Women's Health Action Submission on the Draft Operational Std for Health & Disability Ethics Committees

Submission on the Draft Operational Standard for Health and Disability Ethics Committees From the Women's Health Action Trust

13 August 2001

General Comments

Women's Health Action has a long-standing interest in ethics committees. While we are pleased to finally have the opportunity to comment on the Draft Operational Standard for Health and Disability Ethics Committees we have been frustrated by the length of time the review of the standard has taken and the lack of transparency in the process. We would have preferred to have had some involvement in the review at a much earlier stage

Our organisation is very supportive of the role of ethics committees in ethical review although it is our view that the committees have suffered from the lack of a National Ethics Committee able to provide national leadership and support. Whilst it is most appropriate that the National Ethics Committee take on the responsibility of future reviews of the Standard, the terms of reference recently announced by the Minister are of particular concern.

We continue to argue that ethics committees should come under the umbrella of the Health and Disability Commissioner. This is the most appropriate location as the key focus of ethics committees is on the rights of people in a research or treatment setting. The Code of Rights specifically applies to research settings and to situations where innovative therapies and new treatment protocols are being used.

We would also like to see the requirement for the National Operational Standard to apply to all health ethics committees, not just regional ethics committees. It has been of concern that over the past few years new ethics committees have been established by CHEs and private sector bodies. We believe that all health ethics committees should be required to have approval by the National Ethics Committee, and that these should meet the requirements of the standard and should be accredited by a national body, whether the National Ethics Committee or the Ethics Committee in the Health Research Council

Overall, we found the draft standard to be very wordy, sometimes contradictory and laborious to read in parts.

1.1 Guiding Principles
(page 7)

We believe that these should be reordered so that 'respect for persons' and 'informned consent' come before 'scientific validity and merit'. The primary function of ethics committees is to protect public safety. This should be reflected in the ordering of prlnclples.

We also argue that an additional principle should be added. These are:

1. 'Observance of health consumers'/patients' rights' - this is broader than the 'informed consent' of the existing list and recognises the existence, in the NZ setting, of the Health Commissioner and Code of Health & Disability Consumers' Rights.

Likewise, consideration should be given to eliminating the term 'patient' as this is inconsistent with recent terminology in this area.

2. 'Observance of human rights'. We believe this would embrace international conventions on human rights to which New Zealand is a signatory as well as NZ legislation on human rights. While the standard recognises that there are some particular populations of vulnerable populations because of diminished autonomy or competence, it does not recognise that some large population groups are particularly vulnerable because of their relative lack of power in the wider community.

This is covered to some extent in the section on 'justice', but it is more appropriate to recognise specific New Zealand rights in the principles, rather than generic and somewhat vague philosophical concepts.

The research community and those with most power in the medical community tend to be white males doctors. Lay people of other ethnicities, and women, have less power in research and treatment settings. It was not accidental that women were the subjects of the 'unfortunate experiment' nor that blacks were the subject of the Tuskegee trial. A commitment to observing human rights would highlight the need to protect the rights of these groups.

1.1.1(page 9) - the list in para 25 should include women seeking abortions as a special group. This is discussed later in this submission.

Relevant Legal Provisions
(Page 9)

The Local Government Official Information and Meetings Act 1987 needs to be included in this section as this legislation ensures transparency and public access to the process of ethical review. It also needs to be included in the Appendix 3 list on page 81.

Right 9 of the Code of Health and Disability Services should be added to this section as it specifically states that "the rights in this Code extend to those occasions when a consumer is participating in, or it is proposed that a consumer participate in, teaching or research".

Right 4 (2) also needs to be added, as this right requires all researchers obtain ethical approval prior to efforts to recruit participants.

As the draft standard specifically states that participation in innovative practice or research, or consent to use health information, must be voluntary and not subject to any form of coercion, inducement or intimidation the legal provisions section needs to also refer to Right 2 of the Code of Rights.

As women have historically been excluded from major research studies (because of perceived difficulties in including them) the provisions relating to discrimination in Right 2 are most relevant.

Informed Consent
(Pages 9-12)

We have concerns that the funding available to a research study usually determines whether non-English speaking people are included because of the cost of interpreter services. We have always supported a national interpreter service being established under the umbrella of the Health and Disability Commissioner as the advocacy service is. This would enable access to properly trained interpreters, as they are required, in order to meet Code of Rights obligations. The present system allows for discrimination against some potential participants on the basis of their limited understanding of English. There is also the potential for people with limited English to be included in research without really understanding what they have consented to, or being wrongly informed by an untrained person acting as an interpreter (eg family member or friend) because of the reluctance to purchase interpreter services.

27 should be expanded to include:

the proper title of the research
the person/persons conducting the research and how to contact them
how to complain
the right to withdraw at any time

There is nothing in this section about approaching people in emergency/crisis/stressful situations. For example, women during labour, a person presenting with a heart attack. Special care should be taken in these situations to ensure that the person is able to consent and that the approach does not cause more stress to the person.

1.1.5 Compensation
(Page 15)

This section highlights the risks to participants in research in the New Zealand setting under the current accident compensation legislation. The bill before Parliament continues the harsh tests for compensation following medical misadventure.

It is critical that the National Ethics Committee takes responsibility for ensuring that all potential participants are fully aware of situations where they would not covered or inadequately covered. It should not be left to researchers or regional committees. The national committee should develop national consumer resources in a full range of languages which researchers would be required to use.

The statement in 61 is unacceptable and/or ambiguous. Any procedure or test that is carried out on a research participant that is not part of diagnosis/treatment is extraneous and must be covered.

Activities not requiring ethical review
(Page 28)

We do not support the provisions in 3.1. It is our view that resource allocation, access to services and rationing of services do involve ethical issues that need to be discussed and reviewed in relation to their possible impact on people. Decisions on these matters have implications for people that could cause harm.

This section is unduly draconian and controlling. There is a presumption that rationing decisions will be based on sound criteria and ethical. There is no basis for assuming this.

Rationing decisions should be open for ethical review to provide transparency and the ability to examine the soundness of such decisions.

