Pt. 11 9. Offici a l Co a s t G uar d R ese r ve S e r vice R eco r d Sy s t e m ( DOT/CG 676), m a i n t a i n ed b y t h e Office of R ese r ve, U. S . Co a s t G uar d. 10. I n ves t ig a t ive R eco r d Sy s t e m , m a i n- t a i n ed b y t h e F ede ra l Avi a t io n Ad m i n is t ra- t io n a t F AA R egio na l an d Ce n t e r Ai r Tran s- po r t a t io n S ec ur i t y Divisio n s; t h e I n ves t ig a- t io n s an d S ec ur i t y Divisio n , Ae r o nau t ic a l Ce n t e r ; an d Office of I n ves t ig a t io n s an d S e- c ur i t y , He a dq uar t e r s, Wa s h i n g t o n , D.C. ( DOT/ F AA 815). 11. Mili t ary Tra i n i n g an d E d u c a t io n R ec- o r ds ( DOT/CG 622), m a i n t a i n ed b y t h e Office of P e r so nn el, U. S . Co a s t G uar d. 12. F iles p ur s uan t t o s u i t a bili t y fo r e m - plo y m e n t wi t h N a t io na l Hig h w ay Traffic Safe t y Ad m i n is t ra t io n ( DOT/NH TS A–457) co n t a i n i n g co nfide n t i a l i n ves t ig a t o ry r e- po r t s. Th e p ur pose of t h ese exe m p t io n s is t o p r e- ve n t disclos ur e of t h e ide n t i t ies of so ur ces w h o p r ovide i nfo r m a t io n t o t h e gove rn m e n t co n ce rn i n g t h e s u i t a bili t y , eligibili t y , o r q ua lific a t io n s of i n divid ua ls fo r F ede ra l ci- vili an e m plo y m e n t , co n t ra c t s, a ccess t o cl a s- sified i nfo r m a t io n , o r a ppoi n tm e n t o r p r o- m o t io n i n t h e ar m ed se r vices, an d w h o ar e exp r essl y o r , p r io r t o S ep t e m be r 27, 1975, i m - plied p r o m ised co nfide n t i a li t y (5 U. S .C. 552a( k ) (5) an d (7)). E . Th ose po r t io n s of t h e followi n g s y s t e m s of r eco r ds co n sis t i n g of t es t i n g o r ex a m i na- t io n m a t e r i a l u sed solel y t o de t e r m i n e i n di- vid ua l q ua lific a t io n s fo r a ppoi n tm e n t o r p r o- m o t io n i n t h e F ede ra l S e r vice ar e exe m p t f r o m s u bsec t io n s ( c)(3) ( Acco un t i n g of Ce r - t a i n Disclos ur es), ( d) ( Access t o R eco r ds), ( e)(4) ( G), ( H) an d ( I) ( Age n c y R eq u i r e m e n t s), an d (f) ( Age n c y Ru les) of 5 U. S .C. 552a: 1. Office r , En lis t ed an d R ec ru i t i n g S elec- t io n T es t F iles ( DOT/CG 628), m a i n t a i n ed b y t h e Office of P e r so nn el, U. S . Co a s t G uar d. 2. Offici a l Co a s t G uar d R ese r ve S e r vice R eco r d Sy s t e m ( DOT/CG 676), m a i n t a i n ed b y t h e Office of R ese r ve, U. S . Co a s t G uar d. 3. Mili t ary Tra i n i n g an d E d u c a t io n R ec- o r ds ( DOT/CG 622), m a i n t a i n ed b y t h e Office of P e r so nn el, U. S . Co a s t G uar d. 4. R efe r e n ce F iles ( DOT/NH TS A 457), m a i n- t a i n ed b y t h e N a t io na l Hig h w ay Traffic Safe- t y Ad m i n is t ra t io n pe r so nn el offices t o de t e r - m i n e fi t n ess fo r e m plo y m e n t p r io r t o h i r i n g. Th e p ur pose of t h ese exe m p t io n s is t o p r e- se r ve t h e v a l u e of t h ese r eco r ds a s i m p ar t i a l m e a s ur e m e n t s t an d ar ds fo r a ppoi n tm e n t an d p r o m o t io n wi t h i n t h e F ede ra l se r vice. F . Th ose po r t io n s of t h e followi n g s y s t e m s of r eco r ds w h ic h co n sis t of i nfo r m a t io n p r op- e r l y cl a ssified i n t h e i n t e r es t of na t io na l de- fe n se o r fo r eig n polic y i n a cco r d an ce wi t h 5 U. S .C. 552( b)(1) ar e exe m p t f r o m sec t io n s ( c)(3) ( Acco un t i n g of Ce r t a i n Disclos ur es), ( d) ( Access t o R eco r ds), ( e)(4) ( G), ( H) an d ( I) ( Age n c y R eq u i r e m e n t s), an d (f) ( Age n c y Ru les) of 5 U. S .C. 552a: 1. I n ves t ig a t ive R eco r d Sy s t e m m a i n t a i n ed b y t h e Assis t an t I n spec t o r Ge n e ra l fo r I n ves- 49 CFR Subtitle A (10–1–03 Edition) t ig a t io n s i n t h e Office of t h e I n spec t o r Ge n- e ra l ( DOT/OST 100). 2. P e r so nn el S ec ur i t y R eco r ds Sy s t e m , m a i n t a i n ed b y t h e Office of I n ves t ig a t io n s an d S ec ur i t y , Office of t h e S ec r e t ary ( DOT/ OST 016). 3. Civil Avi a t io n S ec ur i t y Sy s t e m ( DOT/ F AA 813), m a i n t a i n ed b y t h e Office of Civil Avi a t io n S ec ur i t y , F ede ra l Avi a t io n Ad m i n- is t ra t io n . 4. J oi n t M ar i t i m e I n t ellige n ce E le m e n t ( J MI E) Su ppo r t Sy s t e m , m a i n t a i n ed b y t h e Ope ra t io n s Sy s t e m s Ce n t e r , U S Co a s t G uar d ( DOT/CG 642). Th e p ur pose of t h ese exe m p t io n s is t o p r e- ve n t t h e disclos ur e of m a t e r i a l au t h o r ized t o be k ep t sec r e t i n t h e i n t e r es t of na t io na l de- fe n se o r fo r eig n polic y , i n a cco r d an ce wi t h 5 U. S .C. 552( b)(1) an d 552a( k )(1). G. Th ose po r t io n s of t h e followi n g s y s t e m s of r eco r ds w h ic h co n sis t of i nfo r m a t io n p r op- e r l y cl a ssified i n t h e i n t e r es t of na t io na l de- fe n se o r fo r eig n polic y i n a cco r d an ce wi t h 5 U. S .C. 552a( b)(1) ar e exe m p t f r o m s u bsec t io n s ( c)(3) ( Acco un t i n g of Ce r t a i n Disclos ur es) an d ( d) ( Access t o R eco r ds) of 5 U. S .C. 552a: 1. I n ves t ig a t ive R eco r d Sy s t e m ( DOT/ F AA 815) m a i n t a i n ed b y t h e F ede ra l Avi a t io n Ad- m i n is t ra t io n a t t h e Office of Civil Avi a t io n S ec ur i t y i n Wa s h i n g t o n , DC; t h e F AA r e- gio na l Civil Avi a t io n S ec ur i t y Divisio n s; t h e Civil Avi a t io n S ec ur i t y Divisio n a t t h e Mi k e Mo nr o n e y Ae r o nau t ic a l Ce n t e r i n O k l ah o m a Ci t y , O k l ah o m a ; t h e F AA Civil Avi a t io n S e- c ur i t y S t aff a t t h e F AA T ec hn ic a l Ce n t e r i n A t l an t ic Ci t y , New J e r se y; an d t h e v ar io u s F ede ra l R eco r ds Ce n t e r s loc a t ed t hr o u g h o u t t h e co un t ry . Th e p ur pose of t h ese exe m p t io n s is t o p r e- ve n t t h e disclos ur e of m a t e r i a l au t h o r ized t o be k ep t sec r e t i n t h e i n t e r es t of na t io na l de- fe n se o r fo r eig n polic y , i n a cco r d an ce wi t h 5 U. S .C. 552( b)(1) an d 552a( k )(1). [45 F R 8993, F eb. 11, 1980, a s a m e n ded a t 58 F R 67697, Dec. 22, 1993; 59 F R 13662, M ar . 23, 1994; 60 F R 43983, A u g. 24, 1995. R edesig na t ed a t 62 F R 23667, M ay 1, 1997, a s a m e n ded a t 63 F R 2172, J an . 14, 1998; 63 F R 4197, J an . 28, 1998; 66 F R 20407, Ap r . 23, 2001] PART 11—PROTECTION OF HUMAN SUBJECTS S ec. 11.101 T o w ha t does t h is polic y a ppl y? 11.102 Defi n i t io n s. 11.103 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 ppo r t ed b y any F ede ra l Dep ar tm e n t o r Age n c y . 