !nd s,e "ed off the o!d onto ! side,!#>* 0e >i##ed ! ,o%!n ,ho ,!s ,!#>in$ he do$ on the side,!#>* Ei## ,!s con"icted of in"o#unt! + %!ns#!u$hte !nd sentenced to se "e ten +e! s in ! C!#ifo ni! st!te ) ison* 0e ,!s inc! ce !ted !t the !$e of fo t+1nine* Ei## is !n !#coho#ic !nd ,!s di!$nosed ,ith he)!titis C !nd ci hosis of the #i"e !t the !$e of fo t+1th ee* 0e)!titis C is ! 2"i !# dise!se34 th!t !tt!c>3s4 the #i"e *5 46 Beo)#e infected ,ith he)!titis C ! e !t ! hi$he is> fo se"e e #i"e d!%!$e( ci hosis( !nd ! dec e!sed #ifes)!n( co%)! ed to indi"idu!#s ,ithout the "i us* 47 Ci hosis of the #i"e efe s to ! dec e!se in the !%ount of no %!# #i"e tissue !s ! conseHuence of ch onic #i"e dise!se* 48 It inte fe es ,ith the f#o, of &#ood th ou$h the #i"e 46 !nd h!ndic!)s the function of the #i"e ( ,hich( ,ith the #oss of no %!# #i"e tissue( #e!ds to f!i#u e of the #i"e to )e fo % so%e of its c itic!##+ i%)o t!nt functions*M0 Ei## h!s suffe ed e.tensi"e #i"e d!%!$e f o% his conditions !nd h!s e.)e ienced %!n+ of the s+%)to%s !ssoci!ted ,ith ci hosis( inc#udin$ f#uid &ui#d1u) in the !&do%en !nd #un$s( inte n!# &#eedin$( !nd >idne+ f!i#u e*M1 Ei## h!d &een )! tici)!tin$ in d u$ ese! ch t i!#s ) io to his inc! ce !tion to !dd ess &oth his !#coho# !&use !nd his %edic!# conditions* Unti# he sto)s d in>in$( he ,i## not &e e#i$i&#e fo ! #i"e t !ns)#!nt* 3* Nis! Nis! is ! fo t+1t,o1+e! 1o#d ,hite fe%!#e* Du in$ co##e$e( she &ec!%e he!"i#+ in"o#"ed ,ith d u$s !nd h!d difficu#t+ %!int!inin$ ! 'o& !fte $ !du!tion* In 200M( she ,!s con"icted of ) ostitution !nd d u$ )ossession* She is cu ent#+ on ) o&!tion in the st!te of Ne, Ao > fo fi"e +e! s* She "o#unt! i#+ "isits ! d u$1t e!t%ent cente on ! ,ee>#+ &!sis* She ,!s con"icted !t the !$e of fo t+* She tested )ositi"e fo 0IL !t the !$e of thi t+1se"en*
46 47

* IOM( supra note 7( !t M1* . Id. !t 42143* 48 * M!+oc#inic*co%( Di$esti"e S+ste%F Ci hosis( int o* ;?!n* 16( 2007<( htt)F//,,,* %!+oc#inic*co%/he!#th/ci hosis/DS00373* 46 . Id. M0 . Id. M1 . Id.

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180 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 0IL !tt!c>s the ce##s of the &od+/s i%%une s+ste%( dest o+s the &od+/s !&i#it+ to fi$ht infections( !nd %!+ e"entu!##+ #e!d to AIDS* M2 Tod!+( the e ! e o"e one %i##ion A%e ic!ns #i"in$ ,ith 0IL/AIDS( M3 &ut 23!4nti et o"i !# the !)ies !nd e$u#! !ccess to ) i%! + he!#th c! e 34 c!n he#) )eo)#e %!n!$e thei 0IL dise!se !nd #i"e #on$e *5M4 Nis! h!s st! ted to e.)e ience s+%)to%s !ssoci!ted ,ith the dise!se( inc#udin$ f!ti$ue !nd '!undice* She is te ified of the effect he i##ness ,i## h!"e on he in the futu e* She does not h!"e !ccess to !nti"i !# %edic!tions o ) i%! + he!#th c! e to %!n!$e he dise!se !nd s#o, the ) o$ ession f o% 0IL to AIDS* She h!s conside ed )! tici)!tin$ in ! d u$ ese! ch t i!#* II* ERI9@ 0ISTORA O@ B0ARMAC9UTICAN DRUG T9STING ON INMAT9S B io to 1678( ) isone s ,e e ,ide#+ used in &io%edic!# !nd &eh!"io !# ese! ch t i!#s 2,he e the+ ,e e )!id hund eds of do##! s ! %onth to test ite%s !s "! ied !s d!nd uff t e!t%ents !nd dio.in( !nd ,he e the+ ,e e e.)osed to !dio!cti"e( h!##ucino$enic !nd c! cino$enic che%ic!#s*5 MM 2In the e! #+ 16M0s( ne! #+ 100R of )! tici)!nts in Bh!se I c#inic!# t i!#s !c oss the United St!tes ,e e ) isone s(5 M6 !nd !s of 167M( 2!t #e!st 3600 ) isone s in the United St!tes ,e e used &+ d u$ co%)!nies !s the fi st hu%!ns on ,ho% the s!fet+ of ne, %edic!tion ,!s tested*5 M7 Unti# the 1670s( the )u&#ic ,!s neithe ,ide#+ info %ed of( no %uch conce ned ,ith( the %ist e!t%ent of hu%!n %edic!#1 ese! ch su&'ects in the United St!tes* M8 0o,e"e ( ! ound 1670( the e ,!s ! %!'o shift in )u&#ic !,! eness* M6 The Tus>e$ee S+)hi#is Stud+ !nd ! se ies of studies !t 0o#%es&u $ B ison t i$$e ed #oud )u&#ic outc + !$!inst the ho ific t e!t%ent of ) ison in%!tes !s %edic!#1 ese! ch su&'ects*60 The Tus>e$ee S+)hi#is Stud+ %!de he!d#ines in 1672* 61 It ,!s ! fede !##+ funded stud+ o $!niSed in :!shin$ton( D*C*( !nd conducted in

M2

* De)/t of 0e!#th D 0u%!n Se "*( E!sic 0IL/AIDS Info %!tion( AIDS*$o"( htt)F//,,,*!ids*$o"/&!sic/inde.*ht%# ;#!st "isited ?!n* 6( 2008<* M3 . Id. M4 . Id. MM * Sh! on! 0off%!n( %ene+i!ial and Unusual Punis*ment) An Argument in Supp rt + Pris ner Parti!ipati n in Clini!al Trials( 33 IND* N* R9L* 47M( 47M ;2000<* M6 . Id. !t 48M* M7 . Id. !t 486* M8 . Id. !t 488* M6 * ADLISORA COMM* ON 0UMAN RADIATION 9UB9RIM9NTS( D9B/T O@ 9N9RGA( @INAN R9BORT )t* 2( ch* 6 ;166M<( htt)F//,,,*hss*ene $+*$o"/he!#ths!fet+/oh e/ o!d%!)/!ch e/ ch!)6O4*ht%# 3he ein!fte AC0R9 R9BORT4* 60 * 0off%!n( supra note MM( !t 47M( 488* 61 * AC0R9 R9BORT( supra note M6*

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 181 M!con Count+( A#!&!%!*62 The stud+ &e$!n in 1632 !nd #!sted fo t+ +e! s*63 The )u )ose of the stud+ ,!s to ese! ch the effects of unt e!ted s+)hi#is in Af ic!n1A%e ic!n %en* 64 The %en ,ho en o##ed in the stud+ ,e e #! $e#+ i##ite !te !nd h!d no o))o tunit+ to $i"e info %ed consent* 2Afte &#ood tests of the "o#untee s( 366 %en ,ith s+)hi#is !nd ! cont o# $ ou) of 201 %en ,ithout the dise!se ,e e chosen* Eut the 366 ,e e not to#d the+ h!d s+)hi#is o th!t the+ ,e e no, )! t of ! %edic!# e.)e i%ent*56M 0und eds of the %en ,ho too> )! t in the stud+ ,e e #eft unt e!ted e"en !fte ! cu e ,!s disco"e ed( so th!t the ese! che s cou#d stud+ the cou se of the dise!se* 66 In essence( the )! tici)!nts ,e e used !s #!&o !to + s)eci%ens !nd suffe ed se ious conseHuences !s ! esu#t( inc#udin$ de!th*67 In 1667( B esident :i##i!% ?* C#inton !)o#o$iSed to the ei$ht su "i"in$ )! tici)!nts( thei f!%i#ies( !nd the A%e ic!n )u&#ic fo the Tus>e$ee S+)hi#is Stud+* 68 0e st!tedF
The United St!tes $o"e n%ent did so%ethin$ th!t ,!s , on$-dee)#+( ) ofound#+( %o !##+ , on$* It ,!s !n out !$e to ou co%%it%ent to inte$ it+ !nd eHu!#it+ fo !## ou citiSens* * * * No )o,e on 9! th c!n $i"e +ou &!c> the #i"es #ost( the )!in suffe ed( the +e! s of inte n!# to %ent !nd !n$uish* :h!t ,!s done c!nnot &e undone* Eut ,e c!n end the si#ence* :e c!n sto) tu nin$ ou he!ds !,!+* :e c!n #oo> !t +ou in the e+e !nd fin!##+ s!+ on &eh!#f of the A%e ic!n )eo)#e( ,h!t the United St!tes $o"e n%ent did ,!s sh!%efu#( !nd I !% so +* 66

