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Is this research?

(see glossary in Framework

for Research Ethics)

Professional codes of

practice still apply

Does proposal address

subject of ethics?

Principal investigator to write

ethics discussion

Does it involve more thanminimal risk?

(see Section 1 of

Framework for Research

Ethics)

Light touch review by

department REC

Does the research involve

NHS patients, records,

equipment, premises or

vulnerable peopleunder the Mental Capacity

Act 2005?

Review by NHS NRES

Are there approved

protocols for handling this

research situation that are

appropriate to current

research?

Light touch review

Send application to

appropriate REC for full

review

Are there possible conflicts

of interest or an appeal?Review by University REC

Yes No

Yes

Yes

Yes

Yes

Yes

No

No

No

No


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*'$(+%+'$3 >7? 8+2^81& 21U)40 0+713 >P? %81 *'55+22+'$ '& 4001P1( *'55+22+'$ GA 8+5^81& '7 4$A'771$*13 '& >8? 4$A /&'*11(+$P2 7'& 4$A '771$*1 *'55+%%1( '& 4001P1( %' 84I1 G11$*'55+%%1( GA 8+5^81&3 %81 (+2/'240 '7 2)*8 /&'*11(+$P2 '& %81 21$%1$*1 '7 4$A *')&% +$2)*8 /&'*11(+$P2,

O'(>/:('*>0@ 3> '*/*('01 *2130/E H81 7)003 4**)&4%13 4$( '/1$ (+2*0'2)&1 '7 &101I4$%+$7'&54%+'$, [81&1 %81 &1214&*8 +$I'0I12 $1: 4$( +$$'I4%+I1 51%8'('0'P+123 %8+2 +212/1*+400A +5/'&%4$%,

d(B3; 0,>/*>2E 9'& *'$21$% %' G1 `I40+(C %81 /4&%+*+/4$% 5)2% G1 *4/4G01 '7 )$(1&2%4$(+$P400 %81 /'%1$%+40 &+2;2 +$I'0I1(, [81&1 %8+2 54A G1 +$ (')G%3 %81 R1$%40 B4/4*+%A L*% -MMN

54A 4//0A >211 L//1$(+U X?,


42/51

D-

G::*>;3N PR A',.*//3,>(B *2130/ 0,;*/ (>; '*B*K(>2 B*J3/B(23,>

V&+%+28 .2A*8'0'P+*40 @'*+1%A B'(1 '7 B'$()*% 4$( =%8+*40 h)+(10+$12:::,G/2,'&P,);^:84%S:1S('^1%8+*2S2%4$(4&(2^1%8+*2S2%4$(4&(2

B&+5+$40 #


43/51

DK

H&+SB')$*+0 =%8+*2 h0'224&A :::,/&1,1%8+*2,P*,*4^1$P0+28^%)%'&+40^P0'224&A,*75

YW X4%4 L&*8+I1 :::,(4%4S4&*8+I1,4*,);

YW YW(B (//,03(23,>/

L22'*+4%+'$ '7 #$%1&$1% -MMF?:::,G/2,'&P,);^/)G0+*4%+'$2^/'0+*ASP)+(10+$12^&1214&*8SP)+(10+$12S/'0+*AS('*)51$%2 &1214&*8SP)+(10+$12S/'0+*AS('*)5

H81 V&+%+28 @'*+1%A '7 h1&'$%'0'PA :::,G&+%+28P1&'$%'0'PA,'&P

H81 V&+%+28 @'*+'0'P+*40 L22'*+4%+'$ `@%4%151$% '7 =%8+*2 .&4*%+*1C:::,G&+%2'*,*',);^4G')%^16)40+%A,42/U

V&+%+28 =()*4%+'$40


44/51

DD

G::*>;3N !R S*@ 01(>J*/ 2, 21* .'()*+,'-

6787 '*K3/3,>/

H81


45/51

DN

7&451:'&;3 +$*0)(+$P 4 ;1A %1&52 P0'224&A3 4 9Lf2 21*%+'$ 4$( 4 5'&1 +$%1&4*%+I1 :1G2+%1,@11 G10': 7'& 7)&%81& +$7'&54%+'$ '$ %8121 2%&)*%)&40 *84$P12,

A?':,/* ,. #*/*('01 !2130/ $,))322** (>; 32/ ',B* (>; '*/:,>/3+++? $' &1I+1: '7%81 /&'/'21( &1214&*8 +$ *4212 :81&1 $' 1%8+*2 +22)12 4&1 4$%+*+/4%1(,