If the National Ethics Committee is to be subject to this standard, it would prevent that committee examining such decisions, which would make the committee weak and feeble indeed.

The Government should welcome ethical review of such decisions, to ensure that they are soundly based and sustainable.

Clinical Practice
(Page 28)

We would like to suggest another example be included in 114:
Situations where a patient and doctor (or other) practitioner disagree about the treatment and the matter is unable to be resolved by usual means such as second opinions, pursuing other options etc

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Part 4

National Advisory Committee on Health & Disability Support Services Ethics
(Page 31)

We consider it most unfortunate and undesirable for the National Committee to be established as a ministerial advisory committee. Leadership, direction, guidance, coordination and support for all the various ethics committees reviewing research and innovative therapies involving human participants are needed. Previous consultation processes have revealed strong support for a national committee with overarching responsibility for the manner in which all human ethics committees conduct their activities. We are disappointed that this approach has not been pursued. At the very least, the standard should clarify the relevance of its application to all such committees.

The work and credibility of the National Committee will be adversely affected by the lack of independence proposed. We do not support the relationship with the Minister of Health that has been outlined. The committee should have the autonomy to identify those areas where its input is required and to be able to proceed unhampered by political interference. It must be free to initiate investigations and reviews, in its own right.

The committee could report on these matters to the Minister on a regular basis, but it is preferable that it report directly to Parliament, highlighting the status and independence that this committee should have.

The brief of this committee should place priority on networking and liaison with all human ethics committees to enable it to be active in generating a nationwide collaborative working relationship with all committees.

(page 32)

There is a reference to a committee we have never heard of. We are interested to hear when the National Health Research and Innovative Practice Review Committee was established, who is on it and what their terms of reference are.

National Ethics Committee on Assisted Human Reproduction
(page 32)

We would like to see including potential offspring' added after the rights of the people involved will be protected so there is no ambiguity over whether people refers just to those presently in existence.

More importantly, we believe that NECAHR should have as its paramount focus, protection of the interests, rights and welfare of the child. This is not so at present, and in the current situation the rights of adults to access services and techniques have been paramount. This should be the first function listed for NECAHR.

Health Research Council Ethics Committee
(page 32)

This committee should also be required to meet the National Standard, particularly in relation to membership composition. It seems odd for this committee to have the role of providing advice on membership, procedures and standards when it doesn't meet the standard itself. These functions properly belong to the National Committee.

Health and Disability Ethics Committees
(page 33)

A strength of these committees is their ability to act independently. Allowing the Director-General of Health to alter the number of committees and their regions of authority could compromise this. The DG could for example decide to reduce the number of committees to save money. This could adversely effect the quality of ethical review. We support this provision being totally removed. It is more appropriate that the National Committee be responsible for assessing, consulting and making recommendations on the numbers of committees required and their regions of responsibility. These sorts of decisions should always involve public input.

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Section 5

Statutory Approvals
(page 34)

It is not appropriate for the Director-General of Health to approve ethics committees. The DG of Health should be replaced in 137 by the National Committee.

Composition and membership
(page 35)

Health & Disability Ethics Committees should have adequate representation of women. This is not just women members, but women informed on women's health issues. This was recognised in earlier standards. In addition each committee should include a health consumer advocate. Earlier standards required this. The health advocates employed by the Office of the Health & Disability Commissioner are in a unique position to represent health consumers' rights and also report on ethical difficulties they encounter in their work.

The list of qualities required by members in 141 needs to also include perspectives. The perspectives of consumers or lay people, for example, are quite different from the perspectives of health professionals.

Whilst ethics committees are not under the umbrella of the Health and Disability Commissioner we support there being a specific place for a health and disability advocate on each ethics committee. This was the case in most areas when ethics committees were reconstituted following the Cartwright Inquiry, but has not been maintained. We support this being specifically stated in the Standard.

The definition of non-lay members is of concern. There is the potential for all the non-lay people to be retired or non-practicing health professionals. Depending on how the definition is interpreted, there is also the potential to automatically exclude people working in non-clinical areas of a health service who are not health professionals and who do not actually provide any health services at all.

This draft has removed the exclusion of those employed in a disability service (from the 1996 Standard), but left in those employed in the provision of a health service. People employed by an organisation that provides health or disability services often includes those involved with catering, cleaning, administration, information services, as well as quality, complaints and advocacy roles. It isn't reasonable to define all these people as non-lay just because they are employed by an organisation providing health services. A consumer perspective is more likely to be held by these people than health professional not currently engaged in health care delivery.

It would also be rather ironic if the efforts of organisations like Women's Health Action to encourage researchers to actively involve consumers in the development, design and conduct of research studies resulted in those consumers losing their status as a lay person. This definition is not satisfactory and requires further discussion and consultation with consumer organisations.

Duties and Responsibilities of a Member
(page 36)

Committee members should have a commitment to work for the greater public good in their responsibilities to protect the interests of participants (and potential participants) involved in innovative treatment and research - not the good of the committee. This is a very perverse statement that contradicts the principles outlined earlier in the Standard. It should be altered or removed.

Conflicts of interest
(page 37)

We support the requirement in number 7 that a member of the committee whose proposal is before the committee not take part in the committee's assessment of the proposal and leave the meeting while this occurs.

Otherwise, we support the open meeting approach where researchers and members of the public are able to be present. Researchers who are present can then be asked questions and clarify matters as required. Unless the committee decides to go into committee' on the basis of acceptable grounds (consistent with the Local Government Official Information and Meetings Act 1987) we support those present being able to hear the deliberations and decisions of the committee. This is part of the committee being accountable to its constituency.

Confidentiality
(page 37)

Most of this section is problematic and contradictory in places. Substantial changes are needed.

We consider it most important that the activities of ethics committees are conducted in an open and transparent fashion. Meetings should be in public unless there is good reason for confidential discussion to take place. If the meetings are in public then the agendas and minutes cannot be confidential. Committees conforming to the Meetings Act already provide agendas and minutes to libraries and other places to enable access by the public, media and others with an interest. This is an essential part of ensuring committees are accountable and people are informed of their processes and decisions. Only discussions and documents relating to business discussed in committee should be confidential.

