Changes To Legislation
9.1 This proposal is referred to in Term of Reference
Five. By far the most important change which is required to make the
National Cervical Screening Programme fully effective is the removal
of the legal barriers which are preventing the comprehensive evaluation
of the Programme from proceeding. Since the closure of the public
hearings the Committee has received affidavit evidence from the Ministry
of Health which informs it of proposed legislative changes to remove
these barriers. Although it appears the Government is committed to
addressing the problem presented by these legal difficulties, the
information the Committee has received does not indicate how the problem
will be solved, nor do the proposals go far enough in grappling with
the difficulties which the proposed legislation is intended to overcome.
9.2 The advisory papers which the Committee have
seen admit the existence of the problem, set out options and suggest
there should be wide consultation before anything is done. There appears
to be a concern that any departure from requiring a woman’s consent
before her protected information is made available to an evaluation
team will be contrary to notions of informed consent, the recommendations
made in the Cartwright Report, and will cause women to leave the Programme
to the extent that there may be insufficient numbers left to make
analysis of the information worthwhile. No empirical basis to support
this view is put forward.
9.3 The Committee has seen ample evidence to support
the need for a comprehensive national evaluation of the Programme
which includes a cancer audit. It has also seen ample evidence to
convince it that no cancer audit is likely to go ahead, if consent
of the women being audited is required. For example Professor Skegg
proposed carrying out an audit of 42 women from the Gisborne region
who had developed cervical cancer. The purpose of the audit was to
enable the Committee to report on term of reference one. At the time
of the proposed audit it was thought that it was the only way of learning
whether or not there had been an unacceptable level of under-reporting
in Gisborne. Professor Skegg could not get ethics committee approval
for his audit unless he obtained the consent of the women concerned.
There were problems with identifying the women and obtaining their
consent. In addition there was the further problem that some of them
might not consent to their medical case being audited. He told the
Committee that to require him to obtain the consent of the women concerned
posed significant problems for the audit because if only 30 women
out of 42 consented " it would then be difficult or impossible
to draw any firm conclusions relating to term of reference one."
The Committee has heard from a number of expert witnesses about the
necessity to have a sufficient number of subjects to be able to learn
anything meaningful from any epidemiological study or an evaluation
exercise.
9.4 The cancer audit was identified by the Cervical
Screening Advisory Committee as one of the three high priority phases
in the proposed 1997 evaluation which must go ahead. As at March 2001
it still has not been completed. In a briefing paper to the Minister
of Health the Ministry accepted that the cancer audit will enable
defects in systems or treatment to be detected and will improve the
Programme’s safety and effectiveness. However, the briefing paper
sets out a number of concerns about the impact any change in legislation
will have on the privacy of women. The paper appears to be driven
by a concern that unless the privacy of women participating in the
Programme is given top priority women may stop participating in the
Programme. It, therefore, suggests that before any change is made
there should be extensive consultation with women and women’s groups.
9.5 From the material the Committee has seen there
appears to be an undue focus on informed consent. The material quotes
a recommendation from the Cartwright Report which states that:
" Permission might be sought
for purposes other than implementing the screening programme when
research and evaluation of results was contemplated. There should
be consultation with authorities in the field of privacy law to
ensure that confidentiality will be guaranteed to all women whose
names and identifying details are contained on the register"
However, it needs to be remembered that this recommendation
was made in an entirely different context and that the Cartwright
Report was not inquiring into a failure of a screening programme as
has occurred in Gisborne. What has occurred in Gisborne emphasises
the need for effective monitoring and evaluation of all aspects of
the Programme.
9.6 The present circumstance is different from that
which was considered in the Cartwright Inquiry where women found themselves
the subject of medical experimentation without their consent. Here
all that is involved is allowing persons to examine information already
obtained from women for the purpose of checking to see if they were
appropriately treated. In the Committee’s view, this evaluation could
be viewed as a necessary part of the treatment the women have received,
rather than separate from it.
9.7 The lesson to be learned from unduly focussing
on informed consent should have been learned from the deficiencies
of the opt-on screening registers. The choice of opt-on registers
was motivated by concerns to accommodate women exercising informed
consent. The result was sub-optimal registers which had to be replaced
three years later. There is little point in encouraging women to have
smear tests if the quality of the smear test diagnosis is never checked.
