This sample document may not conform to the standards of your local Research Ethics Board.

ISSCR SAMPLE RESEARCH CONSENT FORM

Somatic Cell Donation for Stem Cell Research
Project Title:
Principal Investigator:
Participating Institution(s):
PROJECT INFORMATION
You are ein! as"e# to #onate $$$$$ (insert tpe) cells to create emr%os for a human
emr%onic stem cell research &ro'ect le# % !na"e o# principal investigator$ at
!na"e(s) o# institution(s)$( You are ein! in)ite# to &artici&ate in this &ro'ect ecause
$$$$$$$$$$ (i%enti# participants& "e%ical con%ition)' The &ur&ose of this &ro'ect is
to collect emr%onic stem cells that ha)e $$$$$$$$$$$$$ (i%enti# c(aracteristic)'
Emr%onic stem cells can e foun# in emr%os aroun# the fifth #a% of #e)elo&ment(
These stem cells ha)e the uni*ue ailit% to turn into an% "in# of s&eciali+e# human cell,
such as li)er cells, heart cells, &ancreatic cells, or ner)e cells( For this reason, emr%onic
stem cells can e use# to stu#%, an# &ossil% one #a% hel& treat, #iseases or in'uries that
ha)e cause# &atients- s&eciali+e# cells to #ie or ecome #ama!e# . #iseases an# in'uries
such as Par"inson-s #isease, heart #isease, #iaetes, an# s&inal cor# in'ur%(
!Na"e o# principal investigator$ /ants to collect ne/ human emr%onic stem cells
from emr%os that ha)e een create# usin! $$$$$ cells( To #o this, researchers /ill &ut
$$$$$ cells into unfertili+e# e!!s that ha)e ha# their DNA remo)e#( If successful, this
&rocess, calle# nuclear transfer, can create emr%os that contain stem cells /hich ha)e
the same DNA as the $$$$$ cell #onors( !Insert a%%itional in#or"ation a)out t(is
speci#ic project using ver si"ple language'$
*O+,NTAR- C.OICE
Donatin! %our $$$$$ cells for this research &ro'ect is com&letel% )oluntar%( You ha)e the
ri!ht to a!ree or to refuse to &ro)i#e %our $$$$$ cells for this &ro'ect( The *ualit% of
%our current or future me#ical care an# %our relationshi& /ith !na"e(s) o# institution(s)$
/ill NOT chan!e in an% /a% /hether %ou a!ree or refuse to &ro)i#e an% cells for this
research &ro'ect(
/.AT I0 T.E P,RPO0E OF T.I0 CON0ENT FORM1
!Na"e o# person o)taining consent$ is authori+e# to !i)e %ou information an# to
ans/er %our *uestions aout this research &ro'ect( It is )er% im&ortant that %ou ha)e a
Somatic Cell Donation 0
This sample document may not conform to the standards of your local Research Ethics Board.
#etaile# con)ersation /ith this &erson so that %ou can ma"e a careful, )oluntar% #ecision
aout /hether or not %ou /ant to #onate %our $$$$$ cells for this research &ro'ect(
Your si!nature on the last &a!e of this consent form is meant to sho/ that %ou ha)e ha#
this con)ersation an# that %ou freel% a!ree to #onate %our $$$$$ cells for this research
&ro'ect( This consent form must not re&lace actuall% ha)in! this con)ersation, so e
certain %ou ha)e this con)ersation(
Please ta"e as much time as %ou nee# to as" *uestions an# to tal" aout this &ro'ect /ith
%our famil% or frien#s efore %ou #eci#e /hether or not to si!n this consent form( You
ma% ta"e this form home /ith %ou efore %ou #eci#e /hat to #o( Do not si!n this form if
%ou feel &ressure# in an% /a% % an% &erson to #onate %our $$$$$ cells for this &ro'ect(
This must e %our o/n #ecision, not someone else-s(
/(at /ill .appen To M 22222 Cells1
None of the $$$$$ cells %ou &ro)i#e /ill e use# to &ro#uce a a% or a &re!nanc%( An#
none of the resultin! emr%os /ill e allo/e# to #e)elo& for more than a total of 01 #a%s
after the% ha)e een create# usin! nuclear transfer( If an% of the resultin! emr%os are
fro+en, then the time that the% are fro+en is not counte# as &art of the 01 #a% limit(
Researchers /ill onl% use %our $$$$$ cells to create emr%os from /hich the% /ill
attem&t to !et stem cells efore the 01 #a% limit( The resultin! emr%os /ill e #estro%e#
#urin! the stem cell collection &rocess(

There is no !uarantee that emr%os /ill e create# from %our $$$$$ cells( An# there is
no !uarantee that researchers /ill e ale to !et stem cells from an% resultin! emr%os(
Researchers /ill routinel% #iscar# as me#ical /aste $$$$$ cells or emr%os the% #o not
use for this research &ro'ect(

/.AT /I++ .APPEN TO T.E CO++ECTE3 0TEM CE++01
It is li"el% that the retrie)e# stem cells, /hich /oul# e !eneticall% matche# to %ou, /ill
e store# for man% %ears( Emr%onic stem cells ha)e the ailit% to self2rene/
in#efinitel%, an# the% are li"el% to e use# % researchers at other institutions an# for
man% other research &ur&oses(
One &ossile research use of these store# stem cells mi!ht in)ol)e chan!in! some of their
!enes( Another &ossile research use mi!ht e to stu#% some of the stem cells % &lacin!
