Effects of Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress Among African Americans: A Pilot Study
Phase: NA
Conditions: Racism, Stress, Psychological
Sponsor: Rockefeller University

 
 
 
Effects of C o m p assi o n -B ase d Resilie nc y 
Tr ai ni n g ( C B R T) o n R acis m -B ase d Stress 
A m o n g Afric a n A meric a n A d ults: A Pil ot St u d y  
 
 
N C T 0 6 1 4 6 2 1 8 
Pr ot oc ol V ersi o n:  1. 1 1 
Or g a niz ati o n:  R oc kefell er U ni versit y  
Or g a niz ati o n I D:  R KI - 1 0 4 7 
Pr ot oc ol D ate:   I R B A p pr o ve d - 8/ 2 2/ 2 0 2 5 
P u blic Versi o n f or Cli nic al Tri als. g o v S u b missi o n  
 

 
 
I nstit uti o nal Re vie w B oar d 
Sara h J. Sc hlesi nger , MD,  C hair  
Dale Miller , B A CI P   
Sr. I R B S pecialist ( 2 1 2) 3 2 7-8 4 1 1  
Va nessa S mit h, B A M P S , CI M, CI P 
Sr. I R B S pecialist, ( 2 1 2) 3 2 7-8 4 1 0  
H os pital Bl d g., R o o m 2 0 1 B ox 3 3 1  
 
 
 
Cli nical Trials. g o v  
Nati o nal Li brar y of Me dici ne  
8 6 0 0 R oc k ville Pi ke 
Bet hes da, M D 2 0 8 9 4  
 
Re: C o m passi o n- Base d Resilie nc y Trai ni n g ( C B R T) I nter ve nti o n o n Racis m- base d Stress , R KI-
1 0 4 7, N C T 0 6 1 4 6 2 1 8 
Dear Re prese ntati ve of Cli nical Trials. g o v:  
T his letter is t o c o nfir m t hat t he u pl oa de d St u d y Pr ot oc ol a n d Statistical A nal ysis Pla n P D F/ A 
d oc u me nt f or t he st u d y, C o m passi o n- Base d Resilie nc y Trai ni n g ( C B R T) I nter ve nti o n o n Racis m -
base d Stress , I R B I D: R KI- 1 0 4 7, N C T 0 6 1 4 6 2 1 8 is t he ori gi nal, pre-s pecifie d St u d y Pr ot oc ol a n d 
Statistical A nal ysis Pla n d oc u me nt  a p pr o ve d b y t he R oc kefeller U ni versit y I nstit uti o nal Re vie w 
B oar d . O ur i nstit uti o n utilizes  a n I R B a p plicati o n f or mat, rat her t ha n a se parate Pr ot oc ol a n d/ or 
Statistical A nal ysis Pla n . Please d o n ot hesitate t o c o ntact me  if I ma y be of f urt her assista nce. 
Si ncerel y,  
 
Sara h J. Sc hlesi n ger, M D  
C hair, I nstit uti o nal Re vie w B oar d  
Ass ociate Pr ofess or of Cli nical I n vesti gati o n  
Se ni or Atte n di n g P h ysicia n  
La b orat or y of C he mical Bi ol o g y a n d Si g nal Tra ns d ucti o n 
T he R oc kefeller U ni versit y 
 
 
 
 
 
 
 
 

S t u d y A p pli c a ti o n ( V e r si o n 1. 1 1 )
1. 0   
Ge ner al I nf or m ati o n
* Ple ase e nter t he f ull title of y o ur st u d y::
Eff e ct s of C o m p a s si o n - B a s e d R e sili e n c y Tr ai ni n g ( C B R T ) I nt er v e nti o n o n R a ci s m - b a s e d Str e s s 
a m o n g Afri c a n A m eri c a n s : A Pil ot St u d y
 
 
* Ple ase e nter t he st u d y s h ort title:
C o m p a s si o n - B a s e d R e sili e n c y Tr ai ni n g ( C B R T ) I nt er v e nti o n o n R a ci s m - b a s e d Str e s s
* T hi s fi el d all o w s y o u t o e nt er a n a b br e vi at e d v er si o n of t h e St u d y Titl e t o q ui c kl y i d e ntif y t hi s 
st u d y.
 
 
Is t his St u d y usi n g S u bject M a n a ge me nt ?
Y e s 
N o
   
 
2. 0   
A d d de p art me nts
2. 1 List de p art me nts ass oci ate d wit h t his st u d y:
Ple ase c h o ose at le ast t w o l a bs/ de p art me nts. Y o ur m ai n l a b/ de pt. s h o ul d be t he pri m ar y l a b liste d, e. g. y o ur H O L's 
l a b.  
All pr ot oc ols m ust als o list " R oc kefeller U ni versit y H os pit al ( R U H) " as a sec o n d ar y l a b/ de pt.  
Y o u m a y als o list a d diti o n al,  l a b/ de pt(s) if a p pr o pri ate t o i ncl u de R U c oll a b or at ors.
If y o ur l a b/ de p art me nt is n ot liste d i n t he ' A d d De p art me nt' dr o p d o w n me n u, ple ase c o nt act R U H I T at 
h os pit al _i nf or m atics @r oc kefeller.e d u t o arr a n ge f or t he ne w l a b t o be a d de d t o t he listi n g.
I s 
P ri m a r y ?
D e p a r t m e n t N a m e
R U H  - L a b or at or y of N e ur o g e n eti c s of L a n g u a g e ( J ar vi s )
R U H  - R o c k ef ell er U ni v er sit y H o s pit al ( R U H )
 
3. 0 
Assi g n ke y st u d y pers o n nel( K S P) access t o t he st u d y  
3. 1   Ple ase a d d a Pri nci p al I n vesti g at or f or t he st u d y: 
*
N a m e
R ol e
T r ai ni n g R e c o r d
Ki m a ni, R a c h el  W a n g a ri, D N P   
P ri n ci p al I n v e s ti g a t o r
 Vi e w T r ai ni n g R e c o r d
3. 2 If a p plic a ble, ple ase select t he Rese arc h St aff pers o n nel: 
A ) A d diti o n al I n v e sti g at or s 
N a m e
R ol e
T r ai ni n g R e c o r d
N o A d diti o n al I n v e sti g at or s h a v e b e e n a d d e d
◆◆◆◆

B ) R e s e ar c h S u p p ort St aff 
N a m e
R ol e
T r ai ni n g R e c o r d
N o R e s e ar c h S u p p ort St aff h a v e b e e n a d d e d
3. 3   Ple ase a d d a St u d y C o nt act:
*
N a m e
R ol e
T r ai ni n g R e c o r d
Ki m a ni, R a c h el  W a n g a ri, D N P   
S t u d y C o n t a c t
 Vi e w T r ai ni n g R e c o r d
T h e St u d y C o nt a ct ( s ) will r e c ei v e all i m p ort a nt s y st e m n otifi c ati o n s al o n g wit h t h e Pri n ci p al I n v e sti g at or. ( e. g. T h e 
pr oj e ct c o nt a ct ( s ) ar e t y pi c all y eit h er t h e St u d y C o or di n at or or t h e Pri n ci p al I n v e sti g at or t h e m s el v e s ). 
4. 0  
R oc kefeller U ni versit y C o nflict of I nterest
4. 1  
 
I n vesti g at or Fi n a nci al C o nflict of I nterest All K S P m ust c o m plete a n a n n u al certific ati o n of t heir Si g nific a nt Fi n a nci al I nterest ( “ S FI ”) 
discl os ures i n t he U ni versit y’s o nli ne Rese arc h A d mi nistr ati o n S yste m at htt ps:// R A S.r oc kefeller.e d u.  Discl os ures als o m ust be u p d ate d 
i n c o n necti o n wit h ne w h u m a n s u bjects rese arc h pr ot oc ols ( “ Rese arc h Certific ati o n ”), a n d wit hi n 3 0 d a ys of disc o veri n g or ac q uiri n g a 
 T o a v oi d del a ys i n t he I R B re vie w pr ocess, w he n pr o m pte d b y a n e m ail fr o m 
ne w S FI. 
r asc oi @r oc kefeller.e d u re q uesti n g a n u p d ate d 
Rese arc h Certific ati o n, K S P s h o ul d clic k o n t he Rese arc h Certific ati o n li n k c o nt ai ne d i n t h at e m ail n otific ati o n, or g o t o htt ps:// R A S.
r oc kefeller.e d u, t o ( a) re vie w a n d u p d ate his or her S FI discl os ures or certif y t h at he/s he h as n o u p d ates, as a p pr o pri ate, a n d ( b) i n dic ate 
w het her a n y of his/ her S FI discl os ures are re as o n a bl y rel ate d t o t he desi g n, c o n d uct, or re p orti n g of t he rese arc h pr ot oc ol. If a K S P 
discl oses a S FI t h at mi g ht c o nstit ute a c o nflict of i nterest wit h res pect t o t he pr o p ose d pr ot oc ol, he or s he m ust e- m ail a c o p y of t he L a y 
S u m m ar y of t he dr aft pr ot oc ol t o Teres a S ol o m o n, Es q. ( s ol o m ot @r oc kefeller.e d u).  D oi n g s o will f acilit ate a d dressi n g C OI iss ues i n ste p 
wit h t he de vel o p me nt of t he st u d y pr ot oc ol.  N o n-c o m pli a nce or t ar di ness i n m a ki n g or u p d ati n g C OI discl os ures will res ult i n a del a y i n 
   
I R B re vie w.   I nstit uti o n al C o nflict of I nterest:
 
As e arl y as p ossi ble t he PI ( or a desi g nee) pre p ari n g a cli nic al rese arc h pr ot oc ol m ust re vie w a list of e ntities i n w hic h T he R oc kefeller 
U ni versit y h as a n I nstit uti o n al Fi n a nci al I nterest at htt ps://ic oi.r oc kefeller.e d u/ acc o u nt/l o gi n. p h p.  If t he pr o p ose d st u d y i n v ol ves a n y 
e ntit y o n t h at list, t he PI ( or desi g nee) m ust n otif y Teres a S ol o m o n, st aff t o t he F C OI C o m mittee, b y e- m ail s ol o m ot @r oc kefeller.e d u a n d 
S ar a h Sc hlesi n ger, C h air of t he I R B, b y e m ail: sc hless @r oc kefeller.e d u, pr o vi de t he n a me(s) of t he e ntities a n d a c o p y of t he L a y 
S u m m ar y. D oi n g s o will f acilit ate a d dressi n g i nstit uti o n al C OI iss ues i n ste p wit h t he de vel o p me nt of t he st u d y pr ot oc ol. F ail ure t o t a ke 
 
ste ps t o re vie w a n d a d dress p ote nti al i nstit uti o n al c o nflicts of i nterest will del a y t he I R B re vie w pr ocess.  
5. 0  E xter n al Pers o n nel
5. 1  List e xter n al pers o n nel w h o will be w or ki n g o n t he st u d y:
N a m e
I n s ti t u ti o n  
T el e p h o n e  
E - m ail
R ol e
N o E xt er n al P er s o n n el h a s b e e n a d d e d t o t hi s St u d y
6. 0  D el e g ati o n of A ut h orit y 
6. 1  E nt er a ut h ori z e d a cti viti e s f or all 
 n a m e d o n t h e st u d y. 
R o c k ef ell er U ni v er sit y p er s o n n el
A c ti vi t y C o d e s:
1.   I nf or m e d c o n s e nt  * *
1 1.  P arti ci p a nt r e cr uit m e nt
2 1.  S ki n bi o p s y *
2.   I n cl u si o n / e x cl u si o n crit eri a  
1 2.  P erf or m a s s a y s 
2 2.  C o n d u ct sl e e p st u d y
3.   M e di c al/ m e di c ati o n hi st or y  *
1 3.  S p e ci m e n / s a m pl e a n al y si s 2 3.  Di et d e si g n a n d pr e p ar ati o n
4.   P erf or m P h y si c al E x a m *
4 a. Writ e / Si g n LI P or d er s  *     
1 4.  L u m b ar p u n ct ur e *
2 4.  N utriti o n al a s s e s s m e nt a n d 
c o u n s eli n g
5.   S ki n a s s e s s m e nt s a n d p h ot o s
1 5.  F e m or al li n e pl a c e m e nt *
2 5.  A d diti o n of P A B A t o f o o d 
6.   St u d y dr u g di s p e n si n g *
1 6.  C e ntr al li n e pl a c e m e nt * 
2 6.  D at a a n al y si s
7.   St u d y dr u g a d mi ni str ati o n  *
1 7.  I n s uli n cl a m p pr o c e d ur e *
2 7.  D at a r e vi e w

8.   St u d y dr u g r e c o n cili ati o n
1 8.  L e u k a p h er e si s  *
2 8.  D at a m a n a g e m e nt 
9.   St u d y dr u g c o m pli a n c e
1 9.  Si g m oi d o s c o p y *  
2 9.  M ai nt ai n r e g ul at or y d o c u m e nt s / 
fil e s
1 0. A d mi ni st er st u d y q u e sti o n n air e( s)
2 0.  F at bi o p s y *
3 0.  C o m pl et e C R F' s
A d d u p t o t h r e e a d di ti o n al a u t h o ri z e d a c ti vi ti e s s p e cifi c t o t hi s s t u d y ( d o N O T a d d 
a c ti vi ti e s t h a t h a v e p r e vi o u sl y d e si g n a t e d c o d e s ):
3 1:
3 2:
3 3:
 A cti vit y C o d e s C o nti n u e d:
3 4.  B e h a vi or al T e sti n g
3 5.  B o d P o d
3 6.  B o n e M arr o w A s pir ati o n *
3 7.  N e ur o p s y c h ol o gi c al T e sti n g  *
3 8.  C o n d u ct F o c u s Gr o u p 
3 9.  C o n d u ct S m ell St u d y
4 0.  G e n eti c C o u n s eli n g  *
4 1.  A p pl y E E G El e ctr o d e s  * *
4 2.  Olf a ct o m et er T e st
4 3.  St u d y P arti ci p a nt T e a c hi n g
4 4.  R e sti n g E n er g y E x p e n dit ur e 
4 5.  S o ur c e D o c u m e nt R e vi e w & C orr e cti o n 
4 6.  M e di c al P h ot o gr a p h y
4 7.  S e e 4 a 
4 8.  A d v er s e E v e nt A s s e s s m e nt
4 9.  Cli ni c al Tri al R e gi str ati o n 
5 0.  St u d y S u p p ort Dr u g Di s p e n s ar y
5 1.  I nt er n al M o nit ori n g 
5 2.  R a n d o mi z ati o n 
E nter dele g ati o n of a ut h orit y f or R oc kefeller U ni versit y Ke y St u d y Pers o n nel:
N O T E:
     
*
I n di c at e s pr o c e d ur e s r e q uiri n g t h e i n di vi d u al c o m pl et e s p e cifi c cr e d e nti ali n g   
 t h e 
B E F O R E
a cti vit y m a y b e a d d e d t o t h eir d el e g at e d a cti viti e s.
  
* *
I n di c at e s pr o c e d ur e s r e q uiri n g t h e i n di vi d u al c o m pl et e s p e cifi c tr ai ni n g   
 t h e 
B E F O R E
a cti vit y m a y b e a d d e d t o t h eir d el e g at e d a cti viti e s.
N a m e
Ti tl e
A u t h o ri z e d A c ti vi ti e s
S t a r t D a t e  E n d D a t e
Ki m a ni, 
R a c h el 
W a n g ari, 
D N P
PI
1, 2, 3, 4, 4 a, 
1 0, 1 1, 1 2, 1 3, 2 6, 2 8, 2 9, 3 0, 4 3, 4 8, 5 1
0 9 / 0 5
/ 2 0 2 3
J ar vi s, 
Eri c h, P h D
C o - PI
2 6, 2 7, 2 8, 5 1
0 9 / 0 5
/ 2 0 2 3
0 8 / 2 1
/ 2 0 2 5
D o w d, 
K at hl e e n, 
B S N, R N, 
F a cilit at or  
2 9
0 9 / 0 5
/ 2 0 2 3
0 6 / 3 0
/ 2 0 2 5

C C R C
C a m p b ell, 
A n n, R N, 
M S N, M P H
C o - PI
2 7, 2 9
0 2 / 0 1
/ 2 0 2 4
0 8 / 2 1
/ 2 0 2 5
Ol uf e k o, 
Ol u w at o bi 
T e mit o p e, 
M P H, M A, 
C C R C
F a cilit at or  
2 9
0 2 / 0 1
/ 2 0 2 4
0 6 / 3 0
/ 2 0 2 5
E nter dele g ati o n of a ut h orit y f or a d diti o n al R oc kefeller U ni versit y Ke y St u d y Pers o n nel:
N a m e
Ti tl e
A u t h o ri z e d 
A c ti vi ti e s
S t a r t D a t e  
E n d D a t e
N o r e s ult s f o u n d
E nter t he a ut h orize d acti vities f or E xter n al Pers o n nel:
N a m e
Ti tl e
A u t h o ri z e d 
A c ti vi ti e s
S t a r t D a t e  
E n d D a t e
N o r e s ult s f o u n d
7. 0  St u d y Descri pti o n
7. 1  
St u d y Cl assific ati o n
F ull R e vi e w
7. 2  
 
* S u b missi o n Re q uest C ate g or y
N ote: F or e ac h s u b missi o n, ple ase desi g n ate t he le vel of re vie w, or “ S u b missi o n Re q uest C ate g or y ” y o u are re q uesti n g. W he n c o m pleti n g 
t his fiel d, ple ase i n dic ate t he le vel of re vie w y o u are re q uesti n g f or t he s pecific s u b missi o n y o u are w or ki n g o n.

F or e x a m ple, if y o u are s u b mitti n g a n E x pe dite d A me n d me nt re q uest t o c h a n ge t he Ke y St u d y Pers o n nel o n y o ur e xisti n g F ull B o ar d 
st u d y, y o u s h o ul d select “ E x pe dite d Re vie w ” i n b ot h t he A me n d me nt S u b missi o n F or m a n d St u d y A p plic ati o n. T he I R B will c o nfir m a n 
E x pe dite d re vie w of t he A me n d me nt s u b missi o n is a p pr o pri ate, a n d t he o ver all st u d y will re m ai n cl assifie d as a f ull B o ar d re vie w.  Ple ase 
see t he hel p b u b ble f or g ui d a nce.
T o s u b mit a re q uest f or a N ot H u m a n S u bjects rese arc h deter mi n ati o n, ple ase e xit t his f or m a n d select t he “ N ot H u m a n S u bjects 
Rese arc h Deter mi n ati o n ” f or m u n der Cre ate a Ne w St u dy.
E x e m pt fr o m R e vi e w 
E x e m pt wit h Li mit e d R e vi e w 
E x p e dit e d R e vi e w 
F ull R e vi e w 
7. 3  * L a y S u m m ar y
Ple ase pr o vi de a s u m m ar y of y o ur st u d y i n l a y l a n g u a ge t h at is e asil y u n derst o o d b y a n o n-scie ntist. T he s u m m ar y s h o ul d be n o m ore 
t h a n h alf a p a ge ( 5 0 0 w or ds or less) a n d s h o ul d c o nt ai n a cle ar st ate me nt of t he r ati o n al f or t he st u d y.
Ple ase clic k o n t he hel p b u b ble t o get t he i nf or m ati o n o n " H o w t o use i RI S te xt e dit or. "
Please pr o vi de a s u m mar y of y o ur st u d y i n la y la n g ua ge.  T he s u m mar y s h o ul d be n o m ore t ha n a half pa ge 
( 5 0 0 w or ds or less) a n d s h o ul d c o ntai n a clear state me nt of t he rati o nale f or t he st u d y. 
Racis m a n d racial discri mi nati o n pr of o u n dl y affect me ntal a n d p h ysical healt h a m o n g mi n oritize d et h nic gr o u ps, 
i ncl u di n g Blac k, I n di ge n o us, a n d Pe o ple of C ol or ( BI P O C). T he ne gati ve healt h i m pacts are e vi de nt i n ele vate d 
m ortalit y rates, earl y disease o nset, a n d i ncrease d c o m or bi dit y b ur de n a m o n g BI P O C i n di vi d uals. T his st u d y 
see ks t o a d dress t hese healt h dis parities b y i n vesti gati n g t he p ote ntial of C o nte m plati ve- Base d Resilie nce 
Trai ni n g ( C B R T) t o miti gate t he i m pact of racis m-relate d stress. C B R T h ol ds pr o mise i n c o u nteri n g t he 
ne ur o bi ol o gical c ha n ges attri b ute d t o c hr o nic stress, ali g ni n g wit h t he " weat heri n g h y p ot hesis" a n d All ostatic 
l oa d t he or y.
T he pri mar y ai m of t his pil ot st u d y is t o e x pl ore t he feasi bilit y, acce pta bilit y, a n d preli mi nar y effecti ve ness of 
C B R T i nter ve nti o n a m o n g Africa n A merica ns. T he s pecific o bjecti ves i ncl u de assessi n g feasi bilit y, gat heri n g 
partici pa nt fee d bac k, e val uati n g C B R T's i m pact o n ps yc h ol o gical a n d bi ol o gical o utc o mes, a n d e x pl ori n g t he 
me diati n g r ole of mi n df ul ness.
T he st u d y e m pl o ys a 1 gr o u p desi g n. Partici pa nts are recr uite d fr o m vari o us s o urces a n d u n der g o baseli ne a n d 
f oll o w- u p assess me nts. T he i nter ve nti o n i n v ol ves a 1 0- wee k C B R T pr o gra m f oc usi n g o n mi n df ul ness, 
c o m passi o n, self-a ware ness, a n d stress-re d ucti o n tec h ni q ues. Meas ures i ncl u de s oci o- de m o gra p hics a n d 
ps yc h ol o gical meas ures (race- base d stress, de pressi o n, percei ve d stress, q ualit y of life, s ocial c o n necte d ness, 
slee p, a n d resilie nce) a n d bi ol o gical meas ures ( all ostatic l oa d, sali va c ortis ol, tel o mere le n gt h, a n d ge ne 
e x pressi o n. Data is c ollecte d at baseli ne a n d 1 0 wee ks.
Feasi bilit y will be assesse d base d o n recr uit me nt rates, rete nti o n, atte n da nce, a n d q ualitati ve fee d bac k. T he 
i m pact of C B R T will be e val uate d t hr o u g h vari o us statistical a nal yses, c o nsi deri n g i nte nti o n-t o-treat pri nci ples 
a n d c o ntr olli n g f or c o variates. Preli mi nar y fi n di n gs fr o m a pil ot i n vesti gati o n wit h 2 0 Africa n- A merica n 
partici pa nts s u g gest ass ociati o ns bet wee n ps yc h ol o gical meas ures, mi n df ul ness, slee p, c o pi n g, resilie nce, a n d 
racis m-i n d uce d stress. T hese res ults u n dersc ore t he p ote ntial of C B R T i n a d dressi n g c o m ple x relati o ns hi ps 
a m o n g t hese fact ors. B y i n vesti gati n g t he p ote ntial be nefits of C B R T i n alle viati n g racis m-i n d uce d stress a n d 
ass ociate d healt h dis parities, t his researc h ai ms t o c o ntri b ute i nsi g hts i nt o mi n df ul ness- base d i nter ve nti o ns t o 
a d dress racis m-relate d stress a n d its br oa der i m plicati o ns f or t he well- bei n g of BI P O C c o m m u nities.
7. 4  
 P u bli c H e alt h I m p a ct St at e m e nt
*
Pr o vi de a brief plai n la n g ua ge state me nt ( 1 0 0 w or ds or less) of t he val ue of t he researc h pr o p ose d a n d its 
p ote ntial i m pact o n p o p ulati o n healt h. A d diti o nal i nstr ucti o ns l ocate d i n Hel p.
 
