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7. Informed consent

Introduction

Informed consent is a dynamic process that begins with a researcher’s first contact with a potential participant and continues through to the end of the participant’s involvement in the research. The informed consent process requires effective and reciprocal communication between the researcher and potential participants.

Researchers have a duty to provide participants with information about the research they are being asked to participate in, potential risks and benefits, as well as the opportunity to ask questions and give their free and informed consent to participate in research, or to decline to do so.

In the context of research in New Zealand, the concept of mana tangata (personal autonomy) refers to a person’s right to participate in research and their right to be appropriately informed of risks of harm to themselves or their collective. Through clearly explaining the requirements for informed consent researchers must demonstrate respect for the mana of participants.

Informed consent contributes to a number of ethically important concepts, such as transparency, supporting individual autonomy, protecting participants’ welfare, promoting trust, satisfying regulatory requirements and promoting integrity in research.

Obtaining the informed and voluntary consent of participants is the default starting point in these standards. In limited circumstances, aspects of the consent process may be modified, or the requirement to obtain consent may be waived.

Suitable processes for obtaining consent

Requiring the consent of potential participants may require different approaches. For example, researchers may need to put in place a supported consent process, or provide culturally appropriate information. Researchers must consider the setting and timeliness of the consent process.

7.1 Researchers must seek and obtain the informed consent of individual participants before those participants begin to be involved in research, except in the circumstances outlined in Research with Adults who Cannot Provide Informed Consent.

7.1.a Informed consent must be in writing if a patient is to participate in any research involving a healthcare procedure where informed consent is required.[1]

7.2 Researchers should document participants’ consent.

7.2.a Where participants give consent in a form that is not written, researchers must record it in some other manner (e.g. through audio, video or electronic evidence, or a written note in the file).

7.2.b In some cases, consent can be demonstrated by a participant’s actions; for example, returning a completed questionnaire may be considered implied consent.

7.3 The study protocol must detail the researchers’ process for obtaining consent, or their reasons for not seeking it, along with an ethical justification.

7.4 Researchers must give potential participants sufficient time and support to consider whether to participate in the study, as appropriate to the context of the study.

7.4.a Researchers should consider the circumstances of potential participants during consent discussions. Potential participants have a right to support throughout this process; acknowledging this right is particularly relevant in stressful situations.

7.5 Unless an ethics committee has granted a waiver of consent, or the study does not seek consent due to the research population, researchers must seek consent before their study procedures begin, including consent for study-specific personal data collection and any additional diagnostic testing necessary for eligibility screening.

7.5.a Researchers may review clinical notes and previously completed standard-of-care diagnostic tests prior to obtaining consent for eligibility screening (eg, a diagnostic biopsy or CT scan in the case of lymphoma).

7.6 If participants face barriers, including language barriers, it may be necessary for a researcher to seek their consent with help from an intermediary, such as an interpreter or advocate (Code of Health and Disability Services Consumers’ Rights 1996). If a participant is unable to read, an impartial witness (a person, who is independent of the research, who cannot be unfairly influenced by people involved with the research) should be present during the entire informed consent discussion.

7.6.a In this situation, by signing the consent form, the intermediary or witness attests that the information in the participant information sheet and consent form and any other written information was accurately explained to the participant verbally, that the participant apparently understood that information, and that the participant freely gave informed consent.

7.6.b Involving intermediaries may raise confidentiality issues. Researchers should discuss with participants whether family members are appropriate intermediaries; if the potential participant indicates that a family member does not have their interests in mind, researchers should consider finding someone impartial.

7.7 Researchers must give potential participants adequate time and opportunity to absorb the information provided, ask questions, and finally consider whether they will participate.

7.7.a The amount of time needed for this first phase of the consent process will depend primarily on the needs of the participant, but may take into account such factors as the risk magnitude and probability of harms, the complexity of the information provided and the setting in which the information is given.

7.8 Participants may be faced with the necessity of making multiple simultaneous consent decisions about clinical care, research participation and future unspecified use of tissue. In such circumstances, researchers should take into account the recruitment context, for example whether it is a high stress situation, and consider ways to reduce the risk of undermining the informed consent process.

7.8.a For example, it may be appropriate for researchers to undertake the consent processes for the primary study and any optional components at a different times, as well as identifying conflicts of interest and avoiding therapeutic misconceptions.

Consent as a dynamic process

7.9 Researchers must notify participants of any substantial changes during the study that may affect them. Where researchers amend a study so that it substantially changes from what participants originally agreed to, they must seek participants’ consent to continue to take part.

7.9.a A determination as to whether a change is substantial and whether there is a corresponding need to obtain new consent is based on the context and circumstances of the study.

7.9.b Where researchers seek new consent, the information they provide participants should be new, and relevant to the participant’s original consent. Its importance should be directly related to the participant’s willingness to continue their participation (Dal‐Ré et al 2008). In this case, the new information given to participants should be consistent with what a reasonable person, in that person’s circumstances, would expect to receive to make a decision about continued participation

7.10 If a study requires several interactions between the participant and the researcher over time, or if the participant may be considered momentarily vulnerable for any reason, the researcher should ensure at appropriate points that the participant’s consent is ongoing.

7.11 Researchers must use information and tissue collected about or from research participants only in the specific project to which the participant has consented.

7.12 If, at the time of obtaining consent, it is possible to identify future studies that are either an extension of the current study or in a closely related area, researchers should inform participants of these later studies, and invite them to give consent for data use in that context.

