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AT
HAM' >n MAMUAI.
UKQU I REMENTS GOVERN I NG
f '"
ACTIVITIES WITH HUMAN SUBJECTS
Ri.viv n
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1977
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I
SCOPE
This
policy
statement
applies
to
all
uses
of
human
subjects
at
or
under
the
sponsorship
of
Stanford
Research
Institute.
It
is
intended
to
comply
with
Department
cf
Health,
Education
and
Welfare
( DHEW)
rules
and
regulations
for
the
protection
of human
subjects,
and
is
concerned
with
the
protection
of
any
ind i v idual
. who
may
be
risk
as
a
consequence
of
pa r t ic i pa t ion
as
a
subject
in
an
experimental
activity.
An
individual
is
considered
to
be ££ risk
if
he
or
she
"may
be
exposed
to
the
possibil-
ity
of
injury,
including
physical,
psychological,
or
social
injury,
as
a
consequence
of
participat ion
as
a
subject
in
any
research,
development,
or
related
activity
which
departs
from
the
application
of
those
established
and
accepted methods
necessary
to
meet
his
needs,
or
which
increases
the
ordinary
risks
of
daily
life,
including
the
recognized
risks
inherent
in
a
chosen occupation
or
field
of
service."*
II
STATEMENT
OF
PRINCIPLES
SRI
adheres
to
the
statement
of
principles
issued
by
the
World Medi-
cal
Association,
1841
Broadway,
New
York,
New York
10023.
Known
as
the
Declaration
of
Helsinki,
this
statement
was
last
revised
in
1975.
Copies
are
available
from
the
Chairman
of
the
SRI
Human
Subjects
Committee.
Ill
HUMAN
SUBJECTS COMMITTEE
The
Human
Subjects
Committee
was
established
to
perform
the
reviews
and
make
the
determinations
required
under
this
poLicy.
The
Committee
is
appointed
by
the
Vice
President
and
Chairman,
Office
of
Research
Opera-
tions.
Appointments
are
reviewed
from
time
to
time,
but
no
less
often
than
annually.
The
Committee
consists
of
eleven members.
Six members
constitute
a
quorum.
The
quorum shall
include
two medical
doctors
for
cases
chat
involve medical
or
surgical
questions
or
investigational
new
drugs
(IND),*
Final
approval
or disapproval
requires
a
unanimous
vote
of
the
Committee
members
present
and
voting.
Unfavorable
action
by
the
Committee
can
do
reversed bya
subsequent
vote
of
the
Committee
on
the
basis
of
additional
information
or
revision
of
the
question.
*Title
45,
Code
of
Federal
Regulations,
Part
46.
^SRI
itself
does
not
perform
experiments
with
humans
as
subjects
in medi-
cal,
surgical,
or
IND
studies,
but
such
studies
may
be
performed
by other
organizations
of
recognized
competence
in association with work
at
the
Institute.
The
requirements
of DHEW
and
the
Food
and
Drug Administration
( FDA^pfa4e8%dPRyi§al4e2(J0W0»1>6y GtA-RBP9«e®ft788R001 100440002-1
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TOPIC NO.
812
PAGE NO.
Tne
Committee meets
at
least
once
a month,
usually
on
the
second
Tuesday,
and
maintains
a written
record
of
its
actions.
Replacement
of
a
Committee member
by
an
alternate
of
comparable
experience
and
competence
is
permissible
for
some
limited
period
or
in
respect
to
a
particular
case.
No
member
of
the
Committee
snail
be
involved
in
either
the
initial
or
continuing
review
of
an
activity
in
which
he
or
she
has
a direct
rssponsi-
Dility,
except
to
provide
information
as
requested.
If
the
final
decision
of
the
Committee
is
to
disapprove
proceeding
with
a
project,
that
decision
cannot
be
reversed
by
any
other
Institute
authority.
However,
the
division
executive
director
and
the
ascending
management
levels
have
the
authority
and
responsibility
to
disapprove,
discontinue,
suspend,
or
limit
any
activity
at
any
time
wnen
that
execu-
tive
judges
such
action
to
be
necessary
for
the
protection
of
the
rights
and -welfare
of
human
subjects.
IV
REVIEW
OF
INITIAL
PROPOSALS
INVOLVING
HUMAN
SUBJECTS
SRI
participation
in
activities
involving
human
subjects
can
come
about
in various
ways.
The
activity
is
conducted
sometimes
at
the
Insti-
tute
and
sometimes
on
the
premises
of
a
subcontractor
or
collaborator.
Most
commonly,
it
is
supported
under
a
prime
contract
or
grant,
but
it
can
also
be
carried
out
in
other
ways,
such
as
on
an
overhead
account
or
as
a voluntary
activity.
Whatever
the
basis,
the
Manager
of
Contract
Administration Services
is
designated
to
initiate
the
process
by which
it
is
to
be
determined
if
human
subjects
would
be
placed
aj:
risk
,
and
he
must
be
notified
when
a
plan
to
use
human
subjects
reaches
the
proposal
stage
or
an
equivalent
state
of
preparation
if
no
formal
proposal
is
con-
templated.