R a ci s m i s a p u bli c h e alt h cri si s pr o v e n t o b e a s o ur c e of str e s s c o ntri b uti n g t o h e alt h di s p ariti e s. 
W hil e di s m a ntli n g s y st e mi c r a ci s m i s t h e m o st eff e cti v e w a y t o a d dr e s s t h e h e alt h c o st s of r a ci s m -
r el at e d str e s s, t h er e i s a criti c al n e e d t o a d dr e s s t h e o n g oi n g r a ci s m -r el at e d i nj ur y. T hi s st u d y 
ai m s t o e x pl or e h o w r a ci s m -i n d u c e d str e s s i m p a ct s t h e br ai n a n d b o d y a n d h o w a c ult ur all y 

r e s p o n si v e i nt er v e nti o n c a n r e d u c e t h e m e nt al a n d p h y si c al eff e ct s of t hi s str e s s. T hi s st u d y will 
pr o vi d e v al u a bl e i nf or m ati o n t o h el p d e v el o p t o ol s t o r e d u c e t h e i m p a ct of r a ci s m -r el at e d i nj ur y 
a n d i m pr o v e h e alt h o ut c o m e s f or mi n orit y c o m m u niti e s.
8. 0  
Cli ni c al Tri al R e gi str ati o n
8. 1  
Cli ni c al Tri al R e gi str ati o n
T he t y pes of st u dies liste d bel o w m ust be re gistere d at 
bef ore e nr olli n g t he first 
Cli nic al Tri als we bsite  
partici pa nt i n or der t o be i n c o m plia nce wit h fe deral re g ulati o ns a n d preser ve t he o p p ort u nit y t o p u blis h t he 
st u d y i n j o ur nals t hat a d here t o t he 
. Please c hec k t he a ns wer t hat best a p plies.
I C M J E g ui deli nes
St u d y i n v ol v e s t e sti n g of F D A r e g ul at e d dr u g s or bi ol o gi c s ( S e e H E L P ) 
St u d y i s f u n d e d b y t h e NI H, a n d m e et s t h e d efi niti o n of a “ cli ni c al tri al ” ( s e e H E L P ) 
St u d y m e et s t h e I C M J E d efi niti o n of a “ cli ni c al tri al ” ( S e e H E L P ) 
A d diti o n al f u n di n g a g e n c y or j o ur n al r e q uir e s cli ni c al tri al r e gi str ati o n 
N o n e of t h e a b o v e 
If y o u selecte d 1, 2, 3, or 4 y o u m ust re gister y o ur trial wit h Cli nical Trials. g o v t hr o u g h t he R oc kefeller 
U ni versit y i nstit uti o nal acc o u nt. Please c o ntact t he Cli nical Researc h S u p p ort Office x 7 4 0 8 f or assista nce.
9. 0  
St u d y O v er vi e w/ S u m m ar y
9. 1  
 * W h o i niti at e d t hi s st u d y ?
Please s pecif y o ne:
Pri n ci p al I n v e sti g at or I niti at e d 
I n d u str y I niti at e d 
Ot h er 
9. 2  *Are ot her i nstit uti o ns i n v ol ve d i n t he st u d y ?
N o 
Y e s 
9. 3    Is t his a m ulti-site tri al usi n g a si n gle I R B (sI R B) re vie w arr a n ge me nt ? Ple ase see hel p b u b ble f or defi niti o n.
 *
  Y e s      N o
9. 4  
 * W h o ( W h at) is t o be st u die d ?
H u m a n S u bj e ct s - i n cl u di n g c o d e d s a m pl e s a n d / or d at a wit h li n k s t o I d e ntifi er s
D ei d e ntifi e d S a m pl e s - u n a bl e t o b e li n k e d t o i d e ntifi er s b y r e c ei v er
D at a O nl y - u n a bl e t o b e li n k e d t o i d e ntifi er s

I d e ntifi a bl e s a m pl e s or d at a f or e x e m pti o n s ( p er 1 0 4 ( s ) ( 4 ) )
9. 5   St u d y T y pe:
*
I nt er v e nti o n al 
O b s er v ati o n al 
9. 6  T he i niti al d ate of I R B a p pr o v al/ deter mi n ati o n w as:
1 0 / 0 5 / 2 0 2 3
9. 7  *  W h at is t he e x pecte d d ur ati o n of t he st u d y ?
1 y e ar
9. 8  *  Are a n y of t he f oll o wi n g a ge nts t o be use d i n t he st u d y ?
C hec k all t hat a p pl y:
F D A A p pr o v e d Dr u g
F D A A p pr o v e d Dr u g f or Off - L a b el P ur p o s e ( T hi s mi g ht r e q uir e a n I N D )
I n v e sti g ati o n al N e w Dr u g
Bi ol o gi c A g e nt s
N utriti o n al S u p pl e m e nt s
Pl a c e b o
V a c ci n e s
N o A g e nt s
F D A E x e m pti o n t o u s e St u d y Dr u g
9. 9  *  Are i n vesti g ati o n al de vices t o be use d i n t he st u d y ?
  Y e s      N o
9. 1 5  S peci al Rese arc h Pr oce d ures
D oes t he st u d y pr o p ose t o directl y i n v ol ve partici pa nts i n t he f oll o wi n g s pecial researc h pr oce d ures?
R e c o m bi n a nt D N A
G e n e T h er a p y
F et al Ti s s u e
E m br y o ni c St e m C ell s
I n d u c e d Pl uri p ot e nt St e m C ell s
C RI S P R - C a s 9
If a n y ite m is c hec ke d, please see Hel p f or details.
9. 1 6   
 * R a di o acti ve Is ot o pes I n v ol ve d
Will partici pa nts be e x p ose d t o a n y ra diati o n ot her t ha n r o uti ne x-ra ys s olel y f or cli nical care p ur p oses? 
  Y e s      N o
 

1 0. 0  I nter ve nti o n al
1 0. 1   I nter ve nti o n al, ple ase s pecif y:
*
O p e n L a b el 
Si n gl e Bli n d 
D o u bl e Bli n d 
Ot h er 
1 1. 0  St u d y P h ase:
1 1. 1  St u d y P h ase:
Select w here a p plica ble
P h a s e 0 
P h a s e I 
P h a s e I /II 
P h a s e II 
P h a s e III 
P h a s e I A 
P h a s e I B 
P h a s e II A 
P h a s e II B 
P h a s e I B /II A 
P h a s e II B /III A 
P h a s e III A 
P h a s e III B 
N / A 
1 2. 0    
 a n d R ati o n ale
O bjecti ves
1 2. 1  *  O ver vie w
Briefl y state t he 
. Gi ve e n o u g h bac k gr o u n d a n d rati o nale t o pr o vi de b ot h scie ntists a n d la y 
p ur p ose of t his st u dy
me m bers of t he I R B a n d A C C T S wit h t he basis f or e x p osi n g h u ma n partici pa nts t o t he ris ks i n v ol ve d.
E x perie nces of racis m a n d racial discri mi nati o n pr of o u n dl y affect t he me ntal a n d p h ysical healt h of i n di vi d uals 
fr o m mi n oritize d et h nic gr o u ps ( Para dies et al., 2 0 1 5). T his per nici o us i m pact of racis m has gar nere d si g nifica nt 
p u blic healt h s u p p ort, i ncl u di n g t he s ur ge o n ge neral office me dical a n d n ursi n g or ga nizati o ns ( A merica n P u blic 
Healt h Ass ociati o n, 2 0 2 1). Researc h c o nsiste ntl y de m o nstrates t hat mi n oritize d gr o u ps, es peciall y Blac k, 
I n di ge n o us, a n d Pe o ple of C ol or ( BI P O C), gra p ple wit h dis pr o p orti o natel y a d verse healt h o utc o mes 
c haracterize d b y ele vate d m ortalit y rates, earlier disease o nset, hei g hte ne d disease se verit y, a n d i ncrease d 
c o m or bi dit y b ur de n( Carter et al., 2 0 1 7; Harrell et al., 2 0 1 1). T hese healt h dis parities are attri b ute d t o t he 
c u m ulati ve i m pact of str uct ural racis m, ma nifesti n g i n li mite d healt hcare access, s u b o pti mal q ualit y of care, a n d 
persiste nt e x perie nces of discri mi nati o n a n d i de ntit y t hreats. Alt h o u g h dis ma ntli n g s yste mic racis m re mai ns t he 
para m o u nt strate g y t o miti gate t he healt h t oll of racis m-relate d stress, a d dressi n g t he o n g oi n g i nj uries a n d t he 
res ulti n g me ntal a n d p h ysical healt h re perc ussi o ns is e q uall y i m perati ve. He nce, c o m pre he n di n g t he i ntricate 
i nter pla y bet wee n str uct ural racis m, c hr o nic healt h dis parities, a n d t he casca di n g p h ysi ol o gical res p o nses is 
cr ucial f or de vel o pi n g effecti ve i nter ve nti o ns t o n urt ure e q uita ble healt h o utc o mes a n d u pr o ot t he dee pl y 
i n grai ne d i ne q ualities face d b y BI P O C c o m m u nities.
I n t he c o nte xt of c hr o nic stress's pr of o u n d p h ysi ol o gical i m pacts, c o m pre he nsi ve i nter ve nti o ns li ke 
C o nte m plati ve- Base d Resilie nce Trai ni n g ( C B R T) h ol d si g nifica nt pr o mise i n li g ht of t he " weat heri n g 
h y p ot hesis" a n d All ostatic l oa d t he or y. T he " weat heri n g h y p ot hesis" s u g gests t hat i n di vi d uals fr o m mar gi nalize d 
c o m m u nities, partic ularl y t h ose e x perie nci n g s yste mic racis m a n d discri mi nati o n, u n der g o accelerate d a gi n g a n d 
healt h deteri orati o n d ue t o t he c hr o nic stress ors t he y e nc o u nter t hr o u g h o ut t heir li ves ( Si m o ns et al., 2 0 2 1). T he 

p h ysi ol o gical t oll of c hr o nic e x p os ure t o racis m, as hi g hli g hte d b y t he " weat heri n g h y p ot hesis," acce nt uates t he 
si g nifica nce of i nter ve nti o ns t hat ca n c o u nteract t he ne ur o bi ol o gical c ha n ges c o ntri b uti n g t o healt h dis parities 
( Ger o ni m us et al., 2 0 0 6). T his vie w p oi nt ali g ns wit h t he All ostatic l oa d t he or y p ut f ort h b y Mc E we n ( 1 9 9 8), 
w hic h p osits t hat o n g oi n g e x p os ure t o c hr o nic stress tri g gers mala da pti ve p h ysi ol o gical res p o nses, a m plif yi n g 
v ul nera bilit y t o diseases ( Mc E we n, 1 9 9 8). C o nse q ue ntl y, t he pr ol o n ge d e x perie nce of stress i n d uce d b y racis m 
a n d discri mi nati o n c ul mi nates i n t he accr ual of t o xic all ostatic l oa d —a n e m b o di me nt of t he b o d y's gra d ual 
deteri orati o n u n der pr ol o n ge d stress ( Mc E we n, 2 0 1 2).
T he i ntricate c o n necti o n bet wee n race- base d stress a n d t he e mer ge nce of c o n diti o ns c haracterize d b y 
i nfla m mat or y u n der pi n ni n gs, i ncl u di n g car di o vasc ular diseases ( C V D) a n d dia betes, is u n dersc ore d b y t he 
ma nifestati o n of stress wit hi n brai n re gi o ns li ke t he prefr o ntal c orte x, hi p p oca m p us, a m y g dala, a n d a nteri or 
ci n g ulate c orte x ( Clar k et al., 2 0 1 8; Ber ger a n d Sar n yai, 2 0 1 5; Sa ba n et al., 2 0 1 8). Wit hi n t his c o nte xt, 
i nter ve nti o ns s uc h as C B R T prese nt a pr o misi n g "t o p- d o w n" a p pr oac h b y i nte grati n g mi n df ul ness wit h c o g niti ve 
e d ucati o n, affect m o d ulati o n, m oti vati o nal i ma ger y, breat h c o ntr ol, a n d self- massa ge. C B R T researc h i nt o 
c o m passi o n- base d me ditati ve t hera pies, as de m o nstrate d b y L oizz o ( 2 0 0 9), s u p p orts C B R T efficac y i n n urt uri n g 
pr o-s ocial attri b utes a n d f osteri n g s ocial c o n necti o ns. I n di vi d uals p ossessi n g ele vate d mi n df ul ness traits ofte n 
e x hi bit i m pr o ve d e m oti o nal re g ulati o n a n d re d uce d e m oti o nal reacti vit y, w hile mi n df ul ness i nter ve nti o ns b olster 
i n di vi d ual resilie nce ( F uc hs et al., 2 0 1 3; Za p ols ki et al., 2 0 1 9). Sc h olars li ke Wats o n- Si n glet o n ( 2 0 1 9) a n d 
Hi dal g o ( 2 0 2 0) ha ve als o s u g geste d t hat hei g hte ne d mi n df ul ness le vels c o ul d pr otect a gai nst discri mi nati o n a n d 
race-relate d vi gila nce. I n a d diti o n, mi n df ul ness t hera pies ha ve bee n s h o w n t o i nfl ue nce stress-relate d ne ural 
plasticit y a n d all ostatic l oa d b y m o d ulati o n of ke y me diat ors li ke gl uc oc ortic oi ds a n d e xcitat or y a mi n o 
aci ds  ( Das kala kis et al., 2 0 2 2; Mc E we n, 2 0 1 7; Sa ba n et al., 2 0 2 1). T his c o m pelli n g gr o u n d w or k s u bsta ntiates 
C B R T's p ote ntial t o a d dress t he i ntricate i nter pla y bet wee n s yste mic racis m, c hr o nic stress, a n d p h ysi ol o gical 
res p o nses. T he i nter ve nti o n's ca pacit y t o e n ha nce ps yc h ol o gical well- bei n g a n d alle viate t he p h ysi ol o gical t oll of 
stress warra nts f urt her e x pl orati o n i n t he q uest t o a d dress healt h dis parities wit hi n BI P O C c o m m u nities.
W hile pre vi o us researc h has s h o w n mi n df ul ness i nter ve nti o ns' via bilit y a n d acce pta bilit y acr oss differe nt 
p o p ulati o ns, i ncl u di n g t h ose faci n g c hr o nic stress, a n ota ble ga p e xists i n e x pl ori n g mi n df ul ness's p ote ntial t o 
miti gate t he s pecific c halle n ges of racis m- base d stress a n d its ass ociate d o utc o mes. Des pite t he e xisti n g e vi de nce 
s u g gesti n g mi n df ul ness's p ote ntial t o b uffer t he ps yc h ol o gical i m pact of discri mi nati o n, st u dies tar geti n g racis m-
relate d stress a n d its effects re mai n li mite d, pri maril y f oc usi n g o n ps yc h ol o gical meas ures. C o nse q ue ntl y, we 
h y p ot hesize t hat pers o ns w h o e x perie nce racis m- base d stress a n d e n ga ge i n a C B R T pr o gra m will re p ort 
s u bsta ntial e n ha nce me nts i n vari o us d o mai ns, i ncl u di n g o verall stress le vels, percei ve d discri mi nati o n, 
resilie nce, c o pi n g s kills, a n xiet y, de pressi o n, mi n df ul ness, slee p q ualit y, all ostatic l oa d, a n d sali var y c ortis ol. 
Here, we test t he feasi bilit y of a C B R T i nter ve nti o n a n d acce pta nce, s u bsta ntiate d b y fact ors s uc h as e nr oll me nt 
rates, atte n da nce, e n ga ge me nt, a n d q ualitati ve fee d bac k. B y i n vesti gati n g t hese m ultifacete d o utc o mes, o ur st u d y 
ai ms t o c o ntri b ute esse ntial i nsi g hts i nt o t he p ote ntial of mi n df ul ness- base d i nter ve nti o ns t o a d dress racis m-
base d stress a n d its br oa d-ra n gi n g i m plicati o ns.
Preli mi n ar y st u d y
T he pr o p ose d st u d y b uil ds u p o n a preli mi nar y pil ot i n vesti gati o n ( R KI- 1 0 3 6), w here a c o h ort of 2 0 Africa n-
A merica n partici pa nts was recr uite d. T his i nitial e n dea v or ai me d t o gat her met h o d ol o gical i nsi g hts, esta blis h a 
r o b ust pr ot oc ol, a n d la y t he gr o u n d w or k f or a s u bse q ue nt C o nte m plati ve- Base d Resilie nce Trai ni n g ( C B R T) 
i nter ve nti o nal st u d y t o lesse n t he i m pact of race- base d tra u ma a n d stress. T his preli mi nar y st u d y e m pl o ye d a 
mi xe d- met h o ds a p pr oac h, i nc or p orati n g a n e m be d de d q ualitati ve i n q uir y. I nitiall y, t he st u d y s o u g ht t o ga u ge t he 
feasi bilit y of recr uiti n g 2 0 Africa n- A merica n partici pa nts t o meas ure ps yc h ol o gical a n d p h ysi ol o gical i n dicat ors 
of race- base d stress. S u bse q ue ntl y, t he i n vesti gati o n ai me d t o vali date a n d e x pa n d t he assess me nt of a d diti o nal 
p h ysi ol o gical varia bles, e x pl ori n g h o w racis m is a stress or i nfl ue nci n g all ostatic l oa d, ge ne e x pressi o n, a n d 
tel o mere le n gt h. Al o n gsi de t hese eff orts, i nter vie ws were c o n d ucte d t o ca pt ure partici pa nts' pers pecti ves a n d 
fee d bac k o n a n i nte n de d 1 2- wee k mi n df ul ness i nter ve nti o n st u d y desi g ne d t o miti gate t he c o nse q ue nces of race-
base d stress a m o n g Africa n A merica ns, assessi n g t heir willi n g ness t o e n ga ge i n t he i nter ve nti o n a n d u n der g o 
f urt her testi n g s uc h as f M RI.
T his preli mi nar y pil ot st u d y wit h 2 0 i n di vi d uals c o m pleti n g t he f ull assess me nt s he d li g ht o n i ntri g ui n g 
ass ociati o ns bet wee n ps yc h ol o gical meas ures, mi n df ul ness, slee p q ualit y, c o pi n g strate gies, resilie nce, a n d 
racis m-i n d uce d stress. F or e xa m ple, i n di vi d uals re p orti n g l o wer racis m- base d stress, q ua ntifie d usi n g t he 
E ver y da y Discri mi nati o n Scale ( E D S), e x hi bite d ele vate d hi g h- de nsit y li p o pr otei n ( H D L) c h olester ol le vels 
c o m pare d t o t h ose re p orti n g hi g h E D S. F urt her m ore, a si g nifica nt di ver ge nce i n t he T otal c h olester ol/ H D L 

c h olester ol rati o e mer ge d bet wee n t he L o w E D S gr o u p a n d t he Hi g h E D S gr o u p. T his disti ncti o n i m plies t hat 
i n di vi d uals wit h ele vate d E D S sc ores p ossess a less fa v ora ble li pi d pr ofile, as e vi de nce d b y a hi g her T otal 
c h olester ol/ H D L c h olester ol rati o, i n c o ntrast t o t h ose re p orti n g l o wer percei ve d discri mi nati o n. T he T otal 
c h olester ol/ H D L c h olester ol rati o is a mar ker of car di o vasc ular healt h, wit h a l o wer rati o i n dicati n g a m ore 
fa v ora ble li pi d pr ofile a n d a re d uce d ris k of heart disease, as prese nte d i n Ta ble 1.
Ta ble 1: E ver y da y Discri mi nati o n a n d Cli nical a n d La b orat or y Data
Mi n df ul ness trait was li n ke d t o i m pr o ve d slee p q ualit y, e n ha nce d c o pi n g a bilities, i ncrease d resilie nce, a n d 
re d uce d h y per vi gila nce, si g nif yi n g mi n df ul ness's p ote ntial be nefits i n t hese d o mai ns. See Fi g ure 1. A d diti o nall y, 
t he st u d y ill u mi nate d a si g nifica nt relati o ns hi p bet wee n slee p q ualit y a n d c o pi n g mec ha nis ms. I n di vi d uals wit h 
hi g h racis m-i n d uce d stress ( meas ure d b y E D S) re p orte d hi g h life stress sc ores, p o orer slee p q ualit y, a n d a d verse 
c o pi n g strate gies i n v ol vi n g dr u g a n d alc o h ol use. A d diti o nall y, w hile all ostatic l oa d, a c o m pre he nsi ve ga u ge of 
p h ysi ol o gical stress, di d n ot de m o nstrate si g nifica nt c orrelati o ns wit h ps yc h ol o gical meas ures, disti nct tre n ds 
were o bser ve d. T hese tre n ds p oi nte d t o war ds p ositi ve ass ociati o ns bet wee n all ostatic l oa d a n d racis m- base d 
stress, c o u nter bala nce d b y ne gati ve ass ociati o ns wit h mi n df ul ness traits. T hese preli mi nar y fi n di n gs pr o vi de a 
r o b ust f o u n dati o n f or e x pl ori n g t he p ote ntial of C B R T i nter ve nti o n t o a d dress a n d miti gate t he i ntricate 
relati o ns hi ps a m o n g ps yc h ol o gical meas ures, slee p q ualit y, c o pi n g, resilie nce, a n d racis m-i n d uce d stress. 
P u blicati o n is i n pr o gress.

Fi g ure 1: C orrelati o n Matri x
1 2. 4    E n g a gi n g St a ke h ol ders: Descri be a n y pl a ns t o e n g a ge ot her st a ke h ol ders ( Scie ntists, pr actiti o ners, p atie nts, a d v oc ac y gr o u ps, etc.) f or 
*
h y p ot hesis ge ner ati o n, or fe asi bilit y p ur p oses.  
I n de vel o pi n g t his pr ot oc ol, we ha ve ha d disc ussi o ns wit h se veral sta ke h ol ders w h o ha ve 
e x presse d i nterest a n d see val ue i n de vel o pi n g a n i nter ve nti o n t o re d uce t he effects of 
s yste mic a n d i nter pers o nal racis m. L ocall y we ha ve w or ke d wit h c o m m u nit y c ore researc h at 
R oc kefeller U ni versit y t o e x pl ore p ote ntial c o m m u nit y part ners a n d recr uit me nt strate gies t o 
e n ha nce t he fi delit y of t his pr ot oc ol. I n c o nce pt ualizi n g t he meas ure me nt of race- base d 
stress, we c o ns ulte d wit h Dr. R o bert Carter, w h o de vel o pe d a race- base d tra u matic stress 
s y m pt o m scale desi g ne d t o assess t he ps yc h ol o gical a n d e m oti o nal stress reacti o ns t o racis m 
a n d racial discri mi nati o n. We ha ve als o ha d m ulti ple meeti n gs wit h t he Pat h wa ys pr oject, 
i ncl u di n g scie ntists a n d a d v ocates i ntereste d i n mi n df ul ness practice's s ocial a n d cli nical 
effects. T he Pat h wa ys pr oject i ncl u des Eric h Jar vis, P h D, w h o ser ves as t he pr oject me nt or, 
J oe L oizz o, M D, P h. D., f o u n der of C o m passi o n- base d Resilie nce Trai ni n g ( C B R T), 
aca de mic direct or of Nala n da I nstit ute a n d Cli nical Assista nt Pr ofess or of Ps yc hiatr y at Weill 
C or nell Me dical C olle ge ( W C M C); Ra hs haa na Gree n, C B R T Teac her, a n d Teac her Trai ner, 
C o- Direct or of t he Ne w Y or k Cit y a n d S witzerla n d C o nte m plati ve Ps yc h ot hera p y Pr o gra ms 
a n d Direct or of E q uit y a n d I ncl usi o n at t he Nala n da I nstit ute; Patricia Bl o o m, M D p h ysicia n 
at M o u nt Si nai a n d M B S R teac her, Ja n na G or d o n- Elli ot, M D, a ps yc hiatrist at W C M C, 
Nat halie Blac here, P h. D., i m m u n ol o g y e x pert, J or da n Marr occ o, P h. D., ne ur oe n d ocri n ol o g y 
e x pert, A n n Ca m p bell, M S N, M P H, f o u n der of t he Pat h wa ys pr oject, N urse Practiti o ner a n d 
mi n df ul ness teac her. We ha ve als o disc usse d usi n g ne ur oi ma gi n g i n mi n df ul ness i nter ve nti o n 
wit h Dr. Urai na Clar k fr o m Mt. Si nai H os pital, a n acti ve researc her o n race discri mi nati o n 
a n d s pecializi n g i n f M RI testi n g. T o de vel o p t he C B R T i nter ve nti o n t o be use d i n t his st u d y 
f or racis m- base d stress, we w or ke d wit h Nala n da I nstit ute J oe L oizz o, M D, P h. D., 
a n d  Ra hs haa na Gree n, Direct or of E q uit y a n d C o nte m plati ve Ps yc h ot hera p y at Nala n da 
I nstit ute a n d C B R T Teac her a n d Teac her Trai ner. We ha ve als o c o ns ulte d Dr. Ste ve C ole, a n 
e x pert o n m olec ular pat h wa ys b y w hic h s ocial e n vir o n me nts i nfl ue nce ge ne e x pressi o n. Dr. 
C ole a n d t he U C L A S ocial Ge n o mics C ore offer ge ne e x pressi o n pr ofili n g t hr o u g h t he 
C T R A ( C o nser ve d Tra nscri pti o nal Res p o nse t o A d versit y) as a pai d ser vice.
We als o o btai ne d researc h partici pa nts fee d bac k fr o m 2 0 partici pa nts w h o partici pate d i n t he R KI- 1 0 3 6 st u d y. I n 
t he st u d y, i nter vie ws were c o n d ucte d t o ca pt ure partici pa nts' pers pecti ves a n d fee d bac k o n a n i nte n de d 
mi n df ul ness i nter ve nti o n st u d y desi g ne d t o miti gate t he c o nse q ue nces of race- base d stress a m o n g Africa n 
A merica ns, assessi n g t heir willi n g ness t o e n ga ge i n t he i nter ve nti o n a n d u n der g o f urt her testi n g s uc h as f M RI.

