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Standard Operating Procedures for Health and Disability Ethics Committees (2012)
https://www.bopdhb.govt.nz/media/36069/SOPSforHDECv1%200.pdf
http://leaux.net/URLS/ConvertAPI Text Files/5741A7AE16FBE9B015B2686EFCF270CD.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
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p.000037: What is a locality?
p.000037: 167. For the purposes of these SOPs, a locality is an organisation responsible for a hospital, health centre,
p.000037: surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a
p.000037: study are to be conducted.
p.000037: 168. Almost all intervention studies and many observational studies will involve at least one locality.
p.000037: 169. Localities for studies within the New Zealand public health system will usually be DHBs. Examples of
p.000037: localities outside the public health system may include:
p.000037: 169.1. academic institutions (such as universities)
p.000037: 169.2. private companies (such as clinical trial units)
p.000037: 169.3. private hospitals or clinical practices
p.000037: 169.4. other health and disability research centres.
p.000037: 170. The following are not localities:
p.000037: 170.1. clinicians, clinical units or other organisations making referrals to a research team
p.000037: 170.2. clinicians, clinical units or other organisations involved only in identifying potential participants or
p.000037: facilitating recruitment by the research team, and not responsible for informed consent or any other procedures set out
p.000037: in the study protocol
p.000037: 170.3. research units undertaking support functions such as project management, site monitoring, data analysis or
p.000037: report writing.
p.000037: 171. Where a study will be conducted at more than one site within the same locality (for example, at multiple
p.000037: hospitals within the same DHB), locality review should be carried out just once to cover all sites within that
p.000037: locality.
p.000037: 172. Where a third party under contract to a locality is to undertake any procedures outlined in the protocol of a
p.000037: study, issues specific to the third party should be considered as part of the locality review.
p.000037: Who should complete locality review?
p.000037: 173. Locality review must be completed by either:
p.000037: 173.1. the locality’s chief executive officer, or
p.000037: 173.2. an individual to whom the chief executive officer has delegated responsibility for conducting locality review.
p.000037: 174. It is not the role of the HDEC to ensure that the person who carries out locality review has been
p.000037: appropriately authorised to do so. This is the responsibility of the study team of the study in question.
p.000037: Issues relevant to locality review
p.000037: 175. The central issue relevant to locality review is its suitability for the safe and effective conduct of the
p.000037: study in question. This involves checking that:
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p.000037: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000038: 175.1. the lead/principal investigator(s) at the locality is/are suitably qualified, experienced, registered and
p.000038: indemnified to take professional responsibility (under the direction of the CI) for the conduct of the study at the
p.000038: locality
p.000038: 175.2. the locality’s physical facilities are adequate for the conduct of the study
p.000038: 175.3. conducting the study at the locality would have no adverse effect on the provision of publicly funded health
p.000038: care at that locality
p.000038: 175.4. applicants have taken reasonable steps (particularly consultation with Māori, where appropriate) to ensure that
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p.000045: health and safety, the study team should notify the HDEC as an urgent safety measure (see above).
p.000045: 216. Where a protocol deviation/violation is necessary due to errors, omissions or inadequacies in the protocol or
p.000045: other study documents, the sponsor and CI are responsible for making appropriate amendments. If the amendments are
p.000045: substantial,
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p.000045: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000046: 46
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p.000046: the HDEC must review and approve them in the normal way before they are implemented.
p.000046: Reconsideration of HDEC approval
p.000046: 217. HDECs should keep all approvals for all studies under review at all times. However, other than by means of the
p.000046: documents applicants are required to submit under this section, HDECs are not themselves responsible for proactively
p.000046: monitoring approved studies. Primary responsibility for such monitoring lies at all times with the study sponsor and
p.000046: the CI.
p.000046: 218. An HDEC may reconsider the approval in place for any study at any time on the basis of information contained
p.000046: in:
p.000046: 218.1. an annual progress report
p.000046: 218.2. a notification of an urgent safety measure or temporary halt of the study
p.000046: 218.3. a substantial protocol violation or deviation
p.000046: 218.4. the cancelation of locality approval for a locality in the study (see section 10)
p.000046: 218.5. any other information received by the HDEC in writing from any party which the chair considers, on reasonable
p.000046: grounds, may give grounds for suspending or cancelling approval.
p.000046: 219. An HDEC may only reconsider approval for a study through the full review pathway. Where the chair considers
p.000046: that one of the documents above may give grounds for suspending or cancelling approval, he or she must place the matter
p.000046: on the agenda of the next meeting of the HDEC (under ‘review of approved studies’). The HDEC must notify the applicant
p.000046: of its intention to reconsider approval, and the reasons for this, and invite them to provide a written response and
p.000046: attend the meeting.
p.000046: 220. Consistent with the fact that the HDEC must review items of business mentioned in this section through the
p.000046: expedited review pathway, an HDEC must notify the applicant of a decision to reconsider approval for a study on the
p.000046: basis of information contained in a document within 15 calendar days of the document’s having been submitted.
p.000046: Suspension or cancelation of HDEC approval
p.000046: 221. Following reconsideration, HDEC approval may be suspended or cancelled due to serious concerns about one or
p.000046: more of the following:
p.000046: 221.1. the health and safety of participants
p.000046: 221.2. the competence or conduct of the CI, sponsor, or other investigator
p.000046: 221.3. the feasibility of the study
p.000046: 221.4. suspension or cancelation of regulatory approval for the study.
p.000046: 222. Letters communicating an HDEC’s decision to suspend or cancel approval for a study must detail:
p.000046: 222.1. whether approval is suspended or cancelled
p.000046: 222.2. the reasons for the suspension or cancellation
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Political / vulnerable
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p.000010: 27.3.2. health information will not be disclosed to researchers in a form that:
p.000010: 27.3.3. could identify, or could reasonably be expected to identify, the individual(s) concerned, or
p.000010: 27.3.4. would allow for the information to be matched with other data sets (for example, through the use of
p.000010: non-encrypted identifiers such as National Health Index numbers).
p.000010: Exemptions to main criteria
p.000010: 28. Studies on low-risk devices: A study involving a medical device does not require HDEC review if the device is
p.000010: (or would be) classified as a low-risk (class I) medical device by Australia’s Therapeutic Goods Administration (TGA).2
p.000010: 29. Minimal-risk observational studies: An observational study requires HDEC review only if the study involves
p.000010: more than minimal risk (that is, potential participants could reasonably be expected to regard the probability and
p.000010: magnitude of possible harms resulting from their participation in the study to be greater than those encountered in
p.000010: those aspects of their everyday life that relate to the study).
p.000010: 30. For the avoidance of doubt, an observational study always involves more than minimal risk if it involves one
p.000010: or more of the following:
p.000010: 30.1. one or more participants who will not have given informed consent to participate, or
p.000010: 30.2. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000010: decisions about their participation in the study),3 or
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p.000010: 2 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
p.000010: Australian regulatory guidelines for medical devices, available from the TGA’s website at
p.000010: http://tga.gov.au/pdf/devices-argmd.pdf.
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p.000010:
p.000010: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000011: 11
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p.000011: 30.3. standard treatment being withheld from one or more participants, or
p.000011: 30.4. the storage, preservation or use of human tissue without consent, or
p.000011: 30.5. the disclosure of health information without authorisation.
p.000011: 31. Audits and related activities: An audit or related activity requires HDEC review only if it involves the use,
p.000011: collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at
p.000011: section 20(f) of the Human Tissue Act 2008 and Right 7(10)(c) of the Code of Health and Disability Services Consumers’
p.000011: Rights 1996).
p.000011: 32. Student-led research: From 1 January 2013, a study conducted wholly or principally for the purposes of an
p.000011: educational qualification requires HDEC review only if it:
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p.000016: • expanding the scope of full review to include studies involving class IIb medical devices and new surgical
p.000016: interventions
p.000016: • clarifying that HDECs should allow at least 30 minutes for discussion of new applications
p.000016: • providing for researchers to attend HDEC meetings with other parties involved in the study, such as
p.000016: representatives of sponsors or localities.
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p.000016: What is the full review pathway, and what should be reviewed by it?
p.000016: 49. The full review pathway involves an HDEC reviewing a new application, substantial amendment or other item of
p.000016: business at a meeting held in accordance with the provisions set out in this section.
p.000016:
p.000016:
p.000016: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000017: 17
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p.000017: 50. The full review pathway is appropriate for any intervention or observational study that is within the scope
p.000017: of HDEC review and that involves one or more of the following:
p.000017: 50.1. a new medicine (as defined by the Medicines Act 1981), or
p.000017: 50.2. an approved medicine being used for a new indication or through a new mode of administration, or
p.000017: 50.3. a medical device that is or would be classified as a class IIb, class III or active implantable medical device
p.000017: by the TGA,6 or
p.000017: 50.4. a new surgical intervention, or
p.000017: 50.5. one or more participants who will not have given informed consent to participate, or
p.000017: 50.6. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000017: decisions about their participation in the study),7 or
p.000017: 50.7. standard treatment being withheld from one or more participants, or
p.000017: 50.8. the storage, preservation or use of human tissue without consent.
p.000017: 51. Full review is also appropriate for substantial amendments to previously approved studies that were
p.000017: themselves reviewed by this pathway. However, the chair of an HDEC may direct that the HDEC review any such amendments
p.000017: through the expedited review pathway.
p.000017: Natural justice
p.000017: 52. As public administrative bodies, HDECs must act in accordance with the principles of natural justice. In
p.000017: particular, they must ensure that:
p.000017: 52.1. their decision-making is impartial and transparent, following the processes defined by these SOPs, and
p.000017: 52.2. they give applicants fair opportunity to be heard and to hear the deliberations of the HDEC.
p.000017: Meeting dates and cut-off dates
p.000017: 53. HDECs must make public the dates, times and locations of HDEC meetings sufficiently in advance to give
p.000017: interested members of the public a reasonable chance to organise their attendance as observers.
p.000017: 54. HDECs must also clearly publicise, for each meeting, the last date on which applications and substantial
p.000017: amendments may be received for consideration at that meeting (the ‘cut-off date’). The cut-off date may not be more
p.000017: than 12 calendar days before the date of the meeting.