11.104–11.106 [ R ese r ved] 11.107 I R B m e m be r s h ip. 11.108 I R B fun c t io n s an d ope ra t io n s. 11.109 I R B r eview of r ese ar c h . 11.110 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 n o m o r e 96 Office of the Secretary of Transportation § 11.101 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 . 11.111 Cr i t e r i a fo r I R B a pp r ov a l of r ese ar c h . 11.112 R eview b y i n s t i t u t io n . 11.113 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 . 11.114 Coope ra t ive r ese ar c h . 11.115 I R B r eco r ds. 11.116 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 . 11.117 Doc u m e n t a t io n of i nfo r m ed co n se n t . 11.118 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 of hu m an s u bjec t s. 11.119 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 bjec t s. 11.120 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 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 . 11.121 [ R ese r ved] 11.122 Use of F ede ra l fun ds. 11.123 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 io n s an d p r o- pos a ls. 11.124 Co n di t io n s. AU T HOR I T Y: 5 U. S .C. 301; 42 U. S .C. 300v–1( b). SOU RCE: 56 F R 28012, 28023, J un e 18, 1991, un less o t h e r wise n o t ed. § 11.101 To what does this policy apply? ( 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 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 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 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 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 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 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 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 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- m e n t o u t side t h e U n i t ed S t a t es. (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 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 § 11.102( e), m u s t co m pl y wi t h a ll sec t io n s of t h is polic y . (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 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 § 11.102( e) m u s t be r eviewed an d a pp r oved, i n co m pli- an ce wi t h § 11.101, § 11.102, an d § 11.107 t hr o u g h § 11.117 of t h is polic y , b y an i n- 97 s 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 n t r eq u i r e m e n t s of t h is polic y . ( 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 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 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: (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 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 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) 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 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 ge m e n t m e t h ods. (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 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 r v a- t io n of p u blic be ha vio r , un less: ( 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 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 bjec t s; an d ( 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 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 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 , o r r ep u t a t io n . (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 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 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) of t h is sec t io n , if: ( 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 u blic office; o r ( ii) fede 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 a li t y 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 t t h e r ese ar c h an d t h e r e af t e r . (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 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 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 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 o u g h ide n t ifie r s li n k ed t o t h e s u bjec t s. § 11.101 (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 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 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: ( i) P u blic be n efi t o r se r vice p r o- g ra m s; ( 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 o- g ra m s; ( iii) possible c han ges i n o r a l- t e rna t ives t o t h ose p r og ra m s o r p r oce- d ur es; o r ( iv) possible 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 vices un de r t h ose p r og ra m s. (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, ( 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 ( 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 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 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 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 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 . Dep ar tm e n t of Ag r ic u l t ur e. ( 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 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 . ( 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 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 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 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 h is polic y . ( 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 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 hu m an s u b- jec t s. (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 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 fo r hu m an s u bjec t s. ( 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 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 s u bjec t s of r ese ar c h . ( 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 ies, p r oced ur es n o r m a ll y followed i n t h e fo r eig n co un t r ies t o p r o t ec t hu m an 98 49 CFR Subtitle A (10–1–03 Edition) s u bjec t s m ay diffe r f r o m t h ose se t fo r t h i n t h is polic y . [ A n ex a m ple is a fo r eig n i n s t i t u t io n w h ic h co m plies wi t h g u ideli n es co n sis t e n t wi t h t h e Wo r ld Medic a l Asse m bl y Decl ara t io n ( Decl ara t io n of Helsi n k i a m e n ded 1989) iss u ed ei t h e r b y sove r eig n s t a t es o r b y an o r g an iza t io n w h ose fun c t io n fo r t h e p r o t ec t io n of hu m an r ese ar c h s u bjec t s is i n t e rna t io na ll y r ecog n ized.] I n t h ese ci r c u m s t an ces, if a 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 ha t t h e p r oce- d ur es p r esc r ibed b y t h e i n s t i t u t io n af- fo r d p r o t ec t io n s t ha t ar e a t le a s t eq u iv a le n t t o t h ose p r ovided i n t h is polic y , t h e dep ar tm e n t o r a ge n c y h e a d m ay a pp r ove t h e s u bs t i t u t io n of t h e fo r eig n p r