Approved For Release 2001/03/07
: CIA-RDP96-00788R0015001600g7
ff3jyW
(2)
The
institution
shall
have
provided
to USAMRDC
a
written assurance
that
it
will abide
by
the
policy
for
the pro-
tection
of
human
subjects
as
contained
in
45 CFR
46.
When
an
institution has
an assurance
of compliance satisfactory
to the
Department
of Health
and
Human
Services
(HHS),
evidence
of
IRB
approval
of
the study shall
have been accomplished by submission
to
USAMRDC of
an executed HHS
Form
596.
For
an
institution
without
a
HHS approved
assurance
of
compliance ,
an assurance
^ concerning
the
protection of human subjects
shall
have
been negotiated
with
the
USAMRDC contracting officer,
and
IRB approval given.
(3)
In addition
to
the requirements
of Title
45,
Part
of
the
CFR,
the following
shall
apply
to
all
USAMRDC contracts
supporting
research,
development,
and related activities:
(a)
Informed consent must be obtained
in advance
from
a subject
at
risk,
or
in
the
case
of
research
intended
to be
beneficial
to
the
subject,
a
legal
representative
of
the subject
may give
informed consent
in advance
of
the
research.
(b)
The contractor shall
provide
for
all necessary
medical care
of subjects
at
risk
for
injury or disease which
is
the
proximate result
of participation
in
the
research.
(c)
Prisoners of war
shall
not
be
used
under any
circumstances.
(d)
Use
of prisoners
as research subjects shall
have
been specifically approved by
the USAMRDC contracting officer.
(e)
Studies conducted outside
the United
States,
its
territories
or
possessions,
which
involve
the
use
of
non-U. S.
citizens
as
subjects,
in addition
to compliance with
45 CFR
and
special
DOD
requirements,
shall comply with all
laws,
customs,
and
practices of
the country
in which
the study
is
to
be conducted.
The
minimum
standards
to
be
adhered
to
are
contained
in The
Declaration
of
Helsinki.
The
research
proposal
submitted
for
approval will
document
this
action.
In exceptional circumstances
where
laws,
customs
or
practices
of
the
country
involved take
exception
to
particular procedural
requirements
of
this provision
(as,
for example,
the
documentation
of
informed
consent
or
the
procedures
by
which
it
is
obtained)
,
specific approval will
be
obtained
from
the
Commander,
U.S.
Army
Medical
Research
and
Development Command
as
an
integral part of
the proposal review and
approval process.
(4)
In accordance
with
CFR
56.111(a)(3),
IRBs are
responsible
for
reviewing
the
methods
used by
investigators
to
recruit subjects.
One method
of
recruiting
subjects
is
through
advertisements which should
be
seen as
an extension of
the
informed
consent.
IRB review of advertisements
is necessary
to ensure that
the
information
is
not misleading
to subjects.
The FDA has
established guidelines
on advertisement
for research
subjects.
B-2
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: CIA-RDP96-00788R001 5001 60007-3
Approved For Release 2001/03/07
: CIA-RDP96-00788R001500160Qp£-3UN
iggQ
Generally,
the
FDA
believes
that
any
advertisement
to recruit
subjects
should be
limited
to:
(a)
The
name
and
address
of
the principal
investi-
gator ;
(b)
The purpose of
the research and,
in summary form,
the eligibility criteria that will
be
used to
admit subjects
into
the
study;
(c)
A straightforward
and
truthful description
of
the
benefits
(e.g.,
payments or
free
treatment)
to
the
subject
from
participation
in
the
study?
(d)
The
location of
the research
and
the person
to
contact
for further
information.
(5)
In addition
to
the
requirements
noted
above,
a copy
of
the protocol
and
informed consent
for each phase of
a study will
be
forwarded
to
the
Commander,
U.S.
Army
Medical
Research and
Development
Command,
ATTN:
SGRD-HR,
Fort
Detrick,
Frederick,
MD
21701-5012.