Professor Skegg described the absence of any comprehensive monitoring
and evaluation exercise for the Programme 10 years after its establishment
as being "outrageous and unethical." The Committee agrees
with this view.
9.8 The choice for the Programme is stark. Effective
evaluation can not be guaranteed if women’s consent is required; if
the right of an individual to consent to access to her now-protected
information is to predominate the Programme cannot effectively evaluate
its effectiveness and therefore the safety of all women participants
is potentially at risk.
9.9 There is nothing to be gained from adopting a
procedure which requires an evaluation team first of all to approach
women to request access to their now-protected information, but then,
in order to preserve the value of the study, allows the team access
to this information when consent is not forthcoming. A right of consent
which can be overridden in this way is not a true right of consent.
It would be insulting to women’s intelligence to offer them such a
hollow right.
9.10 There are many instances where personal privacy
concerns must yield to the need to gain access to private information.
The issue is not one of giving general public access to the National
Cervical Screening Register. All that is being sought is for medically
qualified persons and their assistants to have access to the Register
for the purpose of checking that things were done properly.
9.11 Today quality assurance and audit and evaluation
are so much a part of health delivery that it could be said that it
is no more than one of the components of the original treatment, which
happens to be carried out later on. On this view treatment which does
not include a subsequent audit could be seen as incomplete treatment.
At present there is no barrier to laboratories auditing their work
on smear tests because they are seen as the women’s original health
provider. A laboratory can access from the National Cervical Screening
Register a print-out of a woman’s smear test history and any recorded
histology results for the purpose of carrying out an audit of its
work. Looked at realistically a woman’s experience when her medical
case, including smear test history, is audited is no different whether
that is done by the laboratory which read her slide, or by an evaluation
team which is engaged by the Ministry of Health. In both cases she
is unlikely to know that the audit has occurred unless something irregular
is found. In that case in the Committee’s view she has a right to
know of the irregularity.
9.12 The Ministry of Health has received legal advice
that the evaluation could go ahead without women’s consent, if the
evaluation team lost its independent character and became employed
agents of the Ministry. Thus by a change of legal status the same
people would then be able to see the same information that they were
previously denied access to. An important exercise like the national
evaluation should not turn on such legal technicalities.
9.13 The Committee considers that the failure to
carry out a cancer audit is denying those women whose treatment has
been irregular this knowledge. Women have a right to know whether
or not their treatment has been irregular and as that is something
that is difficult for them to discover for themselves, and costly
where the irregularity is disputed, the Programme has an obligation
to ensure that women receive this knowledge. In its present form the
Programme has no effective quality assurance for its performance since
the gold standard test for determining its effectiveness cannot be
carried out for legal reasons.
9.14 If this state of affairs is to continue, then
women enrolling and enrolled in the Programme should be clearly informed.
They should be told that they are participating in a Programme which
cannot carry out the most effective means of monitoring the Programme’s
success. Only then will they be in a position to exercise informed
consent to participate in the Programme. The Programme issues written
material which gives the impression that monitoring and evaluation
of all aspects of the Programme is being carried out. This is not
correct. Some aspects of the Programme are monitored and evaluated,
however, nothing effective is being done to monitor and evaluate laboratory
performance. The exercises which are carried out are nothing like
the cancer audit. Women should be told that the monitoring and evaluation
which is now carried out is not able to detect misread smear tests.
Without this knowledge they can not exercise an informed choice as
to whether or not to participate in the Programme or opt for opportunistic
screening on a more regular basis than the three-year time frame used
by the Programme. It is demeaning to women to place an emphasis on
their rights of informed consent (when considering legislative change
which removes their right to refuse access to their now-protected
information), and yet to not be open about the limitations of the
Programme in which they are encouraged to participate.
9.15 There appears to be a concern or fear that if
women receive any bad news about the Programme they will leave it.
In the Committee’s view while the concern is understandable, it is
not acceptable to act in this way. In the Committee’s view it is unethical
to encourage women to participate in a programme without letting them
know of the Programme’s limitations.