7.13 Participants have the right to withdraw at any point in a study without experiencing disadvantage.[2]

Consent must be voluntary

Voluntariness is threatened by conflicts of interest and sources of vulnerability. See Research Conduct for information on management of conflicts of interest, and ethical management of vulnerability, which covers participants who may be more likely to experience undue influence on the voluntary nature of their decision to participate.

7.14 Participants’ consent to participate in research must be voluntary.

7.14.a Voluntary consent is an ongoing and important expression of a participant’s free will. The consent process must protect participants from coercion, deception, manipulation or other undue influence.

7.14.b Researchers are responsible for ensuring that participants know that they are free to accept or decline an offer to participate in a study, and that they will not experience any disadvantage by making either decision.

Consent must be informed

Effective communication is an essential feature of informed consent. The process of obtaining informed consent involves balancing potential participants’ right to be fully informed against not overburdening them with information that reduces their ability to provide effective informed consent.

7.15 Participants must receive the information that a reasonable consumer, in that consumer’s circumstances, would need to make an informed choice or give informed consent prior to their decision to participate in research.[3]

7.16 Researchers must communicate relevant information in a form, language and manner that enables participants to understand the information provided, in an environment that enables both the participant and the researcher to communicate openly, honestly and effectively. Where necessary and reasonably practicable, this includes the right to a competent interpreter.[4]

7.17 Researchers must provide information in a form, language and manner that participants can understand. Information provided to participants, and any discussion of it, should be appropriate to the individual, taking into account their health literacy and their cultural and language background.

7.18 The person obtaining informed consent must be knowledgeable about the research and capable of answering questions from potential participants.

7.18.a Participants must have the opportunity to ask questions and receive honest and accurate answers before or during the research (Code of Health and Disability Services Consumers’ Rights 1996). Researchers must make every effort to address those questions in a timely and comprehensive manner.

Table 7-1 – Key elements to informed consent
Study participation Relevant information

Nature of the study

  • The purpose of the research, including its expected contribution to knowledge
  • The features of the research design, including an explanation of randomisation, blinding or placebos
  • The nature and sources of funding and resourcing of the study, and the institutional affiliations of the researcher(s)
  • Any actual or potential conflicts of interest or commitment and how they will be managed
  • Details of ethics approval, including the ethics reference number
  • Why the person may be suitable for the study
  • Why the person may not be suitable for the study

Participants’ rights, including:

  • The voluntary nature of participation, including that participants are free to withdraw from the study at any stage (to the extent possible)
  • The right of participants to access tissue and/or data about themselves collected as part of the study
  • How participants will be told of any new information about adverse or beneficial effects related to the study if it becomes available during the study and may have an impact on their health
  • What arrangements will be made for the privacy and confidentiality of participants, including the confidentiality of data in which participants are identified or potentially identifiable
  • Any limits, legal or otherwise, to the researchers’ ability to safeguard confidentiality, and the possible consequences to participants of a breach in confidentiality
  • Arrangements for personal compensation for injury
  • How payments or other forms of reimbursement, if any, will be provided in recognition of participation

Any harms, including foreseeable side effects, pain and discomforts, which:

  • Describe the nature of harms for particular types of participants (e.g. women of childbearing age)
  • Express the likelihood of risk of harm as an event frequency (e.g. one in ten)
  • Define the severity of potential harm in terms of the damage that it would cause (e.g. discomfort, pain, trauma)
  • Communicate any risks of harm that may exist for a participant’s family, whānau, hapū or iwi

Information about the use of participants’ tissue, which covers:

  • How and where their tissue will be stored, used and disposed of, including any processes that will be followed to respect their personal or cultural sensitivity
  • The extent to which their tissue will be reasonably identifiable, and methods for protecting their privacy and confidentiality
  • Whether research using their tissue is likely to provide information that may be important to their health or to the health of their blood relatives or their community, how this kind of information will be managed and whether they have a choice about receiving the information
  • Whether their tissue and associated data may be distributed to other researchers, including those outside New Zealand
  • Their right to withdraw consent for the use of their tissue and associated data in research, and any limitations that may be relevant to their withdrawal of consent; for example, as a consequence of the removal of identifiers or the prior distribution and/or use of their tissue
  • Any relevant financial or personal interests that those engaged in collecting, processing, storing, distributing and using their tissue may have
  • Any potential for commercial application of the outcomes of the research involving their tissue; how this will be managed; and who, if anyone, will benefit from such an application
  • Whether they may be able to have left-over tissue samples returned to them and whether the tissue can be disposed of, with a reassurance that researchers will record their wishes about the method of disposal at the start of the research and take those wishes into account at the time of disposal.