oced ur es i n lie u of t h e p r oce- d ura l r eq u i r e m e n t s p r ovided i n 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, E xec u t ive Or de r , o r t h e de- p ar tm e n t o r a ge n c y h e a d, n o t ices of t h ese a c t io n s a s t h e y occ ur will be p u b- lis h ed i n t h e F E D ER A L R E GI STER o r will be o t h e r wise p u blis h ed a s p r ovided i n dep ar tm e n t o r a ge n c y p r oced ur es. ( 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 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 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 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 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 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, 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 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 ar tm e n t o r a ge n c y p r oced ur es. 1 [56 F R 28012, 28023, J un e 18, 1991; 56 F R 29756, J un e 28, 1991] 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 n s of t i t le 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 ha ve i n co r - 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 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 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 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 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- 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 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 Office of the Secretary of Transportation § 11.103 § 11.102 Definitions. ( 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 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 o m au t h o r i t y ha s bee n deleg a t ed. ( 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 g fed- e ra l , s t a t e, an d o t h e r a ge n cies). ( 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 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 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 t h e r ese ar c h . ( 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 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 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 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 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 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 og ra m s m ay i n cl u de r ese ar c h a c t ivi t ies. ( 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 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 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 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 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 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 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 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 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 ed b y t h e Dep ar tm e n t of La bo r ). (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 ( 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 (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 , o r (2) Ide n t ifi a ble p r iv a t e i nfo r m a t io n . 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 (fo r be ha vio r w h e n t h 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. 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 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 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 a t o r an d s u bjec t . ‘‘ P r iv a t e i nfo r m a t io n’’ i n cl u des i nfo r - m a t io n a bo u t be ha vio r t ha t occ ur s i n a co n t ex t i n w h ic h an i n divid ua l c an r e a- so na bl y expec t t ha t n o obse r v a t io n o r r eco r di n g is t a k i n g pl a ce, an d i nfo r m a- t io n w h ic h ha s bee n p r ovided fo r spe- cific p ur poses b y an i n divid ua l an d w h ic h t h e i n divid ua l c an r e a so na bl y expec t will n o t be m a de p u blic (fo r ex- a m ple, a m edic a l r eco r d). P r iv a t e i nfo r - m a t io n m u s t be i n divid ua ll y ide n t ifi- a ble ( i . e., t h e ide n t i t y of t h e s u bjec t is o r m ay r e a dil y be a sce r t a i n ed b y t h e i n ves t ig a t o r o r a ssoci a t ed wi t h t h e i n- fo r m a t io n) i n o r de r fo r ob t a i n i n g t h e i nfo r m a t io n t o co n s t i t u t e r ese ar c h i n- volvi n g hu m an s u bjec t s. ( g) IRB m e an s an i n s t i t u t io na l r eview bo ar d es t a blis h ed i n a cco r d wi t h an d fo r t h e p ur poses exp r essed i n t h is pol- ic y . ( h) IRB approval m e an s t h e de t e r - m i na t io n of t h e I R B t ha t t h e r ese ar c h ha s bee n r eviewed an d m ay be co n- d u c t ed a t an i n s t i t u t io n wi t h i n t h e co n s t ra i n t s se t fo r t h b y t h e I R B an d b y o t h e r i n s t i t u t io na l an d fede ra l r eq u i r e- m e n t s. ( i) Minimal risk m e an s t ha t t h e p r ob- a bili t y an d m a g n i t u de of har m o r dis- co m fo r t an t icip a t ed i n t h e r ese ar c h ar e n o t g r e a t e r i n an d of t h e m selves t han t h ose o r di nar il y e n co un t e r ed i n d a il y life o r d ur i n g t h e pe r fo r m an ce of r o u- t i n e p hy sic a l o r ps y c h ologic a l ex a m i- na t io n s o r t es t s. ( j) Certification m e an s t h e offici a l n o- t ific a t io n b y t h e i n s t i t u t io n t o t h e s u p- po r t i n g dep ar tm e n t o r a ge n c y , i n a c- co r d an ce wi t h t h e r eq u i r e m e n t s of t h is polic y , t ha t a r ese ar c h p r ojec t o r a c t iv- i t y i n volvi n g hu m an s u bjec t s ha s bee n r eviewed an d a pp r oved b y an I R B i n a c- co r d an ce wi t h an a pp r oved a ss uran ce. § 11.103 Assuring compliance with this policy—research conducted or sup- ported by any Federal Department or Agency. ( a) Ea c h i n s t i t u t io n e n g a ged i n r e- se ar c h w h ic h is cove r ed b y t h is polic y an d w h ic h is co n d u c t ed o r s u ppo r t ed b y a fede ra l dep ar tm e n t o r a ge n c y s ha ll 99 § 11.103 p r ovide w r i tt e n a ss uran ce s a t isfa c t o ry t o t h e dep ar tm e n t o r a ge n c y h e a d t ha t i t will co m pl y wi t h t h e r eq u i r e m e n t s se t fo r t h i n t h is polic y . I n lie u of r e- q u i r i n g s u b m issio n of an a ss uran ce, i n- divid ua l dep ar tm e n t o r a ge n c y h e a ds s ha ll a ccep t t h e exis t e n ce of a c urr e n t a ss uran ce, a pp r op r i a t e fo r t h e r ese ar c h 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, 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 of an HH S- a pp r oved a ss uran ce is a ccep t ed i n 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 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 