79C3C34C52B45572883A05D425EB0F82
28 CFR 46
https://www.govinfo.gov/content/pkg/CFR-2003-title28-vol2/pdf/CFR-2003-title28-vol2-part46.pdf
http://leaux.net/URLS/ConvertAPI Text Files/FBA2AFE6B012A5CC82D39B9CEA232C2C.en.txt
Examining the file media/Synopses/FBA2AFE6B012A5CC82D39B9CEA232C2C.html:
This file was generated: 2020-12-01 05:22:52
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Social | Age | age | 4 |
| Social | Youth/Minors | minor | 1 |
Social / Age
Searching for indicator age:
(return to top)
p.000015:
p.000015: (2) L i m i t ed pe r so na l t elep h o n e/fa x c a lls t o loc a t io n s wi t h i n t h e
p.000015: office’s co mm u t i n g ar e a , o r t ha t ar e c har ged t o n o n- Gove rn m e n t a cco un t s.
p.000015: ( b) Th e fo r egoi n g au t h o r iza t io n does n o t ove rr ide any s t a t u t es, ru les, o r r eg-
p.000015: u l a t io n s gove rn i n g t h e u se of specific t y pes of Gove rn m e n t p r ope r t y ( e. g. i
p.000015: n- t e rna l Dep ar tm e n t a l policies gove rn i n g
p.000015: t h e u se of elec t r o n ic m a il; an d 41 C F R ( FP M R) 101–35.201, gove rn i n g t h e au- t
p.000015: h o r ized u se of lo n g- dis t an ce t elep h o n e se r vices), an d m ay be r evo k ed o r li m -
p.000015: i t ed a t any t i m e b y any s u pe r viso r o r co m po n e n t fo r any b u si n ess r e a so n .
p.000015: ( c) I n u si n g Gove rn m e n t p r ope r t y , e m plo y ees s h o u ld be m i n dfu l of t h
p.000015: ei r r espo n sibili t y t o p r o t ec t an d co n se r ve s u c h p r ope r t y an d t o u se
p.000015: offici a l t i m e i n an h o n es t effo r t t o pe r fo r m offici a l d u t ies. S ee 5
p.000015: C F R 2635.101( b)(9), 2635.704( a), 2635.705( a).
p.000015: [62 F R 23943, M ay 2, 1997]
p.000015:
p.000015: PART 46—PROTECTION OF HUMAN SUBJECTS
p.000015: S ec.
p.000015: 46.101 T o w ha t does t h is polic y a ppl y?
p.000015: 46.102 Defi n i t io n s.
p.000015: 46.103 Ass ur i n g co m pli an ce wi t h t h is pol- ic y—r ese ar c h co n d u c t ed o r s u
p.000015: ppo r t ed b y any F ede ra l Dep ar tm e n t o r Age n c y .
p.000015: 46.104–46.106 [ R ese r ved]
p.000015: 46.107 I R B Me m be r s h ip.
p.000015: 46.108 I R B fun c t io n s an d ope ra t io n s.
p.000015: 46.109 I R B r eview of r ese ar c h .
p.000015: 46.110 E xpedi t ed r eview p r oced ur es fo r ce r - t a i n k i n ds of r ese ar c h i n volvi n g
p.000015: n o m o r e
p.000015: t han m i n i m a l r is k , an d fo r m i n o r c han ges i n a pp r oved r ese ar c h .
p.000015: 46.111 Cr i t e r i a fo r I R B a pp r ov a l of r ese ar c h .
p.000015: 46.112 R eview b y i n s t i t u t io n .
p.000015: 46.113 Su spe n sio n o r t e r m i na t io n of I R B a p- p r ov a l of r ese ar c h .
p.000015: 46.114 Coope ra t ive r ese ar c h .
p.000015: 46.115 I R B r eco r ds.
p.000015: 46.116 Ge n e ra l r eq u i r e m e n t s fo r i nfo r m ed co n se n t .
p.000015: 46.117 Doc u m e n t a t io n of i nfo r m ed co n se n t .
p.000015: 46.118 Applic a t io n s an d p r opos a ls l a c k i n g defi n i t e pl an s fo r i n volve m e n t
p.000015: of hu m an s u bjec t s.
p.000015: 46.119 R ese ar c h un de r t a k e n wi t h o u t t h e i n- t e n t io n of i n volvi n g hu m an s u
p.000015: bjec t s.
p.000015: 46.120 E v a l ua t io n an d disposi t io n of a pplic a- t io n s an d p r opos a ls fo r r ese ar
p.000015: c h t o be co n d u c t ed o r s u ppo r t ed b y a F ede ra l De- p ar tm e n t o r Age n c y .
p.000015: 46.121 [ R ese r ved]
p.000015: 46.122 Use of F ede ra l fun ds.
p.000015:
p.000015: 46.123 Ear l y t e r m i na t io n of r ese ar c h s u p- po r t : E v a l ua t io n of a pplic a t
p.000015: io n s an d p r o- pos a ls.
p.000015: 46.124 Co n di t io n s.
p.000015: AU T HOR I T Y: 5 U. S .C. 301; 28 U. S .C. 509–510; 42 U. S .C. 300v–1( b).
p.000015: SOU RCE: 56 F R 28012, 28020, J un e 18, 1991,
p.000015: un less o t h e r wise n o t ed.
p.000015:
p.000015: § 46.101 To what does this policy apply?
p.000015: ( a) E xcep t a s p r ovided i n p ara g ra p h ( b) of t h is sec t io n , t h is polic y a
p.000015: pplies t o a ll r ese ar c h i n volvi n g hu m an s u b- jec t s co n d u c t ed, s u ppo r t ed o r o t
p.000015: h e r wise s u bjec t t o r eg u l a t io n b y any fede ra l de- p ar tm e n t o r a ge n c y w h ic h t a k
p.000015: es a pp r o- p r i a t e a d m i n is t ra t ive a c t io n t o m a k e t h e polic y a pplic a ble t o
p.000015: s u c h r ese ar c h . Th is i n cl u des r ese ar c h co n d u c t ed b y fede ra l civili an e m
p.000015: plo y ees o r m ili t ary pe r so nn el, excep t t ha t e a c h dep ar tm e n t o r a ge n c y h e a d m
p.000015: ay a dop t s u c h p r oce- d ura l m odific a t io n s a s m ay be a pp r o- p r i a t e f r o m
p.000015: an a d m i n is t ra t ive s t an d- poi n t . I t a lso i n cl u des r ese ar c h co n- d u c t
p.000015: ed, s u ppo r t ed, o r o t h e r wise s u bjec t t o r eg u l a t io n b y t h e fede ra l gove rn-
p.000015: m e n t o u t side t h e U n i t ed S t a t es.
p.000015: (1) R ese ar c h t ha t is co n d u c t ed o r s u p- po r t ed b y a fede ra l dep ar tm e n t
...
p.000015: o u g h ide n t ifie r s li n k ed t o t h e s u bjec t s.
p.000015: (5) R ese ar c h an d de m o n s t ra t io n p r ojec t s w h ic h ar e co n d u c t ed b y o r s
p.000015: u b- jec t t o t h e a pp r ov a l of dep ar tm e n t o r a ge n c y h e a ds, an d w h ic h ar e
p.000015: desig n ed t o s t u d y , ev a l ua t e, o r o t h e r wise ex a m - i n e:
p.000015: ( i) P u blic be n efi t o r se r vice p r o- g ra m s;
p.000015: ( ii) P r oced ur es fo r ob t a i n i n g be n efi t s o r se r vices un de r t h ose p r og ra m s;
p.000015: ( iii) P ossible c han ges i n o r a l t e r - na t ives t o t h ose p r og ra m s o r p
p.000015: r oce- d ur es; o r
p.000015: ( iv) P ossible c han ges i n m e t h ods o r levels of p ay m e n t fo r be n efi t s o r se r v-
p.000015: ices un de r t h ose p r og ra m s.
p.000015:
p.000015: 28 CFR Ch. I (7–1–03 Edition)
p.000015: (6) Ta s t e an d food q ua li t y ev a l ua t io n an d co n s u m e r a ccep t an ce s t u dies,
p.000015: ( i) If w h oleso m e foods wi t h o u t a ddi- t ives ar e co n s u m ed o r
p.000015: ( ii) If a food is co n s u m ed t ha t co n- t a i n s a food i n g r edie n t a t o r below t
p.000015: h e level an d fo r a u se fo un d t o be s afe, o r a g r ic u l t ura l c h e m ic a l o r
p.000015: e n vi r o n- m e n t a l co n t a m i nan t a t o r below t h e level fo un d t o be s afe, b y t
p.000015: h e F ood an d D ru g Ad m i n is t ra t io n o r a pp r oved b y t h e En vi r o n m e n t a l P r o
p.000015: t ec t io n Age n c y o r t h e F ood Safe t y an d I n spec t io n S e r vice of t h e U. S .
p.000015: Dep ar tm e n t of Ag r i- c u l t ur e.
p.000015: ( c) Dep ar tm e n t o r a ge n c y h e a ds r e- t a i n fi na l j u dg m e n t a s t o w h e t
p.000015: h e r a p ar t ic u l ar a c t ivi t y is cove r ed b y t h is polic y .