Unethic!# %edic!# studies ,e e !#so conducted !t 0o#%es&u $ B ison( in Bhi#!de#)hi!F 2@ o% 16M1 to 1674( se"e !# fede !# !$encies !nd %o e th!n 30 co%)!nies used 0o#%es&u $ 3B ison4 fo e.)e i%ents( %ost#+ unde the !us)ices of the Uni"e sit+ of Benns+#"!ni!( ,hich h!d &ui#t #!&o !to ies !t the ) ison*570 Du in$ the 0o#%es&u $ studies( in%!tes ,e e )!id hund eds of do##! s ! %onth to )! tici)!te in ese! ch t i!#s* 71 2Mone+ ,!s !n i%)o t!nt su "i"!# too#5 in ) ison( !nd ) isone s ,e e %!>in$ !n+,he e

62

. Ne/s* ur /it* 0im Le*rer) An Ap l g, '1 2ears Late( ONNIN9 N9:S0OUR( ;BES te#e"ision & o!dc!st M!+ 16( 1667< ;t !nsc i)t<( htt)F//,,,*)&s*o $/ne,shou /&&/he!#th/ %!+67/tus>e$eeOM116*ht%#* 63 * U &in!( supra note 4* 64 * 0off%!n( supra note MM( !t 488* 6M . Ne/s* ur /it* 0im Le*rer) An Ap l g, '1 2ears Late( supra note 62* 66 * U &in!( supra note 4* 67 . Ne/s* ur /it* 0im Le*rer) An Ap l g, '1 2ears Late( supra note 62* 68 . Id. 66 * B ess Re#e!se( Office of the B ess Sec et! +( :hite 0ouse( B esident C#inton/s A)o#o$+ fo the Tus>e$ee S+)hi#is Stud+ ;M!+ 16( 1667<( htt)F//,,,* ese! ch*usf*edu/cs/ i &Odocs/c#inton!)o#o$+fo tus>e$ee*)df* 70 * U &in!( supra note 4* 71 . Id.

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182 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 f o% th ee do##! s u) to ei$ht hund ed do##! s* 72 M!n+ of the% )! tici)!ted in se"e !# studies !t one ti%e* 73 The ese! ch t i!#s tested "! ious ) oducts( f o% d!nd uff t e!t%ents to !dio!cti"e( h!##ucino$enic( !nd c! cino$enic che%ic!#s*74 B ison in%!tes ,ho )! tici)!ted in ese! ch t i!#s !t 0o#%es&u $ e.)e ienced se ious !nd )!infu# side effects f o% the ) oducts th!t ,e e tested on the%*7M A##en M* 0o n&#u%( !utho of A!res + S3in( inte "ie,ed ) isone s !t 0o#%es&u $ in o de to #e! n !&out thei e.)e iences ,hi#e )! tici)!tin$ in ese! ch t i!#s*76 One in%!te( ?ohnnie :i##i!%s( e)o ted th!t he too> )! t in 'ust !&out !n+ ese! ch t i!# th!t )!id ,e## &ec!use he needed the %one+ to )ost his &!i#*77 A#thou$h :i##i!%s ,!s !n e!$e )! tici)!nt( he ,!s !n$ + ,ith e.)e i%ente s fo not te##in$ hi% ,h!t ,!s e!##+ $oin$ on* 78
0e te##s of disco#o !tions on his fo e! % f o% ! 2%ic o,!"e #i$ht5 th!t &u ned hi%J e.)osu e to 2su#fu ic !cid !nd c! &o#ic !cid5J diet %i#>sh!>e tests !t ,hich he ,!s 2c!u$ht che!tin$5 !nd 2>ic>ed off5J )uttin$ his ! % in so#utions fo 2one hou o"e 30 st !i$ht d!+s5 unti# his 2s>in ,!s #i>e #e!the 5J !nd 2!cid5 u&&ed on his testic#es ,hi#e ! 2tin cu) 3,!s4 )#!ced unde ne!th to c!tch the &#iste ed s>in* * * * :e $ot V3 fo th!t test(5 he 3s!id4 disd!infu##+* 76

In di ect es)onse to the !&uses th!t ,e e disco"e ed !t 0o#%es&u $ B ison !nd du in$ the Tus>e$ee S+)hi#is Stud+( the N!tion!# Co%%ission fo the B otection of 0u%!n Su&'ects of Eio%edic!# !nd Eeh!"io !# Rese! ch ;the Co%%ission< ,!s founded*80 The Co%%ission ,!s c e!ted th ou$h the N!tion!# Rese! ch Act on ?u#+ 12( 1674( fo the )u )ose of de"e#o)in$ 2ethic!# $uide#ines fo the conduct of ese! ch in"o#"in$ hu%!n su&'ects !nd to %!>e eco%%end!tions fo the !))#ic!tion of such $uide#ines on ese! ch conducted o su))o ted &+ the De)! t%ent of 0e!#th( 9duc!tion !nd :e#f! e ;D09:<*5 81

72

* ANN9N M* 0ORNENUM( ACR9S O@ SCINF 0UMAN 9UB9RIM9NTS AT 0ONM9SEURG BRISON( 120121 ;1668<* 73 . Id. 74 * U &in!( supra note 4* 7M . Id. 76 * 0ORNENUM( supra note 72( !t 120121* 77 . Id. !t 121122* 78 . Id. !t 122* 76 . Id. !t 120* 80 * B otection of 0u%!n Su&'ects( 42 @ed* Re$* 3076 ;) o)osed ?!n* 14( 1677< ;codified !t 4M C*@*R* )t* 46<* 81 . Id.

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 183 III* CURR9NT @9D9RAN R9GUNATIONS GOL9RNING EIOM9DICAN AND E90ALIORAN R9S9ARC0 INLONLING BRISON9RS Afte e.tensi"e de#i&e !tions( the Co%%ission e"ised fede !# e$u#!tions $o"e nin$ !## hu%!n su&'ect ese! ch funded &+ the D09:* 82 Bu su!nt to the N!tion!# Rese! ch Act( the D09: ,!s eHui ed to )u&#ish the 2Re)o t !nd Reco%%end!tions5 of the Co%%ission !nd to de"e#o) notice of ) o)osed u#e1%!>in$ e$! din$ the ) o%u#$!tion of e$u#!tions ) o"idin$ !ddition!# ) otection fo ) isone s in"o#"ed in &io%edic!# !nd &eh!"io !# ese! ch*83 @in!# e$u#!tions ,e e )u&#ished in the Federal Register on No"e%&e 16( 1678*84 The e$u#!tions sti)u#!ted !ddition!# duties !nd eHui e%ents fo Institution!# Re"ie, Eo! ds ;IREs<( ) isone s( o e) esent!ti"es of ) isone s( !nd s)ecified the conditions unde ,hich ese! ch in"o#"in$ ) isone s is )e %itted* 8M The e$u#!tions ! e !))#ic!&#e to !## &io%edic!# !nd &eh!"io !# ese! ch conducted o su))o ted &+ the D09: in"o#"in$ ) isone s !s su&'ects* 86 The e$u#!tions ,e e ) o%u#$!ted fo the )u )ose of ) o"idin$ !ddition!# s!fe$u! ds fo the ) otection of ) isone s in"o#"ed in ese! ch funded o conducted &+ the D09:*87 The 1678 #!n$u!$e of the fin!# u#e defines the t+)e of ese! ch in"o#"in$ ) isone s th!t is )e %itted !sF
;!< Eio%edic!# o &eh!"io !# ese! ch conducted o su))o ted &+ D09: 34 in"o#"3in$4 ) isone s !s su&'ects on#+ ifF ;1< The institution es)onsi&#e fo the conduct of the ese! ch h!s ce tified to the Sec et! + th!t the Institution!# Re"ie, Eo! d h!s !)) o"ed the ese! ch * * *J !nd ;2< In the 'ud$%ent of the Sec et! + the ) o)osed ese! ch in"o#"es so#e#+ the fo##o,in$F ;A< Stud+ of the )ossi&#e c!uses( effects( !nd ) ocesses of inc! ce !tion( !nd of c i%in!# &eh!"io ( ) o"ided th!t the stud+ ) esents no %o e th!n %ini%!# is> !nd no %o e th!n incon"enience to the su&'ectsJ ;E< Stud+ of ) isons !s institution!# st uctu es o of ) isone s !s inc! ce !ted )e sons( ) o"ided th!t the stud+ ) esents no %o e
82

* O@@IC9 O@ 0UMAN SUE?9CTS R9S9ARC0( NAT/N INST* O@ 09ANT0( T09 E9NMONT R9BORTF 9T0ICAN BRINCIBN9S AND GUID9NIN9S @OR T09 BROT9CTION O@ 0UMAN SUE?9CTS O@ R9S9ARC0 ;1676<( htt)F//ohs *od*nih*$o"/$uide#ines/&e#%ont*ht%#* 83 * B otection of 0u%!n Su&'ects( 42 @ed* Re$* !t 3076* 84 * B otection of 0u%!n Su&'ects( 43 @ed* Re$* M3(6M2 ;No"* 16( 1678< ;codified !t 4M C*@*R* )t* 46<* 8M . Id. 86 . Id. !t M3(6MM ; efe in$ to 4M C*@*R* G 46*301<* 87 . Id. ; efe in$ to 4M C*@*R* G 46*302<*

