A voice for women's health

AWHC Submission on NEAC Draft National Ethics Standards for Health and Disability Research

One of the roles of the National Ethical Advisory Committee (NEAC) is to determine nationally consistent ethical standards across the health and disability sector and provide scrutiny for national health research and health services.

In 2015 NEAC committed to review the 2012 Ethical Guidelines for Intervention Studies and Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities. The Ministry of Health set up a working party to review the 2012 guidelines and develop new standards determined by NEAC.

The Draft National Ethics Standards for Health and Disability Research sets out the established ethical standards that apply to all health and disability research in New Zealand. The draft standards are mostly targeted at individual researchers but are also useful to ethics committees, research sponsors and for training and educating researchers. NEAC reviewed the draft standards and sought the views and feedback of the public.

The draft standards are available online.

The Auckland Women’s Health council lodged a submission on the draft guidelines in September 2018. In the Likert scale answers our answers are indicated by the highlighting. AWHC was not required to, neither did we, answer all the questions. The summary below includes only our responses to the questions that we answered.

Part one: general feedback
Fit for purpose
1 Overall the content of the Standards are helpful, clear, relevant and workable.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons.
We believe that these standards are enormously important in guiding ethical research in the health and disability sector in New Zealand. However, the quality of the standards will only be realised with adequate oversight of research proposals by the ethics committees. It is important that their terms of reference and consideration of research proposals give full power and support to the ethical standards.

2 The standards are applicable to all types of health and disability research.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

3 The standards balance protecting individuals with the realities of conducting research.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons.
The AWHC believes that achieving this balance will often be difficult, but that the standards must always err on the side of protecting participants/individuals even at the cost to research, particularly with regard to vulnerable participants and incapacitated people who may be sought to be involved in research.


4 The standards support researchers to navigate ethical challenges in health research.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

4.a Overall do the guidelines?
 
5
Strongly disagree
4
Disagree
3
Neutral
2
Agree
1
Strongly Agree
safeguard the rights and interests of participants in research          
promote high-quality ethical research for social, cultural and economic wellbeing          
reflect the principles of the Treaty of Waitangi          
foster awareness of ethical principles and practices among health care providers, researchers and the wider community          
help researchers think through and take responsibility for the ethical issues in their studies          
help researchers give due consideration to local and national community views and perspectives          
protect and reassure the community          
 
Coverage of ethical guidance
5 The standards adequately cover the ethical challenges that are present in health and disability research.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please describe the ethical challenges that are missing.
The AWHC believes it is difficult to ensure that all ethical challenges are adequately covered. Rapid changes in technology mean that any set of ethical standards risk being behind progress and advancement. As a result the standards must be as future-proofed as possible and the Ministry of Health as proactive as possible in dealing with ethical issues that may arise in the future. As the standards will be available only in electronic form, the AWHC hopes that this signals a regular review process for the standards to ensure that future challenges and issues are dealt with in a prompt and timely manner.

However, while the standards are developed primarily for researchers, we believe that they should also be accessible for members of the community who wish to access them. The standards should not be just exclusive to researchers. Therefore, it would be important to ensure that the standards are also available in formats for people who have communication access needs, e.g. people who use assistive technologies to access information and New Zealand Sign Language.

 

Merging the observational and interventional guidelines
6 The standards are applicable to both observational and interventional research.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons.
It makes far more sense to have a single document that covers ethical standards for both observational and interventional research as many research proposals involve elements of both and a single document will make it far easier for researchers to negotiate and adhere to the ethical standards. We believe that the same ethical principles apply to all types of research.

 

Scope of the standards and non-research activities

In January and February 2015, the National Ethics Advisory Committee (NEAC) sought feedback on the cross-sectoral ethics arrangements for health and disability research, issues with these arrangements and ideas for enhancing them. One of the questions related to audit and related activities. A theme was the difficulty in determining what an activity was, research or not research, and subsequently the appropriate level of oversight.

The NEAC standards are written for a research audience, as well as those who support research including ethics committees and research offices. The standards are likely to be used to determine oversight of activities. The 2012 set of ethical guidelines contained some guidance on the distinction between research and non-research activities. This distinction is used to help determine ethical oversight, and in some cases whether informed consent is required (for example with audits, which routinely do not require consent). Most submitters did not think that the current classification acts as a barrier to audit and related activity. But many noted that the unclear distinction between observational research and audit could result in:

  • unnecessary ethical review of audits and related activities
  • weakening of research methodology to avoid HDEC review
  • failure to publish important generalisable findings.