p.000015: ( d) Dep ar tm e n t o r a ge n c y h e a ds m ay r eq u i r e t ha t specific r ese ar c h a c t ivi t
p.000015: ies o r cl a sses of r ese ar c h a c t ivi t ies co n- d u c t ed, s u ppo r t ed, o r o t h e r wise
p.000015: s u bjec t t o r eg u l a t io n b y t h e dep ar tm e n t o r a ge n c y b u t n o t o t h e r
p.000015: wise cove r ed b y t h is polic y , co m pl y wi t h so m e o r a ll of t h e r eq u i r e m e n t s of t
p.000015: h is polic y .
p.000015: ( e) Co m pli an ce wi t h t h is polic y r e- q u i r es co m pli an ce wi t h pe r t i n e n t
p.000015: fed- e ra l l a ws o r r eg u l a t io n s w h ic h p r ovide a ddi t io na l p r o t ec t io n s fo r
p.000015: hu m an s u b- jec t s.
p.000015: (f) Th is polic y does n o t affec t any s t a t e o r loc a l l a ws o r r eg u l a t io n s w h
p.000015: ic h m ay o t h e r wise be a pplic a ble an d w h ic h p r ovide a ddi t io na l p r o t ec t io n s
p.000015: fo r hu m an s u bjec t s.
p.000015: ( g) Th is polic y does n o t affec t any fo r eig n l a ws o r r eg u l a t io n s w h ic h m ay
p.000015: o t h e r wise be a pplic a ble an d w h ic h p r o- vide a ddi t io na l p r o t ec t io n s t o hu m an
p.000015: s u bjec t s of r ese ar c h .
p.000015: ( h) Wh e n r ese ar c h cove r ed b y t h is polic y t a k es pl a ce i n fo r eig n co un t r
...
p.000016: ( i) U n less o t h e r wise r eq u i r ed b y l a w, dep ar tm e n t o r a ge n c y h e a ds m ay w a
p.000016: ive t h e a pplic a bili t y of so m e o r a ll of t h e p r ovisio n s of t h is polic y t o
p.000016: specific r e- se ar c h a c t ivi t ies o r cl a sses of r ese ar c h a c t ivi t ies o t h e r wise
p.000016: cove r ed b y t h is polic y . E xcep t w h e n o t h e r wise r eq u i r ed b y s t a t u t e o r E
p.000016: xec u t ive Or de r , t h e de- p ar tm e n t o r a ge n c y h e a d s ha ll fo r w ar d a dv an ce n o t
p.000016: ices of t h ese a c t io n s t o t h e Office fo r P r o t ec t io n f r o m R ese ar c h R is k s,
p.000016: Dep ar tm e n t of He a l t h an d H u m an S e r vices ( HH S), an d s ha ll a lso p u blis h
p.000016: t h e m i n t h e F E D ER A L R E GI STER o r i n s u c h o t h e r m ann e r a s p r ovided i n dep
p.000016: ar tm e n t o r a ge n c y p r oced ur es. 1
p.000016: [56 F R 28012 an d 28020, J un e 18, 1991; 56 F R
p.000016: 29756, J un e 28, 1991]
p.000016:
p.000016: § 46.102 Definitions.
p.000016: ( a) Department or agency head m e an s t h e h e a d of any fede ra l dep ar tm e n t o r a ge n
p.000016: c y an d any o t h e r office r o r e m - plo y ee of any dep ar tm e n t o r a ge n c y t o w h
p.000016: o m au t h o r i t y ha s bee n deleg a t ed.
p.000016:
p.000016: 1 I n s t i t u t io n s wi t h HH S- a pp r oved a ss ur- an ces o n file will a bide b y p r ovisio
p.000016: n s of t i t le
p.000016: 45 C F R p ar t 46 s u bp ar t s A–D. S o m e of t h e o t h e r Dep ar tm e n t s an d Age n cies
p.000016: ha ve i n co r -
p.000016: po ra t ed a ll p r ovisio n s of t i t le 45 C F R p ar t 46 i n t o t h ei r policies an d p r oced
p.000016: ur es a s well. Howeve r , t h e exe m p t io n s a t 45 C F R 46.101( b) do n o t a ppl y t o r ese
p.000016: ar c h i n volvi n g p r iso n e r s, fe t u ses, p r eg nan t wo m e n , o r hu m an i n vi t r o fe r t
p.000016: iliza t io n , s u bp ar t s B an d C. Th e exe m p- t io n a t 45 C F R 46.101( b)(2), fo r r
p.000016: ese ar c h i n- volvi n g s ur ve y o r i n t e r view p r oced ur es o r ob-
p.000016: se r v a t io n of p u blic be ha vio r , does n o t a ppl y t o r ese ar c h wi t h c h ild r e n , s
p.000016: u bp ar t D, excep t fo r r ese ar c h i n volvi n g obse r v a t io n s of p u blic be ha vio r w h e n t h
p.000016: e i n ves t ig a t o r ( s) do n o t p ar- t icip a t e i n t h e a c t ivi t ies bei n g obse r ved.
p.000016:
p.000017: 17
p.000017:
p.000017: ( b) I nstit u tion m e an s any p u blic o r p r iv a t e e n t i t y o r a ge n c y ( i n cl u di n
p.000017: g fed- e ra l , s t a t e, an d o t h e r a ge n cies).
p.000017: ( c) Legally authorized representative m e an s an i n divid ua l o r j u dici a l o r o t h
p.000017: e r bod y au t h o r ized un de r a pplic a ble l a w t o co n se n t o n be ha lf of a p r ospec- t
p.000017: ive s u bjec t t o t h e s u bjec t ’s p ar t icip a- t io n i n t h e p r oced ur e( s) i n volved i n
p.000017: t h e r ese ar c h .
p.000017: ( d) Research m e an s a s y s t e m a t ic i n- ves t ig a t io n , i n cl u di n g r ese ar c h
p.000017: devel- op m e n t , t es t i n g an d ev a l ua t io n , de- sig n ed t o develop o r co n t r ib u t
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000020: of i t s de- cisio n t o a pp r ove o r dis a pp r ove t h e p r o- posed r ese ar c h a c t ivi t y , o r
p.000020: of m odific a-
p.000020: t io n s r eq u i r ed t o sec ur e I R B a pp r ov a l of t h e r ese ar c h a c t ivi t y . If t h e
p.000020: I R B de- cides t o dis a pp r ove a r ese ar c h a c t ivi t y ,
p.000020: i t s ha ll i n cl u de i n i t s w r i tt e n n o t ific a- t io n a s t a t e m e n t of t h e r e
p.000020: a so n s fo r i t s decisio n an d give t h e i n ves t ig a t o r an oppo r t un i t y t o r espo n d
p.000020: i n pe r so n o r i n w r i t i n g.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Department of Justice § 46.111
p.000020:
p.000020:
p.000020: ( e) A n I R B s ha ll co n d u c t co n t i nu i n g r eview of r ese ar c h cove r ed b y t h is
p.000020: pol-
p.000020: ic y a t i n t e r v a ls a pp r op r i a t e t o t h e de- g r ee of r is k , b u t n o t less t
p.000020: han o n ce pe r y e ar , an d s ha ll ha ve au t h o r i t y t o ob- se r ve o r ha ve a t h i r d
p.000020: p ar t y obse r ve t h e co n se n t p r ocess an d t h e r ese ar c h .
p.000020: ( App r oved b y t h e Office of M ana ge m e n t an d B u dge t un de r co n t r ol nu m be r 9999–0020)
p.000020:
p.000020: § 46.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000020: minor changes in approved re- search.
p.000020: ( a) Th e S ec r e t ary , HH S , ha s es t a b- lis h ed, an d p u blis h ed a s a No t ice i n t h e
p.000020: F E D ER A L R E GI STER , a lis t of c a t ego r ies of r ese ar c h t ha t m ay be r eviewed b
p.000020: y t h e I R B t hr o u g h an expedi t ed r eview p r oced ur e. Th e lis t will be a m e n ded, a s a
p.000020: pp r op r i a t e af t e r co n s u l t a t io n wi t h o t h e r dep ar tm e n t s an d
p.000020: a ge n cies, t hr o u g h pe r iodic r ep u blic a t io n b y t h e
p.000020: S ec r e t ary , HH S , i n t h e F E D ER A L R E G- I STER . A cop y of t h e lis t is a v
p.000020: a il a ble f r o m t h e Office fo r P r o t ec t io n f r o m R e- se ar c h R is k s, N a t io na l I
p.000020: n s t i t u t es of He a l t h , HH S , Be t h esd a , M ary l an d 20892.
p.000020: ( b) A n I R B m ay u se t h e expedi t ed r e- view p r oced ur e t o r eview ei t h e r o r bo t h of t
p.000020: h e followi n g:
p.000020: (1) S o m e o r a ll of t h e r ese ar c h a p- pe ar i n g o n t h e lis t an d fo un d b y t h e
p.000020: r e- viewe r ( s) t o i n volve n o m o r e t han m i n i- m a l r is k ,
p.000020: (2) Mi n o r c han ges i n p r evio u sl y a p- p r oved r ese ar c h d ur i n g t h e pe r iod (
p.000020: of o n e y e ar o r less) fo r w h ic h a pp r ov a l is au t h o r ized.
p.000020: U n de r an expedi t ed r eview p r oced ur e, t h e r eview m ay be c arr ied o u t b y t h e
p.000020: I R B c ha i r pe r so n o r b y o n e o r m o r e ex- pe r ie n ced r eviewe r s desig na t ed b y
p.000020: t h e
...