What participation in the study will mean for participants, including:

  • What will be done in the study in addition to usual health care or disability services (including dosing details, if applicable)
  • How participation will differ from non-participation
  • The time involved in participation
  • Any inconveniences likely to result from study participation, such as time off work
  • The nature, purpose and expected number of any extra tests to be performed during the study

Information about:

  • How study data will be used and where it will be stored (including any specified or unspecified future use or uses)
  • Whether any data linkage will be performed and whether the data will be stored in a databank
  • The form (identifiable, re-identifiable or non-identifiable) in which the data will be accessed, used and stored during the life cycle of the research data
  • How long the data will be retained
  • Who will access the data, and the form in which it will be accessed and shared
  • Whether data will be transferred to other countries and, if so, the impact (if any) of this on
    participants’ rights
  • Whether participants may be able to withdraw their data, including the date up to which they can withdraw it
  • Procedures for withdrawing their data
  • Whether their data will be destroyed, and the procedures for destroying data

Suitable contact details, including for:

  • The researchers
  • A suitable cultural support person
  • An independent advocacy service (e.g. the Health and Disability Commissioner)
  • The ethics committee that has approved the study

Researcher information

  • Whether the research findings may be commercialised, and any ownership rights participants may have over these
  • Whether researchers may remove participants from the study for any reason

Findings

  • What findings could be identified from the study testing, and how any findings that are relevant to the health of participants will be communicated to participants

Possible benefits of research participation

  • For individual participants, whānau communities, hapū or iwi; and society at large; or any contributions it could have to scientific knowledge

Researchers’ responsibility

  • Extent of the researchers’ responsibility to provide care for participants’ health needs during and after the research, who will pay for costs associated with such care and the relationship between the participant’s usual health care provider and the research team

Information about what will happen after the study, including:

  • Whether an intervention or care related to the research will be available to participants after the study and, if so, under what conditions (including any cost to participants)
  • How researchers will communicate the research findings to participants and communities, and the expected timeframe for this
  • How the researchers will disseminate research results publicly, and whether published results will identify participants directly or indirectly
  • How the researchers will communicate the results of tests to participants, including incidental findings
  • Whether and how the research findings will be translated into health care

7.19 Information sheets should not contain excessive information. Their main purpose should be to inform participants, rather than to protect researchers or sponsors, or to achieve any other purpose.

7.19.a Researchers should develop study information with potential participant input, to ensure it is appropriate and relevant.

7.19.b Information provided to participants should be proportional to the risk associated with study participation and appropriate to participants’ circumstances. As a general rule, the greater the risks participants face through their participation in a study, the more detailed the information and the greater the support they receive need to be.

7.19.c In some research that involves an intervention, participants may overestimate the likelihood or degree of benefit of the intervention (this is called ‘therapeutic mis-estimation’), overlook the implications of study participation, or mistake research procedures for therapeutic ones (this is called ‘therapeutic mis-conception’). Researchers should make particular efforts to obtain a valid informed consent by avoiding these effects.

7.19.d Researchers should also consider their own bias towards the study benefits. It is important that they recognise any such bias, and ensure they are providing accurate information; for example, by seeking input from other researchers in the field who are not directly involved in the study.

Table 7-1 includes a list of key elements of informed consent. They will not be relevant for all studies, and depending on the complexity and risk of the study, may be described in detail or briefly. Ethically, a balance must be struck between amount of information and the burden of information[5]. Researchers should provide participants with information, as relevant for the particular study, taking into account proportionality of information in relation to both the potential harms and benefits of the research and the type (or complexity) of the study.

Modifying the consent process

Sometimes, because of a study’s design or the characteristics of the research population being studied, it is necessary for a researcher to modify the informed consent process. Alterations to the traditional consent model have ethical implications, which researchers have a duty to evaluate when proposing modifications to consent.

7.20 Any modification to informed consent procedures requires approval from an ethics committee.

7.20.a Examples are withholding information and deception, abbreviated consent, integrated consent, opt-out, health data or tissue waivers and research with adults who cannot provide informed consent.

7.21 When seeking approval for a modification to informed consent procedures, researchers must explain to an ethics committee how traditional consent (a written information sheet and consent form) would impact on the study in terms of its design or the research population, and consider and explain to what degree proposed alternatives affect participants’ rights.

7.21.a These Standards aim to provide flexibility with respect to the ethical justifications made in modifying the consent process. Consent processes must still meet the Code of Health and Disability Services Consumers’ Rights 1996.

Electronic consent

Electronic procedures for consent, either online or in other digital formats, are increasingly replacing printed copies of participant information sheets and consent forms. Electronic consent forms can provide many advantages over handwritten equivalents, including customisability, fewer mistakes on forms, greater clarity on the purpose of the study and alternatives to participation, more flexibility as to adjusting or translating the form into other languages, increased availability of tools to assist comprehension, and flexibility as to where participants can complete the form. However, for disadvantaged groups with little or no disposable income to access and use electronic devices, electronic consent can be a barrier for participation in research.

7.22 Electronic consent forms must contain the same elements of informed consent as a paper equivalent, in a language the participant can understand.

7.23 Interactive formats should be simple to navigate. Researchers should not use electronic methods if participants indicate a lack of comfort with electronic media.

7.24 Researchers should make paper-based processes available where an individual or a community does not have access to the internet or a device on which to complete the electronic consent process.

7.25 Electronic consent methods must entail a means to ensure that the participant himself or herself provided consent.

7.26 Researchers should ensure that they can verify which version of the information sheet and consent form the electronic signature applies to.

7.27 Information about a study does not have to be in writing, and can be provided to potential participants using electronic methods. In deciding whether to use electronic methods, researchers should pay special attention to the information needs of specific patient populations and individual participants.

7.28 Electronic consent forms must contain information that assists the patients in understanding information relevant to the trial; for example, by using hyperlinked glossary terms.

7.29 Electronic consent applications must be compliant with relevant data security standards.

7.30 When utilising electronic consent, interaction between researcher and participant should remain an integral part of the consent process.

Withholding information and deception

7.31 Participants must still consent to participate in the research overall.

7.32 Where deception and/or concealment are part of the research design, researchers must justify this choice to an ethics committee, according to the following criteria.