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 s, HH S . ( 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 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 i n 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 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 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 r eview b y t h e I R B. Ass uran ces a pplic a ble t o fede ra ll y 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: (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 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 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 ar dless of w h e t h e r t h e r ese ar c h is s u bjec t t o fede ra l r eg u- l a t io n . Th is m ay i n cl u de an a pp r o- p r i a t e exis t i n g code, decl ara t io n , o r s t a t e m e n t of e t h ic a l p r i n ciples, o r a s t a t e m e n t fo r m u l a t ed b y t h e i n s t i t u- t io n i t self. Th is r eq u i r e m e n t does n o t p r ee m p t p r ovisio n s of t h is polic y a ppli- c a ble t o dep ar tm e n t - o r a ge n c y- s u p- po r t ed o r r eg u l a t ed r ese ar c h an d n eed n o t be a pplic a ble t o any r ese ar c h ex- e m p t ed o r w a ived un de r § 11.101 ( b) o r ( i). (2) Desig na t io n of o n e o r m o r e I R Bs es t a blis h ed i n a cco r d an ce wi t h t h e r e- q u i r e m e n t s of t h is polic y , an d fo r w h ic h p r ovisio n s ar e m a de fo r m ee t i n g sp a ce an d s ufficie n t s t aff t o s u ppo r t t h e I R B’s r eview an d r eco r d k eepi n g d u- t ies. (3) A lis t of I R B m e m be r s ide n t ified b y na m e; e arn ed deg r ees; r ep r ese n t a- 49 CFR Subtitle A (10–1–03 Edition) t ive c a p a ci t y; i n dic a t io n s of expe r ie n ce s u c h a s bo ar d ce r t ific a t io n s, lice n ses, e t c., s ufficie n t t o desc r ibe e a c h m e m - be r’s c h ief an t icip a t ed co n t r ib u t io n s t o I R B delibe ra t io n s; an d any e m plo y- m e n t o r o t h e r r el a t io n s h ip be t wee n e a c h m e m be r an d t h e i n s t i t u t io n; fo r ex a m ple: fu ll- t i m e e m plo y ee, p ar t - t i m e e m plo y ee, m e m be r of gove rn i n g p an el o r bo ar d, s t oc k h olde r , p a id o r un p a id co n s u l t an t . Chan ges i n I R B m e m be r - s h ip s ha ll be r epo r t ed t o t h e dep ar t - m e n t o r a ge n c y h e a d, un less i n a cco r d wi t h § 11.103( a) of t h is polic y , t h e exis t - e n ce of an HH S- a pp r oved a ss uran ce is a ccep t ed. I n t h is c a se, c han ge i n I R B m e m be r s h ip s ha ll be r epo r t ed 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, HH S . (4) Wr i tt e n p r oced ur es w h ic h t h e I R B will follow ( i) fo r co n d u c t i n g i t s i n i t i a l an d co n t i nu i n g r eview of r ese ar c h an d fo r r epo r t i n g i t s fi n di n gs an d a c t io n s t o t h e i n ves t ig a t o r an d t h e i n s t i t u t io n; ( ii) fo r de t e r m i n i n g w h ic h p r ojec t s r e- q u i r e r eview m o r e of t e n t han annua ll y an d w h ic h p r ojec t s n eed ve r ific a t io n f r o m so ur ces o t h e r t han t h e i n ves t ig a- t o r s t ha t n o m a t e r i a l c han ges ha ve oc- c urr ed si n ce p r evio u s I R B r eview; an d ( iii) 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 of p r oposed c han ges i n a r e- se ar c h a c t ivi t y , an d fo r e n s ur i n g t ha t s u c h c han ges i n a pp r oved r ese ar c h , d ur i n g t h e pe r iod fo r w h ic h I R B a p- p r ov a l ha s a l r e a d y bee n give n , m 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 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 . (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, 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 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 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 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 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 . ( 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 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 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 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. 100 Office of the Secretary of Transportation § 11.107 ( 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 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 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 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 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 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 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 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 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 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 . ( 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 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 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 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 oved a ss uran ces 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 . (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 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 § 11.101 ( 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 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 § 11.103 of t h is P olic y ha s bee n r eviewed an d a pp r oved 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 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 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 n o co n di t io n s ha ll r ese ar c h cove r ed b y § 11.103 of t h e P ol- ic y be s u ppo r t ed 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 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 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 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 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 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 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 . ( 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) [56 F R 28012, 28023, J un e 18, 1991; 56 F R 29756, J un e 28, 1991] §§ 11.104–11.106 [Reserved] § 11.107 IRB membership. ( 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 t o p r o m o t e co m ple t e an d a deq ua t e r eview 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 e I R B s ha ll be s ufficie n t l y q ua lified t hr o u g h 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 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 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 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 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 r ofessio na l co m pe t e n ce n ecess ary t o r eview specific r ese ar c h 