Orphaned Trigger Words
p.000015: 46.104–46.106 [ R ese r ved]
p.000015: 46.107 I R B Me m be r s h ip.
p.000015: 46.108 I R B fun c t io n s an d ope ra t io n s.
p.000015: 46.109 I R B r eview of r ese ar c h .
p.000015: 46.110 E xpedi t ed r eview p r oced ur es fo r ce r - t a i n k i n ds of r ese ar c h i n volvi n g
p.000015: n o m o r e
p.000015: t han m i n i m a l r is k , an d fo r m i n o r c han ges i n a pp r oved r ese ar c h .
p.000015: 46.111 Cr i t e r i a fo r I R B a pp r ov a l of r ese ar c h .
p.000015: 46.112 R eview b y i n s t i t u t io n .
p.000015: 46.113 Su spe n sio n o r t e r m i na t io n of I R B a p- p r ov a l of r ese ar c h .
p.000015: 46.114 Coope ra t ive r ese ar c h .
p.000015: 46.115 I R B r eco r ds.
p.000015: 46.116 Ge n e ra l r eq u i r e m e n t s fo r i nfo r m ed co n se n t .
p.000015: 46.117 Doc u m e n t a t io n of i nfo r m ed co n se n t .
p.000015: 46.118 Applic a t io n s an d p r opos a ls l a c k i n g defi n i t e pl an s fo r i n volve m e n t
p.000015: of hu m an s u bjec t s.
p.000015: 46.119 R ese ar c h un de r t a k e n wi t h o u t t h e i n- t e n t io n of i n volvi n g hu m an s u
p.000015: bjec t s.
p.000015: 46.120 E v a l ua t io n an d disposi t io n of a pplic a- t io n s an d p r opos a ls fo r r ese ar
p.000015: c h t o be co n d u c t ed o r s u ppo r t ed b y a F ede ra l De- p ar tm e n t o r Age n c y .
p.000015: 46.121 [ R ese r ved]
p.000015: 46.122 Use of F ede ra l fun ds.
p.000015:
p.000015: 46.123 Ear l y t e r m i na t io n of r ese ar c h s u p- po r t : E v a l ua t io n of a pplic a t
p.000015: io n s an d p r o- pos a ls.
p.000015: 46.124 Co n di t io n s.
p.000015: AU T HOR I T Y: 5 U. S .C. 301; 28 U. S .C. 509–510; 42 U. S .C. 300v–1( b).
p.000015: SOU RCE: 56 F R 28012, 28020, J un e 18, 1991,
p.000015: un less o t h e r wise n o t ed.
p.000015:
p.000015: § 46.101 To what does this policy apply?
p.000015: ( a) E xcep t a s p r ovided i n p ara g ra p h ( b) of t h is sec t io n , t h is polic y a
p.000015: pplies t o a ll r ese ar c h i n volvi n g hu m an s u b- jec t s co n d u c t ed, s u ppo r t ed o r o t
p.000015: h e r wise s u bjec t t o r eg u l a t io n b y any fede ra l de- p ar tm e n t o r a ge n c y w h ic h t a k
p.000015: es a pp r o- p r i a t e a d m i n is t ra t ive a c t io n t o m a k e t h e polic y a pplic a ble t o
p.000015: s u c h r ese ar c h . Th is i n cl u des r ese ar c h co n d u c t ed b y fede ra l civili an e m
p.000015: plo y ees o r m ili t ary pe r so nn el, excep t t ha t e a c h dep ar tm e n t o r a ge n c y h e a d m
p.000015: ay a dop t s u c h p r oce- d ura l m odific a t io n s a s m ay be a pp r o- p r i a t e f r o m
p.000015: an a d m i n is t ra t ive s t an d- poi n t . I t a lso i n cl u des r ese ar c h co n- d u c t
p.000015: ed, s u ppo r t ed, o r o t h e r wise s u bjec t t o r eg u l a t io n b y t h e fede ra l gove rn-
p.000015: m e n t o u t side t h e U n i t ed S t a t es.
p.000015: (1) R ese ar c h t ha t is co n d u c t ed o r s u p- po r t ed b y a fede ra l dep ar tm e n t
p.000015: o r a ge n c y , w h e t h e r o r n o t i t is r eg u l a t ed a s defi n ed i n § 46.102( e), m u
p.000015: s t co m pl y wi t h a ll sec t io n s of t h is polic y .
p.000015: (2) R ese ar c h t ha t is n ei t h e r co n- d u c t ed n o r s u ppo r t ed b y a fede ra
p.000015: l de- p ar tm e n t o r a ge n c y b u t is s u bjec t t o r eg u l a t io n a s defi n ed i n §
p.000015: 46.102( e) m u s t be r eviewed an d a pp r oved, i n co m pli-
p.000015: an ce wi t h § 46.101, § 46.102, an d § 46.107 t hr o u g h § 46.117 of t h is polic y , b y an i n- s
p.000015: t i t u t io na l r eview bo ar d ( I R B) t ha t op- e ra t es i n a cco r d an ce wi t h t h e pe r t i n e
p.000015: n t r eq u i r e m e n t s of t h is polic y .
p.000015: ( b) U n less o t h e r wise r eq u i r ed b y de- p ar tm e n t o r a ge n c y h e a ds, r ese ar c h a
p.000015: c- t ivi t ies i n w h ic h t h e o n l y i n volve m e n t of hu m an s u bjec t s will be i n o n
p.000015: e o r m o r e of t h e followi n g c a t ego r ies ar e exe m p t f r o m t h is polic y:
p.000015: (1) R ese ar c h co n d u c t ed i n es t a blis h ed o r co mm o n l y a ccep t ed ed u c a t io na l se t - t
p.000015: i n gs, i n volvi n g n o r m a l ed u c a t io na l p ra c t ices, s u c h a s ( i) r ese ar c h
p.000015: o n r eg- u l ar an d speci a l ed u c a t io n i n s t ru c- t io na l s t ra t egies, o r ( ii)
p.000015: r ese ar c h o n t h e effec t ive n ess of o r t h e co m p ar iso n
p.000015:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: § 46.101
p.000015: a m o n g i n s t ru c t io na l t ec hn iq u es, c ur- r ic u l a , o r cl a ss r oo m m ana
p.000015: ge m e n t m e t h ods.
p.000015: (2) R ese ar c h i n volvi n g t h e u se of ed u- c a t io na l t es t s ( cog n i t ive, di a g n os t
p.000015: ic, a p t i t u de, a c h ieve m e n t ), s ur ve y p r oce- d ur es, i n t e r view p r oced ur es o r obse
p.000015: r v a- t io n of p u blic be ha vio r , un less:
p.000015: ( i) I nfo r m a t io n ob t a i n ed is r eco r ded i n s u c h a m ann e r t ha t hu m an s u
p.000015: bjec t s c an be ide n t ified, di r ec t l y o r t hr o u g h ide n t ifie r s li n k ed t o t h e s u
p.000015: bjec t s; an d
p.000015: ( ii) A ny disclos ur e of t h e hu m an s u b- jec t s’ r espo n ses o u t side t h e r ese ar c h
p.000015: co u ld r e a so na bl y pl a ce t h e s u bjec t s a t r is k of c r i m i na l o r civil li a bili t
p.000015: y o r be d a m a gi n g t o t h e s u bjec t s’ fi nan ci a l s t an di n g, e m plo ya bili t y ,
p.000015: o r r ep u t a t io n .
p.000015: (3) R ese ar c h i n volvi n g t h e u se of ed u- c a t io na l t es t s ( cog n i t ive, di a g n os t
p.000015: ic, a p t i t u de, a c h ieve m e n t ), s ur ve y p r oce- d ur es, i n t e r view p r oced ur es, o r
p.000015: obse r - v a t io n of p u blic be ha vio r t ha t is n o t exe m p t un de r p ara g ra p h ( b)(2)
p.000015: of t h is sec t io n , if:
p.000015: ( i) Th e hu m an s u bjec t s ar e elec t ed o r a ppoi n t ed p u blic offici a ls o r c an did a t es fo r
p.000015: p u blic office; o r
p.000015: ( ii) F ede ra l s t a t u t e( s) r eq u i r e( s) wi t h- o u t excep t io n t ha t t h e co nfide n t i
p.000015: a li t y
p.000015: of t h e pe r so na ll y ide n t ifi a ble i nfo r m a- t io n will be m a i n t a i n ed t hr o u g h o u
p.000015: t t h e r ese ar c h an d t h e r e af t e r .
p.000015: (4) R ese ar c h , i n volvi n g t h e collec t io n o r s t u d y of exis t i n g d a t a , doc u m e n
p.000015: t s, r eco r ds, p a t h ologic a l speci m e n s, o r di- a g n os t ic speci m e n s, if t h ese so ur
p.000015: ces ar e p u blicl y a v a il a ble o r if t h e i nfo r m a t io n is r eco r ded b y t h e i n ves t ig a
p.000015: t o r i n s u c h a m ann e r t ha t s u bjec t s c ann o t be ide n- t ified, di r ec t l y o r t hr
p.000015: o u g h ide n t ifie r s li n k ed t o t h e s u bjec t s.