1 2. 5  *  H y p ot hesis
Descri be t he 
 i n a si n gle se nte nce.
rese arc h hy p ot hesis
Pers o ns w h o e x perie nce racis m- base d stress a n d e n ga ge i n a C B R T pr o gra m will re p ort s u bsta ntial 
e n ha nce me nts i n vari o us d o mai ns (i ncl u di n g o verall stress le vels, percei ve d discri mi nati o n, resilie nce, c o pi n g 
s kills, a n xiet y, de pressi o n, mi n df ul ness, slee p q ualit y, all ostatic l oa d, sali var y c ortis ol, tel o mere le n gt h )a n d t he 
st u d y c o ntri b ute esse ntial i nsi g hts i nt o t he p ote ntial of mi n df ul ness- base d i nter ve nti o ns t o a d dress racis m- base d 
stress a n d its br oa d-ra n gi n g i m plicati o ns.
1 2. 6    
Ai m(s)
 *
I n dicate h o w y o u will 
 (e. g., t o c o m pare gr o u ps, t o esti mate a para meter, t o ascertai n 
a d dress t he hy p ot hesis
feasi bilit y). Si nce t he sa m ple size deter mi nati o n is us uall y base d o n t he pri mar y ai m o nl y, t he pri mar y ai m 
s h o ul d be s ufficie nt t o j ustif y t he st u d y.
T his st u d y ai ms t o assess t he feasi bilit y a n d acce pta bilit y of C o m passi o n- Base d Resilie nc y Trai ni n g ( C B R T) 
i nter ve nti o n t o re d uce racis m- base d stress a m o n g Africa n A merica ns. 
T he s pecific ai ms of t his pil ot are t o:
1. A) Assess t he feasi bilit y of C B R T b y e xa mi ni n g recr uit me nt, rete nti o n, a n d atte n da nce rates i n mi n df ul ness 
sessi o ns t o i nf or m t he desi g n of f ut ure lar ge-scale efficac y trials.
B) Gat her partici pa nts' fee d bac k a n d e x perie nces of t he C B R T t o refi ne a n d e n ha nce t he i nter ve nti o n 
pr ot oc ol f or f ut ure i m ple me ntati o n. Partici pa nts will be as ke d q uesti o ns re gar di n g t he i nter ve nti o n, 
e x perie nces of t he sessi o ns, feat ures of t he i nter ve nti o n, li kes a n d disli kes, a n d c ha n ges e x perie nce d.
2. E val uate t he p ote ntial effecti ve ness of t he C B R T i nter ve nti o n i n i m pr o vi n g b ot h ps yc h ol o gical o utc o mes 
( o verall stress, e ver y da y discri mi nati o n, resilie nce, c o pi n g, a n xiet y, de pressi o n, mi n df ul ness, a n d Healt h- Relate d 
Q ualit y of Life ( H R Q o L) a n d bi ol o gical meas ures (sali var y c ortis ol, all ostatic l oa d, C T R A ge ne e x pressi o n).
3. Deter mi ne if c ha n ges i n mi n df ul ness me diate ps yc h ol o gical ( o verall stress, e ver y da y discri mi nati o n, 
resilie nce, c o pi n g, a n xiet y, de pressi o n, mi n df ul ness) a n d bi ol o gical meas ures (sali var y c ortis ol, all ostatic l oa d, 
C T R A ge ne e x pressi o n).
1 2. 7  *  Pri m ar y O utc o me(s)
I n dicate w hic h  
 will be assesse d t o j u d ge t he pri mar y s pecific ai m.  Gi ve meas ure me nt u nits, if 
v ari a ble(s)
a p plica ble.
Feasi bilit y a n d acce pta bilit y of C B R T b y e xa mi ni n g recr uit me nt, rete nti o n, a n d atte n da nce rates i n mi n df ul ness 
sessi o ns a n d partici pa nt fee d bac k re gar di n g t he i nter ve nti o n, e x perie nces of t he sessi o ns, feat ures of t he 
i nter ve nti o n, li kes a n d disli kes, a n d c ha n ges e x perie nce d.
1 2. 8  *  Sec o n d ar y O utc o me(s)
I n dicate w hic h 
 will be assesse d t o j u d ge t he sec o n dar y o utc o me(s). Gi ve meas ure me nt 
a d diti o n al v ari a ble(s)
u nits, if a p plica ble.
 
1. All ostatic l oa d 
2. Tel o mere le n gt h 
3. Sali var y C ortis ol
4. C-reacti ve pr otei n.
5. Ge ne e x pressi o n ( C T R A)

6. De pressi ve s y m pt o ms 
7. Slee p 
8. C o pi n g 
9. Mi n df ul ness 
1 2. 9  *  Met h o ds a n d Pr oce d ures
Please pr o vi de a descri pti o n of t he la b orat or y a n d cli nical a nal yses a n d pr oce d ures t hat will be perf or me d. 
I ncl u de t he r ole of e xter nal c olla b orat ors a n d c o ns ulta nts w he n a p pr o priate. Please refer t o Hel p te xt f or 
G ui da nce.
St u d y Desi g n a n d P artici p a nts
T his st u d y's desi g n is a 1- gr o u p desi g n i n v ol vi n g 2 0 partici pa nts. We will c ollect baseli ne data bef ore a n d after 
a n i nter ve nti o n.
T he st u d y will ta ke place at R oc kefeller U ni versit y H os pital f oll o wi n g t he a p pr o val of t he I nstit uti o nal Re vie w 
B oar d, a n d partici pa nts ha ve si g ne d i nf or me d c o nse nt. Partici pa nts will be recr uite d fr o m a c o m bi nati o n of 
a d vertise me nts o n Researc h matc h. or g a n d Crai gslist. Partici pa nts w h o partici pate d i n t he ple nar y st u d y o n 
racis m a n d bi o mar kers of stress ( R KI- 1 0 3 6) are eli gi ble t o e nr oll i n t his st u d y). 
Pr oce d ures:
 Partici pa nts will be e nr olle d at R oc kefeller U ni versit y H os pital a n d see n i n t he 
E nr oll me nt a n d scree ni n g :
o ut patie nt researc h cli nic. I n t he first visit, a cli nicia n will c o n d uct i nitial scree ni n g, a n d patie nts w h o meet t he 
i ncl usi o n criteria will be a d mitte d i nt o t he st u d y. A f ull e x pla nati o n of t he st u d y, i ncl u di n g st u d y pr oce d ures, 
ris ks, a n d be nefits, will be e x plai ne d t o eac h partici pa nt, a n d a cli nicia n will o btai n i nf or me d c o nse nt fr o m all 
st u d y partici pa nts. T he ori gi nal i nf or me d c o nse nt will be place d i n t he R oc kefeller U ni versit y H os pital c hart.
C B R T i nter ve nti o n  
T he i nter ve nti o n is base d o n a n esta blis he d c o nte m plati ve self- heali n g pr o gra m i nte grati n g mi n df ul ness wit h 
c o g niti ve a nal ysis, affect m o d ulati o n, m oti vati o nal i ma ger y, a n d breat hi n g. T he practice is a da pte d fr o m I n d o-
Ti beta n tra diti o ns of mi n d- b o d y scie nce, re d uci n g c o g niti ve, affecti ve, a n d be ha vi oral stress. T his i nter ve nti o n 
has bee n use d a m o n g w o me n wit h breast a n d g y nec ol o gical ca ncer a n d has bee n s h o w n t o i m pr o ve t he q ualit y 
of life ( L oizz o et al., 2 0 0 9) . T he i nter ve nti o n is a 1 0- wee k pr o gra m t hat will a d dress mi n df ul ness, c o m passi o n, 
s ocial-e m oti o nal self-care, e x p osi n g stress-reacti ve ha bits, self-a ware ness, vis ualizati o n, a n d dee p breat hi n g. O ur 
rati o nale f or a p pl yi n g t his mi n df ul ness i nter ve nti o n t o pr o m ote ps yc h ol o gical resilie nce f oll o wi n g t he 
de vel o p me nt of race- base d tra u matic s y m pt o ms is base d o n t he n oti o n t hat mi n df ul ness pr o m otes acce pta nce of 
c o m ple x t h o u g hts a n d feeli n gs, re d uces r u mi nati o n, a n d i m pr o ves ps yc h ol o gical f u ncti o n, c o g niti ve fle xi bilit y, 
a n d c o pi n g pr ocesses. T his will als o re d uce t he effect of stress o n t he b o d y, as e vi de nce d b y a re d uce d all ostatic 
l oa d.
T o de vel o p t he C B R T i nter ve nti o n t o be use d i n t his st u d y f or racis m- base d stress, we w or ke d wit h Nala n da 
I nstit ute J oe L oizz o, M D, P h. D., a n d  Ra hs haa na Gree n, Direct or of E q uit y a n d C o nte m plati ve Ps yc h ot hera p y at 
Nala n da I nstit ute a n d C B R T Teac her a n d Teac her Trai ner. Ra hs haa na Gree n, w h o has C B R T e x perie nce 
teac hi n g t he C B R T, will deli ver t he C B R T i nter ve nti o n via Z o o m. 
C o m p a s si o n - B a s e d R e sili e n c e T r ai ni n g ( C B R T ) I n t e r v e n ti o n Pl a n
S e
s si
o n
C o n t e n t
T o pi c s
H o m e w o r k
1  
R e c o g ni zi n g t h e Pr e ci o u s n e s s of 
Lif e – S hifti n g G e ar s Fr o m 
S ur vi vi n g t o T hri vi n g
• Di s c u s s 1 0 - w e e k pl a n
• O v er vi e w of C B R T
• D efi niti o n s
• H o w Mi n df ul n e s s b uil d s r e sili e n c e
• R e vi e w 
i ntr o d u cti o n 
of m a n u al
• Pr a cti c e 
m e dit ati o n s
2  
E m br a ci n g S uff eri n g wit h B o d y 
Mi n df ul n e s s
• C u m ul ati v e I m p a ct of Str e s s a n d Tr a u m a
• C ulti v ati n g S elf - A c c e pt a n c e
• R e vi e w 
M o d ul e 1 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
3

St o p pi n g R e a cti v e H a bit s wit h 
Mi n df ul S e n siti vit y
• T h e C y cl e of Str e s s a n d Tr a u m a a n d t h e 
H a bit of Str e s s - R e a cti vit y
• L e ar ni n g t o S elf - S o ot h e
• R e vi e w 
M o d ul e 2 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
4  
Br e a ki n g Fr e e of t h e Str e s s C y cl e 
wit h Mi n df ul A w ar e n e s s
• U nl e ar ni n g Str e s s a n d Tr a u m a
• L e ar ni n g t o S oft e n a n d O p e n
• R e vi e w 
M o d ul e 3 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
5   
Mi n df ul I n si g ht : T h e Lif el o n g P at h 
of S elf - H e ali n g
• M a ki n g H e alt h y B e h a vi or C h a n g e
• D e v el o pi n g a S elf - C ar e pr a cti c e
• R e vi e w 
M o d ul e 4
• Pr a cti c e 
m e dit ati o n s
6   
H o w Mi n df ul n e s s a n d C o m p a s si o n 
B uil d R e sili e n c e
• C o n n e cti o n b et w e e n Mi n df ul n e s s a n d 
C o m p a s si o n
• H o w C o m p a s si o n b uil d s r e sili e n c e
• R e vi e wI nt er
m e z z o
• Pr a cti c e 
m e dit ati o n s
7   
Di s ar mi n g S o ci al Str e s s a n d Bi a s 
wit h E q u al E m p at h y
• H o w I m pli cit S o ci al Bi a s a n d R e a cti v e 
E m oti o n s ar e t h e Bl o c k s t o C o m m o n 
H u m a nit y a n d e m p at h y
• D e v el o pi n g P er c e pti v e C o m p a s si o n
• R e vi e w 
M o d ul e 5 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
8   
H e ali n g R e a cti v e E m oti o n s a n d 
B eli ef s wit h S elf - C o m p a s si o n
• L e ar ni n g t o A c c e pt a n d R e p ar e nt Y o ur s elf
• D e v el o pi n g E m oti o n al C o m p a s si o n
• R e vi e w 
M o d ul e 6 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
9  
C ulti v ati n g Pr o s o ci al E m oti o n s 
wit h Wi s e Gi v e a n d T a k e
• B al a n ci n g C ar e f or S elf wit h C ar e f or 
ot h er s
• D e v el o pi n g I nt e nti o n al C o m p a s si o n
• R e vi e w 
M o d ul e 7 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
1 0 E m b o d yi n g a R e sili e nt S elf a n d 
Lif e wit h C ari n g I m a g er y
• D e v el o p m e nt al P s y c h ol o g y a n d R ol e - 
M o d eli n g I m a g er y
• D e v el o pi n g E m b o di e d C o m p a s si o n
• Wr a p - u p
• R e vi e w 
M o d ul e 8 of 
m a n u al
• Pr a cti c e 
m e dit ati o n s
• P arti ci p a nt s will r e c ei v e a c c e s s t o w e b - b a s e d m e dit ati o n s, vi d e o s a n d a m a n u al
• S e s si o n s will i n cl u d e l e d m e dit ati o n s, e m b o di e d pr a cti c e s (li k e br e at h w or k a n d g e ntl e 
m o v e m e nt ), a n d r efl e cti o n q u e sti o n s
Bel o w is t he detaile d brea k d o w n of eac h visit:
St u d y Visit # 1: Scree ni n g/ E nr oll me nt ( a p pr o xi m atel y 3 h o urs)
I n t he first visit, a cli nicia n will c o n d uct i nitial scree ni n g, a n d patie nts w h o meet t he i ncl usi o n criteria will be 
a d mitte d i nt o t he st u d y. A f ull e x pla nati o n of t he st u d y, i ncl u di n g st u d y pr oce d ures, ris ks, a n d be nefits, will be 
e x plai ne d t o eac h partici pa nt, a n d a cli nicia n will o btai n i nf or me d c o nse nt fr o m all st u d y partici pa nts. T he 
Ori gi nal i nf or me d c o nse nt will be place d i n t he R oc kefeller U ni versit y H os pital c hart. A lice nse d cli nicia n/ n urse 
practiti o ner will perf or m a brief me dical e xa mi nati o n of t he st u d y partici pa nts. T o scree n f or ps yc hiatric 
dia g n oses, a n urse practiti o ner will i nter vie w partici pa nts usi n g a Str uct ure d I nter vie w f or D S M- 5 
( Q UI C K S CI D- 5) ( First a n d Willia ms, 2 0 2 1). D uri n g t he first visit, P O C T HI V will be use d t o scree n f or HI V. I n 
a d diti o n, P O C T pre g na nc y will be o btai ne d a m o n g w o me n of c hil d beari n g a ge. Cli nical data, i ncl u di n g Bl o o d 
press ure, waist, a n d hi p meas ure me nts, a n d B MI, will be o btai ne d.
Partici pa nts will als o be pr o vi de d wit h sali va c ollecti o n kits a n d detaile d i nstr ucti o ns. T he y will be g ui de d t o 
c ollect t hree sali va sa m ples o n o ne c h ose n da y bef ore t he ne xt a p p oi nt me nt. T he t hree sa m ples will be c ollecte d 
i n a si n gle da y: u p o n wa ki n g, 3 0 mi n utes after wa ki n g, a n d at be dti me. T o e ns ure acc urate sa m ples, partici pa nts 
will be i nstr ucte d n ot t o c o ns u me f o o d a n d be vera ges, or br us h t heir teet h d uri n g t he 3 0 mi n utes of eac h 
c ollecti o n ti me. After c ollecti o n, partici pa nts will be re q ueste d t o pr o perl y st ore a n d ret ur n t he sa m ples usi n g t he 
pr o vi de d h o me c ollecti o n kit a n d bri n g t he m t o t heir ne xt a p p oi nt me nt at R U O ut patie nt.

1.  
2.  
St u d y Visit # 2: ( a p pr o xi m atel y 3 h o urs)  ( 1 0 d a ys +/- 2 d a ys)
D uri n g t his visit, partici pa nts' vital si g ns will be ta ke n. W o me n of c hil d beari n g p ote ntial will be gi ve n a P O C T 
pre g na nc y test. Bl o o d d o nati o n of 1 0 0 ml will be c ollecte d f or a nal ysis of  ( C B C, C M P creati ni ne, A S T, A L T, 
T otal c h olester ol, H D L c h olester ol, al b u mi n, C R P I nterle u ke n 6, T N F-a, H b A 1c, ra n d o m gl uc ose, tel o mere, a n d 
ge ne e x pressi o n). A meal will be pr o vi de d after t he bl o o d dra w. I n a d diti o n, partici pa nts will be as ke d t o 
c o m plete a set of q uesti o n naires. 
Partici pa nts will als o be pr o vi de d wit h sali va c ollecti o n kits a n d detaile d i nstr ucti o ns. T he y will be g ui de d t o 
c ollect t hree sali va sa m ples o n o ne c h ose n da y bef ore t he 1 0- wee k f oll o w- u p a p p oi nt me nt. T he t hree sa m ples 
will be c ollecte d i n a si n gle da y: u p o n wa ki n g, 3 0 mi n utes after wa ki n g, a n d at be dti me. T o e ns ure acc urate 
sa m ples, partici pa nts will be i nstr ucte d n ot t o c o ns u me f o o d, a n d be vera ges, or br us h t heir teet h d uri n g t he 3 0 
mi n utes of eac h c ollecti o n ti me. After c ollecti o n, partici pa nts will be re q ueste d t o pr o perl y st ore a n d ret ur n t he 
sa m ples usi n g t he pr o vi de d h o me c ollecti o n kit a n d bri n g t he m t o t heir ne xt a p p oi nt me nt at R U O ut patie nt.
O nce t he partici pa nts a gree t o partici pate a n d a c o h ort of 2 0 partici pa nts has bee n scree ne d a n d baseli ne data 
c ollecte d, partici pa nts will partici pate i n a 1 0 wee ks C B R T i nter ve nti o n. Partici pa nts will recei ve a series of 1 0 
wee kl y 1- h o ur C o m passi o n- Base d Resilie nc y Trai ni n g ( C B R T) sessi o ns c o n d ucte d o nli ne via a sec ure 
R oc kefeller U ni versit y Z o o m li n k. S u bse q ue ntl y, partici pa nts will ret ur n t o t he R oc kefeller U ni versit y 
O ut patie nt Cli nic f or bl o o d w or k a n d s ur ve ys. 
St u d y Visit # 3: ( a p pr o xi m atel y 3 h o urs) ( after 1 0 wee ks of i nter ve nti o n)
T he t hir d visit will be after 1 0 wee ks of recei vi n g t he i nter ve nti o n . D uri n g t his visit, partici pa nts' vital si g ns will 
be ta ke n. W o me n of c hil d beari n g p ote ntial will be gi ve n a P O C T pre g na nc y test. B l o o d d o nati o n of 1 0 0 ml will 
be c ollecte d f or a nal ysis of  ( C B C, C M P creati ni ne, A S T, A L T, T otal c h olester ol, H D L c h olester ol, al b u mi n, 
C R P I nterle u ke n 6, T N F-a, H b A 1c, ra n d o m gl uc ose, tel o mere, a n d ge ne e x pressi o n). A meal will be pr o vi de d 
after t he bl o o d dra w. I n a d diti o n, partici pa nts will be as ke d t o c o m plete a set of q uesti o n naires. 
Partici pa nts will be as ke d t o gi ve o pe n a n d h o nest acc o u nts of t heir e x perie nces a n d o pi ni o ns of t he i nter ve nti o n. 
T heir res p o nses will be rec or de d a n d tra nscri be d usi n g n Vi v o s oft ware. 
Me as ures
Str uct ure d ps yc h ol o gic al i nstr u me nts.
Cli nical data, i ncl u di n g ps yc h ol o gical assess me nts, will be d o ne b y partici pa nts o n a n i Pa d wit h t he i nstr ucti o ns 
of a cli nicia n. S oci o- de m o gra p hic varia bles ( A ge, se x, self-i de ntifie d A A, marital stat us, i nc o me, e d ucati o n, 
h o usi n g, l ocalit y, a n d c hr o nic c o n diti o ns) will be c ollecte d. T he Race- base d Tra u matic Stress S y m pt o ms Scale 
( R B T S S) a n d t he E ver y da y Discri mi nati o n Scale are use d f or race- base d stress assess me nt. I n a d diti o n, we 
i ncl u de d ps yc h o metric meas ures t o assess de pressi o n, percei ve d stress, healt h a n d q ualit y of life, s ocial 
c o n necte d ness, slee p, a n d resilie nce. Partici pa nts will be assesse d a t w o mai n ti me p oi nts: Baseli ne 
( prei nter ve nti o n) a n d 1 0 wee ks see Ta ble 1 ( St u d y Assess me nts Ti meli nes), wit h selecte d meas ures at eac h ti me 
p oi nt.
R acis m- B ase d Stress S ur ve ys 
Race- base d Tra u matic Stress S y m pt o ms R B T S S S ( Carter et al., 2 0 1 3). T he scale is 5 2 a self-re p ort 
i nstr u me nt t hat assesses reacti o ns res ulti n g fr o m ne gati ve racial e x perie nces. Partici pa nts i de ntif y t he 
m ost me m ora ble ne gati ve racial e nc o u nter a n d c o m plete e m oti o nal s y m pt o m reacti o n ite ms. Ite ms are 
rate d al o n g a 5- p oi nt Li kert scale. R B T S S S c o m prises of 7 s y m pt o m scales: De pressi o n ( 1 0 ite ms), 
I ntr usi o n ( 8 ite ms), A n ger ( 8 ite ms), h y per vi gila nce ( 8 ite ms), p h ysical reacti o ns ( 8 ite ms), L o w self-
estee m ( 6 ite ms), a n d a v oi da nce ( 4 ite ms). Hi g her sc ores i n dicate a greater prese nce of reacti o n 
s y m pt o ms.
 E ver y da y discri mi nati o n Scale( Willia ms et al. 1 9 9 7). A n ori gi nal versi o n of t he E D S c o nsists of ni ne 
ite ms o n a 6- p oi nt Li kert-t y pe res p o nse f or mat, wit h m o difie d versi o ns of t he E D S ha vi n g differe nt 
n u m bers of ite ms. T he t otal p ossi ble ra n ge of t he ori gi nal E D S is 1 t o 5 4, wit h hi g her sc ores i n dicati n g 
hi g her le vels of percei ve d discri mi nati o n. Ite ms i ncl u de d i n t he E D S are dail y e x perie nces wit h u nfair 
treat me nt, s uc h as bei n g treate d wit h less res pect, bei n g treate d wit h less c o urtes y, bei n g calle d na mes or 
i ns ulte d, a n d bei n g t hreate ne d or harasse d.
Me nt al he alt h a n d lifest yle- b ase d s ur ve ys