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184

CRIMINAL AND CIVIL CONFINEMENT

3Lo#* 34F426

th!n %ini%!# is> !nd no %o e th!n incon"enience to the su&'ectsJ ;C< Rese! ch on conditions )! ticu#! #+ !ffectin$ ) isone s !s ! c#!ss ;fo e.!%)#e( "!ccine t i!#s !nd othe ese! ch on he)!titis ,hich is %uch %o e ) e"!#ent in ) isons th!n e#se,he eJ !nd ese! ch on soci!# !nd )s+cho#o$ic!# ) o&#e%s such !s !#coho#is%( d u$ !ddiction !nd se.u!# !ss!u#ts< ) o"ided th!t the stud+ %!+ ) oceed on#+ !fte the Sec et! + h!s consu#ted ,ith !)) o) i!te e.)e ts inc#udin$ e.)e ts in )eno#o$+ %edicine !nd ethics( !nd )u&#ished notice( in the Federal Register( of his intent to !)) o"e such ese! chJ o ;D< Rese! ch on ) !ctices( &oth inno"!ti"e !nd !cce)ted( ,hich h!"e the intent !nd e!son!&#e ) o&!&i#it+ of i%) o"in$ the he!#th o ,e##1&ein$ of the su&'ect* In c!ses in ,hich those studies eHui e the !ssi$n%ent of ) isone s in ! %!nne consistent ,ith ) otoco#s !)) o"ed &+ the IRE to cont o# $ ou)s ,hich %!+ not &enefit f o% the ese! ch( the stud+ %!+ ) oceed on#+ !fte the Sec et! + h!s consu#ted ,ith the !)) o) i!te e.)e ts( inc#udin$ e.)e ts in )eno#o$+ %edicine !nd ethics( !nd )u&#ished notice( in the Federal Register( of his intent to !)) o"e such ese! ch* ;&< 9.ce)t !s ) o"ided in )! !$ !)h ;!< of this section( &io%edic!# o &eh!"io !# ese! ch conducted o su))o ted &+ D09: sh!## not in"o#"e ) isone s !s su&'ects*88

IL* 9@@9CT O@ R9GUNATIONS BROMUNGAT9D IN 1678 B io to )u&#ishin$ thei fin!# u#es( the D09: so#icited es)onses f o% inte ested )! ties*86 At #e!st one es)ondent %!de !n i%)o t!nt o&se "!tion !&out ) o)osed G 46*302( ,hich st!tes th!t 2the )u )ose of this su&)! t is to ) o"ide !ddition!# s!fe$u! ds fo the ) otection of ) isone s in"o#"ed in ese! ch*560 The es)ondent st!tedF
3t4h!t the int oduction of !ddition!# ) otections ,ou#d %!>e it "i tu!##+ i%)ossi&#e fo ) isone s to )! tici)!te in ese! ch !nd th!t this uns counte to the )hi#oso)hic!# co ne stones of %ode n )eno#o$+* The 3 es)ondent4 ! $ued th!t )! tici)!tion in ese! ch ;1< educes the )e "!si"e id#eness of ) isone s( !nd ;2< encou !$es the !ssu%)tion of es)onsi&i#it+ on the )! t of the ) isone s fo thei !ctions !nd ,e#f! e* The 3 es)ondent4 fe#t th!t ese! ch )! tici)!tion shou#d &e encou !$ed(
88 86 60

. . .

Id. ; efe in$ to 4M C*@*R* G 46*306<* Id. !t M3(6M2* Id.

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20084

de"e#o)ed( !nd sust!ined*61

%IOMEDICAL AND %E&AVIORAL RESEARC&

18M

The D09: es)onded &+ st!tin$ 23t4esti%on+ $!the ed &+ the Co%%ission does not ef#ect $ene !# !$ ee%ent !%on$ )eno#o$ists th!t )! tici)!tion in ese! ch is !n !cce)t!&#e %e!ns to counte !ct undesi !&#e !s)ects of inc! ce !tion o to !ssist in the eh!&i#it!tion of ) isone s*5 62 In essence( the es)ondent/s !sse tion ,!s co ect in th!t the D09:/s ne, e$u#!tions se"e e#+ #i%ited ) isone )! tici)!tion in &io%edic!# !nd &eh!"io !# ese! ch*63 The on#+ situ!tion in ,hich ! ) isone %!+ )! tici)!te in such ese! ch is if D00S h!s dete %ined th!t the ese! ch is in the #on$1 !n$e inte est of ) isone s !s ! c#!ss !nd is !)) o"ed &+ the Sec et! + !fte consu#t!tion ,ith !)) o) i!te e.)e ts !nd )u&#ic!tion of notice in the Federal Register*64 B io to i%)#e%ent!tion of the 1678 e$u#!tions( ) isone s such !s ?!c>( Ei##( !nd Nis! cou#d )! tici)!te in !n+ fo % of &io%edic!# !nd &eh!"io !# ese! ch*6M The e ,e e no #i%it!tions e$! din$ thei )! tici)!tion( !nd the e ,e e !#so no e$u#!tions ) o"idin$ ) otection fo the%* 66 The #!c> of e$u#!tions enco%)!ssin$ ) otections fo ) isone )! tici)!nts c#e! #+ #eft the doo o)en fo !&use*67 B isone s #i>e ?!c>( Ei##( !nd Nis! ,ou#d h!"e )! tici)!ted unde the !ssu%)tion th!t the )u )ose of the ese! ch ,!s to find ! cu e o t e!t%ent fo dise!ses such !s schiSo)h eni!( he)!titis C( ci hosis( !nd 0IL( !nd th!t thei )! tici)!tion ,ou#d e!) so%e %edic!# &enefit* 0o,e"e ( %!n+ !ctu!# )! tici)!nts( such !s ?ohnnie :i##i!%s( 68 )! tici)!ted in ese! ch t i!#s th!t ,ou#d offe the% no %edic!# &enefit* The ) isone s !t 0o#%es&u $ B ison ,e e ne"e info %ed of ne$!ti"e side effects( ,hich inc#uded !n+thin$ f o% !##e $ic e!ction to de!th* 66 In so%e situ!tions( ese! che s !ctu!##+ inocu#!ted ) isone s ,ith s)ecific dise!ses to 2e#ucid!te the n!tu !# histo + of these dise!ses !nd to de"e#o) "!ccines !nd "! ious the !)ies fo the%*5 100 Not on#+ ,e e ) isone s e.)e iencin$ se"e e side effects of &io%edic!# d u$s ,ithout e!)in$ !n+ %edic!# &enefits( &ut the+ ,e e cont !ctin$ dise!ses to ,hich the+ ,ou#d othe ,ise
61 62

. Id. . Id. !t M3(6M21M3* 63 * C i%in!# N!, N!,+e Sou ce( Panel Re! mmends Inmates + r Drug Trials ( htt)F//,,,*c i%in!#1#!,1#!,+e 1sou ce*co%/! tic#es/in%!tesOd u$Ot i!#*ht%# ;#!st "isited @e&* 26( 2007<* 64 * 4M C*@*R* G 46*306 ;2007<* 6M . See 0off%!n( supra note MM( !t 47M177* 66 . See id. 67 . See id. 68 . See 0ORNENUM( supra note 72( !t 120122* 66 . See Ne/s* ur /it* 0im Le*rer) An Ap l g, '1 2ears Late( supra note 62J U &in!( supra note 4* 100 * ROE9RT ?* N9LIN9( 9T0ICS AND R9GUNATION O@ CNINICAN R9S9ARC0 28M ;2d ed*( A!#e Uni"* B ess 1688<*

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186 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 ne"e h!"e &een e.)osed*101 The 1678 D09: e$u#!tions ,e e desi$ned to e#i%in!te !## such !&uses* Unde these e$u#!tions( ho,e"e ( ! ) isone /s !&i#it+ to )! tici)!te in &io%edic!# !nd &eh!"io !# ese! ch ,!s se"e e#+ #i%ited* 102 A#thou$h ) isone s ,e e ) otected f o% the )otenti!# !&uses of hu%!n1su&'ect ese! ch( the+ ,e e !#so e.c#uded f o% the )otenti!# &enefits of ese! ch* @u the ( 2the e!ch of the 3cu ent4 e$u#!tions to ) otect ) isone s in"o#"ed in ese! ch does not e.tend to the "!st %!'o it+ of ) isone ese! ch )! tici)!nts*5103 On#+ se"enteen de)! t%ents !nd !$encies of the fede !# $o"e n%ent h!"e !do)ted the e$u#!tions ) o%u#$!ted &+ the D09: in 1678*104 Thus( e$u#!tions $o"e nin$ ) isone )! tici)!tion in ese! ch in the United St!tes ! e not unifo %* 10M Unde cu ent e$u#!tions( ?!c> !nd Ei## ! e e.c#uded f o% )! tici)!tin$ in fede !##+ funded &io%edic!# !nd &eh!"io !# ese! ch un#ess it is ese! ch th!t focuses on ) isone s !s ! c#!ss !nd h!s &een !)) o"ed &+ the Sec et! + !fte consu#tin$ !)) o) i!te e.)e ts !nd )u&#ishin$ ! notice in the Federal Register*106 ?!c> !nd Ei## ! e e.c#uded &ec!use the+ fit into the definition of 2) isone 5 unde cu ent e$u#!tions( ,hich is defined !s 2!n+ indi"idu!# in"o#unt! i#+ confined o det!ined in ! )en!# institution5 107 !nd 2enco%)!ss3es4 indi"idu!#s sentenced to such !n institution unde ! c i%in!# o ci"i# st!tute5108 !nd indi"idu!#s det!ined in f!ci#ities th!t ! e used !s 2!#te n!ti"es to c i%in!# ) osecution o inc! ce !tion*5 106 Ei## h!s &een sentenced to !n institution unde ! c i%in!# st!tute( !nd ?!c> is in ci"i# confine%ent in ! hos)it!# th!t t e!ts )eo)#e ,ith %ent!# i##ness( !s !n !#te n!ti"e to inc! ce !tion* A#thou$h cu ent e$u#!tions indeed %!+ ) otect ?!c> !nd Ei## f o% !&uses in the conduct of ese! ch in the ) ison settin$( the+ !#so e.c#ude ?!c> !nd Ei## f o% the )otenti!# &enefits of ese! ch* ?!c> ,i## suffe &ec!use he is co%%itted to ! hos)it!#( )otenti!##+ fo #ife( !nd un#ess the e is ! ese! ch t i!# th!t focuses on ) isone s ,ith schiSo)h eni! !s ! c#!ss( he %!+ ne"e &e !&#e to )! tici)!te in ese! ch t i!#s th!t cou#d t e!t o cu e his condition*110 Ei## ,i## !#so suffe * B io to inc! ce !tion( Ei## ,!s
101 102