p.000015: (5) R ese ar c h an d de m o n s t ra t io n p r ojec t s w h ic h ar e co n d u c t ed b y o r s
p.000015: u b- jec t t o t h e a pp r ov a l of dep ar tm e n t o r a ge n c y h e a ds, an d w h ic h ar e
p.000015: desig n ed t o s t u d y , ev a l ua t e, o r o t h e r wise ex a m - i n e:
p.000015: ( i) P u blic be n efi t o r se r vice p r o- g ra m s;
p.000015: ( ii) P r oced ur es fo r ob t a i n i n g be n efi t s o r se r vices un de r t h ose p r og ra m s;
p.000015: ( iii) P ossible c han ges i n o r a l t e r - na t ives t o t h ose p r og ra m s o r p
p.000015: r oce- d ur es; o r
p.000015: ( iv) P ossible c han ges i n m e t h ods o r levels of p ay m e n t fo r be n efi t s o r se r v-
p.000015: ices un de r t h ose p r og ra m s.
p.000015:
p.000015: 28 CFR Ch. I (7–1–03 Edition)
p.000015: (6) Ta s t e an d food q ua li t y ev a l ua t io n an d co n s u m e r a ccep t an ce s t u dies,
p.000015: ( i) If w h oleso m e foods wi t h o u t a ddi- t ives ar e co n s u m ed o r
p.000015: ( ii) If a food is co n s u m ed t ha t co n- t a i n s a food i n g r edie n t a t o r below t
p.000015: h e level an d fo r a u se fo un d t o be s afe, o r a g r ic u l t ura l c h e m ic a l o r
p.000015: e n vi r o n- m e n t a l co n t a m i nan t a t o r below t h e level fo un d t o be s afe, b y t
p.000015: h e F ood an d D ru g Ad m i n is t ra t io n o r a pp r oved b y t h e En vi r o n m e n t a l P r o
p.000015: t ec t io n Age n c y o r t h e F ood Safe t y an d I n spec t io n S e r vice of t h e U. S .
p.000015: Dep ar tm e n t of Ag r i- c u l t ur e.
p.000015: ( c) Dep ar tm e n t o r a ge n c y h e a ds r e- t a i n fi na l j u dg m e n t a s t o w h e t
p.000015: h e r a p ar t ic u l ar a c t ivi t y is cove r ed b y t h is polic y .
p.000015: ( d) Dep ar tm e n t o r a ge n c y h e a ds m ay r eq u i r e t ha t specific r ese ar c h a c t ivi t
p.000015: ies o r cl a sses of r ese ar c h a c t ivi t ies co n- d u c t ed, s u ppo r t ed, o r o t h e r wise
p.000015: s u bjec t t o r eg u l a t io n b y t h e dep ar tm e n t o r a ge n c y b u t n o t o t h e r
p.000015: wise cove r ed b y t h is polic y , co m pl y wi t h so m e o r a ll of t h e r eq u i r e m e n t s of t
p.000015: h is polic y .
...
p.000016: t h e m i n t h e F E D ER A L R E GI STER o r i n s u c h o t h e r m ann e r a s p r ovided i n dep
p.000016: ar tm e n t o r a ge n c y p r oced ur es. 1
p.000016: [56 F R 28012 an d 28020, J un e 18, 1991; 56 F R
p.000016: 29756, J un e 28, 1991]
p.000016:
p.000016: § 46.102 Definitions.
p.000016: ( a) Department or agency head m e an s t h e h e a d of any fede ra l dep ar tm e n t o r a ge n
p.000016: c y an d any o t h e r office r o r e m - plo y ee of any dep ar tm e n t o r a ge n c y t o w h
p.000016: o m au t h o r i t y ha s bee n deleg a t ed.
p.000016:
p.000016: 1 I n s t i t u t io n s wi t h HH S- a pp r oved a ss ur- an ces o n file will a bide b y p r ovisio
p.000016: n s of t i t le
p.000016: 45 C F R p ar t 46 s u bp ar t s A–D. S o m e of t h e o t h e r Dep ar tm e n t s an d Age n cies
p.000016: ha ve i n co r -
p.000016: po ra t ed a ll p r ovisio n s of t i t le 45 C F R p ar t 46 i n t o t h ei r policies an d p r oced
p.000016: ur es a s well. Howeve r , t h e exe m p t io n s a t 45 C F R 46.101( b) do n o t a ppl y t o r ese
p.000016: ar c h i n volvi n g p r iso n e r s, fe t u ses, p r eg nan t wo m e n , o r hu m an i n vi t r o fe r t
p.000016: iliza t io n , s u bp ar t s B an d C. Th e exe m p- t io n a t 45 C F R 46.101( b)(2), fo r r
p.000016: ese ar c h i n- volvi n g s ur ve y o r i n t e r view p r oced ur es o r ob-
p.000016: se r v a t io n of p u blic be ha vio r , does n o t a ppl y t o r ese ar c h wi t h c h ild r e n , s
p.000016: u bp ar t D, excep t fo r r ese ar c h i n volvi n g obse r v a t io n s of p u blic be ha vio r w h e n t h
p.000016: e i n ves t ig a t o r ( s) do n o t p ar- t icip a t e i n t h e a c t ivi t ies bei n g obse r ved.
p.000016:
p.000017: 17
p.000017:
p.000017: ( b) I nstit u tion m e an s any p u blic o r p r iv a t e e n t i t y o r a ge n c y ( i n cl u di n
p.000017: g fed- e ra l , s t a t e, an d o t h e r a ge n cies).
p.000017: ( c) Legally authorized representative m e an s an i n divid ua l o r j u dici a l o r o t h
p.000017: e r bod y au t h o r ized un de r a pplic a ble l a w t o co n se n t o n be ha lf of a p r ospec- t
p.000017: ive s u bjec t t o t h e s u bjec t ’s p ar t icip a- t io n i n t h e p r oced ur e( s) i n volved i n
p.000017: t h e r ese ar c h .
p.000017: ( d) Research m e an s a s y s t e m a t ic i n- ves t ig a t io n , i n cl u di n g r ese ar c h
p.000017: devel- op m e n t , t es t i n g an d ev a l ua t io n , de- sig n ed t o develop o r co n t r ib u t
p.000017: e t o ge n- e ra liza ble k n owledge. Ac t ivi t ies w h ic h m ee t t h is defi n i t io n co n
p.000017: s t i t u t e r e- se ar c h fo r p ur poses of t h is polic y , w h e t h e r o r n o t
p.000017: t h e y ar e co n d u c t ed o r s u ppo r t ed un de r a p r og ra m w h ic h is co n side r ed
p.000017: r ese ar c h fo r o t h e r p ur poses. F o r ex a m ple, so m e de m o n s t ra t io n an d se r vice p r
p.000017: og ra m s m ay i n cl u de r ese ar c h a c t ivi t ies.
p.000017: ( e) Research subject to regulation , an d si m il ar t e r m s ar e i n t e n ded t o e n co m - p a
p.000017: ss t h ose r ese ar c h a c t ivi t ies fo r w h ic h a fede ra l dep ar tm e n t o r a ge n c y ha
p.000017: s specific r espo n sibili t y fo r r eg u l a t i n g a s a r ese ar c h a c t ivi t y , (fo r ex a m
p.000017: ple, I n- ves t ig a t io na l New D ru g r eq u i r e m e n t s a d m i n is t e r ed b y t h e F ood an
p.000017: d D ru g Ad- m i n is t ra t io n). I t does n o t i n cl u de r e- se ar c h a c t ivi t ies w h ic
p.000017: h ar e i n cide n- t a ll y r eg u l a t ed b y a fede ra l dep ar tm e n t o r a ge n c y solel y a
p.000017: s p ar t of t h e dep ar t - m e n t ’s o r a ge n c y’s b r o a de r r espo n si- bili t y t o r
p.000017: eg u l a t e ce r t a i n t y pes of a c- t ivi t ies w h e t h e r r ese ar c h o r n o n- r e- se
p.000017: ar c h i n na t ur e (fo r ex a m ple, Wa ge an d Ho ur r eq u i r e m e n t s a d m i n is t e r
p.000017: ed b y t h e Dep ar tm e n t of La bo r ).
p.000017: (f) Human subject m e an s a livi n g i n di- vid ua l a bo u t w h o m an i n ves t ig a t o r
p.000017: ( w h e t h e r p r ofessio na l o r s t u de n t ) co n- d u c t i n g r ese ar c h ob t a i n s
p.000017: (1) D a t a t hr o u g h i n t e r ve n t io n o r i n t e ra c t io n wi t h t h e i n divid ua l ,
p.000017: o r
p.000017: (2) Ide n t ifi a ble p r iv a t e i nfo r m a t io n .
p.000017: I n terven tion i n cl u des bo t h p hy sic a l p r o- ced ur es b y w h ic h d a t a ar e g a t h e r ed
p.000017: (fo r ex a m ple, ve n ip un c t ur e) an d m an ip u l a- t io n s of t h e s u bjec t o r t h e s u bjec
p.000017: t ’s e n- vi r o n m e n t t ha t ar e pe r fo r m ed fo r r e- se ar c h p ur poses. I n t e ra c t
p.000017: io n i n cl u des co mm un ic a t io n o r i n t e r pe r so na l co n- t a c t be t wee n i n ves t ig
...
