79C3C34C52B45572883A05D425EB0F82

49 CFR 11

https://www.govinfo.gov/content/pkg/CFR-2003-title49-vol1/pdf/CFR-2003-title49-vol1-part11.pdf

http://leaux.net/URLS/ConvertAPI Text Files/E3B7B35FA00524CB28A4025B9FA62A0A.en.txt

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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 TypeVulnerabilityIndicator# Matches
SocialAccess to Social Goodsaccess3
SocialAgeage8
SocialYouth/Minorsminor1

Social / Access to Social Goods

Searching for indicator access:

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p.000096: 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
p.000096: t h e Office
p.000096: of P e r so nn el, U. S . Co a s t G uar d.
p.000096: 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
p.000096: 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
p.000096: a l i n ves t ig a t o ry r e- po r t s.
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: ) (5) an d (7)).
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: t o R eco r ds),
p.000096: ( 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
p.000096: .C. 552a:
p.000096: 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
p.000096: 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.
p.000096: 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
p.000096: a i n ed b y t h e Office of R ese r ve, U. S . Co a s t G uar d.
p.000096: 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
p.000096: t h e Office
p.000096: of P e r so nn el, U. S . Co a s t G uar d.
p.000096: 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
p.000096: 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
p.000096: t p r io r t o h i r i n g.
p.000096: 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
p.000096: 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
p.000096: t h e F ede ra l se r vice.
p.000096: 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
p.000096: 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
p.000096: 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 (
p.000096: 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), (
p.000096: 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.
p.000096: 552a:
p.000096: 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
p.000096: ra l fo r I n ves-
p.000096:
p.000096: 49 CFR Subtitle A (10–1–03 Edition)
p.000096: 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).
p.000096: 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
p.000096: 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).
p.000096: 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
p.000096: 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 .
p.000096: 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
p.000096: 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).
p.000096: 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
p.000096: 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
p.000096: 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).
p.000096: 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
p.000096: 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
p.000096: 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)
p.000096: ( 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.
p.000096: 552a:
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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 .
p.000096: 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
p.000096: 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
p.000096: 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).
p.000096: [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,
p.000096: M ar . 23,
p.000096: 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
p.000096: t 63 F R 2172, J an . 14, 1998; 63 F R 4197, J an . 28,
p.000096: 1998; 66 F R 20407, Ap r . 23, 2001]
p.000096:
p.000096: PART 11—PROTECTION OF HUMAN SUBJECTS
p.000096: S ec.
p.000096: 11.101 T o w ha t does t h is polic y a ppl y?
p.000096: 11.102 Defi n i t io n s.
...

Social / Age

Searching for indicator age:

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p.000096: t h e Office
p.000096: of P e r so nn el, U. S . Co a s t G uar d.
p.000096: 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
p.000096: 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
p.000096: a l i n ves t ig a t o ry r e- po r t s.
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: ) (5) an d (7)).
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: t o R eco r ds),
p.000096: ( 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
p.000096: .C. 552a:
p.000096: 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
p.000096: 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.
p.000096: 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
p.000096: a i n ed b y t h e Office of R ese r ve, U. S . Co a s t G uar d.
p.000096: 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
p.000096: t h e Office
p.000096: of P e r so nn el, U. S . Co a s t G uar d.
p.000096: 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
p.000096: 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
p.000096: t p r io r t o h i r i n g.
p.000096: 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
p.000096: 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
p.000096: t h e F ede ra l se r vice.
p.000096: 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
p.000096: 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
p.000096: 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 (
p.000096: 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), (
p.000096: 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.
p.000096: 552a:
p.000096: 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
p.000096: ra l fo r I n ves-
p.000096:
p.000096: 49 CFR Subtitle A (10–1–03 Edition)
p.000096: 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).
p.000096: 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
p.000096: 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).
p.000096: 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
p.000096: 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 .
p.000096: 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
p.000096: 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).
p.000096: 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
p.000096: 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
p.000096: 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).
p.000096: 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
p.000096: 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
p.000096: 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)
...