H81 &1I+21( 7&451:'&; *04&+7+12 %84% 400 &1214&*8 5)2% P' %8&')P8 4% 0142% 4 0+P8% %')*8&1I+1: 42 4 5+$+5)5 2%4$(4&(, H8+2 0+P8% %')*8 &1I+1: +2 0+;10A %' G1 &101I4$% 7'& &1214&*8:81&1 %81 /'%1$%+40 7'& &+2; '7 84&5 %' /4&%+*+/4$%2 4$( '%81&2 4771*%1( GA %81 /&'/'21(&1214&*8 +2 5+$+540,

H81 &1I+21( 7&451:'&; 402' *04&+7+12 %84% 1U/1(+%1( &1I+1: 28')0( G1 )21( +$ 1U*1/%+'$40

*+&*)52%4$*12 :81&1 4 &1214&*8 /&'/'240 +$I'0I+$P /'22+G01 &+2; '7 84&5 *4$ &1*1+I1 4 7)00&1I+1: 4% 28'&% $'%+*1, #% +2 /&'/'21( %84% 4$ 1U/1(+%1( &1I+1: +2 *4&&+1( ')% GA '$1 '&5'&1 515G1&2 '7 4


46/51

DO

+$%1&$1% G421( &1214&*8 >/4&%+*)04&0A +$I'0I+$P I+2)40 +54P12?3 (4%4 284&+$P 4$( (4%4 4&*8+I+$P54A 402' &4+21 +22)12 ()&+$P 4$( 47%1& %81 &1214&*8 *'551$*12 :8+*8 28')0( G1 *'$2+(1&1(,

M>J,3>J '*K3*+

H81 &1I+21( 7&451:'&; 8+P80+P8%2 %81 +5/'&%4$*1 '7 &154+$+$P 4:4&1 '7 /'%1$%+40 &+2;2 %' 400

P&')/2 +$I'0I1( +$ &1214&*8 %8&')P8')% +%2 0+71%+51, H81&17'&13 +% 54A G1 $1*1224&A %'*'$2)0% :+%8 4 4$( /4&1$%^*4&1&?, #7 7'& 1U45/01 4 *8+0( '& I)0$1&4G01 /1&2'$ &1I1402%84% %81A 4&1 +$ 2+P$+7+*4$% 4$( +551(+4%1 (4$P1&3 %81 &1214&*81& :+00 G1 'G0+P1( %' 1$2)&1%84% %81 *8+0(^I)0$1&4G01 /1&2'$ +2 /&'%1*%1(, V17'&1 2%4&%+$P 4 /&'_1*%3 %81 /&+$*+/40&1214&*81& :+00 $'&5400A 84I1 12%4G0+281( 4 /&'*1()&1 4$( %81 $451 '7 4 /1&2'$ :8' :+00%4;1 %81 &12/'$2+G+0+%A 7'& /&'%1*%+$P %81 I)0$1&4G01 /1&2'$2^*8+0( +$ %81 1I1$% '7 4(+2*0'2)&1, #7 %81 &1214&*81& 71102 +% +2 $1*1224&A %' G&14; *'$7+(1$%+40+%A3 %81 *8+0(^I)0$1&4G01/1&2'$ :+00 $'&5400A G1 +$7'&51( :84% 4*%+'$ 842 G11$ %4;1$ GA %81 &1214&*81&, VA/&'I+(+$P *014& P)+(4$*1 '$ %8+2 4$( '%81& +22)12 +$ %81 7&451:'&;3 +% +2 1U/1*%1( %84%&1214&*81&2 :+00 %4;1 2%1/2 %' 5+%+P4%1 )$$1*1224&A &+2; %' /4&%+*+/4$%2 42 5)*8 42 /'22+G01,


47/51

DF

=>2*'>*2 (>; 2*01>,B,J@

G'%8+$ *4&&A+$P ')% &1214&*8 '$ %81 +$%1&$1% 4$( :+%8 2%'&+$P 4$( 284&+$P (4%4?, H81 +22)122)&&')$(+$P +$%1&$1% 4$( %1*8$'0'PA :1&1 %81 5'2% 7&16)1$%0A *+%1( +$ %81 *')&21 '7 %81*'$2)0%4%+'$, #$ 0+P8% '7 %8+23 %81 &1I+21( 7&451:'&; 211;2 %' 4((&122 %8121 *'$*1&$2 GA