p.000017:
p.000018: 18
p.000018:
p.000018: 28 CFR Ch. I (7–1–03 Edition)
p.000018: i n q u es t io n , o n file wi t h t h e Office fo r P r o t ec t io n f r o m R ese ar c h R is k s,
p.000018: HH S , an d a pp r oved fo r fede ra lwide u se b y t ha t office. Wh e n t h e exis t e n ce
p.000018: of an HH S- a pp r oved a ss uran ce is a ccep t ed i n
p.000018: lie u of r eq u i r i n g s u b m issio n of an a s- s uran ce, r epo r t s ( excep t ce r t ific a t
p.000018: io n) r eq u i r ed b y t h is polic y t o be m a de t o dep ar tm e n t an d a ge n c y h e
p.000018: a ds s ha ll a lso be m a de t o t h e Office fo r P r o t ec- t io n f r o m R ese ar c h R is k
p.000018: s, HH S .
p.000018: ( b) Dep ar tm e n t s an d a ge n cies will co n d u c t o r s u ppo r t r ese ar c h cove r ed b y t
p.000018: h is polic y o n l y if t h e i n s t i t u t io n ha s an a ss uran ce a pp r oved a s p r ovided
p.000018: i n
p.000018: t h is sec t io n , an d o n l y if t h e i n s t i t u t io n ha s ce r t ified t o t h e dep ar
p.000018: tm e n t o r a ge n c y h e a d t ha t t h e r ese ar c h ha s bee n r eviewed an d a pp r oved b y
p.000018: an I R B p r o- vided fo r i n t h e a ss uran ce, an d will be s u bjec t t o co n t i nu i n g
p.000018: r eview b y t h e I R B. Ass uran ces a pplic a ble t o fede ra ll y
p.000018: s u ppo r t ed o r co n d u c t ed r ese ar c h s ha ll a t a m i n i m u m i n cl u de:
p.000018: (1) A s t a t e m e n t of p r i n ciples gov- e rn i n g t h e i n s t i t u t io n i n t h e
p.000018: disc har ge of i t s r espo n sibili t ies fo r p r o t ec t i n g t h e r ig h t s an d welfar e of hu m an
p.000018: s u bjec t s of r ese ar c h co n d u c t ed a t o r spo n so r ed b y t h e i n s t i t u t io n , r eg
...
p.000018: ay n o t be i n i t i a t ed wi t h o u t I R B r eview an d a pp r ov a l excep t w h e n n
p.000018: ecess ary t o eli m i na t e a pp ar e n t i mm edi a t e hazar ds t o t h e s u bjec t .
p.000018: (5) Wr i tt e n p r oced ur es fo r e n s ur i n g p r o m p t r epo r t i n g t o t h e I R B,
p.000018: a pp r o- p r i a t e i n s t i t u t io na l offici a ls, an d t h e dep ar tm e n t o r a ge n c y h e
p.000018: a d of ( i) any unan t icip a t ed p r oble m s i n volvi n g r is k s
p.000018: t o s u bjec t s o r o t h e r s o r any se r io u s o r co n t i nu i n g n o n co m pli an ce wi t h
p.000018: t h is polic y o r t h e r eq u i r e m e n t s o r de t e r - m i na t io n s of t h e I R B
p.000018: an d ( ii) any s u s- pe n sio n o r t e r m i na t io n of I R B a p- p r ov a l .
p.000018: ( c) Th e a ss uran ce s ha ll be exec u t ed b y an i n divid ua l au t h o r ized t o a c t fo
p.000018: r t h e i n s t i t u t io n an d t o a ss u m e o n be ha lf of t h e i n s t i t u t io n t h e oblig a
p.000018: t io n s i m - posed b y t h is polic y an d s ha ll be filed i n s u c h fo r m an d m ann e r a
p.000018: s t h e dep ar t - m e n t o r a ge n c y h e a d p r esc r ibes.
p.000018: ( d) Th e dep ar tm e n t o r a ge n c y h e a d will ev a l ua t e a ll a ss uran ces s u b m i tt
p.000018: ed i n a cco r d an ce wi t h t h is polic y t hr o u g h s u c h office r s an d e m plo y ees of t
p.000018: h e de- p ar tm e n t o r a ge n c y an d s u c h expe r t s o r co n s u l t an t s e n g a ged fo r t
p.000018: h is p ur pose a s t h e dep ar tm e n t o r a ge n c y h e a d de- t e r m i n es t o be a pp r op r i
p.000018: a t e. Th e dep ar t - m e n t o r a ge n c y h e a d’s ev a l ua t io n will
p.000018:
p.000019: 19
p.000019:
p.000019: t a k e i n t o co n side ra t io n t h e a deq ua c y of t h e p r oposed I R B i n lig h t of t h e
p.000019: an- t icip a t ed scope of t h e i n s t i t u t io n’s r e- se ar c h a c t ivi t ies an d t h e t y
p.000019: pes of s u b- jec t pop u l a t io n s li k el y t o be i n volved, t h e a pp r op r i a t e n ess of
p.000019: t h e p r oposed i n i- t i a l an d co n t i nu i n g r eview p r oced ur es i n lig h t of t h e p
p.000019: r ob a ble r is k s, an d t h e size an d co m plexi t y of t h e i n s t i t u t io n .
p.000019: ( e) On t h e b a sis of t h is ev a l ua t io n , t h e dep ar tm e n t o r a ge n c y h e a d
p.000019: m ay a pp r ove o r dis a pp r ove t h e a ss uran ce, o r e n t e r i n t o n ego t i a t io n s t o
p.000019: develop an a pp r ov a ble o n e. Th e dep ar tm e n t o r a ge n c y h e a d m ay li m i t t h
p.000019: e pe r iod d ur- i n g w h ic h any p ar t ic u l ar a pp r oved a s- s uran ce o r cl a ss of a pp r
p.000019: oved a ss uran ces
p.000019: s ha ll r e m a i n effec t ive o r o t h e r wise co n di t io n o r r es t r ic t a pp r ov a l .
p.000019: (f) Ce r t ific a t io n is r eq u i r ed w h e n t h e r ese ar c h is s u ppo r t ed b y a fede ra l
p.000019: de- p ar tm e n t o r a ge n c y an d n o t o t h e r wise exe m p t ed o r w a ived un de r § 46.101 (
p.000019: b) o r ( i). A n i n s t i t u t io n wi t h an a pp r oved a s- s uran ce s ha ll ce r t ify t ha t e a c h
p.000019: a pplic a- t io n o r p r opos a l fo r r ese ar c h cove r ed b y t h e a ss uran ce an d b y §
p.000019: 46.103 of t h is P olic y ha s bee n r eviewed an d a pp r oved
p.000019: b y t h e I R B. Su c h ce r t ific a t io n m u s t be s u b m i tt ed wi t h t h e a pplic a t io n o
p.000019: r p r o- pos a l o r b y s u c h l a t e r d a t e a s m ay be p r esc r ibed b y t h e dep ar
p.000019: tm e n t o r a ge n- c y t o w h ic h t h e a pplic a t io n o r p r opos a l is s u b m i tt ed. U n de r
p.000019: n o co n di t io n s ha ll r ese ar c h cove r ed b y § 46.103 of t h e P ol- ic y be s u ppo r t ed
p.000019: p r io r t o r eceip t of t h e ce r t ific a t io n t ha t t h e r ese ar c h ha s bee n
p.000019: r eviewed an d a pp r oved b y t h e I R B. I n- s t i t u t io n s wi t h o u t an a pp r oved a ss
p.000019: ur- an ce cove r i n g t h e r ese ar c h s ha ll ce r t ify wi t h i n 30 d ay s af t e r r eceip t of a r
p.000019: eq u es t fo r s u c h a ce r t ific a t io n f r o m t h e de- p ar tm e n t o r a ge n c y , t ha
p.000019: t t h e a pplic a- t io n o r p r opos a l ha s bee n a pp r oved b y
p.000019: t h e I R B. If t h e ce r t ific a t io n is n o t s u b- m i tt ed wi t h i n t h ese t i m e li m i
p.000019: t s, t h e a pplic a t io n o r p r opos a l m ay be r e- t urn ed t o t h e i n s t i t u t io n
p.000019: .
p.000019: ( App r oved b y t h e Office of M ana ge m e n t an d B u dge t un de r co n t r ol nu m be r 9999–0020)
p.000019: [56 F R 28012 an d 28020, J un e 18, 1991; 56 F R
p.000019: 29756, J un e 28, 1991]
p.000019: §§ 46.104–46.106 [Reserved]
p.000019: § 46.107 IRB membership.