p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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
p.000096: 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 .
p.000096: 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
p.000096: 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
p.000096: 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).
p.000096: [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,
p.000096: M ar . 23,
p.000096: 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
p.000096: t 63 F R 2172, J an . 14, 1998; 63 F R 4197, J an . 28,
p.000096: 1998; 66 F R 20407, Ap r . 23, 2001]
p.000096:
p.000096: PART 11—PROTECTION OF HUMAN SUBJECTS
p.000096: S ec.
p.000096: 11.101 T o w ha t does t h is polic y a ppl y?
p.000096: 11.102 Defi n i t io n s.
p.000096: 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
p.000096: ppo r t ed b y any F ede ra l Dep ar tm e n t o r Age n c y .
p.000096: 11.104–11.106 [ R ese r ved]
p.000096: 11.107 I R B m e m be r s h ip.
p.000096: 11.108 I R B fun c t io n s an d ope ra t io n s.
p.000096: 11.109 I R B r eview of r ese ar c h .
p.000096: 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
p.000096: n o m o r e
p.000096:
p.000096: 96
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: Office of the Secretary of Transportation § 11.101
p.000096:
p.000096:
p.000096: 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.000096: 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 .
p.000096: 11.112 R eview b y i n s t i t u t io n .
p.000096: 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 .
p.000096: 11.114 Coope ra t ive r ese ar c h .
p.000096: 11.115 I R B r eco r ds.
p.000096: 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 .
p.000096: 11.117 Doc u m e n t a t io n of i nfo r m ed co n se n t .
p.000096: 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
p.000096: of hu m an s u bjec t s.
p.000096: 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
p.000096: bjec t s.
p.000096: 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
p.000096: 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.000096: 11.121 [ R ese r ved]
p.000096: 11.122 Use of F ede ra l fun ds.
p.000096: 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
p.000096: io n s an d p r o- pos a ls.
p.000096: 11.124 Co n di t io n s.
p.000096: 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,
p.000096: 1991,
p.000096: un less o t h e r wise n o t ed.
p.000096:
p.000096: § 11.101 To what does this policy apply?
p.000096: ( 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.000096: 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.000096: 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.000096: 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.000096: 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.000096: 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.000096: 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.000096: 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.000096: 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.000096: m e n t o u t side t h e U n i t ed S t a t es.
p.000096: (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.000097: 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.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097: § 11.101
p.000097: (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.000097: 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.000097: 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.000097: ( 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
p.000097: 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
p.000097: 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
p.000097: 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.
p.000097: (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
p.000097: 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
p.000097: 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
p.000097: 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
p.000097: 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
p.000097: 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
p.000097: 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.
p.000097: ( 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.000097: 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.000097: ( 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.000097: 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.000097: 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.000097: 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.000097: h is polic y .
p.000097: ( 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.000097: 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.000097: hu m an s u b- jec t s.
p.000097: (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.000097: 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.000097: fo r hu m an s u bjec t s.
p.000097: ( 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.000097: 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.000097: s u bjec t s of r ese ar c h .
p.000097: ( 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.000098: 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
p.000098: 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
p.000098: 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.
p.000098: ( 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.000098: 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.000098: 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.000098: 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.000098: 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.000098: 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.000098: 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.000098: 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.000098: ar tm e n t o r a ge n c y p r oced ur es. 1
p.000098: [56 F R 28012, 28023, J un e 18, 1991; 56 F R 29756,
p.000098: J un e 28, 1991]
p.000098:
p.000098: 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.000098: n s of t i t le
p.000098: 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.000098: ha ve i n co r -
p.000098: 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.000098: 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.000098: 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.000098: 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.000098: 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.000098: 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.000098: 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
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: Office of the Secretary of Transportation § 11.103
p.000098:
p.000098:
p.000098: § 11.102 Definitions.
p.000098: ( 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.000098: 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.000098: o m au t h o r i t y ha s bee n deleg a t ed.
p.000098: ( 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.000098: g fed- e ra l , s t a t e, an d o t h e r a ge n cies).
p.000098: ( 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.000098: 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
...