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Life Stress or C hec klist- Re vise d ( L S C- R)  ( Ki merli n g et al., 2 0 0 0). T his is a self-re p ort meas ure t hat 
assesses tra u matic or stressf ul life e ve nts. T he q uesti o n naire i ncl u des 3 0 life e ve nts, i ncl u di n g 
e x perie nces wit h nat ural disasters, p h ysical or se x ual assa ult, deat h of a relati ve, a n d ot her e ve nts, 
f oll o wi n g a yes/ n o res p o nse f or mat.
De pressi o n A n xiet y Stress Scale - 2 1 ( He nr y a n d Cra wf or d, 2 0 0 5)- meas ures self-re p orte d ne gati ve 
e m oti o nal states of de pressi o n, a n xiet y, a n d stress. T he D A S S- Stress scale is se nsiti ve t o le vels of 
c hr o nic n o n-s pecific ar o usal. It assesses diffic ult y rela xi n g, ner v o us ar o usal, a n d bei n g easil y u pset
/a gitate d, irrita ble/ o ver-reacti ve, a n d i m patie nt. S u bjects are as ke d t o use a 4- p oi nt se verit y/fre q ue nc y 
scale ( 0 = Di d n ot a p pl y t o me at all, 1 = A p plie d t o me t o s o me de gree, or s o me of t he ti me, 2 = 
A p plie d t o me a c o nsi dera ble de gree, or a g o o d part of t he ti me, a n d 3 = A p plie d t o me ver y m uc h, or 
m ost of t he ti me) t o rate t he e xte nt t o w hic h t he y ha ve e x perie nce d eac h state o ver t he past wee k. T his 
scale has bee n use d i n cli nical researc h a n d practice t o i de ntif y i n di vi d uals wit h hi g h stress w h o ma y be 
v ul nera ble t o ps yc h o pat h ol o gies.
Me dical O utc o mes St u d y S h ort F or m 1 2 ( S F 1 2)  ( Ware Jr et al., 1 9 9 6). T he S F- 1 2 v 2 is a healt h-relate d 
q ualit y- of-life q uesti o n naire c o nsisti n g of t wel ve q uesti o ns t hat meas ure ei g ht healt h d o mai ns t o assess 
p h ysical a n d me ntal healt h. 
C o n n or- Da vi ds o n Resilie nce Scale ( C D- RI S C) has 2 5 ite ms, eac h rate d o n a 5- p oi nt scale ( 0 – 4), wit h 
hi g her sc ores reflecti n g greater resilie nce ( C o n n or a n d Da vi ds o n, 2 0 0 3). Scale de m o nstrates t hat 
resilie nce is m o difia ble a n d ca n i m pr o ve wit h treat me nt.
S ocial C o n necte d ness Scale( Lee a n d R o b bi ns, 1 9 9 5) 8-ite m meas ure sc ore d o n a 6- p oi nt Li kert Scale 
assessi n g i nter pers o nal cl ose ness i n t he s ocial real m. T he S C S is a u ni- di me nsi o nal assess me nt, wit h a 
hi g her s u m me d rati n g reflecti n g a n e n ha nce d se nse of s ocial c o n necti o n ( # = . 9 3). 
Pitts b ur g Slee p Q ualit y I n de x ( P S QI) ( B u ysse et al., 1 9 8 9) – 1 9-ite m q uesti o n naire t o meas ure slee p 
q ualit y a n d dist ur ba nces o ver a 1 m o nt h peri o d
C o pi n g wit h Discri mi nati o n Scale ( C D S)( Wei et al., 2 0 1 0): 2 5-ite m scale t hat assesses c o pi n g strate gies 
wit h discri mi nati o n. Ite ms are a ns were d usi n g a 6- p oi nt Li kert scale f or mat ra n gi n g fr o m str o n gl y a gree 
t o str o n gl y disa gree. Sc ores are calc ulate d f or 5 s u bscales: E d ucati o n/a d v ocac y, I nter nalizati o n, Dr u g
/alc o h ol use, Resista nce, a n d Detac h me nt. Mea n sc ores f or eac h s u bscale ra n ge fr o m 1 t o 6 wit h hi g her 
sc ores i n dicati n g a hi g her prese nce of t he attri b ute meas ure d.
P ost-tra u matic Gr o wt h I n ve nt or y ( P T GI- S F) ( Ca n n et al., 2 0 1 0). 1 0-ite m i n ve nt or y meas uri n g p ositi ve 
c ha n ges tra u ma rec o ver y b y f oc usi n g o n t he be neficial c o g niti ve a n d pers o nalit y s hifts res ulti n g fr o m 
gra p pli n g wit h tra u matic e ve nts ( Te desc hi a n d Cal h o u n, 1 9 9 6). It rec or ds P T G i n fi ve d o mai ns: 1) 
relati n g t o ot hers, 2) perce pti o n of ne w c ha n ges 3) Pers o nal stre n gt h 4) S pirit ual c ha n ge 5) A p preciati o n 
of life.
Fi ve- Facet Mi n df ul ness Q uesti o n naire ( F F M Q) ( Baer et al., 2 0 0 6)- a 3 9-ite m Li kert-t y pe scale t hat 
meas ures trait mi n df ul ness wit h res p o nses ra n gi n g fr o m ( 1) ne ver or ver y rarel y tr ue t o ( 5) ver y ofte n or 
al wa ys tr ue. T he F F M Q c o nsists of fi ve facets: o bser vi n g, descri bi n g, acti n g wit h a ware ness, n o n-
j u d gi n g, a n d n o n-reacti vit y. Hi g her sc ores are i n dicati ve of hi g her le vels of trait mi n df ul ness.
Bi ol o gic al me as ures
All ostatic l oa d. T his i ncl u des bi o mar kers of car di o vasc ular a n d meta b olic acti vit y. I n a d diti o n t o B MI, 
we i ncl u de d para meters t hat are us uall y c o nsi dere d i n meta b olic s y n dr o mes, s uc h as waist 
circ u mfere nce, waist-t o- hei g ht rati o ( bl o o d press ure, fli pi d a n d bl o o d gl uc ose le vels, i ns uli n resista nce, 
a n d sali var y c ortis ol as a ne ur oe n d ocri ne mar ker of stress. C h olester ol a n d gl uc ose le vel la bs will 
re q uire partici pa nts t o fast 8 h o urs pri or t o bl o o d c ollecti o n. T he all ostatic l oa d will be deter mi ne d usi n g 
t he cli nicall y rele va nt c ut- off p oi nts deter mi ne d b y pre-esta blis he d val ues i n cli nical me dici ne.
Tel o mere Le n gt h. Ge n o mic D N A will be e xtracte d usi n g a D N A bl o o d kit, Scie n Cell’s A bs ol ute 
H u ma n Tel o mere Le n gt h Q ua ntificati o n q P C R Assa y Kit. Q ua ntitati ve R T- P C R will be use d t o 
deter mi ne c ha n ges i n a vera ge tel o mere le n gt h. A refere nce D N A sa m ple pr o vi de d wit h t he kit will be 
use d t o c o m pare t he res ults fr o m t he partici pa nts. Tel o mere-le n gt h st u dies will be c o n d ucte d at 
R oc kefeller U ni versit y. H o m o sa pie ns (ta xi d: 9 6 0 6) sa m ple wit h k n o w n tel o mere le n gt h i n kil o bases will 
ser ve as a refere nce t o calc ulate sa m ples’ tel o mere le n gt h
Ge ne e x pressi o n c o nser ve d tra nscri pti o nal res p o nse t o a d versit y ( C T R A). Bl o o d will be c ollecte d usi n g 
P A X ge ne t u bes a n d st ore d at - 2 0 C u ntil it is s hi p pe d o n dr y ice t o t he U ni versit y of Calif or nia, L os 
A n geles ( U C L A) S ocial Ge n o mics C ore f or ge ne e x pressi o n pr ofili n g b y R N A-se q. We c o ns ulte d Dr. 
Ste ve C ole, a n d t he U C L A S ocial Ge n o mics C ore C T R A ge ne e x pressi o n pr ofili n g is a pai d ser vice. 
Ge ne e x pressi o n le vels of all ge nes will be teste d f or c orrelati o ns wit h be ha vi oral a n d ot her bi ol o gical 
meas ures.
Sali var y c ortis ol. Sa m ples will be c ollecte d usi n g t he passi ve dr o ol tec h ni q ue usi n g a Sali metric 
Sali va bi o s wa b a n d t u be. Partici pa nts will be i nstr ucte d t o gat her sali va sa m ples 3 ti mes i n o ne da y: at 
wa ki n g, 3 0 mi n utes after wa ki n g, a n d at be dti me. Partici pa nts will be i nstr ucte d n ot t o eat, dri n k, or 

Me as ures
0-
B aseli ne
 
1 0 w
ks
S oci o- de m o gra p hic varia bles.
x
All ostatic L oa d *
x  
x
Sali va c ortis ol
x  
x
Tel o mere Le n gt h
x  
x
Ge ne E x pressi o n C T R A
x  
x
E ver y da y Discri mi nati o n ( E D S)
x  
x
Pitts b ur g Slee p Q ualit y I n de x ( P S QI)
x  
x
Me dical O utc o mes St u d y S F 1 2 
x  
x
C o n n or- Da vi ds o n Resilie nce Scale ( C D- RI S C)
x  
x
De pressi o n A n xiet y Stress Scale
x  
x
Race- base d Tra u matic stress s y m pt o ms R B T S S S
x
Life stress or C hec klist- Re vise d ( L S C- R)
x
S ocial C o n necte d ness Scale S C S
x  
x
C o pi n g wit h Discri mi nati o n Scale ( C D S)
x  
x
P ost-tra u matic Gr o wt h I n ve nt or y ( P T GI- S F)
x  
x
Fi ve- Facet Mi n df ul ness Q uesti o n naire ( F F M Q
x  
x
* All ostatic L oa d i ncl u des bl o o d press ure, li pi ds, B MI, Gl ycate d he m o gl o bi n, Waist- hi p rati o, 
Al b u mi n, C R P, creati ni ne
4.  
br us h t heir teet h d uri n g t he 3 0 mi n pri or t o sa m ple c ollecti o n ti mes. After c ollecti o n, t he partici pa nts 
will be as ke d t o st ore t heir sa m ples i n a c o ol area or refri gerat or a n d ret ur n t he m o n t heir ne xt 
a p p oi nt me nt. Sa m ples will be st ore d at R oc kefeller U ni versit y La b orat or y of Ne ur o ge netics of 
La n g ua ge at 2 0 C a n d t he n s hi p pe d t o Sali metrics f or a nal ysis usi n g t he Sali metrics Sali var y C ortis ol 
E nz y me I m m u n oassa y Kit.
 Partici pa nts will ha ve bl o o d w or k dra w n d uri n g i n- pers o n visits ( visits 2, 3 a n d 4) at R oc kefeller 
Ve ni p u nct ure:
U ni versit y O ut patie nt De part me nt. A n urse or trai ne d tec h nicia n will perf or m ve ni p u nct ure t o o btai n 
a p pr o xi matel y 1 0 0 ml of bl o o d/ visit f or a t otal of 3 0 0 ml f or t he st u d y, f oll o wi n g t he o utli ne d bl o o d d o nati o n 
g ui deli nes. A p orti o n of t he bl o o d ( a p pr o xi matel y 8 0 ml) will be se nt t o M S K C C ( C B C, C M P, H D L c h olester ol, 
t otal c h olester ol, H b A 1c, gl uc ose, al b u mi n, C R P, a n d creati ni ne cleara nce) a n d La b C or p (I nterle u ki n- 6, T N F-a, 
D H E A). A p orti o n of t he bl o o d s peci me n ( a p pr o xi matel y 2 0 ml) D N A will be e xtracte d a n d st ore d i n t he 
La b orat or y of Ne ur o ge netics of La n g ua ge at R oc kefeller U ni versit y f or ge ne e x pressi o n a nal ysis a n d tel o mere 
le n gt h testi n g.
Q u alit ati ve I nter vie w
Partici pa nt fee d bac k a n d e x perie nces of t he C B R T will be assesse d usi n g a str uct ure d i nter vie w. Partici pa nts 
will be as ke d q uesti o ns re gar di n g t he i nter ve nti o n, e x perie nces of t he sessi o ns, feat ures of t he i nter ve nti o n, li kes 
a n d disli kes, a n d c ha n ges e x perie nce d. I nter vie ws will be c o n d ucte d at t he e n d of t he 1 0- wee k i nter ve nti o n 
peri o d f or eac h gr o u p t o assess t he acce pta bilit y of t he C B R T pr o gra m. We will use a str uct ure d i nter vie w g ui de 
t o as k q uesti o ns re gar di n g t he i nter ve nti o n, e x perie nces of t he sessi o ns, feat ures of t he i nter ve nti o n, li kes a n d 
disli kes, a n d c ha n ges e x perie nce d. T he i nter vie ws will be rec or de d usi n g a de dicate d di gital a u di o rec or der t hat 
will be ke pt sec urel y l oc ke d w he n n ot i n use. T he a u di o will t he n be u pl oa de d o nt o N Vi v o a n d delete d fr o m t he 
a u di o rec or der. N vi v o will be use d t o tra nscri be t he a u di o i nt o te xt. All a u di o rec or di n gs will be re vie we d f or 
acc urac y a n d a n y i de ntifiers pri or t o usi n g data a nal ysis s oft ware ( N Vi v o des kt o p versi o n). After all rec or di n gs 
ha ve bee n tra nscri be d, t he a u di o files will be delete d a n d files st ore d i n R U R oc kefeller U ni versit y Ce ntral File 
T he matic a nal ysis will be c o n d ucte d t o i de ntif y rec urri n g t he mes.
s hare. 
A d verse E ve nt Assess me nt 
I n t his researc h st u d y, we ha ve esta blis he d a c o m pre he nsi ve safet y pla n t o pr otect t he well- bei n g of o ur 
partici pa nts. Partici pa nts will be clearl y i nf or me d of t heir ri g ht t o decli ne t o a ns wer q uesti o ns or s hare 
i nf or mati o n t hat ma y ca use distress or disc o mf ort. We will mai ntai n c o nti n u o us vi gila nce o ver t heir well- bei n g 
b y cl osel y m o nit ori n g t heir e x perie nces a n d mai ntai ni n g o pe n li nes of c o m m u nicati o n. T he I n vesti gat or a n d 
C B R T pr o vi ders are de dicate d t o e nc o ura gi n g partici pa nts t o e x press a n y c o ncer ns or disc o mf ort t he y ma y 
e nc o u nter d uri n g t he st u d y. If, at a n y p oi nt, a partici pa nt e x hi bits si g nifica nt distress or re q uests assista nce, t he y 
will be i m me diatel y referre d t o o ur Lice nse d S ocial W or ker f or a t h or o u g h e val uati o n a n d t he necessar y s u p p ort. 
S u bse q ue ntl y, o ur de dicate d st u d y tea m will f oll o w u p wit h t he m t o e ns ure t heir o n g oi n g well- bei n g a n d assess 

t he nee d f or a n y m o dificati o ns t o t heir partici pati o n. A d verse e ve nts will be d oc u me nte d i n t he R U H c hart a n d 
re p orte d t o t he I nstit uti o nal Re vie w B oar d (I R B) as re q uire d.
Cli nical researc h data will be c o de d a n d e ntere d i nt o t he Re dca p data base. Cli nical data 
D at a St or a ge: 
c o ntai ni n g pers o nal i de ntifiers or li n ke d t o partici pa nts' na mes will be c o de d bef ore st ora ge. Pa per f or ms will be 
st ore d i n a l oc ke d ca bi net. Q ualitati ve i nter vie ws will be a u di o-rec or de d, tra nscri be d, c o de d, a n d st ore d o n 
R oc kefeller U ni versit y Ce ntral File s hare, pass w or d- pr otecte d a n d e ncr y pte d per R oc kefeller U ni versit y I T 
p olic y.
 
D at a Pr otecti o n:
All sa m ples, a n d ass ociate d meta data will u n der g o a G C P-c o m plia nt c o di n g pr ocess bef ore s hari n g wit h t he 
U C L A Ge n o mic C ore. T he c o de ke y will n ot be s hare d wit h t he U C L A ge n o mic C ore. T he ori gi nal data a n d 
c o de ke y will be sec urel y mai ntai ne d i n a pass w or d- pr otecte d a n d e ncr y pte d c o m p uter at R oc kefeller U ni versit y. 
Access t o data at t he U C L A C ore will be li mite d t o t he c o de d sa m ples a n d ass ociate d meta data, e nc o m passi n g 
a ge, ge n der, all ostatic l oa d, a n d sali va c ortis ol. All data, i ncl u di n g se q ue nci n g data a n d c orres p o n di n g meta data, 
will be tra nsferre d via R U sec ure Dr o p b o x i n a gree me nt wit h t he material tra nsfer a gree me nt create d f or t his 
pr oject a n d R oc kefeller Data Pr otecti o n g ui deli nes f or cli nical sa m ples.
1 2. 1 0   
 * D at a A n al ysis
Descri be met h o d(s) of data a nal ysis. 
We will e val uate t he recr uit me nt pr ocess b y a nal yzi n g t he n u m ber of i ntereste d partici pa nts, t h ose scree ne d, a n d 
s uccessf ul e nr oll me nts t o assess feasi bilit y. F urt her m ore, we will calc ulate t he eli gi bilit y perce nta ges, dr o p o ut 
rates, a n d atte n da nce at i nter ve nti o n sessi o ns. T he acce pta bilit y of t he i nter ve nti o n will be e val uate d t hr o u g h 
i n d ucti ve t he matic a nal ysis of t he i nter vie w res p o nses, i de ntif yi n g rec urri n g t he mes a n d i nsi g hts. 
T o p urs ue e x pl orat or y ai ms, we will c o n d uct a 2-taile d, paire d sa m ple t-test ( or paire d sa m ple Wilc o x o n si g ne d-
ra n k test) a n d c o m p ute C o he n effect size val ues f or varia bles pre-i nter ve nti o n.
1 2. 1 1   
 * E x pl ai n t he r ati o n ale f or t he c h oice of st atistic al me as ures a n d t he n u m ber of p artici p a nts pr o p ose d f or t he st u d y, i ncl u di n g t he 
p o wer c alc ul ati o ns w he n a p plic a ble.
A c o n ve nie nce sa m ple of 2 0 was c h ose n d ue t o t he e x pl orati ve nat ure of t his st u d y t o deter mi ne w het her 
varia bles are meas ura ble wit h s ufficie nt precisi o n t o be st u die d i n later e x peri me ntal st u dies a n d t o c hec k t he 
l o gistics of a pr o p ose d e x peri me nt. 
T his is pri maril y a n acce pta bilit y a n d feasi bilit y st u d y s o t hat t he a nal ysis will f oc us o n t he ke y para meters 
necessar y f or a f ut ure R C T. M ost of t he a nal ysis will be descri pti ve i n nat ure. M ore o ver, we are c o n d ucti n g 
n u mer o us tests o n a s mall p o p ulati o n; t heref ore, we will n ot a p pl y a restricti ve c orrecti o n f or m ulti ple statistical 
tests t o re veal t he tre n ds clearl y. 
1 2. 1 2  *  Will s a m ples be c o de d ?
 Y e s     N o
If Yes, Please descri be c o di n g sc he me c o nsiste nt wit h G C P.  If sa m ples will n ot be c o de d, please pr o vi de 
j ustificati o n f or t his pr o p ose d de part ure fr o m G C P practice.
 
All sa m ples will be c o de d wit h u ni q ue i de ntifiers base d o n t he st u d y n u m ber assi g ne d t o eac h i n di vi d ual u p o n 
e nr oll me nt (f or e xa m ple, R KI- 1 0 4 7- 0 0 1). St u d y v ol u nteers' HI P A A- pr otecte d i nf or mati o n will n ot be ass ociate d 
wit h a n y researc h data. All c o m p uters use d t o st ore a n d a nal yze researc h data will be pass w or d- pr otecte d a n d 
e ncr y pte d. All data will be bac ke d u p i nt o t he s yste m mai ntai ne d b y t he I nf or mati o n Tec h n ol o g y Ser vice at 
R oc kefeller U ni versit y.

T he i nter vie ws will be rec or de d usi n g a de dicate d di gital a u di o rec or der t hat will be l oc ke d sec urel y w he n n ot i n 
use. T he a u di o will t he n be u pl oa de d o nt o N Vi v o a n d delete d fr o m t he a u di o rec or der. N vi v o will be use d t o 
tra nscri be t he a u di o i nt o te xt. All a u di o rec or di n gs will be re vie we d f or acc urac y a n d a n y i de ntifiers pri or t o 
usi n g data a nal ysis s oft ware ( N Vi v o des kt o p versi o n). After all rec or di n gs ha ve bee n tra nscri be d, t he a u di o files 
will be delete d, a n d files st ore d i n R U R oc kefeller U ni versit y Ce ntral File s hare. T he matic a nal ysis will be 
c o n d ucte d t o i de ntif y rec urri n g t he mes.
If a vaila ble, u pl oa d t he Data a n d Sa m ple S hari n g Ma na ge me nt Pla n a p pr o ve d b y R U I T.
V e r si o n  
Ti tl e
C a t e g o r y
E x pi r a ti o n 
D a t e
D o c u m e n t 
O u t c o m e
Vi e w D o c u m e n t
N o D o c u m e nt ( s ) h a v e b e e n att a c h e d t o t hi s f or m.
1 3. 0  
P arti ci p a nt s of St u d y
1 3. 1  S pecif y a ge r a n ge of p artici p a nts: 
Mi ni m u m A ge:
* 
1 8
* Ma xi m u m A ge:
5 0
Please n ote:  If t he a ge of partici pa nts i n dicate d is less t ha n 1 8 years ol d, y o u will be pr o m pte d t o attac h a 
Pe diatric Asse nt f or m later o n i n t he s u b missi o n pr ocess.  A li n k t o t he Pe diatric Asse nt f or m ca n be f o u n d i n 
t he Hel p li n k t o t he ri g ht, or t his f or m ca n be d o w nl oa de d later o n i n t he s u b missi o n pr ocess.
 
 
1 3. 2  *  I n dic ate t he ge n der(s) of t he p artici p a nts:
F e m al e
M al e
U n k n o w n
N ot R e p ort e d
1 3. 3  * 
 
I n dic ate pr ojecte d e nr oll me nt b y r ace a n d et h nicit y.  See Hel p f or dise ase/ v ol u nteer p o p ul ati o n de m o gr a p hics.
1 3. 4  E xcl usi o n of Pr otecte d Gr o u ps:
* R e s e a r c h i n v ol vi n g h u m a n p a r ti ci p a n t s s h o ul d b e d e si g n e d / c o n d u c t e d t o b e a s 
b r o a dl y i n cl u si v e a s p o s si bl e r e g a r di n g s e x, g e n d e r, r a c e, a g e, a n d e t h ni ci t y. 
E x cl u si o n s r e g a r di n g t h e s e c h a r a c t e ri s ti c s r e q ui r e a n e x pl a n a ti o n of t h e r a ti o n al e a n d 
j u s tifi c a ti o n.
Will p a r ti ci p a n t s of a s p e cifi c s e x / g e n d e r / r a c e / e t h ni ci t y / a g e o r o t h e r p r o t e c t e d g r o u p 
c h a r a c t e ri s ti c b e e x cl u d e d f r o m p a r ti ci p a ti o n ?
 Y e s     N o
Pl e a s e i d e ntif y t h e gr o u p / c h ar a ct eri sti c t h at will b e e x cl u d e d :
A g e
S e x

G e n d er
R a c e
Et h ni cit y
Ot h er gr o u p s e x cl u d e d b a s e d o n a n i d e ntifi a bl e gr o u p c h ar a ct eri sti c ; pl e a s e s p e cif y b el o w, 
wit h j u stifi c ati o n
Pl e a s e d e s cri b e t h e s p e cifi c s of t h e e x cl u si o n ( e. g., “ m al e s ”  or “i n di vi d u al s a g e 6 0 a n d ol d er ” 
or  “ st u d y i n cl u d e s o nl y p er s o n s w h o s elf -i d e ntif y a s Bl a c k ” ) a n d t h e j u stifi c ati o n f or t h e 
e x cl u si o n :
A g e a n d HI V st at u s - P arti ci p a nt s ol d er t h a n 5 1 y e ar s of a g e a n d t h o s e li vi n g wit h HI V will b e 
e x cl u d e d fr o m p arti ci p ati n g i n t h e st u d y. E vi d e n c e s h o w s t h at p er s o n s li vi n g wit h HI V h a v e 
s h ort er t el o m er e s t h a n t h e g e n er al p u bli c ( Al ej o s et al., 2 0 1 9 ). L o n git u di n al st u di e s h a v e al s o 
s h o w e d t h at t el o m er e l e n gt h s s h ort e n wit h a g e ( H u a n g et al., 2 0 2 1 )
1 3. 5  V ul ner a ble P o p ul ati o ns
I n dicate w het her a n y of t he f oll o wi n g p o p ulati o ns will be i ncl u de d i n t he st u d y:
C hil dr e n
Pr e g n a nt W o m e n
C o g niti v el y I m p air e d P er s o n s
R U E m pl o y e e s
R U St u d e nt s
Ot h er :
1 3. 6    W h at is t he t ot al n u m ber of   
 p artici p a nts y o u pl a n t o e nr oll at R oc kefeller U ni versit y H os pit al o ver t he c o urse of t he e ntire 
*
e v al u a ble
st u d y ?
2 0
1 3. 7    * W h at is t he t ot al n u m ber of p artici p a nts w h o will nee d t o si g n c o nse nt 
 
at R oc kefeller U niversity H os pit al over t he c o urse of t he e ntire 
t o res ult i n t he desire d n u m ber of e v al u a ble p artici p a nts ?
st u dy 
3 0
1 3. 8    * W h at is t he t ot al n u m ber of p artici p a nts y o u pl a n t o si g n c o nse nt 
 
at R oc kefeller U niversity H os pit al i n t he ne xt ye ar ?
0
1 3. 9   
 * W h at will be t he t ot al n u m ber of e v al u a ble p artici p a nts at all sites over t he c o urse of t he e ntire st u dy ?
2 0
1 3. 1 0  I ncl usi o n Criteri a
Please list partici pa nt i ncl usi o n criteria:
O r d e r 
N u m b e r
C ri t e ri a
1 
S elf I d e ntit y a s Afri c a n A m eri c a n or Bl a c k
 
2 
1 8 - 5 0 y e ar s ol d
 
3 
Fl u e nt i n E n gli s h
 
4 
B or n a n d or r ai s e d i n t h e U nit e d St at e s
 

1 3. 1 1  E xcl usi o n Criteri a
Please list partici pa nt e xcl usi o n criteria:
O r d e r 
N u m b e r
C ri t e ri a
1 
Hist or y of si g nifica nt pre-e xisti n g brai n disease or i nj ur y (e. g., de me ntia, str o ke, seiz ure 
dis or der, a n d hea d i nj ur y wit h c o g niti ve se q uelae or l oss of c o nsci o us ness > 3 0 mi n., seiz ure 
dis or der)
 
2 
Re p orte d hist or y of lear ni n g disa bilit y/ me ntal retar dati o n
 
3 
C urre nt A D H D, de pressi o n, bi p olar dis or der, p ost-tra u matic stress dis or der ( P T S D), or 
ps yc h otic dis or der dia g n osis
 
4 
C urre nt ps yc h otr o pic me dicati o n (as t hese me dicati o ns ha ve k n o w n i m pacts o n brai n f u ncti o n) 
e g. a nti ps yc h otics, a ntia n xiet y
 
5 
S e v er e / c hr o ni c m e di c al ill n e s s ( e. g., r e p ort e d HI V + st at u s, c ar di o v a s c ul ar di s e a s e, 
li v er di s e a s e / cirr h o si s, c hr o ni c ki d n e y di s e a s e, c urr e nt / p a st c a n c er wit h r a di ati o n
/ c h e m ot h er a p y tr e at m e nt, et c. )
 
6 
C urr e nt m et h a d o n e / s u b o x o n e / b u pr e n or p hi n e ( or si mil ar ) m ai nt e n a n c e
 
7 
U s e of illi cit s u b st a n c e s ot h er t h a n c a n n a bi s wit hi n t h e p a st 9 0 d a y s
 
8 
Pr e g n a n c y
 
9 
M aj or lif e e v e nt s i n t h e l a st 3 0 d a y s ( h o s pit ali z ati o n, m arri a g e, d e at h i n t h e f a mil y 
of fri e n d s, di s a st er )
 
1 0 
A n y me dical, ps yc h ol o gical, or s ocial c o n diti o n t hat, i n t he o pi ni o n of t he I n vesti gat or, w o ul d 
je o par dize t he healt h or well- bei n g of t he partici pa nt d uri n g a n y st u d y pr oce d ures or t he 
i nte grit y of t he data.
 