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Health / Healthy People
Searching for indicator healthy volunteers:
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p.000052: Medsafe New Zealand Medicines and Medical Devices Safety Authority
p.000052: Minor amendment Any amendment to a previously approved study that is not a substantial amendment
p.000052: NEAC National Ethics Advisory Committee
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p.000052:
p.000052:
p.000052: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000053: 53
p.000053:
p.000053: New medicine Has the meaning given to it by the Medicines Act 1981
p.000053: Observational research Has the meaning given to it by the Ethical Guidelines for Observational Studies; namely,
p.000053: an observational study that involves participants but in which investigators do not control and study the
p.000053: intervention(s) provided to them, if any
p.000053: Observational study Has the meaning given to it by the Ethical Guidelines for Observational Studies;
p.000053: namely, a study in which investigators do not control and study the intervention(s) provided to participants, if any
p.000053: Participant An individual who actively participates in a study. HDEC review of a study may
p.000053: be required where participants are recruited in their capacity as:
p.000053: consumers of health and disability support services, or
p.000053: relatives or caregivers of such consumers, or
p.000053: healthy volunteers in clinical trials
p.000053: Post-approval item An item of business (such as an amendment, annual progress report, final report,
p.000053: protocol deviation/violation, or notification of conclusion of study) submitted for review following HDEC approval for
p.000053: a study.
p.000053: Principal Investigator (PI) The investigator with primary responsibility for the design and conduct of a study,
p.000053: including compliance with all relevant legal and ethical standards. All applications for ethics committee review of a
p.000053: study must be submitted by its PI.
p.000053: Protocol A document describing the objectives, design, methodology, analysis and
p.000053: organisation of a study
p.000053: Reference number A unique identifier assigned to an application for HDEC review
p.000053: Review clock The timeframe within which an HDEC must give a final opinion on a new application
p.000053: or a substantial amendment to a previously approved application
p.000053: SAE Serious adverse event; an untoward occurrence at any dose that:
p.000053: results in death, or
p.000053: is life-threatening, or
p.000053: requires inpatient hospitalisation or prolongs hospitalisation, or
p.000053: results in a persistent or significant disability or incapacity, or
p.000053: is a congenital anomaly or birth defect
p.000053: SCOTT Standing Committee on Therapeutic Trials; a standing committee of the HRC whose
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p.000007: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000008: 3. Scope of HDEC review
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p.000008: Introduction
p.000008: The Government response to the Health Committee’s clinical trials inquiry requires updated SOPs for HDECs to clarify
p.000008: and reduce the scope of HDEC review. This section gives effect to this requirement. It replaces the definition of scope
p.000008: contained in:
p.000008: • section 3 of the Operational Standard for Ethics Committees
p.000008: • chapter 11 of the Ethical Guidelines for Observational Studies
p.000008: • the Guidelines for an Accredited Institutional Ethics Committee to refer Studies to an Accredited Health and
p.000008: Disability Ethics Committee.
p.000008: The definition of scope in this section will reduce the scope of HDEC review, for example by excluding studies that:
p.000008: • involve participants recruited other than in their capacity as consumers of health and disability services,
p.000008: relatives of consumers, or volunteers in early-phase clinical trials (for instance, health professionals or members of
p.000008: the general public)
p.000008: • involve the use of existing anonymised human tissue samples with consent
p.000008: • involve low-risk (class I) medical devices
p.000008: • are audits or related studies (except where HDEC review is required by law)
p.000008: • are observational studies that do not involve more than minimal risk
p.000008: • are to be conducted wholly or principally for the purposes of an educational qualification, in some
p.000008: circumstances.
p.000008: Regardless of whether HDEC approval is required, researchers in such studies will still be required by the Code of
p.000008: Health and Disability Services Consumers’ Rights 1996 to comply with the established ethical standards that apply to
p.000008: them.
p.000008: Key changes to this section following consultation include:
p.000008: • more clearly basing definitions of ‘intervention study’ and ‘observational study’ on relevant NEAC guidelines
p.000008: • dividing the scope of HDEC review into ‘main criteria’, ‘exemptions’ and ‘inclusions’
p.000008: • clarifying and restricting the types of observational study that may be considered to be of minimal risk, and
p.000008: therefore exempt from HDEC review
p.000008: • restricting the scope of the exemption from HDEC review for some student-led studies, and delaying the
p.000008: introduction of this exemption until 1 January 2013
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p.000009: health and disability research that is not an intervention study is an observational study. Like intervention studies,
p.000009: observational studies may involve looking at the health effects of interventions provided to human participants.
p.000009: However, researchers in such an observational study do not control these interventions, which would have been provided
p.000009: regardless of participation in the study.
p.000009: 25. There are two types of observational studies: observational research, and audits and related studies.
p.000009: 26. The ethical standards that researchers must meet or exceed in conducting observational studies are contained
p.000009: in the Ethical Guidelines for Observational Studies.
p.000009: When does a study require HDEC review?
p.000009:
p.000009: Main criteria
p.000009: 27. Health and disability research requires HDEC review only if it involves one or more of the following:
p.000009: 27.1. human participants recruited in their capacity as:
p.000009: 27.1.1. consumers of health or disability support services, or
p.000009: 27.1.2. relatives or caregivers of consumers of health or disability support services, or
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p.000009:
p.000009: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000010: 27.1.3. volunteers in clinical trials (including, for the avoidance of doubt, bioequivalence and bioavailability
p.000010: studies)
p.000010: 27.2. the use, collection or storage of human tissue (as defined by the Human Tissue Act 2008), unless:
p.000010: 27.2.1. informed consent (which may include informed consent to future unspecified research) has been obtained for
p.000010: such use, and tissue will not be made available to researchers in a form that could reasonably be expected to identify
p.000010: the individual(s) concerned, or
p.000010: 27.2.2. one or more of the statutory exceptions to the need to gain informed consent set out at section 20(f) of
p.000010: the Human Tissue Act 2008 (or Right 7(10)(c) of the Code of Health and Disability Services Consumers’ Rights 1996)
p.000010: applies
p.000010: 27.3. the use or disclosure of health information (as defined by the Health Information Privacy Code 1994), unless:
p.000010: 27.3.1. this use or disclosure has been authorised by the individual(s) concerned, or
p.000010: 27.3.2. health information will not be disclosed to researchers in a form that:
p.000010: 27.3.3. could identify, or could reasonably be expected to identify, the individual(s) concerned, or
p.000010: 27.3.4. would allow for the information to be matched with other data sets (for example, through the use of
p.000010: non-encrypted identifiers such as National Health Index numbers).
p.000010: Exemptions to main criteria
p.000010: 28. Studies on low-risk devices: A study involving a medical device does not require HDEC review if the device is
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Health / Mentally Disabled
Searching for indicator disability:
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p.000002: Standard Operating Procedures for Health and Disability Ethics Committees
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p.000002: Version 1.0
p.000002: May 2012
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p.000002: Published in May 2012
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p.000002: by the Ministry of Health
p.000002: PO Box 5013, Wellington, New Zealand ISBN: 978-0-478-39337-8 (online) HP 5507
p.000002: This document is available on the New Zealand Health and Disability Ethics Committees’ website:
p.000002: http://www.ethics.health.govt.nz
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p.000002: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000002: 2
p.000002:
p.000002: Contents
p.000002:
p.000002:
p.000002: 1. Purpose and application
p.000004: 4
p.000004: 2. The role of HDECs
p.000006: 6
p.000006: 3. Scope of HDEC review
p.000009: 9
p.000009: 4. Applying for HDEC review
p.000014: 14
p.000014: 5. The full review pathway
p.000017: 17
p.000017: 6. The expedited review pathway
p.000025: 25
p.000025: 7. Decisions open to HDECs
p.000028: 28
p.000028: 8. HDECs and the Accident Compensation Act 2001 32
p.000028: 9. Challenging HDEC decisions
p.000034: 34
p.000034: 10. Locality authorisation
p.000037: 37
p.000037: 11. Amendments to approved studies 41
p.000037: 12. Post-approval processes
p.000044: 44
p.000044: 13. HDEC review of tissue banks
p.000049: 49
p.000049: Glossary
p.000052: 52
p.000052: NB: At the beginning of most sections of these SOPs, a brief explanatory note (in Times New Roman typeface)
p.000052: summarises the main changes to HDEC procedures that will result from the provisions of the section. These notes are
p.000052: intended as informal introductions and should not be cited as an authoritative part of the SOPs.
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p.000052: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000003: 3
p.000003:
p.000003: 1. Purpose and application
p.000003:
p.000003:
p.000003: Purpose
p.000003: 1. The purpose of these standard operating procedures (SOPs) is to support health and disability ethics
p.000003: committees (HDECs) to operate in a way that is:
p.000003: - robust, so that the public can be confident that health and disability research conducted in New Zealand meets or
p.000003: exceeds established ethical standards
p.000003: - efficient, so that ethical health and disability research is facilitated, and so that HDEC resources are used in
p.000003: a way that maximises protection for participants within the resources available
p.000003: - transparent, so that applicants and HDECs can engage with each other with confidence, and so that the HDEC review
p.000003: process can be easily understood by consumers and third parties
p.000003: - consistent, so that applicants can expect to be treated similarly by different HDECs and at different times.
p.000003: 2. These SOPs aim to achieve this purpose by clearly defining the role of HDECs and the HDEC review process,
p.000003: and providing rules and guidance on:
p.000003: - what HDECs do, and what they rely on others to do (section 2)
p.000003: - when health and disability research requires HDEC review (section 3)
p.000003: - the requirements that must be met in applying for HDEC review (section 4)
p.000003: - the processes that HDECs must follow in reviewing applications (sections 5 and 6)
p.000003: - the decisions that HDECs may make following review (section 7)
p.000003: - the role of HDECs in checking compensation arrangements in commercially sponsored clinical trials (section 8)
p.000003: - how HDEC decisions may be challenged, and by whom (section 9)
p.000003: - the distinct role of localities in addressing local research governance issues (section 10)
p.000003: - HDEC review of amendments to approved studies (section 11)
p.000003: - the role of HDECs in monitoring approved studies, and the process for suspending or cancelling approval (section
p.000003: 12)
p.000003: - HDEC review of arrangements for establishing and managing tissue banks (section 13).
p.000003: Procedural guidance, not ethical standards
p.000003: 3. These SOPs contain procedural guidance on the HDEC review process. They do not set out the established
p.000003: ethical standards that must be met or exceeded in all health and disability research, regardless of whether or not HDEC
p.000003: review is required. These
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000004: 4
p.000004:
p.000004: ethical standards are set out in guidelines authored by the National Ethics Advisory Committee (NEAC), namely:
p.000004: - the Ethical Guidelines for Observational Studies and
p.000004: - the Ethical Guidelines for Intervention Studies.
