National Ethical Standards
- Part one
- Part two
- 1. Scope of the Standards
- 2. Ethical principles
- 3. Research and Māori
- 4. Research and Pacific peoples
- 5. Disability research
- 6. Ethical management of vulnerability
- 7. Informed consent
- 8. Research benefits and harms
- 9. Research development and design
- 10. Ethical features of studies
- 11. Research conduct
- 12. Health data
- 13. Health data and new technologies
- 14. Human tissue
- 15. Biobanks
- 16. Research with stem cells and reprogrammed cells
- 17. Compensation for injury in commercially sponsored intervention studies
- 18. Quality improvement
- Part three
14. Human tissue
Human tissue is commonly used in health research. Its use is increasing as the cost of new technologies decreases. Tissue is a broad term that, in this chapter, refers to any biological material obtained from a living person or a body, including tissue, blood, urine, sputum, hair, nails and any derivative from these, including cell lines. It does not include non-human biological material, such as micro-organisms that live on or in a person. Blood serum is acellular and not considered a material subject to the Human Tissue Act 2008.
For legal purposes, human tissue is defined in section 7 of the Human Tissue Act 2008.
14.1 For the ethical considerations for using tissue in future unspecified research, see Consent for future use of health data and human tissue.
Research involving human tissue has special ethical considerations because of the:
- way that tissue is obtained – for example, it may be collected prospectively with consent from individuals or retrospectively from stored samples with or without consent
- information that tissue may provide and the implications of that information for the individual donor, their blood relatives and their community
- significance that may be attached to the tissue by individuals, donors or communities.
Some groups hold beliefs about the sacred or shared value of human tissue; researchers should respect these beliefs.
When research involves Māori tissue
Researchers should consider the following in research on human tissue.
- The traditional Māori view is that tissue is a taonga – tissue itself and any associated data are of value, and should be appropriately managed.
- Protecting whakapapa must be a key concern; this involves protecting the connection between tissue and the person from whom it originated, as well as the family and whānau.
- In the Māori view, provision of tissue may be seen as a tākoha – a form of gifting whereby there is tapu associated with the gift, and certain conditions therefore apply.
- Given the range of views among Māori, researchers may need to consult beyond the family and whānau; that is, they may need to consult the wider community or iwi (Hudson et al 2016b).
At a physical and spiritual level, whakapapa is embodied within the DNA of a person. Therefore, the storage and use of human tissue for genetic research is a culturally informed activity.
Researchers must consider the ethical issues related to collecting and using human tissue alongside the ethical issues related to the information derived from the tissue.
The use of stem cells in research is considered as a special case of tissue use. ‘Research with stem cells and reprogrammed cells’, contains separate Standards for this area.
Use of tissue
14.3 Researchers should use existing tissue in an ethical manner, and in accordance with the terms of the original gift or consent.
14.3.a Where possible, researchers should give preference to existing sources of tissue, if these fulfil their scientific goals, rather than collecting new samples.
14.4 Researchers must not retain samples of tissue where they cannot justify continued storage. Equally, they should not destroy samples where there is a clear rationale and ethical justification for continuing to store them.
14.5 Researchers must have a clear strategy in place for managing health-related findings (expected or incidental) from tissue analysis.
14.6 Those who collect, use and store the tissue must be suitably qualified or experienced (or supervised by those who are).
14.7 Access to tissue obtained for a study must be restricted to those who need it to undertake the study.
Consent and waivers
14.8 Researchers must get informed consent from the person from whom the tissue was or will be collected before they use it for research, unless;
14.8.a consent from a family member has been provided in the case of a person being deceased or
14.8.b a waiver of consent is approved by an ethics committee.
14.9 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.
14.10 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.
14.10.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.
14.11 When considering 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.
14.12 When research involves using clinical samples, researchers’ use of tissue must not compromise the primary clinical reason for collecting the tissue.
14.13 Researchers must maintain participants’ privacy and confidentiality throughout the period during which they are using and storing the tissue and its associated data.
14.14 Researchers must consider the potential psychological, social and cultural significance of their use of tissue, and plan to minimise all research harms.