If available,
a
copy
of
the
local
IRB
review and
approval should
be provided.
Research
involving
the
use
of human
subjects
may
not
commence
until
approved
by
the
contracting
officer.
d.
Requirements
for
the
Use
of Investigational Drugs
and
Vaccines
The contractor shall comply with
21 CFR
312
for the study
and evaluation of those new drugs
restricted by the
Federal
Food,
Drug,
and
Cosmetic Act.
The drug
shall
be used
by,
or under
the
supervision
of
an
investigator
pursuant
to
an
Investigational New
Drug Application
(IND).
A copy of
the current applicable
forms
as
related under Part
312 shall
have
been provided
with
the contrac-
tor's
proposal.
e
.
Requirements
for
the
Use
of
Investigational
Medical
Devices
The contractor shall comply with
21 CFR
812
for
the
study
and evaluation,
of
those devices which are
not generally recognized
as
safe and/or effective,
intended
for use
in
the diagnosis,
cure,
mitigation,
treatment,
or prevention of disease
in,
or research on
humans.
Should
the contractor
propose
to
use
an
investigational
device
in
the
research,
he
shall provide with his proposal
a copy
of
Food and Drug Administration
(FDA)
approval
of,
or
grant
of
waiver
for,
use of an
investigational device exemption
(IDE).
f .
Requirements
for Reporting
and Documentation :
(1)
Immediate
telephone
notification
shall
be given
to
the USAMRDC Human Use Review and
Regulatory Affairs
Office of any
significant adverse
reactions.
(Telephone weekdays.
Area
B-3
Approved For Release 2001/03/07
: CIA-RDP96-00788R001 5001 60007-3
Approved For Release 2001/03/07
: CIA-RDP96-00788R00150016a0I)7H3N
1990
Code 301/663-2165;
nights,
weekends,
and holidays,
the Duty Officer
Telephone Area Code
301/ 663-7114.)
(2)
Copies of
all
documents
presented
or
required
for
initial
and
continuing
review
by
the
IRB,
e.g..
Board minutes
pertaining only
to
the
contract,
record
of
subject's consent,
transmittals
on
actions,
instructions,
and conditions resulting
from
IRB deliberations addressed
to
the
activity director,
are
to
be
retained
by
the
contractor
for
at
least three years after
completion of
the
research.
All documents
shall
be
accessible
for
inspection during
normal working hours,
by the USAMRDC contracting
officer or authorized representative.
(3)
Information on volunteers used
in research sponsored
by USAMRDC
will
be
entered
in
the USAMRDC Volunteer Registry data
base.
The data
base
is required
to ensure that USAMRDC can readily
exercise
its
"duty
to
warn"
individuals
of any newly acquired
information which may affect
their well-being,
even after partici-
pation
in
the
research.
The
SGRD-HR
may,
on request
of
the
contractor,
exempt
the
research
from
this
requirement;
such
exemption may
only be
granted
for studies which
the
local
IRB has
determined
to be minimal
risk.
The Volunteer
Registry Data Sheet
USAMRDC
Form
60-R
(Tab
E)
is
to
be completed at
the
time
the
subject consents
to participate and
is entered
into
the
study.
The
forms
shall
be
submitted
to
the
HURRAO upon completion of
the
research project or upon
expiration/termination
of
the contract,
whichever occurs
first.
The USAMRDC will retain
information m the
data base
for
75 years.
Persons on
whom data
is collected,
or
a
designated representative or
legal guardian, may have access
to
the
record pertaining
to that
individual.
(4)
Except as otherwise provided
by
law,
information
in
the records
or possession of
the contractor which refers
to or can
be
identified
with
a
particular
subject
may
not
be disclosed
except
:
(a)
with
the consent
of
the
subject or his
legally
authorized representative,
or
(b)
as may be necessary
for
the USAMRDC
to carry out
its
legal responsibilities.
(5)
Upon
expiration
or
termination of
this contract,
a
list of all unused
test material
shall
be
provided
to
the USAMRDC
contracting officer.
