| Ethics
Committees
and
access
to
health
records
for
post
mortem
research |
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| Introduction |
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| This
chapter
describes
the
guidance
on
Ethics
Committees
and
on
access
to
medical
records
for
research
purposes.
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| Background |
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| The
establishment
of
Ethics
Committees
within
the
NHS
began
following
recommendations
within
the
Report
of
the
Medical
Research
Council
for
1962/63.
This
was
presented
to
Parliament
in
July
1964.
The
Report
of
the
Royal
College
of
Physicians
of
London
followed
in
July
1967.
The
first
Ethics
Committees
were
set
up
to
give
guidance
to
staff
in
hospitals
only.
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Appendix
8
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| In
these
early
documents
the
emphasis
was
on
the
rights
of
patients
freely
to
accept
or
refuse
procedures
that
were
of
no
direct
benefit
to
their
care.
From
these
beginnings
the
responsibilities
of
Ethics
Committees
have
evolved
progressively,
but
it
was
not
until
1991
that
Ethics
Committees
were
specifically
made
responsible
for
considering
research
on
the
dead.
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| Ministry
of
Health,
DHSS
and
Department
of
Health
Circulars
on
Ethics
Committees
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| HM(68)33:
'Supervision
of
the
Ethics
of
Clinical
Investigations'
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| This
first
circular
about
Ethics
Committees,
issued
on
13
May
1968
to
Regional
Hospital
Boards,
Hospital
Management
Committees
and
Boards
of
Governors
by
the
then
Ministry
of
Health,
referred
to
the
earlier
reports
of
the
Medical
Research
Council
and
the
Royal
College
of
Physicians
of
London.
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| HSC(IS)153:
'Supervision
of
the
Ethics
of
Clinical
Research
Investigations
and
Fetal
Research'
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| This
was
issued
in
June
1975
and
cancelled
HM(68)33.
HSC(IS)153
emphasised
that
'all
proposed
clinical
investigations
should
be
referred
to
an
ethical
committee'
and
included
specific
references
to
fetal
research,
research
on
minors
and
on
mentally
handicapped
adults.
There
was
no
mention
of
research
on
the
dead.
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| Following
HSC(IS)153,
all
researchers
who
planned
to
investigate
patients
during
life
and
to
correlate
in-life
findings
with
later
results
obtained
from
post
mortem
examinations
should
have
submitted
their
research
protocols
for
ethical
review.
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| HSC(91)15:
'Local
Research
Ethics
Committees'
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| On
19
August
1991
the
Department
of
Health
issued
HSG(91)5
to
cover
distribution
of
the
guidance
booklet,
also
entitled
'Local
Research
Ethics
Committee'
but
colloquially
referred
to
as
'the
Red
Book'.
This
guidance
set
out
the
role
and
responsibilities
of
Local
Ethics
Committees.
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Appendix
12
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| HSC(91)15
cancelled
HSC(IS)153
and
for
the
first
time
brought
research
on
the
dead
into
the
list
of
research
that
should
be
referred
to
Local
Research
Ethics
Committees
(LRECs).
The
Red
Book
on
page
5
states
'An
LREC
must
be
consulted
about
any
research
proposal
involving
the
recently
dead,
in
NHS
premises.'
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The
Red
Book
also
drew
particular
attention
to
the
need
for
LRECs
to
be
consulted
on
research
on
children
and
those
with
mental
illness.
On
page
17,
the
Code
of
Practice
prepared
by
the
Royal
College
of
Psychiatrists
was
commended
to
LRECs
as
a
source
of
advice
when
research
on
mentally
ill
patients
is
being
considered.
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| From
1991
onwards,
LRECs
considering
research
proposals
on
patients
with
Alzheimer's
disease,
schizophrenia
and
other
neuro-psychiatric
diseases
had
the
benefit
of
this
Code
to
assist
their
evaluation
of
the
research
protocol.