  • No suitable alternative methods are available.
  • Participants are not exposed to increased risk of harm due to the deception or concealment.
  • The study protocol defines the extent of deception or concealment.
  • Researchers disclose the deception or concealment adequately and promptly to participants, and debrief them, as soon as it is appropriate and practicable to do so.
  • Researchers offer participants the option of withdrawing study data that they collected through deception or concealment.
  • The deception or concealment will not compromise the relationship between the participants, the community and the researchers or research.

7.33 In limited circumstances, providing very specific information about the study to participants in advance of seeking their consent could prejudice the purposes of collecting data, which would compromise the scientific validity of the study (e.g. advising participants about which arm of a trial (for example placebo or active drug) they will be allocated to). In such cases, researchers should ask potential participants to consent to remain uninformed about some procedures until the research is completed. After their participation in the study ends, the researchers must then give participants the information they withheld.

7.34 In other cases, because a request for permission to withhold some information could jeopardise the validity of the research (e.g. because participants may modify their behaviour in response), the researchers cannot tell participants that they have withheld some information until the data has been collected. In this case, before analysing study results, researchers must give participants the information that they withheld earlier, and give them the option of withdrawing their data collected during the study.

7.34.a In this case, before the study starts, researchers must consider how participants’ withdrawal of their data could impact on the validity of the study.

7.35 Researchers may (as part of the research design) sometimes deliberately misinform participants in order to study certain attitudes and behaviour. Active deception of participants is considerably more controversial than withholding information. Researchers must be aware that deceiving participants may wrong as well as harm them; participants may resent not having been informed when they learn that they have participated in a study under false pretences.

7.36 If actively deceiving participants is necessary to maintain the scientific validity of the research, researchers must justify the deception, and obtain the approval of an ethics committee for it.

7.37 After the research is completed, researchers must inform participants of the deception and the reasons for it, in a process often called ‘debriefing’. Debriefing is an essential part of trying to rectify the wrong of deception. Where participants disapprove of having been deceived for research purposes, researchers must offer them an opportunity to withdraw their data collected through deception.

Integrated consent

Increasingly, research is being conducted as part of service delivery. Health systems can aim to improve medical care at the same time as they deliver it, by integrating the delivery of medical services with clinical research. The traditional lengthy process of informed consent for research participation can complicate the process of embedding research into routine clinical care, reducing the time clinicians are able to devote to ordinary clinical care.

To address this, in some circumstances, for example comparative effectiveness research, researchers may be able to justify using an integrated consent process, in which consent to participate in research occurs as part of a clinical discussion. In this case, the usual clinical discussion about treatment includes explaining that participants will include some research elements, such as being randomly assigned to one of the clinical options, and that their health data will be collected and used for the purposes of research.

However practical this may be, and even in low-risk comparisons between existing standard of care, significant practical and ethical concerns with integrated consent remain, particularly with respect to patient rights and individual autonomy. Unless they manage these concerns appropriately, researchers should not proceed with research protocols involving integrated consent procedures justified in terms of expediency or convenience. By integrating consent to research participation into a clinical discussion, they are likely to give information to participants that is substantially briefer, for practical reasons, than the information that would appear on a written participant information sheet. Notably, explicit statements about voluntariness and confidentiality tend to be less detailed. Such a discussion must clarify that the patient will still receive treatment if they choose not to participate in the research; the discussion must distinguish between consent to treatment and consent to participate in research.

7.38 In this situation, researchers must seek consent to treatment prior to seeking consent for research.

7.39 At a minimum, the process of integrating consent for research into the interaction between health professional and patients/participants must include the basic aspects of voluntary and informed consent. In particular, researchers must:

  • make the research component (including randomisation, the use of data and any additional research procedures) transparent, and distinguish it from treatment
  • explain the risks, benefits and rationale of the research component, and ensure that the risks of the research are no more than minimal
  • document the consent processes and the discussion with the patient , where separate written consent is not obtained (the Code of Health and Disability Services Consumers’ Rights 1996),
  • respect the preferences and values of potential participants.

7.40 It is imperative that clinicians obtaining informed consent are experienced in obtaining consent, and are able to clearly explain the separate clinical and research components to potential participants. They must be able to weigh reasons of practicality against potential impacts on patients’ rights, including the implications of reducing transparency and limiting patients’ freedom of choice about treatment options.

Abbreviated consent in the case of medical emergencies or acute pain

In some circumstances, researchers may be able to justify using an abbreviated consent process to enrol an individual if following a standard consent process could seriously compromise that individual’s health. An abbreviated consent process involves giving potential participants the information a person in their position would expect to receive given the circumstances they are in. This may be briefer than the information they would provide in the standard consent process, outside of a medical emergency.

For example, certain types of medical emergency practice can be evaluated only when a particular medical emergency occurs that necessitates the practice. Features of this context are acute pain, limited time to treat and competing care demands.

7.41 Subject to all applicable legal and regulatory requirements, researchers should consider whether an abbreviated consent would be appropriate, in order to balance informed consent with minimising harm.

7.42 When a participant’s circumstances become more stable, researchers should offer them full information about the study. They should also seek the participant’s fully informed consent to continue to participate in the study and for their already collected data to be included in the study.

7.43 If the participant is unconscious or lacks capacity to understand the risks, methods and purposes of the study, see Research without consent with adults who cannot provide informed consent.