We sought an opinion from the Ombudsmen in 1991 as to whether ethics committees were subject to the Local Government Official Information and Meetings Act 1987. The Ombudsmen confirmed that they were and that under this legislation those meetings of the ethics committees should be conducted in public, with the provision to go into committee when the criteria stated in the Act was met. It is important for this to be stated in the standard as there are varying practices amongst the committees.

It doesn't make sense to say on one hand that committee members should publicly support a course of action decided by a committee or not publicly comment if they don't agree when there is supposed to be consensus decision-making. This also compromises the independence of members who should be free to speak out on matters of concern. It is unethical to compel members to support something they have ethical concerns about.

Number 11 refers to the Privacy Act. It also needs to refer to the Official Information Act.

Number 12 needs to be changed to reflect the open nature of meetings with provision for confidentiality to be maintained for matters held in committee. Release of information also needs to include proposals and documents as well as the correspondence and papers referred to.

Chairperson
(page 39)

Although 5.2 refers to the lay chairperson, this section (5.7) needs to specifically state the chairperson is to be one of the lay people or it appears contradictory to 5.2.

Committee Meetings
(page 40)

This section needs to state that committee meetings will be conducted in accordance with the Local Government Official Information and Meetings Act 1987. The first sentence of

170 should say " Meetings shall be open to the public and held at such times…"

There is something rather nonsensical about having a consensus process where a majority vote is OK. It is either one or the other. We support a consensus approach. Ethics committees are able to seek additional opinions and expertise and should be able to call on the assistance of the National Committee where difficult situations arise and consensus agreement is not possible.

There is a need for consensus so that particular public interests represented on the committee are not able to be overridden. It is not inconceivable that a single committee member may have important reservations that need to be taken into account. Consensus decision-making is an important mechanism for protecting public safety.

Records
(page 42)

There needs to be a statement relating to authorised people and to procedures relating to access of files and documents to ensure the autonomy and independence of the committees is maintained as well as statutory requirements.

178 is ambiguous and the use of the word records open to interpretation. We suggest making the following addition..."Records of all proposals submitted should be retained for either the duration of a research or treatment…"

Checklist of requirements for annual reports
(page 41)

We consider the reference in 181 to confidentiality is not in keeping with the public duty role of Ethics Committees. These committees have the responsibility of ensuring those members of the public involved (or potentially involved) in research and innovative treatments are provided with adequate safeguards and protections. The committees need to be able to be seen to be carrying out this duty. Surely if a person is considered a fit and proper person to be a member of an ethics committee, members are able to collectively determine what is appropriate to have in the annual report of their activities.

Missing sections

We are concerned that the Standard does not include some important matters relevant to the effective functioning of ethics committees. We would like to see, for example the following included in the Standard:

The process for

Public accountabilitv
We support the establishment of an Ethics Committee web site so the public as well as researchers can easily access information about ethics committees. Although this is not a complete list, we suggest the web site have on it the following:

A list of all the ethics committees and their contact details

The names and contact details of the chairpersons The names of EC members and the perspective they provide

Relevant regional information (including EC meeting agendas and minute positions available on the committee)

Terms of Reference for all the different ethics committees NECAHR, Nation Ethics Committee, HRC Ethics Committee etc)

Ethics Committees annual reports The National Application Forms The National Standard Guidelines relating to research involving Maori

Encouraging Ethical and Non-discriminatory Research with Mental Healt Consumers

Research Involving People with Intellectual Disabilities: Issues of informed consen and participation

The roles and responsibilities of EC members

Links to the web sites of the HRC, ACC, HDC, Privacy, Ombudsmen, MOH and other relevant agencies

Links to relevant legislation ~ Information about obtaining consent from SCOTT, GTAC and the NRL

Multi-centre proposals
The multi-centre process and dealing with overseas research proposals should be described in the Standard. The decision-making process also needs to be outlined. Although the present system has one committee taking on the role as the lead committee there is a lack of clarity about the nature of the feedback given to the researcher by a single committee (in relation to their region) if the researcher attends to discuss the proposal. There are also varying views about whether the study is able to proceed if not all committees approve it. One view is that all committees must approve it first. Another view is that the study can proceed in the areas where ethical approval has been given. There needs to be clarity about this and whether the situation differs in certain circumstances. For instance, are there some proposals where the latter approach would be acceptable and others where an all or nothing approach is required. The Standard is unfortunately silent on these matters. The role of the National Committee also needs to be clarified.

Student research proposals
It would be helpful for the Standard to state what standard or quality is expected of student research and what status the completed research holds. Student research is conducted principally to enable the student to complete an academic qualification so may not necessarily meet the criteria of being scientifically valid, making interpreters available or even being in the public interest. Clearly ethics committees have a duty to ensure this type of research will do no harm but there is nothing in the Standard that exempts it from the degree of scientific rigour or other criteria that would be required of a non-student proposal.
It would also be helpful to highlight the role and responsibility of the named supervisors on a student research proposal.

Other matters that should be addressed in the Standard include:

conflict of interest issues relating to researchers
There needs to be clarification over what constitutes a conflict of interest and when and how this needs to be declared, as well as when the conflict is to such an extent that the proposal should be declined.
Some examples of conflicts and situations that have already arisen where there are varying viewpoints on what to do about it include the primary investigator (PI) being a shareholder in the company sponsoring the study, or holding the patent on the device being tested. The Standard needs to state whether a small shareholding is acceptable, for instance, or whether another person should be the PI. If this is the case would it be acceptable for the shareholding researcher to still be part of the research team? Are there some situations where this doesn't matter? Is it acceptable if the shareholding researcher is not involved in the recruitment or analysis? If some situations are acceptable should it be mandatory to state the conflict of interest in the participant information sheet?