them into laorator% animals( In a##ition, the store# stem cells mi!ht e use# in the
future for ne/ research relate# to human stem cell trans&lantation( These are 'ust three
common e3am&les of /hat mi!ht ha&&en to the store# stem cells( 4ut there are man%
other future &ossile research uses that are sim&l% un"no/n at this time(
You /ill ha)e no sa% as to /hich institutions or researchers ma% share the stem cells
ma#e from the emr%os that /ere create# usin! %our $$$$$ cells( If stem cell
Somatic Cell Donation 5
This sample document may not conform to the standards of your local Research Ethics Board.
trans&lantation stu#ies are #e)elo&e# in the future, %ou /ill ha)e no sa% as to /ho ma% e
a trans&lant reci&ient of the collecte# stem cells !as applica)le: e4cept in t(e case o#
autologous transplantation$'
Future uses of store# stem cells must e a&&ro)e# % local ethical an# scientific re)ie/
committees to ma"e sure that the% are use# in scientificall%, ethicall%, an# le!all%
a&&ro&riate /a%s( Please contact the in#i)i#uals liste# on the last &a!e of this form if %ou
ha)e an% *uestions or concerns aout the future &ossile uses of the stem cells collecte#
throu!h this research &ro'ect(
.O/ /I++ M- 22222 CE++0 5E CO++ECTE31
!As applica)le: -ou 6ill )e as7e% to provi%e a 22222 sa"ple'$
!As applica)le: /it( our approval8 our store% 22222 sa"ple 6ill )e trans#erre% )
!na"e o# institution$ to t(e researc( tea"'$
/.AT IF I C.AN9E M- MIN31
You ma% /ith#ra/ %our consent for /hate)er reason at an% time efore %our $$$$$ cells
are use# to create emr%os for this &ro'ect(
Ho/e)er, once the resultin! emr%os are #estro%e# in the stem cell collection &rocess,
%ou /ill not e ale to chan!e %our min# or re*uest that an% of the collecte# stem cells e
remo)e# from this research &ro'ect(
If %ou #eci#e to /ith#ra/ %our consent after %ou ha)e si!ne# this form, &lease contact
an% of the in#i)i#uals liste# at the en# of this #ocument imme#iatel%(
/.AT ARE T.E A+TERNATI*E0 TO 3ONATIN9 M- 22222 CE++0 FOR
T.I0 PROJECT1
One of %our alternati)es is to refuse to &artici&ate at all in this research &ro'ect(
In the case that %our $$$$$ cells are retrie)e# ut %ou #eci#e not to &artici&ate an% lon!er
in this research &ro'ect, %ou ma% 607 ha)e %our $$$$$ cells #iscar#e# accor#in! to the
routine &ractice of !na"e o# institution$, 657 #onate %our $$$$$ cells to other research
&ro'ect, or 687 !as applica)le: return our 22222 sa"ple to storage$(
/.AT ARE T.E POTENTIA+ 5ENEFIT0 OF 3ONATIN9 M- 22222 CE++0
FOR T.I0 PROJECT1
This research &ro'ect is not inten#e# to &ro)i#e an% #irect me#ical enefit to %ou or
an%one else( You /oul# e #onatin! %our $$$$$ cells solel% for the a#)ancement of this
research &ro'ect an# stem cell research in !eneral(
Somatic Cell Donation 8
This sample document may not conform to the standards of your local Research Ethics Board.