A
proposal,
whether
formal
or
informal,
will
always
be
neces-
sary
for
evaluation.
The
Institute
does
not
participate
in
certain
classes
of
research
with human
subjects,
such
as
those
involving
fetuses,
pregnant
women,
or human
in vitro
fertilization.
If
a researcher
is
in doubt
as
to
the
ac c e p t
a
b iTI t y
oT a
concept
for
research with
human
subjects,
he
or
she
should
consult
the
Chairman
of
the
Human
Subjects
Committee
before
a
detailed
proposal
is
prepared.
No
activities
involving
human
subjects
may
be
begun before
an
evaluation
has
been
completed
by
the
Committee.
A
.
Fo rwarding
of
Proposals
and
Requests
for
Review
The Manager
of
Contract Administration
Services
will
direct
that
a
copy of
each
proposal
that
involves
human
subjects
be
sent, to
the Chairman
ot
the
Human
Subjects
Committee,
who
will
advise
the
proposal
author
and
division
executive
director regarding
the
submission
of
a Request
for
Re-
view.
The completed
Request
for
Review,
including
supporting
attachments,
will
be
submitted
to
the Committee
via
the division executive director.
If
the
subjects,
he
or
she will
sign
and
forward
the Request
for Review
to
tne
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Chairman
of
the
Committee.
At
this
stage,
the
nature
of
the
human
sub-
ject
involvement
should
be well-defined .*
Whenever
feasible,
proposals
should
be
reviewed
before
submission
to
the
client.
However,
when
this
cannot
reasonably
be
done
and
client
ru
es
permit,
the
proposal
may
be
submitted
with
appropriate
notifica-
tion
that
the
Committee's
review
is
yet
to
be
accomo 1 ished
.
The
review
should
be
accomplished
expeditiously
thereafter,
and
the
client
will
be
advised
of
any
consequent
material
change
in
protocol.
In
no
event
may
actual
work with
human
subjects
be
initiated
prior
to
approval
by
the
Committee.
For
timely consideration,
the
completed
Request
for
Review
should
reach
the
Chairman
at
least
ten working
days
before
the
Committee
meeeting
at
which
it
is
to
be
reviewed.
*\
^
"
Determining Whether
or
Not
Subjects
Are
at
Risk
If
needed
by
the Committee,
the
proposal
author
will
be
present
when
the
proposal
and
Request
for
Review
are
considered.
Consultants
from with-
ln
or
outside
the
Institute
may
be
used
to
advise
the
Committee.
A quorum
ot
the
Committee
will
decide
if,
in
its
judgment,
the human
subjects
would
be
£jj. risk ,
as
defined
on
Page
of
this
policy.
Those
cases
that
are
tound
to
place
the
subjects
at
risk will
be
processed
as
provided
below.
V
REVIEW OF
INITIAL PROPOSALS WITH
SUBJECTS AT RISK
initial
proposals
with
subjects
at
risk
are
reviewed
and
acted
on
as
described m
this
section.
The
procedure
followed
is
intended
to
con
form
to
DHEW policy
as
expressed
in Reference
1,
and
includes:
Consideration
of
the
risks
in relation
to
the
benefits.
Assessment
of
the
adequacy
and
appropriateness
of
consent
procedures
Review of
the
protection afforded
the
rights
and welfare
of
the
subjects.
However,
when
a
protocol
cannot
be
prepared
until
certain
project
work
has
been
completed,
the
Request
for Review may
be
submitted
initially
in
such
detail
as
is
possible
for
a
tentative
review
in
principle
to
meet
requirements
for
timely
review,
followed
by
a
full
review when
the
protocol
has
been
prepared.
Favorable completion
of
the
full
review
is
necessary before
human
subjects may
be
involved.
tin
the
absence
of
a written
notice
requiring
earlier
action,
DHEW
fol-
lows
a
rule
that
it must
receive
the
results
of
a
review within
days
a
ter
the
deadline
for
submission
of
a
proposal,
or
days
after
the
U mi
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t
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PAGE
NO.
The
consent
agreement
shall
be
legally effective
and
shall
include
no
exculpatory
language
through
which
the
subject
is
made
to
waive
any
of
his
or
her
legal
rights
or
to
release
the
Institute
from
liability
for
neg 1 i gence
.
C.
Protection
of
the
Rights
and Welfare
of
Subjects
Special
attention will
be
directed
to
the
protocol
to
ensure
that
tiie
rights
and
welfare
of
the
subjects
will
be
adequately
protected.
Provisions
will
be
included
for
emergency
situations
if
there
is
reason
to
believe
that
emergencies
might
arise.
Information
will
be ^handled
in
such
a manner
as
to
prevent
unauthorized
parties
from
tracing
or
iden-
tifying
it
with
a
particular
human
subject.
Preservation
of
the
confi-
dentiality
and
security
of
data
according
to
the
requirements
of
the.
client,
the
Institute,
and
applicable
law will
be
the
direct
responsibil-
ity
of
the
principal
investigator
and
his
division
executive
director.