Clarifying the legal situation in relation to proxy consent to participate in research where the person concerned is unable to give consent on his or her own behalf. This should include the requirements for someone with an enduring power of attorney to give consent as well as clarification of Right 4 (Code of Rights) and how this relates to the research and innovative treatments situation.
This has already been identified as a particular issue in research situations involving tissue, organs and other body parts, patients in intensive care units and those likely to die where an innovative approach may make a difference.

Part 6

Proposals for Review
(page 43)

The Standard needs to state that there is a requirement to submit a proposal on the approved National Application Form. There should also be some minimum requirements outlined for the participant information sheet. For example,

it should always start with "You are invited. . . "
researcher contact details (not home details) need to be included
the details of the local Health and Disability Advocacy Service need to be included
it needs to be consistent with the application and protocol
it should be on letterhead (where applicable).

There should also be the requirement to use the standardised consent form unless the committee approves a deviation.

Principles of Natural Justice
(page 43)

Whilst it is heartening to see the requirement that all processes are open, transparent and fair, this is somewhat at variance with previous references where there is an unnecessary preoccupation with confidentiality. We would like to see the rest of the Standard brought into line with the approach in this section.

Meetings
(page 44)

196 should require meetings to be open to the public and the reference to the Meetings

Act should be included in this section. Closed meetings should only take place when the criteria outlined in the Meetings Act have been met.

198 should be reworded to say "Committees should encourage applicants to attend meetings. . . ". Asking applicants to leave the room should be the exception rather than the rule and going into a closed session should be consistent with the Meetings Act.

Approval Processes and Terminology
(page 44)

Under provisionally approved there should also be the option for the Chairperson to delegate final approval to another committee member or members as is stated in 6.8.

There also needs to be another category for proposals not suitable for review.

This would include requests for retrospective approval for research that has already been completed. (NOTE: WHA requested a review of a study in these circumstances in 2000.)

The Standard should also address the matter of penalties where a researcher fails to obtain ethical approval and proceeds with the study. In the first instance these studies should be reported to the National Ethical Committee but there needs to be some form of penalty and reporting of ethical approval breaches. They could, for instance, be reported to the board of the institution/agency where the researcher/clinician works, reported in relevant journals or bulletins and the details published on the Ethics web site (see previous recommendation on public accountability). The actions listed in 218 would be appropriate in this circumstance.

Delegation of decisions
(page 46)

6.8 needs to be reflected in 6.5 as the final approval process referred to in these sections is contradictory.

Review of a decision
(page 46)

We support the intention for a review to be carried out after a request from 'any person'. It is important not to restrict this capacity to a person involved in the research or a study participant.

We consider a request to review a decision should be able to be made without having to produce new information. The request could be made on the basis of a different perspective not considered by the committee, for instance, a cultural perspective.

Such a review may be requested because a proposal is not being implemented in a safe/ethical manner. It is not clear that the wording of 6.10 would cover this situation.

It is also not clear when a matter should be reviewed by the National Ethics Committee or whether it can be reviewed by a Health and Disability Ethics Committee as the Standard and the terms of reference for the National Committee appear contradictory on this matter.

Withdrawing ethical approval
(page 47)

It seems rather a significant omission to not be notifying the National Committee in this situation.

The first dot point should also be an and/or as in some situations the organisation employing the researcher will be different from the organisation providing the funding.

This list also needs to include the academic institution where applicable, as well as the place where the research is being carried out, where this is applicable.

Complaints regarding decisions of committees
(page 48)

It would be more sensible for there to be a standardised approach for dealing with complaints. We do not support each committee developing its own complaints process as suggested in 223.

Part 7

7.0 229 (page 50) Women seeking abortions are another special population as they require legal approval before the procedure can be carried out. There is a specific problem in ensuring consent to research or new procedures is freely given by these women, and not because they fear they will not get an abortion if they do not comply. These women are competent, but there is a problem of duress in seeking consent. A section in Part 7 should be devoted to this group.

Guidelines for health research with children
(page 50)

We would like to note that the focus on the child as an individual does not reflect the whanau approach valued by Maori. This absence suggests the need for specific consultation with Maori on this aspect. It would also be helpful to include confidentiality matters in relation to children, as this is not addressed. It would be appropriate to also include the need to inform children that whilst the information they share with the researcher will be kept confidential, the researcher has an ethical and professional duty to pass on any information to the appropriate person or agency about the risk of harm to the child or others that is revealed during the research process.

Cognitively impaired persons
(page 55)

Even if they are committed patients, these people should be discharged from hospital not released as this sounds as if they are in a prison. (page 56)

The definitions are out of place here and should be moved to the glossary. This also applies to the definition in 7.5.0 on page 65

Inmates
(page 62)

274 and 275 refer to payment of participants as if this is acceptable normally but presents a dilemma if the study involves inmates in a prison. This is at variance with our understanding of the accepted view in NZ that participants are not paid for their participation due to the possibility of this being coercive. Reimbursement of out-of-pocket expenses such as travel or childcare is acceptable, but these would not be an issue for inmates. This section needs to be rewritten so it is consistent with the NZ setting and views. This also applies to 316 on page 70 where reimbursement only needs to be emphasised.

The most odd part of this section is in 7.3.1 where the ethics committee is required to consider whether it has the necessary inmate-related members! It would probably be more useful to have the committee consider whether they are sufficiently well informed enough about the prison setting to make a decision on whether inmates should be invited to participate in the research.

History of Health and Disability Ethics in New Zealand
(page 78)

There are some rather glaring omissions from the history. These include the establishment of the offices of the Health and Disability Commissioner and the Privacy Commissioner. Reference to the establishment of the nationwide advocacy service, the development of the Code of Health and Disability Services Consumers' Rights and the Health Information Privacy Code, are also relevant and need to be documented as part of this history.

Appendix 4
(page 82-83)

The 1996 Standard is still in use subject to the completion of this process. This Standard is 5 years old. It therefore seems inappropriate to include the names and personal contact details of committee members when this information is certain to become out-of-date when the Standard is still current. It would be more appropriate to have this information on a handout and on the proposed web site so it can be regularly updated.