Social / Youth/Minors

Searching for indicator minor:

(return to top)
p.000101: ive doc u m e n t a t io n i n a cco r d an ce wi t h
p.000101: § 11.117.
p.000101:
p.000101: 49 CFR Subtitle A (10–1–03 Edition)
p.000101: ( 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.000101: 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.000101: of m odific a-
p.000101: 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.000101: 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.000101: 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.000101: 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.000101: i n pe r so n o r i n w r i t i n g.
p.000101: ( 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.000101: pol-
p.000101: 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.000101: 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.000101: 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.000101: ( 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.000101:
p.000101: § 11.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000101: minor changes in approved re- search.
p.000101: ( 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.000101: 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.000101: 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.000101: 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.000101: 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.000101: 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.000101: 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.000101: 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.000101: ( 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.000101: h e followi n g:
p.000101: (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.000101: 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.000101: (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.000101: 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.000101: 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.000101: 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.000101: t h e
...

Orphaned Trigger Words



p.000098: 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
p.000098: 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
p.000098: 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
p.000098: 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
p.000098: 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
p.000098: 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
p.000098: . 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
p.000098: 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-
p.000098: 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
p.000098: ese ar c h i n- volvi n g hu m an s u bjec t s.
p.000098: ( 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
p.000098: fo r t h e p ur poses exp r essed i n t h is pol- ic y .
p.000098: ( 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
p.000098: 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
p.000098: 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
p.000098: an d fede ra l r eq u i r e- m e n t s.
p.000098: ( 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-
p.000098: 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
p.000098: 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
p.000098: 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.
p.000098: ( 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
p.000098: 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
p.000098: 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-
p.000098: 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
p.000098: r d an ce wi t h an a pp r oved a ss uran ce.
p.000098: § 11.103 Assuring compliance with this policy—research conducted or sup- ported by any Federal Department or
p.000098: Agency.
p.000098: ( 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
p.000098: 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
p.000098: y s ha ll
p.000098:
p.000099: 99
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: § 11.103
p.000099: 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
p.000099: 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 ...

p.000103: 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
p.000103: 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
p.000103: iss u es an d t h ei r r esol u t io n .
p.000103: (3) R eco r ds of co n t i nu i n g r eview a c- t ivi t ies.
p.000103: (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.
p.000103: (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).
p.000103: (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
p.000103: i n
p.000103: § 11.103( b)(4) an d § 11.103( b)(5).
p.000103: (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
p.000103: r e- q u i r ed b y § 11.116( b)(5).
p.000103: ( 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
p.000103: 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
p.000103: 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 .
p.000103: 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
p.000103: r ese n t a t ives of t h e dep ar t -
p.000103:
p.000103: 49 CFR Subtitle A (10–1–03 Edition)
p.000103: 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 .
p.000103: ( 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.000103:
p.000103: § 11.116 General requirements for in- formed consent.
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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 -
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: 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
p.000103: li a bili t y fo r n eglige n ce.
p.000103: ( 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 ...

p.000104: 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
p.000104: 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 :
p.000104: (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;
p.000104: (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
p.000104: welfar e of t h e s u bjec t s;
p.000104: (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
p.000104: t t h e w a ive r o r a l t e ra t io n; an d
p.000104: (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
p.000104: 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 .
p.000104: ( 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
p.000104: 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
p.000104: 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
p.000104: se n t t o be le- g a ll y effec t ive.
p.000104: (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
p.000104: 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
p.000104: 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.
p.000104: ( 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.000104:
p.000104: § 11.117 Documentation of informed consent.
p.000104: ( 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
p.000104: n t s ha ll be doc u m e n t ed b y t h e u se of a
p.000105: 105
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: § 11.118
p.000105: 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
p.000105: 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
p.000105: t h e pe r - so n sig n i n g t h e fo r m .
p.000105: ( 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
p.000105: r m m ay be ei t h e r of t h e followi n g:
p.000105: (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
p.000105: 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
p.000105: 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
p.000105: 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
p.000105: e oppo r t un i t y t o
p.000105: r e a d i t befo r e i t is sig n ed; o r
p.000105: (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
p.000105: 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
p.000105: 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 ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
ageAge
minorYouth/Minors

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers

Trigger Words

consent

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
SocialAccess to Social Goodsaccess3
SocialAgeage8
SocialYouth/Minorsminor1