. See id. . See B otection of 0u%!n Su&'ects( 43 @ed* Re$* M3(6M2 ;No"* 16( 1678< ;codified !t 4M C*@*R* )t* 46<* 103 * IOM( supra note 7( !t 66* 104 . Id. !t 74* 10M . See id. 106 * B otection of 0u%!n Su&'ects( 43 @ed* Re$* !t M3(6M2 ; efe in$ to 4M C*@*R* G 46*306<* 107 * 4M C*@*R* G 46*301 ;2007<* 108 . Id. 106 . Id. 110 . See 4M C*@*R* G 46*306 ;2007<*

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 187 )! tici)!tin$ in ! fede !##+ funded ese! ch t i!# fo indi"idu!#s ,ith he)!titis C* A#thou$h %!n+ ) isone s ! e infected ,ith he)!titis C( the t i!# in ,hich Ei## ,!s )! tici)!tin$ ,!s not $e! ed to,! d t e!tin$ ) isone s ,ith he)!titis C !s ! c#!ss* The efo e( unde cu ent e$u#!tions( Ei##/s )! tici)!tion is %ost #i>e#+ ) ohi&ited*111 This %!+ c!use hi% to suffe side effects f o% the te %in!tion of ce t!in d u$s he ,!s t!>in$ du in$ his )! tici)!tion* @u the %o e( Ei##/s condition %!+ !ctu!##+ ,o sen un#ess he c!n find ! ese! ch stud+ to )! tici)!te in th!t focuses on ) isone s ,ith he)!titis C !s ! c#!ss*112 ?!c> !nd Ei## %!+ sti## see the )otenti!# &enefits !ssoci!ted ,ith &io%edic!# !nd &eh!"io !# ese! ch th!t is n t fede !##+ funded( &ec!use ese! ch th!t is not fede !##+ funded does not f!## ,ithin the )u "ie, of cu ent e$u#!tions !nd does not enco%)!ss ) otections fo ) ison )! tici)!nts*113 :hen ) isone s )! tici)!te in ese! ch th!t is not fede !##+ funded( the+ is> &eco%in$ ! "icti% of unethic!# ese! ch !nd %!+ &e e.)osed to the s!%e !&uses th!t e.isted ) io to the ) o%u#$!tion of fede !# e$u#!tions*114 Nis! does not fit into the definition of 2) isone 5 unde cu ent e$u#!tions*11M The definition does not enco%)!ss those ,ho ! e on ) o&!tion o )! o#e*116 Unde cu ent e$u#!tions( Nis! is )e %itted to )! tici)!te in !n+ fo % of &io%edic!# !nd &eh!"io !# ese! ch( inc#udin$ fede !##+ funded ese! ch*117 A#thou$h she %!+ &enefit f o% he )! tici)!tion( she is not ) otected &+ fede !# e$u#!tions* 118 L* T09 INSTITUT9 O@ M9DICIN9/S R9COMM9NDATIONS @OR R9LISING R9GUNATIONS On Au$ust 1( 2006( the Institute of Medicine/s Co%%ittee on 9thic!# Conside !tions fo Re"isions to the D00S Re$u#!tions fo B otection of B isone s In"o#"ed in Rese! ch ;the Co%%ittee< su&%itted its e)o t to the $o"e n%ent e$! din$ &io%edic!# !nd &eh!"io !# ese! ch in"o#"in$ ) isone s*116 In its e)o t( the Co%%ittee ) o)osed to #oosen ce t!in e$u#!tions ,hi#e !ddin$ fu the ) otections &+ e.)!ndin$ the defined )o)u#!tion of ) isone s !nd &+ eco%%endin$ !ddition!# s!fe$u! ds* 120 The Co%%ittee/s e)o t ,!s su))o ted &+ the N!tion!# Ac!de%+ of Sciences(
111 112 113 114 11M 116 117 118 116 120

. . . . * . . . * *

See id. See id. See id. See U &in!( supra note 4* 4M C*@*R* G 46*301 ;2007<* Id. See 4M C*@*R* G 46*306 ;2007<* See id. U &in!( supra note 4* IOM( supra note 7( !t 4*

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188 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 D00S( !nd the N!tion!# Institute of 0e!#th121 !nd ,!s !)) o"ed &+ the N!tion!# Rese! ch Counci#*122 The Co%%ittee/s ese! ch is i%)o t!nt not on#+ in the fo %u#!tion of %o e1en#i$htened ) ison )o#ic+ &ut fo the desi$n of &enefits !nd ) otections to ) isone s !s ,e##*123 The Co%%ittee !c>no,#ed$ed th!t a!!ess to ese! ch %!+ &e the c uci!# fi st ste) in i%) o"in$ ) isone s/ he!#th !nd the conditions in ,hich the+ #i"e* 124 0o,e"e ( the Co%%ittee !#so eco$niSed th!t ese! ch cou#d i%)ose un!cce)t!&#e is>s on ) isone s !nd th!t the e ! e se ious conce ns !&out coe cion in the ) ison en"i on%ent*12M The Co%%ittee ) o)osed the $o!# of &!#!ncin$ scientific!##+ i$o ous ese! ch ,ith ethic!##+ !)) o) i!te t e!t%ent of ) isone s126 &+ t!>in$ into !ccount )! ticu#! ) isone histo +( de%o$ !)h+( "u#ne !&i#it+( !nd the est ictions of ) isone f eedo%s $ene !##+* 127 The Co%%ittee/s t!s> ,!s to e"ie, ethic!# issues e$! din$ ese! ch in"o#"in$ ) isone s !nd to co%)i#e ! e)o t to su&%it to D00S indic!tin$ ,hethe cu ent e$u#!tions shou#d &e e"ised* 128 The %!'o issue the+ !dd essed in e"ie,in$ ethic!# issues ,!s ,hethe the conc#usions e!ched thi t+ +e! s e! #ie &+ the N!tion!# Co%%ission fo the B otection of 0u%!n Su&'ects of Eio%edic!# !nd Eeh!"io !# Rese! ch e%!in !)) o) i!te tod!+* 126 The Co%%ittee dete %ined th!t !#thou$h the ethic!# ) inci)#es ! ticu#!ted &+ the Co%%ission in 1676 ! e sti## #! $e#+ !))#ic!&#e( the fede !# s+ste% of hu%!n su&'ect ) otections is deficient* 130
S)ecific!##+( the Co%%ittee ,!s !s>ed toF ;1< conside ,hethe the ethic!# &!ses fo ese! ch ,ith ) isone s diffe f o% those fo ese! ch ,ith non) isone s( ;2< de"e#o) !n ethic!# f !%e,o > fo the conduct of ese! ch ,ith ) isone s( ;3< &!sed on the ethic!# f !%e,o > de"e#o)ed( identif+ conside !tions o s!fe$u! ds necess! + to ensu e th!t ese! ch ,ith ) isone s is conducted ethic!##+( !nd ;4< identif+ issues !nd needs fo futu e conside !tion !nd stud+*131

In o de to !dd ess these %!tte s s)ecific!##+ !nd !tt!in its $o!# of )e %ittin$ scientific!##+ i$o ous ese! ch to the e.tent th!t it confe s
121 122 123 124 12M 126 127 128 126 130 131

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Id. !t ii* Id. Id. !t i.* Id. !t .1.i* Id. !t i.* Id. Id. Id. Id. Id. !t .i* Id. !t .i1.ii*

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 186 si$nific!nt &enefit ,ithout undue is>( 132 the Co%%ittee eco%%ends fi"e )! !di$%!tic ch!n$esF ;1< to 2e.)!nd the definition of pris ner to inc#ude ! %uch #! $e )o)u#!tion of )e sons ,hose #i&e t+ is est icted &+ "i tue of sentence( ) o&!tion( )! o#e( o co%%unit+ )#!ce%entJ5 133 ;2< to 2ensu e uni"e s!#( consistent st!nd! ds of ) otection so th!t s!fe$u! ds &!sed on sound ethic!# "!#ues !))#+ to ) isone ese! ch i es)ecti"e of the sou ce of fundin$J5134 ;3< to 2shift f o% ! c!te$o +1&!sed to ! is>1&enefit !)) o!ch to definin$ ethic!##+ !cce)t!&#e ese! ch so th!t ) isone s ! e ne"e e.)osed to ese! ch un#ess the e is ! distinct#+ f!"o !&#e &enefit1to1 is> !tioJ513M ;4< to 2u)d!te the ethic!# f !%e,o > est!&#ished &+ the Co%%ission to inc#ude co##!&o !ti"e es)onsi&i#it+-the conce)t th!t ese! ch shou#d &e conducted in %e!nin$fu# co##!&o !tion ,ith the >e+ st!>eho#de s-not!&#+ ) isone s !nd ) ison st!ffJ5 136 !nd ;M< to 2enh!nce s+ste%!tic o"e si$ht of ese! ch in"o#"in$ ) isone s so th!t hu%!n su&'ect ) otections ! e %o e i$o ous !nd %o e e#i!&#e th!n those th!t e.ist unde the e.istin$ institution!# e"ie, &o! d %ech!nis%*5 137 A* 9.)!ndin$ the Definition of 2B isone 5 to Inc#ude ! %uch N! $e Bo)u#!tion of Be sons :hose Ni&e t+ is Rest icted &+ Li tue of Sentence( B o&!tion( B! o#e o Co%%unit+ B#!ce%ent 2The $o!# of this definition is to e.)!nd the e!ch of the e$u#!to + ) ocedu es !nd o"e si$ht %ech!nis%s * * * to the fu##e )o)u#!tion of indi"idu!#s ,ho ! e unde est icted #i&e t+* * * *5 138 Indi"idu!#s ,hose #i&e t+ is est icted 2f!ce )otenti!##+ $ e!te is>s th!n the $ene !# )o)u#!tion ,hen )! tici)!tin$ in ese! ch*5136 The found!tion of ethic!# ese! ch ests on es)ect fo )! tici)!nts !nd the 'ust dist i&ution of &enefits !nd is>s*140 Res)ect fo )! tici)!nts is e!ched th ou$h o&t!inin$ thei f ee !nd info %ed consent ) io to )! tici)!tion* 141 2In the conte.t of ese! ch in"o#"in$ ) isone s( 'ustice eHui es th!t ) isone s not &e! ! dis) o)o tion!te sh! e of the ese! ch &u den ,ithout ! co%%ensu !te sh! e of &enefit( !nd !#so th!t ) isone s h!"e the f eedo% to decide Huestions of ese! ch )! tici)!tion fo the%se#"es*5 142 If the definition of 2) isone 5 is ch!n$ed to enco%)!ss !## indi"idu!#s
132 133 134 13M 136 137 138 136 140 141 142

. . . . . . . . . . .