Appendix 5
(page 84-87)
The same issues relating to names and personal details apply to this section. Generic contact details are all right but personal details become immediately out-of-date if someone leave their position and moves on.

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	Submission on the Draft Operational Standard for Health and Disability Ethics Committees From the Women's Health Action Trust 13 August 2001 General Comments Women's Health Action has a long-standing interest in ethics committees. While we are pleased to finally have the opportunity to comment on the Draft Operational Standard for Health and Disability Ethics Committees we have been frustrated by the length of time the review of the standard has taken and the lack of transparency in the process. We would have preferred to have had some involvement in the review at a much earlier stage Our organisation is very supportive of the role of ethics committees in ethical review although it is our view that the committees have suffered from the lack of a National Ethics Committee able to provide national leadership and support. Whilst it is most appropriate that the National Ethics Committee take on the responsibility of future reviews of the Standard, the terms of reference recently announced by the Minister are of particular concern. We continue to argue that ethics committees should come under the umbrella of the Health and Disability Commissioner. This is the most appropriate location as the key focus of ethics committees is on the rights of people in a research or treatment setting. The Code of Rights specifically applies to research settings and to situations where innovative therapies and new treatment protocols are being used. We would also like to see the requirement for the National Operational Standard to apply to all health ethics committees, not just regional ethics committees. It has been of concern that over the past few years new ethics committees have been established by CHEs and private sector bodies. We believe that all health ethics committees should be required to have approval by the National Ethics Committee, and that these should meet the requirements of the standard and should be accredited by a national body, whether the National Ethics Committee or the Ethics Committee in the Health Research Council Overall, we found the draft standard to be very wordy, sometimes contradictory and laborious to read in parts. 1.1 Guiding Principles (page 7) We believe that these should be reordered so that 'respect for persons' and 'informned consent' come before 'scientific validity and merit'. The primary function of ethics committees is to protect public safety. This should be reflected in the ordering of prlnclples. We also argue that an additional principle should be added. These are: 1. 'Observance of health consumers'/patients' rights' - this is broader than the 'informed consent' of the existing list and recognises the existence, in the NZ setting, of the Health Commissioner and Code of Health & Disability Consumers' Rights. Likewise, consideration should be given to eliminating the term 'patient' as this is inconsistent with recent terminology in this area. 2. 'Observance of human rights'. We believe this would embrace international conventions on human rights to which New Zealand is a signatory as well as NZ legislation on human rights. While the standard recognises that there are some particular populations of vulnerable populations because of diminished autonomy or competence, it does not recognise that some large population groups are particularly vulnerable because of their relative lack of power in the wider community. This is covered to some extent in the section on 'justice', but it is more appropriate to recognise specific New Zealand rights in the principles, rather than generic and somewhat vague philosophical concepts. The research community and those with most power in the medical community tend to be white males doctors. Lay people of other ethnicities, and women, have less power in research and treatment settings. It was not accidental that women were the subjects of the 'unfortunate experiment' nor that blacks were the subject of the Tuskegee trial. A commitment to observing human rights would highlight the need to protect the rights of these groups. 1.1.1(page 9) - the list in para 25 should include women seeking abortions as a special group. This is discussed later in this submission. Relevant Legal Provisions (Page 9) The Local Government Official Information and Meetings Act 1987 needs to be included in this section as this legislation ensures transparency and public access to the process of ethical review. It also needs to be included in the Appendix 3 list on page 81. Right 9 of the Code of Health and Disability Services should be added to this section as it specifically states that "the rights in this Code extend to those occasions when a consumer is participating in, or it is proposed that a consumer participate in, teaching or research". Right 4 (2) also needs to be added, as this right requires all researchers obtain ethical approval prior to efforts to recruit participants. As the draft standard specifically states that participation in innovative practice or research, or consent to use health information, must be voluntary and not subject to any form of coercion, inducement or intimidation the legal provisions section needs to also refer to Right 2 of the Code of Rights. As women have historically been excluded from major research studies (because of perceived difficulties in including them) the provisions relating to discrimination in Right 2 are most relevant. Informed Consent (Pages 9-12) We have concerns that the funding available to a research study usually determines whether non-English speaking people are included because of the cost of interpreter services. We have always supported a national interpreter service being established under the umbrella of the Health and Disability Commissioner as the advocacy service is. This would enable access to properly trained interpreters, as they are required, in order to meet Code of Rights obligations. The present system allows for discrimination against some potential participants on the basis of their limited understanding of English. There is also the potential for people with limited English to be included in research without really understanding what they have consented to, or being wrongly informed by an untrained person acting as an interpreter (eg family member or friend) because of the reluctance to purchase interpreter services. 27 should be expanded to include: the proper title of the research the person/persons conducting the research and how to contact them how to complain the right to withdraw at any time There is nothing in this section about approaching people in emergency/crisis/stressful situations. For example, women during labour, a person presenting with a heart attack. Special care should be taken in these situations to ensure that the person is able to consent and that the approach does not cause more stress to the person. 1.1.5 Compensation (Page 15) This section highlights the risks to participants in research in the New Zealand setting under the current accident compensation legislation. The bill before Parliament continues the harsh tests for compensation following medical misadventure. It is critical that the National Ethics Committee takes responsibility for ensuring that all potential participants are fully aware of situations where they would not covered or inadequately covered. It should not be left to researchers or regional committees. The national committee should develop national consumer resources in a full range of languages which researchers would be required to use. The statement in 61 is unacceptable and/or ambiguous. Any procedure or test that is carried out on a research participant that is not part of diagnosis/treatment is extraneous and must be covered. Activities not requiring ethical review (Page 28) We do not support the provisions in 3.1. It is our view that resource allocation, access to services and rationing of services do involve ethical issues that need to be discussed and reviewed in relation to their possible impact on people. Decisions on these matters have implications for people that could cause harm. This section is unduly draconian and controlling. There is a presumption that rationing decisions will be based on sound criteria and ethical. There is no basis for assuming this. Rationing decisions should be open for ethical review to provide transparency and the ability to examine the soundness of such decisions. If the National Ethics Committee