Definitions have been included in the draft standards, and some have been tightened, however how to determine what an activity is has not been included.

It is difficult to provide a clear cut distinction for the following reasons:

  • The intent or aim (and justification) of both research and non-research activities relating to health and disability is often to improve patient outcomes.
  • In both kinds of activities, the patients who benefit may be different to those who are involved in the activities.
  • Creating knowledge is fundamental to research but is also clearly the aim of audit. Although some might claim broadly that research aims to create generalisable knowledge:
    • some kinds of health and disability research (eg, qualitative research) do not have this aim
    • some non-research activities clearly produce generalisable knowledge. For example, the audit of a particular department might well alert others to relationships between outcomes and practice in their own location.
  • Some methods used in research are often also used in non-research activities. For example, many forms of research collect and analyse patient data but so do those who are auditing a clinical department.
  • Both research and non-research activities can carry risk of harm – but some research may not go beyond minimal risk.

The Standards contain more information on determining risk and benefit of activities which may assist in determining appropriate level of oversight, opposed to oversight based on classification.

7 Is the scope of the document clear?
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree
 
Part two: feedback on sections
Ethical principles
General questions
9 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons why the section is or is not fit for purpose.
We value the way in which Te Ara Tika principles and bioethics principles dovetail and complement each other while offering unique and important contributions to the ethical standards and way in which research is conducted in Aotearoa New Zealand. The inclusion of both sets of principles, and the way in which they work together to honour the physical, emotional, intellectual and spiritual health and well-being of all our people, sets the tone for the remainder of the standards and provides important guidance for researchers.

 

10 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

11 Please provide feedback with reference to the paragraph(s) in question.
Paragraph 5.8 Bioethics principles
We believe that the non-maleficence principle must be stated more strongly. It is insufficient to say that the “risks of harm in research should not be greater than its expected benefits.” The risk of harm should be significantly less than the potential benefits. The threshold for harm must be much higher in research in a healthy cohort and the definitions of harm (e.g. minimal harm) must not be set by any person with a vested interest in the research (e.g. anyone involved in the research). It is unconscionable that individuals might be put in a position in which greater than minimal harm is caused irrespective of how great the benefit of the research to either the individual participants or any group they may represent (future benefits to other patients/consumers). While we accept that all research, as does all medical treatment, carries an inherent potential for harm, the principle of primum non nocere must be a foremost consideration in ethical standards for research, and this cannot be overstated.

Similarly, it is not sufficient to say that researchers “must put appropriate measures in place to reduce the risk of harm”. This must be stated more strongly and to the effect that researchers “must put appropriate measures in place to minimise the risk of harm”. The use of the word reduce in this principle is inadequate as any reduction in potential harm may be interpreted as being adequate – reduction is a relative term – and what is required is a complete minimisation of harm.

 

Research involving Māori
General questions
12 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons why the section is or is not fit for purpose.
We agree with all ethical standards that support and facilitate research that will improve Māori health and well-being and health outcomes for Māori, and reduce inequalities and inequities in Māori health.

 

13 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

14 NEAC notes the importance of all health research for Maori. The Committee seek feedback on the level of guidance on consultation – does it make what is required clear, and are the levels of consultation required appropriate?
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please provide feedback with reference to the paragraph(s) in question.
We support the guidance provided in the ethical standards on consultation with Māori. However, we believe that it is necessary for ethics committees (not limited to HDECs, but including other ethics committees) that consider research, are tasked with approving or declining research or providing oversight of research in the health and disability sector, include at least one member with a strong understanding of tikanga Māori and the health and disability issues facing Māori, particularly regarding inequalities and inequities, and disparities in access and outcomes.

Research involving Pacific peoples
General questions
15 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons why the section is or is not fit for purpose.
We support the guidance provided to researchers regarding the involvement of Pasifika people in research and the specific cultural factors that should be considered in research involving these groups. We believe that it is particularly important that research involving Pasifika peoples is undertaken with a clear understanding of potential language barriers for some Pasifika people and that patient information is provided in a way that ensures that they are able to provide fully informed consent to their participation.

 

Categories of participants
General questions
18 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

19 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline any missing ethical issues or principles.
It is difficult for us to be sure that all relevant ethical issues and or principles for health and disability research in New Zealand are covered in this section, but we appreciate the extensive list of potentially vulnerable participants and the particular emphasis on their increased risk of harm, the need to protect such participants and minimise harms to them.