p.000004: 4. For the avoidance of doubt, these SOPs do not in any way affect the rights of participants in health and
p.000004: disability research, including by way of example and without limitation rights under the:
p.000004: - Protection of Personal and Property Rights Act 1988
p.000004: - New Zealand Bill of Rights Act 1990
p.000004: - Privacy Act 1993
p.000004: - Health and Disability Commissioner Act 1994
p.000004: - Accident Compensation Act 2001
p.000004: - Human Tissue Act 2008
p.000004: - Treaty of Waitangi.
p.000004:
p.000004: Application
p.000004: 5. These SOPs come into force on 1 July 2012, and apply in full to all applications for HDEC review submitted
p.000004: on or after that date. They supersede all other process guidance for HDECs, including that contained in the Operational
p.000004: Standard for Ethics Committees.
p.000004: 6. Similarly, from 1 July 2012 the SOPs apply in full to all studies approved prior to 1 July 2012. They
p.000004: supersede all other process guidance for such studies, including that contained in the Operational Standard for Ethics
p.000004: Committees and approval letters. However, review timelines for amendments and other ‘post-approval’ items for studies
p.000004: approved prior to 1 July 2012 do not apply where these items are submitted other than through the HDECs’ online
p.000004: application system
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p.000004:
p.000004: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000005: 5
p.000005:
p.000005: 2. The role of HDECs
p.000005:
p.000005:
p.000005:
p.000005: Introduction
p.000005: The Government response to the Health Committee’s clinical trials inquiry requires updated SOPs to reduce duplication
p.000005: by clarifying that HDECs’ role is to check ethical issues, rather than scientific or governance issues. This section
p.000005: addresses that requirement, and clarifies who HDECs can expect to rely on to consider such issues.
p.000005: Key proposed changes and clarifications include:
p.000005: • affirming the central role of HDECs in checking that health and disability research meets or exceeds established
p.000005: ethical standards
p.000005: • clarifying that HDECs check that appropriate peer review for scientific validity has been carried out, rather
p.000005: than doing it themselves
p.000005: • clearly separating HDEC review (which is done by HDECs, and focuses on the ethics of a study as a whole) from
p.000005: locality review (which is done by localities, and addresses issues arising from the conduct of a study at a given
p.000005: locality).
p.000005: Further details of the issues that HDECs can expect localities to address as part of locality review are contained in
p.000005: section 10 of this document.
p.000005: Key changes to this section following consultation include:
p.000005: • expanding the circumstances in which HDECs may suggest or require further peer review of a study
p.000005: • clarifying that consultation with Māori should be carried out in accordance with the HRC’s Guidelines for
p.000005: Researchers on Health Research Involving Māori, and that this consultation may continue to be carried out in parallel
p.000005: with HDEC review.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 7. This section defines the role of HDECs. In doing so, it outlines what HDECs can expect from other parties
p.000005: involved with health and disability research, including researchers, sponsors, localities and the Standing Committee on
p.000005: Therapeutic Trials (SCOTT).
p.000005: What HDECs do
p.000005: 8. HDECs check that proposed health and disability research meets established ethical standards that aim to
p.000005: protect participants. These ethical standards are set out in guidelines authored by the National Ethics Advisory
p.000005: Committee (NEAC), namely:
p.000005: - the Ethical Guidelines for Observational Studies and
p.000005: - the Ethical Guidelines for Intervention Studies.
p.000005: 9. However, health and disability researchers – not HDECs – are themselves responsible for ensuring that their
p.000005: research meets these standards at all times. This responsibility is consistent with the duty imposed on researchers by
p.000005: Right 4(2) of the Code of Health and Disability Services Consumer’ Rights 1996.
p.000005:
p.000005:
p.000005:
p.000005: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000006: 6
p.000006:
p.000006: What HDECs do not do
p.000006:
p.000006: HDECs are not themselves directly responsible for assessing the scientific validity of proposed studies.
p.000006: 10. In order to meet established ethical standards, health and disability research must be scientifically valid.1
p.000006: Researchers and sponsors must ensure that the scientific validity of proposed research has been peer-reviewed before an
p.000006: application is made to an HDEC. While HDECs are responsible for checking that appropriate peer review has been carried
p.000006: out, they do not conduct it themselves.
p.000006: 11. Where an HDEC considers that the peer review that has been carried out for a study may not have been
p.000006: sufficiently robust, or that the study may not be scientifically valid, the HDEC may suggest (or, consistent with
p.000006: established ethical standards, require) that additional peer review be carried out. Where an HDEC has concerns with
p.000006: particular aspects of the study’s design, it should be specific about these.
p.000006: 12. Where a study involves the administration of a new medicine, HDECs can expect issues of scientific validity
p.000006: to have been satisfactorily addressed as part of that study’s being approved by SCOTT under section 30 of the Medicines
p.000006: Act 1981. Accordingly, HDECs may not usually require that additional peer review be carried out in respect of such
p.000006: studies.
p.000006: HDECs do not address locality-specific governance issues.
p.000006: 13. HDEC review concerns ethical issues relating to studies. Localities themselves, rather than HDECs, consider
p.000006: locality-specific research governance issues.
p.000006: 14. It is a standard condition of HDEC approval that locality authorisation, which focusses on these
p.000006: locality-specific research governance issues, be obtained before a study commences at that locality. Section 10
p.000006: describes the locality authorisation process in more detail.
p.000006: HDECs do not provide legal advice.
p.000006: 15. Researchers and sponsors are responsible for ensuring that their health and disability research is conducted
p.000006: lawfully. Where an HDEC suspects that a research proposal is not lawful, it should advise the applicant of its
p.000006: concerns, and may suggest that they seek formal legal advice. However, HDECs are not themselves responsible for
p.000006: providing such legal advice.
p.000006: 16. However, New Zealand law gives HDECs responsibility for decisions that may have legal consequences. Most
p.000006: obviously, the Accident Compensation Act 2001 (the ACC Act) requires HDECs to determine whether publicly funded
p.000006: no-fault compensation will be available to participants injured in a clinical trial. Section 8 explains the statutory
p.000006: role of HDECs under the ACC Act in more detail.
p.000006: HDEC review does not constitute consultation with Māori, or other population groups.
p.000006: 17. Researchers are responsible for ensuring that Māori (and, where relevant, other population groups) are
p.000006: consulted in the development and conduct of studies that are of relevance to them. Where formal consultation with
p.000006: Māori is required by the Guidelines for Researchers on Health Research Involving Māori, HDECs should
p.000006:
p.000006: 1 Ethical Guidelines for Observational Studies, para 5.7, Ethical Guidelines for Intervention Studies, para 5.5.
p.000006:
p.000006:
p.000006:
p.000006: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000007: 7
p.000007:
p.000007: check that this consultation has been or will be carried out appropriately. However, HDEC review does not constitute
p.000007: or replace such consultation.
p.000007: 18. Localities, rather than HDECs, are responsible for checking that studies appropriately address local cultural
p.000007: issues (including by formal consultation with Māori, where required).
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p.000007: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000008: 8
p.000008:
p.000008: 3. Scope of HDEC review
p.000008:
p.000008:
p.000008:
p.000008: Introduction
p.000008: The Government response to the Health Committee’s clinical trials inquiry requires updated SOPs for HDECs to clarify
p.000008: and reduce the scope of HDEC review. This section gives effect to this requirement. It replaces the definition of scope
p.000008: contained in:
p.000008: • section 3 of the Operational Standard for Ethics Committees
p.000008: • chapter 11 of the Ethical Guidelines for Observational Studies
p.000008: • the Guidelines for an Accredited Institutional Ethics Committee to refer Studies to an Accredited Health and
p.000008: Disability Ethics Committee.
p.000008: The definition of scope in this section will reduce the scope of HDEC review, for example by excluding studies that:
p.000008: • involve participants recruited other than in their capacity as consumers of health and disability services,
p.000008: relatives of consumers, or volunteers in early-phase clinical trials (for instance, health professionals or members of
p.000008: the general public)
p.000008: • involve the use of existing anonymised human tissue samples with consent
p.000008: • involve low-risk (class I) medical devices
p.000008: • are audits or related studies (except where HDEC review is required by law)
p.000008: • are observational studies that do not involve more than minimal risk
p.000008: • are to be conducted wholly or principally for the purposes of an educational qualification, in some
p.000008: circumstances.
p.000008: Regardless of whether HDEC approval is required, researchers in such studies will still be required by the Code of
p.000008: Health and Disability Services Consumers’ Rights 1996 to comply with the established ethical standards that apply to
p.000008: them.
p.000008: Key changes to this section following consultation include:
p.000008: • more clearly basing definitions of ‘intervention study’ and ‘observational study’ on relevant NEAC guidelines
p.000008: • dividing the scope of HDEC review into ‘main criteria’, ‘exemptions’ and ‘inclusions’
p.000008: • clarifying and restricting the types of observational study that may be considered to be of minimal risk, and
p.000008: therefore exempt from HDEC review
p.000008: • restricting the scope of the exemption from HDEC review for some student-led studies, and delaying the
p.000008: introduction of this exemption until 1 January 2013
p.000008: • requiring (rather than allowing) HDEC review for the establishment or maintenance of tissue banks.