1 4. 0  
S c h e d ul e of E v e nt s/ St u d y Pl a n
1 4. 1  
I nstr ucti o ns:Ne w St u dies:
A Sc he d ule of E ve nts is re q uire d f or all ne w st u dies i n v ol vi n g i nter acti o ns wit h h u m a n s u bjects.
T he i RI S St u d y Pl a n will 
 f or ne w pr ot oc ols. 
n ot be acce pte d
A te m pl ate Sc he d ule of E ve nts is a v ail a ble o n t he I R B We bsite. F or a n y ne w st u d y, p o p ul ate t he te m pl ate wit h t he visits a n d 
pr oce d ures f or t he st u d y. 
T he c o nte nt of t he Sc he d ule of E ve nts s h o ul d be c o nsiste nt wit h a n y descri pti o ns of st u d y pr oce d ures t h at m a y be i n t he 
pr ot oc ol te xt a n d i nf or me d c o nse nt. 
Att ac h t he c o m plete d Sc he d ule of E ve nts d oc u me nt t o t he S u b missi o n F or m i n t he Sc he d ule of E ve nts secti o n.
E xisti n g St u dies:  F or e xisti n g st u dies, i n vesti g at ors m a y elect t o u p d ate t he e xisti n g St u d y Pl a n O R m a y re pl ace t he St u d y Pl a n wit h a 
Sc he d ule of E ve nts, f oll o wi n g t he i nstr ucti o ns a b o ve f or ne w st u dies.
A t t a c h t h e S t u d y Pl a n ( a n o p ti o n o nl y f o r s t u di e s wi t h p r e - e xi s ti n g 
S t u d y Pl a n s ):
*    
 
W h at is t he
t ot al n u m ber of o ut p atie nt visits f or all p artici p a nts pr ojecte d f or t he ne xt ye ar ?

0
* W h at is t he a ver a ge le n gt h of e ac h o ut p atie nt visit (i n h o urs) ?
0
* W h at is t he t ot al n u m ber of D a y P atie nt visits f or all p artici p a nts pr ojecte d f or t he ne xt ye ar ?
0
* W h at is t he a ver a ge le n gt h of e ac h D a y P atie nt visit (i n h o urs) ?
0
*   W h at is t he t ot al n u m ber of i n p atie nt d a ys f or all p artici p a nts pr ojecte d f or t he ne xt ye ar ?
0
1 5. 0  
C o nse nt Pr oce d ure
1 5. 1   
 * T his st u d y will use t he f oll o wi n g t y pes of i nf or me d c o nse nt:
I nf or m e d C o n s e nt F or m St a n d ar d - a st a n d ar d c o n s e nt f or m wit h i n str u cti o n s f or a d a pti n g it 
t o y o ur st u d y
C o n s e nt F or m G e n eti c - a c o n s e nt f or m d e si g n e d f or a st u d y w h er e g e n eti c t e sti n g ( a s d efi n e d 
b y N Y S l a w ) i s t o b e d o n e i n t h e C U R R E N T st u d y
C o n s e nt f or st u di e s i n cl u di n g g e n o m e wi d e s e q u e n ci n g
P e di atri c A s s e nt F or m ( T o b e u s e d i n a d diti o n t o C o n s e nt ) f or P e di atri c p ati e nt s
Ot h er ( e. g., w ai v er s, el e ctr o ni c i nf or m e d c o n s e nt )
Li n ks t o t he 
a n d t he 
 f or ms ca n be f o u n d i n t he 
St a n d ar d C o nse nt, Ge netic Testi n g C o nse nt   
Pe di atric Asse nt
Hel p li n k t o t he ri g ht, or t hese f or ms ca n be d o w nl oa de d later o n i n t he s u b missi o n pr ocess.
1 5. 2  * I n dic ate t he c o nse nt pr ocess t o be use d.  
   ( See Hel p f or C C T S S O P)
Descri be h o w t he re q uire d i nf or mati o n is bei n g prese nte d t o partici pa nts (c o nse nt f or m, orall y, i nf or mati o n 
s heet, etc.).  Attac h a c o p y of w hat is bei n g prese nte d t o partici pa nts ( us uall y t he I C F a n d Asse nt f or ms).
B ef or e i niti ati n g a n y st u d y-r el at e d pr o c e d ur e s, t h e p ot e nti al p arti ci p a nt s will b e gi v e n a c o p y of t h e m o st r e c e nt 
I R B- a p pr o v e d a n d st a m p e d i nf or m e d c o n s e nt t o r e a d. T h e PI or st u d y st aff m e m b er w h o h a s b e e n d e si g n at e d 
t o c o n s e nt will di s c u s s vi a Z o o m or i n p er s o n t h e s p e cifi c s of t h e st u d y, i n cl u di n g b ut n ot li mit e d t o t h e p ur p o s e 
of t h e r e s e ar c h, pr o c e d ur e s, ti m e c o m mit m e nt, r e q uir e d t a s k s, t e st arti cl e or d e vi c e, alt er n ati v e tr e at m e nt s, 
b e n efit s, ri s k s, c o nfi d e nti alit y, et c. I nf or m ati o n will b e pr o vi d e d c o m pr e h e n si bl y ( n o n- s ci e ntifi c), u si n g l a n g u a g e 
r e a dil y u n d er st a n d a bl e b y t h e p arti ci p a nt. P arti ci p a nt s will b e i nf or m e d t h at p arti ci p ati o n i s v ol u nt ar y a n d t h at 
t h e y will n ot b e p e n ali z e d if t h e y d o n ot c o n s e nt. P arti ci p a nt s will b e gi v e n a m pl e o p p ort u nit y t o a s k q u e sti o n s 
u ntil s ati sfi e d b ef or e si g ni n g t h e c o n s e nt.
P arti ci p a nt s w h o ar e e nr oll e d r e m ot el y m a y r e c ei v e t h e pr ot o c ol R E D C a p e C o n s e nt vi a e m ail, 
f oll o wi n g t h e R U e C o n s e nt S O P. F oll o wi n g t h e c o n s e nt di s c u s si o n, t h e p er s o n o bt ai ni n g c o n s e nt 
will e m ail t h e p arti ci p a nt a li n k t o t h e R E D C a p e C o n s e nt f or r e vi e w a n d si g n at ur e. O n c e t h e 
p arti ci p a nt si g n s, t h e st u d y m e m b er will c o u nt er si g n a n d e m ail a P D F of t h e f ull y si g n e d c o n s e nt 
f or m, w hi c h will b e e m ail e d b a c k t o t h e p arti ci p a nt. T h e r e s e ar c h t e a m m e m b er o bt ai ni n g t h e 
c o n s e nt will c o m pl et e d o c u m e nt ati o n, i n cl u di n g t h e el e m e nt s of t h e c o n s e nt.
Descri be t he circ u msta nces u n der w hic h c o nse nt will be o btai ne d, w here t he pr ocess will ta ke place a n d a n y 
waiti n g peri o d bet wee n i nf or mi n g t he pr os pecti ve partici pa nt a n d o btai ni n g c o nse nt. 
P ot e nti al p arti ci p a nt s will b e pr o vi d e d wit h a pri v at e, c o nfi d e nti al s etti n g t o r e a d a n d di s c u s s t h e i nf or m e d 
c o n s e nt, fr e e fr o m c o er ci o n, u n d u e i nfl u e n c e, or ti m e c o n str ai nt s. All p arti ci p a nt s will b e gi v e n a c h a n c e t o a s k 
q u e sti o n s a n d e x pr e s s c o n c er n s. T h e y will b e gi v e n t h e o pti o n t o t a k e t h e c o n s e nt h o m e a n d di s c u s s it wit h 
f a mil y, fri e n d s, a n d / or h e alt h c ar e pr o vi d er s. Aft er a p arti ci p a nt a n d t h e p er s o n c o n d u cti n g t h e c o n s e nti n g si g n s 
a n d d at e s t h e c o n s e nt, t h e p arti ci p a nt will b e gi v e n a c o p y of t h e si g n e d i nf or m e d c o n s e nt f or m. T h e ori gi n al 
c o n s e nt f or m will b e r et ai n e d i n t h e R o c k ef ell er U ni v er sit y p ati e nt c h art. A n e nr oll m e nt n ot e will b e writt e n i n t h e 
p ati e nt c h art a s t o w h o o bt ai n e d c o n s e nt, h o w, w h at w er e q u e sti o n s a s k e d a n d a n s w er e d, a n d t h at a c o p y of t h e 
i nf or m e d c o n s e nt w a s gi v e n

t o t h e p arti ci p a nt.
 
Descri be t he e x perie nce of t he i n vesti gat ors desi g nate d f or t his tas k i n t he D O A i n o btai ni n g c o nse nt fr o m 
partici pa nts.
R a c h el Ki m a ni h a s b e e n tr ai n e d, d e m o n str at e d c o m p et e n c y, a n d h a s e xt e n si v e e x p eri e n c e wit h c o n s e nti n g 
r e s e ar c h p arti ci p a nt s.
H o w will it be deter mi ne d t hat t he partici pa nts or t he partici pa nts' a ut h orize d re prese ntati ves u n dersta n d t he 
i nf or mati o n prese nte d? 
W e will u s e t h e 't e a c h- b a c k' m et h o d t o a s s e s s p arti ci p a nt u n d er st a n di n g a n d r et e nti o n of pr ot o c ol r e q uir e m e nt s, 
a d v er s e e v e nt i nf or m ati o n, ri s k s a n d b e n efit s, a n d t h e p arti ci p a nt' s ri g ht s d e s cri b e d i n t h e i nf or m e d c o n s e nt 
pr o c e s s.
If E n glis h is n ot t he partici pa nts' nati ve la n g ua ge, h o w will writte n a n d/ or ver bal tra nslati o n be pr o vi de d?
Gi v e n t h e i n cl u si o n crit eri a a n d r e q uir e d E n gli s h c o m pr e h e n si o n, w e d o n ot a nti ci p at e c o n s e nti n g p arti ci p a nt s 
w h o s e n ati v e l a n g u a g e i s n ot E n gli s h. H o w e v er, f or t h e i s ol at e d p arti ci p a nt s w h o n e e d a tr a n sl at or,
P a cifi c I nt er pr et er s will b e u s e d t o f a cilit at e t h e e x pl a n ati o n of t h e st u d y.
 
Will a n y partici pa nts be c o g niti vel y i m paire d s o t hat t he y ma y n ot ha ve t he ca pacit y t o gi ve c o nse nt?
  Y e s      N o
F or partici pa nts w here it has bee n deter mi ne d t hat t he y lac k t he ca pacit y t o gi ve c o nse nt, descri be t he pr o visi o ns 
f or o btai ni n g c o nse nt fr o m t he partici pa nts' le gall y a ut h orize d re prese ntati ve.
P arti ci p a nt s w h o ar e d et er mi n e d n ot t o h a v e t h e c a p a cit y t o c o n s e nt will n ot b e e nr oll e d i n t h e st u d y.
1 5. 3   
 *
 
B ase d o n t he de m o gr a p hics, will t his st u d y's p artici p a nt p o p ul ati o n re q uire f orei g n l a n g u a ge c o nse nt f or m ?
  Y e s      N o
1 5. 4  * T his st u d y's c o nse nt pr oce d ure will re q uire t he f oll o wi n g w ai vers:   
( See Hel p f or a d diti o n al i nf or m ati o n.)
W ai v er of o n e or m or e el e m e nt s of i nf or m e d c o n s e nt, 4 5 C F R 4 6. 1 1 6 (f ) 
W ai v er of d o c u m e nt ati o n of i nf or m e d c o n s e nt, 4 5 C F R 4 6. 1 1 7 ( c ) 
N o w ai v er i s r e q u e st e d 
1 5. 5   
Will y o u o bt ai n a Certific ate of C o nfi de nti alit y ( C o C) f or t his st u d y ?
 Y e s     N o
A C o C will b e pr o vi d e d a ut o m ati c all y a s p art of it s f u n di n g m e c h a ni s m wit h NI H
T h e PI will a p pl y i n d e p e n d e ntl y t o NI H f or a C o C
N ot e t o I n v e sti g at or : If t hi s st u d y h a s a C o C, t h e I nf or m e d C o n s e nt d o c u m e nt m u st c o nt ai n C o C 
t e m pl at e l a n g u a g e
1 5. 6  *  D oes t his st u d y i ncl u de vi de o/ a u di o rec or di n g, p h ot o gr a p h y or ot her electr o nic rec or di n g of h u m a n p artici p a nts ?
 Y e s     N o
1 5. 7  Ple ase select fr o m f oll o wi n g:
P h ot o gr a p h y ( Pl e a s e s e e t h e R U P oli c y o n p h ot o gr a p h y i n r e s e ar c h )
Vi d e o R e c or di n g
A u di o R e c or di n g

Ot h er El e ctr o ni c R e c or di n g
1 5. 8  Descri be w h at will be d o ne:
I nt er vi e w s will b e c o n d u ct e d i n di vi d u all y i n a pri v at e r o o m at R o c k ef ell er U ni v er sit y' s O ut p ati e nt 
d e p art m e nt. B ef or e b e gi n ni n g t h e i nt er vi e w, t h e i nt er vi e w er will e x pl ai n t h e p ur p o s e of t h e 
i nt er vi e w, t h e f or m at, a n d t h e l e n gt h of ti m e f or t h e i nt er vi e w. P arti ci p a nt s will b e r e mi n d e d 
w h e n t h e r e c or di n g b e gi n s.
Q u alit ati v e i nt er vi e w s u si n g s e mi str u ct ur e d q u e sti o n s will b e c o n d u ct e d t o o bt ai n f e e d b a c k o n 
C B R T i nt er v e nti o n
1 6. 0  
Recr uit me nt a n d A d vertisi n g
F or assist a nce c o ns ult C R S O t o cre ate a r o b ust Recr uit me nt Pl a n see Hel p.
1 6. 1  *  W h at is t he pl a n f or recr uit me nt ?
W h a t i s t h e pl a n f o r r e c r ui t m e n t ?
O v er vi e w : T h e C R R O S S s e e k s t o pr e s cr e e n 4 0 h e alt h y v ol u nt e er s b et w e e n t h e a g e s of 1 8 - 5 0 t o 
a c hi e v e t h e o v er all g o al of 2 0 e v al u a bl e p arti ci p a nt s. 
F e a si bili t y a n d A s s e s s m e n t:
I n c e n ti v e s:  1 ) Altr ui s m ; 2 ) I nt er e st i n st u d y t o pi c 3 ) C o m p e n s ati o n 
C h all e n g e s:  1 ) O v e r all i m p a c t of t h e C o vi d - 1 9 p a n d e mi c m a y di s s u a d e i n di vi d u al s f r o m 
v ol u n t a ril y p a r ti ci p a ti n g i n r e s e a r c h s t u di e s; 2 ) S c h e d uli n g 2 0 p a r ti ci p a n t s f o r w e e kl y 
Z o o m m e e ti n g s f o r t h e i n t e r v e n ti o n; 3 ) all p a r ti ci p a n t s m u s t b e e n r oll e d b ef o r e t h e 
i n t e r v e n ti o n al p o r ti o n of t h e s t u d y c a n b e gi n; 4 ) R e t ai ni n g p a r ti ci p a n t s o v e r t h e c o u r s e 
of 1 0 w e e k s; 4 ) R e c r ui ti n g a n d c o m pl e ti n g s t u d y i n ti m e f o r P I’ s g r a d u a ti o n d e a dli n e.
I s s u e s r el e v a n t t o r a pi d a c c r u al:
P o siti v e :  1 ) E xi sti n g c o h ort of h e alt h y v ol u nt e er s i n t h e r e p o sit or y ; 2 ) M a n y p arti ci p a nt s fr o m 
fir st pil ot st u d y c o n d u ct e d l a st y e ar m a y b e g o o d c a n di d at e s f or t h e c urr e nt st u d y ; 3 ) C a s h 
c o m pl eti o n b o n u s f or p arti ci p a nt s w h o c o m pl et e t h e e ntir e st u d y.
N e g ati v e : 1 ) Hi g h n o - s h o w t ur n o ut f or h e alt h y p arti ci p a nt st u di e s i n g e n er al. 
P r oj e c t e d Ti m e t o A c c r u al C o m pl e ti o n ( P T A C ):
T h e r e s e ar c h t e a m pl a n s t o s cr e e n u p t o 2 p arti ci p a nt s 3 d a y s p er w e e k w hi c h tr a n sl at e s t o 
e nr olli n g u p t o 6 v ol u nt e er s a w e e k. 
F a ct or s Aff e cti n g Pr e di ct e d Ti m e t o A c cr u al C o m pl eti o n
W e e k s
R e s e ar c h t e a m pl a n s t o s cr e e n 2 p arti ci p a nt s 3 d a y s p er w e e k
2 0 t ot al / 6 / w e e k e nr oll e d = 4 w e e k s t o r e cr uit m e nt
4
A nti ci p at e d st art u p : Mi s c ell a n e o u s d el a y
2
A d d a n y v a c ati o n ti m e w h e n s cr e e n / vi sit c a p a cit y will b e r e d u c e d 
-
R e cr uit m e nt i s t o o c c ur d uri n g A u g u st ? a d d 2 w e e k s d u e t o hi st ori c al sl o wi n g 
-
R e cr uit m e nt t o o c c ur a cr o s s D e c J a n u ar y ti m efr a m e ; a d d 2 w e e k s f or u nit cl o s ur e -
St af f or K S P c h a n g e s – a d d o n b o ar di n g ti m e
-
St aff tr a v el f or m aj or c o nf er e n c e s – a d d w e e k s l o st c a p a cit y 
1
I n stit uti o n al i nt err u pti o n s ( gr a d u ati o n, s y m p o si u m d a y s, et c. ) a d d t e a m e sti m at e -
Pr oj e ct e d Ti m e t o A c cr u al C o m pl eti o n ( P T A C )
7
R e c r ui t m e n t I m pl e m e n t a ti o n:
A d v erti si n g - C R R O S S will a d v erti s e o n Cr ai g sli st. V ol u nt e er s will al s o b e dr a w n fr o m t h e R e s e ar c h 
V ol u nt e er R e p o sit or y i n Cli ni c al C o n d u ct or.   Eli gi bl e p arti ci p a nt s fr o m R KI - 1 0 3 6 will b e i n vit e d t o 
s cr e e n f or t hi s st u d y.
C e ntr ali z e d C all M a n a g e m e nt – C R R O S S will w or k wit h t h e r e s e ar c h t e a m t o d e v el o p a pr ot o c ol -
s p e cifi c pr e - s cr e e ni n g s cri pt b a s e d o n I R B a p pr o v e d pr ot o c ol eli gi bilit y crit eri a t o pr e s cr e e n 
v ol u nt e er s w h o c all 1 8 0 0 R U C A R E S. P ot e nti all y eli gi bl e c a n di d at e s will b e s c h e d ul e d f or t h e st u d y 
t e a m f or f urt h er s cr e e ni n g. C R R O S S st aff will al s o c all v ol u nt e er s b a s e d o n R e p o sit or y q u eri e s 
d e s cri b e d a b o v e. R e s e ar c h t e a m s ar e r e s p o n si bl e t o pr o vi d e ti m el y u p d at e s o n pr e / s cr e e ni n g 

o ut c o m e s b y u p d ati n g v ol u nt e er s’ St u d y St at u s i n C er n er. T h e R e cr uit m e nt t e a m u s e s s cr e e ni n g 
o ut c o m e s t o r e vi e w pr o gr e s s a n d str at e g y t o k e e p e nr oll m e nt o n t ar g et.
Pl e a s e d e s c ri b e h o w t h e R e c r ui t m e n t Pl a n a d d r e s s e s r e c r ui t m e n t of t h e v ol u n t e e r s 
c o n si s t e n t wi t h t h e d e m o g r a p hi c s of t h e c o n di ti o n u n d e r s t u d y:  (r ef er e n c eC e n s u s, M a p s,
C D C d at a )
H e al t h y, s elf -i d e n tif yi n g Bl a c k / Af ri c a n A m e ri c a n p a r ti ci p a n t s  of all g e n d e r s b e t w e e n 
t h e a g e s 1 8 - 5 0 will b e c o n si d e r e d f o r t h e s t u d y. R U E M P L O Y E E S A N D S T U D E N T S A R E 
N O T E L I G I B L E T O P A R T I C I P A T E I N T H I S S T U D Y.
1 6. 2  * Fr o m t he d ate of fi n al I R B a p pr o v al, h o w l o n g will it t a ke t o c o m plete e nr oll me nt of t he st u d y ?
6 M o nt h s 
1 2 M o nt h s 
1 8 M o nt h s 
2 4 M o nt h s 
M or e t h a n 2 y e ar s ( s p e cif y i n y e ar s ) 
1 6. 3  T his St u d y
I n v ol v e s a n i nt er v e nti o n or c o m p ari s o n a n d a d efi n e d e nr oll m e nt t ar g et 
I s a n at ur al hi st or y st u d y wit h e x p e ct e d a n n u al e nr oll m e nt o v er m a n y y e ar s 
I s a n e x pl or at or y m e c h a ni sti c st u d y 
Ot h er 
1 6. 4  T his St u d y will e nr oll:
H e alt h y v ol u nt e er s 
I n di vi d u al s aff e ct e d wit h a s p e cifi c di s e a s e / di s or d er 
B ot h 
1 6. 5    D o y o u pl a n o n usi n g t he Rese arc h P artici p a nt Re p osit or y ( R K O- 0 6 4 8) ?
*
 Y e s     N o
1 6. 6    
Are y o u scree ni n g or recr uiti n g fr o m or t hr o u g h a rec or d re vie w of a n e xisti n g p atie nt d at a b ase of a he alt hc are pr o vi der ? 
* 
 
  Y e s      N o
1 6. 7  * Ple ase descri be h o w t he Recr uit me nt Pl a n a d dresses recr uit me nt of t he v ol u nteers c o nsiste nt wit h t he de m o gr a p hics of t he c o n diti o n 
u n der st u d y:  
H e al t h y, s elf -i d e n tif yi n g Bl a c k / Af ri c a n A m e ri c a n p a r ti ci p a n t s  of all g e n d e r s b e t w e e n 
t h e a g e s 1 8 - 5 0 will b e c o n si d e r e d f o r t h e s t u d y . R U E M P L O Y E E S A N D S T U D E N T S A R E 
N O T E L I G I B L E T O P A R T I C I P A T E I N T H I S S T U D Y.
1 6. 8   
 * D o y o u pl a n t o a d vertise directl y t o p ote nti al v ol u nteers ?  ( As o p p ose d t o rel yi n g o n pr actiti o ner referr als  or fl yers t o pr actiti o ners)
 Y e s     N o
1 6. 9  *  D o y o u pl a n t o use t he free, we b- b ase d v ol u nteer re gistr y, Rese arc h M atc h. or g, as a recr uit me nt t o ol ?