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 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 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 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 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 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 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 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 ced i n wo r k i n g wi t h t h ese s u bjec t s. ( 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 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 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 selec t io n is m a de 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 e m be r s of o n e p r ofessio n . ( 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 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 ar e i n n o n scie n t ific ar e a s. 101 § 11.108 ( 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 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 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 . ( 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 r co n- t i nu i n g r eview of any p r ojec t i n w h ic h 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 n r e- q u es t ed b y t h e I R B. (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 i n speci a l ar e a s t o a ssis t i n t h e r eview of 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 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. § 11.108 IRB functions and operations. 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: ( 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 § 11.103( b)(4) an d, t o t h e ex t e n t r eq u i r ed b y , § 11.103( b)(5). ( b) E xcep t w h e n an expedi t ed r eview p r oced ur e is u sed ( see § 11.110), r eview p r oposed r ese ar c h a t co n ve n ed m ee t - 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 , 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 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 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 i n g. § 11.109 IRB review of research. ( 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- 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 cove r ed b y t h is polic y . ( 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 of i n- fo r m ed co n se n t is i n a cco r d an ce wi t h § 11.116. 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 specifi- c a ll y m e n t io n ed i n § 11.116, be give n t o t h e s u bjec t s w h e n i n t h e I 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 io n of t h e r ig h t s an d welfar e of s u bjec t s. ( 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 ive doc u m e n t a t io n i n a cco r d an ce wi t h § 11.117. 49 CFR Subtitle A (10–1–03 Edition) ( 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 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 of m odific a- 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 I R B de- cides t o dis a pp r ove a r ese ar c h a c t ivi t y , 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 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 i n pe r so n o r i n w r i t i n g. ( 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 pol- 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 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 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 . ( 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) § 11.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for minor changes in approved re- search. ( 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 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 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 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 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 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 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 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. ( 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 h e followi n g: (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 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 , (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 ( 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. 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 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 t h e 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 , t h e 102 Office of the Secretary of Transportation § 11.114 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 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 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 t ed p r oced ur e se t fo r t h i n § 11.108( b). ( 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 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 oved un de r t h e p r oced ur e. ( 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, 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 expedi t ed r e- view p r oced ur e. § 11.111 Criteria for IRB approval of research. ( 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 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: (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 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- 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 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 ur poses. (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 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 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 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 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 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 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 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 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 i t s r espo n sibili t y . (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 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 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 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 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 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. (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 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 h e ex- t e n t r eq u i r ed b y § 11.116. (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 ce wi t h , an d t o t h e ex t e n t r eq u i r ed b y § 11.117. (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 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. (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 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 . ( 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 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 , 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 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 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. § 11.112 Review by institution. 