!As applica)le: T(e ste" cells t(at are collecte% #ro" t(e resulting e")ros "a
(ave signi#icant co""ercial potential in t(e #uture' .o6ever8 ) signing t(is #or"
ou un%erstan% t(at t(ere are no plans #or ou to receive an %irect #inancial
)ene#its #ro" an #uture co""ercial %evelop"ent an% scienti#ic patents o#
%iscoveries "a%e t(roug( t(e use o# t(ese ste" cells'$
/.AT ARE T.E POTENTIA+ RI0:0 OF 3ONATIN9 M- 22222 CE++0 FOR
T.I0 PROJECT1
There are no foreseeale &h%sical ris"s for %ou in #onatin! $$$$$ cells for this research
&ro'ect(
Ho/e)er, there are some &s%cholo!ical ris"s %ou nee# to consi#er( Some &eo&le /ho
#onate $$$$$ cells for stem cell research mi!ht e3&erience feelin!s of an3iet% or re!ret,
es&eciall% /hen consi#erin! the &ossiilit% that their #onation ma% result in the creation
of !eneticall%2matche# emr%os /hich /ill e #estro%e# #urin! the stem cell collection
&rocess( Some ma% also feel )ulnerale an# an3ious #urin! the consent &rocess(
!As applica)le: As a cell %onor #or t(is project ou 6ill )e as7e% to un%ergo "e%ical
screen tests #or t(ese genetic %iseases: 2222222 (speci#)' Alt(oug( t(is screen test
carries no #oreseea)le p(sical ris7s8 so"e %onors "a #eel an4ious a)out t(eir test
results'$
Due care /ill e ta"en to hel& minimi+e these &s%cholo!ical ris"s( !0peci# (o6 t(is
6ill )e %one'$
Donatin! $$$$$ cells for this &ro'ect in)ol)es some ris" to %our &ri)ac%( Efforts to
&rotect %ou a!ainst this ris" are #iscusse# in the ne3t section(
.O/ /I++ M- PRI*AC- 5E PROTECTE31
The recor#s of %our in)ol)ement /ith this research &ro'ect /ill e "e&t confi#ential(
I#entification co#es /ill e use# instea# of #onors- names, an# all recor#s /ill e "e&t in
a &ri)ate #ataase that can onl% e accesse# % $$$$$$$$$$$$$$$$$$$ 6&erson7(
!0peci# (o6 t(is in#or"ation 6ill )e protecte% an% 6(et(er t(e i%enti#ication co%e
6ill )e lin7e% t(e cell %onors8 an% un%er 6(at circu"stances t(ese %onors 6ill )e
i%enti#ie%'$
If %our $$$$$ cells are use# to create emr%os, then the resultin! stem cells an# an% ne/
stem cells that the% &ro#uce /ill e a com&lete !enetic match to %ou( To &rotect %our
!enetic &ri)ac%, onl% %our i#entification co#e, not %our name, /ill e #isco)erale to the
researchers /ho collect stem cells from the resultin! emr%os an# the researchers /ho
ma% later /or" /ith the resultin! store# stem cells( The results of %our me#ical screen
tests /ill also e confi#entiall% han#le# throu!h the use of i#entification co#es instea# of
names(
Somatic Cell Donation 1
This sample document may not conform to the standards of your local Research Ethics Board.
!As applica)le: 0o"e ste" cell researc(ers 6or7ing 6it( genetic %iseases "a 6ant
to see genetic in#or"ation a)out t(e 22222 cell %onors' I# ou agree to allo6 t(ese
researc(ers to see t(is co%e% in#or"ation8 please c(ec7 es' 22222 es 22222 no $
!As applica)le: Researc( on t(e collecte% ste" cells #ro" t(e resulting e")ros "a
reveal in#or"ation t(at coul% )e i"portant to our (ealt(' I# ou 6is( to )e
contacte% in t(e #uture a)out an suc( in#or"ation8 please c(ec7 es' 22222 es
22222 no $
!As applica)le: I# ou ans6ere% ;es< to t(is =uestion8 (na"e o# institution) 6ill8 to
t(e e4tent possi)le8 pass to ou an in#or"ation t(at it is given #ro" ot(er
researc(ers or ot(er institutions regar%ing i"portant in#or"ation receive% t(roug(
researc( on t(e ste" cells collecte% #ro" t(e resulting e")ros'$
Local an# other re!ulator% a!encies, an# &ro'ect s&onsors an# fun#in! a!encies ma%
re)ie/ the research &ro'ect recor#s to ensure that %our ri!hts as a $$$$$ cell #onor /ere
a#e*uatel% &rotecte#( Ho/e)er, %our i#entit% /ill not e rea#il% #isco)erale to these
in#i)i#uals(
An% re&ort that the researchers &ulish /ill not inclu#e an% information that /ill ma"e it
&ossile for rea#ers to i#entif% %ou as a $$$$$ cell #onor(
/I++ I RECEI*E PA-MENT1
You /ill not recei)e an% cash or &a%ment /ith !oo#s or ser)ices for the $$$$$ cells %ou
#onate to this research &ro'ect(
!As applica)le: -ou 6ill not )e rei")urse% #or t(e cost o# our 22222 sa"ple storage
#or t(e ti"e perio% )e#ore our 22222 cells are %onate% #or t(is researc( project'$
!As applica)le: An rei")urse"ents #or "one ou (a% to spen% to participate in
t(e consent process 6ill )e %eci%e% ) local an% ot(er relevant revie6 co""ittees'$
3I0C+O0,RE OF RE0EARC.ER0& POTENTIA+ FINANCIA+ INTERE0T0
In a##ition to their scientific interests in this research &ro'ect, the in#i)i#uals con#uctin!