Id. !t .i* Id. Id. Id. Id. Id. Id. !t 101* Id. Id. !t 101102* Id. !t 102* Id.

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160 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 ,ho ! e unde est icted #i&e t+( then !## indi"idu!#s in the co ection!# s+ste%( inc#udin$ ?!c>( Ei##( !nd Nis!( ,ou#d h!"e !"!i#!&#e to the% the )otenti!# &enefits of ese! ch !nd the ) otections c e!ted th ou$h e$u#!tions* Unde cu ent e$u#!tions( ?!c> !nd Ei## ! e ) otected on#+ in thei )! tici)!tion ,ith fede !##+ funded ese! ch* 143 @u the %o e( thei !&i#it+ to )! tici)!te in fede !##+ funded ese! ch is #i%ited* 144 If the definition of 2) isone 5 is ch!n$ed( ?!c> !nd Ei## ,ou#d &e !&#e to )! tici)!te in %o e ese! ch t i!#s &ut ,ou#d sti## en'o+ the ) otections the+ ! e !ffo ded unde cu ent e$u#!tions* 14M Si%i#! #+( unde cu ent e$u#!tions( Nis!( ,ho is on ) o&!tion( h!s !ccess to ! "! iet+ of ese! ch t i!#s &ut is not !ffo ded !n+ of the ) otections of such e$u#!tions* 146 If the definition is ch!n$ed( Nis! ,i## sti## h!"e !ccess to ! "! iet+ of ese! ch t i!#s &ut ,i## !#so &e ) otected &+ fede !# e$u#!tions* 147 E* 9nsu e Uni"e s!#( Consistent St!nd! ds of B otection so th!t S!fe$u! ds E!sed on Sound 9thic!# L!#ues A))#+ to B isone Rese! ch I es)ecti"e of the Sou ce of @undin$ The Co%%ittee e)o ts th!t 23!4## hu%!n su&'ects ese! ch in"o#"in$ ) isone s shou#d &e e$u#!ted &+ the s!%e ethic!# st!nd! ds i es)ecti"e of sou ce of fundin$( su))o tin$ !$enc+( o t+)e of co ection!# f!ci#it+ ;fede !#( st!te( #oc!#( o ) i"!te< o ) o$ !% th!t houses the ) isone *5 148 This %e!ns th!t once e$u#!tions ! e ed !fted to inco )o !te the Co%%ittee/s eco%%end!tions( the+ ,ou#d !))#+ to all &io%edic!# !nd &eh!"io !# ese! ch t i!#s in"o#"in$ ) isone s* 146 The Co%%ittee finds no 'ustific!tion fo not h!"in$ unifo % e$u#!tions th!t ) otect 2the i$hts( he!#th( !nd di$nit+ of ) isone s )! tici)!tin$ in hu%!n su&'ects ese! ch*51M0 Once unifo % $uide#ines ! e i%)#e%ented( the Co%%ittee eco%%ends ese! che s %!int!in ! n!tion!# )u&#ic d!t!&!se ,ith info %!tion !&out the !%ount !nd t+)e of ese! ch usin$ ) isone s !s su&'ects*1M1 Cu ent#+( no cent !# d!t!&!se e.ists cont!inin$ 2info %!tion !&out the !%ount !nd t+)e of ese! ch ,ith ) isone s !s su&'ects*5 1M2 Cee)in$ t !c> of the !%ount !nd t+)es of ese! ch usin$ ) isone s ,ou#d not on#+ & in$ to #i$ht !n+ ese! ch th!t %i$ht &e ethic!##+ unsound( &ut
143 144 14M 146 147 148 146 1M0 1M1 1M2

. . . . . . . . . .

See supra te.t !cco%)!n+in$ notes 106112* See supra te.t !cco%)!n+in$ notes 106112* See IOM( supra note 7( !t 102* See supra te.t !cco%)!n+in$ notes 11M118* See IOM( supra note 7( !t 102* Id. !t 6* Id. Id. !t 7* Id. Id.

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 161 !#so hi$h#i$ht ese! ch th!t $ e!t#+ &enefits )! tici)!tin$ ) isone s* 1M3 If this eco%%end!tion is inco )o !ted into cu ent e$u#!tions( ) isone s such !s ?!c>( Ei##( !nd Nis! ,ou#d e!ch h!"e !ccess to the s!%e !%ounts !nd t+)es of ese! ch usin$ ) isone s !s su&'ects( e$! d#ess of the sou ce of fundin$*1M4 Be h!)s e"en %o e i%)o t!nt( the eco%%ended n!tion!# d!t!&!se ,ou#d en!&#e ese! che s !nd the $ene !# )u&#ic to !ccess info %!tion such !s 2,ho is conductin$ ese! ch ,ith ,h!t su))o t( ,ith ,h!t >ind of ese! ch on ,h!t )o)u#!tions( !nd the n!tu e !nd e.tent of ethic!# o"e si$ht ) o"ided*51MM Such ! d!t!&!se ,ou#d e.)ose )otenti!##+ unethic!# ) otoco#s !nd sh! )#+ #i%it the is> of studies th!t &e! !n+ ese%&#!nce to the 0o#%es&u $ B ison Stud+ o the Tus>e$ee S+)hi#is Stud+* 1M6

C* Shift f o% ! C!te$o +1E!sed to ! Ris>1Eenefit A)) o!ch to Definin$ 9thic!##+ Acce)t!&#e Rese! ch so th!t B isone s A e Ne"e 9.)osed to Rese! ch Un#ess The e is ! @!"o !&#e Eenefit1 Ris> R!tio The Institute of Medicine/s eco%%ended is>1&enefit !)) o!ch ,ou#d 2;1< focus on the )otenti!# &enefits !nd h! %s of e!ch su$$ested ese! ch ) otoco#( !nd ;2< identif+ the )! ticu#! ethic!# issues th!t e!ch ) otoco# !ises in the s)ecific conte.t of the co ection!# settin$*5 1M7 The Co%%ittee su$$ests th!t ! 2 is>1&enefit !)) o!ch shou#d !))#+ to !## t+)es of ese! ch51M8 !nd !s the 2 is>1&enefit sc!#e ti#ts %o e to,! d is>(5 1M6 ) otections shou#d inc e!se*160 Unde this !)) o!ch( ese! ch th!t cou#d offe no &enefit to ) isone )! tici)!nts ,ou#d &e e.c#uded out i$ht* 161 Thus( 2Bh!se 1 !nd 2 studies( !s defined &+ the @ood !nd D u$ Ad%inist !tion ;@DA<( fo e.!%)#e( ,ou#d not &e !##o,!&#e &ec!use s!fet+ !nd effic!c+ ! e not +et c#e! in these e! #+ )h!ses of &io%edic!# ese! chJ the efo e( is> ,ou#d o"e sh!do, )otenti!# &enefit*5 162 The Co%%ittee ) o)oses th!t &io%edic!# ese! ch in"o#"in$ ) isone s is ethic!##+ !cce)t!&#e in t,o n! o, ci cu%st!ncesF
1M3 1M4 1MM 1M6 1M7 1M8 1M6 160 161 162

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Id. Id. Id. Id. Id. !t 8* Id. Id. Id. Id. Id.

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162

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1* In no %!# ci cu%st!nces( ! &io%edic!# ese! ch stud+ %!+ &e ethic!##+ !cce)t!&#e ifF fo ese! ch on ne, the !)ies o ) e"enti"e %e!su es( the e is !# e!d+ so%e e"idence of s!fet+ !nd effic!c+( !s in Bh!se 3 testin$ fo ne, d u$s( !s defined &+ the @DAJ !nd the !tio of ) isone to non1) isone su&'ects does not e.ceed M0 )e cent* 2* In e.ce)tion!# ci cu%st!nces( ! &io%edic!# ese! ch stud+ %!+ &e ethic!##+ !cce)t!&#e e"en if the &enefit of !n inte "ention h!s not &een co%)#ete#+ est!&#ished( o if the ese! ch )o)u#!tion is dis) o)o tion!te#+ co%) ised of ) isone s*163