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p.000008:
p.000008:
p.000008: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000009: 9
p.000009:
p.000009: What is health and disability research?
p.000009: 19. Health and disability research is research that aims to generate knowledge for the purpose of improving
p.000009: health and independence outcomes.
p.000009: 20. ‘Health and disability research’, for the purposes of these SOPs, does not include research that creates or
p.000009: uses a human gamete, human embryo or hybrid embryo. The Human Assisted Reproductive Technology Act 2004 requires that
p.000009: such ‘human reproductive research’ be approved by the Ethics Committee on Assisted Reproductive Technology.
p.000009: Types of health and disability research
p.000009: 21. There are two main types of health and disability research: intervention studies and observational studies.
p.000009: Intervention studies
p.000009: 22. ‘Intervention study’ has the meaning given to it by the Ethical Guidelines for Intervention Studies; namely,
p.000009: a study in which the investigator controls and studies the intervention(s) provided to participants for the purpose of
p.000009: adding to knowledge of the health effects of the intervention(s). The term ‘intervention study’ is often used
p.000009: interchangeably with the terms ‘experimental study’ and ‘clinical trial’.
p.000009: 23. The ethical standards that researchers must meet or exceed in conducting intervention studies are contained
p.000009: in the Ethical Guidelines for Intervention Studies.
p.000009:
p.000009: Observational studies
p.000009: 24. ‘Observational study’ has the meaning given to it by the Ethical Guidelines for Observational Studies. All
p.000009: health and disability research that is not an intervention study is an observational study. Like intervention studies,
p.000009: observational studies may involve looking at the health effects of interventions provided to human participants.
p.000009: However, researchers in such an observational study do not control these interventions, which would have been provided
p.000009: regardless of participation in the study.
p.000009: 25. There are two types of observational studies: observational research, and audits and related studies.
p.000009: 26. The ethical standards that researchers must meet or exceed in conducting observational studies are contained
p.000009: in the Ethical Guidelines for Observational Studies.
p.000009: When does a study require HDEC review?
p.000009:
p.000009: Main criteria
p.000009: 27. Health and disability research requires HDEC review only if it involves one or more of the following:
p.000009: 27.1. human participants recruited in their capacity as:
p.000009: 27.1.1. consumers of health or disability support services, or
p.000009: 27.1.2. relatives or caregivers of consumers of health or disability support services, or
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000010: 10
p.000010:
p.000010: 27.1.3. volunteers in clinical trials (including, for the avoidance of doubt, bioequivalence and bioavailability
p.000010: studies)
p.000010: 27.2. the use, collection or storage of human tissue (as defined by the Human Tissue Act 2008), unless:
p.000010: 27.2.1. informed consent (which may include informed consent to future unspecified research) has been obtained for
p.000010: such use, and tissue will not be made available to researchers in a form that could reasonably be expected to identify
p.000010: the individual(s) concerned, or
p.000010: 27.2.2. one or more of the statutory exceptions to the need to gain informed consent set out at section 20(f) of
p.000010: the Human Tissue Act 2008 (or Right 7(10)(c) of the Code of Health and Disability Services Consumers’ Rights 1996)
p.000010: applies
p.000010: 27.3. the use or disclosure of health information (as defined by the Health Information Privacy Code 1994), unless:
p.000010: 27.3.1. this use or disclosure has been authorised by the individual(s) concerned, or
p.000010: 27.3.2. health information will not be disclosed to researchers in a form that:
p.000010: 27.3.3. could identify, or could reasonably be expected to identify, the individual(s) concerned, or
p.000010: 27.3.4. would allow for the information to be matched with other data sets (for example, through the use of
p.000010: non-encrypted identifiers such as National Health Index numbers).
p.000010: Exemptions to main criteria
p.000010: 28. Studies on low-risk devices: A study involving a medical device does not require HDEC review if the device is
p.000010: (or would be) classified as a low-risk (class I) medical device by Australia’s Therapeutic Goods Administration (TGA).2
p.000010: 29. Minimal-risk observational studies: An observational study requires HDEC review only if the study involves
p.000010: more than minimal risk (that is, potential participants could reasonably be expected to regard the probability and
p.000010: magnitude of possible harms resulting from their participation in the study to be greater than those encountered in
p.000010: those aspects of their everyday life that relate to the study).
p.000010: 30. For the avoidance of doubt, an observational study always involves more than minimal risk if it involves one
p.000010: or more of the following:
p.000010: 30.1. one or more participants who will not have given informed consent to participate, or
p.000010: 30.2. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000010: decisions about their participation in the study),3 or
p.000010:
p.000010:
p.000010: 2 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
p.000010: Australian regulatory guidelines for medical devices, available from the TGA’s website at
p.000010: http://tga.gov.au/pdf/devices-argmd.pdf.
p.000010:
p.000010:
p.000010:
p.000010: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000011: 11
p.000011:
p.000011: 30.3. standard treatment being withheld from one or more participants, or
p.000011: 30.4. the storage, preservation or use of human tissue without consent, or
p.000011: 30.5. the disclosure of health information without authorisation.
p.000011: 31. Audits and related activities: An audit or related activity requires HDEC review only if it involves the use,
p.000011: collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at
p.000011: section 20(f) of the Human Tissue Act 2008 and Right 7(10)(c) of the Code of Health and Disability Services Consumers’
p.000011: Rights 1996).
p.000011: 32. Student-led research: From 1 January 2013, a study conducted wholly or principally for the purposes of an
p.000011: educational qualification requires HDEC review only if it:
p.000011: 32.1. is an intervention study, or
p.000011: 32.2. is not conducted at or below Master’s level.
p.000011:
p.000011: Inclusions
p.000011: 33. Regardless of the exemptions to the main criteria outlined above, a study requires HDEC review if it:
p.000011: 33.1. involves the use of human tissue samples taken as part of New Zealand’s Newborn Metabolic Screening Programme
p.000011: (known as ‘Guthrie cards’), or
p.000011: 33.2. is funded by the Health Research Council of New Zealand (HRC) and is not able to be reviewed by an
p.000011: institutional ethics committee approved by the HRC’s Ethics Committee (HRCEC).
p.000011: 33.3. involves the establishment or maintenance of a tissue bank (see section 13).
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p.000011: 3 This term is defined more fully in the Ethical Guidelines for Intervention Studies.
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p.000011:
p.000011: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000013:
p.000013: 4. Applying for HDEC review
p.000013:
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p.000013:
p.000013:
p.000013: Introduction
p.000013: The Government’s response to the Health Committee’s clinical trials inquiry requires that applications to HDECs be able
p.000013: to be made online by 1 July 2012, and that researchers be able to ask that an application be reviewed by the HDEC
p.000013: nearest to them (rather than being allocated for review as soon as possible by any HDEC).
p.000013: This section addresses these requirements. It also contains basic administrative rules relating to:
p.000013: • how to apply for HDEC review
p.000013: • who may apply for HDEC review
p.000013: • validation of new applications and substantial amendments by the HDEC secretariat.
p.000013: Key changes to this section following consultation include:
p.000013: • requiring applicants for HDEC review to be based in New Zealand
p.000013: • aligning HDEC terminology with that used in international GCP guidelines (for example using the term
p.000013: ‘co-ordinating investigator’ instead of ‘principal investigator’)
p.000013: • clarifying that letters from reviewing bodies may constitute evidence of favourable peer review.
p.000013:
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p.000013: 34. Applications for HDEC review must be submitted through the HDECs’ electronic submission system. Applications
p.000013: and associated documents submitted in hard copy will not be accepted or acknowledged without prior agreement.
p.000013: 35. Applications for HDEC review of new applications and substantial amendments must be submitted or authorised
p.000013: by the co-ordinating investigator (CI) of the study in question, who may delegate responsibility for completing the
p.000013: application form and uploading study documents to other members of the study team at their discretion.
p.000013: 36. The CI for a study must be professionally based, in whole or in part, in New Zealand. In the case of
p.000013: international studies, a local investigator should be nominated as the CI for the New Zealand arm of the study.
p.000013: 37. Only one application may be submitted in relation to a study, including, generally, those that entail
p.000013: separate protocols governing sub-studies in addition to the main study. Applicants who intend to conduct related
p.000013: studies that are substantially similar to each other (for instance, studies that involve the administration of the same
p.000013: intervention for different indications) should contact the HDEC secretariat prior to submission to discuss how best to
p.000013: proceed.
p.000013:
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p.000013:
p.000013:
p.000013: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000014: 14
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p.000014: 38. Where an application will be reviewed by the full review pathway, the applicant may indicate at the time of
p.000014: submission that they would prefer their application to be considered by the closest possible HDEC (that is, the HDEC
p.000014: that meets closest to the address given by the CI in the application). Where such a preference has not been indicated,
p.000014: applications will be allocated for review to the next available HDEC meeting.
p.000014: Validation of new applications
p.000014: 39. HDECs must assign all new applications and substantial amendments a unique identifier (an ‘HDEC reference
p.000014: number’) upon submission. The secretariat must then validate applications before assigning them to an HDEC for review.
p.000014: 40. The HDEC secretariat may validate a new application only if:
p.000014: 40.1. the application is within the scope of HDEC review, and
p.000014: 40.2. the application is not similar enough to another application that it would be more appropriate for a single
p.000014: application to be made in respect of both studies, or for the application to be dealt with as a substantial amendment
p.000014: to an approved study, and
p.000014: 40.3. all relevant questions in the application form have been answered in a manner that is reasonably likely to
p.000014: allow the HDEC to make a final decision on the application the first time it is considered, and
p.000014: 40.4. the application is accompanied by the following mandatory documents:
p.000014: 40.4.1. a study protocol
p.000014: 40.4.2. a brief CV for the CI
p.000014: 40.4.3. in the case of studies that do not involve a new medicine, evidence of favourable peer review4
p.000014: 40.4.4. in the case of studies involving a new medicine, an investigator’s brochure
p.000014: 40.4.5. in the case of studies involving participants, a participation information sheet and consent form
p.000014: 40.4.6. in the case of studies involving the administration of surveys or questionnaires, copies of the surveys or
p.000014: questionnaires
p.000014: 40.4.7. in the case of ‘commercially sponsored’ studies (see section 9), evidence of the insurance held by the
p.000014: study sponsor and evidence of the professional indemnity held by the CI
p.000014: 40.4.8. in the case of studies where a previous application for the same study (or a substantially similar study)
p.000014: has been declined by an HDEC, a copy of the letter from the HDEC declining the previous application and a covering
p.000014: letter from the CI explaining how the new application addresses the reasons given by the HDEC to decline.
p.000014: 41. Applicants may attach other documents to their application at their discretion. This should normally include
p.000014: other written information to be provided to participants in the
p.000014:
p.000014: 4 For example, letter/s from the reviewing body/ies. Such evidence is not mandatory for studies involving new
p.000014: medicines, since HDECs can expect issues of scientific validity in such studies to be addressed by SCOTT.
p.000014:
p.000014:
p.000014:
p.000014: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000015: 15
p.000015:
p.000015: study. However, it is not necessary to submit all written information to be provided to participants;5 applicants
p.000015: should use common sense in deciding whether a document is likely to be relevant to the HDEC in making its decision, and
p.000015: may seek advice from the HDECs in case of doubt.
p.000015: 42. Valid applications should be assigned for HDEC review within three calendar days of their being submitted.
p.000015: The CI should be informed of this and given details of:
p.000015: 42.1. the date on which the 15- or 35-day review clock for a final decision begins
p.000015: 42.2. the application’s HDEC reference number
p.000015: 42.3. whether the application is to be reviewed through the full or expedited review pathway
p.000015: 42.4. the name and membership of the HDEC that will review the application.