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| The
Red
Book
also
contained
sections
on
access
to
health
records,
which
are
discussed
in
the
next
section.
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Medical
records:
obtaining
health
and
lifestyle
data
about
the
deceased
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| HSC(IS)153
does
not
mention
access
to
records.
In
the
1980s
the
position
of
a
researcher
who
wished
to
obtain
information
from
records
of
the
dead
was
not
clear
cut.
There
was
uncertainty
about
what,
if
any,
ethical
clearance
a
researcher
required
when
he
had
had
no
contact
with
or
consent
from
the
deceased
during
life,
but
wished
to
obtain
information
about
the
deceased's
previous
health
or
life
style
in
order
to
correlate
post
mortem
findings
with
health
and
life
events.
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| For
many
studies,
researchers
planned
to
retrieve
health
and
personal
information
from
the
records
of
dead
patients,
from
the
recollections
of
general
practitioners,
other
doctors
or
from
relatives
of
the
deceased.
This
access
posed
questions
about
who
should
give
consent
for
the
researcher
to
see
the
records.
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| As
a
result,
before
1991
practice
varied.
Some
Ethics
Committees
expected
researchers
to
submit
protocols
that
involved
retrieval
of
clinical
data
on
dead
persons
who
had
not
given
their
consent
to
collection
of
their
personal
or
health
information.
Other
Ethics
Committees
were
less
concerned
about
the
retrieval
of
data
about
deceased
persons.
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| A
further
complexity
occurred
when
the
dead
person's
health
or
lifestyle
data
was
to
be
accessed
by
a
researcher
to
check
whether
the
deceased
was
suitable
as
a
research
'control'.
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| General
Medical
Council
guidance
on
'Professional
Conduct
and
Discipline:
Fitness
to
Practise' |
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| The
following
excerpts
provided
by
the
General
Medical
Council
from
guidance
issued
to
registered
medical
practitioners
between
1980
and
2000.
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| August
1980 |
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| A
section
of
this
guidance,
headed
'Professional
Confidence',
states:
'The
following
guidance
has
been
given
on
the
principles
which
should
govern
the
confidentiality
of
information
relating
to
patients:
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i. It
is
a
doctor's
duty
(except
as
below)
strictly
to
observe
the
rule
of
professional
secrecy
by
refraining
from
disclosing
voluntarily
to
any
third
party
information
which
he
has
learned
directly
or
indirectly
in
his
professional
relationship
with
the
patient.
The
death
of
the
patient
does
not
absolve
the
doctor
from
the
obligation
to
maintain
secrecy.
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ii. There
are
some
exceptions
to
this
principle
…
(e)
information
may
be
disclosed
for
the
purposes
of
a
medical
research
project.
In
such
a
case
the
project
should
have
been
approved
by
a
recognised
Ethical
Committee
appointed
for
such
a
purpose'.
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| August
1983 |
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| The
same
heading
of
the
updated
guidance
states:
'The
death
of
the
patient
does
not
absolve
the
doctor
from
the
obligation
to
maintain
secrecy'.
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| The
exception
in
relation
to
disclosure
for
medical
research
states:
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| 'h. Information
may
also
be
disclosed
if
necessary
for
the
purpose
of
a
medical
research
project
which
has
been
approved
by
a
recognised
ethical
committee'.
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| August
1985 |
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| The
introductory
section
and
section
h,
as
above,
has
not
changed,
but
there
is
a
new
section
in
relation
to
disclosure
after
the
death
of
the
patient:
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'6. The
extent
to
which
disclosure
of
medical
information
after
the
death
of
a
patient
is
regarded
as
improper
will
depend
on
a
number
of
factors,
for
example:
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(i)
the
nature
of
the
information
disclosed;
(ii)
the
extent
to
which
such
information
has
already
appeared
in
published
material;
(iii)
the
circumstances
of
the
disclosure,
including
the
period
which
has
elapsed
since
the
patient's
death.