Unde this is>1&enefit !)) o!ch( ?!c>( Ei##( !nd Nis! ,ou#d &e !&#e to )! tici)!te in studies( inc#udin$ &io%edic!# studies ;e*$*( ese! ch on ne, the !)ies !nd d u$s<( !s #on$ !s the e ,!s e"idence of s!fet+* 164 2Gi"en the histo + of !nd continued )otenti!# fo ) isone e.)#oit!tion( &io%edic!# ese! ch shou#d &e )e %itted on#+ if the e is ! st on$#+ f!"o !&#e &enefit1 is> !tio fo the ) isone *5 16M This eco%%end!tion e%)h!siSes the f!i dist i&ution of &enefits !nd &u dens !%on$ su&'ects( !nd the conside !tion of )otenti!# &enefits to the 2indi"idu!#5 ) isone su&'ect( !the th!n to the c#!ss $ene !##+* 166 In the h+)othetic!# c!ses of ?!c>( Ei##( !nd Nis!( the )otenti!# &enefits !nd is>s of ! ese! ch t i!# ,ou#d &e !ssessed indi"idu!##+ fo e!ch of the% &efo e the+ cou#d )! tici)!te*167 :he e )! tici)!tion in ! $i"en t i!# %i$ht &e !)) o) i!te fo one indi"idu!#( it %!+ &e co%)#ete#+ in!)) o) i!te fo !nothe * B io to his inc! ce !tion( Ei## ,!s )! tici)!tin$ in ! ese! ch t i!# fo ! d u$ c!##ed A#&ufe on( ! )otenti!# t e!t%ent fo ch onic he)!titis C* Its ese! che s su$$ested th!t 2A#&ufe on ,i## ) o"ide 3he)!titis4 )!tients ,ith t e!t%ent o)tions th!t ! e %o e con"enient !nd ho)efu##+ h!"e fe,e side effects*5168 D!t! su$$ested th!t A#&ufe on 2cou#d offe he)!titis C )!tients ! the !)eutic o)tion eHui in$ h!#f !s %!n+ in'ections 3of othe d u$s4( ,ith the )otenti!# fo #ess i%)!i %ent of he!#th1 e#!ted Hu!#it+ of #ife( !nd sust!ined "i o#o$ic es)onse* * * *5 166 Bh!se 3 t i!#s of A#&ufe on ! e !# e!d+
163 164

. Id. !t 816* . See id. !t 6* 16M . Id. 166 . Id. 167 . Id. 168 * M!+o C#inic( &epatitis C Patients O++ered Ne/ & pe /it* Drug Trial + Al$u+er n( Dec* 16( 2004( htt)F//,,,*%!+oc#inic*o $/ne,s20041sct/2M42*ht%#* 166 * 0u%!n Geno%e Sciences( Al$u+er n) & / Al$u+er n 4 r3s ;Dec* 11( 2007<(

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 163 unde ,!+* 170 A#thou$h c#inic!# t i!#s fo A#&ufe on ! e ,e## >no,n fo thei s!fet+ !nd effic!c+(171 it is un#i>e#+ th!t Ei## ,i## &e !&#e to )! tici)!te in ! fede !##+ funded Bh!se 3 c#inic!# t i!# fo A#&ufe on !s e$u#!tions cu ent#+ st!nd* Unde cu ent e$u#!tions( Ei## c!nnot )! tici)!te in ! fede !##+ funded Bh!se 3 &io%edic!# stud+ un#ess it focuses on ) isone s !s ! c#!ss* 172 Unde the eco%%ended e$u#!tions( ho,e"e ( not on#+ ,ou#d Ei## &e !&#e to )! tici)!te in &io%edic!# Bh!se 3 studies if the &enefit to the indi"idu!# out,ei$hs the is>(173 &ut he ,ou#d !#so &e ) otected ,hethe the stud+ is fede !##+ o ) i"!te#+ funded* 174 As ) e"ious#+ %entioned( unde cu ent e$u#!tions( ) isone s ! e not !ffo ded !n+ fede !# ) otections fo )! tici)!tion in ) i"!te#+ funded ese! ch*17M ?!c> !nd Nis! h!d not )! tici)!ted in !n+ c#inic!# t i!#s ) io to )#!ce%ent unde co ection!# su)e "ision* ?!c> !nd Nis! h!"e "e + se ious %edic!# conditionsF schiSo)h eni! !nd 0IL( es)ecti"e#+* Unde cu ent e$u#!tions( Nis! c!n )! tici)!te in %!n+ ese! ch t i!#s &ec!use she is on ) o&!tion !nd does not fit the cu ent definition of 2) isone *5 176 Unde eco%%ended e$u#!tions( she ,ou#d si%)#+ &e !ffo ded $ e!te ) otections ,hen )! tici)!tin$ in ese! ch t i!#s &ec!use !## ese! ch ,ou#d &e e$u#!ted( no %!tte ,h!t the sou ce of fundin$( !nd he indi"idu!# &enefits !nd is>s ,i## &e !ssessed ) io to he )! tici)!tion* 177 Un#i>e Ti%oth+ Soude s(178 ?!c> is fo tun!te to &e in ci"i# confine%ent unde the su)e "ision of he!#thc! e ) ofession!#s( !the th!n in ) ison( ,ith his di!$nosis of schiSo)h eni!* 0o,e"e ( unde cu ent e$u#!tions( ?!c> is e.c#uded f o% fede !##+ funded &io%edic!# ese! ch t i!#s th!t do not focus on ) isone s !s ! c#!ss( 176 !nd he is not $u! !nteed !n+ ) otections !t !## if he )! tici)!tes in ) i"!te#+ funded ese! ch t i!#s* 180 A#thou$h in his cu ent situ!tion he %!+ &e in ! &ette )osition to !ccess %edic!# c! e th!n ! e %ent!##+ i## indi"idu!#s in ) isons( he sti## cou#d &enefit f o% &ein$ %!de e#i$i&#e fo ce t!in &io%edic!# t i!#s* M!n+ studies( &oth fede !##+ !nd ) i"!te#+ funded( ! e cu ent#+ &ein$
htt)F//,,,*h$si*co%/!#&ufe on*ht%# ;) o"idin$ the co%)!n+/s ) oduct info %!tion fo A#&ufe on<* 170 . Id. 171 . See id. 172 * 4M C*@*R* G 46*306 ;2007<* 173 . See IOM( supra note 7( !t 6110* 174 . Id. !t 6* 17M . See 4M C*@*R* G 46* 176 . See supra te.t !cco%)!n+in$ notes 11M118* 177 . See IOM( supra note 7( !t 6110* 178 . See '( Minutes) T*e Deat* + Tim t*, S uders( supra note 23* 176 * 4M C*@*R* G 46*306* 180 . See IOM( supra note 7( !t 6*

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164 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 conducted in the se! ch to t e!t o ) e"ent schiSo)h eni!* 181 Anti)s+chotic %edic!tions to t e!t schiSo)h eni! h!"e &een !"!i#!&#e since the 16M0s !nd h!"e $ e!t#+ i%) o"ed in te %s of un,!nted side effects in the )!st thi t+ +e! s*182 Cu ent#+( the N!tion!# Institute of Ment!# 0e!#th is conductin$ ! #! $e c#inic!# t i!# >no,n !s CATI9 ;C#inic!# Anti)s+chotic T i!#s of Inte "ention 9ffecti"eness<(183 ,hich co%)! es the effecti"eness !nd side effects of ne, !nd o#d !nti)s+chotic %edic!tions* 184 Unde cu ent e$u#!tions( ) ison in%!tes !nd ci"i##+ confined indi"idu!#s( inc#udin$ ?!c>( c!nnot )! tici)!te in CATI9 &ec!use it is ! fede !##+ funded &io%edic!# stud+*18M In essence( the+ ! e ) e"ented f o% )! tici)!tin$ in ! t i!# fo ! d u$ th!t cou#d &enefit the% !s indi"idu!#s suffe in$ f o% schiSo)h eni!* D* U)d!te the 9thic!# @ !%e,o > 9st!&#ished &+ the N!tion!# Co%%ission to Inc#ude Co##!&o !ti"e Res)onsi&i#it+-The Conce)t th!t Rese! ch Shou#d &e Conducted in Me!nin$fu# Co##!&o !tion ,ith the Ce+ St!>e 0o#de s( Not!&#+ B isone s !nd B ison St!ff :ith this eco%%end!tion( the Co%%ittee st!ted th!t 2 es)ect fo )e sons( 'ustice( !nd &eneficence 3! e4 the fund!%ent!# ethic!# ) inci)#es th!t shou#d $uide the conduct !nd e$u#!tion of ese! ch ,ith ) isone s(5 186 'ust !s ,!s e%)h!siSed in the 1676 Ee#%ont Re)o t* 187 0o,e"e ( the Co%%ittee eco$niSes th!t ese! ch h!s e"o#"ed in the )!st thi t+ +e! s( !nd the e needs to &e ! co##!&o !ti"e es)onsi&i#it+ !dded to these ethic!# ) inci)#es*188 The Co%%ittee eco$niSes th!t e!ch ) ison f!ci#it+ is diffe ent !nd th!t ese! che s shou#d 2en$!$e ) ison !d%inist !tion !nd ) isone s the%se#"es fo thei in)ut*5 186 The #!c> of !deHu!te he!#thc! e in so%e ) isons c e!tes !n inhe ent#+ coe ci"e en"i on%ent* 160 Thus( it is unethic!# to conduct ese! ch in ! ) ison settin$ ,he e the e is not !deHu!te !ccess to he!#thc! e*161 Th ou$h ! co##!&o !ti"e !)) o!ch( the Co%%ittee eco%%ends ese! che s ensu e !n !deHu!te st!nd! d of c! e* 162 20u%!n ese! ch )! tici)!nt ) otection ) o$ !%s( to$ethe ,ith the ) ison !d%inist !tion !nd ) ison he!#th1c! e ) ofession!#s( ! e es)onsi&#e fo
181 182 183 184 18M 186 187 188 186 160 161 162

* . . . * * . . . . . .

NIM0( supra note 44( !t 6* Id. Id. !t 10* Id. 4M C*@*R* G 46*306 ;2007<* IOM( supra note 7( !t 10* Id. Id. Id. Id. !t 11* Id. Id.