p.000015: 43. If the application is to be reviewed through the full review pathway, the HDEC should also give the CI
p.000015: details of:
p.000015: 43.1. the date, time and venue of the meeting at which it is to consider the application
p.000015: 43.2. the time slot reserved for discussion of the application
p.000015: 43.3. how to attend the meeting, in person or by teleconference.
p.000015: 44. If an application does not meet the criteria for validation, the secretariat should advise the applicant of
p.000015: this, giving reasons. The applicant may then complete and resubmit the application.
p.000015: 45. Once validated, the HDEC may invalidate or assign the application to another review pathway only with the
p.000015: prior agreement of the applicant.
p.000015: 46. Where an HDEC subsequently reassigns a validated application to another review pathway, the review clock for
p.000015: the new pathway starts from the date on which the application was submitted, not the date on which the application was
p.000015: reassigned.
p.000015: Withdrawal of applications
p.000015: 47. Applicants may withdraw applications for HDEC review at any time. In this case, the secretariat should
p.000015: confirm withdrawal formally as soon as possible. Resubmission of an application that has been withdrawn is considered
p.000015: as a separate application and given a new HDEC reference number.
p.000015: Changess not able to be made between submission and approval
p.000015: 48. Applicants may not make changes to an application between submission and approval, and may not submit
p.000015: amendments or other “post-approval” items during this period.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: 5 This aspect of these SOPs diverges from paragraph 3.1.2 of ICH GCP guideline E6(R1). However, it does not affect the
p.000015: ability of applicants to attach all written information to be provided to participants if they wish.
p.000015:
p.000015:
p.000015:
p.000015: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000016: 16
p.000016:
p.000016: 5. The full review pathway
p.000016:
p.000016:
p.000016:
p.000016: Introduction
p.000016: The Government response to the Health Committee’s clinical trials inquiry requires that updated SOPs allow HDECs to
p.000016: review some low-risk clinical trials through the expedited review pathway. This section addresses this requirement by
p.000016: defining the features that make an intervention or observational study eligible for full review. Studies that lack all
p.000016: of these features would be reviewed through the expedited review pathway described in section 6.
p.000016: The Government response also requires that updated SOPs impose a 35-day time limit for final decisions on applications
p.000016: considered through the full review pathway. This section presents details on when this 35-day ‘review clock’ begins,
p.000016: depending on whether the applicant prefers review to occur as soon as possible or as geographically close as possible.
p.000016: More generally, this section also presents rules for the conduct of HDEC meetings considering decisions through the
p.000016: full review pathway. Many of these rules replace similar provisions in the Operational Standard for Ethics Committees
p.000016: and individual HDECs’ terms of reference.
p.000016: Standardising these rules is likely to reduce duplication, and allow for HDEC meeting procedures to be modified more
p.000016: easily in response to future issues and pressures.
p.000016: Other key changes and clarifications include:
p.000016: • more specific requirements for the information to be included in meeting minutes (and agendas)
p.000016: • clearer procedures for the declaration and management of conflicts of interest among members of HDECs
p.000016: • a smaller quorum (of five members), consistent with a reduction in HDEC size from twelve to eight members
p.000016: • a limited ability for HDEC chairs to co-opt members of other HDECs to meet quorum
p.000016: • clearer rules on the attendance of applicants and observers at HDEC meetings.
p.000016: Key changes to this section following consultation include:
p.000016: • clarifying that criteria for full review apply to both intervention and observational studies
p.000016: • expanding the scope of full review to include studies involving class IIb medical devices and new surgical
p.000016: interventions
p.000016: • clarifying that HDECs should allow at least 30 minutes for discussion of new applications
p.000016: • providing for researchers to attend HDEC meetings with other parties involved in the study, such as
p.000016: representatives of sponsors or localities.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: What is the full review pathway, and what should be reviewed by it?
p.000016: 49. The full review pathway involves an HDEC reviewing a new application, substantial amendment or other item of
p.000016: business at a meeting held in accordance with the provisions set out in this section.
p.000016:
p.000016:
p.000016: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000017: 17
p.000017:
p.000017: 50. The full review pathway is appropriate for any intervention or observational study that is within the scope
p.000017: of HDEC review and that involves one or more of the following:
p.000017: 50.1. a new medicine (as defined by the Medicines Act 1981), or
p.000017: 50.2. an approved medicine being used for a new indication or through a new mode of administration, or
p.000017: 50.3. a medical device that is or would be classified as a class IIb, class III or active implantable medical device
p.000017: by the TGA,6 or
p.000017: 50.4. a new surgical intervention, or
p.000017: 50.5. one or more participants who will not have given informed consent to participate, or
p.000017: 50.6. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000017: decisions about their participation in the study),7 or
p.000017: 50.7. standard treatment being withheld from one or more participants, or
p.000017: 50.8. the storage, preservation or use of human tissue without consent.
p.000017: 51. Full review is also appropriate for substantial amendments to previously approved studies that were
p.000017: themselves reviewed by this pathway. However, the chair of an HDEC may direct that the HDEC review any such amendments
p.000017: through the expedited review pathway.
p.000017: Natural justice
p.000017: 52. As public administrative bodies, HDECs must act in accordance with the principles of natural justice. In
p.000017: particular, they must ensure that:
p.000017: 52.1. their decision-making is impartial and transparent, following the processes defined by these SOPs, and
p.000017: 52.2. they give applicants fair opportunity to be heard and to hear the deliberations of the HDEC.
p.000017: Meeting dates and cut-off dates
p.000017: 53. HDECs must make public the dates, times and locations of HDEC meetings sufficiently in advance to give
p.000017: interested members of the public a reasonable chance to organise their attendance as observers.
p.000017: 54. HDECs must also clearly publicise, for each meeting, the last date on which applications and substantial
p.000017: amendments may be received for consideration at that meeting (the ‘cut-off date’). The cut-off date may not be more
p.000017: than 12 calendar days before the date of the meeting.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 6 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
p.000017: Australian regulatory guidelines for medical devices, available from the TGA’s website at
p.000017: http://tga.gov.au/pdf/devices-argmd.pdf.
p.000017: 7 This term is defined more fully in the Ethical Guidelines for Intervention Studies.
p.000017:
p.000017:
p.000017:
p.000017: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000018: 18
p.000018:
p.000018: The 35-day review clock
p.000018: 55. In the full review pathway, HDECs must make a final decision within 35 calendar days. They may suspend this
p.000018: timeframe once for up to 90 calendar days where they require additional information in order to make a final decision
p.000018: (see section 7).
p.000018: 56. Calendar days from 25 December to 15 January inclusive do not count for the purposes of the 35-day review
p.000018: clock.
p.000018: 57. The 35-day review clock begins on the cut-off date for the first meeting at which the HDEC could have
p.000018: reviewed the matter. This means that:
p.000018: 57.1. for substantial amendments: the review clock starts on the cut-off date for the next meeting of the HDEC that
p.000018: considered the original application (or, in the case of applications approved prior to 1 July 2012, the HDEC with
p.000018: responsibility for on-going review)
p.000018: 57.2. for new applications where the applicant wishes review to occur as near as possible: the review clock starts
p.000018: on the cut-off date for the next meeting of the nearest HDEC (or HDECs), excluding any meetings whose agendas are
p.000018: already full
p.000018: 57.3. for new applications where the applicant wishes review to occur as soon as possible: the review clock starts
p.000018: on the cut-off date for the next HDEC meeting, regardless of whether its agenda is full.
p.000018: 58. This means that applicants who wish HDEC review to occur as soon as possible will not be disadvantaged when
p.000018: the next HDEC meeting cannot consider their application due to workload constraints. It may be necessary for one or
p.000018: more HDECs to hold additional meetings from time to time in order to ensure respect for the 35-day review clock. The
p.000018: secretariat and chairs should agree on the number and timing of such meetings, and publicise details as soon as
p.000018: possible.
p.000018: 59. A valid application or substantial amendment submitted before 12 noon on the cut-off date for an HDEC meeting
p.000018: will be considered to have been able to be reviewed at that meeting.
p.000018: 60. In the unlikely event that an HDEC is not able to respect the 35-day review clock, it must contact the
p.000018: applicant as soon as possible to inform them of reasons. HDECs’ annual reports must list and explain all cases in which
p.000018: the HDEC did not respect the review clock.
p.000018: HDEC meeting agendas
p.000018: 61. The agenda for an HDEC meeting should include:
p.000018: 61.1. the date, time and venue of the meeting
p.000018: 61.2. the names of members of the HDEC, and whether they have tendered apologies
p.000018: 61.3. the minutes of the previous meeting for ratification
p.000018: 61.4. the titles and reference numbers of new applications that the HDEC will review at the meeting, and the time
p.000018: slots allocated to them
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000019: 19
p.000019:
p.000019: 61.5. the titles and reference numbers of approved studies for which the HDEC will review a substantial amendment at
p.000019: the meeting, and the time slots allocated to them
p.000019: 61.6. the titles and reference numbers of approved studies for which the HDEC will reconsider approval at the
p.000019: meeting, and the time slots allocated to them
p.000019: 61.7. items for general business
p.000019: 61.8. a ‘noting section’ summarising decisions the HDEC has taken through the expedited review pathway between the
p.000019: cut-off dates for the previous and the current meetings. This section will include:
p.000019: 61.8.1. final decisions made on new applications that were provisionally approved at previous meetings
p.000019: 61.8.2. final decisions made on new applications through the expedited review pathway
p.000019: 61.8.3. final decisions made on notifications of substantial amendment through the expedited review pathway
p.000019: 61.8.4. annual progress reports received
p.000019: 61.8.5. notifications of conclusion of study received
p.000019: 61.8.6. final reports received
p.000019: 61.8.7. approvals cancelled for failure to submit an annual progress report.
p.000019: 62. HDECs should normally allocate no less than 30 minutes of discussion for each new application, no less than
p.000019: 15 minutes for each substantial amendment, and no less than 20 minutes for each matter relating to the monitoring of
p.000019: approved studies. HDECs must clearly advise applicants of relevant time slots in advance of the meeting, to facilitate
p.000019: their attendance.
p.000019: 63. No more than 12 new applications should normally be accepted for review at an HDEC meeting. HDECs should not
p.000019: schedule meetings to last for longer than eight hours, including regular breaks for refreshments.
p.000019: 64. HDECs should distribute agendas and papers for meetings in hard copy to members (apart from those who have
p.000019: tendered apologies) at least seven calendar days prior to the meeting. Along with the agenda, members should receive
p.000019: the completed application form, together with supporting documents. Large documents such as investigators’ brochures
p.000019: may be excluded, given that such documents will be available to members electronically in any case.
