Document ID: EPA-HQ-ORD-2006-0187-0117
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-04-06T04:00Z

CONDUCT
OF
HUMAN
VOLUNTEER
STUDIES:

ETHICS
&
METHODOLOGIES
Angus
Cameron
From
1985
to
Feb
2002
Regulatory
Affairs
Manager
at
Inveresk
Research,
Tranent,
Scotland
Responsible
for
coordination
of
Independent
Inveresk
Research
Ethics
Committee
4
April
2006
Inveresk
Research
°
One
of
world's
largest,
full
service,
Contract
Research
Organisations
(
CROs)

°
Pre­
clinical
testing
in
animals
 
pharmaceuticals
(
human
and
veterinary),
agrochemicals,

industrial
chemicals
°
Clinical
testing
in
humans
 
healthy
volunteer
studies
(
Phase
I)
and
patient
studies
(
Phase
II
and
III)

°
Phase
I
Studies
 
testing
of
new
and
established
molecules
conducted
in
healthy
volunteers
at
62
bed
clinical
unit
in
Edinburgh
Independent
Inveresk
Research
Ethics
Committee
°
Committee
established
in
1979
to
 
"
advise
Inveresk
Research
on
the
ethical
acceptability
of
clinical
research"

°
Written
Constitution
and
committee
processes
controlled
by
SOPs
 
Standard
Operating
Procedures
reviewed
annually
°
Initially,
21CFR
(
FDA)
used
 
USA
only
country
with
"
codified"
regulations
°
Compliance
with
 
Declaration
of
Helsinki
 
"
Common
Rule"

 
Good
Clinical
Practice
(
GCP)
in
accordance
with
ICH
 
UK/
RCP
and
UK/
ABPI
recommendations
Independent
Inveresk
Research
Ethics
Committee
°
Committee
comprises
panel
of
approx
30
members
 
Hospital
consultants
(
physicians,
haematologists,

obstetricians,
neurologists,
psychiatrists)

 
General
practitioners
 
Nurses
 
Lay
(
ministers
of
religion,
housewives,
administrator)

°
None
of
members
has
any
affiliation
with
Inveresk
Research
or
study
sponsors
 
Compare
with
"
Common
Rule"
IRB
requirements
 
"
at
least
one
not
affiliated
with
institution"
Independent
Inveresk
Research
Ethics
Committee
Process
at
meeting
°
Chairman
gives
overview
of
study
°
Roundtable
discussion
 
input
from
each
member
°
Issues
of
concern
minuted
by
committee
secretary
 
all
comments
are
unattributed
and
given
equal
weight
°
Consensus
is
required
 
all
members
must
agree
to
ethical
acceptability
of
all
studies
°
Detailed
draft
Minutes
prepared
 
sent
to
Chairman
for
approval
and
countersigning
Independent
Inveresk
Research
Ethics
Committee
Process
after
meeting
°
Final
approved
Minutes
 
circulated
to
all
committee
members,
Inveresk
medical
staff,

sponsoring
company
°
Responses
to
Minutes
 
issues
raised
must
be
responded
to
by
clinical
investigator
in
conjunction
with
study
sponsor
°
Responses
plus
amended
documents
 
Sent
to
chairman
for
review
and
approval
 
Rarely
whole
committee
requests
to
approve
amendments
°
Study
cannot
commence
until
 
Formally
approved
minutes,
approved
protocol,
consent
and
volunteer
information
available
Safety
°
Inveresk
Research
procedures
are
designed
 
To
ensure
complete
safety
of
all
subjects
in
all
studies
 
To
ensure
highest
ethical
standards
are
met
°
This
is
achieved
by
 
Fully
documented
safety
review
process
 
Completely
independent
ethical
review
of
all
clinical
studies
 
Careful
selection
of
all
volunteers
 
Intensive
monitoring
of
volunteers
by
experienced
medical
and
nursing
staff
 
Conducting
studies
in
a
fully
equipped
clinical
setting