In relation to people with disabilities being identified as ‘vulnerable’, we agree that research does show that people living with intellectual, visual and hearing impairments are vulnerable to abuse. However, we would argue that the standards promote a lack of disability awareness amongst the research community as one of the biggest abuses that these people experience in the health system is of their right to be fully informed. Information is not made accessible to them. It does not come in alternative forms, such as NZ Sign Language or Easy Read English. We want the standards to be inclusive and to see in the standards that explicit mention is made of the need to ensure that information is accessible to people who have visual impairments, literacy issues or who are New Zealand Sign Language users.

 

20 Please provide feedback with reference to the paragraph(s) in question.
Paragraphs 8.15 – 8.19 Diminished Capacity to Consent
We have specific concerns about the inclusion of people with diminished capacity to consent. Essentially we believe that only people who can make a fully informed decision to participate in research should be asked to participate; people who clearly understand that they have a choice, understand the probable benefits, risks and side-effects, what the research entails and what is expected of them in terms of time, travel, participation in research activities, and can consent to these without coercion and duress.

Our Code of Health and Disability Services Consumers' Rights still allows for research on adults not capable of providing fully informed consent on the basis that the researcher decides it is in the consumer/patient’s best interests. The AWHC does not believe that researchers are capable of making an unbiased decision that is truly in the best interests of the consumer/patient.

In terms of supported decision making, this issue is fraught as family/whānau of vulnerable patients/consumers may be subject to potential coercion and duress. Most want what is best for their loved ones, but may not be best placed to make important decisions regarding research of which they may have little understanding, in particular if they harbour hope that there will be significant benefits for the participant.

We understand the need to undertake research that might generate knowledge that may improve the lives of the participants or similar cohorts of people in the future. However, this must be balanced against the rights of, and protecting from harm, those research participants. When research participants have diminished capacity to consent then the right to protection from harm must necessarily be higher.

Paragraphs 8.26 – 8.29 Research in Children and young people
We are concerned that research involving children and young people be as limited as possible and only when absolutely necessary. An issue that is not discussed is the adverse impacts of normalising medical intervention for children, when the behaviours that should be modelled for children are healthy lifestyles and choices, and disease prevention. Some studies can imply that normal life is riddled with issues that require medical intervention and that normal life events are diseases or conditions that “should” be cured or remedied. This is not helpful in raising resilient, healthy people but instead encourage an attitude that health comes from drugs and procedures..

 

Informed consent
General questions
21 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons why the section is or is not fit for purpose.
While we agree, we repeat here the point that we have made above: we would argue that the standards promote a lack of disability awareness amongst the research community as one of the biggest abuses that these people experience in the health system is of their right to be fully informed. Information is not made accessible to them. It does not come in alternative forms, such as NZ Sign Language or Easy Read English. We recommend that explicit mention is made of the need to ensure that information is accessible to people who have visual impairments, literacy issues or who are New Zealand Sign Language users.

 

22 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline any missing ethical issues or principles.
It is difficult for us to be sure that all relevant ethical issues and or principles for health and disability research in New Zealand are covered in this section. However, the discussion on issues of informed consent appear to be thorough and provide substantial guidance to researchers regarding the necessity of obtaining truly informed consent and the information that must be provided to potential participants to enable them to make informed decisions. Of particular importance to the AWHC are the sections on harms and rights (para 9.34).

 

23 Please provide feedback with reference to the paragraph(s) in question.
Para 9.42-9.46 Withholding information and deception
We have concerns about the withholding of information and/or deception of participants as part of the study design, and believe that these methods should be used rarely and only with significant ethical oversight. While we understand the need to withhold information or temporarily deceive participants for specific purposes in essence these practices are the antithesis of informed consent, and truly informed consent cannot be said to have been obtained in these situations. There must be extenuating and unavoidable circumstance for such practices to be approved.

Para 9.52-9.57 Abbreviated consent in medical emergencies
We are concerned that abbreviated consent in medical emergencies places potential participants in the position of consenting under duress or in a coercive or perceived coercive situation. There must be overwhelming benefit to the participant relative to potential harm in such research, and considerable ethical oversight of such research to ensure that rights and welfare of the participants are foremost.