is to be subject to this standard, it would prevent that committee examining such decisions, which would make the committee weak and feeble indeed. The Government should welcome ethical review of such decisions, to ensure that they are soundly based and sustainable. Clinical Practice (Page 28) We would like to suggest another example be included in 114: Situations where a patient and doctor (or other) practitioner disagree about the treatment and the matter is unable to be resolved by usual means such as second opinions, pursuing other options etc back to top Part 4 National Advisory Committee on Health & Disability Support Services Ethics (Page 31) We consider it most unfortunate and undesirable for the National Committee to be established as a ministerial advisory committee. Leadership, direction, guidance, coordination and support for all the various ethics committees reviewing research and innovative therapies involving human participants are needed. Previous consultation processes have revealed strong support for a national committee with overarching responsibility for the manner in which all human ethics committees conduct their activities. We are disappointed that this approach has not been pursued. At the very least, the standard should clarify the relevance of its application to all such committees. The work and credibility of the National Committee will be adversely affected by the lack of independence proposed. We do not support the relationship with the Minister of Health that has been outlined. The committee should have the autonomy to identify those areas where its input is required and to be able to proceed unhampered by political interference. It must be free to initiate investigations and reviews, in its own right. The committee could report on these matters to the Minister on a regular basis, but it is preferable that it report directly to Parliament, highlighting the status and independence that this committee should have. The brief of this committee should place priority on networking and liaison with all human ethics committees to enable it to be active in generating a nationwide collaborative working relationship with all committees. (page 32) There is a reference to a committee we have never heard of. We are interested to hear when the National Health Research and Innovative Practice Review Committee was established, who is on it and what their terms of reference are. National Ethics Committee on Assisted Human Reproduction (page 32) We would like to see including potential offspring' added after the rights of the people involved will be protected so there is no ambiguity over whether people refers just to those presently in existence. More importantly, we believe that NECAHR should have as its paramount focus, protection of the interests, rights and welfare of the child. This is not so at present, and in the current situation the rights of adults to access services and techniques have been paramount. This should be the first function listed for NECAHR. Health Research Council Ethics Committee (page 32) This committee should also be required to meet the National Standard, particularly in relation to membership composition. It seems odd for this committee to have the role of providing advice on membership, procedures and standards when it doesn't meet the standard itself. These functions properly belong to the National Committee. Health and Disability Ethics Committees (page 33) A strength of these committees is their ability to act independently. Allowing the Director-General of Health to alter the number of committees and their regions of authority could compromise this. The DG could for example decide to reduce the number of committees to save money. This could adversely effect the quality of ethical review. We support this provision being totally removed. It is more appropriate that the National Committee be responsible for assessing, consulting and making recommendations on the numbers of committees required and their regions of responsibility. These sorts of decisions should always involve public input. back to top Section 5 Statutory Approvals (page 34) It is not appropriate for the Director-General of Health to approve ethics committees. The DG of Health should be replaced in 137 by the National Committee. Composition and membership (page 35) Health & Disability Ethics Committees should have adequate representation of women. This is not just women members, but women informed on women's health issues. This was recognised in earlier standards. In addition each committee should include a health consumer advocate. Earlier standards required this. The health advocates employed by the Office of the Health & Disability Commissioner are in a unique position to represent health consumers' rights and also report on ethical difficulties they encounter in their work. The list of qualities required by members in 141 needs to also include perspectives. The perspectives of consumers or lay people, for example, are quite different from the perspectives of health professionals. Whilst ethics committees are not under the umbrella of the Health and Disability Commissioner we support there being a specific place for a health and disability advocate on each ethics committee. This was the case in most areas when ethics committees were reconstituted following the Cartwright Inquiry, but has not been maintained. We support this being specifically stated in the Standard. The definition of non-lay members is of concern. There is the potential for all the non-lay people to be retired or non-practicing health professionals. Depending on how the definition is interpreted, there is also the potential to automatically exclude people working in non-clinical areas of a health service who are not health professionals and who do not actually provide any health services at all. This draft has removed the exclusion of those employed in a disability service (from the 1996 Standard), but left in those employed in the provision of a health service. People employed by an organisation that provides health or disability services often includes those involved with catering, cleaning, administration, information services, as well as quality, complaints and advocacy roles. It isn't reasonable to define all these people as non-lay just because they are employed by an organisation providing health services. A consumer perspective is more likely to be held by these people than health professional not currently engaged in health care delivery. It would also be rather ironic if the efforts of organisations like Women's Health Action to encourage researchers to actively involve consumers in the development, design and conduct of research studies resulted in those consumers losing their status as a lay person. This definition is not satisfactory and requires further discussion and consultation with consumer organisations. Duties and Responsibilities of a Member (page 36) Committee members should have a commitment to work for the greater public good in their responsibilities to protect the interests of participants (and potential participants) involved in innovative treatment and research - not the good of the committee. This is a very perverse statement that contradicts the principles outlined earlier in the Standard. It should be altered or removed. Conflicts of interest (page 37) We support the requirement in number 7 that a member of the committee whose proposal is before the committee not take part in the committee's assessment of the proposal and leave the meeting while this occurs. Otherwise, we support the open meeting approach where researchers and members of the public are able to be present. Researchers who are present can then be asked questions and clarify matters as required. Unless the committee decides to go into committee' on the basis of acceptable grounds (consistent with the Local Government Official Information and Meetings Act 1987) we support those present being able to hear the deliberations and decisions of the committee. This is part of the committee being accountable to its constituency. Confidentiality (page 37) Most of this section is problematic and contradictory in places. Substantial changes are needed. We consider it most important that the activities of ethics committees are conducted in an open and transparent fashion. Meetings should be in public unless there is good reason for confidential discussion to take place. If the meetings are in public then the agendas and minutes cannot be confidential. Committees conforming to the Meetings Act already provide agendas and minutes to libraries and other places to enable access by the public, media and others with an