9.16 In the Committee’s view the time has come for
the Government to introduce legislative change through primary legislation
which will ensure the Programme functions effectively and is safe
for women. To achieve this goal independent evaluation teams of medically
qualified persons must be given unhindered access to now-protected
information. Concerns about consumer ownership of the Programme and
how that might be harmed by reduced protection of information must
take second place. A simple legislative scheme contained in primary
legislation which allows comprehensive evaluations to occur, by both
external teams or Ministry-led teams, without the need for consent
from the subjects or ethics committees is the best and most effective
solution.
Changes To Guidelines Under Which Ethics Committees
Operate
9.17 The proposal is not covered by Terms of Reference
Four or Five. The Committee has had first hand experience of encountering
difficulties in obtaining information which requires ethics committee
approval. Initially, Professor Skegg proposed a cancer study as a
way of providing evidence for the Committee to answer Term of Reference
One. He submitted a protocol to the Tairawhiti Regional Ethics Committee
and late in April that Committee gave consent for the study to proceed,
but on the condition that the consent of all the women first be obtained.
Professor Skegg was of the view that the study could not go ahead
on this basis because of the need to have as complete a sample of
cases as possible. The purpose of Professor Skegg’s study was to look
at the treatment of 42 women who had developed cervical cancer with
a view to discovering whether or not their treatment provided evidence
of unacceptable under-reporting by Gisborne Laboratories. The study
never went ahead. The Committee was able to rely on other evidence
to be able to reach a conclusion under Term of Reference One. However,
if this other evidence had not been available, the Committee could
well have found itself in a position where a reliable means of obtaining
evidence to answer Term of Reference One was barred to it. Professor
Skegg was understandably critical of the role of ethic committees
in this regard. He expressed certain concerns including :
That the committees suffered from a lack of oversight
and they had not been evaluated;
Regional ethics committees gave rise to a fragmented
approach, as committees around the country reached different decisions;
Committees sometimes fail to see the cost of not
doing things, for example the cost in terms of lives lost because
of failure to do a proper audit evaluation on the Cervical Screening
Programme.
9.18 Professor Skegg expressed concern about the
way in which Committees approach the Health Information Privacy Code
and how they interpreted it. He made the point that if current concerns
about protection of privacy and ethics committees’ approval had prevailed
at a time when the medical research upon which the article in Metro
that led to the Cartwright Inquiry was written, that inquiry may never
have happened. It was the assemblage of material by McIndoe et Al
that was necessary for the independent assessment of Professor Green’s
research. It was the McIndoe et Al research which alerted the authors
of the Metro article to the events at National Women’s Hospital. Without
that research the Metro article could not have been written, and there
may never have been an inquiry into the unfortunate experiment at
National Women’s Hospital. The medical research was written at a time
when there was no Privacy Act and the requirements for research to
be subject to ethics committee approval was less rigorous. Similar
sentiments were expressed by Dr Cox.
9.19 Professor Evans initally disputed this possibility,
however, as a result of information provided to the Committee by Mr
Rennie, counsel for the Royal College of Pathology of Australasis
all parties to the Inquiry, including counsel for the Regional Ethics
Committees, accepted that Dr McIndoe and the other medical practitioners
who contributed to the research were not involved in the care of the
women upon whom the research was based. Furthermore, the Cartwright
Report records that Professor Bonham referred to McIndoe et Al as
reviewing the cases of other consultants without approval. In the
Committee’s view Professor Skegg is most probably correct. If McIndoe
et Al were not participating in the care of the women involved they
would have had difficulty obtaining access to the women’s records
without their consent. As it would be unlikely for persons in McIndoe
et Al’s position to approach women for their consent the more likely
outcome would have been that the research was not done. Thus it seems
that the Cartwright Inquiry may never have happened if the current
ethical and legal requirements for conducting medical research had
been in place at the time the unfortunate experiment was being conducted
at National Women’s hospital.
9.20 Professor Skegg gave an example of the first
statistical report omitting Wellington data because the local ethics
committee would not agree to its release. He described them at times
as being a barrier to research, and said that the culmination of ethics
committees, privacy concerns and s.74A had created a logjam insofar
as a cancer audit of the cervical screening was concerned.
