It was felt that much of the
controversy surrounding Alder Hey arose because of
the poor standard of the consent form. The Department
of Health ( 1)
(DOH) published the results (December 2000) from a
national study investigating how hospitals around the
country obtain agreement from relatives for post-mortems.
167 hospital trusts, with pathology services, participated.
The main conclusion drawn from the study was the lack
of clear explanations about the nature of the examination.
'Clarity is the key' but not at the risk of making
the form too long and overwhelming, requiring parents
to make numerous decisions.
Some of the main criticisms from this study are outlined
below:
Wording of the form.
- The standard form states that the examination 'may' involve
the retention of tissue for laboratory study when
this is agreed to be a standard procedure. The use
of 'may' is therefore misleading.
- The word tissue is not clearly defined.
Some of the investigators felt this would imply external
tissue rather than internal tissue. It was also being
used to include organs, without making this clear.
College guidelines state that…..'Ethically,
it is important that any tissue retained must match
the relatives' perception of what they agreed to
being retained and its purpose.'
Minimal information regarding the purpose of the
examination
These have been outlined above.
Lack of clear options for relatives
There was no indication on many of the forms that
the relatives could limit the post-mortem if they so
wished. A suggestion from the Forum is that we could
offer 'packages'. These would outline different options
that are available and their implications. It should
be clear though that a limited post-mortem would therefore
limit the findings available for the parents and may
miss vital information in the diagnosis.
Absence of information about storage and disposal
of retained tissue or organs
- This should deal with the issue of tissue being
stored as wax blocks of tissue and slides that are
archived and retained for possible future reference.
- To avoid the need for repeat consents, the option
of organs/tissue being used for medical research
and education needs to be clarified and consented
for.
- The option for organs to be returned to the body
for the purposes of funeral, although a time delay
may be involved. For instance, a fetal brain is very
difficult to examine and is usually placed in preserving
fluid for up to a week before examination.
- Options for disposal: burial, cremation and funeral
arrangements. This is a more difficult area when
dealing with fetuses that have been miscarried in
the first trimester and may only measure a few centimetres
in length. Protocols need to be in place for these
situations. Does an ectopic specimen require a consent
form for example? The College of Pathologists do
state in their guidelines that 'parental agreement
must be obtained 'regardless of gestational age' although
interestingly, the HTA 1961 (Human Tissue Act) only
strictly applies to those who were born alive.
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Suggestions:
- Clear and unambiguous language
- To provide an information leaflet to the
parents to accompany the consent form
- To give a copy of the agreement to the
parents
- To offer a package of options for parental
consent
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Conclusion
This is an important area that requires legal, ethical
and emotional understanding by staff involved. Sadly,
Alder Hey has made it obvious that our consent forms
are lacking in detail and need to be updated and clarified.
There is, at present, no specific consent form dealing
with the perinatal post-mortem. We are aiming to have
a follow-up Forum on this subject to see the improvements
and adjustments made in the wake of the Alder Hey investigations.
This is a subject that should be reviewed periodically.
References
1. Consent to organ and tissue retention at post-mortem
examination and disposal of human materials. Department
of Health publication. December 2000
2. The Fetal and Infant Post-mortem: Brief notes for the professional. CESDI publication
1998 (please note that this is in the process of being reviewed)
Further information
1. Stillbirth and Neonatal Death Society (SANDS) 0207
436 5881
2. The Foundation for the Study of Infant Deaths (FSID) 0207 235 1721
3. Antenatal Results and Choices 0207 631 028/439 6124
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