Para 9.62-9.64 Opt-out Consent
We oppose opt-out consent and have concerns about the tendency of many potential participants to “just go along with” what is proposed. Many people take the path of least resistance or avoid the sort of conflict that they feel may arise by asserting their right to opt-out in such situations. We also have considerable concerns about the use of the term “minimal risk” as this is a highly subjective and relative term, and inherently cannot be quantified. “Minimal risk” is very much an “in the eye of the beholder” term and we have considerable concerns about who it is that determines that the research carries no more than minimal risk to participants; this should not be decided by anyone who has a vested interest in the research, e.g. the researchers themselves.

It is difficult for us to foresee a situation in which researchers complying with all the requirements of paragraph 9.64 cannot simply obtain opt-in consent from the participant.

 

Research with participants who are unable to consent

NEAC’s role is to determine nationally consistent ethical standards across the health and disability sector and provide scrutiny for national health research and health services. NEAC must also ensure that any advice and guidelines comply with the laws of New Zealand. This requirement created a tension between providing ethical guidance that may be in conflict with New Zealand law. NEAC notes that the law on research with participants who are unable to consent restricts when research can be carried out in this population.

Once researchers have demonstrated that the participation of individuals who are unable to consent are necessary to answer the research question, Researchers must balance risks of harm with benefits.

Although in some cases it may be ethically justifiable to use different calculations of benefit and harm depending on the level of risk to which the participant is exposed, as well as whether the participants in the study have potential prospective benefit derived from their involvement, New Zealand law requires participation in all cases of health research without consent to be in the individual participants’ best interest.

Therefore NEAC was unable to set alternative levels of risk and benefit as that guidance / those standards would not be able to be legally met.

Given the current legal environment, does the ethical guidance provided in the draft standards provide clarity for the regulatory and ethical environment? NEAC notes that they can revisit the ethical advice if the law changes.

Please outline your reasons.

We believe that the ethical guidance in the draft standards provides clarity to researchers and importantly encourages researchers to check the relevant legislation and seek legal advice. However, we would like to add to this response.

The AWHC would like to make clear our philosophical opposition to conducting medical experiments, including within the auspices of clinical trials, on any New Zealanders without their fully informed consent. That vulnerable groups of consumers can, and are, being exploited for research gain under the current law goes against the principles of the Nuremberg Code (1947), the founding document that gave rise to modern medical research ethics. It is clear that the law as it stands is sufficiently weak and uncertain as to allow studies to proceed in relation to participants who are unable to consent if participation in the research is in their “best interests” where the researcher is able to make the decision as to what constitutes in the patients “best interests”.

The AWHC believes that absolutely no incapacitated/incompetent adults should be enrolled for medical experiments/clinical trials/research until there are sufficient protections and safeguards established in law that first and foremost protect their rights and interests, health and well-being.

The Nuremberg Code (1947) on medical experimentation on human subjects was followed by the Geneva Convention and then the Declaration of Helsinki formulated by the World Medical Association, of which the New Zealand Medical association was and is a member. The Declaration of Helsinki clearly states that:

  • “while the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects”;
  • “some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm… All vulnerable groups and individuals should receive specifically considered protection.”
  • “participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.
    Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.”

Yet despite these existing protections, which New Zealand’s Medical Association ratified, medical experimentation on competent women at National Women’s Hospital occurred without their knowledge or consent in the 1960s and 70s.

Our Code of Health and Disability Services Consumers' Rights, while a step in the right direction, still allows for research on adults not capable of providing informed consent on the basis that the researcher decides it is in the consumer/patient’s best interests. The AWHC does not believe that researchers are capable of making an unbiased decision that is truly in the best interests of the consumer/patient. In addition, it is the AWHC’s view that the current Health and Disability Ethics Committees (HDEC) do not prioritise the protection of research subjects. It should not be left to a researcher to “balance the risks of harms with benefits” and permitting researchers to make these decisions is grossly insufficient protection for incapacitated research subjects.

Once an adequate ethical and legal framework is in place (including specific definitions of terms such as “minimal risk/burden”, “benefits”, “best interests”, and who constitutes an authorised legal representative) further nationwide discussion involving all stakeholders, including patient and consumer advocates, should revisit the circumstances, if any, in which research involving vulnerable groups such as incapacitated/incompetent adults might be permitted.

If an adequate ethical and legal framework was established that provided sufficient protections for incapacitated/incompetent research subjects, including a Special Ethics Committee to oversee approval to such research proposals, the AWHC may change its stance on the involvement of incapacitated people in medical research.