 Y e s     N o
1 7. 0  
Rese arc h P artici p a nt Re p osit or y ( R K O- 0 6 4 8)
1 7. 1  T his pr ot oc ol, will be li n ke d wit h t he Rese arc h V ol u nteer Scree ni n g/ Recr uit me nt D at a Re p osit or y r u n b y t he Recr uit me nt st aff a n d t he 
  
Cli nic al Rese arc h S u p p ort Office ( pr ot oc ol R K O- 0 6 4 8- 1 0 0 8).  I n or der t o p artici p ate i n t he ge ner ati o n of t he Re p osit or y t he PI will 
e nter i nt o a C ollect or/ C oll a b or at or a gree me nt re g ar di n g t he Re p osit or y. T he r ole of C ollect or/ C oll a b or at or is t o c o ntri b ute t o t he 
Re p osit or y t he n a me, c o nt act a n d de m o gr a p hic i nf or m ati o n, recr uit me nt referr al i nf or m ati o n, a n d scree ni n g o utc o me i nf or m ati o n, as 
well as a p pr o pri ate pr ot oc ol s pecific scree ni n g i nf or m ati o n, of v ol u nteers w h o are scree ne d b y tele p h o ne or i n pers o n f or e ntr y i nt o t he 
pr ot oc ol re g ar dless of t he scree ni n g o utc o me. I n a d diti o n t o scree ni n g v ol u nteers f or t he PI's c urre nt st u d y, ver b al c o nse nt will be 
o bt ai ne d fr o m t he v ol u nteers re g ar di n g t heir willi n g ness t o be c o nt acte d i n t he f ut ure a b o ut p ossi ble a d diti o n al rese arc h st u dies. T his 
per missi o n m a y be o bt ai ne d b y t he Recr uit me nt office st aff t hr o u g h t he ce ntr al C all Ce nter.  If t he  PI recei ves c alls directl y fr o m 
p artici p a nts f or i niti al prescree ni n g, t he n t he PI is res p o nsi ble f or c ollecti n g t he re q uire d i nf or m ati o n a n d c o n ve yi n g it t o t he 
Recr uit me nt st aff f or d at a e ntr y.  T he c o nse nt or wit h h ol di n g of per missi o n will be rec or de d i n t he Re p osit or y as will t he n a me of t he 
pers o n w h o o bt ai ne d t he per missi o n. A v ol u nteer’s per missi o n or decli n ati o n will n ot affect t heir eli gi bilit y f or m y c urre nt pr ot oc ol, or 
f ut ure pr ot oc ols. T he Recr uit me nt st aff of t he Cli nic al Rese arc h S u p p ort Office m a y g at her t he Re p osit or y i nf or m ati o n a n d re q uest t he 
  
ver b al c o nse nt of t he v ol u nteer f or re-c o nt acti n g o n m y be h alf as p art of o ur recr uit me nt pl a n.  I n or der t o be nefit fr o m t he 
Re p osit or y,  t he PI will e nter i nt o a Reci pie nt/ C oll a b or at or a gree me nt wit h t he Re p osit or y.  T he Reci pie nt/ C oll a b or at or m a y recei ve 
fr o m t he Re p osit or y pre-scree ne d lists of p ote nti all y eli gi ble p artici p a nts f or his/ her st u d y as a me a ns t o f acilit ate recr uit me nt. T he 
Recr uit me nt st aff will pre p are t he Re p osit or y q ueries acc or di n g t o t he pr ot oc ol eli gi bilit y re q uire me nts a n d a v ail a ble Re p osit or y 
i nf or m ati o n, a n d m a y re- affir m per missi o n t o re-c o nt act v ol u nteers as necess ar y. T he PI m a y use t he i nf or m ati o n a n d n a mes i n t he list 
fr o m t he Re p osit or y o nl y f or t he c urre nt st u d y a n d m a y n ot s a ve t he list t o use f or a f ut ure st u d y of his/ her o w n, n or m a y he/s he s h are 
t he list wit h c olle a g ues f or ot her st u dies. "
1 8. 0  
 
Utiliz ati o n of Rese arc h M atc h. or g
1 8. 1  Utiliz ati o n of Rese arc h M atc h. or g f or Recr uit me nt
 
B asic i nf or m ati o n re g ar di n g t his t o ol:
 
Rese arc h M atc h. or g is a n ati o n al electr o nic, we b- b ase d recr uit me nt t o ol t h at w as cre ate d t hr o u g h t he Cli nic al & Tr a nsl ati o n al 
Scie nce A w ar ds C o ns orti u m i n 2 0 0 9 a n d is m ai nt ai ne d at V a n der bilt U ni versit y.  T here is n o c ost f or rese arc hers at 
p artici p ati n g i nstit uti o ns i n t he Rese arc h M atc h. or g Net w or k t o use Rese arc h M atc h. or g. T he V a n der bilt I R B pr o vi des 
o versi g ht f or Rese arc h M atc h. or g as a recr uit me nt t o ol a n d t his h as bee n d oc u me nte d wit hi n t he Rese arc h M atc h. or g I R B 
Letter of U n derst a n di n g w hic h w as e xec ute d b y Dr. G otsc hlic h i n Oct o ber, 2 0 0 9.  H o we ver, i n di vi d u al re q uests t o use 
Rese arc h M atc h. or g as a recr uit me nt t o ol m ust be s u b mitte d t o t his i nstit uti o ns’ I R B.
Re gistr ati o n:
 
T his recr uit me nt t o ol m a y be utilize d o nce t he PI or rese arc h st aff re gisters f or recr uit me nt access t hr o u g h Rese arc h M atc h. or g 
a n d t he I nstit uti o n al Li ais o n pr o vi des a p pr o v al.
T he Rese arc h M atc h. or g I nstit uti o n al Li ais o n will re vie w t he st u d y i nf or m ati o n a n d e vi de nce of I R B a p pr o v al. He/s he will set 
t he rese arc her’s e x pir ati o n d ate t o mirr or t h at of t he st u d y’s I R B a p pr o v al.
Se arc h C a p a bilit y:
 
After bei n g gr a nte d recr uit me nt access, t he rese arc her c a n se arc h f or a p pr o pri ate m atc hes a m o n gst t he n o n-i de ntifi a ble 
Rese arc h M atc h. or g V ol u nteer pr ofiles i n t he s yste m.  He/s he c a n e nter st u d y i ncl usi o n/e xcl usi o n criteri a i n t he Rese arc h M atc h.
or g Se arc h B uil der w hic h will yiel d a list of p ote nti al m atc hes t o t he st u d y’s criteri a. 
C o nt acti n g Rese arc h M atc h. or g V ol u nteers:
 
O nce yiel di n g a list of p ote nti al m atc hes ( Rese arc h M atc h. or g V ol u nteers), t he rese arc her will se n d o ut I R B- a p pr o ve d c o nte nt 
t h at will be t he i niti al recr uit me nt mess a ge t h at t hese v ol u nteers recei ve a b o ut t he st u d y t hr o u g h Rese arc h M atc h. or g. T he 
st u d y’s recr uit me nt mess a ge will be i nserte d i nt o t he st a n d ar d Rese arc h M atc h. or g electr o nic n otific ati o n t h at i nf or ms p ossi ble 
m atc he d V ol u nteers t h at he/s he h as bee n i de ntifie d as a p ote nti al m atc h f or t he st u d y.  T he sec ure Rese arc h M atc h. or g 
cle ari n g h o use will r o ute t his st a n d ar d Rese arc h M atc h. or g e m ail n otific ati o n. T hese p ote nti al m atc hi n g v ol u nteers will h a ve t he 
o pti o n of re pl yi n g yes, n o, or n ot res p o n d t hr o u g h a set of q uic k li n ks a v ail a ble i n t his n otific ati o n t o t he st u d y a n n o u nce me nt. 
 (e. g. E M AI L, 
T H E C O N T A C T M E S S A G E WI L L N O T I N C L U D E T H E S T U D Y’ S DI R E C T C O N T A C T I N F O R M A TI O N
P H O N E).  B y res p o n di n g yes, t he V ol u nteer h as a ut h orize d Rese arc h M atc h. or g t o rele ase his/ her c o nt act i nf or m ati o n t o t he 
rese arc her.  T he rese arc her will be res p o nsi ble f or m a n a gi n g t his c o nt act i nf or m ati o n as c alle d f or b y t his I R B- a p pr o ve d st u d y 
pr ot oc ol. 
St u d y M a n a ge me nt i n Rese arc h M atc h. or g:
 
Rese arc hers ( a n d t he Li ais o n) c a n vie w i nf or m ati o n re g ar di n g his/ her st u d y’s st at us i n Rese arc h M atc h. or g (e. g. n u m ber of 
v ol u nteers c o nt acte d f or t he st u d y vi a Rese arc h M atc h. or g t o d ate, res p o nse r ate of v ol u nteers, etc.).  Rese arc h M atc h. or g will 
als o be c ollecti n g a g gre g ate d at a re g ar di n g t he st at us of Rese arc h M atc h. or g v ol u nteers wit hi n t he st u d y. V ol u nteers c o nse nt t o 
t his wit hi n t he Rese arc h M atc h. or g V ol u nteer A gree me nt. T his i nf or m ati o n will all o w t he rese arc her t o i n dic ate w here t he 

V ol u nteer c urre ntl y st a n ds wit hi n t he recr uit me nt pr ocess a n d t h us will hel p t he rese arc her m o nit or t he utilit y a n d 
effecti ve ness of usi n g t his res o urce (e. g. Di d n ot c o nt act, N ot eli gi ble, E nr olle d, C o m plete d, etc.).
1 9. 0  P ote nti al Be nefits t o P artici p a nts
1 9. 1   
 * Will p artici p ati o n i n t his st u d y pr o vi de direct be nefits t o t he p artici p a nt ?
 Y e s     N o
1 9. 2  If Yes, descri be t he p ote nti al direct be nefits:
C B R T i s a c o nt e m pl ati v e s elf - h e ali n g pr o gr a m t h at i nt e gr at e s mi n df ul n e s s wit h c o g niti v e 
e d u c ati o n, aff e ct m o d ul ati o n, m oti v ati o n al i m a g er y, br e at h c o ntr ol, a n d s elf - m a s s a g e. R e s e ar c h 
d e m o n str at e s t h at c o m p a s si o n - b a s e d m e dit ati v e t h er a pi e s s u p p ort t h e d e v el o p m e nt of pr o - s o ci al 
attri b ut e s a n d s o ci al c o n n e cti o n s. I n di vi d u al s wit h hi g h er mi n df ul n e s s tr ait s ar e t h o u g ht t o b e 
m or e a bl e t o r e g ul at e t h eir e m oti o n s a n d l e s s e m oti o n all y r e a cti v e. I n a d diti o n, mi n df ul n e s s 
i nt er v e nti o n s c a n al s o l e a d t o t h e d e v el o p m e nt of i n di vi d u al r e sili e n c e, a n d b y f o c u si n g o n t h e 
pr e s e nt m o m e nt, n e g ati v e f e eli n g s ar e l e s s li k el y t o p er si st, l e a di n g t o p s y c h ol o gi c al w ell - b ei n g 
a n d, c o n s e q u e ntl y, p h y si ol o gi c al h e alt h.
2 0. 0  P ote nti al Ris ks t o P artici p a nts
2 0. 1  
 *  Descri be a n y p ote nti al ris ks: p h ysic al, ps yc h ol o gic al, s oci al, le g al or ot her a n d assess t heir li keli h o o d a n d seri o us ness. I n dic ate ris ks 
b ot h t o t he p artici p a nts a n d t o t he e m br y o or fet us if t he p artici p a nt is or m a y bec o me pre g n a nt.  Ple ase pr o vi de t he p ote nti al ris ks 
bel o w:
V e ni p u n c t u r e: P o s si bl e ri s k s i n cl u d e mil d di s c o mf ort, p ai n, p o s si bl e bl e e di n g, f ai nti n g, br ui si n g, 
a n d t h e ri s k of i nf e cti o n a s s o ci at e d wit h v e ni p u n ct ur e.
 
P s y c h ol o gi c al : S o m e of t h e q u e sti o n s o n p s y c h ol o gi c al q u e sti o n n air e s a n d mi n df ul n e s s 
i nt er v e nti o n mi g ht b e c o n si d er e d p er s o n al a n d s e n siti v e t o s o m e p arti ci p a nt s. I n a d diti o n, t h e y 
m a y b e tri g g eri n g a n d c a u si n g p s y c h ol o gi c al di str e s s.
P arti ci p a nt s e x p eri e n ci n g di str e s s will b e r ef err e d t o t h e R o c k ef ell er U ni v er sit y Li c e n s e d s o ci al 
w or k er f or f urt h er e v al u ati o n.
 
C o nfi d e n ti ali t y : T h er e i s a ri s k of a br e a c h of c o nfi d e nti al i nf or m ati o n g ai n e d d uri n g t hi s st u d y. 
I n a d diti o n, t h e i nt er v e nti o n will b e h el d vi a a s e c ur e Z o o m wit h n o r e c or di n g. T h er e will b e n o 
r e c or di n g of s e s si o n s ; h o w e v er, it i s p o s si bl e t o b e e x p o s e d t hr o u g h ot h er p arti ci p a nt s.
2 1. 0
 Pr oce d ures t o Mi ni mize Ris ks
2 1. 1   
 * Descri be t he pr oce d ures f or pr otecti n g a g ai nst or mi ni mizi n g a n y p ote nti al ris ks, a n d i ncl u de a n assess me nt of t heir li kel y 
effecti ve ness. I ncl u de a disc ussi o n of c o nfi de nti alit y s afe g u ar ds, w here rele v a nt, a n d arr a n ge me nts f or pr o vi di n g me dic al tre at me nt, if 
nee de d.
V e ni p u n c t u r e. Bl o o d is o nl y dra w n b y e x perie nce d tec h nicia ns, n urses, or lice nse d cli nical practiti o ners.
 
Partici pa nts will be a p prise d of t he p ote ntiall y se nsiti ve c o nte nt of t he st u d y a n d will als o be 
Ps yc h ol o gic al: 
a p prise d of t heir ri g ht n ot t o a ns wer a n y q uesti o n p ose d t o t he m. I n a d diti o n, partici pa nts are i nf or me d of t heir 
ri g ht t o wit h dra w fr o m t he st u d y at a n y ti me. Partici pa nts e x perie nci n g distress will be referre d t o t he R oc kefeller 
U ni versit y Lice nse d s ocial w or ker f or f urt her e val uati o n.
 
All researc h data will be st ore d i n pass w or d- pr otecte d a n d c o m p uter-e ncr y pte d c o m p uters. Data 
Pri v ac y: 
c ollecte d will als o be c o de d, a n d n o i de ntif yi n g i nf or mati o n will be st ore d i n a n electr o nic researc h data base.
C B R T sessi o n will be hel d via a sec ure Z o o m li n k wit h n o vi de o rec or di n g; all partici pa nts will be ta u g ht t o bl ur 
t heir bac k gr o u n d t o pre ve nt e x p os ure t o t heir e n vir o n me nt. 

St u d y S afet y Pl a n
In t he st u d y safet y pla n, partici pa nts will be f ull y i nf or me d of t heir ri g ht t o refrai n fr o m a ns weri n g q uesti o ns or 
s hari n g i nf or mati o n t he y ma y fi n d distressi n g or u nc o mf orta ble. T hr o u g h o ut t he st u d y, t he well- bei n g of 
partici pa nts will be cl osel y m o nit ore d b y t he I n vesti gat or a n d C B R T pr o vi ders, w h o will mai ntai n o pe n li nes of 
c o m m u nicati o n, acti vel y e nc o ura gi n g partici pa nts t o e x press a n y c o ncer ns or disc o mf ort. S h o ul d a partici pa nt 
e x hi bit si g nifica nt distress or re q uest assista nce, t he y will be pr o m ptl y referre d t o o ur Lice nse d S ocial W or ker f or 
i m me diate e val uati o n a n d s u p p ort. S u bse q ue ntl y, o ur st u d y tea m will f oll o w u p t o e ns ure t heir o n g oi n g well-
bei n g a n d assess t he nee d f or a n y m o dificati o ns t o t heir partici pati o n. All i nci de nts of partici pa nt distress, 
referrals, a n d f oll o w- u p acti o ns will be metic ul o usl y d oc u me nte d i n t he R U H c hart a n d, as ma n date d, re p orte d t o 
t he I nstit uti o nal Re vie w B oar d (I R B). 
2 2. 0  
 or Tre at me nts
Alter n ati ve Met h o ds
2 2. 1  *  Descri be alter n ati ve met h o ds or tre at me nts f or t he dise ase(s) u n der st u d y, if a n y, t h at were c o nsi dere d a n d w h y t he y will n ot be use d:  
N o n e
2 3. 0
 
D at a a n d S afet y M o nit ori n g
T his secti o n descri bes t he D at a a n d S afet y M o nit ori n g Pl a n ( D S M P) re q uire d of e ac h pr ot oc ol 
u n dert a ke n at t he C C T S acc or di n g t o H R P P a n d NI H p olicies N otice 9 8 - 0 8 4 a n d N otice 0 0- 0 3 8, as 
cite d i n Hel p Secti o ns bel o w.   De pe n di n g o n t he le vel or ris k a n d tri al p h ase, s o me pr ot oc ols will 
nee d D at a a n d S afet y M o nit ori n g B o ar ds.
2 3. 1   
 * O ver all Ris k Cl assific ati o n
A n esti m ate of ris k is necess ar y t o e v al u ate t he a de q u ac y of t he pl a n ne d m o nit ori n g.  T he H E L P secti o n pr o vi des g ui d a nce i n m a ki n g 
t he ris k assess me nt. 
Re a d t he ris k defi niti o ns a n d e x a m ples of ris k i n t he H E L P secti o n a n d select t he ris k c ate g or y t h at best descri bes t he c urre nt st u d y. 
If y o ur assess me nt differs fr o m t he defi niti o ns t he H E L P secti o n, descri be a n y f act ors t h at m o dif y y o ur j u d g me nt of t he o ver all ris k i n 
t he te xt b o x after t he ris k desi g n ati o n.
MI NI M A L RI S K 
L O W RI S K 
M O D E R A T E RI S K 
SI G NI FI C A N T RI S K 
Please pr o vi de a n y o pti o nal descri pti o n(s):
2 3. 2  Pr ot oc ols I n v ol vi n g Mi n ors
T he c ha nce of direct be nefit t o t he c hil d, or t o u n dersta n di n g a dis or der n ot ot her wise u n derst o o d, ma y be maj or 
fact ors i n j ustif yi n g m ore t ha n mi ni mal ris k i n researc h i n v ol vi n g c hil dre n.  
Base d o n t he a b o ve defi niti o ns, please s pecif y y o ur st u d y's ris k classificati o n bel o w:
N O T G R E A T E R T H A N MI NI M A L RI S K (t h e ri s k of d ail y lif e t o a h e alt h y c hil d li vi n g i n a s af e 
e n vir o n m e nt ) 4 5 C F R 4 6. 4 0 4 
G R E A T E R T H A N MI NI M A L RI S K WI T H DI R E C T B E N E FI T T O P A R TI CI P A N T ; 4 5 C F R 4 6. 4 0 5 
G R E A T E R T H A N MI NI M A L RI S K, N O DI R E C T B E N E FI T, B U T B E N E FI T T O U N D E R S T A N DI N G O F 
P A R TI C P A N T' S DI S O R D E R ; 4 5 C F R 4 6. 4 0 6 
R E S E A R C H N O T O T H E R WI S E A P P R O V E D P R E S E N TI N G O P P O R T U NI T Y T O U N D E R S T A N D, 
P R E V E N T O R A L L E VI A T E S E RI O U S P R O B L E M A F F E C TI N G C HI L D R E N 4 5 C F R 4 6. 4 0 7 ( c a n n ot 
b e a p pr o v e d b y I R B ; r e q uir e s p u bli c c o m m e nt ) 
2 3. 3  D S M B

1.  
1.  
2.  
2.  
3.  
4.  
3.  
4.  
T he NI H re q uires t hat all 
 pr ot oc ols ha ve a 
 
SI G NI FI C A N T RI S K
D at a a n d S afet y M o nit ori n g B o ar d
a n d pr o vi de i nf or mati o n a b o ut t he e x pertise a n d i n de pe n de nce of t hat B oar d 
P hase III trials re q uire a Data a n d Safet y M o nit ori n g B oar d, 
A D S M B ma y be a p pr o priate f or s o me P hase I a n d II pr ot oc ols. ( See Hel p f or e xa m ples.)
It is t he i n vesti gat or's res p o nsi bilit y t o re p ort t o t he I R B, t he fi n di n gs a n d rec o m me n dati o ns of t he 
D S M B as t he y bec o me a vaila ble.
Please s pecif y:
A D S M B i s r e q uir e d f or t hi s st u d y 
A D S M B i s n ot r e q uir e d f or t hi s st u d y 
U n s ur e 
If a D S M B is n ot re q uire d, b ut is bei n g c o nstit ute d f or ot her reas o ns, please e x plai n:
2 3. 4   
 * S afet y Re vie w
Select o ne:
S af et y R e vi e w i s c o n d u ct e d a s f oll o w s : L a b or at or y r e s ult s f or r e s e ar c h v ol u nt e er s will b e 
r e vi e w e d i n a ti m el y m a n n er, u s u all y wit hi n 2 4 h o ur s of r e c ei pt b y a li c e n s e d pr a ctiti o n er. T h e 
p ot e nti al cli ni c al si g nifi c a n c e of a n y a b n or m al fi n di n g will b e d o c u m e nt e d i n t h e m e di c al a n d 
r e s e ar c h r e c or d ( s ), a n d a n a p pr o pri at e pl a n or r ef err al d e v el o p e d. T h e PI' s r e vi e w of s af et y 
i s s u e s at r e s e ar c h t e a m r o u n d s will b e d o c u m e nt e d i n t h e m e eti n g mi n ut e s. 
Pr ot o c ol S p e cifi c 
2 3. 5   M o nit ori n g
M o nit ori n g Pers o n nel:  See Hel p B u b ble t o t he ri g ht.
I nter nal M o nit ori n g
T he PI or his/ her desi g nee s hall c o n d uct i nter nal m o nit ori n g t o ass ure t he safe a n d pr o per c o n d uct of t he 
pr ot oc ol a n d all t he ele me nts list a b o ve i n m o nit ori n g, f oll o wi n g t he ge neral pri nci ples of q ualit y 
ma na ge me nt.  T he i nte nsit y a n d fre q ue nc y of i nter nal m o nit ori n g will de pe n d o n t he pr ot oc ol ris k t o 
partici pa nts, t he e x perie nce of t he PI a n d researc h tea m, rate of e nr oll me nt, a n d s pecific details of t he pr ot oc ol. 
I nter nal m o nit ori n g of i nf or me d c o nse nt a n d eli gi bilit y d oc u me ntati o n will be c o n d ucte d b y t he researc h tea m 
s h ortl y after e nr oll me nt be gi ns.  I nter nal m o nit ori n g acti vities will be d oc u me nte d b y l o gs, meeti n g mi n utes or 
ot her s yste matic mea ns.  
S pecif y t he researc h tea m me m bers w h o will c o n d uct t he i nter nal m o nit ori n g of t he st u d y (see Hel p f or w h o 
ma y m o nit or):
I nt er n al M o nit ori n g
T h e PI or hi s / h er d e si g n e e s h all c o n d u ct i nt er n al m o nit ori n g t o e n s ur e t h e s af e a n d pr o p er 
c o n d u ct of t h e pr ot o c ol a n d all t h e el e m e nt s li st e d a b o v e i n m o nit ori n g, f oll o wi n g t h e g e n er al 
pri n ci pl e s of q u alit y m a n a g e m e nt. T h e i nt e n sit y a n d fr e q u e n c y of i nt er n al m o nit ori n g will d e p e n d 
o n t h e pr ot o c ol ri s k t o p arti ci p a nt s, t h e e x p eri e n c e of t h e PI a n d r e s e ar c h t e a m, t h e r at e of 
e nr oll m e nt, a n d s p e cifi c d et ail s of t h e pr ot o c ol.
 
T h e r e s e ar c h t e a m will c o n d u ct i nt er n al m o nit ori n g of i nf or m e d c o n s e nt a n d eli gi bilit y 
d o c u m e nt ati o n s h ortl y aft er e nr oll m e nt b e gi n s.  L o g s, m e eti n g mi n ut e s, or ot h er s y st e m ati c 
m e a n s will d o c u m e nt i nt er n al m o nit ori n g a cti viti e s.
 
F or ne w i n vesti gat ors:  I nter nal m o nit ori n g s h o ul d be c o n d ucte d at least m o nt hl y b y ne w i n vesti gat ors u ntil 
t here are esse ntiall y n o fi n di n gs t o c orrect at eac h re vie w.

E xter nal M o nit ori n g
  Is e xter nal m o nit ori n g pla n ne d f or t his pr ot oc ol?
*
Y e s 
N o 
U n s ur e 
If e xter nal m o nit ori n g is pla n ne d, please s pecif y (see Hel p f or w h o ma y m o nit or):
( Si g nifi c a nt Ri s k ) E xt er n al m o nit ori n g will o c c ur at l e a st e v er y si x w e e k s u nl e s s t h er e i s n o 
e nr oll m e nt 
( M o d er at e Ri s k ) E xt er n al m o nit ori n g will o c c ur at l e a st q u art erl y 
( L o w or Mi ni m al Ri s k ) E xt er n al m o nit ori n g will o c c ur at l e a st a n n u all y 
If e xter nal m o nit ori n g is pla n ne d, please s pecif y t he na me of t he m o nit or:
N ot e t h at c o pi e s of e xt er n al m o nit ori n g r e p ort s m u st b e s u p pli e d t o t h e I R B a n d t h e C R S O a s 
s o o n a s t h e y ar e m a d e a v ail a bl e
A d diti o nall y, a u dits of t he researc h rec or ds of mi ni mal, m o derate or si g nifica nt-ris k pr ot oc ols ma y be 
perf or me d b y t he C R S O staff o n a ra n d o m basis or as part of a pr os pecti vel y i de ntifie d a u diti n g pla n. 
2 3. 6  A d verse E ve nt Cl assific ati o n
A d verse e ve nts are classifie d b y defi niti o n, se verit y, a n d ass ociati o n wit h t he i n vesti gati o nal trial.
 
Defi niti o n of a n A d verse E ve nt
A n y u nfa v ora ble or u ni nte n de d si g n (i ncl u di n g a b n or mal la b fi n di n gs), s y m pt o m or disease te m p orall y 
ass ociate d wit h t he use of a me dical treat me nt or pr oce d ure, or pr ot oc ol,  re gar dless of w het her it is c o nsi dere d 
relate d t o t he me dical treat me nt or pr oce d ure or pr ot oc ol.
 