p.000019: Role of the chair
p.000019: 65. The chair is responsible for ensuring that:
p.000019: 65.1. the conduct of meetings accords with these SOPs
p.000019: 65.2. the meeting follows and respects the agenda
p.000019: 65.3. the HDEC reaches clear decisions on all matters before it
p.000019: 65.4. the meeting allows all members present a reasonable opportunity to participate in discussion.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000020: 20
p.000020:
p.000020: 66. Where the chair is unable to attend a meeting, the HDEC must elect an acting chair at the start of the
p.000020: meeting by majority vote of appointed members present. While it may elect any appointed member for this purpose, it
p.000020: should usually identify in advance the member who will be expected to act in the absence of the chair.
p.000020: Quorum
p.000020: 67. The quorum for any HDEC meeting is five members (including the chair or acting chair), of whom at least two
p.000020: must be lay members and at least two non-lay members. Members should make all reasonable attempts to attend meetings in
p.000020: person, but may if necessary attend by video conference (or, exceptionally, teleconference).
p.000020: 68. Where there is no quorum, an HDEC may not commence, continue or conclude a discussion on any item of business
p.000020: relating to any application, and may not take any decision on any matter.
p.000020: Co-opted members
p.000020: 69. Where a meeting would otherwise be inquorate, the chair or acting chair may co-opt up to two appointed
p.000020: members of other HDECs for that meeting. Co-opted members count towards quorum and may participate fully in
p.000020: decision-making. However, the meeting may not elect them to act as chair, and may not delegate them with authority to
p.000020: make final decisions on items of business on which no final decision is made at the meeting.
p.000020: 70. The minutes for any HDEC meeting at which members have been co-opted must note that they have been co-opted
p.000020: before the meeting declares a quorum or discusses any substantive item of business.
p.000020: 71. Where the chair of an HDEC believes it will be necessary to co-opt members in order to meet quorum, the HDEC
p.000020: secretariat is responsible for contacting members of other HDECs to arrange this. Neither HDECs nor their chairs may
p.000020: insist on co-opting a named member of another HDEC.
p.000020: 72. An individual member may not be co-opted more than three times in any 12-month period.
p.000020: Potential conflicts of interest
p.000020: 73. HDEC members must be mindful to avoid situations that might compromise the impartiality and integrity of the
p.000020: HDEC review process.
p.000020: 74. In particular, members should declare any potential conflict of interests they have or may reasonably be
p.000020: perceived to have in relation to any item of business the HDEC is considering. The chair must remind all members
p.000020: present at a meeting to declare potential conflicts of interest prior to discussion of each item of business.
p.000020: 75. Where a member declares a potential conflict of interest, the HDEC may decide, by consensus or vote, to:
p.000020: 75.1. require that the member leave the meeting room and take no part in the discussion or decision relating to that
p.000020: item of business, or
p.000020: 75.2. allow the member to remain in the meeting room and take a full part in the discussion and decision relating to
p.000020: that item of business.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000021: 21
p.000021:
p.000021: 76. Where a member declares a potential conflict of interest, the HDEC must clearly record the declaration and
p.000021: the HDEC’s decision on how to manage it in the minutes. (It is not necessary to record details of the declaration;
p.000021: merely that one has been made, and by whom.)
p.000021: 77. Members who are also investigators on studies submitted for HDEC review have a particularly strong
p.000021: responsibility to avoid the appearance of potential conflicts of interest. Where a member (including a co-opted member)
p.000021: of an HDEC is also an investigator on a study, the HDEC should usually require the member to leave the meeting room and
p.000021: take no part in the discussion or decision, especially when another investigator is available to attend the meeting to
p.000021: speak to the application.
p.000021: Lead reviewers
p.000021: 78. An HDEC may assign a member of the HDEC other than the chair to be the lead reviewer for a new application or
p.000021: substantial amendment.
p.000021: 79. The role of the lead reviewer is to lead and facilitate discussion. This role does not require any technical
p.000021: expertise or experience in the subject matter of the application or amendment in question. For instance, a member who
p.000021: happens to be a dentist need not necessarily be the lead reviewer for an application involving research in dentistry.
p.000021: 80. Regardless of whether an HDEC assigns a lead reviewer for a given application or substantial amendment, the
p.000021: chair retains ultimate responsibility for ensuring that the HDEC’s decision-making process accords with these SOPs.
p.000021: Attendance of CI (or other investigator)
p.000021: 81. HDECs must invite the CI to attend, in person or by teleconference, all meetings at which it will consider
p.000021: matters relating to their study, specifying the relevant time slot.
p.000021: 82. Where CIs or co-investigators attend by teleconference, all HDEC members present must be able to hear and be
p.000021: heard by them.
p.000021: 83. CIs do not attend in order to make a formal presentation of the aims or design of the study. Rather, they
p.000021: attend in order to improve the quality of the HDEC’s discussion and the speed of their decision-making, by providing
p.000021: further information, clarification or reassurance. Their attendance may allow for potential issues to be resolved
p.000021: expeditiously during meetings, rather than in correspondence after it.
p.000021: 84. If the CI cannot attend an HDEC meeting, another investigator on the study may attend in their place. Other
p.000021: parties to a study (such as representatives of localities or sponsors) may also attend meetings.
p.000021: 85. HDECs may not require the CI (or other investigator) and other parties to a study to leave a meeting while
p.000021: they are discussing or deciding on matters relating to their application, other than in accordance with paragraph 89.
p.000021: Attendance of observers
p.000021: 86. All meetings of HDECs are open to the public. Observers may attend meetings but may not take any part in the
p.000021: HDEC’s discussion or decisions without the permission of the chair.
p.000021:
p.000021:
p.000021:
p.000021:
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p.000022: 22
p.000022:
p.000022: 87. The chair may require observers to leave a meeting while the HDEC is considering matters relating to a study
p.000022: only if:
p.000022: 87.1. the CI (or co-investigator) of that study specifically asks the chair verbally to do so, and
p.000022: 87.2. the CI (or co-investigator) provides reasonable assurances that there may be grounds to withhold information
p.000022: about their application under the Official Information Act 1982.
p.000022: 88. The chair may require observers to leave an HDEC meeting at times other than while the committee is
p.000022: considering matters relating to a study (for instance, during general business) at their sole discretion.
p.000022: 89. Notwithstanding the above, the chair may at their sole discretion require any person to leave an HDEC meeting
p.000022: at any time where they consider, on reasonable grounds, that that person’s behaviour is having an unduly adverse impact
p.000022: on the HDEC’s ability to perform its functions.
p.000022: The decision-making process
p.000022: 90. HDECs must reach one of the decisions listed in section 7 of these SOPs on every new application and
p.000022: substantial amendment they consider.
p.000022: 91. HDECs should reach decisions by consensus wherever possible. Where this is not possible, a formal vote should
p.000022: be taken by a counting of hands, the decision being determined by a simple majority of members present and the chair
p.000022: having a casting vote.
p.000022: 92. Where an HDEC decision is taken by vote, members who dissent from the decision may ask that the minutes note
p.000022: their dissent.
p.000022: Minutes
p.000022: 93. The minutes of an HDEC meeting must contain a true and accurate summary of the discussion that takes place
p.000022: during the meeting, and the decisions made at it.
p.000022: 94. For each application or substantial amendment reviewed at a meeting, the minutes must clearly record:
p.000022: 94.1. which members (if any) declared a potential conflict of interest, and the decision the HDEC took to manage
p.000022: these declarations (it is not necessary to record details of the potential conflict of interest; only that one was
p.000022: made)
p.000022: 94.2. a brief summary of the main ethical issues considered
p.000022: 94.3. the decision (see section 7)
p.000022: 94.4. whether the decision was reached by consensus or by vote; if by vote, the numbers for and against
p.000022: 94.5. any formal dissent from the decision by a named member
p.000022: 94.6. where the decision is to approve, any minor conditions applicants must meet prior to the start of the study
p.000022: 94.7. where the decision is to decline, reasons for this
p.000022: 94.8. where no decision is made pending receipt of further information:
p.000022:
p.000022:
p.000022:
p.000022:
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p.000023: 23
p.000023:
p.000023: 94.8.1. details of the further information requested, and
p.000023: 94.8.2. the established ethical standard or standards in respect of which the HDEC requests the further
p.000023: information, and
p.000023: 94.8.3. who will have responsibility for considering this information and making a final decision.
p.000023: 95. The summary of ethical issues should set out the main issues considered in making the decision. It is not
p.000023: necessary to include requests for explanations of technical or non-ethical matters, or to record every aspect of the
p.000023: HDEC’s discussion. The summary should include, for example, substantive ethical issues discussed and resolved with the
p.000023: CI at an HDEC meeting, and any oral clarifications given of information contained in the application.
p.000023: 96. The secretariat should prepare draft minutes and the chair (or acting chair) agree to them as soon as
p.000023: possible after the meeting. The chair (or acting chair) may consult with other HDEC members at their sole discretion
p.000023: before agreeing to minutes. However, such consultation should not prevent the HDEC sending letters communicating
p.000023: decisions made at the meeting to the applicant within four working days of the decision being made (see section 7)
p.000023: 97. Except where a named member wishes to be named as dissenting from a decision taken by vote, the HDEC must
p.000023: present minutes entirely as the outcome of collective discussion. It should not attribute comments and questions to
p.000023: named members.
p.000023: 98. Draft minutes should be submitted to the following meeting of the HDEC for formal confirmation as a true and
p.000023: accurate record. Any minor changes necessary should be noted and the minutes amended accordingly after the meeting. The
p.000023: chair (or acting chair) should sign the final minutes, which should then be published electronically.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
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p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000024: 24
p.000024:
p.000024: 6. The expedited review pathway
p.000024:
p.000024:
p.000024:
p.000024: Introduction
p.000024: The Government response to the Health Committee’s clinical trials inquiry requires that updated SOPs for HDECs impose a
p.000024: 15-day time limit for making final decisions on applications through the expedited review pathway. This section
p.000024: addresses that requirement, and defines the expedited review pathway in more detail.
p.000024: Key changes and clarifications include:
p.000024: • clarifying the items of business for which expedited review is appropriate, which may include some applications
p.000024: for low-risk clinical trials
p.000024: • allowing chairs to share the workload within the expedited review pathway by creating subcommittees consisting of
p.000024: up to three other members of the HDEC to advise them on their decisions.