p.000019: ( a) Ea c h I R B s ha ll ha ve a t le a s t five m e m be r s, wi t h v ary i n g b a c k g r o un ds
p.000019: t o p r o m o t e co m ple t e an d a deq ua t e r eview
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: § 46.108
p.000019: of r ese ar c h a c t ivi t ies co mm o n l y co n- d u c t ed b y t h e i n s t i t u t io n . Th
p.000019: e I R B s ha ll be s ufficie n t l y q ua lified t hr o u g h
p.000019: t h e expe r ie n ce an d expe r t ise of i t s m e m be r s, an d t h e dive r si t y of
p.000019: t h e m e m be r s, i n cl u di n g co n side ra t io n of ra ce, ge n de r , an d c u l t ura l b a c
p.000019: k g r o un ds an d se n si t ivi t y t o s u c h iss u es a s co m - m un i t y a tt i t u des, t o p
p.000019: r o m o t e r espec t fo r i t s a dvice an d co un sel i n s afe- g uar di n g t h e r ig h
p.000019: t s an d welfar e of hu m an s u bjec t s. I n a ddi t io n t o pos- sessi n g t h e p
p.000019: r ofessio na l co m pe t e n ce n ecess ary t o r eview specific r ese ar c h
p.000019: a c t ivi t ies, t h e I R B s ha ll be a ble t o a s- ce r t a i n t h e a ccep t a bili t y of
p.000019: p r oposed r ese ar c h i n t e r m s of i n s t i t u t io na l co m - m i tm e n t s an d r eg u l a t
p.000019: io n s, a pplic a ble l a w, an d s t an d ar ds of p r ofessio na l co n- d u c t an d p ra c t ice. Th e
p.000019: I R B s ha ll t h e r e- fo r e i n cl u de pe r so n s k n owledge a ble i n t h ese ar e a s. If an I
p.000019: R B r eg u l ar l y r eviews r ese ar c h t ha t i n volves a v u l n e ra ble c a t ego ry of s u
p.000019: bjec t s, s u c h a s c h ild r e n , p r iso n e r s, p r eg nan t wo m e n , o r han di- c a pped o
p.000019: r m e n t a ll y dis a bled pe r so n s, co n side ra t io n s ha ll be give n t o t h e i n- cl u
p.000019: sio n of o n e o r m o r e i n divid ua ls w h o ar e k n owledge a ble a bo u t an d expe r i- e n
p.000019: ced i n wo r k i n g wi t h t h ese s u bjec t s.
p.000019: ( b) E ve ry n o n disc r i m i na t o ry effo r t will be m a de t o e n s ur e t ha t n o
p.000019: I R B co n sis t s e n t i r el y of m e n o r e n t i r el y of wo m e n , i n cl u di n g t h e i n s
p.000019: t i t u t io n’s co n- side ra t io n of q ua lified pe r so n s of bo t h sexes, so lo n g a s n o
p.000019: selec t io n is m a de
p.000019: t o t h e I R B o n t h e b a sis of ge n de r . No I R B m ay co n sis t e n t i r el y of m
p.000019: e m be r s of o n e p r ofessio n .
p.000019: ( c) Ea c h I R B s ha ll i n cl u de a t le a s t o n e m e m be r w h ose p r i m ary co n ce
p.000019: rn s ar e i n scie n t ific ar e a s an d a t le a s t o n e m e m be r w h ose p r i m ary co n ce rn s
p.000019: ar e i n n o n scie n t ific ar e a s.
p.000019: ( d) Ea c h I R B s ha ll i n cl u de a t le a s t o n e m e m be r w h o is n o t o t h e r wise
p.000019: affili- a t ed wi t h t h e i n s t i t u t io n an d w h o is n o t p ar t of t h e i mm edi a t
p.000019: e fa m il y of a pe r so n w h o is affili a t ed wi t h t h e i n s t i- t u t io n .
p.000019: ( e) No I R B m ay ha ve a m e m be r p ar- t icip a t e i n t h e I R B’s i n i t i a l o
p.000019: r co n- t i nu i n g r eview of any p r ojec t i n w h ic h
p.000019: t h e m e m be r ha s a co nflic t i n g i n t e r es t , excep t t o p r ovide i nfo r m a t io
p.000019: n r e- q u es t ed b y t h e I R B.
p.000019: (f) A n I R B m ay , i n i t s disc r e t io n , i n- vi t e i n divid ua ls wi t h co m pe t e n ce
p.000019: i n speci a l ar e a s t o a ssis t i n t h e r eview of
p.000020: 20
p.000020:
p.000020: 28 CFR Ch. I (7–1–03 Edition)
p.000020: iss u es w h ic h r eq u i r e expe r t ise be y o n d o r i n a ddi t io n t o t ha t a v a il a ble
p.000020: o n t h e I R B. Th ese i n divid ua ls m ay n o t vo t e wi t h t h e I R B.
p.000020: § 46.108 IRB functions and operations.
p.000020: I n o r de r t o fu lfill t h e r eq u i r e m e n t s of t h is polic y e a c h I R B s ha ll:
p.000020: ( a) F ollow w r i tt e n p r oced ur es i n t h e s a m e de t a il a s desc r ibed i n § 46.103( b)(4)
p.000020: an d, t o t h e ex t e n t r eq u i r ed b y ,
p.000020: § 46.103( b)(5).
p.000020: ( b) E xcep t w h e n an expedi t ed r eview p r oced ur e is u sed ( see § 46.110), r eview p r
p.000020: oposed r ese ar c h a t co n ve n ed m ee t -
p.000020: i n gs a t w h ic h a m a jo r i t y of t h e m e m - be r s of t h e I R B ar e p r ese n t ,
p.000020: i n cl u di n g a t le a s t o n e m e m be r w h ose p r i m ary co n ce rn s ar e i n n o n
p.000020: scie n t ific ar e a s. I n o r de r fo r t h e r ese ar c h t o be a pp r oved, i t s ha ll r
p.000020: eceive t h e a pp r ov a l of a m a- jo r i t y of t h ose m e m be r s p r ese n t a t t h e m ee t
p.000020: i n g.
p.000020: § 46.109 IRB review of research.
p.000020: ( a) A n I R B s ha ll r eview an d ha ve au- t h o r i t y t o a pp r ove, r eq u i r e m odific a-
p.000020: t io n s i n ( t o sec ur e a pp r ov a l), o r dis- a pp r ove a ll r ese ar c h a c t ivi t ies
p.000020: cove r ed b y t h is polic y .
p.000020: ( b) A n I R B s ha ll r eq u i r e t ha t i nfo r - m a t io n give n t o s u bjec t s a s p ar t
p.000020: of i n- fo r m ed co n se n t is i n a cco r d an ce wi t h
p.000020: § 46.116. Th e I R B m ay r eq u i r e t ha t i n- fo r m a t io n , i n a ddi t io n t o t ha t
p.000020: specifi- c a ll y m e n t io n ed i n § 46.116, be give n t o t h e s u bjec t s w h e n i n t h e I
p.000020: R B’s j u dg- m e n t t h e i nfo r m a t io n wo u ld m e an i n g- fu ll y a dd t o t h e p r o t ec t
p.000020: io n of t h e r ig h t s an d welfar e of s u bjec t s.
p.000020: ( c) A n I R B s ha ll r eq u i r e doc u m e n t a- t io n of i nfo r m ed co n se n t o r m ay w a
p.000020: ive doc u m e n t a t io n i n a cco r d an ce wi t h
p.000020: § 46.117.
p.000020: ( d) A n I R B s ha ll n o t ify i n ves t ig a t o r s an d t h e i n s t i t u t io n i n w r i t i n g
p.000020: of i t s de- cisio n t o a pp r ove o r dis a pp r ove t h e p r o- posed r ese ar c h a c t ivi t y , o r
p.000020: of m odific a-
p.000020: t io n s r eq u i r ed t o sec ur e I R B a pp r ov a l of t h e r ese ar c h a c t ivi t y . If t h e
p.000020: I R B de- cides t o dis a pp r ove a r ese ar c h a c t ivi t y ,
p.000020: i t s ha ll i n cl u de i n i t s w r i tt e n n o t ific a- t io n a s t a t e m e n t of t h e r e
p.000020: a so n s fo r i t s decisio n an d give t h e i n ves t ig a t o r an oppo r t un i t y t o r espo n d
p.000020: i n pe r so n o r i n w r i t i n g.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Department of Justice § 46.111
p.000020:
p.000020:
p.000020: ( e) A n I R B s ha ll co n d u c t co n t i nu i n g r eview of r ese ar c h cove r ed b y t h is
p.000020: pol-
p.000020: ic y a t i n t e r v a ls a pp r op r i a t e t o t h e de- g r ee of r is k , b u t n o t less t
p.000020: han o n ce pe r y e ar , an d s ha ll ha ve au t h o r i t y t o ob- se r ve o r ha ve a t h i r d
p.000020: p ar t y obse r ve t h e co n se n t p r ocess an d t h e r ese ar c h .
p.000020: ( App r oved b y t h e Office of M ana ge m e n t an d B u dge t un de r co n t r ol nu m be r 9999–0020)
p.000020:
p.000020: § 46.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000020: minor changes in approved re- search.
p.000020: ( a) Th e S ec r e t ary , HH S , ha s es t a b- lis h ed, an d p u blis h ed a s a No t ice i n t h e
p.000020: F E D ER A L R E GI STER , a lis t of c a t ego r ies of r ese ar c h t ha t m ay be r eviewed b
p.000020: y t h e I R B t hr o u g h an expedi t ed r eview p r oced ur e. Th e lis t will be a m e n ded, a s a
p.000020: pp r op r i a t e af t e r co n s u l t a t io n wi t h o t h e r dep ar tm e n t s an d
p.000020: a ge n cies, t hr o u g h pe r iodic r ep u blic a t io n b y t h e
p.000020: S ec r e t ary , HH S , i n t h e F E D ER A L R E G- I STER . A cop y of t h e lis t is a v
p.000020: a il a ble f r o m t h e Office fo r P r o t ec t io n f r o m R e- se ar c h R is k s, N a t io na l I
p.000020: n s t i t u t es of He a l t h , HH S , Be t h esd a , M ary l an d 20892.
p.000020: ( b) A n I R B m ay u se t h e expedi t ed r e- view p r oced ur e t o r eview ei t h e r o r bo t h of t
p.000020: h e followi n g:
p.000020: (1) S o m e o r a ll of t h e r ese ar c h a p- pe ar i n g o n t h e lis t an d fo un d b y t h e
p.000020: r e- viewe r ( s) t o i n volve n o m o r e t han m i n i- m a l r is k ,
p.000020: (2) Mi n o r c han ges i n p r evio u sl y a p- p r oved r ese ar c h d ur i n g t h e pe r iod (
p.000020: of o n e y e ar o r less) fo r w h ic h a pp r ov a l is au t h o r ized.