When
specified
in
Reference
1,
additional
protections
for
certain
cate
gories
of
subjects
(e.g.,
children)
will
be
observed
in
the
application
of
this
policy.
D
.
Committee Action
After
reviewing
a
protocol,
a
quorum
of
the
Committee
may
approve,
approve
conditionally,
or
disapprove.
Approval
will
be
communicated
in
writing
to
the
principal
investigator
and
the
division
executive
direc-
tor.
If
the
approval
is
conditional,
the Committee
itself
may
formulate
explicit
terms
under which
the
activity might
proceed,
or
it
may make
approval
dependent
on
revision
of
the
protocol
to
meet
specif ied
general
requirements.
If
the
protocol
is
disapproved,
the
reasons
for
disapproval
will
be
stated
in writing
to
the
principal
investigator
and
the
division
executive
director.
Unfavorable
action
can
be
reversed
by
a
subsequent
favorable
vote
of
a
quorum
of
the
Committee
on
the
basis
of
a
revised
protocol
or
resubmission
of
the
original
question
with
additional
sup-
porting
information.
.
Before
introducing
any material
change
after
the
initial
approval
has
been
given,
the
protocol
revised
to
reflect
the
proposed
change must
first
be
submitted
to
and
approved
by
a quorum
of
the
Committee.
As
in
Che
initial
review,
the
Committee
may
approve,
approve
subject
to
speci-
fied
restrictions,
or
diapprove
.
If unanticipated
hazardous
conditions
emerge,
they must
be
reported
immediately
by
the
principal
investigator
to
the
Committee,
which
will
then
determine
the
circumstances,
if
any,
under
which
the
project
may
continue.
At
the
time
of
the
initial
approval,
the Committee
will
indicate
the
nature
and
frequency
of reevaluation necessary
to ensure
continued
acceptability
of
the
protocol.
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no.
£*
Amendment
to
Proposal
When,
in
order
to
meet
the
Committee's
requirements,
there
is
a
ma-
terial
change
in
the
protocol
compared
with
that
described
in
a
proposal
issued
to
a
research
client,
a
formal
amendment
or
revision
of
the
pro-
posal
should
be
prepared
and
forwarded
to
the
client
through
normal
pro-
posal
channels.
VI
REVIEW
OF CONTINUING
PROJECTS THAT
INVOLVE
HUMAN
SUBJECTS
The
continuing
review
of
previously
approved
projects
that
involve
human
subjects
will
be
conducted
by
a quorum
of
the
Committee
at
inter-
vals
determined
by
the
most
recent
assessment
of
risk.
At
a minimum,
such
projects
will
be
reviewed
at
yearly
intervals;
any
potentially haz-
ardous
projects
will
be
reviewed
at
intervals
of
every
six months,
or
more
frequently
commensurate
with
the
risk.
Spot
checks
will
be
made
from
time
to
time
at
the
judgment
of
the
Committee.
The
review
data
will
be
kept
on
file.
The
Committee
may
elect
to
review
the
records
of human
subject
part icipation
and
may
interview
the
investigational
staff
and
persons
at
risk
as
necessary.
VII
COOPERATIVE ACTIVITIES
When
SRI
is
to
have
access
to human
subjects
through
another
organi-
zation,
in
addition
to
its
review of
any
related
human
subject
involve-
ment
by
SRI,
the
Human
Subjects
Committee
will
assure
itself
that
the
proposed
human
subject
involvement
by
the
other organization
is
prima
facie
acceptable
and
that
it
has
been
approved
by
a
committee
established
by
the
other organization
to
make
such
reviews.
If
the
work
of
SRI
is
sponsored
by
DHEW,
the
review committee
of
the
other
organization must
have
been established
according
to
DHEW
requirements.
VIII
RECORDS
Minutes
of meetings
are
retained
in
the
Committee
files
for
ten
years
after
origination.
When
no
project* ensues,
case
files
will
be
retained
for
three
years.
Case
files
that
concern
active
and
formerly
active
projects
will
be
retained
for
at
least
five
years
after
project
completion.
Principal
investigators
will
transmit
executed
consent
forms
to
the
Committee
chairman
to
be
placed
in
the
project
case
file,
*The
term
project
is
used
to denote
any
form
of
an
activity,
whether
or
not
under
contract.
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and
will
keep
records
of
subject
participation
in
logs
that
are
trans-
mitted
to
the
Committee
chairman
prior
to
project
completion.
IX
PROMULGATION
Copies
of
this
statement
of
policy
are
provided
to
all
division
exec-
utive
directors
and
division
business
offices.
Copies
are
available
from
members
of
the Human Subjects
Committee
and
from Contract
Administration
Services.
Proposal
authors
are
referred
to
this
policy
by
the
Request
for
Review.
^Consent
forms
and
records
of
subject
participation
may
be
retained
by^
another
organization when
it
conducts
research
with
human
subjects
while
acting
on
behalf
of
or
in collaboration with
the
Institute.
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