p.000024: Key changes to this section following consultation include:
p.000024: • clarifying that studies of class IIa medical devices may qualify for expedited review, and that final reports
p.000024: should also be reviewed through this pathway
p.000024: • removing the ability of the chair to select the member who will act in their place for the purposes of the
p.000024: expedited review pathway
p.000024: • increasing the maximum size of subcommittees from three to four members
p.000024: • requiring that all new applications for expedited review be reviewed by a subcommittee comprising the chair plus
p.000024: at least one other member (and, where the application is for an intervention study, that at least one of these members
p.000024: be a non-lay member)
p.000024: • reducing the power of HDEC chairs to make decisions without input from other subcommittee members, while
p.000024: recognising that this may be continue to be necessary in exceptional circumstances, and requiring such decisions to be
p.000024: brought to the attention of the full HDEC.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: What is the expedited review pathway, and what should be reviewed by it?
p.000024: 99. In the expedited review pathway, a subcommittee of an HDEC reviews an application, substantial amendment or
p.000024: other item of business in accordance with the provisions set out in this section.
p.000024: 100. The expedited review pathway is appropriate for:
p.000024: 100.1. all new applications for which full review is not required (including studies of class IIa medical devices,
p.000024: where none of the other features making full review appropriate are present)
p.000024: 100.2. all substantial amendments to approved studies that were reviewed through the expedited review pathway
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000025: 25
p.000025:
p.000025: 100.3. any substantial amendments to other studies, at the discretion of the chair
p.000025: 100.4. all annual progress reports and final reports
p.000025: 100.5. all protocol deviations or violations
p.000025: 100.6. all notifications of the conclusion or early termination of a study.
p.000025:
p.000025: The 15-day review clock
p.000025: 101. The expedited review pathway does not involve physical meetings of HDECs. For this reason, the expedited
p.000025: review pathway entails a shorter review clock than the full review pathway.
p.000025: 102. In the expedited review pathway, HDECs must give a final opinion within 15 calendar days. They may suspend
p.000025: this timeframe once in the case of provisional approval of an application or substantial amendment (see section 7).
p.000025: 103. The 15-day review clock begins on the working day following submission of the application or substantial
p.000025: amendment.
p.000025: 104. Calendar days from 25 December to 15 January inclusive do not count for the purposes of the 15-day review
p.000025: clock.
p.000025: Declarations of conflict of interest
p.000025: 105. HDEC members must be mindful to avoid situations that might compromise the impartiality and integrity of the
p.000025: HDEC review process. This obligation is particularly strong in the context of the expedited review pathway.
p.000025: 106. An HDEC member who is assigned an item of business to review within the expedited review pathway must decline
p.000025: to review it if they believe they have (or might reasonably be perceived to have) a potential conflict of interest.
p.000025: 107. Where the chair believes that they personally have (or might reasonably be perceived to have) a potential
p.000025: conflict of interest on a new application, they may request the secretariat to assign the application to another HDEC.
p.000025: 108. The 15-day review clock for giving a final opinion does not stop when a chair or member declines to review an
p.000025: item of business due to a potential conflict of interest.
p.000025: Role of the chair
p.000025: 109. In the expedited review pathway, the chair is responsible for:
p.000025: 109.1. selecting the subcommittee members who will be involved in the review of items of business
p.000025: 109.2. ensuring that final decisions are made within the 15-day timeframe.
p.000025: 110. Where the chair is unavailable, any other member of the HDEC may act in their place for the purposes of the
p.000025: expedited review pathway, although this role should usually be taken by the member identified by the HDEC as a whole to
p.000025: act in the absence of the chair at meetings. The HDEC as a whole should usually choose this member at the meeting
p.000025: preceding the chair’s period of unavailability.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000026: 26
p.000026:
p.000026: Size and composition of subcommittees
p.000026: 111. A subcommittee consists of the chair plus up to three other appointed members. The size and composition of
p.000026: subcommittees is at the chair’s discretion, subject to the following rules.
p.000026: 111.1. A subcommittee reviewing a new application must consist of the chair plus at least one other member.
p.000026: 111.2. A subcommittee reviewing a new application for an intervention study must include at least one non-lay member.
p.000026: 111.3. A subcommittee composed of three or more members (including the chair) must include at least one lay member and
p.000026: at least one non-lay member.
p.000026: 112. HDECs may maintain standing subcommittees to review all or some items of business within the expedited review
p.000026: pathway. For instance, new expedited applications might be reviewed by the chair plus one or two named members,
p.000026: substantial amendments by the chair plus a third named member, and all annual progress reports by the chair alone.
p.000026: Alternatively, the HDEC may create a new subcommittee for each item of business to be reviewed.
p.000026: 113. In exceptional circumstances, to ensure respect for the 15-day review clock it may be necessary for the chair
p.000026: to take a decision on an item of business themselves. This may be the case, for example, where other members become
p.000026: unavailable at short notice. The chair should bring decisions taken in this way to the attention of the full HDEC at
p.000026: its next meeting.
p.000026: The decision-making process
p.000026: 114. The HDEC subcommittee must reach one of the decisions listed in section 7 on every new application or
p.000026: substantial amendment they consider.
p.000026: 115. Decisions should be reached by consensus wherever possible. Where this is not possible, the subcommittee may
p.000026: take a formal vote, the decision being determined by a simple majority of members and the chair having a casting vote.
p.000026: 116. There are no restrictions on the way in which subcommittees may reach decisions. The process may involve
p.000026: written communication, teleconferences or face-to-face meetings. The latter should only take place in exceptional
p.000026: circumstances, and after consultation with the secretariat.
p.000026: 117. Subcommittees should communicate decisions taken through the expedited review pathway to the full HDEC through
p.000026: meeting agendas. The full HDEC does not need to ratify these decisions.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000027: 27
p.000027:
p.000027: 7. Decisions open to HDECs
p.000027:
p.000027:
p.000027:
p.000027: Introduction
p.000027: This section describes the decisions open to HDECs, and sets out in more detail the timeframes within which the HDEC
p.000027: must make and communicate those decisions. Consistent with the established practice of other jurisdictions in which
p.000027: ethics committees are expected to make decisions within a given timeframe, the 35- or 15-day review clock is able to be
p.000027: suspended once, where an application has been provisionally approved.
p.000027: Key changes and clarifications include:
p.000027: • removing the ability of HDECs to ‘defer’ consideration of an application through the full review pathway until
p.000027: their next meeting, since retaining this ability would be inconsistent with the 35-day review clock
p.000027: • allowing the 35- and 15-day review clocks to be suspended once, for up to 90 calendar days, where the HDEC gives
p.000027: provisional approval
p.000027: • making regulatory approval, locality approval and clinical trial registration standard conditions of HDEC
p.000027: approval, and allowing HDECs to impose other minor conditions of approval (such as corrections to study documents)
p.000027: • clarifying that researchers and sponsors, rather than HDECs, are responsible for ensuring that standard and minor
p.000027: conditions of HDEC approval are met before a study commences
p.000027: • clarifying that HDECs must provide reasons based on established ethical standards wherever they provisionally
p.000027: approve or decline a new application or substantial amendment.
p.000027: Key changes to this section following consultation include:
p.000027: • clarifying that HDECs should communicate decisions within four working days
p.000027: • consistent with changes to the definition of ‘locality’ in section 9, making locality authorisation a standard
p.000027: condition of all HDEC approvals, rather than just those involving intervention studies
p.000027: • clarifying standard and minor conditions of approval, and specifying that changes requiring reconsideration of
p.000027: ethical issues should be re-checked by HDECs after provisional approval.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Decisions
p.000027: 118. Chairs are responsible for ensuring that HDECs make one of the following decisions on all new applications and
p.000027: substantial amendments through the full and expedited review pathways:
p.000027: 118.1. approve
p.000027: 118.2. decline
p.000027: 118.3. provisionally approve.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000028: 28
p.000028:
p.000028: 119. For the purposes of the 35- and 15-day review clocks, the date of decision is the date on which the HDEC sends
p.000028: the decision letter.
p.000028: 120. HDECs should formally communicate all decisions on new applications and substantial amendments to applicants
p.000028: within four working days of their being made. This four-day timeframe applies to decisions made at HDEC meetings as
p.000028: well as to decisions made within the expedited review pathway.
p.000028: 121. All decision letters should be in the name of the chair of the HDEC.
p.000028: 122. All decision letters must include the following information:
p.000028: 122.1. a brief summary of the main ethical issues considered by the HDEC in making the decision
p.000028: 122.2. the decision
p.000028: 122.3. a list of study documents, including version numbers and dates
p.000028: 122.4. where the decision was made through the full review pathway: a list of HDEC members, indicating their
p.000028: membership category, whether they were present at the meeting at which the matter was discussed and, if so, whether
p.000028: they declared a potential conflict of interest.
p.000028: 123. Decision letters should not attribute particular comments, questions or concerns to individual HDEC members.
p.000028: Similarly, where a decision was made through the expedited review pathway, decision letters must not reveal the names
p.000028: of the members of the subcommittee involved.
p.000028: Letters communicating a decision to approve
p.000028: 124. In addition to the information specified at paragraph 122, approval letters must confirm:
p.000028: 124.1. that the HDEC operates in accordance with these SOPs and with the principles of international good clinical
p.000028: practice
p.000028: 124.2. whether participants injured as a result of treatment received in the study will be eligible for publicly
p.000028: funded compensation through ACC (see also section 8).
p.000028: Conditions of HDEC approval
p.000028: 125. All HDEC approvals are subject to the following standard conditions.
p.000028: 125.1. Applicants must obtain all necessary regulatory approvals and authorisations before the study commences in New
p.000028: Zealand.
p.000028: 125.2. Applicants must obtain locality authorisation before the study commences at a given locality (see section 10).
p.000028: 125.3. If the study is an intervention study, it must be registered in a clinical trials registry approved by the
p.000028: World Health Organisation before it commences in New Zealand.
p.000028: 126. HDECs may also impose minor conditions on approval. By way of example, such conditions might include minor
p.000028: corrections or changes to study documentation. However, where the changes required would necessitate further ethical
p.000028: consideration (for example, significant or unspecified revision of study documentation), the HDEC
p.000028:
p.000028:
p.000028:
p.000028: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000029: 29
p.000029:
p.000029: should provisionally approve the study and formally review these revisions before giving final approval.