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 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 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 h if i t ha s n o t bee n a pp r oved b y an I R B. § 11.113 Suspension or termination of IRB approval of research. 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 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 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 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 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 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, an d t h e dep ar tm e n t o r a ge n c y h e a d. ( 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) § 11.114 Cooperative research. 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 103 § 11.115 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 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 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 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 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 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 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 . § 11.115 IRB records. ( 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 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 followi n g: (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 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 t s, p r og r ess r epo r t s s u b m i tt ed b y i n ves- 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. (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 - 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 n t h ese a c- t io n s i n cl u di n g t h e nu m be r of m e m be r s vo t i n g fo r , a g a i n s t , an d a bs t a i n i n g; t h e b a sis fo r r eq u i r i n g c han ges i n o r dis- a pp r ovi n g r ese ar c h; an d a w r i tt e n s u m - m ary of t h e disc u ssio n of co n t r ove r t ed iss u es an d t h ei r r esol u t io n . (3) R eco r ds of co n t i nu i n g r eview a c- t ivi t ies. (4) Copies of a ll co rr espo n de n ce be- t wee n t h e I R B an d t h e i n ves t ig a t o r s. (5) A lis t of I R B m e m be r s i n t h e s a m e de t a il a s desc r ibed is § 11.103( b)(3). (6) Wr i tt e n p r oced ur es fo r t h e I R B i n t h e s a m e de t a il a s desc r ibed i n § 11.103( b)(4) an d § 11.103( b)(5). (7) S t a t e m e n t s of sig n ific an t n ew fi n di n gs p r ovided t o s u bjec t s, a s r e- q u i r ed b y § 11.116( b)(5). ( b) Th e r eco r ds r eq u i r ed b y t h is pol- ic y s ha ll be r e t a i n ed fo r a t le a s t 3 y e ar s, an d r eco r ds r el a t i n g t o r ese ar c h w h ic h is co n d u c t ed s ha ll be r e t a i n ed fo r a t le a s t 3 y e ar s af t e r co m ple t io n of t h e r ese ar c h . All r eco r ds s ha ll be a cces- sible fo r i n spec t io n an d cop y i n g b y au- t h o r ized r ep r ese n t a t ives of t h e dep ar t - 49 CFR Subtitle A (10–1–03 Edition) m e n t o r a ge n c y a t r e a so na ble t i m es an d i n a r e a so na ble m ann e r . ( 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) § 11.116 General requirements for in- formed consent. E xcep t a s p r ovided elsew h e r e i n t h is polic y , n o i n ves t ig a t o r m ay i n volve a hu m an bei n g a s a s u bjec t i n r ese ar c h cove r ed b y t h is polic y un less t h e i n ves- t ig a t o r ha s ob t a i n ed t h e leg a ll y effec- t ive i nfo r m ed co n se n t of t h e s u bjec t o r t 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. A n i n ves t ig a t o r s ha ll see k s u c h co n se n t o n l y un de r ci r c u m s t an ces t ha t p r ovide t h e p r ospec t ive s u bjec t o r t h e r ep r ese n t a t ive s ufficie n t oppo r - t un i t y t o co n side r w h e t h e r o r n o t t o p ar t icip a t e an d t ha t m i n i m ize t h e pos- sibili t y of coe r cio n o r un d u e i nfl u e n ce. Th e i nfo r m a t io n t ha t is 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 s ha ll be i n l an g ua ge un de r s t an d a ble t o t h e s u b- jec t o r t h e r ep r ese n t a t ive. No i nfo r m ed co n se n t , w h e t h e r o ra l o r w r i tt e n , m ay i n cl u de any exc u lp a t o ry l an g ua ge t hr o u g h w h ic h t h e s u bjec t o r t h e r ep- r ese n t a t ive is m a de t o w a ive o r a ppe ar t o w a ive any of t h e s u bjec t ’s leg a l r ig h t s, o r r ele a ses o r a ppe ar s t o r ele a se t h e i n ves t ig a t o r , t h e spo n so r , t h e i n s t i- t u t io n o r i t s a ge n t s f r o m li a bili t y fo r n eglige n ce. ( a) B a sic ele m e n t s of i nfo r m ed co n- se n t . E xcep t a s p r ovided i n p ara g ra p h ( c) o r ( d) of t h is sec t io n , i n see k i n g i n- fo r m ed co n se n t t h e followi n g i nfo r m a- t io n s ha ll be p r ovided t o e a c h s u bjec t : (1) A s t a t e m e n t t ha t t h e s t u d y i n- volves r ese ar c h , an expl ana t io n of t h e 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 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 io n of any p r oced ur es w h ic h ar e expe r i- m e n t a l; (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 e s u bjec t ; (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 e a- so na bl y be expec t ed f r o m t h e r ese ar c h; (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 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 ; (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 t y of 104 Office of the Secretary of Transportation § 11.117 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; (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 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 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 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; (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 n s a bo u t t h e r ese ar c h an d r ese ar c h s u b- 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 i n j ury t o t h e s u bjec t ; an d (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 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 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 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. ( 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 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 ovided t o e a c h s u bjec t : (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 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 