interest. This is an essential part of ensuring committees are accountable and people are informed of their processes and decisions. Only discussions and documents relating to business discussed in committee should be confidential. We sought an opinion from the Ombudsmen in 1991 as to whether ethics committees were subject to the Local Government Official Information and Meetings Act 1987. The Ombudsmen confirmed that they were and that under this legislation those meetings of the ethics committees should be conducted in public, with the provision to go into committee when the criteria stated in the Act was met. It is important for this to be stated in the standard as there are varying practices amongst the committees. It doesn't make sense to say on one hand that committee members should publicly support a course of action decided by a committee or not publicly comment if they don't agree when there is supposed to be consensus decision-making. This also compromises the independence of members who should be free to speak out on matters of concern. It is unethical to compel members to support something they have ethical concerns about. Number 11 refers to the Privacy Act. It also needs to refer to the Official Information Act. Number 12 needs to be changed to reflect the open nature of meetings with provision for confidentiality to be maintained for matters held in committee. Release of information also needs to include proposals and documents as well as the correspondence and papers referred to. Chairperson (page 39) Although 5.2 refers to the lay chairperson, this section (5.7) needs to specifically state the chairperson is to be one of the lay people or it appears contradictory to 5.2. Committee Meetings (page 40) This section needs to state that committee meetings will be conducted in accordance with the Local Government Official Information and Meetings Act 1987. The first sentence of 170 should say " Meetings shall be open to the public and held at such times…" There is something rather nonsensical about having a consensus process where a majority vote is OK. It is either one or the other. We support a consensus approach. Ethics committees are able to seek additional opinions and expertise and should be able to call on the assistance of the National Committee where difficult situations arise and consensus agreement is not possible. There is a need for consensus so that particular public interests represented on the committee are not able to be overridden. It is not inconceivable that a single committee member may have important reservations that need to be taken into account. Consensus decision-making is an important mechanism for protecting public safety. Records (page 42) There needs to be a statement relating to authorised people and to procedures relating to access of files and documents to ensure the autonomy and independence of the committees is maintained as well as statutory requirements. 178 is ambiguous and the use of the word records open to interpretation. We suggest making the following addition..."Records of all proposals submitted should be retained for either the duration of a research or treatment…" Checklist of requirements for annual reports (page 41) We consider the reference in 181 to confidentiality is not in keeping with the public duty role of Ethics Committees. These committees have the responsibility of ensuring those members of the public involved (or potentially involved) in research and innovative treatments are provided with adequate safeguards and protections. The committees need to be able to be seen to be carrying out this duty. Surely if a person is considered a fit and proper person to be a member of an ethics committee, members are able to collectively determine what is appropriate to have in the annual report of their activities. back to top Missing sections We are concerned that the Standard does not include some important matters relevant to the effective functioning of ethics committees. We would like to see, for example the following included in the Standard: The process for Public accountabilitv We support the establishment of an Ethics Committee web site so the public as well as researchers can easily access information about ethics committees. Although this is not a complete list, we suggest the web site have on it the following: A list of all the ethics committees and their contact details The names and contact details of the chairpersons The names of EC members and the perspective they provide Relevant regional information (including EC meeting agendas and minute positions available on the committee) Terms of Reference for all the different ethics committees NECAHR, Nation Ethics Committee, HRC Ethics Committee etc) Ethics Committees annual reports The National Application Forms The National Standard Guidelines relating to research involving Maori Encouraging Ethical and Non-discriminatory Research with Mental Healt Consumers Research Involving People with Intellectual Disabilities: Issues of informed consen and participation The roles and responsibilities of EC members Links to the web sites of the HRC, ACC, HDC, Privacy, Ombudsmen, MOH and other relevant agencies Links to relevant legislation ~ Information about obtaining consent from SCOTT, GTAC and the NRL Multi-centre proposals The multi-centre process and dealing with overseas research proposals should be described in the Standard. The decision-making process also needs to be outlined. Although the present system has one committee taking on the role as the lead committee there is a lack of clarity about the nature of the feedback given to the researcher by a single committee (in relation to their region) if the researcher attends to discuss the proposal. There are also varying views about whether the study is able to proceed if not all committees approve it. One view is that all committees must approve it first. Another view is that the study can proceed in the areas where ethical approval has been given. There needs to be clarity about this and whether the situation differs in certain circumstances. For instance, are there some proposals where the latter approach would be acceptable and others where an all or nothing approach is required. The Standard is unfortunately silent on these matters. The role of the National Committee also needs to be clarified. Student research proposals It would be helpful for the Standard to state what standard or quality is expected of student research and what status the completed research holds. Student research is conducted principally to enable the student to complete an academic qualification so may not necessarily meet the criteria of being scientifically valid, making interpreters available or even being in the public interest. Clearly ethics committees have a duty to ensure this type of research will do no harm but there is nothing in the Standard that exempts it from the degree of scientific rigour or other criteria that would be required of a non-student proposal. It would also be helpful to highlight the role and responsibility of the named supervisors on a student research proposal. Other matters that should be addressed in the Standard include: conflict of interest issues relating to researchers There needs to be clarification over what constitutes a conflict of interest and when and how this needs to be declared, as well as when the conflict is to such an extent that the proposal should be declined. Some examples of conflicts and situations that have already arisen where there are varying viewpoints on what to do about it include the primary investigator (PI) being a shareholder in the company sponsoring the study, or holding the patent on the device being tested. The Standard needs to state whether a small shareholding is acceptable, for instance, or whether another person should be the PI. If this is the case would it be acceptable for the shareholding researcher to still be part of the research team? Are there some situations where this doesn't matter? Is it acceptable if the shareholding researcher is not involved in the recruitment or analysis? If some situations are acceptable should it be mandatory to state the conflict of interest in the participant information sheet? Clarifying the legal situation in relation to proxy consent to participate in research where the person concerned is unable to give consent on his or her own behalf. This should include the requirements for someone with an enduring power of attorney to give consent as well as clarification of Right 4 (Code of Rights) and how this relates to the research and innovative treatments situation. This has already been identified as a particular issue in research