 

Deception

The standards must apply to all cases of health research. In some fields of research, for example psychological research, deception may be used for scientific validity. Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational, or applied value and that effective non-deceptive alternative procedures are not feasible. NEAC has not considered deception as inherently unethical, but it should only be used as a last resort, not as a first resort, and certainly not a norm in health research.

NEAC seeks views on whether the guidance will meet the needs of different disciplines of research.

Please provide feedback.

While we have concerns about the use of deception of participants as part of the study design, and believe that these methods should be used rarely and only with significant ethical oversight, as far as we have the ability to determine the guidance provided in the draft standards meets research needs.

 

Research benefits and harms
General questions
24 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

26 Please provide feedback with reference to the paragraph(s) in question.
Paragraph 10.2, 10.4 and 10.7
The concept of the greater good – or the potential benefits to society and science – must be secondary to the rights and protection of individual participants. There can be no situation in which the benefit to society and science is given a greater value than the individual and no individual should be sacrificed at any level for “the greater good”. Notwithstanding that all medical treatments and procedures, and by extension all medical research, carry some risk of harm, the protection of the health and well-being of participants should be the foremost consideration. It is insufficient to say that “To justify any risks of harm to study participants, the research must have social and scientific value” as significant harm such as death or disability for any individual cannot be justified because the research has social and scientific value. Mild, transient and localised harm/side-effects may be acceptable to some individuals when balanced against the generation of knowledge with social and scientific value. However, it is a matter of degree and it must be up to the potential participant to determine the risk she/he is prepared to accept to assist with the generation of knowledge with social and scientific value. This section should be reworded to ensure that this concept is understood by researchers.

Paragraph 10.12
While there may be few research proposals in New Zealand of the kind to cause serious physical harm, the risk of death or permanent disability is not unknown. There are well known clinical trials in which severe injury and death have been documented, including the highly publicised 2006 clinical trial of a cancer drug in the UK which left six previously healthy men fighting for their lives with multiple organ failure and with at least one having fingers and toes amputated and all men being told that they were at risk of developing cancer or auto-immune diseases as a result.

We have our own significant history of medical experimentation that caused women permanent injury including death in Herbert Green’s cervical cancer experiment.

The physical harms listed in this table must include death and permanent disability as examples of harm, and to not include these is remiss.

Paragraphs 10.15 – 10.21 The distribution of potential benefits and risks of harm
Researchers must ensure that potential participants do not acquire an inflated understanding of the potential benefits of participating in research, such that they may be willing to risk greater potential harms because they perceive that the benefits are greater than they really are. All discussions with and information provided to potential participants (written and verbal) must be absolutely transparent, couched in plain language and err on the side of caution/overstating the potential harms to ensure that potential participants have as complete an understanding as possible of the risks of taking part in the research.

 

Research conduct
General questions
33 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

34 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

35 Please provide feedback with reference to the paragraph(s) in question.
Para 13.25 – 13.28 Advertising
We value the guidance provided in this section and place a high importance on advice to researchers not to advertise the research to potential participants in such a way as to “cause potential participants to underestimate or dismiss their risk of harm”, or to overtly appeal potential participants’ sense of doing public good by participating.

Para 13.29-13.36 Social Media
While we don’t oppose the use of social media to advertise the research to potential participants, and understand the value of social media in communicating with a target audience, we also believe that people are often unduly influenced by information they access on social media and in particular may be influenced by comments left by other users. Use of social media should be done with care and with considerable regard to the issues and disadvantages/negative impacts that are inherent in engaging with social media.

Para 13.37 – 13.39 Reimbursements, koha and incentives for participants
We believe that it is important to strike a balance between not providing such a high incentive to participation that such incentives have a coercive effect and impact on the ability of potential participants to make truly informed decisions about participation, and ensuring that involvement in the research does not cost participants. This is especially important for vulnerable cohorts/participants. Many New Zealanders or those representing groups of New Zealanders who could ultimately most benefit from research (e.g. diabetes, obesity and other conditions influenced by lifestyle and poverty) are in areas of higher deprivation and it is important that they are not disadvantaged in any way at all by their participation, including but not limited to such issues as transport to and from appointments, costs of childcare if necessary, taking time off work, etc.