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 16M ensu in$ th!t ese! ch ,ith ) isone s occu s in !n en"i on%ent th!t is !)) o) i!te to the he!#th !nd ,e##1&ein$ of ) isone s( inc#udin$ !ccess to e.istin$ %edic!# !nd %ent!# he!#th c! e * * * *5 163 B ison !d%inist !to s !nd ) ison he!#thc! e ) ofession!#s %ust ensu e th!t ) isone s h!"e !deHu!te he!#th c! e &efo e !##o,in$ the% to )! tici)!te in c#inic!# t i!#s* 164 The Co%%ittee )osits th!t it is es)eci!##+ i%)o t!nt to use scientific ese! ch to &ette unde st!nd ho, to ) o%ote the ,e##1&ein$ of ) isone s* 16M This eco%%end!tion is )! ticu#! #+ i%)o t!nt fo indi"idu!#s such !s Nis! !nd Ei##* Nis! h!s 0IL !nd does not h!"e !ccess to !nti"i !# %edic!tions o ) i%! + he!#thc! e to %!n!$e he dise!se* A#thou$h )eo)#e in co ection!# confine%ent h!"e $ e!te est ictions u)on thei #i&e ties !nd Nis! is on#+ on ) o&!tion( she is sti## susce)ti&#e to coe cion &ec!use ! ese! ch t i!# is he on#+ ho)e fo t e!t%ent* 166 Ei## is susce)ti&#e to coe cion ,hen )! tici)!tin$ in ese! ch t i!#s( not on#+ &ec!use he is inc! ce !ted !nd his #i&e ties ! e $ e!t#+ est icted( &ut !#so &ec!use he is in !n en"i on%ent th!t often does not h!"e !deHu!te he!#th c! e*167 0e is inc! ce !ted in C!#ifo ni! ,he e fede !# Cou ts h!"e t!>en cont o# of the ) ison he!#thc! e s+ste% to !dd ess de)#o !&#e conditions*168 9* 9nh!nce S+ste%!tic O"e si$ht of Rese! ch In"o#"in$ B isone s so th!t 0u%!n1Su&'ect B otections ! e Mo e Ri$o ous !nd Mo e Re#i!&#e th!n Those Unde the 9.istin$ Institution!# Re"ie, Eo! d Mech!nis% Unde cu ent e$u#!tions( the e is no sin$#e fede !# %ech!nis% to o"e see !## ese! ch in"o#"in$ ) isone s* 166 Such ese! ch is e"ie,ed !nd !)) o"ed &+ IREs*200 The Co%%ittee eco$niSes the i%)o t!nce of this th esho#d e"ie, &+ !n IRE( &ut e%)h!siSes in its e)o t th!t IRE !)) o"!# !#one is not !deHu!te to the t!s> !t h!nd* 201 The Co%%ittee su$$ests th!t ese! ch in"o#"in$ ) isone s shou#d &e %onito ed th ou$hout the enti e cou se of !n+ stud+* 202 This cou#d &e !cco%)#ished &+ usin$ B ison Rese! ch Su&'ect Ad"oc!tes ;BRSA< to %onito studies on site !nd co%%unic!te f eHuent#+ ,ith !n IRE* 203 The Co%%ittee !#so su$$ests
163 164 16M 166 167 168 166 200 201 202 203

. . . . . . . . . . .

Id. See id. !t 12* Id. See id. !t 11112* See id. !t M01M2* Id. !t M1 &o. 211* See id. !t 74* Id. !t 77* Id. !t 12* Id. Id. !t 12113*

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166 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 st en$thenin$ the Office of 0u%!n Rese! ch B otections ;O0RB< &+ e.tendin$ its 'u isdiction to co"e !## ese! ch in"o#"in$ ) isone s( e$! d#ess of fundin$ sou ce* 204 Cu ent#+( 23t4he "!st %!'o it+ of ese! ch in"o#"in$ ) isone s does not f!## ,ithin O0RB o"e "ie, 'u isdiction*5 20M 9.tendin$ O0RB/s 'u isdiction 2,i## f!ci#it!te s!fe !nd ethic!# ese! ch !c oss the fu## !n$e of ese! ch in"o#"in$ ) isone s*5 206 The Co%%ittee su$$ests th!t O0RB/s c!)!cit+ %ust &e 2 e"it!#iSed !nd efocused5 to inc#ude the fo##o,in$ functionsF ;1< %!int!in ! n!tion!# e$ist + of !## ) isone ese! chJ ;2< dete %ine ,hethe ! stud+ eHui es fede !#1#e"e# e"ie,J ;3< enfo ce e$u#!tions !nd cu t!i# !&usesJ !nd ;4< se "e !s ! n!tion!# esou ce to ) o%ote unifo % !))#ic!tion of e$u#!tions* 207 If O0RB/s 'u isdiction is not e.tended( the Co%%ittee eco%%ends th!t the 2enh!nced O0RB %ode# %ust &e e)#ic!ted fo !## !$encies !nd ) i"!te#+ funded ese! ch*5208 As ) e"ious#+ %entioned( conce ns of coe cion ! ise ,hene"e ese! ch is conducted in the ) ison settin$* 206 The Co%%ittee/s eco%%end!tions to enh!nce s+ste%!tic o"e si$ht of ese! ch in"o#"in$ ) isone s !dd ess these conce ns* I%)#e%entin$ ! n!tion!# s+ste% of o"e si$ht( !#on$ ,ith uti#iSin$ IREs !nd BRSAs( ,ou#d ensu e th!t ) isone s ! e $i"in$ "o#unt! + info %ed consent ) io to )! tici)!tion( th!t thei ) i"!c+ is ) otected !s %uch !s )ossi&#e( !nd th!t ese! ch t i!#s ! e conducted !cco din$ to #ucid st!nd! ds of s!fet+ !nd effic!c+ th ou$hout the cou se of the stud+* 210 E+ i%)#e%entin$ !n enh!nced s+ste% of o"e si$ht !#on$ ,ith ! co##!&o !ti"e ese! ch !)) o!ch( ) ison !d%inist !to s !nd ese! che s ,i## &e co%)e##ed to ensu e th!t ) isone s h!"e !deHu!te !ccess to he!#thc! e &efo e the+ &eco%e in"o#"ed in ese! ch t i!#s* 211 Indi ect#+( this eco%%end!tion %!+ i%) o"e ) ison he!#thc! e s+ste%s &ec!use de)#o !&#e conditions ,ou#d &e e.)osed ,hen BRSAs !nd IREs in"esti$!te ! ) isone /s !ccess to he!#thc! e in the ) ocess of !)) o"in$ his )! tici)!tion in ese! ch t i!#s* 212 Once de)#o !&#e conditions ! e e.)osed( #i>e those o&se "ed in Michi$!n !nd C!#ifo ni! ) isons( 213 the+ %!+ !)) o) i!te#+ &e !dd essed* Unde cu ent e$u#!tions( ?!c>( Ei##( !nd Nis! ! e not ) otected if the+ )! tici)!te in ) i"!te#+ funded ese! ch( !nd ) otections the+ ! e ) o%ised
204 20M 206 207 208 206 210 211 212 213

. . . . . . . . . .

Id. !t 13114* Id. !t 14* Id. Id. Id. Id. !t 103* Id. !t 13116* See id. !t 11* See id. !t 12113* See id. !t 26J '( Minutes) T*e Deat* + Tim t*, S uders( supra note 23*

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20084 %IOMEDICAL AND %E&AVIORAL RESEARC& 167 ,hen )! tici)!tin$ in fede !##+ funded ese! ch ! e in!deHu!te* 214 If the Co%%ittee/s eco%%end!tions ! e !do)ted( ) isone s such !s ?!c>( Ei##( !nd Nis! ,ou#d &e !&#e to )! tici)!te in fede !# o ) i"!te ese! ch t i!#s ,ithout fe! of coe cion o !&uses* An+ conce ns the )! tici)!nts h!"e ) io to o du in$ the cou se of the stud+ cou#d &e e)o ted to ! BRSA* 21M :ith ! n!tion!# s+ste% of o"e si$ht( the is> of !&usi"e studies ,ou#d &e "!st#+ di%inished &ec!use the+ ,ou#d &e detected Huic>#+ &+ the BRSA( IRE( O0RB( o the )u&#ic th ou$h n!tion!# d!t!&!ses*216 LI* CONSTITUTIONANITA O@ R9GUNATIONSF DISTINGUIS0ING T09 CONSTITUTIONANITA O@ CURR9NT R9GUNATIONS @ROM T09 INSTITUT9 O@ M9DICIN9/S R9COMM9ND9D R9GUNATIONS In 1680( in Fante #. Dep5t + &ealt* and &uman Ser#i!es (217 ! $ ou) of ) isone s !t the St!te B ison of Southe n Michi$!n fi#ed ! #!,suit !$!inst the fede !# $o"e n%ent in es)onse to the @DA/s ) o)os!# to )u&#ish fin!# u#es !n!#o$ous to those ) o%u#$!ted &+ D09: in 1678-to e#i%in!te ) ison sites !s !cce)t!&#e "enues fo &io%edic!# !nd &eh!"io !# ese! ch* 218 B isone s c#!i%ed th!t the ) o)osed @DA e$u#!tions "io#!ted thei 2 i$ht to choose5 )! tici)!tion in %edic!# ese! ch* 216 A#thou$h ! 2 i$ht5 to )! tici)!te in %edic!# ese! ch t i!#s h!s not &een est!&#ished( the @DA ,ithd e, its ) o)osed e$u#!tions !nd ne"e eissued ! diffe ent ) o)os!#*220 Since Fante( no #!,suits h!"e &een fi#ed e$! din$ ! ) isone /s i$ht to )! tici)!te in &io%edic!# o &eh!"io !# ese! ch* In %ene+i!ial and Unusual Punis*ment) An Argument in Supp rt + Pris ner Parti!ipati n in Clini!al Trials( !utho Sh! on! 0off%!n !dd esses the constitution!#it+ of st!te e$u#!tions( !n!#o$ous to those ) o%u#$!ted &+ the D09:( th!t e#i%in!te ) isone )! tici)!tion in %edic!# ese! ch t i!#s.221 Unde !n 9i$hth A%end%ent !n!#+sis( she ) o)oses th!t 2,hi#e i es)onsi&#e c#inic!# ese! ch %!+ "io#!te ) isone s/ 9i$hth A%end%ent i$hts( deni!# of )otenti!##+ #ife1s!"in$ e.)e i%ent!# t e!t%ent to ) isone s !#so constitutes unconstitution!# c ue# !nd unusu!# )unish%ent*5222 A#thou$h 0off%!n su$$ests th!t it is difficu#t fo ! ) isone to ) e"!i# on !n 9i$hth A%end%ent c#!i% &!sed on the deni!# of
214 21M