Opt-out consent

The phrase ‘opt-out consent’ (sometimes called ‘passive consent’) refers to ‘consent’ in which potential participants inform the researcher only when they do not wish to participate.

7.44 Researchers must take care that this recruitment method does not cause harm by making individuals unwitting participants.

7.45 An opt-out approach to recruitment may be appropriate when opt-in consent is neither practical nor feasible. Researchers must be able to justify an opt-out approach by ensuring that:

  • potential participants have received appropriate materials informing them about the recruitment and study
  • potential participants are made aware of the existence of the opt-out procedure, and are informed that they can choose not to participate or not to have their personal information included in the study
  • potential participants are offered clear and accessible ways to decline to participate and a reasonable time period in which to do so
  • potential participants are given an opportunity to speak with the researchers if they are confused by the instructions or need to discuss the study further
  • researchers address privacy concerns for sensitive research
  • being involved in the research carries no more than minimal risk to participants
  • the public interest in the research outweighs the public interest in protecting privacy
  • the requirement for opt-in consent would compromise the necessary level of participation to achieve study aims
  • data management and governance are in line with appropriate standards
  • the opt-out approach is not prohibited by law.

A note on ethics and the law: opt-out consent feasibility

The use of this method of consent is very limited in New Zealand. This is because the opt-out or passive consent does not meet the legal requirements of prospective informed consent.[6]

NEAC recognise that there is a tension between ethics and the legal framework for consent. This tension creates a legal barrier to some research that may otherwise meet ethical standards. NEAC are aware of the tension and support a review of the law in this area.

Waiver of consent for secondary re-use of identifiable health data

Gaining informed consent to use previously collected identifiable data (including data-linking) should always be the default starting point. Where researchers propose to use identifiable data without specific consent for a study or project (e.g. where data was collected for care, or the proposed data use is not consistent with the scope of the original research consent), they must:

7.46 Satisfy national data standards, local data governance requirements

7.47 Justify to an Ethics Committee that the nature, degree and likelihood of possible benefits (including to participant and/or individuals and the value of the research to the public) outweigh the nature, degree and likelihood of possible harms (including to any participant and/or individual, other individuals, whānau, hapū, iwi, Māori communities and any other groups or communities). In determining whether to grant a waiver of consent, local data governance or Ethics Committees may also have regard to the following factors:

7.47.a There are scientific, practical, or ethical reasons why consent cannot be obtained.

7.47.b Appropriate data governance plans are in place.

7.47.c The researchers have identified whether consultation is required, and if required they have undertaken appropriate consultation with cultural or other relevant groups, and those consulted support the proposed use.

7.48 When considering a waiver, researchers should identify if there is any known or likely reason to expect that the participant and/or individual(s) would not have consented if they had been asked.

7.48.a It should be understood that a waiver of consent is not a waiver of responsibility, e.g. should there be an actionable incidental finding then it should be disclosed to the participant and/or individual.[7]

Waiver of consent for secondary use (re-use) of human tissue

7.49 Researchers must get informed consent from the person from whom the tissue was or will be collected before they use it for research, unless;

7.49.a consent from a family member has been provided in the case of a person being deceased or

7.49.b a waiver of consent is approved by an ethics committee.

7.50 Gaining informed consent to use tissue in research should always be the default starting point. Where researchers propose to use tissue without specific consent for research (e.g. where tissue was collected for clinical investigation, or the proposed tissue use is not consistent with the scope of the original research consent), researchers must satisfy an ethics committee that all of the following conditions for a waiver of consent are satisfied:

  • There are scientific, practical or ethical reasons why consent cannot be obtained.
  • The nature, degree and likelihood of possible benefits outweigh the nature, degree and likelihood of possible harms, including to any participant, other individuals, whānau, hapū, iwi, Māori communities and any other groups or communities.
  • Appropriate data and tissue governance plans are in place.

7.51 Researchers should carefully consider whether they should undertake robust, active and ongoing engagement with relevant communities and stakeholders to establish whether the proposed tissue use is acceptable.

7.51.a Any such engagement should be transparent and fair, done in good faith and be truthful, consistent with the concepts and practice of whakapono and whakataukī.

7.52 When seeking a waiver, researchers should identify if there is any known or likely reason to expect that the participant(s) would not have consented if they had been asked. For example, are there elements which would be upsetting to the people who the tissue belongs?” This is not something for researchers to prove beyond reasonable doubt, but the researcher needs to consider this aspect of use of tissue without consent.

7.53 When research involves using clinical samples, researchers’ use of tissue must not compromise the primary clinical reason for collecting the tissue.

7.54 Researchers must maintain participants’ privacy and confidentiality throughout the period during which they are using and storing the tissue and its associated data.

7.55 Researchers must consider the potential psychological, social and cultural significance of their use of tissue, and plan to minimise all research harms.

7.56 Managing the ethical risks associated with the collection and use of human tissue in research includes:

  • conducting the study according to a detailed and approved tissue management plan
  • managing privacy and confidentiality
  • returning results appropriately and managing incidental findings
  • giving special consideration to the issues involved in exporting or importing tissue.

Consent for future use of health data and human tissue

Increasingly, re-use of data and tissue is planned at the time of seeking consent for a study.

Future use of data

Future use of data refers to new data being prospectively collected and is different from previously collected data being re-used (refer to secondary data use). Future use of data encompasses both specified or unspecified future analysis, and future analyses related or unrelated to the research area leading to original data collection.