Defi niti o n of a Seri o us A d verse E ve nt
A n y u na ntici pate d e ve nt t hat i n v ol ves t he f oll o wi n g:
o   res ults i n deat h
o   is life-t hreate ni n g
o   re q uires h os pitalizati o n or pr ol o n gs e xisti n g h os pitalizati o n
o   res ults i n persiste nt or si g nifica nt disa bilit y/i nca pacit y
o   is a n y me dical e ve nt w hic h re q uires treat me nt t o pre ve nt o ne of t he o utc o mes liste d a b o ve
Ot her e ve nts ca n be classifie d as "seri o us a d verse e ve nts" at t he discreti o n of t he PI.
 
Defi niti o n of A ntici p ate d/ E x pecte d A d verse E ve nt
A n y a d verse e ve nt, w hic h has bee n re p orte d i n t he I n vesti gat or's Br oc h ure, pac ka ge i nsert, safet y re p orts, 
cli nical pr ot oc ol, c o nse nt f or m or liste d i n t he N CI a ge nt-s pecific E x pecte d A d verse E ve nt List , is classifie d as 
3
a n e x pecte d a d verse e ve nt.  T he i n vesti gat or m ust pr o vi de t he a vaila ble data of k n o w n a d verse e ve nts a n d 
.  T his i nf or mati o n 
t o xicities t hat ha ve bee n ass ociate d wit h t he st u d y dr u g, de vice, i nter ve nti o n, or pr oce d ures
hel ps t o defi ne t he le vel of ris k of t he trial a n d e na bles safet y m o nit ori n g.  A mi ni mal ris k trial ma y n ot ha ve 
a n y defi ne d ris ks a n d a state me nt t o t hat effect is s ufficie nt t o meet t he D S M P re q uire me nts.
 
Defi niti o n of a n U na ntici pate d/ U ne x pecte d A d verse E ve nt
A n y a d verse e ve nt t hat is n ot c o nsiste nt wit h t he k n o w n, pre dicte d p ossi ble effects of t he researc h pr ot oc ol.  A n 
u ne x pecte d a d verse e ve nt varies i n nat ure, i nte nsit y or fre q ue nc y fr o m i nf or mati o n o n t he i n vesti gati o nal 
pr o d uct pr o vi de d i n t he I n vesti gat or's Br oc h ure, pac ka ge i nsert, safet y re p orts, cli nical pr ot oc ol, or liste d i n t he 
c o nse nt f or m.
 
Defi niti o n of a n U na ntici pate d Pr o ble m ( Ua P)
A Ua P is a n e ve nt or circ u msta nce t hat meets all t he f oll o wi n g t hree criteria: [ 1] t he nat ure, se verit y, fre q ue nc y 
of t he e ve nt(s) or i nf or mati o n was n ot e x pecte d i n t he descri pti o ns i n t he st u d y d oc u me nts or t he c haracteristics 
of t he partici pa nt p o p ulati o n bei n g st u die d; [ 2] t here is a reas o na ble p ossi bilit y t hat t he pr oce d ures i n v ol ve d i n 
t he researc h ca use d or are li n ke d i n a si g nifica nt wa y t o t he pr o ble m; [ 3]t he e ve nt or i nf or mati o n s u g gests t hat 
t he researc h places partic pa nts or ot hers at a greater ris k of har m t ha n was pre vi o usl y k n o w n or rec o g nize d 
(i ncl u di n g p h ysical, ps yc h ol o gical, ec o n o mic, or s ocial har m.
 
 
Gr a de a n d Rel ate d ness of A d verse E ve nts:

A d verse E ve nts are gra de d f or se verit y a n d sc ore d f or relate d ness t o t he pr ot oc ol, acc or di n g t o a p u blis he d 
scale.  Se veral sta n dar dize d A E Re p orti n g scales are a vaila ble.  ( See Hel p f or li n ks t o t hese scales.)  
 Please i n dicate t he scale y o u i nte n d t o use:
*
C T C v 2. 0 ( htt p : / / ct e p.i nf o. ni h. g o v /r e p orti n g / ct c. ht ml ) 
C T C A E v 3. 0 ( htt p : / / ct e p.i nf o. ni h. g o v / pr ot o c ol D e v el o p m e nt / el e ctr o ni c _ a p pli c ati o n s / d o c s
/ ct c a e v 3. p df ) 
C T C A E v 4. 0 ( htt p : / / e v s. n ci. ni h. g o v /ft p 1 / C T C A E / C T C A E _ 4. 0 3 _ 2 0 1 0 - 0 6 - 1 4 _ Q ui c k R ef er e n c e _ 8.
5 x 1 1. p df ) 
C T C A E v 5. 0 ( htt p s : / / ct e p. c a n c er. g o v / pr ot o c ol d e v el o p m e nt / el e ctr o ni c _ a p pli c ati o n s / d o c s
/ C T C A E _ v 5 _ Q ui c k _ R ef er e n c e _ 8. 5 x 1 1. p df ) 
AI D S Cli ni c al Tri al s Gr o u p ( htt p : / / a a ct g. s - 3. c o m / ) 
Ot h er 
2 3. 7  Re p orti n g A d verse E ve nts
All A Es will be re p orte d t o t he I R B at le ast a n n u all y.
Re p orti n g Seri o us A Es
S eri o u s A d v er s e E v e nt s, ( S A E s ) will b e r e p ort e d t o t h e I R B a c c or di n g t o p oli c y, wit hi n t w o 
w or ki n g d a y s of i d e ntifi c ati o n of t h e S A E.
Select all t hat a p pl y:
S A E s will b e r e p ort e d t o t h e S p o n s or a n d or E S C R O W
S A Es will be re p orte d t o t he s p o ns or wit hi n h o w ma n y da ys of t he e ve nt?
 
S A E s will b e r e p ort e d dir e ctl y t o t h e F D A, p er 2 1 C F R 3 1 2
      S A Es m ust be re p orte d directl y t o t he F D A wit hi n 7 da ys of t he e ve nt b y t he i n vesti gat or/s p o ns or.
S A E s will b e r e p ort e d t o a n ot h er e ntit y
Descri be:
Re p orti n g U n a ntici p ate d A Es:
Select all t hat a p pl y:
U A E s will b e r e p ort e d t o t h e I R B
U A Es t hat are relate d a n d greater t ha n m o derate se verit y m ust be re p orte d t o t he I R B acc or di n g t o p olic y, 
wit hi n t w o w or ki n g da ys of i de ntificati o n of t he U A E. 
 
U A E s will b e r e p ort e d t o t h e S p o n s or
U A E will be re p orte d t o t he s p o ns or wit hi n h o w ma n y da ys of t he e ve nt?
U A E s will b e r e p ort e d t o t h e F D A, p er 2 1 C R F 3 1 2
U A Es will be re p orte d t o t he F D A, per 2 1 C R F 3 1 2, wit hi n 1 5 da ys.

U A E s will b e r e p ort e d t o a n ot h er e ntit y
Descri be:
2 3. 8  Re p orti n g U n a ntici p ate d Pr o ble ms
U n a nti ci p at e d pr o bl e m s i n v ol vi n g ri s k s t o p arti ci p a nt s or ot h er s will b e r e p ort e d t o t h e I R B 
a n d t h e C R S O wit hi n fi v e w or ki n g d a y s.
2 3. 9  C LI A/ C L E P
 
O nl y l a b or at or y a n d rese arc h tests t h at are C LI A/ C L E P certifie d or w ai ve d m a y be use d t o deter mi ne eli gi bilit y, s h are d wit h rese arc h 
v ol u nteers, a n d use d i n cli nic al decisi o n m a ki n g.
Select if a p plica ble:
T hi s st u d y i n cl u d e s t e st s t h at ar e n ot C LI A / C L E P c ertifi e d ; t h e r e s ult s of s u c h t e st s will n ot b e 
u s e d i n cli ni c al d e ci si o n m a ki n g, or t o d et er mi n e eli gi bilit y, or s h ar e d wit h p arti ci p a nt s or t h eir 
h e alt h c ar e pr o vi d er s.
2 3. 1 0  Tiss ue Re p osit or y
H u m a n Tiss ue a n d D at a Re p osit ories c ollect, st ore, a n d distri b ute h u m a n tiss ue m ateri als a n d or d at a f or rese arc h p ur p oses. 
Re p osit or y acti vities i n v ol ve t hree c o m p o ne nts: (i) t he c ollect ors of tiss ue s a m ples\ d at a;  (ii) t he re p osit or y st or a ge a n d d at a 
m a n a ge me nt ce nter; a n d (iii) t he reci pie nt i n vesti g at ors.
*   Select o ne:
I D O N O T i nt e n d t o c oll e ct, st or e, a n d di stri b ut e h u m a n ti s s u e m at eri al s f or r e s e ar c h p ur p o s e s 
I D O i nt e n d t o c oll e ct, st or e, a n d di stri b ut e h u m a n ti s s u e m at eri al s f or r e s e ar c h p ur p o s e s, 
t h er ef or e t hi s pr ot o c ol e nt ail s t h e O p er ati o n of a Ti s s u e R e p o sit or y. T h e I R B r e q uir e s t h at t h e 
pr ot o c ol s p e cif y t h e c o n diti o n s u n d er w hi c h d at a a n d s p e ci m e n s m a y b e a c c e pt e d a n d s h ar e d, 
a n d e n s uri n g a d e q u at e pr o vi si o n s t o pr ot e ct t h e pri v a c y of p arti ci p a nt s a n d m ai nt ai n t h e 
c o nfi d e nti alit y of d at a. 
If y o u d o i nte n d t o c ollect, st ore, a n d distri b ute h u ma n tiss ue materials, y o u will be as ke d t o u pl oa d t he 
f oll o wi n g d oc u me nts later o n i n t he s u b missi o n:
A Sa m ple c ollecti o n pr ot oc ol (f or tiss ue c ollect or c olla b orat ors t o f oll o w) a n d i nf or me d c o nse nt 
d oc u me nt f or distri b uti o n t o tiss ue c ollect ors a n d t heir l ocal I R Bs. 
A Certificate of C o nfi de ntialit y (t o pr otect c o nfi de ntialit y of re p osit or y s peci me ns a n d data).
A Reci pie nts A gree me nt descri bi n g t he c o m mit me nt of t he reci pie nt t o preser ve t he a n o n y mit y of t he 
sa m ples s hare d.
2 4. 0  
T o xicit y M a n a ge me nt a n d St o p pi n g R ules
2 4. 1  *  Descri be a n y dr u g t o xicit y or ot her c o n diti o ns u n der w hic h t he p artici p ati o n of a p artici p a nt or t he c o n d uct of t he st u d y w o ul d be 
st o p pe d i n or der t o m a xi mize s afet y (e. g., t o xicit y m a n a ge me nt a n d st o p pi n g r ules):
 
1. P arti ci p a nt s m a y wit h dr a w at a n y ti m e.
2. P arti ci p a nt s m a y b e wit h dr a w n fr o m t h e st u d y at t h e di s cr eti o n of t h e PI f or n o n c o m pli a n c e, 
p s y c h ol o gi c al e v al u ati o n, l a b or at or y a b n or m aliti e s, s u b st a n c e u s e, u n willi n g n e s s t o c o nti n u e 
t h e st u d y, or di sr u pti v e b e h a vi or d uri n g i nt er v e nti o n s e s si o n s
3. W e will st o p t h e i nt er vi e w if t h e p arti ci p a nt e x p eri e n c e s a n y di str e s s d uri n g t h e i nt er vi e w, a n d t h e 
i nt er vi e w will b e di s c o nti n u e d. T h e st e p s i n t h e miti g ati o n pl a n will b e f oll o w e d t o r ef er t h e m t o a 
f oll o w- u p R o c k ef ell er U ni v er sit y li c e n s e d S o ci al w or k er f or f urt h er e v al u ati o n.

4. T h e st u d y will al s o b e st o p p e d if u n a nti ci p at e d pr o bl e m s pl a c e p arti ci p a nt s at gr e at er ri s k 
of p s y c h ol o gi c al a n d s o ci al h ar m t h a n pr e vi o u sl y k n o w n or r e c o g ni z e d.
*  I n dic ate wit h dr a w al criteri a a n d pr oce d ures bel o w:
1. P arti ci p a nt s m a y b e wit h dr a w n fr o m t h e st u d y at t h e di s cr eti o n of c o m pli a n c e wit h f a sti n g, 
p s y c h ol o gi c al e v al u ati o n a s n ot e d o n t h e p s y c h ol o gi c al i n str u m e nt s, l a b or at or y a b n or m aliti e s, a n d 
s u b st a n c e u s e.
2. T h e i nt er vi e w will b e st o p p e d if a p arti ci p a nt e x p eri e n c e s a n y di str e s s d uri n g t h e i nt er vi e w a n d 
i nt er v e nti o n, a n d t h e i nt er vi e w will b e di s c o nti n u e d. T h e st e p s i n t h e miti g ati o n pl a n will b e f oll o w e d t o 
r ef er t h e m t o a f oll o w- u p R o c k ef ell er U ni v er sit y Li c e n s e d S o ci al w or k er f or e v al u ati o n
2 5. 0  
C o m pe ns ati o n/ C osts
2 5. 1  
 
* Will a n y c o m pe ns ati o n be offere d t o p artici p a nts i n ret ur n f or t heir p artici p ati o n, e. g., direct p a y me nt, me dic al c are, tests, etc. ?  
N o 
Y e s ( Pl e a s e d e s cri b e ) 
Please Descri be
Partici pa nts will recei ve c o m pe nsati o n of $ 1 0 0 f or eac h visit n u m bere d 2 a n d 3. A d diti o nall y, partici pa nts will be 
eli gi ble t o recei ve $ 2 0 f or e ver y C o m passi o n- Base d Resilie nc y Trai ni n g ( C B R T) class, wit h a n a d diti o nal $ 5 0 
b o n us f or t h ose atte n di n g at least 8 o ut of t he 1 0 C B R T classes. C o m pe nsati o n will be iss ue d i n cas h at t he e n d of 
i n- pers o n visits 2 a n d 3 acc or di n g t o t he c o m plete d acti vities). Partici pa nts w h o c o m plete all t he acti vities will be 
pai d a t otal of $ 4 5 0.
Pa y me nt will be ma de t o partici pa nts w h o are eli gi ble f or a n d wa nt t o recei ve pa y me nt a n d w h o fill o ut a brief 
f or m wit h ta x i de ntificati o n i nf or mati o n fr o m T he R oc kefeller U ni versit y Fi na nce Office.
2 5. 2  * Will t here be a n y c osts t o p artici p a nts ass oci ate d wit h t heir p artici p ati o n i n rese arc h ?
  Y e s      N o
2 6. 0  Bi bli o gr a p h y
2 6. 1   E nter y o ur bi bli o gr a p h y bel o w:
R ef er e n c e s
A m eri c a n P u bli c H e alt h A s s o ci ati o n ( 2 0 2 1 ) A n al y si s : D e cl ar ati o n s of R a ci s m a s a P u bli c 
H e alt h Cri si s. 
B er g er M a n d S ar n y ai Z ( 2 0 1 5 ) “ M or e t h a n s ki n d e e p ” : str e s s n e ur o bi ol o g y a n d m e nt al 
h e alt h c o n s e q u e n c e s of r a ci al di s cri mi n ati o n.  
 1 8 ( 1 ) : 1 - 1 0.
Str e s s
C art er R T, L a u M Y, J o h n s o n V, et al. ( 2 0 1 7 ) R a ci al di s cri mi n ati o n a n d h e alt h o ut c o m e s 
a m o n g r a ci al / et h ni c mi n oriti e s : A m et a - a n al yti c r e vi e w. J o ur n al of M ulti c ult ur al C o u n s eli n g 
 4 5 ( 4 ) : 2 3 2 - 2 5 9.
a n d D e v el o p m e nt
Cl ar k U S, Mill er E R a n d H e g d e R R ( 2 0 1 8 ) E x p eri e n c e s of di s cri mi n ati o n ar e a s s o ci at e d wit h 
gr e at er r e sti n g a m y g d al a a cti vit y a n d f u n cti o n al c o n n e cti vit y. Bi ol o gi c al P s y c hi atr y : 
 3 ( 4 ) : 3 6 7 - 3 7 8.
C o g niti v e N e ur o s ci e n c e a n d N e ur oi m a gi n g
C o h e n, S. B., 2 0 0 3. D e si g n str at e gi e s a n d i n n o v ati o n s i n t h e m e di c al e x p e n dit ur e p a n el 
s ur v e y. 
, p p.III 5 -III 1 2.
M e di c al c ar e
D a s k al a ki s N P, M eij er O C a n d d e Kl o et E R ( 2 0 2 2 ) Mi n er al o c orti c oi d r e c e pt or a n d 
gl u c o c orti c oi d r e c e pt or w or k al o n e a n d t o g et h er i n a c ell -t y p e - s p e cifi c m a n n er : 

i m pli c ati o n s f or r e sili e n c e pr e di cti o n a n d t ar g et e d t h er a p y. 
 1 8 : 
N e ur o bi ol o g y of str e s s
1 0 0 4 5 5.
F u c h s C, L e e J K, R o e m er L, et al. ( 2 0 1 3 ) U si n g mi n df ul n e s s - a n d a c c e pt a n c e - b a s e d 
tr e at m e nt s wit h cli e nt s fr o m n o n d o mi n a nt c ult ur al a n d / or m ar gi n ali z e d b a c k gr o u n d s : 
Cli ni c al c o n si d er ati o n s, m et a - a n al y si s fi n di n g s, a n d i ntr o d u cti o n t o t h e s p e ci al s eri e s : 
Cli ni c al c o n si d er ati o n s i n u si n g a c c e pt a n c e - a n d mi n df ul n e s s - b a s e d tr e at m e nt s wit h di v er s e 
p o p ul ati o n s. El s e vi er, 1 - 1 2.
Fir st, M. B. a n d Willi a m s, J. B., 2 0 2 1. Q ui c k S CI D - 5 : Q ui c k Str u ct ur e d Cli ni c al I nt er vi e w f or 
. A m eri c a n P s y c hi atri c A s s o ci ati o n P u bli s hi n g.
D S M - 5 Di s or d er s
G er o ni m u s A T, Hi c k e n M, K e e n e D, et al. ( 2 0 0 6 ) “ W e at h eri n g ” a n d a g e p att er n s of 
all o st ati c l o a d s c or e s a m o n g bl a c k s a n d w hit e s i n t h e U nit e d St at e s. A m eri c a n j o ur n al of 
 9 6 ( 5 ) : 8 2 6 - 8 3 3.
p u bli c h e alt h
H arr ell C J P, B urf or d TI, C a g e B N, et al. ( 2 0 1 1 ) M ulti pl e p at h w a y s li n ki n g r a ci s m t o h e alt h 
o ut c o m e s. 
 8 ( 1 ) : 1 4 3 - 1 5 7.
D u B oi s r e vi e w : s o ci al s ci e n c e r e s e ar c h o n r a c e
Hi d al g o M A, L a yl a n d E, K u bi c e k K, et al. ( 2 0 2 0 ) S e x u al r a ci s m, p s y c h ol o gi c al s y m pt o m s, 
a n d mi n df ul n e s s a m o n g et h ni c all y /r a ci all y di v er s e y o u n g m e n w h o h a v e s e x wit h m e n : A 
m o d er ati o n a n al y si s. 
 1 1 : 4 5 2 - 4 6 1.
Mi n df ul n e s s
L oi z z o J, C h arl s o n M a n d P et er s o n J ( 2 0 0 9 ) A pr o gr a m i n c o nt e m pl ati v e s elf - h e ali n g : 
str e s s, all o st a si s, a n d l e ar ni n g i n t h e I n d o - Ti b et a n tr a diti o n. 
 1 1 7 2 : 1 2 3 -
A n n N Y A c a d S ci
1 4 7.
M c E w e n B S ( 1 9 9 8 ) Str e s s, a d a pt ati o n, a n d di s e a s e : All o st a si s a n d all o st ati c l o a d. A n n al s 
 8 4 0 ( 1 ) : 3 3 - 4 4.
of t h e N e w Y or k a c a d e m y of s ci e n c e s
M c E w e n B S ( 2 0 1 2 ) Br ai n o n str e s s : h o w t h e s o ci al e n vir o n m e nt g et s u n d er t h e s ki n. Pr o c e e
 1 0 9 ( S u p pl e m e nt 2 ) : 1 7 1 8 0 - 1 7 1 8 5.
di n g s of t h e N ati o n al A c a d e m y of S ci e n c e s
M c E w e n B S ( 2 0 1 7 ) I nt e gr ati v e m e di ci n e : Br e a ki n g d o w n sil o s of k n o wl e d g e a n d pr a cti c e 
a n e pi g e n eti c a p pr o a c h. 
 6 9 : S 2 1 - S 2 9.
M et a b oli s m
P ar a di e s Y, B e n J, D e n s o n N, et al. ( 2 0 1 5 ) R a ci s m a s a d et er mi n a nt of h e alt h : a 
s y st e m ati c r e vi e w a n d m et a - a n al y si s.   
 1 0 ( 9 ) : e 0 1 3 8 5 1 1.
Pl o S o n e
S a b a n K L, M at h e w s H L, Br y a nt F B, et al. ( 2 0 1 8 ) P er c ei v e d di s cri mi n ati o n i s a s s o ci at e d 
wit h t h e i nfl a m m at or y r e s p o n s e t o a c ut e l a b or at or y str e s s i n w o m e n at ri s k f or 
c ar di o v a s c ul ar di s e a s e. 
 7 3 : 6 2 5 - 6 3 2.
Br ai n, B e h a vi or, a n d I m m u nit y
S a b a n K L, M otl e y D, S h a w a hi n L, et al. ( 2 0 2 1 ) Pr eli mi n ar y e vi d e n c e f or a r a c e - b a s e d 
str e s s r e d u cti o n i nt er v e nti o n f or Bl a c k w o m e n at ri s k f or c ar di o v a s c ul ar di s e a s e. C o m pl e m e
 5 8 : 1 0 2 7 1 0.
nt ar y T h er a pi e s i n M e di ci n e
W at s o n - Si n gl et o n N N, Hill L K a n d C a s e A D ( 2 0 1 9 ) P a st di s cri mi n ati o n, r a c e -r el at e d 
vi gil a n c e, a n d d e pr e s si v e s y m pt o m s : T h e m o d er ati n g r ol e of mi n df ul n e s s. 
 1 0 : 
Mi n df ul n e s s
1 7 6 8 - 1 7 7 8.
Z a p ol s ki T C, F ai dl e y M T a n d B e utli c h M R ( 2 0 1 9 ) T h e e x p eri e n c e of r a ci s m o n b e h a vi or al 
h e alt h o ut c o m e s : T h e m o d er ati n g i m p a ct of mi n df ul n e s s. 
 1 0 : 1 6 8 - 1 7 8.
Mi n df ul n e s s
 Si m o n s, R. L., L ei, M. K., Kl o p a c k, E., B e a c h, S. R., Gi b b o n s, F. X. a n d P hili b ert, R. A., 2 0 2 1. 
T h e eff e ct s of s o ci al a d v er sit y, di s cri mi n ati o n, a n d h e alt h ri s k b e h a vi or s o n t h e a c c el er at e d 
a gi n g of Afri c a n A m eri c a n s : f urt h er s u p p ort f or t h e w e at h eri n g h y p ot h e si s. S o ci al S ci e n c e 
,   
, p. 1 1 3 1 6 9.
& M e di ci n e 
2 8 2
B u y s s e D J, R e y n ol d s III C F, M o n k T H, et al. ( 1 9 8 9 ) T h e Pitt s b ur g h Sl e e p Q u alit y I n d e x : a 
n e w i n str u m e nt f or p s y c hi atri c pr a cti c e a n d r e s e ar c h. 
2 8 ( 2 ) : 1 9 3 - 2 1 3.
P s y c hi atr y r e s e ar c h
B a er, R. A., S mit h, G. T., H o p ki n s, J., Kri et e m e y er, J. a n d T o n e y, L., 2 0 0 6. U si n g s elf -r e p ort 
a s s e s s m e nt m et h o d s t o e x pl or e f a c et s of mi n df ul n e s s. 
,   
( 1 ), p p. 2 7 - 4 5.
A s s e s s m e nt 
1 3
C a n n A, C al h o u n L G, T e d e s c hi R G, et al. ( 2 0 1 0 ) A s h ort f or m of t h e P o sttr a u m ati c Gr o wt h 
I n v e nt or y. 
 2 3 ( 2 ) : 1 2 7 - 1 3 7.
A n xi et y, Str e s s, & C o pi n g
C art er R T, M a z z ul a S, Vi ct ori a R, et al. ( 2 0 1 3 ) I niti al d e v el o p m e nt of t h e R a c e - B a s e d 
Tr a u m ati c Str e s s S y m pt o m S c al e : A s s e s si n g t h e e m oti o n al i m p a ct of r a ci s m. P s y c h ol o gi c al 
 5 ( 1 ) : 1.
Tr a u m a : T h e or y, R e s e ar c h, Pr a cti c e, a n d P oli c y
C o n n or K M a n d D a vi d s o n J R ( 2 0 0 3 ) D e v el o p m e nt of a n e w r e sili e n c e s c al e : T h e C o n n or 
D a vi d s o n r e sili e n c e s c al e ( C D RI S C ). 
 1 8 ( 2 ) : 7 6 - 8 2.
D e pr e s si o n a n d a n xi et y
H e nr y J D a n d Cr a wf or d J R ( 2 0 0 5 ) T h e s h ort f or m v er si o n of t h e D e pr e s si o n A n xi et y Str e s s 
S c al e s ( D A S S 2 1 ) : C o n str u ct v ali dit y a n d n or m ati v e d at a i n a l ar g e n o n cli ni c al s a m pl e. Brit
 4 4 ( 2 ) : 2 2 7 - 2 3 9.
i s h j o ur n al of cli ni c al p s y c h ol o g y
Ki m erli n g R, Cl u m G A a n d W olf e J ( 2 0 0 0 ) R el ati o n s hi p s a m o n g tr a u m a e x p o s ur e, c hr o ni c 
p o sttr a u m ati c str e s s di s or d er s y m pt o m s, a n d s elf -r e p ort e d h e alt h i n w o m e n : R e pli c ati o n 
a n d e xt e n si o n. 
 1 3 ( 1 ) : 1 1 5 - 1 2 8.
J o ur n al of tr a u m ati c str e s s
L e e R M a n d R o b bi n s S B ( 1 9 9 5 ) M e a s uri n g b el o n gi n g n e s s : T h e s o ci al c o n n e ct e d n e s s a n d 
t h e s o ci al a s s ur a n c e s c al e s. 
 4 2 ( 2 ) : 2 3 2.
J o ur n al of c o u n s eli n g p s y c h ol o g y
T e d e s c hi R G a n d C al h o u n L G ( 1 9 9 6 ) T h e P o sttr a u m ati c Gr o wt h I n v e nt or y : M e a s uri n g t h e 
p o siti v e l e g a c y of tr a u m a. 
 9 ( 3 ) : 4 5 5 - 4 7 1.
J o ur n al of tr a u m ati c str e s s
W ar e Jr J E, K o si n s ki M a n d K ell er S D ( 1 9 9 6 ) A 1 2 -It e m S h ort - F or m H e alt h S ur v e y : 
c o n str u cti o n of s c al e s a n d pr eli mi n ar y t e st s of r eli a bilit y a n d v ali dit y. 
. 2 2 0 -
M e di c al c ar e
2 3 3.
W ei M, Al v ar e z A N, K u T - Y, et al. ( 2 0 1 0 ) D e v el o p m e nt a n d v ali d ati o n of a C o pi n g wit h 
Di s cri mi n ati o n S c al e : f a ct or str u ct ur e, r eli a bilit y, a n d v ali dit y. J o ur n al of C o u n s eli n g 
 5 7 ( 3 ) : 3 2 8.
P s y c h ol o g y