9.21 The Committee also heard from Professor Evans
who is a professor of bioethics at Otago University, and is on the
Otago Regional Ethics Committee. Having heard all the evidence it
has become clear to the Committee that at present, ethics committees
are operating under National Guidelines For Ethics Committees In
New Zealand, these are issued by the Minister of Health.
They also take heed of international documents such as the Helsinki
Declaration and the CIOMS Guidelines.
9.22 The Helsinki Declaration and the CIOMS Guidelines
do not expressly refer to audits or evaluation of medical programmes
or medical treatment. Professor Evans’ view was that they did, but
that was by implication. When he was taken to these documents, in
the Committee’s view, he did not provide a satisfactory explanation
for reading this implication into them. The Committee, therefore,
does not find them relevant to audits or evaluations of medical treatment.
9.23 The National Guidelines For Ethics Committees
In New Zealand are somewhat different. The difficulty with
these guidelines is that they are not well expressed. The Committee’s
view is that they need to be reconsidered. The confusion concerning
these guidelines arises because they contain three separate references
to auditing and monitoring. Clause 3.1 headed Research or Innovative
Treatments Involving Human Participants states : all proposed health
and disability research investigations must be submitted for appraisal
by an accredited ethics committee where the investigation involves
human participants whether health or disability service consumers,
healthy volunteers, or members of the community at large, and … involves
access to personal information for purposes other than direct patient
care or internal clinic audit. Thus, clause 3.1 excludes internal
clinical audit from ethics committee approval. Clause 3.3 declares
the matters not requiring ethical appraisal, and says that these are
outlined in greater detail in appendix 5 and that they include audit,
which can be defined as examining practice and outcomes in a particular
time and place to see whether they conform with expectations with
a view to informing and improving management rather than adding to
general knowledge, and access to personal health information for the
purpose of monitoring the quality of care.
9.24 Appendix 5 which is headed Matters Not Requiring
Ethics Committee Appraisal states : Audit - where the audit is undertaken
by or under supervision of senior members of the healthcare or disability
services team directly responsible for the care of that group of health
and disability support service consumers, and where there is no access
to confidential medical information by persons who do not owe a professional
duty of confidentiality to those consumers. Audit can be defined as
examining practice and outcomes in a particular time and place to
see whether they conform with expectations with a view to informing
and improving management rather than adding to general knowledge.
This means that the patient’s caregivers can use the patient’s private
information to audit treatment. Whether or not an independent evaluation
team comprised of medical experts and their assistants can do so is
questionable. These persons would, as medical practitioners, owe an
ethical duty to preserve the confidentiality of the patient’s information.
However, there is no patient-doctor relationship between the evaluation
team and the patient. It is unlikely that the evaluation team can
be said to owe a professional duty of confidentiality to those consumers,
for the reason that there is no professional relationship between
them.
9.25 Under the heading Access to Personal Health
and Disability Information for the Purpose of Monitoring the Quality
of Care it is said – access to personal health and disability information
for the purposes of monitoring the quality care. At an institutional
level this may go beyond the processes involved in internal clinical
audit and may require expertise possessed by members not involved
in a healthcare or disability services team, for example expertise
in statistical methods, pathological diagnosis or classification.
Ethical committee review is not required for this process as long
as all persons involved in the process are operating under the same
professional standard as the individual’s caregiver. This may cover
the independent evaluation team. The medical practitioners working
under that team would be operating under the same professional standards
as the individual’s caregiver. This provision contemplates persons
not involved directly in healthcare having access to the information.
9.26 In the Committee’s view the evaluation to be
carried out by the independent evaluation team fits the description
of monitoring the quality of care. That provision in appendix 5 also
appears to provide for persons not directly involved in the healthcare
or disability services team to be involved in the monitoring process.
However, the ethics committees which applied these guidelines to the
national evaluation obviously considered that their approval was necessary,
otherwise they would have refused to deal with the application on
the basis that their approval was unnecessary.