14.15 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.
14.16 When undertaking research involving human tissue, researchers must prepare and follow a tissue management plan that clearly describes the specific purpose of the tissue collection and how the researcher intends to process, store, distribute, use and dispose of the collected tissue.
14.17 The tissue management plan should be contained in either the study protocol or laboratory manual, and should specify:
- the methods of collection to be used, volume of tissue to be collected and schedule of collection
- measures taken to de-identify tissue samples and maintain privacy and confidentiality
- methods, location and duration of storage
- planned analyses
- access to tissue during the study
- what will happen to the tissue after the study is completed, including details of ongoing storage, whether other researchers will have access to the tissue or be able to distribute it, and whether it will be returned to donors
- the method of disposal.
14.18 Researchers must communicate the contents of the tissue management plan to participants in plain, non-specialist language as part of the process of obtaining their fully informed consent.
Identifiability of tissue
In the context of advances in genetic analysis and data-linking, and the prevalence of biobanks that contain identifiable tissue, researchers should always see human tissue samples, in principle, as re‑identifiable. However, levels of identifiability do not affect the ethical implications of using tissue in research.
14.19 Researchers should remove unnecessary identifiers associated with human tissue samples before storage and analysis, to reduce the risk of confidentiality breaches.
14.20 Where identifiers on human tissue are necessary (for instance, where researchers test tissue samples provided in clinical trials and report on them for a purpose that is fed back to the clinical team and in some way determines or directs the treatment of participants), researchers should include this fact in the information they give to participants as part of the process of obtaining their informed consent.
Import and export of human tissue
14.21 Human tissue may be sent overseas for research, if the person from whom the tissue was collected has consented to exporting it. It may also be sent overseas for analysis, if that is necessary for a study conducted and ethically approved in New Zealand.
14.21.a Local iwi and or local research institutions may have different views on exporting tissue; researchers should consult them early to obtain those views.
14.22 When considering the import of tissue from another country for use in research in New Zealand, researchers should attempt to establish whether the tissue was obtained in a manner consistent with these Standards. If they cannot, they should not use the tissue for research in New Zealand.
14.23 Standards under ‘Returning results and incidental findings’ apply to incidental findings in the context of the use of human tissue. Before research begins, the study protocol or laboratory manual must contain a plan for how any individual test results or incidental findings will be handled. See researcher conduct.
14.24 Researchers have a duty and responsibility to inform participants, and ensure adequate follow-up is in place after providing feedback on results or incidental findings. In some research situations it may only be ethical to return clinically significant or clinically actionable individual results.
14.25 Confirming if follow-up is appropriate may involve a referral to a suitable health professional or specialist. Suitable counselling (clinical, genetic or emotional) may be necessary for participants, depending on the information uncovered. The study protocol should detail these plans.
14.26 Researchers should also consider whether any study results relating to human tissue may have direct implications for the health of a participant’s family, especially in the case of genetics research.
Genetic research may involve the study of:
- single or multiple genes, gene-to-gene interaction or gene-environment interaction
- acquired somatic variation
- inherited gene sequences and their variants or their products
- gene expression, including environmental factors, pharmaceutics and other therapeutic products
- the genes of individuals, families or populations
- use of informatics and genetic information
- clinical phenotypes.
Researchers are increasingly studying genes and genetic information in clinical, epidemiological and social research, as well as in basic research. The guidelines in this section differentiate between research for which special precautions are necessary and research that is unlikely to be of concern to individual participants, their families or their communities. These Standards are in addition to the Standards on the use of human tissue.
Genetic research needs careful and specific ethical consideration, because it may reveal information about the predispositions to disease of both an individual and their family. Whether or not the disease develops in the individual, information arising from research may have implications for people’s access to employment and education, and to benefits or services, including financial services such as banking, insurance and superannuation. The information may also have important implications for blood relatives and family.
At a physical and spiritual level, whakapapa is embodied within the DNA of a person. Therefore, the storage and use of human tissue for genetic or genomic research is a culturally informed activity. When individuals consent to participate in this type of research, the biological material and personal information contributed may be considered to be culturally significant by Māori and other groups.