&1*'551$(+$P 7)00 1%8+*2 &1I+1: :81&1 +$%1&$1% &1214&*8 '& (4%4 284&+$P 714%)&1 +$ 4&1214&*8 /&'/'240 4$( 54A G1 _)(P1( $1*1224&A, H81 7&451:'&; 15/842+212 %84% 42 4 &4/+(0A(1I10'/+$P 4&143 01P+204%+'$ 4$( P)+(4$*1 :+00 *'$%+$)1 %' 1I'0I1 4$( %8+2 $11(2 %' G1&1*'P$+21( GA &1214&*81&2 4$( ; 0(/* /2?;3*/

2B@ G/-*; e?*/23,>/ 4&Ge/5 /*023,>

L $1: 9Lf2 21*%+'$ +2 +$*0)(1( :+%8+$ %81 &1I+21( 7&451:'&;, H8+2 21*%+'$ 4+52 %' 8+P80+P8%151&P+$P +22)12 4$( 4((&122 6)12%+'$2 4$( *04&+7+*4%+'$2 7&'5 %81 *'$2)0%4%+'$, VA +$*0)(+$P%8+2 21*%+'$3 %81 9+1I40+(^+$7'&51( *'$21$%?,

$1*0-B3/2/T&B,+01('2/

H81 '&+P+$40 1%8+*2 70':*84&% 842 G11$ )/(4%1( %' &1701*% $1: 01P+204%+'$ :+%8 4$ 15/842+2'$ &+2; 4:4&1$122 &4%81& %84$ &+2; 4I1&2+'$, #$ 4((+%+'$3 4 0+2% '7 +22)12 %' G1 *'$2+(1&1(:81$ /04$$+$P &1214&*8 842 G11$ +$*0)(1( %' 1$4G01 &1214&*81&2 %' 4((&122 %81 1%8+*22)&&')$(+$P %81+& /&'/'21( &1214&*8, H8+23 40'$P2+(1 %81 70':*84&%3 :+00 2)//'&% &1214&*81&2

+$ 54;+$P _)(P151$%2 4G')% :81%81& 4 7)00 &1I+1: +2 $1*1224&A3 :81%81& %81A 84I1 7)00A*'$2+(1&1( /'%1$%+40 1%8+*2 +22)123 4$( 2' '$, H8121 %''02 :+00 402' G1 54(1 4I4+04G01 '$ %81


48/51


49/51

DQ

G::*>;3N &R $(/* /2?;3*/ (>; :',2,0,B/

[1 :10*'51 $1: *421 2%)(+12 4$( /&'%'*'02 :8+*8 +00)2%&4%1 %81 *84001$P12 4&')$(&1214&*8 1%8+*2 +$ (+771&1$% 4&142, #7 A') '& A')& &1214&*8 '&P4$+24%+'$ :')0( 0+;1 %' 2)G5+%4 *421 2%)(A '& /&'%'*'03 /01421 *'$%4*% %81 1%8+*2 %145E 1%8+*2q12&*,4*,);, Z')& *421 2%)(A

28')0( $'% 1U*11( %8&11 2+(12 '7 LD 4$( +$*0)(1E

=@G&+17 (1%4+02 '7 A')& /&'_1*% +$*0)(+$P 4+523 2)G_1*%2 4$(51%8'(2?

=%8+*2 6)12%+'$2 &4+21( 4$( 4//&'4*812 >G&+17 (1%4+02 '7 %81 1%8+*2 4//&'4*812 4$(+22)12 4((&1221( 7'& %8+2 2%)(A +$*0)(+$P 2/1*+7+* 1%8+*40 +22)123 +1 4//&'I40 &')%123P)+(4$*1 7'00':1(, H8+2 28')0( +$*0)(1 4$A +22)12 %84% 4&'21 ()&+$P %81 0+71 '7 %81P&4$% 42 :100 42 %8'21 4((&1221( /&+'& %' %81 2%4&% '7 %81 P&4$%?