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| The
Council
feels
unable
to
specify
an
interval
of
years
to
apply
in
all
such
cases,
and
a
doctor
who
discloses
such
information
without
the
consent
of
the
patient
or
a
surviving
close
relative
of
the
patient
may
be
required
to
justify
his
action'.
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There
was
further
revision
of
the
guidance
in
1992
which
did
not
affect
the
principles
of
disclosure
after
the
death
of
an
adult
patient,
set
out
in
the
1985
guidance.
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| 2000 |
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| The
GMC's
advice
'Confidentiality:
Protecting
and
Providing
Information'
contains
a
new
section
on
medical
research,
but
the
prohibition
on
disclosure
after
the
death
of
a
patient
remains
similar
to
the
1985
guidance.
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| Access
to
Health
Records
Act
(1990)
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| This
Act
provided
the
right
of
access
by
an
individual,
or
in
some
circumstances
his
representatives,
to
his
own
health
record
and
to
correct
any
inaccurate
information
in
that
record.
Section
3
lists
those
who
may
apply
for
access
to
a
health
record,
but
the
list
does
not
refer
to
any
right
of
access
by
researchers
to
health
records
of
living
or
dead
people.
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| In
addition,
the
Red
Book
on
page
5
states
'an
LREC
must
be
consulted
about
any
research
proposal
involving
access
to
the
records
of
past
or
present
NHS
patients'.
This
clarified
for
the
first
time
the
need
for
researchers
to
obtain
Ethical
Committee
approval
for
access
to
the
health
records
of
dead
NHS
patients.
Paragraphs
3.12
and
3.13
in
the
1991
book
impose
a
duty
on
LRECs
to
consider
research
that
involves
access
to
records
where
'individual
consent'
is
impossible,
as
will
clearly
be
the
case
where
the
data
subject
is
dead.
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| Coroners
Rules
(1984) |
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Records
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| For
Coroners'
cases,
access
to
the
post
mortem
report
is
regulated
by
Rule
10
which
requires
the
Coroner's
agreement
to
any
disclosure
of
the
report.
However,
the
Coroner
has
discretion
to
disclose
other
documents.
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| Rule
56:
'Retention
and
delivery
of
documents':
'…Provided
that
the
coroner
may
deliver
any
such
document
to
any
person
who
in
the
opinion
of
the
coroner
is
a
proper
person
to
have
possession
of
it.'
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| Rule
57:
'Inspection
of,
or
supply
of
copies
of,
documents
etc'
is
similarly
worded
to
rule
56
and
allows
access
to
documents
at
the
discretion
of
the
Coroner.
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| Data
Protection
Act |
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| In
1998
the
legal
position
of
data
access
was
clarified
in
the
Data
Protection
Act
(1998),
and
by
the
appointment
of
the
Data
Protection
Commissioner
(now
Information
Commissioner).
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NHS
confidentiality:
Code
of
Practice
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| Discussions
are
currently
proceeding
on
the
scope
and
content
of
a
Code
of
Practice
on
confidentiality
for
the
NHS.
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| Involvement
of
Ethics
Committees
in
research
on
the
dead
in
Manchester
University
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| As
Chapter
8
records,
all
research
studies
on
patients
undertaken
by
the
Cerebral
Function
Unit
were
submitted
for
and
received
approval
from
Ethics
Committees.
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| Chapters
12,
13,
14
and
15
discuss
the
protocols
submitted
to
Ethics
Committees
by
the
joint
research
team
from
the
Departments
of
Psychiatry
and
Physiology.
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| Ethics
Committee
involvement
at
other
locations
is
discussed
in
the
chapter
on
each
location.
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| Summary |
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| Ethics
Committees
were
first
established
in
the
1960s
since
when
their
role
has
evolved.
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| Until
1991
Ethics
Committees
were
not
required
to
consider
research
on
the
dead.
From
1980
the
General
Medical
Council
gave
guidance
on
the
confidentiality
of
medical
records,
including
records
of
dead
patients.
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