(6)
The contractor
shall
immediately
notify the USAMRDC
contracting
officer,
by
telephone,
of
inquiries
outside
the
Department of Defense concerning
the
use
of human subjects
under this contract.
In addition,
the contracting officer shall
be
notified
as
soon
as possible
of
inspections
of
the
facility or
contract protocols by
the
FDA.
B-4
Approved For Release 2001/03/07
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Approved For Release 2001/03/07
: CIA-RDP96-00788R001 50016^0^ iggo
q.
Subcontracts.
Compliance
by subcontractors with Code
of
Federal Regulations
45 CFR
and
this contract
provision
is
the
responsibility of
the prime contractor.
All
subcontracts which
contain
this
contract provision shall
be approved by
the contract-
ing officer prior
to award.
The
requirements
of
paragraph c{2)
above
shall apply
to subcontractors.
h.
If
at
any time
during performance
of
this contract,
the
contracting officer determines,
in
consultation
with
the USAMRDC
Human Use Review and Regulatory Affairs Office,
that
the contractor
is
not
in compliance with any of
the
requirements
and/or standards
stated
in paragraphs
c,
d,
and
e above,
the contracting officer may
immediately suspend,
in whole or
in part,
work
and further payments
under this
contract until
the contractor corrects
such noncompli-
ance.
Notice of
the
suspension may
be communicated
by telephone
and
confirmed
in
writing.
If
the contractor
fails
to complete
corrective action within
the
period
of
time
designated
in
the
contracting officer's written notice of suspension,
the contracting
officer may terminate
this contract
in
whole or
in part,
and
the
contractor's
name may be removed
from the
list
of
those contractors
with approved policies on the
use of human subjects.
B-5
Approved For Release 2001/03/07
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Approved For Release 2001/03/07
: CIA-RDP96-00788R001 5001 60007-3
Use
of Anatomical Substances
*
5 JUN 1990
Any anatomical
substance
(organs,
tissues,
or
tissue
fluids)
linked by
identifiers
to
a particular person and
used
for research
under this contract
shall be donated
for
the purpose
of
research or
investigation.
The
donor
shall
be
the
person
from
whom the
substance
is removed
or,
in
the event of death or
legal disability
of
the
person from
whom
the substance
is
removed,
the next of kin
or legal representative of such person.
Donation
shall
be made by
written consent and shall relinquish all ownership and/or rights
to
the substance.
All human
anatomical
substance
used
in research
under this contract shall be lawfully acquired.
It should be noted
that
a general autopsy consent
form or
a consent
to perform surgery
in and
of themselves,
may not
be adequate.
If excised or autopsy
tissue
is
to
be
used,
the
protocol should
include
a
copy of
the
consent form used
to obtain
the
tissue.
Tab
C
Approved For Release 2001/03/07
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: CIA-RDP96-00788R001 5001 60007-3
5 JUN
1990
THE DECLARATION OF HELSINKI
1.
BASIC PRINCIPLES
a.
Biomedical
research
involving
human subjects must conform
to generally accepted scientific principles
and
should
be based
on adequately performed
laboratory and animal experimentation
and
on
a thorough
knowledge
of
the scientific
literature.
b.
The design and performance
of
each experimental procedure
involving human subjects should
be clearly formulated
in an
experimental protocol which should
be
transmitted
to
a specially
appointed
independent committee
for
consideration,
comment,
and
guidance.
c.
Biomedical research
involving human subjects should
be
conducted only by scientifically qualified persons
and
under
the
supervision
of
a clinically competent medical person.
The
responsibility
for
the human subject must
always
rest with
a
medically qualified person and
never
rest on
the subject of
the
research,
even though
the subject has given his or her
consent.
d.
Biomedical research
involving human subjects cannot
legitimately be carried out unless
the
importance of
the
objective
is
in proportion
to the
inherent
risk
to
the subject.
e.