situations involving tissue, organs and other body parts, patients in intensive care units and those likely to die where an innovative approach may make a difference. back to top Part 6 Proposals for Review (page 43) The Standard needs to state that there is a requirement to submit a proposal on the approved National Application Form. There should also be some minimum requirements outlined for the participant information sheet. For example, it should always start with "You are invited. . . " researcher contact details (not home details) need to be included the details of the local Health and Disability Advocacy Service need to be included it needs to be consistent with the application and protocol it should be on letterhead (where applicable). There should also be the requirement to use the standardised consent form unless the committee approves a deviation. Principles of Natural Justice (page 43) Whilst it is heartening to see the requirement that all processes are open, transparent and fair, this is somewhat at variance with previous references where there is an unnecessary preoccupation with confidentiality. We would like to see the rest of the Standard brought into line with the approach in this section. Meetings (page 44) 196 should require meetings to be open to the public and the reference to the Meetings Act should be included in this section. Closed meetings should only take place when the criteria outlined in the Meetings Act have been met. 198 should be reworded to say "Committees should encourage applicants to attend meetings. . . ". Asking applicants to leave the room should be the exception rather than the rule and going into a closed session should be consistent with the Meetings Act. Approval Processes and Terminology (page 44) Under provisionally approved there should also be the option for the Chairperson to delegate final approval to another committee member or members as is stated in 6.8. There also needs to be another category for proposals not suitable for review. This would include requests for retrospective approval for research that has already been completed. (NOTE: WHA requested a review of a study in these circumstances in 2000.) The Standard should also address the matter of penalties where a researcher fails to obtain ethical approval and proceeds with the study. In the first instance these studies should be reported to the National Ethical Committee but there needs to be some form of penalty and reporting of ethical approval breaches. They could, for instance, be reported to the board of the institution/agency where the researcher/clinician works, reported in relevant journals or bulletins and the details published on the Ethics web site (see previous recommendation on public accountability). The actions listed in 218 would be appropriate in this circumstance. Delegation of decisions (page 46) 6.8 needs to be reflected in 6.5 as the final approval process referred to in these sections is contradictory. Review of a decision (page 46) We support the intention for a review to be carried out after a request from 'any person'. It is important not to restrict this capacity to a person involved in the research or a study participant. We consider a request to review a decision should be able to be made without having to produce new information. The request could be made on the basis of a different perspective not considered by the committee, for instance, a cultural perspective. Such a review may be requested because a proposal is not being implemented in a safe/ethical manner. It is not clear that the wording of 6.10 would cover this situation. It is also not clear when a matter should be reviewed by the National Ethics Committee or whether it can be reviewed by a Health and Disability Ethics Committee as the Standard and the terms of reference for the National Committee appear contradictory on this matter. Withdrawing ethical approval (page 47) It seems rather a significant omission to not be notifying the National Committee in this situation. The first dot point should also be an and/or as in some situations the organisation employing the researcher will be different from the organisation providing the funding. This list also needs to include the academic institution where applicable, as well as the place where the research is being carried out, where this is applicable. Complaints regarding decisions of committees (page 48) It would be more sensible for there to be a standardised approach for dealing with complaints. We do not support each committee developing its own complaints process as suggested in 223. back to top Part 7 7.0 229 (page 50) Women seeking abortions are another special population as they require legal approval before the procedure can be carried out. There is a specific problem in ensuring consent to research or new procedures is freely given by these women, and not because they fear they will not get an abortion if they do not comply. These women are competent, but there is a problem of duress in seeking consent. A section in Part 7 should be devoted to this group. Guidelines for health research with children (page 50) We would like to note that the focus on the child as an individual does not reflect the whanau approach valued by Maori. This absence suggests the need for specific consultation with Maori on this aspect. It would also be helpful to include confidentiality matters in relation to children, as this is not addressed. It would be appropriate to also include the need to inform children that whilst the information they share with the researcher will be kept confidential, the researcher has an ethical and professional duty to pass on any information to the appropriate person or agency about the risk of harm to the child or others that is revealed during the research process. Cognitively impaired persons (page 55) Even if they are committed patients, these people should be discharged from hospital not released as this sounds as if they are in a prison. (page 56) The definitions are out of place here and should be moved to the glossary. This also applies to the definition in 7.5.0 on page 65 Inmates (page 62) 274 and 275 refer to payment of participants as if this is acceptable normally but presents a dilemma if the study involves inmates in a prison. This is at variance with our understanding of the accepted view in NZ that participants are not paid for their participation due to the possibility of this being coercive. Reimbursement of out-of-pocket expenses such as travel or childcare is acceptable, but these would not be an issue for inmates. This section needs to be rewritten so it is consistent with the NZ setting and views. This also applies to 316 on page 70 where reimbursement only needs to be emphasised. The most odd part of this section is in 7.3.1 where the ethics committee is required to consider whether it has the necessary inmate-related members! It would probably be more useful to have the committee consider whether they are sufficiently well informed enough about the prison setting to make a decision on whether inmates should be invited to participate in the research. History of Health and Disability Ethics in New Zealand (page 78) There are some rather glaring omissions from the history. These include the establishment of the offices of the Health and Disability Commissioner and the Privacy Commissioner. Reference to the establishment of the nationwide advocacy service, the development of the Code of Health and Disability Services Consumers' Rights and the Health Information Privacy Code, are also relevant and need to be documented as part of this history. Appendix 4 (page 82-83) The 1996 Standard is still in use subject to the completion of this process. This Standard is 5 years old. It therefore seems inappropriate to include the names and personal contact details of committee members when this information is certain to become out-of-date when the Standard is still current. It would be more appropriate to have this information on a handout and on the proposed web site so it can be regularly updated. Appendix 5 (page 84-87) The same issues relating to names and personal details apply to this section. Generic contact details are all right but personal details become immediately out-of-date if someone leave their position and moves on. back to top

General Comments

1.1 Guiding Principles (page 7)

Activities not requiring ethical review (Page 28)

Clinical Practice (Page 28)

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Part 4

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Section 5

1.1 Guiding Principles
(page 7)

Activities not requiring ethical review
(Page 28)

Clinical Practice
(Page 28)