9.27 The Committee considers that whoever drafted
the guidelines obviously intended to exclude monitoring and auditing
exercises and therefore evaluations as well. It is important, therefore,
that the guidelines are expressed in such a way that they accurately
reflect the reality of how monitoring and evaluation is carried out
in the health sector today. The Committee has heard evidence that
it is usual to use independent contractors under short term contracts
to carry out these tasks. This is because the Ministry does not itself
employ persons with all the necessary skills to be able to carry out
the exercises using in-house personnel. If this is so, and if it is
also the reality for other sections of the health sector, it is important
that the guidelines to ethics committees clearly exclude exercises
of this type from the need for ethics committee approval. Otherwise,
the result will be, as can be seen from what has occurred with the
national evaluation, a logjam in which the monitoring and evaluation
exercise is either delayed or never carried out.
9.28 Since the closure of the public hearings the
Committee has received an affidavit from the Director-General of Health.
This affidavit advises the Committee that the Ministry has carried
out extensive researches into practices overseas with a view to highlighting
general health ethical issues that have international support. Dr Poutasi
advised the Committee that an extensive comparison of ethical review
practices overseas had shown that international ethical review bodies
do not and should not have a mandate to ethically review service evaluation
activities. She said that the international consensus that is currently
emerging suggests that research and audit/quality assurance activities
need to be differentiated in order to guide ethics committees. That
whereas ethical oversight was appropriate in research activities,
it was superfluous in quality assurance activities. The Committee
thoroughly supports this approach. The Committee has seen at first
hand how the intervention of ethics committees in audit and evaluation
activities can result in those activities not being carried out. Dr Poutasi
noted that in New Zealand and elsewhere ethics committees appear
to believe that they have jurisdiction in both research and quality
assurance activities, and that it was desirable to clarify when ethical
oversight is appropriate. The Committee considers that this must be
done as a matter of urgency. For too long the evaluation of the National
Cervical Screening Programme has lain dormant. A major contributory
factor to this is the decisions of ethics committees. The Committee
can see no logical reason for involving ethics committees in approving
audit / quality assurance activities. In today’s climate these activities
should be seen as an integral part of a patient’s treatment. Indeed,
what has occurred in regard to the evaluation of the National Cervical
Screening Programme has for the moment, in the Committee’s view, rendered
the Programme unethical in the sense that women are participating
in this Programme without being told of its limitations.
9.29 The Committee also considers that further thought
needs to be given to the status of independently funded evaluation
studies. The Committee learnt from Professor Skegg that, as an epidemiologist,
he considered that he would not be able to gain access to sufficient
information to allow him to carry out an independently funded evaluation
study of the Programme if he wished. The Committee considers that
there is a place for independently funded evaluation studies of medical
treatment.
9.30 There is much to be gained from a health system
where private medical researchers are free to carry out such studies.
For example, the Committee learnt from Professor Skegg that, in his
view, there was a need to do a study of breast cancer, because New
Zealand has the second-highest death rate in the OECD, and he believed
that some of the high mortality may be due to women not receiving
the best treatment. He said that someone needed to do an audit of
the treatment of breast cancer in New Zealand. In his view he
did not think that anyone would even propose doing such a study at
the moment because they would not expect the ethics committees to
approve it.
9.31 Whether that statement about ethics committee
approval is accurate or not, it is an indication of how medical researchers
currently view access to information. Granting such persons access
to information has an additional benefit where a health authority
may not be carrying out the task. For this reason the Committee thinks
that when reconsideration of the guidelines to ethics committees occurs,
thought should be given to making provision for private evaluation
studies of medical treatments to go ahead in a less confined environment
than the researchers now believe applies.
9.32 The impression the Committee gained from Professor
Evan’s evidence was that there was ethics committees were confused
about the inter-relationship of the Privacy Act, the Privacy health
and Information Code and the Official Information Act. This suggests
to the Committee that the ethics committees would benefit from having
at least one legally qualified person on each regional committee.
9.33 The Committee was also concerned to hear that
the presence of regional ethics committee caused researchers problems
when the research covered more than one area. The different regional
ethics committees have caused problems for the Programme, for example
the decision of the Wellington Ethics Committee not to release data
from that region to the Programme for the preparation of the First
Statistical report. This suggests that for national studies there
should be a national ethics committee.