@)554&A '7 0122'$2 014&$1( >%84% 54A G1 )217)0 %' '%81& &1214&*81&2 +$ 4 &104%1(

4&14? 9)&%81& &14(+$P >&101I4$% 0+$;2 4$( /)G0+*4%+'$2 +7 4//&'/&+4%1?,

$(/* /2?;@R a,?>J Q3K*/

P*/0'3:23,> ,. /2?;@RZ')$P T+I12 +2 4$ +$%1&$4%+'$40 2%)(A '7 *8+0(8''( /'I1&%A 7)$(1(GA %81 YW X1/4&%51$% 7'& #$%1&$4%+'$40 X1I10'/51$% >X9#X?, H81 2%)(A +2 0'$P+%)(+$40 4$(+$I'0I12 !-3MMM *8+0(&1$ P&':+$P )/ +$ 7')& *')$%&+12 'I1& !N A14&2E =%8+'/+43 %81 2%4%1 '7L$(8&4 .&4(128 +$ #$(+43 .1&) 4$( k+1%$45, H:' *'8'&%2 '7 *8+0(&1$ a 4 A')$P1& *'8'&%:8' :1&1 G'&$ +$ -MM!S- 4$( 4$ '0(1& *'8'&% G'&$ +$ !QQDSN a 4&1 G1+$P 7'00':1(3 :+%8 %81

A')$P1& *8+0(&1$ G1+$P %&4*;1( 7&'5 +$74$*A %' %81+& 5+(S%11$23 4$( %81 '0(1& *8+0(&1$ +$%'4()0%8''(, L I4&+1%A '7 2)&I1A 4$( 6)40+%4%+I1 51%8'(2 4&1 )21( %' *'001*% (4%4 :+%8*8+0(&1$3 /4&1$%23 4$( '%81&2 +$ *'55)$+%+12, Z')$P T+I12 4+52 %' P4+$ 4 (11/1&)$(1&2%4$(+$P '7 *8+0(&1$C2 1U/1&+1$*12 '7 /'I1&%A3 %81 ')%*'512 '7 /'I1&%A 7'& *8+0(&1$3%81 +$%1&P1$1&4%+'$40 %&4$25+22+'$ '7 /'I1&%A3 8': 745+0+12 '$ %81 54&P+$2 5'I1 +$ 4$( ')%'7 /'I1&%A3 4$( %81 /'0+*+12 %84% *4$ 54;1 4 (+771&1$*1 %' %81+& 0+I12,

!2130/ D?*/23,>/ '(3/*; (>; (::',(01*/R

H81 2%)(A &4+212 $)51&')2 1%8+*2 6)12%+'$2 4G')% &1214&*8 :+%8 *8+0(&1$ 4$( +$ (1I10'/+$P*')$%&+12c &1214&*8 %84% +2 0'$P+%)(+$403 %8)2 &16)+&+$P 2)2%4+$+$P '7 &104%+'$28+/2 'I1& %+51c4$( &1214&*8 %84% +$I'0I12 %81 4&*8+I+$P '7 *'001*%1( (4%4, H8)2 1%8+*2 6)12%+'$2 4&1 '$P'+$P34$( 4771*% %81 :4A :1 :'&; +$ 54$A :4A2,

#$ /04$$+$P %81 7+&2% 2)&I1A &')$(3 %81 4*4(15+* *'$2'&%+)5 %84% 21% )/ Z')$P T+I12 :424%%1$%+I1 %' &1214&*8 1%8+*2 :+%8+$ %81 1/+(15+'0'P+*40^51(+*40 /4&4(+P5, 9'&540 4//&'I407'& Z')$P T+I12 :42 'G%4+$1( 7&'5 %81 1%8+*2 *'55+%%11 '7 %81 @'*+40 @*+1$*1 X+I+2+'$ '7%81 Y$+I1&2+%A '7 ]U7'&( +$ -MMO >:::,4(5+$,'U,4*,);^*)&1*?, V1*4)21 %81 2%)(A :42G&14;+$P $1: P&')$(3 %81 7'00':+$P 1%8+*2 P)+(10+$12 :1&1 )21(E

h)+(10+$12 7&'5 %81 Y$+I1&2+%A '7 ]U7'&(C2 X1/4&%51$% '7 #$%1&$4%+'$40X1I10'/51$%3 4(4/%1( 7&'5 %81 1%8+*40 P)+(10+$12 '7 %81 L22'*+4%+'$ '7 @'*+40

L$%8&'/'0'P+2%2 '7 %81 B'55'$:140%83 4$( G421( '$ %81 \102+$;+ P)+(10+$12, @4I1 %81 B8+0(&1$ B8+0( .&'%1*%+'$ .'0+*A >-MMK?,


50/51

NM

#$+%+400A3 1%8+*2 4//&'4*812 +$ Z')$P T+I12 :1&1 (1I10'/1( *'004G'&4%+I10A :+%8 %81 *')$%&A&1214&*8 %1452, #$ 4((+%+'$3 G'%8 %81 2)&I1A 4$( %81 6)40+%4%+I1 &1214&*8 %1452 )$(1&:1$%%&4+$+$P 2122+'$2 4% :8+*8 1%8+*2 :1&1 (+2*)221(3 4$( 7+10(:'&; 54$)402 *'$%4+$ (1%4+01(1%8+*2 P)+(4$*1, 9'00':+$P /+0'%+$P '7 %81 6)40+%4%+I1 &1214&*8 51%8'(2 +$ -MMF3 4