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; (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 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 bjec t ’s co n- se n t ; (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 io n i n t h e r ese ar c h; (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 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 ; (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 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 ar- t icip a t io n will be p r ovided t o t h e s u b- jec t ; an d (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 . ( 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 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 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 ovided t h e I R B fi n ds an d doc u m e n t s t ha t : (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 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 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: ( 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 o r se r vices un de r t h ose p r og ra m s; ( iii) possible c han ges i n o r a l t e rna t ives t o t h ose p r og ra m s o r p r oced ur es; o r ( iv) possible 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 vices un de r t h ose p r og ra m s; an d (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 t t h e w a ive r o r a l t e ra t io n . ( 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 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 fo r t h i n t h is sec t io n , o r w a ive t h e r eq u i r e m e n t s t o ob t a i n i nfo r m ed co n se n t p r ovided t h e I R B fi n ds an d doc u m e n t s t ha t : (1) Th e r ese ar c h i n volves n o m o r e t han m i n i m a l r is k t o t h e s u bjec t s; (2) Th e w a ive r o r a l t e ra t io n will n o t a dve r sel y affec t t h e r ig h t s an d welfar e of t h e s u bjec t s; (3) 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 t t h e w a ive r o r a l t e ra t io n; an d (4) Wh e n eve r a pp r op r i a t e, t h e s u b- jec t s will be p r ovided wi t h a ddi t io na l pe r t i n e n t i nfo r m a t io n af t e r p ar t icip a- t io n . ( e) Th e i nfo r m ed co n se n t r eq u i r e- m e n t s i n t h is polic y ar e n o t i n t e n ded t o p r ee m p t any a pplic a ble F ede ra l , s t a t e, o r loc a l l a ws w h ic h r eq u i r e a ddi- t io na l i nfo r m a t io n t o be disclosed i n o r de r fo r i nfo r m ed co n se n t t o be le- g a ll y effec t ive. (f) No t h i n g i n t h is polic y is i n t e n ded t o li m i t t h e au t h o r i t y of a p hy sici an t o p r ovide e m e r ge n c y m edic a l c ar e, t o t h e ex t e n t t h e p hy sici an is pe r m i tt ed t o do so un de r a pplic a ble F ede ra l , s t a t e, o r loc a l l a w. ( 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) § 11.117 Documentation of informed consent. ( a) E xcep t a s p r ovided i n p ara g ra p h ( c) of t h is sec t io n , i nfo r m ed co n se n t s ha ll be doc u m e n t ed b y t h e u se of a 105 § 11.118 w r i tt e n co n se n t fo r m a pp r oved b y t h e I R B an d sig n ed b y t h e s u bjec t o r t 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. A cop y s ha ll be give n t o t h e pe r - so n sig n i n g t h e fo r m . ( b) E xcep t a s p r ovided i n p ara g ra p h ( c) of t h is sec t io n , t h e co n se n t fo r m m ay be ei t h e r of t h e followi n g: (1) A w r i tt e n co n se n t doc u m e n t t ha t e m bodies t h e ele m e n t s of i nfo r m ed co n se n t r eq u i r ed b y § 11.116. Th is fo r m m ay be r e a d t o t h e s u bjec t o r t h e s u b- jec t ’s leg a ll y au t h o r ized r ep r ese n t a- t ive, b u t i n any eve n t , t h e i n ves t ig a t o r s ha ll give ei t h e r t h e s u bjec t o r t h e r ep- r ese n t a t ive a deq ua t e oppo r t un i t y t o r e a d i t befo r e i t is sig n ed; o r (2) A s h o r t fo r m w r i tt e n co n se n t doc- u m e n t s t a t i n g t ha t t h e ele m e n t s of i n- fo r m ed co n se n t r eq u i r ed b y § 11.116 ha ve bee n p r ese n t ed o ra ll y t o t h e s u b- jec t o r t 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. Wh e n t h is m e t h od is u sed, t h e r e s ha ll be a wi t n ess t o t h e o ra l p r ese n t a t io n . Also, t h e I R B s ha ll a pp r ove a w r i tt e n s u mm ary of w ha t is t o be s a 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 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 t n ess 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 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 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 ddi t io n t o a cop y of t h e s h o r t fo r m . ( 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 a i n a sig n ed co n se n t fo r m fo r so m e o r a ll s u bjec t s if i t fi n ds ei t h e r : (1) Tha t t h e o n l y r eco r d li n k i n g t h e s u bjec t an d t h e r ese ar c h wo u ld be t h e co n se n t doc u m e n t an d t h e p r i n cip a l r is k wo u ld be po t e n t i a l har m r es u l t i n g f r o m a b r e a c h of co nfide n t i a li t y . Ea c h s u bjec t will be a s k ed w h e t h e r t h e s u b- jec t w an t s doc u m e n t a t io n li n k i n g t h e s u bjec t wi t h t h e r ese ar c h , an d t h e s u b- jec t ’s wis h es will gove rn; o r (2) Tha t t h e r ese ar c h p r ese n t s n o m o r e t han m i n i m a l r is k of har m t o s u bjec t s an d i n volves n o p r oced ur es fo r w h ic h w r i tt e n co n se n t is n o r m a ll y r e- q u i r ed o u t side of t h e r ese ar c h co n t ex t . I n c a ses i n w h ic h t h e doc u m e n t a t io n r eq u i r e m e n t is w a ived, t h e I R B m ay r e- q u i r e t h e i n ves t ig a t o r t o p r ovide s u b- 49 CFR Subtitle A (10–1–03 Edition) jec t s wi t h a w r i tt e n s t a t e m e n t r eg ar d- i n g t h e r ese ar c h . ( 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) § 11.118 Applications and proposals lacking definite plans for involve- ment of human subjects. Ce r t a i n t y pes of a pplic a t io n s fo r g ran t s, coope ra t ive a g r ee m e n t s, o r co n- t ra c t s ar e s u b m i tt ed t o dep ar tm e n t s o r a ge n cies wi t h t h e k n owledge t ha t s u b- jec t s m ay be i n volved wi t h i n t h e pe r iod of s u ppo r t , b u t defi n i t e pl an s wo u ld n o t n o r m a ll y be se t fo r t h i n t h e a pplic a- t io n o r p r opos a l . Th ese i n cl u de a c t ivi- t ies s u c h a s i n s t i t u t io na l t y pe g ran t s w h e n selec t io n of specific p r ojec t s is t h e i n s t i t u t io n’s r espo n sibili t y; r e- se ar c h t ra i n i n g g ran t s i n w h ic h t h e a c- t ivi t ies i n volvi n g s u bjec t s r e m a i n t o be selec t ed; an d p