W o o B, F a n W, Tr a n T V, et al. ( 2 0 1 9 ) T h e r ol e of r a ci al / et h ni c i d e ntit y i n t h e a s s o ci ati o n 
b et w e e n r a ci al di s cri mi n ati o n a n d p s y c hi atri c di s or d er s : A b uff er or e x a c er b at or ? S S M -
 7 : 1 0 0 3 7 8.
p o p ul ati o n h e alt h
Willi a m s, D. R., Y u, Y., J a c k s o n, J., & A n d er s o n, N. B. ( 1 9 9 7 ). R a ci al diff er e n c e s i n 
p h y si c al a n d m e nt al h e alt h : S o ci o - e c o n o mi c st at u s, str e s s, a n d di s cri mi n ati o n. J o ur n al of 
H e alt h P s y c h ol o g y, 2, 3 3 5 – 3 5 1. d oi : 1 0. 1 1 7 7 / 1 3 5 9 1 0 5 3 9 7 0 0 2 0 0 3 0 5
2 7. 0  
A p pe n dices
2 7. 1  E nter y o ur a p pe n dices bel o w:
2 8. 0  F u n di n g
2 8. 1  *  D o y o u h a ve s ufficie nt fi n a nci al res o urces t o s u p p ort y o ur st u d y ? 
 Y e s     N o
2 8. 2  
If t his st u d y is/ w as pil ot f u n de d, ple ase s pecif y d ates of f u n di n g:
Fr o m date:
T o date:
2 8. 3  S o urce of i n vesti g ati o n al a ge nts:
N / A ( n o i n v e sti g ati o n al a g e nt s ) 
Pr o vi d e d b y a p h ar m a c e uti c al s p o n s or / p art n er wit h f u n di n g a s d e s cri b e d b el o w 
Pr o vi d e d b y a p h ar m a c e uti c al s p o n s or / p art n er wit h o ut a d diti o n al f u n di n g 
Pr o vi d e d b y i n v e sti g at or, p arti ci p a nt s, or ot h er 
2 8. 4  S pecif y f u n di n g b y R oc kefeller U ni versit y, i n d ustr y s p o ns or a n d/ or gr a nt:
2 8. 5  List gr a nts i n w hic h t his st u d y is n a me d:
P H S o r N o n -
P H S
P r o g r a m
G r a n t 
N u m b e r
G r a n t N a m e  
F r o m D a t e  
T o D a t e
N o r e s ult s f o u n d
2 9. 0  
Cli nic al Ser vices
2 9. 1  
W ell / Mi ni m all y Ill
M o d er at el y Ill
S e v er el y Ill
Ot h er
N ot A p pli c a bl e
If ot her t ha n Well/ Mi ni mall y Ill, please descri be:

2 9. 2  *  
 
D oes y o ur st u d y gr o u p h a ve s peci al c are nee ds ?
  Y e s      N o
2 9. 3  *  
 
D oes y o ur st u d y h a ve s peci al e q ui p me nt nee ds ?
  Y e s      N o
2 9. 4   
 * Will y o u re q uire st or a ge s p ace o n t he cli nic al u nits f or s u p plies t o c o n d uct t his st u d y ?
  Y e s      N o
2 9. 5  * Is s peci al tr ai ni n g of h os pit al st aff re q uire d ?
  Y e s      N o
3 0. 0  P h ar m a c y S er vi c e s
3 0. 1  * D o e s t h e st u d y r e q uir e P h ar m a c y S er vi c e s ?
  Y e s      N o
3 1. 0  Bi o n utriti o n
3 1. 1  * Will st u d y r e q uir e p ati e nt m e al s ? 
  Y e s      N o
If Yes, please s pecif y:
T y p e of Di e t
I n / O u t p a ti e n t
P a c k M e al
Sta n dar d
I n p ati e nt
O ut p ati e nt
P a c k M e al 
T hera pe utic
I n p ati e nt
O ut p ati e nt
P a c k M e al 
Researc h Diet
I n p ati e nt
O ut p ati e nt
P a c k M e al 
F or m ula Diet
I n p ati e nt
O ut p ati e nt
P a c k M e al 
N utrie nt(s) t o be c o ntr olle d (s pecif y):
3 1. 2  Will m e al ti m e s b e alt er e d ? 

  Y e s      N o
If Yes, please e x plai n:
3 1. 3  D oes t he pr ot oc ol re q uire a n y of t he f oll o wi n g acti vities ?
F o o d Fr e q u e n c y Q u e sti o n n air e
B o d P o d / A nt hr o p o m etri c M e a s ur e m e nt s
Di et Hi st or y / F o o d R e c or d s
Di et / N utriti o n E d u c ati o n
3 1. 4  Will f o o d b e pr o vi d e d t o c ar e gi v er, p ar e nt or si g nifi c a nt ot h er ?   
  Y e s      N o
3 1. 5  F or m et a b oli c di et s, i s di et h o m o g e ni z ati o n r e q uir e d f or n utri e nt a n al y si s 
 b y i n d e p e n d e nt l a b ?
Y e s 
N o 
N / A 
3 2. 0  Cli nic al a n d Tr a nsl ati o n al Rese arc h F acilit ati o n Office
3 2. 1  I n dic ate n a vi g ati o n assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t he st u d y:
R e q u e s t e d
R e c ei v e d
Pr ot oc ol De vel o p me nt
Pr ot oc ol I m ple me ntati o n
Pr ot oc ol C o n d uct
A C C T S/I R B S u b missi o n
3 2. 2  I n dic ate a d diti o n al e d uc ati o n assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t he st u d y:
R e q u e s t e d
R e c ei v e d
I N D
I D E
Tea m Scie nce E d ucati o n

St u d y Pr o gress Meeti n g
I n vesti gat or Res p o nsi bilities
Re g ulat or y Bi n der/ F ol der
S o urce D oc u me ntati o n
Partici pa nt I n v ol ve me nt i n 
Researc h
3 3. 0  
Cli nic al Rese arc h S u p p ort Office Res o urces ( C R S O)
3 3. 1  I n dic ate re g ul at or y i n p ut assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t he st u d y:
R e g ul a t o r y S u p p o r t / D e si g n   
R e q u e s t e d
R e c ei v e d
Ge neral, 
V ul nera ble P o p ulati o ns, 
Mi n ors, Gr o u p Har ms
I N D/I D E a d vice, assista nce, 
a n d referral
I nf or me d C o nse nt/ Asse nt
Data Safet y M o nit ori n g Pla n
Cli nical Trial Re gistrati o n
Pla n F or Ret ur n of Researc h 
Res ults
A u dit/ M o nit ori n g Ser vice, 
Referrals, S O Ps
3 3. 2  
 
I n dic ate recr uit me nt assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t he st u d y:  
R e c r ui t m e n t of P a r ti ci p a n t s   
R e q u e s t e d
R e c ei v e d
Recr uit me nt Pla n ni n g a n d/ or 
writte n Pla n

A d vertisi n g Strate g y, C o nte nt, 
Place me nt
Re p osit or y/ Researc h Matc h 
Q ueries
Call Ce nter/ Prescree ni n g
/ Sc he d uli n g
C ost S hari n g f or A d vertisi n g
3 3. 3  I n dic ate c o m m u nit y e n g a gi n g assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t he st u d y:
C o m m u ni t y E n g a g e m e n t   
R e q u e s t e d
R e c ei v e d
P HI State me nt/ E n ga gi n g 
Sta ke h ol ders Secti o n
C E n R Na vi gati o n – f osteri n g pt
/c o m m u nit y part ners hi p
O utreac h t o c o m m u nit y/ part ner
/a d v ocac y gr o u p/ C E St u di o
3 3. 4  I n dic ate ot her assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t he st u d y:
O t h e r
R e q u e s t e d
R e c ei v e d
S ur ve y desi g n, fiel di n g, 
vali dati o n
Data tra nsfer a n d sec urit y 
pla n ni n g
3 4. 0  
B E R D: Bi ost atistics, E pi de mi ol o g y a n d Rese arc h Desi g n Res o urce
3 4. 1  I n dic ate t he Bi ost atistic al assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t his st u d y:
R e q u e s t e d
R e c ei v e d
De vel o p me nt of e x peri me ntal 
desi g n

P o wer a nal ysis/ Sa m ple size 
deter mi nati o n ( # of s u bjects)
Na vi gati o n ( Di d Statisticia n 
partici pate i n a na vi gati o n 
meeti n g)
Ra n d o mizati o n sc he d ule
Data a nal ysis
De vel o p me nt of ne w statistical 
tec h ni q ues f or data a nal ysis 
( Statistical researc h)
Pr ot oc ol i m ple me ntati o n
Ot her
3 4. 2  If y o u are/ will be usi n g d at a a n al ysis s pecif y:
E x pl or at or y
D e s cri pti v e
H y p ot h e si s t e sti n g
St ati sti c al m o d eli n g
Ot h er
3 4. 3  If y o u are/ will be assiste d wit h pr ot oc ol i m ple me nt ati o n, s pecif y:
P u bli c ati o n
C o nf er e n c e
Ot h er (t y p e of di s s e mi n ati o n )
Gr a nt ( s )
3 4. 4  Ple ase select t he Bi ost atistici a n o n t his Pr ot oc ol:
R o g er V a u g h a n, Dr P H
C ar oli n e Ji a n g, M S
S a n dr a G ar c et, P h D
A d a m Q ur e s hi, M A
Ot h er
3 5. 0  Bi o me dic al I nf or m atics Res o urces
3 5. 1  I n dic ate Bi oi nf or m atics assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t his st u d y:
R e q u e s t e d
R e c ei v e d

Micr oarra y a nal ysis
Pat h wa y a nal ysis
R N A-se q a nal ysis
Bi oi nf or matics trai ni n g a n d 
c o ns ultati o n
Bi oi nf or matics e x peri me ntal 
desi g n
H P C c o m p uti n g
Ot her
3 5. 2  If y o u are/ will be usi n g p at h w a y a n al ysis s oft w are, s pecif y:
I n g e n uit y I P A
D a vi d
G S E A
Ot h er
3 5. 3  If y o u are/ will be usi n g R N Ase q a n al ysis s oft w are, s pecif y:
T o p h at
C uffli n k s
C uff diff
C u m m R b u n d
S T A R
f e at ur e C o u nt s
D E S e q 2
V O O M
R N A - S e Q C
If ot her, s pecif y:
3 5. 4  
I n dic ate Me dic al I nf or m atics assist a nce re q ueste d a n d/ or recei ve d i n t he de vel o p me nt of t his st u d y:
R e q u e s t e d
R e c ei v e d
Data st ora ge i nsi de of i RI S
Re dca p Data base

C ust o m or A d H oc re p orts
St u d y pla n creati o n
S pecialize data base or c ust o m 
s oft ware
Ot her
3 6. 0  
HI P A A F or m
3 6. 1  A st u d y's s pecific HI P A A f or m si g ne d b y t he v ol u nteer is re q uire d f or i nstit uti o ns t h at are HI P A A c o vere d e ntities s o t h at t he y m a y 
c o m m u nic ate Pri v ate He alt h I nf or m ati o n ( P HI) t o t he I n vesti g at or.  
Bel o w, Me m ori al Sl o a n Ketteri n g C a ncer Ce nter, Ne w Y or k- Pres byteri a n H os pit al a n d Weill Me dic al C olle ge of C or nell U niversity are 
liste d s o t h at t h at t hey m ay re p ort l a b or at ory res ults a n d X-r ay re a di n gs res pectively.  If y o u f oresee t h at a ny ot her e ntity m ay nee d t o pr ovi de 
P HI t he n a d d t he m t o t he fiel d hi g hli g hte d i n gree n .
3 6. 2  
     
N a me of St u d y:
Eff e ct s of C o m p a s si o n - B a s e d R e sili e n c y Tr ai ni n g ( C B R T ) I nt er v e nti o n o n R a ci s m - b a s e d Str e s s 
a m o n g Afri c a n A m eri c a n s : A Pil ot St u d y
3 6. 3  Pri nci p al I n vesti g at or:
R a c h el W a n g ari Ki m a ni, D N P
3 6. 4  I n d ustr y S p o ns or:
If t he f u n di n g s o urce is i n d ustr y please t y pe i n t he s p o ns or here
h o m a y o bt ai n, use, a n d/ or discl ose y o ur he alt h i nf or m ati o n ?
W
T he f oll o wi n g pers o ns a n d or ga nizati o ns ma y o btai n, use, or discl ose healt h i nf or mati o n a b o ut y o u.
T he Pri nci pal I n vesti gat or(s) liste d at t he t o p of t his f or m, a n d pers o ns w h o assist t he I n vesti gat or(s) i n 
carr yi n g o ut t he researc h
Eac h researc h site f or t his st u d y, i ncl u di n g T he R oc kefeller U ni versit y, a n d t he researc h ma na ge me nt 
a n d s u p p ort staff a n d t he me dical staff at eac h site
Healt h care pr o vi ders w h o ha ve pr o vi de d i n t he past, or c urre ntl y pr o vi de, healt h care ser vices t o y o u
La b orat ories a n d ot her pers o ns a n d or ga nizati o ns t hat will a nal yze y o ur healt h i nf or mati o n a n d/ or 
bi ol o gical sa m ples as part of t his st u d y, i ncl u di n g Me m orial Sl oa n Ketteri n g Ca ncer Ce nter, Ne w Y or k-
Pres b yteria n H os pital a n d Weill Me dical C olle ge of C or nell U ni versit y
Ot her e ntities t hat ma y nee d t o pr o vi de P HI:
U C L A G e n o mi c C or e
L a b c or p
Me m bers a n d staff of t he I nstit uti o nal Re vie w B oar d a n d ot her b oar ds a n d c o m mittees t hat watc h o ver 
researc h at T he R oc kefeller U ni versit y 
Me m bers a n d staff of T he R oc kefeller U ni versit y's Office of S p o ns ore d Researc h

T he s p o ns or(s) of t he researc h, na me d a b o ve, a n d pers o ns w h o watc h o ver t he researc h f or t he s p o ns or
(s)
T he U nite d States F o o d a n d Dr u g A d mi nistrati o n, ot her g o ver n me nt a ge ncies, re g ulat or y e ntities a n d 
R oc kefeller U ni versit y c o ns ulta nts t hat watc h o ver t he safet y, effecti ve ness, a n d q ualit y of researc h a n d
/ or f u n d T he R oc kefeller U ni versit y H os pital
Ot hers (as descri be d here):
W h at i nf or m ati o n will be o bt ai ne d, use d, or discl ose d ?   
T he pers o ns a n d or ga nizati o ns liste d a b o ve ma y o btai n, use, a n d discl ose:  
I nf or mati o n a b o ut y o u t hat is create d or c ollecte d d uri n g t he researc h st u d y ( b ut n ot i ncl u di n g a n y HI V-
relate d i nf or mati o n) 
Healt h i nf or mati o n i n y o ur me dical rec or ds t hat is rele va nt t o t he researc h st u d y ( b ut n ot i ncl u di n g a n y 
HI V-relate d i nf or mati o n)
A n d , if c hec ke d bel o w:
 
_ _ _ HI V-relate d i nf or mati o n (t his i ncl u des a n y i nf or mati o n i n dicati n g t hat y o u ha ve ha d a n HI V-relate d 
test or ha ve HI V i nfecti o n, HI V-relate d ill ness, or AI D S, as well as i nf or mati o n t hat c o ul d i n dicate y o u 
ma y ha ve bee n e x p ose d t o HI V) 
_ _ _ Ot her i nf or mati o n (as descri be d here):
                                                                                                                                              
                                                                                                                                              
                                                                                                                                              
                                                                                                                                               
Ot her i nf or mati o n (as descri be d here):
 
B y si g ni n g t his f or m, y o u gi ve per missi o n t o t he pers o ns a n d or ga nizati o ns liste d a b o ve t o o btai n, use a n d 
discl ose y o ur healt h i nf or mati o n n ote d a b o ve. 
 
 
H o w will y o ur he alt h i nf or m ati o n be use d ?
 
T he healt h i nf or mati o n n ote d a b o ve, as well as i nf or mati o n s h o w n b y t he b o xes c hec ke d a b o ve (if a n y), ma y be 
o btai ne d, use d, a n d discl ose d: 
t o c o n d uct t he researc h st u d y e x plai ne d t o y o u d uri n g t he i nf or me d c o nse nt pr ocess; a n d
t o ass ure t he q ualit y, safet y, a n d effecti ve ness of t he researc h st u d y 
 
Please n ote t hat t he pers o ns a n d or ga nizati o ns liste d a b o ve ma y re- use or f urt her discl ose y o ur i nf or mati o n if 
t he y are per mitte d b y la w t o d o s o.
 
 
W h at are y o ur ri g hts ?
 
It is y o ur ri g ht t o ref use t o si g n t his a ut h orizati o n f or m.  If y o u d o n ot si g n t his f or m, y o u will n ot be a ble t o 
partici pate i n t he researc h st u d y.  Y o ur healt h care o utsi de t he st u d y will n ot be affecte d.  T he pa y me nt f or y o ur 
healt h care a n d y o ur healt h care be nefits will n ot be affecte d.
If y o u si g n t his a ut h orizati o n f or m, y o u will ha ve t he ri g ht t o wit h dra w it at a n y ti me e xce pt t o t he e xte nt t hat 
t he pers o ns a n d or ga nizati o ns liste d a b o ve:
ha ve alrea d y ta ke n acti o n base d u p o n y o ur a ut h orizati o n;
nee d t he pre vi o usl y c ollecte d i nf or mati o n t o c o m plete a nal ysis a n d re p orts of data f or t his researc h; or
will c o nti n ue t o use a n d discl ose pre vi o usl y c ollecte d i nf or mati o n as per mitte d b y t he i nf or me d c o nse nt 
f or m si g ne d b y y o u (e xce pt as t o HI V-relate d i nf or mati o n, f or w hic h discl os ure t o ne w pers o ns or 
or ga nizati o ns will n ot occ ur u nless per mitte d b y fe deral or state la w). 
If y o u wit h dra w t he a ut h orizati o n, y o u will n ot be per mitte d t o c o nti n ue ta ki n g part i n t he researc h st u d y.  T his 
a ut h orizati o n f or m will n ot e x pire u nless y o u wit h dra w it.  If y o u wa nt t o wit h dra w t his a ut h orizati o n, please 
write t o t he a b o ve na me d i n vesti gat ors. 
Y o u ha ve a ri g ht t o see a n d c o p y y o ur healt h i nf or mati o n descri be d i n t his a ut h orizati o n f or m i n acc or da nce 
wit h T he R oc kefeller U ni versit y's p olicies; i n certai n circ u msta nces w here t he i nte grit y of t he st u d y will be 
affecte d, y o u will n ot be a ble t o o btai n y o ur healt h rec or ds i n t his st u d y u ntil t he st u d y has bee n c o m plete d.
Y o u will recei ve a c o p y of t his f or m after y o u ha ve si g ne d it.
 
 

N o ti c e C o n c e r ni n g H I V - R el a t e d I nf o r m a ti o n
If y o u ar e a ut h ori zi n g t h e r el e a s e of HI V -r el at e d i nf or m ati o n, y o u s h o ul d b e a w ar e t h at 
s u c h i nf or m ati o n m a y n ot b e s h ar e d wit h o ut y o ur a p pr o v al u nl e s s p er mitt e d b y f e d er al or 
st at e l a w.  Y o u al s o h a v e a ri g ht t o r e q u e st a li st of p e o pl e w h o m a y r e c ei v e or u s e y o ur 
HI V -r el at e d i nf or m ati o n wit h o ut a ut h ori z ati o n.  If y o u e x p eri e n c e di s cri mi n ati o n b e c a u s e 
of t h e r el e a s e or di s cl o s ur e of HI V -r el at e d i nf or m ati o n, y o u 
m a y c o nt a ct t h e N e w Y or k 
St at e Di vi si o n of H u m a n Ri g ht s at ( 2 1 2 ) 4 8 0 - 2 4 9 3 or t h e N e w Y or k Cit y C o m mi s si o n of 
H u m a n Ri g ht s at ( 2 1 2 ) 3 0 6 - 7 4 5 0.  T h e s e a g e n ci e s ar e r e s p o n si bl e f or pr ot e cti n g y o ur 
ri g ht s.
 
Y o ur si g n at ure
I h ave re a d t his f or m, a n d all of my q uesti o ns h ave bee n a ns were d.  By si g ni n g bel o w, I ack n o wle d ge t h at I h ave 
re a d a n d acce pt all of t he i nf or m ati o n a b ove.
 
 
 
                                                           
Si g n at ur e of p arti ci p a nt or p arti ci p a nt' s l e g al 
r e pr e s e nt ati v e
 
                                                           
Pri nt e d n a m e of p arti ci p a nt
 
 
 
 
                                                           
D at e
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Pri nt e d n a m e of l e g al r e pr e s e nt ati v e (if 
a p pli c a bl e )
 
 
                                    _ _ _ _ _ _ _ _ _ _ _
R e pr e s e nt ati v e' s r el ati o n s hi p t o p arti ci p a nt
 
 
 
 
 
 
T H E S T U D Y P A R TI CI P A N T O R HI S O R H E R P E R S O N A L R E P R E S E N T A TI V E M U S T B E P R O VI D E D WI T H 
A C O P Y O F T HI S F O R M A F T E R I T H A S B E E N SI G N E D.
 
3 7. 0  E n d of A p pli c ati o n F or m
3 7. 1  T h e st u d y a p pli c ati o n f or m i s c o m pl et e.   
T h e n e x t s t e p i n t h e s u b mi s si o n  p r o c e s s i s t o g a t h e r a t t a c h m e n t s b ef o r e p r o c e e di n g 
t o t h e s u b mi s si o n f o r m. 
 
T he f oll o wi n g s u b missi o n re p orts are ge nerate d i n t he La b/ De pt Re p orts me n u, S u b missi o n Re p orts secti o n:
   - 
 (if a p plica ble, a n d if n ot pre vi o usl y ge nerate d)
Dele g ati o n of A ut h orit y
   - 
(if a p plica ble)
HI P A A f or m 
   - 
 (re q uire d f or all s u b missi o ns)
C C T S Utiliz ati o n Re p ort
   - 
 (if t he st u d y has bee n ma na ge d i n i RI S f or a mi ni m u m of o ne year, ge nerate t he 
St u d y Pr o gress Re p ort 
Pr o gress Re p ort fr o m t he re p ort me n u i n i RI S.  if t he st u d y has n ot bee n ma na ge d i n i RI S f or o ne year, c o m plete 
t he Pr o gress Re p ort l ocate d o n t he I R B we bsite.)
 
All ot h er r e q uir e d f or m s c a n b e d o w nl o a d e d fr o m t h e c orr e s p o n di n g s e cti o n s' h el p li n k s a b o v e or 
fr o m t h e I R B w e b sit e.