7.57 Participant and/or individuals in prospective data collection, in which future use under this definition is planned, must be informed as to the scope and relatedness of the request for consent for future use.

7.57.a Examples of information that might be relevant are:

  • the identifiability of the data to be collected
  • participants’ rights of withdrawal of consent and, in particular, the possibility that, where data is made non-identifiable, an individual may not be able to know what is done with their data and will not have the option of withdrawing their consent
  • the future foreseeable use of the data, whether that use is limited to an already fully defined study or extends to a number of wholly or partially undefined studies, and the intended goal of such use (in terms of whether it is only for basic or applied research or also for commercial purposes)
  • the procedures for return of results, including incidental findings
  • the rules of access to the data, and who will manage access
  • how confidentiality and privacy is protected
  • where applicable, potential commercial use and benefit sharing, intellectual property issues and the transfer of data to other institutions or countries
  • the conditions and duration of storage of the data
  • the ways in which the individual can contact the databank or registry custodian and remain informed about future uses of the data
  • the ways in which the individual can request corrections of mistakes or omissions and, in particular, the possibility that, where data is made non-identifiable, the individual may not have the option of correction
  • the risks and burdens associated with collection, storage and use of data.

Consent for biobanking (future unspecified use of human tissue)

New Zealand individuals can give consent to their tissue being used for future unspecified research, provided that they have received sufficient information and options for consent through a process that is distinct from that involved in the main study (Ministry of Health 2007). Storage and future use is ethically justifiable through a combination of informed consent, transparency and good governance structures. All tissue stored beyond the duration of a research study is considered biobanking. See ‘Biobanks’ for more information.

7.58 When donors give consent for future unspecified research, researchers must:

  • indicate the type and nature of the research to be carried out and its implications for the donor, where possible
  • state whether genetic testing may be carried out on the tissue
  • explain to the potential donor why he or she is being approached for his or her tissue, and specifically what tissue they are seeking
  • state where and for how long a tissue sample will be stored, how it will be disposed of and whether there is a cultural protocol for its disposal
  • identify known possible researchers or institutions that might use the tissue sample, if possible
  • state whether the donor’s sample (or part of it) is likely to be sent overseas and, where possible, to what country or countries
  • acknowledge that all future unspecified research in New Zealand will be subject to ethical review and note that, when a tissue sample is sent overseas, unless it is sent in conjunction with a New Zealand study, future research is likely to be considered by an overseas ethics committee without New Zealand representation
  • state whether the donor’s identity and details will remain linked with the sample or whether the sample will be delinked
  • state whether the donor can withdraw consent for the use of their human tissue samples in the future
  • state that, if a donor consents to a tissue sample being unidentified or delinked, they relinquish their right to withdraw consent in the future
  • state whether the donor may be contacted in the future about their tissue sample
  • state whether, and under what circumstances, information about the future unspecified research will be made available to the donor and/or (where relevant) their clinician
  • acknowledge that the donor will not own any intellectual property that may arise from any future research
  • acknowledge that the donor’s decision about the consent for use of their tissue sample for unspecified future research will in no way affect the quality of a donor’s current or future clinical care.

Research with adults who cannot provide informed consent

This section addresses the ethical issues that arise in research involving adult participants who cannot provide their own consent. Most people, with adequate support, can provide their own consent to participate in research. See the section on supported decision making for guidance on seeking consent where adults have variable degrees of competency but with support are considered able to provide their own informed consent. See ‘waivers’ for retrospective research without consent involving data or tissue that has already been collected. In some cases another person may be legally able to give consent on behalf of an adult who is not competent to consent (see “Substituted decision making”).

Informed consent is still the primary means of protecting patient autonomy but in exceptional cases NEAC considered the ethics of research in the absence of consent[8]. In some studies, informed consent is not an option, because the people involved in the study cannot provide consent. However, given that medical treatment extends to those with impaired decision-making capacity, it is important that researchers do not exclude people from research just because they cannot consent to participate.[9] Where certain populations (eg, people in intensive care units, people with dementia, the severely disabled and those in emergency care) have been excluded from research because they are unable to give consent, care or treatment options for those populations may be less strongly evidence-based, because insufficient research evidence is available.

The risks and benefits of studies with participants who cannot consent may vary from extremely high to negligible (See Categories of Risk). At one extreme, where significant incapacity or death is almost certain, a new therapeutic measure may offer a person a reasonable chance for recovery, sustaining life or preventing serious and permanent deficits. In other situations, the potential benefits and risks may be equally great – one may not outweigh the other. For example, drugs given in an effort to save the lives of trauma victims might do so at the risk of preserving those lives in a persistent vegetative state. Lastly, the research may involve treatments that are in standard of care, where it is not known which one is better, or which one should be used for different situations, and the only research elements are randomisation between the standards of care and data collection (see Comparative Effectiveness Research).

Many studies involving participants who cannot consent may be almost without risk, yet yield information useful in the treatment of the participant (e.g. by monitoring certain physiological events by non-invasive means).

When considering the ethical justification for research that involves adults who cannot provide their own consent, researchers must balance ethical principles in each study, as well as in each individual case of enrolment.

General ethical standards

7.59 Before participants unable to consent can be involved in research, an ethics committee must be satisfied that the particular research question cannot be appropriately answered by conducting research in consenting populations.

7.60 Health and disability research with participants unable to consent must be connected or responsive to the health needs or priorities of the group that the participants represent.