p.000020: U n de r an expedi t ed r eview p r oced ur e, t h e r eview m ay be c arr ied o u t b y t h e
p.000020: I R B c ha i r pe r so n o r b y o n e o r m o r e ex- pe r ie n ced r eviewe r s desig na t ed b y
p.000020: t h e
p.000020: c ha i r pe r so n f r o m a m o n g m e m be r s of t h e I R B. I n r eviewi n g t h e r ese ar c h
p.000020: , t h e r eviewe r s m ay exe r cise a ll of t h e au- t h o r i t ies of t h e I R B excep t t ha
p.000020: t t h e r e- viewe r s m ay n o t dis a pp r ove t h e r e- se ar c h . A r ese ar c h a c t ivi t
p.000020: y m ay be dis- a pp r oved o n l y af t e r r eview i n a cco r d- an ce wi t h t h e n o n- expedi
p.000020: t ed p r oced ur e se t fo r t h i n § 46.108( b).
p.000020: ( c) Ea c h I R B w h ic h u ses an expedi t ed r eview p r oced ur e s ha ll a dop t a m e t h od fo r
p.000020: k eepi n g a ll m e m be r s a dvised of r e- se ar c h p r opos a ls w h ic h ha ve bee n a p- p r
p.000020: oved un de r t h e p r oced ur e.
p.000020:
p.000020: ( d) Th e dep ar tm e n t o r a ge n c y h e a d m ay r es t r ic t , s u spe n d, t e r m i na t e,
p.000020: o r c h oose n o t t o au t h o r ize an i n s t i t u- t io n’s o r I R B’s u se of t h e
p.000020: expedi t ed r e- view p r oced ur e.
p.000020: § 46.111 Criteria for IRB approval of research.
p.000020: ( a) I n o r de r t o a pp r ove r ese ar c h cov- e r ed b y t h is polic y t h e I R B s ha ll de t
p.000020: e r - m i n e t ha t a ll of t h e followi n g r eq u i r e- m e n t s ar e s a t isfied:
p.000020: (1) R is k s t o s u bjec t s ar e m i n i m ized: ( i) B y u si n g p r oced ur es w h ic h ar e co
p.000020: n- sis t e n t wi t h so un d r ese ar c h desig n an d w h ic h do n o t unn ecess ar il y expose s u b-
p.000020: jec t s t o r is k , an d ( ii) w h e n eve r a pp r o- p r i a t e, b y u si n g p r oced ur es
p.000020: a l r e a d y bei n g pe r fo r m ed o n t h e s u bjec t s fo r di- a g n os t ic o r t r e a tm e n t p
p.000020: ur poses.
p.000020: (2) R is k s t o s u bjec t s ar e r e a so na ble i n r el a t io n t o an t icip a t ed be n efi t
p.000020: s, if any , t o s u bjec t s, an d t h e i m po r t an ce of t h e k n owledge t ha t m ay r e a so na
p.000020: bl y be expec t ed t o r es u l t . I n ev a l ua t i n g r is k s an d be n efi t s, t h e I R B s
p.000020: h o u ld co n side r o n l y t h ose r is k s an d be n efi t s t ha t m ay r es u l t f r o m t h e
p.000020: r ese ar c h ( a s dis t i n- g u is h ed f r o m r is k s an d be n efi t s of t h e ra pies
p.000020: s u bjec t s wo u ld r eceive eve n if n o t p ar t icip a t i n g i n t h e r ese ar c h). Th e I R B s
p.000020: h o u ld n o t co n side r possible lo n g- ran ge effec t s of a ppl y i n g k n owledge g a i n
p.000020: ed i n t h e r ese ar c h (fo r ex a m ple, t h e possible effec t s of t h e r ese ar c h o
p.000020: n p u blic polic y) a s a m o n g t h ose r ese ar c h r is k s t ha t fa ll wi t h i n t h e p ur view of
p.000020: i t s r espo n sibili t y .
p.000020: (3) S elec t io n of s u bjec t s is eq u i t a ble. I n m a k i n g t h is a ssess m e n t t h e
p.000020: I R B s h o u ld t a k e i n t o a cco un t t h e p ur poses of t h e r ese ar c h an d t h e
p.000020: se tt i n g i n w h ic h t h e r ese ar c h will be co n d u c t ed an d s h o u ld be p ar t ic u l ar
p.000020: l y cog n izan t of t h e speci a l p r oble m s of r ese ar c h i n- volvi n g v u l n e ra ble pop
p.000020: u l a t io n s, s u c h a s c h ild r e n , p r iso n e r s, p r eg nan t wo m e n , m e n t a ll y dis a
p.000020: bled pe r so n s, o r eco n o m i- c a ll y o r ed u c a t io na ll y dis a dv an t a ged pe r so n s.
p.000020: (4) I nfo r m ed co n se n t will be so u g h t f r o m e a c h p r ospec t ive s u bjec t o r t
p.000020: h e s u bjec t ’s leg a ll y au t h o r ized r ep r ese n t a- t ive, i n a cco r d an ce wi t h , an d t o t
p.000020: h e ex- t e n t r eq u i r ed b y § 46.116.
p.000020: (5) I nfo r m ed co n se n t will be a pp r o- p r i a t el y doc u m e n t ed, i n a cco r d an
p.000020: ce wi t h , an d t o t h e ex t e n t r eq u i r ed b y
p.000020: § 46.117.
p.000020:
p.000021: 21
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: § 46.112
p.000021: (6) Wh e n a pp r op r i a t e, t h e r ese ar c h pl an m a k es a deq ua t e p r ovisio n
p.000021: fo r m o n i t o r i n g t h e d a t a collec t ed t o e n- s ur e t h e s afe t y of s u bjec t s.
p.000021: (7) Wh e n a pp r op r i a t e, t h e r e ar e a de- q ua t e p r ovisio n s t o p r o t ec t t h e p r
p.000021: iv a c y of s u bjec t s an d t o m a i n t a i n t h e co n- fide n t i a li t y of d a t a .
p.000021: ( b) Wh e n so m e o r a ll of t h e s u bjec t s ar e li k el y t o be v u l n e ra ble t o coe r
p.000021: cio n o r un d u e i nfl u e n ce, s u c h a s c h ild r e n , p r iso n e r s, p r eg nan t wo m e n ,
p.000021: m e n t a ll y dis a bled pe r so n s, o r eco n o m ic a ll y o r ed u c a t io na ll y dis a dv an
p.000021: t a ged pe r so n s, a ddi t io na l s afeg uar ds ha ve bee n i n- cl u ded i n t h e s t u d
p.000021: y t o p r o t ec t t h e r ig h t s an d welfar e of t h ese s u bjec t s.
p.000021: § 46.112 Review by institution.
p.000021: R ese ar c h cove r ed b y t h is polic y t ha t ha s bee n a pp r oved b y an I R B m ay be s u
p.000021: bjec t t o fur t h e r a pp r op r i a t e r eview an d a pp r ov a l o r dis a pp r ov a l b y offici a
p.000021: ls of t h e i n s t i t u t io n . Howeve r , t h ose offi- ci a ls m ay n o t a pp r ove t h e r ese ar c
p.000021: h if i t ha s n o t bee n a pp r oved b y an I R B.
p.000021: § 46.113 Suspension or termination of IRB approval of research.
p.000021: A n I R B s ha ll ha ve au t h o r i t y t o s u s- pe n d o r t e r m i na t e a pp r ov a l of r
p.000021: ese ar c h t ha t is n o t bei n g co n d u c t ed i n a cco r d- an ce wi t h t h e I R B’s r eq
p.000021: u i r e m e n t s o r t ha t ha s bee n a ssoci a t ed wi t h un ex- pec t ed se r io u s har m
p.000021: t o s u bjec t s. A ny s u spe n sio n o r t e r m i na t io n of a pp r ov a l s ha ll i n cl u de a
p.000021: s t a t e m e n t of t h e r e a- so n s fo r t h e I R B’s a c t io n an d s ha ll be r epo r t ed
p.000021: p r o m p t l y t o t h e i n ves t ig a t o r , a pp r op r i a t e i n s t i t u t io na l offici a ls,
p.000021: an d t h e dep ar tm e n t o r a ge n c y h e a d.
p.000021: ( App r oved b y t h e Office of M ana ge m e n t an d B u dge t un de r co n t r ol nu m be r 9999–0020)
p.000021: § 46.114 Cooperative research.
p.000021: Coope ra t ive r ese ar c h p r ojec t s ar e t h ose p r ojec t s cove r ed b y t h is polic y
p.000021: w h ic h i n volve m o r e t han o n e i n s t i t u- t io n . I n t h e co n d u c t of coope ra t
p.000021: ive r e- se ar c h p r ojec t s, e a c h i n s t i t u t io n is r e- spo n sible fo r s afeg uar di n
p.000021: g t h e r ig h t s an d welfar e of hu m an s u bjec t s an d fo r co m pl y i n g wi t h t h is
p.000021: polic y . Wi t h t h e a pp r ov a l of t h e dep ar tm e n t o r a ge n c y h e a d, an i n s t i t
p.000021: u t io n p ar t icip a t i n g i n a coope ra t ive p r ojec t m ay e n t e r i n t o a joi n t r
p.000021: eview arran ge m e n t , r el y u po n t h e r eview of an o t h e r q ua lified I R B, o r
p.000021:
p.000021: 28 CFR Ch. I (7–1–03 Edition)
p.000021: m a k e si m il ar arran ge m e n t s fo r a void- i n g d u plic a t io n of effo r t .
