.
Approved For Release 2003/09/09
: CIA-RDP96-00788R001 ^001 10014-0
Contract MDA903-8I-C-0292
Modification P00002
(New Contract MDA908-8I-C-OOO4
)
Page 3 of
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thtt death^or dlMbll^ lnjir^l”llitflf
d
tf
,
.fi
er* ^ H* lBh,rent «••«” to ballava
cxpcrlnents, or
«**«*«
« laboratory
acceptable Make prior to
the uae of hn IubJ«tS“
*
* “,ur* Bce °f
Juatlfled^by^the^beneflt^o^the'eub^e^t
**!•/" ^J
1 B,,* r ,xct#d that which la
the knowledge
to be gained.
J
*nd/° r *he humanitarian importance of
»
* X1
\_ A Phy* lcl®n 1,111
*>• reaponalbla for the medical cere of sublets
th!
n
«iiine
the p^Ject leader »
tfce physician mill have authority to terminate
*
the atudy at any time that he believe, death, injury or harm i. likely "“lult.
(12)
Proper preparation, will be made, and adequate facilities
to protect the aubject agalnat all foreaeeable poaalbllltlea of injury
disability
or death.
Thia include, but
i. not limited to ho.pit.llLtlon and Zllcil lltltlin
Iith
l
likei
reqUired *
In *ddltlon »
epparatua and inatrumenta neceaaary to d£al
with likely emergency aituationa will be available.
y
(13)
Human aubjecta will have no phyalcal or mental conditions which win
Mke participation .ore h.a.rdou. for the. than It »ul“£ ^0^? *^
“3.£d‘ ander"thla
f
contract?*
Cr1^ ~
-
.clentlflcally qualified pereon conducting the atudy. end each
HI b« pr.pered t. tenilnet. the «bje“^ ^t“5-
auperlor .kill
and cfrllful*a
t#
ln
tl“ exercl.e of the good faith,
Jin‘i:ij:n“
,,“tlon *• akeiy
.uht.fr’
b€fore T
1?11*1"* *n? P»«0" to participate .. . hiaaan
«re
J
c«JljSS rtrt!
“ ,,0t •
ln,ur* tltt the following ^nln. condition.
Legally effective Informed conaent will be obtained by adeauate
d appropriate methods
in accordance with the proviaions of this clause.
tbs
i«tiiqrii
2)
i
A11 conaent must be voluntary.
It muat be the knowing consent of
the individual or his legally authorized representative,
ao situated as to be able
to exerciae free power of choice without there having teen any ^eoffo^cefrau^
if J^i.r?”
,tr* lnt * C0*rct0n > 01 Uvfal « 5-proper lJd“««f S:
ments of information neceaaary to such consent Include:
^
(i)
A fair explanation of the procedure, to be followed
and their
purposes,
including identification of any procedures Which are experimental.
to be anticipated.
A de#crlptl<>n of anp •ttwndmnt discomfort, or risks reasonably
( continued
)
Approved For Release 2003/09/09
: CIA-RDP96-00788R001 5001 1001 4-0
Approved For Release 2003/09/09
: CIA-RDP96-00788R00rl 5001 1001 4-0
Contract MDA9O3-81-C-O292
Modification P00002
(New Contract No. MDA908-81-C-0004)
Page
h of
(iii)
A description of any benefits reasonably to be anticipated.
m4
.+ u-
^
* lv)
A dl#cJ°,ure of «ny appropriate alternative procedures that
ight be advantageous to the subject.
(v)
An offer to answer any questions concerning the procedure.
and
««
4,1
J
n* tr«ction that the subject is free to revoke his consent
and
to discontinue participation at any time without prejudice to hiaself.
(d)
.Exculpatory language through which the subject is wade to waive, or
appear to waive, any of his legal rights. Including any release from liability
for negligence. Is prohibited.
(e)
Prior consent by a subject or his legally authorised representative
shall be obtained in all cases.
Such consent shall be in writing whenever it
is reasonably possible to do so.
The consent fora nay be read to the subject
or his legally authorized representative, but in any event he or his legally
authorized representative aust be given adequate opportunity to read it and to
ask questions they alght have.
This consent fora should then be signed by the
subject or hie legally authorized representative and by a witness not directly
involved in the study.
Oral consent way be used only when it has been specifi-
cally described and Justified in the scope of the work to be performed under
this contract or approved in writing by the contracting officer.
When so author-
ized and used, oral consent vls subject to all the aaae standards as apply to
written consent, except that the signature of the subject or Ms legally author-
ized representative is not required.
(f)
Prior to conduct of the study, the contractor shall submit for approval
to the contracting officer a detailed description of the means by which Informed
consent will be obtained, to Include any forms to be used.
Upon completion of the
study, the contractor will submit to the contracting officer detailed report demon-
strating compliance with paragraph (c), to include copies of the written consent if
such was obtained.
(g)
The Contractor shall not undertake to conduct wither the clinical
pharmacology or clinical trails of an Investigational drug unless this contract
contains the clause entitled "Clinical Study of Investigational Drugs."
(h)
Prisoners of war will mot be used under any circumstances.
Add the following as paragraph H.10 of the
contract:
H.10 W?
f
participating as human subjects,
as defined by paragraph
H:?
(
k
(?^ h®reof >
EharL be
to possess the abilities and qualities
which will be observed and analyzed during the
conduct of this
contract
Approved For Release 2003/09/09
: CIA-RDP96-00788R0015001 10014-0
Approved For Release 2003/09/09
: CIA-RDP96-00788R001 §001 10014-0
Contract No. MDAQ03-81-C-02QP
Modification P00002
(New Contract No. MDAQ08-8l-C-000h)
Page
5 of
'
G,
as modified shall be 'maintained
? ^ pe
^
formance of contract MDA908-8I-C-
attached hereto
The hlTelt ^fl?S^
Ce
« Wlth the .^vised DD Form 254
of this
contract as modified
is TOP SECRET?
11 lnVOlved ln the Performance
•0004
SGFOIA2
Approved For Release 2003/09/09
: CIA-RDP96-00788R001 5001 1001 4-0