r ojec t s i n w h ic h hu m an s u bjec t s’ i n volve m e n t will depe n d u po n co m ple t io n of i n s t ru m e n t s, p r io r an i- m a l s t u dies, o r p ur ific a t io n of co m - po un ds. Th ese a pplic a t io n s n eed n o t be r eviewed b y an I R B befo r e an a w ar d m ay be m a de. Howeve r , excep t fo r r e- se ar c h exe m p t ed o r w a ived un de r § 11.101 ( b) o r ( i), n o hu m an s u bjec t s m ay be i n volved i n any p r ojec t s u p- po r t ed b y t h ese a w ar ds un t il t h e p r ojec t ha s bee n r eviewed an d a pp r oved b y t h e I R B, a s p r ovided i n t h is polic y , an d ce r t ific a t io n s u b m i tt ed, b y t h e i n- s t i t u t io n , t o t h e dep ar tm e n t o r a ge n c y . § 11.119 Research undertaken without the intention of involving human subjects. I n t h e eve n t r ese ar c h is 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 bjec t s, b u t i t is l a t e r p r o- posed t o i n volve hu m an s u bjec t s i n t h e r ese ar c h , t h e r ese ar c h s ha ll fi r s t be r e- viewed an d a pp r oved b y an I R B, a s p r o- vided i n t h is polic y , a ce r t ific a t io n s u b- m i tt ed, b y t h e i n s t i t u t io n , t o t h e de- p ar tm e n t o r a ge n c y , an d fi na l a pp r ov a l give n t o t h e p r oposed c han ge b y t h e de- p ar tm e n t o r a ge n c y . § 11.120 Evaluation and disposition of applications and proposals for re- search to be conducted or sup- ported by a Federal Department or Agency. 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 pplic a t io n s an d p r opos a ls 106 Office of the Secretary of Transportation Pt. 17 i n volvi n g hu m an s u bjec t s s u b m i tt ed t o t h e dep ar tm e n t o r a ge n c y t hr o u g h s u c h office r s an d e m plo y ees of t h e dep ar t - m e n t o r a ge n c y an d s u c h expe r t s an d co n s u l t an t s 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 a t e. Th is ev a l ua t io n will t a k e i n t o co n sid- e ra t io n t h e r is k s t o t h e s u bjec t s, t h e a deq ua c y of p r o t ec t io n a g a i n s t t h ese r is k s, t h e po t e n t i a l be n efi t s of t h e r e- se ar c h t o t h e s u bjec t s an d o t h e r s, an d t h e i m po r t an ce of t h e k n owledge g a i n ed o r t o be g a i n ed. ( b) 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 m ay a pp r ove o r dis a pp r ove t h e a pplic a t io n o r p r opos a l , o r e n t e r i n t o n ego t i a t io n s t o develop an a pp r ov a ble o n e. § 11.121 [Reserved] § 11.122 Use of Federal funds. F ede ra l fun ds a d m i n is t e r ed b y a de- p ar tm e n t o r a ge n c y m ay n o t be ex- pe n ded fo r r ese ar c h i n volvi n g hu m an s u bjec t s un less t h e r eq u i r e m e n t s of t h is polic y ha ve bee n s a t isfied. § 11.123 Early termination of research support: Evaluation of applications and proposals. ( a) Th e dep ar tm e n t o r a ge n c y h e a d m ay r eq u i r e t ha t dep ar tm e n t o r a ge n c y s u ppo r t fo r any p r ojec t be t e r m i na t ed o r s u spe n ded i n t h e m ann e r p r esc r ibed i n a pplic a ble p r og ra m r eq u i r e m e n t s, w h e n t h e dep ar tm e n t o r a ge n c y h e a d fi n ds an i n s t i t u t io n ha s m a t e r i a ll y fa iled t o co m pl y wi t h t h e t e r m s of t h is polic y . ( b) I n m a k i n g decisio n s a bo u t s u p- po r t i n g o r a pp r ovi n g a pplic a t io n s o r p r opos a ls cove r ed b y t h is polic y t h e de- p ar tm e n t o r a ge n c y h e a d m ay t a k e i n t o a cco un t , i n a ddi t io n t o a ll o t h e r eligibili t y r eq u i r e m e n t s an d p r og ra m c r i t e r i a , fa c t o r s s u c h a s w h e t h e r t h e a pplic an t ha s bee n s u bjec t t o a t e r m i- na t io n o r s u spe n sio n un de r p ara g ar p h ( a) of t h is sec t io n an d w h e t h e r t h e a p- plic an t o r t h e pe r so n o r pe r so n s w h o wo u ld di r ec t o r ha s/ha ve di r ec t ed t h e scie n t ific an d t ec hn ic a l a spec t s of an a c t ivi t y ha s/ha ve, i n t h e j u dg m e n t of t h e dep ar tm e n t o r a ge n c y h e a d, m a t e- r i a ll y fa iled t o disc har ge r espo n sibili t y fo r t h e p r o t ec t io n of t h e r ig h t s an d welfar e of hu m an s u bjec t s ( w h e t h e r o r n o t t h e r ese ar c h w a s s u bjec t t o F ede ra l r eg u l a t io n). § 11.124 Conditions. Wi t h r espec t t o any r ese ar c h p r ojec t o r any cl a ss of r ese ar c h p r ojec t s t h e de- p ar tm e n t o r a ge n c y h e a d m ay i m pose a ddi t io na l co n di t io n s p r io r t o o r a t t h e t i m e of a pp r ov a l w h e n i n t h e j u dg m e n t of t h e dep ar tm e n t o r a ge n c y h e a d a ddi- t io na l co n di t io n s ar e n ecess ary fo r t h e p r o t ec t io n of hu m an s u bjec t s. PART 17—INTERGOVERNMENTAL REVIEW OF DEPARTMENT OF TRANSPORTATION PROGRAMS AND ACTIVITIES S ec. 17.1 Wha t is t h e p ur pose of t h ese r eg u l a- t io n s? 17.2 Wha t defi n i t io n s a ppl y t o t h ese r eg u l a- t io n s? 17.3 Wha t p r og ra m s an d a c t ivi t ies of t h e Dep ar tm e n t ar e s u bjec t t o t h ese r eg u l a- t io n s? 17.4 [ R ese r ved] 17.5 Wha t is t h e S ec r e t ary’s oblig a t io n wi t h r espec t t o F ede ra l i n t e ra ge n c y coo r di na- t io n? 17.6 Wha t p r oced ur es a ppl y t o t h e selec t io n of p r og ra m s an d a c t ivi t ies un de r t h ese r eg u l a t io n s? 17.7 How does t h e S ec r e t ary co mm un ic a t e wi t h s t a t e an d loc a l offici a ls co n ce rn i n g t h e Dep ar tm e n t ’s p r og ra m s an d a c t ivi- t ies? 17.8 How does t h e sec r e t ary p r ovide s t a t es an oppo r t un i t y t o co mm e n t o n p r oposed F ede ra l fi nan ci a l a ssis t an ce an d di r ec t F ede ra l develop m e n t ? 17.9 How does t h e S ec r e t ary r eceive an d r e- spo n d t o co mm e n t s? 17.10 How does t h e S ec r e t ary m a k e effo r t s t o a cco mm od a t e i n t e r gove rn m e n t a l co n- ce rn s? 17.11 Wha t ar e t h e S ec r e t ary’s oblig a t io n s i n i n t e r s t a t e si t ua t io n s? 17.12 How m ay a s t a t e si m plify , co n solid a t e, o r s u bs t i t u t e fede ra ll y r eq u i r ed s t a t e pl an s? 17.13 M ay t h e S ec r e t ary w a ive any p r ovi- sio n of t h ese r eg u l a t io n s? AU T HOR I T Y: E xec u t ive Or de r 12372, J u l y 14, 1982 (47 F R 30959), a s a m e n ded Ap r il 8, 1983 (48 F R 15887): sec. 401 of t h e I n t e r gove rn m e n t a l Coope ra t io n Ac t of 1968, a s a m e n ded (31 U. S .C. 6506); sec. 204 of t h e De m o n s t ra t io n Ci t ies an d Me t r opoli t an Develop m e n t Ac t of 1966, a s a m e n ded (42 U. S .C. 3334). SOU RCE: 48 F R 29272, J un e 24, 1983, un less o t h e r wise n o t ed 107