Para 13.40-13.44 Managing conflicts of interest or role conflict
It is the experience of members of the AWHC that not all health practitioners (some of whom are involved to a greater or lesser extent with research) are fully cognisant of potential conflicts of interest or downplay such conflicts. All people involved with research should err on the side of overstating conflicts of interest. Of considerable concern to us is the issue of subjective assessments on the part of researchers particularly in establishing “minimal risk” and “best interests” as significant conflicts of interest are present when a research has a vested professional, personal, reputational, or financial interest in the progress and outcome of the research.

Para 13.47-13.48 Trial oversight committees
We believe that that DMC should be 100% independent of the study team in order to be able to effectively monitor and impact on safety of participants. Monitoring. In addition, we believe that having a trial management group that may comprise only the principal researcher will not be sufficiently objective and that trial management groups should include at least another person or some sort of institutional reference group to whom the PI should report.

Para 13.51-13.53 Responsibilities for adverse event monitoring
The monitoring of adverse events is extremely important and we believe that the language in this section must be strengthened, and “should” must become “musts”.

Para 13.56 Terminating a study
This paragraph should read “Therapeutic studies where participants are potentially receiving therapeutic benefit must not be terminated simply for reasons of commercial interest.”

Para 13.73-13.76 Interpreting and presenting study results
We value the sensitivity of the guidance to researchers in this section and agree that deficit thinking and victim blaming should be avoided. The language used in presenting and discussing the results of research is important and much consideration should be given to this aspect of the research by researchers and authors.

Para 13.77 Returning results and incidental findings
We are concerned that participants should not be disadvantaged or negatively impacted by the results of the research or any incidental findings. Such outcomes should be anticipated by the researchers and protocols must be established and included in the research design for handling such potential adverse impacts for participants.

 

Charging participants
36 NEAC acknowledge that charging participants is an ethical dilemma that has not been addressed in earlier guidelines. The current guidance places a high barrier to charging participants. Are the above standards a high enough barrier to very seldom allow charging for participation, and only permit it when it would facilitate important research?
Please outline your reasons.
We strongly oppose the charging of participants for any part in research. We do not agree with the statement that “the research has a very high likelihood of generating benefit to the worst-off in society in the long run” provides any justification for charging participants. No participant should be expected to pay because there is a perceived (and not yet realised or guaranteed) downstream benefit to the worst-off members of society. In essence, we do not agree that the draft standards provide a high enough barrier to allow for any charging for participation. If the research is so important that it must be carried out, the onus should be on the researchers or the wider community to ensure that funding is found to enable it to go ahead and no individual participant should be charged.

 

Health information
General questions
37 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons why the section is or is not fit for purpose.
We believe that this section is clear and relevant and thorough in the guidance that it provides to researches on protecting and curating participants health information, in particular the consideration of and definitions of the identifiability of data.

 

38 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree
 
Compensation for commercially sponsored intervention studies
General questions
53 The section is fit for purpose (the content of the section is helpful, clear, and relevant and workable).
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

Please outline your reasons why the section is or is not fit for purpose.
We believe that all participants in medical/health research should have ACC cover and access to no fault compensation and rehabilitation entitlements, whether the clinical research is publicly or commercially sponsored. However, we realise that for this to happen a law change would be required.

While the new draft standards appear to strengthen the protections for participants, and improve the amount of information given to potential participants, they are still not adequate.

We believe that all commercially sponsored studies must be required to provide adequate no fault compensation and rehabilitation entitlements. Commercially sponsored research that does not include such provisions must not be approved in New Zealand. The provision of compensation must be legally enforceable and participants must not have to engage legal representation in order to obtain compensation for injuries or harm sustained as a result of participating in research.

While the guidance in the standards requires greater transparency on the part of researchers and their commercial sponsors, there is still a lack of compulsion or enforceability to provide compensation even if the sponsors are required to provide evidence of holding adequate insurance. Injured and harmed participants must not have to fight to get just and reasonable compensation for their injuries.

Under the current situation, we also do not believe that most participants/potential participants are made sufficiently aware - before they consent to participate - of their vulnerability in the event that they sustain an injury as a result of the research in which they participate. Recent changes in the PIS template text regarding compensation in commercially sponsored research have improved the situation, but this is still inadequate.

The underlying principle is that there should be no cost – financial or to their health and well-being - to participants for their participation in research no matter who is sponsoring the research, and in the knowledge that the risk of harm, no matter how small, still exists in each and every study, any participant harmed in any way should be compensated for that harm.

 

54 The section covers all relevant ethical issues and or principles for health and disability research in New Zealand.
5 4 3 2 1
Strongly disagree Disagree Neutral Agree Strongly agree

 
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