7.60.a Such research is only ethical when the purpose of the research is to advance knowledge about the condition causing the participant's impairment or its treatment or relevant services.

7.61 Researchers are responsible for demonstrating to an ethics committee how their research meets these standards, by detailing the potential risks to individuals and the potential benefits to individuals and to others.

7.61.a Researchers should compare potential benefits and risks with standard-of-care options currently available, or with not participating, and explain any additional risks or benefits of participation to an ethics committee.

7.62 Where the researcher is also the treatment provider there may be a real or perceived conflict of interest when enrolling participants without consent. In such cases, it may be appropriate for researchers to seek an independent view on whether a particular participant’s enrolment in a study meets legal and ethical standards.

7.62.a In the medical context, this may involve obtaining an independent clinical assessment.

7.62.b The requirement to seek an independent view should generally be limited to studies that pose more than minimal risk.

7.63 If a research participant regains capacity to consent, or some capacity to be supported in a decision, as soon as reasonably practicable researchers must give that participant the opportunity to give or decline informed consent to continued participation in the research, and to the use of data or tissue about them that has already been collected.

7.64 Where potential participants are capable of verbally or physically dissenting or declining, to participate in research, researchers should seek and respect that decision.

7.65 When a study enrols a participant without their consent, researchers must pay special attention and make extra efforts to minimise that person’s pain, anxiety and related social harms in relation to the enrolment.

7.65.a This requirement applies especially in cases where participants may not be able to adequately communicate pain or discomfort due to their condition.

7.66 When conducting research with adults who cannot provide consent, particularly in emergency contexts where seeking the views of a person interested in that individual’s welfare is not possible, the research protocol should include additional safeguards.

7.66.a Additional safeguards should be discussed with an ethics committee, and might include:

  • additional scientific, medical or ethics committee consultation
  • procedures to identify prospective participants in advance, so that consent may be sought prior to the occurrence of incapacity
  • consultation with former and or prospective participants
  • special monitoring procedures to be followed by data safety and monitoring boards (Canadian Institutes of Health Research et al. 2014).

Respecting and seeking views

Adults who cannot provide their own consent cannot protect their own interests or indicate their preferences. Accordingly:

7.67 Researchers should respect the views held by people interested in the potential participant’s welfare on whether participation in the research is consistent with the informed choice the participant would make if her or she were competent.

7.68 Researchers should also take reasonable steps to consult person(s) interested in the potential participant’s welfare about that participant’s continued involvement in the research, particularly if the research protocol is amended after enrolment.

7.69 If such a person is not able to be consulted and an intervention must be conducted in acute circumstances (e.g. emergency research), the research may proceed without that consultation, but researchers should continue to make efforts to consult a person interested in the welfare of the participant to establish whether the participant should continue to participate.

Enrolling participants in research

7.70 To meet New Zealand legal requirements, in order to enrol participants into research without consent, enrolment must be in the best interests of the individual, and reasonable steps have to be taken to ascertain the views of the potential participant.[10]

7.70.a Best interests is determined on an individual basis, and while such determinations do not take into account potential benefits for other people, best interests determinations do include consideration of direct benefits (e.g. improvement of medical condition) and indirect medical benefits (increased monitoring) as well as non-medical factors (e.g. emotional and other benefits) to the person themselves.

7.70.b The best interests test requires a net benefit, where participating is more beneficial than not participating.

7.71 When taking reasonable steps to ascertain the views of the potential participant, either:

  • the potential participant’s views are ascertained, and having regard to those views, the provider believes, on reasonable grounds, that the provision of the services is consistent with the informed choice the potential participant would make if he or she were competent; or
  • the potential participant’s views are not ascertained, and the provider takes into account the views of other suitable persons who are interested in the welfare of the potential participant and available to advise the provider.

Substituted decision-making

Substituted decision making is when a legally authorised person consents on behalf of another person. Under New Zealand law, the group of people who can give consent for another adult to participate in health research is smaller than often assumed, and for research that involves medical experimentation their powers are very limited.

Generally, unless an adult has a welfare guardian, or someone holds an enduring power of attorney in relation to that adult, there will be rarely, if ever, be any individual who can provide legally effective substituted decisions.

The High Court may be able to make an order for clinical measures that are in the patient’s best interests and of direct benefit to the patient themselves, however there is currently no precedent for this in the context of research.

7.72 Researchers should check the relevant legislation to ensure their enrolment processes meet legal requirements.

Welfare guardians

The Protection of Personal and Property Rights Act 1988 (PPPRA) empowers a Family Court to appoint a “welfare guardian” for some incapacitated adults.

Section 18(1)(f) states that no welfare guardian can consent to a person, for whom they are acting as a welfare guardian, taking part in any medical experiment other than one to be conducted for the purpose of saving that person’s life or of preventing serious damage to that person’s health. The term “medical experiment” is not defined in the PPPRA, and its meaning has not been considered by the New Zealand courts. Some health and disability research are unlikely to be considered medical experimentation.

However, section 18(1)(f) does not preclude a ‘medical experiment’ involving a patient being carried out other than for the purposes specified in the PPPRA. It simply prevents this being done based on a welfare guardians’ consent. For example, a practitioner may believe that the best interests of the patient dictate that the patient receives a treatment that is experimental in nature and thereby use right 7(4) of the Code to justify this course of action. This could equally apply to research believed to be in the best interests of a patient.