Genetic research involves risks that the information arising from genetic research may be misrepresented or misused in ways that lead to prejudice, stigma, disrespect, discrimination or other harms to participants, their families and communities.
14.27 In designing, conducting and reporting genetic research, researchers must consider the potential psychological, social and cultural significance of their research, plan how to minimise harms, and provide full information about the risks to prospective participants.
14.28 Researchers must consider the potential psychological, social and cultural significance of their research and plan to minimise all research harms.
14.29 Researchers must prepare and follow a detailed plan for generating and using genetic material and information.
14.30 Researchers should inform relevant clinicians or seek further advice if clinical action is possible in response to the genetic information they discover, if participants consent to this.
14.31 Researchers must inform participants whether their research might generate information that the participant may be legally required to disclose to a third party (e.g. for the purposes of insurance, employment, finance or education).
14.32 Researchers must not use or release genetic material and data for purposes unrelated to their specific research without participants’ consent, unless they are required to by law.
14.33 If their research involves participants’ family members, researchers must consider whether those family members are themselves participants, and whether it is therefore appropriate to seek their informed consent.
14.34 Unless required to fulfil primary study objectives, donation of tissue for broad genetic testing (such as whole genome sequencing) should be optional for participants.
14.34.a Studies that require mandatory broad genetic testing for research outside the main study may result in under-representation of Maori and other groups.
Genomic research is research with the potential for hereditary implications (effects on other family members) which may range from single-gene genetic research to whole genome sequencing and other ‘-omic’ research (e.g. exomic or proteomic research) with potential hereditary implications.
14.35 Researchers undertaking genomic research involving identifiable hapū, iwi or Māori communities should consult with collective groups early in the research planning phase, and throughout it (Hudson et al 2016b).
14.36 Genomic research involving Pacific people or communities should comply with the HRC’s Pacific Health Research Guidelines (HRC 2014b).
Incidental genetic results
Research results, genetic material and information collected for genetic research may be significant for research participants, their blood relatives and families. It may interest family members who are not blood relatives (e.g. partners and spouses, who have an interest in the health of their children). Research may have complex and socially significant implications for communities. It may potentially inform people’s life decisions, including health decisions.
Genetic research can reveal information about previously unknown paternity or maternity. It has uses outside health, such as for tracing migration patterns and in studies of cultural relatedness.
However, researchers must acknowledge that some people may prefer not to receive information arising from genetic research, or even to know of its existence.
14.37 Where research generates information of potential importance to the future health of participants or their blood relatives and family, researchers must prepare and follow a detailed protocol, which takes into account the clinical relevance of the research information, the types of genetic tests used in the research and the significance of those results for participants and others. The plan should:
- enable participants to decide whether they wish to receive the information, and who else may be given the information
- give participants sufficient time to decide whether they wish to receive the information
- set out a process for finding out whether other people want to receive information
- detail the degree to which information would remain re-identifiable
- either provide for access to genetic and clinical advice and counselling about information of health significance, or clearly recommend to participants that they seek these services from professionals with appropriate training, qualifications and experience
- detail special provisions in place to protect the privacy and confidentiality of genetic information
- record any circumstances under which participants may be statutorily or contractually obliged to disclose the results of genetic tests or analysis to third parties (e.g. insurance companies, employers or financial and educational institutions)
- detail any restrictions in place on the release of stored data or material, especially in the context of studies of rare genetic disorders, where it may be possible to identify individuals, families or members of a community even if information is given to others in non-identifiable form.
14.38 Where participants or relatives choose not to receive genetic information that could be important for their health, researchers should advise them that they will approach them again to confirm this decision when the results of the research are available, regardless of what the results show.