Every biomedical research project
involving human
subjects should
be preceded
by careful assessment of predictable
risks
in comparison with foreseeable benefits
to
the
subject
or
to others.
Concern
for
the
interests
of
the subject must always
prevail over
the
interests of
science
and
society.
f.
The
right of
the
research subject
to safeguard
his
or
her
integrity must always
be
respected.
Every precaution should
be
taken
to
respect
the privacy of
the
subject,
and
to minimize
the
impact of
the
study on
the
subject's physical
and mental
integrity and on
the personality of
the
subject.
g.
Doctors should abstain
from engaging
in research projects
involving
human subjects unless
they are satisfied
that
the
hazards
involved
are believed
to
be predictable.
Doctors
should
cease any
investigation
if
the hazards
are
found
to outweigh
the
potential benefits.
h.
In publication of
the
results
of
his
or
her
research,
the
doctor
is obliged
to preserve
the accuracy of
the
results.
Reports
of experimentation
not
in accordance with
the principles
laid down
in
this Declaration should
not
be accepted
for
publication
.
Tab D
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: CIA-RDP96-00788R00150016ggg7^
i.
In any research on human beings,
each potential subject
must
be adequately
informed of
the
aims,
methods,
anticipated
benefits
and potential hazards
of
the study and
the discomfort
it
may entail.
He or
she should
be
informed
that he
or
she
is
at
liberty
to abstain
from participation
in
the
study and
that
he
or
she
is
free
to withdraw his or
her consent
to participation
at
any
time.
The doctor
should
then obtain
the
subject's given
informed
consent,
preferably
in writing.
j.
When obtaining
informed consent
for
the
research project,
the doctor should
be particularly cautious
if
the subject
is
in
a
dependent relationship
to him or
her
or may consent
under duress.
In
that case
the
informed consent should
be obtained by
a doctor
who
is
not engaged
in
the
investigation
and who
is completely
independent of
this official relationship.
k.
In
case of
legal
incompetence,
informed consent should
be
obtained
from the legal guardian
in accordance with national
legislation.
Where physical
or mental
incapacity makes
it
impossible
to obtain
informed consent,
or
when
the subject
is
a
minor, permission from the responsible
relative
replaces
that
of
the
subject
in accordance with national
legislation.
l.
The
research protocol should always contain
a
statement
of
the ethical considerations
involved
and
should
indicate
that
the principles enunciated
in
the present Declaration
are complied
with
.
2.
MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
(CLINICAL RESEARCH)
a.
In
the
treatment
of
the sick person,
the doctor must
be
free
to use
a new diagnostic and
therapeutic measure,
if
in his
or
her
judgment
it offers hope
of
saving
life,
reestablishing
health,
or alleviating
suffering.
b.
The potential benefits,
hazards
and discomforts
of
a new
method
should
be weighed against
the advantages
of
the
best
current diagnostic
and
therapeutic methods.
c.
In any medical study,
every patient— including
those of
a
control group,
if
any— should be assured of
the
best proven
diagnostic
and
therapeutic methods.
d.
The
refusal of
the patient
to participate
in
a
study must
never
interfere with
the doctor—patient relationship.
e.
If
the doctor considers
it essential not
to obtain
informed consent,
the specific reasons
for
this proposal should
be
stated
in
the experimental protocol
for
transmission
to
the
independent committee.
D-2
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: CIA-RDP96-00788R001 5001 60007-3
5 JUN 1990
f.
The doctor can combine medical research with professional
care,
the objective
being
the acquisition of new medical
knowledge,
only
to
the
extent
that medical research
is
justified
by
its potential diagnostic or
therapeutic value
for
the patient.
3.
NON-THERAPEUTIC BIOMEDICAL RESEARCH
INVOLVING HUMAN SUBJECTS
(NON-CLINICAL BIOMEDICAL RESEARCH)
a.
in
the purely scientific application of medical
research
carried out on
a human
being,
it
is
the duty of
the doctor
to
remain
the protector
of
the
life and health
of
that person on
whom biomedical research
is being carried
out.
b.