Attorneys, under enduring powers of attorney

Enduring powers of attorney in relation to personal care and welfare come into force after the ‘donor’ (the individual conferring the power) becomes mentally incapable and at this point the ‘attorney’ (the individual given the power) has the power to make decisions about the donor’s personal care and welfare. The legal framework for this process is outlined in part 9 of the PPPRA.

In terms of medical research, section 98(4) of the PPPRA means that an attorney cannot consent to a person, for whom they are acting as a attorney, taking part in any medical experiment other than one to be conducted for the purpose of saving that person’s life or of preventing serious damage to that person’s health.

As for welfare guardians (see above), a practitioner may be able to rely on right 7(4) where they believe that the participation in the research would promote and protect the patient’s welfare and best interests.

7.73 Where there is a legally authorised person, and the research is not a medical experiment, a legally authorised person may consent on behalf of an adult if they are satisfied that participation would promote and protect the person’s welfare and best interest.

7.74 Researchers should check the relevant legislation to ensure their enrolment processes meets legal requirements.

The legality of research with adults who cannot consent

The legality of undertaking research with adults who cannot consent involves significant gaps in application. This area of law is governed by a number of legislative instruments, together with the common law. See, for example:

The provisions in both the New Zealand Bill of Rights Act and the Code of Health and Disability Services Consumers’ Rights arguably relate to a person being physically involved in the research. When considering the legality of research involving unconscious consumers it is therefore important to distinguish between research where individuals directly participate (such as that involving an innovative practice or a clinical trial) and research that uses information normally gathered during the course of the delivery of a currently recognised health care practice or treatment (such as the clinical evaluation of a particular treatment). If the latter is the case (the research does not involve any additional information gathering above what would normally be associated with a particular treatment), the research may be able to proceed if it is conducted in compliance with the Health Information Privacy Code 1994.

However as the terms “health research” and “disability research” are open to broad interpretation and are not defined in the law, it is unclear whether the requirements of the Code for the provision of information and written informed consent may also apply to collection of data for the purposes of research at the time of treatment, as opposed to where data is sought to be used retrospectively. See waiver of consent for secondary use of health data.

7.75 Due to the complex legal environment, researchers should seek legal advice to ensure that their research in this area is conducted in line with New Zealand law.

A note on ethics and the law - risks, benefits and the two-step approach

The role of NEAC is to determine nationally consistent ethical standards across the health and disability sector and provide scrutiny for national health research and health services. It must also ensure that any advice and guidelines it issues comply with the laws of New Zealand.

This requirement creates a tension, particularly in the case of research with participants who are unable to consent, in which area the law is complex. For guidance in navigating this tension, NEAC recommends that researchers consult the Health and Disability Commission Code of Rights, which restrict research with this population to cases where participation is in the individual’s best interest.

The National Ethics Advisory Committee will publicly consult on any changes to the ethical standards if there is a proposed change in the law.

NEAC support a two-step approach that requires the level of risk of the research and the potential benefits to the individual, to determine the acceptable benefits that enable ethical recruitment of participants who cannot provide their own consent:

  • Where the research imposes only minimal risk, it should have the prospect of providing benefits to the participants or the group to which they belong.
  • Where the research exposes participants to greater than minimal risk, it should have the prospect of benefit for the individual participant. Benefits should be commensurate with the level of foreseeable risk. In balancing benefit to risk, the risk/benefit ratio should be ‘at least as favourable to the participants’ as alternative approaches.

[1] Right 7 (6)(a) of the Code of Health and Disability Services Consumers’ Rights 1996.

[2] See Right 7(7) of the Code of Health and Disability Services Consumers’ Rights 1996, which provides: ‘Every consumer has the right to refuse services and to withdraw consent to services’.

[3] Right 6 (2) Code of Health and Disability Services Consumers’ Rights 1996.

[5] Right 6 of the Code of Rights sets out the legal requirements for informed consent. Right to be fully informed

  1. Every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, would expect to receive, including:
    1. an explanation of his or her condition; and
    2. an explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and
    3. advice of the estimated time within which the services will be provided; and
    4. notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and
    5. any other information required by legal, professional, ethical, and other relevant standards; and
    6. the results of tests; and
    7. the results of procedures.
  2. Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, needs to make an informed choice or give informed consent.

[6] Right 7(1) of the Code of Health and Disability Services Consumers’ Rights 1996 states that services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent.

[8] This is in line with the Declaration of Helsinki.

[9] Right 7(3) of the Code of Health and Disability Services Consumers’ Rights 1996 states that a person with diminished competence retains the right to make informed choices and give informed consent to the extent appropriate to their level of competence.

[10] Right 7(4) of the Code of Health and Disability Services Consumers’ Rights 1996 outlines the steps that must be taken if a provider is to provide services (including health research carried out in respect of any person) without consent:

Where a consumer is not competent to make an informed choice and give informed consent, and no person entitled to consent on behalf of the consumer is available, the provider may provide services where

  1. It is in the best interests of the consumer; and
  2. Reasonable steps have been taken to ascertain the views of the consumer; and
  3. Either:
    1. If the consumer’s views have been ascertained, and having regard to those views, the provider believes, on reasonable grounds, that the provision of the services is consistent with the informed choice the consumer would make if he or she were competent; or
    2. If the consumer’s views have not been ascertained, the provider takes into account the views of other suitable persons who are interested in the welfare of the consumer and available to advise the provider.