this stem cell stu#% mi!ht &rofit financiall% from the research( There ma% e current or
&otential financial enefits to the Princi&al In)esti!ator, !na"e$, the &artici&atin!
institution6s7, !na"es$, an# other research institutions or researchers arisin! from
#isco)eries ma#e throu!h this research &ro'ect an# the stem cells collecte# from the
resultin! emr%os( !3isclose using plain language t(e researc(ers& an% t(e
institution(s)& #inancial interests in t(e researc('$ If %ou ha)e an% *uestions or
concerns aout these matters, &lease contact the &ersons liste# elo/(
Somatic Cell Donation 9
This sample document may not conform to the standards of your local Research Ethics Board.
If %ou are a $$$$$$ (speci# "e%ical con%ition) &atient, it is im&ortant that %our treatin!
&h%sician inform %ou of an% &ersonal enefits he or she ma% !ain % %our a!reement to
#onate $$$$$ cells for this research &ro'ect( !3isclose (ere an potential personal
)ene#its t(e treating p(sician "a receive t(roug( t(is researc( protocol'$
The &erson /ho has een authori+e# to &ro)i#e %ou /ith information ma% also ha)e a
&ersonal )este# interest in this research &ro'ect( !3isclose (ere an potential personal
)ene#its t(is person "a (ave in t(is researc( protocol'$
CONTACT INFORMATION
If %ou ha)e an% *uestions aout this research &ro'ect, contact:
6Princi&al In)esti!ator7$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$6&hone7$$$$$$$$$$$$$$$$$
!+ist an toll>#ree or reverse>c(arge line'$
6Research A#ministrator7 $$$$$$$$$$$$$$$$$$$$$$$$$$$6&hone7$$$$$$$$$$$$$$$$$
!+ist an toll>#ree or reverse>c(arge line'$
If %ou ha)e an% *uestions aout %our ri!hts as a $$$$$ cell #onor, contact:
6Re)ie/ 4oar# Memer7$$$$$$$$$$$$$$$$$$$$$$$$$$$$6&hone7$$$$$$$$$$$$$$$$$
!+ist an toll>#ree or reverse>c(arge line'$
CON0ENT AN3 0I9NAT,RE
Please rea# the statements elo/, thin" aout %our choice, an# si!n if an# /hen %ou are
rea#% to a!ree, or ta"e this form home an# #iscuss it /ith an%one %ou /ish to an# then
return it to us later if %ou /ish to &artici&ate in this research:
!Na"e o# person o)taining consent$ has full% e3&laine# to me the nature an# &ur&ose of
this research &ro'ect in a /a% that I ha)e un#erstoo#(
!.e?s(e$ has encoura!e# me to e acti)el% in)ol)e# #urin! the information inter)ie/ an#
has res&on#e# to all of m% *uestions an# concerns in a satisfactor% an# res&ectful /a%(
!.e?s(e$ has offere# me o&&ortunities to consult /ith an in#e&en#ent &erson /hom I
trust, inclu#in! a counselor or a &h%sician, &rior to m% ma"in! m% #ecision an# has !i)en
me a#e*uate time to #eci#e(
Somatic Cell Donation ;
This sample document may not conform to the standards of your local Research Ethics Board.
I here% !i)e m% )oluntar% consent to #onate m% $$$$$ cells for the research &ro'ect
entitle# !Project Title$ con#ucte# % !Principal Investigator$ at !Participating
Institution(s)$(
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$3ate:$$$$$$$$$$ $$$$$$$$$$$$$$$$$$$$$$$$$$
0ignature o# Cell 3onor Printe% Na"e
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$3ate:$$$$$$$$$$ $$$$$$$$$$$$$$$$$$$$$$$$$$
0ignature o# Parent or +egal 9uar%ian Printe% Na"e
I# Cell 3onor is a Minor or 3ecisionall>
Incapacitate%
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$3ate:$$$$$$$$$$ $$$$$$$$$$$$$$$$$$$$$$$$$$
0ignature o# Person O)taining Consent Printe% Na"e
Co&% !i)en to #onor:$$$$$Yes
Co&% !i)en to &arent or le!al !uar#ian 6if a&&licale7:$$$$$$ Yes
Somatic Cell Donation <