The subjects should
be volunteers— either healthy persons
or patients
for whom
the experimental design
is
not
related
to
the patient's
illness.
c.
The
investigator
or
the
investigating
team should
discontinue
the
research
if
in his
or
her
or
their
judgment
it
may,
if continued,
be harmful
to
the
individual.
d.
In
research on man,
the
interest
of science
and society
should never
take precedence over considerations
related
to
the
well-being
of
the subject.
D-3
Approved For Release 2001/03/07
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Approved For Release 2001/03/07
: CIA-RDP96-00788R001 5001 60007-3 m
VOLUNTEER REGISTRY DATA SHEET
6 JUN
1990
111AUTHORITY:
2.
Principal and Routine
•
:
«pbnsoredl.
:l^>^£''iLs«
:Amiqr Medical
Research and Development CommandL
Personal tnfonnadon mil be used for identificatiro :iind> toarirat of partkipaat*, \
3.
Mandatoiy or Voluntary pfccl6ture;:. : T^iiiiHiB&iii&i|:pj|||l|^^
and to contact you if fatnre infoixnatioa
may be
;
' Failure to provide die' iafiaranaititoii
•
111,1
'
"
»
.m i
'
i
,
i
•
•'
PART A-JNVESTIGATOR INFORMATION
(To Be CompletedBy Investigator)
PLEASE PRINT, USING INK OR BALLPOINT PEN
1.
Study NR:
2. Protocol Title:
3. Contractor (Laboratory/Institute Conducting Study):
4. Study
Period: From:
01 /
/
To: 15/
/
(DA/MO/YR)
(DA/MO/YR)
5. Principal/Other Investigators) Names(s)
( 1 ).
('Lon)
(First)
(MI)
(2).
(3)
6. Location/Laboratory
/
/
I
PART B-VOLUNTEER INFORMATION
(To Be CompletedBy Volunteer)
PLEASE PRINT, USING INK OR BALLPOINT PEN
7. SSN:
/
/
8. Name:
(Last)
(First)
(MI)
9. Sex: M_F_
10. Date of Birth:
/
/
11. *MOS/Job Series:
12. *Rank/Grade:
13. Permanent Home Address (Home of Record) or Study Location Address:
(Street)
(P.O. Box/Apartment No.)
(City)
(
)
(Country)
(State)
(Zip Code)
(Perm Home Phone No)
14. * Local Address (If Different From Permanent Address):
(Street)
(P.O. Box!Apartment No.)
(City)
(
)
{Country)
(State)
(Zip Code)
(Local Phone No)
5.*Military Unit*
Zip Code:
OrRanizatioii:
Post:
Duty Phone No.
(
)
_
usamrdc F^^^ep^y^^ieaseeaeeA/oarfOdJtibKSiA-RDPse-ooTfefeRboi soOl 60007-3
TAB E
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3 PART C-ADDITIONAL INFORMATION: (To Be Completed By Investigator) e—_—__ee a SS SS PLEASE PRINT, USING INK OR BALLPOINT PEN 16. Location of Study: 17. Is Study Completed: Y___ N Did volunteef finish participation: Y__N__ If YES, Date finished: _ / f_ (DAIMO/IYR) If NO, Date withdrawn: __/ jf eason wi : (DAIMO/YR) 7 eae 18. Did Any Serious or Unexpected Adverse Incident or Reaction Occur: Y__N__ If YES, Explain: 19.* Volunteer Followup: Purpose: Date: _ sf Was contact made: Y___N____ If No action taken, explain: (DA/MOIYR) 20.*Hard Copy Records Retired: Place: File NR: 21.*Product Information: Product: Manufacturer: Lot NR: Expiration Date:. NDA NR: IND/IDE NR: Ee PRET EEE EEREr ESE Weta Wr EEE Wary SEY SERENE EE SEEN or one ae EN “Indicates that item may be left blank if information is unavailable or does not apply. Entries must be made for all other items. _ Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3