. See 4M C*@*R* G 46 ;2007<* . See IOM( supra note 7( !t 12113* 216 . Id. !t 13116* 217 * @!nte "* De)/t of 0e!#th D 0u%!n Se "ices( No* CIL*A*80172778( 1681 :N 383671( !t W1 ;9*D* Mich* No"* 2M( 1681<* 218 * AC0R9 R9BORT( supra note M6( !t )t* 2( ch* 6J see als Fante( 1681 :N 383671 !t W1* 216 * AC0R9 R9BORT( supra note M6( !t )t* 2( ch* 6J 0off%!n( supra note MM( !t M0M* 220 * 0off%!n( supra note MM( !t M0M106* 221 . Id. !t M04106* 222 . Id. !t 463*

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168 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 !ccess to c#inic!# t i!#s( she !n!#+Ses )otenti!# ! $u%ents unde t,o distinct tests*223

One of the tests is !))#ied ,hen !n 9i$hth A%end%ent "io#!tion ! ises f o% the conduct of )! ticu#! ) ison offici!#s* 224 The Su) e%e Cou t h!s he#d th!t 2!n in%!te !##e$in$ !n 9i$hth A%end%ent "io#!tion %ust est!&#ish ! $ !"e de) i"!tion of i$hts to ,hich ) ison offici!#s h!"e e!cted ,ith de#i&e !te indiffe ence*522M To est!&#ish ! de#i&e !te indiffe ence( 2!n in%!te %ust sho, th!t ) ison offici!#s ;1< ,e e !,! e of the indi"idu!#/s se ious %edic!# needJ !nd ;2< dis e$! ded( i$no ed( o efused to ) o"ide the in%!te ,ith t e!t%ent fo th!t need*5 226 0off%!n ! $ues th!t 23i4f ! c#inic!# t i!# is !"!i#!&#e fo ! ) isone ,ho suffe s f o% AIDS o !nothe se ious i##ness !nd ) ison offici!#s den+ the in%!te !ccess to the t i!#( the in%!te %i$ht &e !&#e to est!&#ish ! "!#id c!use of !ction(5 227 es)eci!##+ &ec!use the futu e ) o$nosis fo AIDS )!tients de)ends he!"i#+ on t e!t%ent th ou$h e.)e i%ent!# d u$ t i!#s*228 The second test ,!s est!&#ished &+ the Su) e%e Cou t in Turner #. Sa+le,226 !nd !))#ies ,hen ! "io#!tion ! ises f o% ! ) ison )o#ic+* 230 2In 3Turner4( the Cou t he#d th!t =,hen ! ) ison e$u#!tion i%)in$es on in%!tes/ constitution!# i$hts( the e$u#!tion is "!#id if it is e!son!&#+ e#!ted to #e$iti%!te )eno#o$ic!# inte ests*/5 231 M!n+ cou ts h!"e !do)ted Turner/s defe enti!# st!nd! d of e"ie, fo constitution!# ch!##en$es to ) ison e$u#!tions !nd )o#icies*232 Turner #!id out ! fou 1f!cto inHui + to dete %ine ,hethe ! ) ison e$u#!tion is e!son!&#+ e#!ted to ! #e$iti%!te )eno#o$ic!# inte estF
;1< Is the e ! "!#id( !tion!# connection &et,een the e$u#!tion !nd the $o"e n%ent!# inte est )ut fo ,! d to 'ustif+ it( !nd is the $o"e n%ent!# inte est #e$iti%!te !nd neut !#J ;2< do !#te n!ti"e %e!ns of e.e cisin$ the ch!##en$ed i$ht e%!in o)en to in%!tesJ ;3< ,i## !cco%%od!tin$ the ch!##en$ed i$ht h!"e ! si$nific!nt 2 i))#e effect5 on $u! ds( othe in%!tes( !nd the !##oc!tion of ) ison esou ces in $ene !#J !nd ;4< does !n !#te n!ti"e to the e$u#!tion e.ist ,hich ,ou#d fu##+ !cco%%od!te
223 224

. Id. !t 4631M03* . Id. !t 463164* 22M . Id. !t 463* 226 . Id. !t 464* 227 . Id. !t M00101* 228 . Id. !t M00* 226 * Tu ne "* S!f#e+( 482 U*S* 78 ;1687<* 230 * 0off%!n( supra note MM( !t 464* 231 * Id.J see als Turner( 482 U*S* !t 86* 232 . See M!ss* B isone s Ass/n Bo#itic!# Action Co%%* "* Actin$ Go"e no ( 761 N*9*2d 6M2( 6M6160 ;M!ss* 2002<*

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the in%!tes/ i$hts !t de %ini%is cost to "!#id )eno#o$ic!# inte estsK 233

%IOMEDICAL AND %E&AVIORAL RESEARC&

166

0off%!n conc#uded th!t 23 4e$u#!tions ) ohi&itin$ se ious#+ i## ) isone s f o% )! tici)!tion in c#inic!# t i!#s in !## c!ses( inc#udin$ those in ,hich thei e.c#usion esu#ts in the deni!# of )otenti!##+ #ife1s!"in$ the !)+( ! e "u#ne !&#e to constitution!# !tt!c>*5234 0off%!n/s !n!#+sis of the constitution!#it+ of e$u#!tions #i%itin$ ) isone )! tici)!tion in ese! ch focused on e$u#!tions !n!#o$ous to those ) o%u#$!ted &+ the D09:* 23M If the Co%%ittee/s eco%%end!tions ! e !do)ted !nd inco )o !ted into fede !# e$u#!tions( this !n!#+sis cou#d ch!n$e si$nific!nt#+* The Co%%ittee/s eco%%ended e$u#!tions ,i## #i%it the incidence of ) isone s &ein$ denied )otenti!##+ #ife1s!"in$ t e!t%ent( !s #on$ !s the ese! ch t i!# is conducted !cco din$ to the eco%%ended e$u#!tions*236 B isone s ,i## &e denied !ccess on#+ to those &io%edic!# !nd &eh!"io !# t i!#s th!t ! e not &ein$ conducted !cco din$ to sound ethic!# st!nd! ds* Thus( if the eco%%ended e$u#!tions ! e !do)ted( ! ) isone /s 9i$hth A%end%ent i$hts ,i## &e &ette ) otected &ec!use he ,i## &e !ffo ded !ccess to &io%edic!# !nd &eh!"io !# t i!#s th!t ,i## &enefit his ,e##1&ein$( ,hi#e !t the s!%e ti%e he ,i## &e ) otected f o% !&uses* LII* CONCNUSION

B o)onents of e"ised fede !# e$u#!tions( inc#udin$ the Institute of Medicine( h!"e t!>en ! 2) otectionist5 !ttitude to,! d the )! tici)!tion of ) isone s*237 This ) otectionist "ie, ,ou#d !##o, ) isone s to )! tici)!te %o e ,ide#+ !nd %o e f!i #+ in ese! ch th!t is ethic!##+ sound* Indeed( the Co%%ittee eco$niSes th!t the e ! e ci cu%st!nces in ,hich 'ustice %!+ )e %it o e"en eHui e ) isone s to h!"e !ccess to ese! ch t i!#s* 238 If the Co%%ittee/s e$u#!tions ! e !do)ted( the+ ,i## &enefit &oth ) isone s !nd societ+* B isone s ,i## &enefit &ec!use the+ ,i## &e !&#e to )! tici)!te in &io%edic!# !nd &eh!"io !# ese! ch t i!#s th!t %!+ t e!t o e"en cu e thei %edic!# conditions( ,hi#e &ein$ !ffo ded ) otections $ e!te th!n those e.tended &+ cu ent e$u#!tions* Societ+ ,i## &enefit &ec!use the Co%%ittee/s eco%%end!tions ,i## e.)ose !n+ de)#o !&#e conditions in he!#thc! e s+ste%s !nd !##o, the% to &e !dd essed* :hen the conduct of ese! ch on ) isone su&'ects is he#d to hi$h ethic!# st!nd! ds !c oss !## fie#ds( !nd ne"e !$!in is !##o,ed to f!## to the #e"e# of the studies !t 0o#%es&u $ B ison o the Tus>e$ee S+)hi#is Stud+( societ+ ,i## e$!in confidence in the !&i#it+ of scientists !nd %edic!# ) ofession!#s to conduct
233

* C!cicio "* Sec/+ of Bu&* S!fet+( 66M N*9*2d 8M( 60 ;M!ss* 1666< ;citin$ Turner( 482 U*S* !t 86161<* 234 * 0off%!n( supra note MM( !t 466* 23M . See id. !t 464J see als Turner( 482 U*S* !t 78* 236 . See generall, IOM( supra note 7* 237 * CA0N 9T AN*( supra note 1( !t 126* 238 . See6 e.g.( id. !t 127J IOM( supra note 7( !t 116*

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200 CRIMINAL AND CIVIL CONFINEMENT 3Lo#* 34F426 ethic!# ese! ch in the ) ison settin$* @u the %o e( ) isone s such !s ?!c>( Ei##( !nd Nis! ,i## &e ) o"ided the o))o tunit+ to $i"e info %ed consent to "!#id ese! ch t i!#s th!t %!+ !ctu!##+ cont i&ute to thei ,e##&ein$( ,hi#e !t the s!%e ti%e !ffo din$ the% the ) otections of sound ethic!# st!nd! ds* Andrea L,nn Osganian

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