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24 February 1984
USAINSCO^l Regulation
15-3
a •
Specimens
to be collected .
(1)
Schedule of collections .
(2)
Evaluations
to be made on specimens «
are required.
<If
aPPlicable >
state
where
and
if
special
conditions
4)
Labeling and disposition .
(5)
Laboratories performing evaluations
,
(6)
Special precautions .
.
b
*
gLA^cal/behavioral
assessments .
(Include
how adverse
effects
are
to
dg
recorded)
c *
V-j^a!
8igns .
(State when desired and
the
frequency),
d.
Follow-up procedures .
®* ^
.apositlon °f data .
(State
location and duration
of
storage.
Include
pertinent
information
regarding
Privacy
Act
and
AR
381-10
considerations,
if
applicable) .
*
.
f \ gfthods used for data collection.
(State
critical measurements used
as
end
points
to characterize
safety,
efficacy or equivalency).
15 *
Departure from protocol for Individual subjects.
..
a *
H?jfen allowed.
(Use
flexible,
but
definite
criteria.
If none
is
to
be
allowed,
so
state).
_
,
b *
jhQ
w111
be
notified .
(Include
both
those
regarding
the
individual
subject,
if appropriate,
and
those elsewhere within the INSCOM.
Must notify at
icaSt
tne HTRB )
16,
Adveijse reactions.
(Must correlate with paragraph
12m,
above),
a.
Definition of subject reactions .
b *
Injmediate reporting procedures .
c •
Routine reporting procedures .
•
Potential
post-project adverse reactions
.
B-4
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24 February 1984
USAINSCOM Regulation 15-3
Section IV
ADMINISTRATION
17.
Modification
of
protocol .
(Describe
the
procedure
to
be
followed
to
modify,
terminate
or extend
the protocol).
18.
Disposition
of unused
project
material .
(Give
a
statement
pertaining
to
disposition
of
unused project material
and devices,
if
applicable).
19.
Publications
and
reports.
(Describe
use,
including
potential
restric-
tions,
of information and publications
and reports arising from the project).
20.
Funding .
(Identify source
of
funds and any special
or unusual funding im-
plications).
21.
Medical monitor .
(State
the name
and
telephone number
of medical monitor,
when applicable).
22.
Protocol
review.
(Identify
the human
use
committee
or
institutional
re-
view board which will provide
initial, continued
and annual review of
this pro-
tocol) .
( Signature)
;
___
(Name, rank and organization
of
person submitting protocol)
(Signature)
(Name,
rank and organization of
principal
investigator)
( Signature )
(Name,
rank and organization of approving official)
Attachments
A - Proposed Volunteer Agreement
B - Proposed Explanation Portion of
the Volunteer Agreement
C - Review of Scientific and Human Research Issues
(if applicable)
D - Biographic Sketch
of principal and associate
investigators
B-5
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USAINSCOM Regulation
15-3
24 February -1984
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B-6
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24 February
1984
USAINSCOM Regulation 15-3
APPENDIX C
VOLUNTEER AGREEMENT
Part A
, having attained my eighteenth
(18th) birthday,
and
otherwise having
full
capacity
to consent,
do
hereby vol-
unteer
to participate
in an investigation study entitled:
——
"
,
and
under
the direction
of
-
The
implications
of
my
voluntary
participation;
the
nature,
duration
and
purpose,
and
the methods
and means
by which
it
is
to
be
conducted;
and
the
in-
conveniences
and hazards
to
be
expected have been thoroughly explained
to me
by
,
and
are
set
forth
in Part
B
of
this
Agreement,
which
I have
signed.
I have been given
the
opportunity
to
ask ques-
tions
concerning
this
investigative
study,
and
any
such
questions
have
been
answered
to my full and complete
satisfaction.
I understand
that
I may at any time during
the course
of
this
investigative
study
revoke
my
consent,
and withdraw
from
the
study
without
prejudice;
how-
ever,
I
may
be
required
to
undergo
certain
further
examinations,
if,
in
the
opinion
of
competent
authority,
such
examinations
are
necessary
for
my
health
or well being.
Signature
Date
Witness's Signature
Date
C-l
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15-3
24 February
1984
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C-2
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24 February 1984
USAINSCOM Regulation 15-3
x
'a.
APPENDIX D
VOLUNTEER AGREEMENT
Part B
(
Explanation Portion of
the Volunteer Agreement
1.
Project
title .
(The
title
of
the
project
and
the
place where
it
is
to
be
conducted).
2.
Principal investigator .
(Must agree with
the protocol).
3.
Discussion.
(A statement
that
the study involves research.
An explanation
of
the
purpose
of
the
study and
the
expected duration
of
the
subject
s partici
pation.
A description
of
the
procedures
to
be
followed.
An
identification
of
any experimental procedures.
A statement
giving
information about
prior,
simi
lar,
or related
studies
that provide
the
rationale
for
this
project).
4.
Risks
or discomforts .
(A description
of
any
reasonably
foreseeable
risks
or discomforts
to
the
subject)
.
5.
Benefits.
(A description
of
any benefits
to
the
subject
or
to
others
that
may reasonably be expected from the study).
6.
Alternative procedures.
(A disclosure
of
proper
alternative
procedures
or
courses
of
treatment,
if
applicable,
that
might
be
advantageous
to
the
sub-
ject).
7.
Confidentiality of records.
(A statement describing
the
extent,
if
any,
to
which
confidentiality
of
records
identifying
the
subject
will
be
maintained.
Also,
if
more
than
a
minimal
risk
is
involved,
a
statement
that
authorities
outside
the US may inspect
the
records).
8.
Subject's rights.
(An explanation of whom
to
contact
for answers
to
perti-
nent questions
about
the
study
and
the
subject's
rights
and whom
to
contact
in
the
event
of
study-related
injury
to
the
subject).
9.
Voluntary participation .
(A statement
that —
a.
Participation
is voluntary.
b.
Refusal
to
participate
will
involve
no
penalty
or
loss
of
benefits
to
which the subject
is otherwise entitled.
c.
The
subject
may discontinue
participation
at
any
time
without
penalty
or
loss
of benefits
to which
the
subject
is
otherwise
entitled).
10.
Compensation and medical treatment
.
(For
a
study involving more
than min-
imal
risk,
an explanation
as
to whether
any compensation
and medical
treatment
D—
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