p.000021: § 46.115 IRB records.
p.000021: ( a) A n i n s t i t u t io n , o r w h e n a pp r o- p r i a t e an I R B, s ha ll p r ep ar e an
p.000021: d m a i n- t a i n a deq ua t e doc u m e n t a t io n of I R B a c t ivi t ies, i n cl u di n g t h e
p.000021: followi n g:
p.000021: (1) Copies of a ll r ese ar c h p r opos a ls r e- viewed, scie n t ific ev a l ua t io n s, if any , t
p.000021: ha t a cco m p any t h e p r opos a ls, a p- p r oved s a m ple co n se n t doc u m e n
p.000021: t s, p r og r ess r epo r t s s u b m i tt ed b y i n ves-
p.000021: t ig a t o r s, an d r epo r t s of i n j ur ies t o s u b- jec t s.
p.000021: (2) Mi nu t es of I R B m ee t i n gs w h ic h s ha ll be i n s ufficie n t de t a il t o s h ow a t
p.000021: - t e n d an ce a t t h e m ee t i n gs; a c t io n s t a k e n b y t h e I R B; t h e vo t e o
...
p.000022: t h e
p.000022: p ur poses of t h e r ese ar c h an d t h e ex- pec t ed d ura t io n of t h e s u bjec t ’s p ar t
p.000022: ici- p a t io n , a desc r ip t io n of t h e p r oced ur es t o be followed, an d ide n t ific a t
p.000022: io n of any p r oced ur es w h ic h ar e expe r i- m e n t a l;
p.000022: (2) A desc r ip t io n of any r e a so na bl y fo r esee a ble r is k s o r disco m fo r t s t o t h
p.000022: e s u bjec t ;
p.000022: (3) A desc r ip t io n of any be n efi t s t o t h e s u bjec t o r t o o t h e r s w h ic h m ay r
p.000022: e a- so na bl y be expec t ed f r o m t h e r ese ar c h;
p.000022: (4) A disclos ur e of a pp r op r i a t e a l t e r - na t ive p r oced ur es o r co ur ses of t r e
p.000022: a t - m e n t , if any , t ha t m ig h t be a dv an- t a geo u s t o t h e s u bjec t ;
p.000022: (5) A s t a t e m e n t desc r ibi n g t h e ex- t e n t , if any , t o w h ic h co nfide n t i a li
p.000022: t y of r eco r ds ide n t ify i n g t h e s u bjec t will be m a i n t a i n ed;
p.000022: (6) F o r r ese ar c h i n volvi n g m o r e t han m i n i m a l r is k , an expl ana t io n a s
p.000022: t o w h e t h e r any co m pe n s a t io n an d an ex- pl ana t io n a s t o w h e t h e r any m
p.000022: edic a l t r e a tm e n t s ar e a v a il a ble if i n j ury oc- c ur s an d, if so, w ha t t h e y co
p.000022: n sis t of, o r w h e r e fur t h e r i nfo r m a t io n m ay be ob- t a i n ed;
p.000022: (7) A n expl ana t io n of w h o m t o co n- t a c t fo r an swe r s t o pe r t i n e n t q u es t io
p.000022: n s a bo u t t h e r ese ar c h an d r ese ar c h s u b-
p.000022:
p.000023: 23
p.000023:
p.000023: jec t s’ r ig h t s, an d w h o m t o co n t a c t i n t h e eve n t of a r ese ar c h- r el a t ed
p.000023: i n j ury t o t h e s u bjec t ; an d
p.000023: (8) A s t a t e m e n t t ha t p ar t icip a t io n is vol un t ary , r efu s a l t o p ar t icip a t e
p.000023: will i n volve n o pe na l t y o r loss of be n efi t s t o w h ic h t h e s u bjec t is o t h e r wise e
p.000023: n t i t led, an d t h e s u bjec t m ay disco n t i nu e p ar- t icip a t io n a t any t i m e wi t h o
p.000023: u t pe na l t y o r loss of be n efi t s t o w h ic h t h e s u bjec t is o t h e r wise e n t i t led.
p.000023: ( b) Addi t io na l ele m e n t s of i nfo r m ed co n se n t . Wh e n a pp r op r i a t e, o n e
p.000023: o r m o r e of t h e followi n g ele m e n t s of i n- fo r m a t io n s ha ll a lso be p r
p.000023: ovided t o e a c h s u bjec t :
p.000023: (1) A s t a t e m e n t t ha t t h e p ar t ic u l ar t r e a tm e n t o r p r oced ur e m ay i
p.000023: n volve r is k s t o t h e s u bjec t ( o r t o t h e e m b ry o o r fe t u s, if t h e s u bjec
p.000023: t is o r m ay be- co m e p r eg nan t ) w h ic h ar e c urr e n t l y unfo r esee a ble;
p.000023: (2) A n t icip a t ed ci r c u m s t an ces un de r w h ic h t h e s u bjec t ’s p ar t icip a t io n m
p.000023: ay be t e r m i na t ed b y t h e i n ves t ig a t o r wi t h o u t r eg ar d t o t h e s u
p.000023: bjec t ’s co n- se n t ;
p.000023: (3) A ny a ddi t io na l cos t s t o t h e s u b- jec t t ha t m ay r es u l t f r o m p ar t icip a t
p.000023: io n i n t h e r ese ar c h;
p.000023: (4) Th e co n seq u e n ces of a s u bjec t ’s decisio n t o wi t h d ra w f r o m t h e r ese ar c h
p.000023: an d p r oced ur es fo r o r de r l y t e r m i na t io n of p ar t icip a t io n b y t h e s u bjec t ;
p.000023: (5) A s t a t e m e n t t ha t sig n ific an t n ew fi n di n gs developed d ur i n g t h e co ur se of
p.000023: t h e r ese ar c h w h ic h m ay r el a t e t o t h e s u bjec t ’s willi n g n ess t o co n t i nu e
p.000023: p ar- t icip a t io n will be p r ovided t o t h e s u b- jec t ; an d
p.000023: (6) Th e a pp r oxi m a t e nu m be r of s u b- jec t s i n volved i n t h e s t u d y .
p.000023: ( c) A n I R B m ay a pp r ove a co n se n t p r oced ur e w h ic h does n o t i n cl u de, o r
p.000023: w h ic h a l t e r s, so m e o r a ll of t h e ele- m e n t s of i nfo r m ed co n se n t se t
p.000023: fo r t h a bove, o r w a ive t h e r eq u i r e m e n t t o ob- t a i n i nfo r m ed co n se n t p r
p.000023: ovided t h e I R B fi n ds an d doc u m e n t s t ha t :
p.000023: (1) Th e r ese ar c h o r de m o n s t ra t io n p r ojec t is t o be co n d u c t ed b y o r s u
p.000023: bjec t t o t h e a pp r ov a l of s t a t e o r loc a l gov- e rn m e n t offici a ls an d is
p.000023: desig n ed t o s t u d y , ev a l ua t e, o r o t h e r wise ex a m i n e:
p.000023: ( i) P u blic be n efi t of se r vice p r og ra m s; ( ii) P r oced ur es fo r ob t a i n i n g be n efi t s
p.000023: o r se r vices un de r t h ose p r og ra m s;
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: § 46.117
p.000023: ( iii) P ossible c han ges i n o r a l t e r - na t ives t o t h ose p r og ra m s o r p
p.000023: r oce- d ur es; o r
p.000023: ( iv) P ossible c han ges i n m e t h ods o r levels of p ay m e n t fo r be n efi t s o r se r v-
p.000023: ices un de r t h ose p r og ra m s; an d
p.000023: (2) Th e r ese ar c h co u ld n o t p ra c- t ic a bl y be c arr ied o u t wi t h o u
p.000023: t t h e w a ive r o r a l t e ra t io n .
p.000023: ( d) A n I R B m ay a pp r ove a co n se n t p r oced ur e w h ic h does n o t i n cl u de, o r w
...
p.000024: id t o t h e s u bjec t o r t h e r ep- r ese n t a t ive. On l y t h e s h o r t fo r m i t self
p.000024: is t o be sig n ed b y t h e s u bjec t o r t h e r ep r ese n t a t ive. Howeve r , t h e wi
p.000024: t n ess
p.000024: s ha ll sig n bo t h t h e s h o r t fo r m an d a cop y of t h e s u mm ary , an d t h e pe
p.000024: r so n a c t ua ll y ob t a i n i n g co n se n t s ha ll sig n a cop y of t h e s u mm ary . A cop y
p.000024: of t h e s u mm ary s ha ll be give n t o t h e s u bjec t o r t h e r ep r ese n t a t ive, i n a
p.000024: ddi t io n t o a cop y of t h e s h o r t fo r m .
p.000024: ( c) A n I R B m ay w a ive t h e r eq u i r e- m e n t fo r t h e i n ves t ig a t o r t o ob t
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| minor | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
justice
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Social | Age | age | 4 |
| Social | Youth/Minors | minor | 1 |