14.39 Before seeking their consent to genetic research, researchers must inform participants:
- about the degree to which confidentiality is possible, and of arrangements to keep genetic information private and confidential with regard to both family members and others, as well to future researchers who may receive the material or information
- whether information from or about their family members, in addition to that provided by participants, is required for the research
- whether, if a participant consents to researchers approaching their relatives, the participant has the opportunity to make initial contact with those relatives
- whether the research may reveal information of potential importance to the participant’s future health, or the future health of their children and other relatives
- whether the research has the potential to detect previously unknown paternity or maternity, or non-blood relationship to siblings, and whether, how and to whom researchers will disclose this information
- that, if the research discovers that a family member may be at risk of a life-threatening or serious illness for which treatment is available or soon to be available, researchers may offer this information to the family member concerned, with the approval of a health and disability ethics committee, even if the participant does not consent to this disclosure
14.40 Advice researchers provide to participants about the results of genetic research needs to include a clear explanation of the difference between research and clinical testing, and to clarify the potential need for clinical testing of research results. The research design could include a plan of how researchers will handle this situation. Where the potential relevance of genetic information to participants’ health is not clear until after interim analysis of the research information, researchers should give participants:
- the option of being notified of the existence of that information
- the option of receiving the information and
- access to, or a recommendation to seek, advice or counselling about the possible implications of the information.
14.41 In research studying large numbers of genes simultaneously, participants may not be informed of all of the names of all the individual genes to be studied.
Gene editing is a group of technologies that give scientists the ability to change an organism's DNA. These technologies allow genetic material to be added, removed, or altered at particular locations in the genome. Because gene editing is a frontier science, these Standards focus on principles for respecting, protecting and promoting the health and wellbeing of individuals, whānau and communities; guarding against unwanted societal effects; and equitably distributing information, burdens and benefits.
The ethical and regulatory issues surrounding the use of gene editing for therapeutic purposes are not very different from those associated with any experimental therapies. Patient safety is a crucial consideration; researchers can address this through improved techniques, procedural guidelines as to appropriate risk and patient consent processes.
14.42 Gene editing research should aim to promote the health and wellbeing of individuals, such as by treating or preventing disease.
14.43 Gene editing research must comply with relevant legislation and guidelines, including:
- the Hazardous Substances and New Organisms Act 1996
- the Human Assisted Reproductive Technology Act 2004
- the Royal Society’s Code of Professional Standards and Ethics in science, technology and the humanities.
14.44 Clinical trials that involve the use of a new or unregistered medicine require approval from the Standing Committee on Therapeutic Trials (SCOTT).
14.45 Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated micro-organisms, or viruses or cells into human subjects must have approval from the HRC’s Gene Technology Advisory Committee (GTAC).
14.46 No gene editing or research may be performed on viable human embryos.
14.47 Gene editing research must be approved by the Environmental Risk Management Authority (ERMA) and comply with ERMA regulations
14.48 Researchers must obtain informed consent for the future use of tissue separately from informed consent for clinical treatment.
14.49 All researchers conducting gene editing research must be respectful to other people, to this end they must act with cultural intelligence and intellectual rigour (pūkenga), and respect diverse values and communities (under the Te Ara Tika principle of manaakitanga).
14.50 Researchers must recognise the personal dignity of all individuals, acknowledge the centrality of personal choice and respect individual decisions.
14.51 Under the Te Ara Tika principles, all gene editing research should endeavour to identify and engage with affected communities (whakapapa), recognise their rights (mana) and respect their interests (tika).
14.52 Researchers must manage collected data responsibly.
14.53 All gene editing research should recognise the potential impacts of the research on communities, including in an intergenerational sense.
14.54 Researchers undertaking research involving the development of genetically edited cells for clinical use must be able to scientifically justify that research. Such research must be conducted (and peer reviewed) by individuals with appropriate expertise and training.
14.55 Where applicable, researchers should recruit participants for clinical gene editing research from populations that can benefit from the results of this research.
14.56 Where gene editing techniques are proven to have a therapeutic benefit, researchers should widely distribute this information to the appropriate research community in a timely manner, to foster equitable access to the benefits of the resulting clinical applications.
 For example, performing a muscle biopsy is a ‘Restricted Procedure’ under the Health Practitioners Competence Assurance Act 2003 and the Health Practitioners Competence Assurance (Restricted Activities) Order 2005.
 Basic research is experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any particular application or use in view.