R15'&4$()5 '7 Y$(1&2%4$(+$P 7'& 7+10(:'&;1&2 :42 (1I10'/1(3 21%%+$P ')% 2'51 G42+*P)+(4$*1 4G')% &1214&*8 /&'*1()&12 4$( &12/1*%7)0 *'55)$+*4%+'$ :+%8 &1214&*8/4&%+*+/4$%2, H8+2 +2 $': G1+$P )21( :+%8 %81 2)&I1A %1452 %'',

23$(0.0( $,/0('4 0--5$-6 ("&-$&,

#$ %&4+$+$P 7+10(:'&;1&2 (+2*)22 4$( )$(1&2%4$( %84% +$7'&51( *'$21$% 5)2% G1 7&110A P+I1$4$( I'0)$%4&A3 4$( %84% /1'/01 $11( %+51 %' %8+$; 4G')% /4&%+*+/4%+'$E

b' /&'_1*% 2%477 28')0( /&122)&+213 *'1&*1 '& (1*1+I1 &12/'$(1$%2 +$ 4$ 177'&% %' 1$2)&1%81+& /4&%+*+/4%+'$, @%477 28')0( 402' %&A %' 1$2)&1 %84% &12/'$(1$%2 4&1 $'% /&122)&+21( GA'%81& 745+0A '& *'55)$+%A 515G1&2, @%477 28')0( $'% 54;1 4$A /&'5+212 %81A *4$$'% '&

4&1 )$0+;10A %' ;11/, H81 &12/'$(1$%2 :+00 84I1 4% 0142% -D 8')&2 %' *'$2+(1& :81%81& %81A:4$% %' %4;1 /4&% 4$( :+00 G1 7&11 %' :+%8(&4: 7&'5 %81 2%)(A 4% 4$A %+51, [8+02% %81 2%)(A/&'*1()&12 4&1 (12+P$1( %' 1$2)&1 %84% *'$21$% +2 +$7'&51( 4$( I'0)$%4&A3 %81 '$0A /1&2'$:8' *4$ &1400A 1$2)&1 %84% +2 A')3 %81 7+10(:'&;1&, Z') 5)2% 54;1 1I1&A 177'&% %' 54;12)&1 %81 /4&%+*+/4$%2 )$(1&2%4$( %81 2%)(A 4$( 7110 7&11 $'% %' %4;1 /4&% '& %' :+%8(&4: +7%81A :+28 %', >9+10(:'&;1& R4$)40 7'& %81


51/51

@)&I1A 4$( 6)40+%4%+I1 &1214&*8 %1452 )$(1&P' 4((+%+'$40 %&4+$+$P 2122+'$2 G17'&114*8 &')$( '7 7+10(:'&;3 4$( 1%8+*2 6)12%+'$2 4&1 (+2*)221( 4*&'22 %81 2%)(A3 :+%8%81 4+5 '7 (1I10'/+$P 4 284&1( )$(1&2%4$(+$P '7 &1214&*8 1%8+*2,

Z')$P T+I12 842 (1I10'/1( 4$ '$P'+$P R15'&4$()5 '7 Y$(1&2%4$(+$P 7'&

7+10(:'&;1&2, H8+2 4*;$':01(P12 /':1& (+771&1$%+402 G1%:11$ &1214&*81& %1452 4$(/4&%+*+/4$%2 4**'&(+$P %' P1$(1& 1%8$+*+%A 4$( *04223 42 :100 42 4P1,

B'$21$% +2 )$(1&2%''( 42 4$ '$P'+$P /&'*122 4$( +2 &1$1P'%+4%1( 4% 14*8 2%4P1 '7%81 2%)(A,

H' 1$2)&1 %84% 2%477 ;$1: :84% %' (' 28')0( %81A 1$*')$%1& *8+0(&1$ %81A G10+1I154A G1 2)771&+$P 7&'5 4G)21 '& 1U/0'+%4%+'$c :1 )21 %81 *8+0( /&'%1*%+'$ /&'%'*'02(1I10'/1( GA @4I1 %81 B8+0(&1$ >-MMK?,

framework for research ethics 09 12 tcm8 4586

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