p.000029: 127. The approval letter must clearly state both standard and minor conditions of approval, and applicants must
p.000029: fully meet these in order for HDEC approval to be effective. Until the conditions are met, the study cannot commence
p.000029: (or cannot commence at a given locality).
p.000029: 128. It is the responsibility of the CI and study sponsor to ensure that applicants meet all standard and minor
p.000029: conditions of HDEC approval before the study commences (or commences at a given locality). Neither the HDEC nor the
p.000029: secretariat is required to undertake any further review to ensure that this is the case, or to confirm approval.
p.000029: Duration of HDEC approval
p.000029: 129. HDEC approval applies for the duration of the study as specified in the original application, subject to
p.000029: approval being suspended or cancelled in accordance with the provisions of section 12.
p.000029: 130. Extension of the duration of a study beyond that specified in the original application is not in and of itself
p.000029: a substantial amendment to that study, except where it is related to other amendments that would be substantial (such
p.000029: as an increase in recruitment targets, the addition of new procedures, or an extension of follow-up activities).
p.000029: Consequently, applicants will usually not require an HDEC’s approval to extend a study’s duration (see section 11).
p.000029: Letters communicating a decision to decline
p.000029: 131. In addition to the information specified at paragraph 122, letters declining an application must clearly
p.000029: state:
p.000029: 131.1. the ethical standard(s) that the HDEC believes the study would not meet, with reasons
p.000029: 131.2. how the applicant may challenge the decision of the HDEC to decline (see section 9).
p.000029: 132. An applicant may make a second application in respect of a study that an HDEC has declined at any time. In
p.000029: such cases, the second application is considered to be a new application, and assigned a new reference number (in
p.000029: accordance with section 4).
p.000029: Letters communicating a decision to provisionally approve
p.000029: 133. An HDEC may provisionally approve a new application or substantial amendment pending receipt of further
p.000029: information or satisfaction of non-minor conditions. This decision may only be made once in respect of any new
p.000029: application or substantial amendment.
p.000029: 134. In addition to the information specified at paragraph 122, provisional approval letters must clearly state:
p.000029: 134.1. the established ethical standard(s) that the HDEC is not satisfied the study would meet on the basis of the
p.000029: information in the original application
p.000029: 134.2. the further information (or non-minor conditions) that the HDEC requires (or imposes) in order to make a final
p.000029: decision
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000030: 30
p.000030:
p.000030: 134.3. the number of days remaining on the 35- or 15-day review clock
p.000030: 134.4. the date by which the HDEC must receive a response from the applicant.
p.000030:
p.000030: Stopping and restarting the review clock
p.000030: 135. The 35- or 15-day review clock stops on the date of the provisional approval letter, and restarts on the date
p.000030: on which the HDEC receives a complete response. If an applicant submits an incomplete response, the review clock
p.000030: remains suspended. Where the HDEC receives a response that is incomplete, it should inform the applicant of this as
p.000030: soon as possible.
p.000030: 136. A complete response must be received within 90 calendar days of the date of the provisional approval letter.
p.000030: The secretariat should send a reminder of this request after 60 calendar days.
p.000030: 137. Where the HDEC does not receive a complete response after 90 calendar days, the application or substantial
p.000030: amendment will be considered to have been withdrawn. The secretariat must confirm this.
p.000030: Authority for considering further information – full review
p.000030: 138. In order to ensure compliance with the relevant review clock for making a final decision, an HDEC may not
p.000030: require that a response be considered by the full committee at a future meeting. Instead, the HDEC must clearly
p.000030: delegate authority for checking the response and for making a final decision to either:
p.000030: 138.1. the chair (or acting chair) alone, or
p.000030: 138.2. the chair (or acting chair) in consultation with one or more named members who contributed to the decision to
p.000030: provisionally approve the application, or
p.000030: 138.3. the secretariat.
p.000030: 139. In delegating authority to make a final decision, the HDEC should consider the significance of the further
p.000030: information requested or conditions imposed. If the requirement is straightforward or administrative, the secretariat
p.000030: may take responsibility for it. However, the chair (and, potentially, other members) should review the response if
p.000030: substantive questions of ethical judgement are likely to arise.
p.000030: 140. Notwithstanding the above, the chair may make a final decision on any provisionally approved application or
p.000030: substantial amendment where he or she believes, on reasonable grounds, that this is necessary to ensure respect for the
p.000030: 35-day review clock. This might be the case, for example, if other members became unavailable at short notice.
p.000030: Authority for considering further information – expedited review
p.000030: 141. Where the expedited review pathway results in a grant of provisional appeal, the subcommittee responsible for
p.000030: the original decision should usually consider any further information submitted. Where this is not possible, the chair
p.000030: (or acting chair) should consider the information and make a final decision.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000031: 31
p.000031:
p.000031: 8. HDECs and the Accident Compensation Act 2001
p.000031:
p.000031:
p.000031:
p.000031: Introduction
p.000031: This section explains the statutory role of HDECs under the Accident Compensation Act 2001 (‘the ACC Act’). This Act
p.000031: excludes participants injured as a result of treatment received as part of some clinical trials from access to
p.000031: compensation through New Zealand’s no-fault compensation scheme.
p.000031: In this section, the role of HDECs is interpreted consistently with the Government response to the Health Committee’s
p.000031: clinical trials inquiry. This response provided that HDECs are not responsible for considering local research
p.000031: governance issues (such as locality-specific insurance and indemnity arrangements).
p.000031: No major changes have been made to this section following consultation.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 142. HDECs have two roles with regard to compensation arrangements for participants who are injured as a result of
p.000031: treatment given as part of an intervention study. These roles derive from the ACC Act.
p.000031: Determining the principal benefactor of the study
p.000031: 143. First, HDECs must determine whether the intervention study is to be conducted principally for the benefit of
p.000031: the manufacturer or distributor of the medicine or item being trialled. Such studies are often referred to simply as
p.000031: commercially sponsored (or ‘form B’) studies, since the relevant manufacturer or distributor will normally (but not
p.000031: necessarily) also be the study’s sponsor.
p.000031: 144. The provision of financial or material support alone is not determinative of whether a study is conducted
p.000031: principally for the benefit of a particular manufacturer or distributor. In making this determination, HDECs should
p.000031: ask:
p.000031: 144.1. who is initiating the study?
p.000031: 144.2. who is designing and planning the research questions that the study will ask?
p.000031: 144.3. will the CI or other investigators receive remuneration from the manufacturer or distributor?
p.000031: 144.4. is the manufacturer or distributor putting any unreasonable restrictions or delays on the timely publication of
p.000031: the results of the study?
p.000031: 144.5. is the manufacturer or distributor providing any funding or materials for the study?
p.000031: If the study is ‘commercially sponsored’, checking that compensation would be available to at least ACC-equivalent
p.000031: standard
p.000031: 145. Section 32 of the ACC Act provides that participants injured as a result of treatment given as part of
p.000031: ‘commercially sponsored’ intervention studies are not eligible for publicly funded compensation through ACC.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000032: 32
p.000032:
p.000032: 146. Investigators and sponsors of ‘commercially sponsored’ intervention studies are therefore responsible for
p.000032: ensuring that compensation for such injuries would be available to at least ACC-equivalent standard.8 HDECs are
p.000032: responsible for checking that such arrangements are in place.
p.000032: 147. In so checking, HDECs are not expected or resourced to undertake detailed expert scrutiny of insurance
p.000032: policies held by the sponsor or any other parties to a ‘commercially sponsored’ intervention study, or to examine the
p.000032: indemnity agreements that may exist between them and localities. HDECs can expect to rely on localities to ensure that
p.000032: these arrangements are robust and appropriate.
p.000032: 148. Given the limited information and resources available to them, and the complexity of determining entitlements
p.000032: under the ACC scheme, HDECs should interpret ACC- equivalence in terms of parity of entitlements available.
p.000032: 149. As evidence that ACC-equivalent compensation would be available, it will be sufficient for HDECs to be
p.000032: provided with copies of the following documents:
p.000032: 149.1. in the case of the CI: evidence of appropriate professional indemnity, for example through membership of the
p.000032: Medical Protection Society
p.000032: 149.2. in the case of the study sponsor: evidence of the insurance that will be in place for the study (for example, a
p.000032: certificate of insurance).
p.000032: 150. However, HDECs may not require documents relating to insurance or indemnity arrangements specific to
p.000032: localities in a ‘commercially sponsored’ intervention study, or specific to any individuals involved in the study other
p.000032: than the CI. This is because localities themselves are responsible for checking that they and relevant members of the
p.000032: local research team are appropriately indemnified and insured (see section 10).
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 8 Ethical Guidelines for Intervention Studies , para 8.4.
p.000032:
p.000032:
p.000032:
p.000032: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000033: 33
p.000033:
p.000033: 9. Challenging HDEC decisions
p.000033:
p.000033:
p.000033:
p.000033: Introduction
p.000033: This section defines how applicants may challenge certain HDEC decisions. In addition to the complaint and
p.000033: second-opinion processes that are currently available, the option of appeal to the HRCEC has been added pursuant to
p.000033: ministerial decision in 2010.
p.000033: Key changes to this section following consultation include:
p.000033: • clarifying that the timeframe for formal complaint and second opinion is 20 working days.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: 151. An applicant may challenge an HDEC decision to:
p.000033: 151.1. decline to approve a new application or a substantial amendment to an approved study, or
p.000033: 151.2. suspend approval for a study, or
p.000033: 151.3. cancel approval for a study.
p.000033: 152. There are three options open to applicants who wish to challenge an HDEC decision to decline, suspend or
p.000033: cancel approval:
p.000033: 152.1. formal complaint about the decision-making process, or
p.000033: 152.2. second opinion on the merits of the decision, or
p.000033: 152.3. appeal.
p.000033: 153. While third parties (including members of the public) may not challenge HDEC decisions, they may submit
p.000033: information that they believe may give grounds for the HDEC to review approval for a study in accordance with the
p.000033: provisions of section 12.
p.000033: 154. The principles of natural justice underlie the process of challenging an HDEC decision. HDECs should advise
p.000033: all relevant parties of the process that it will follow, give them an opportunity to comment and respond, and keep them
p.000033: informed of progress. While there is no fixed timeframe within which reconsideration must occur, considerations of
p.000033: natural justice mean that the process should be completed as expeditiously as possible.
p.000033: Formal complaints about the decision-making process
p.000033: 155. Where an applicant considers that the process followed by an HDEC in making a decision to decline, suspend or
p.000033: cancel approval did not accord with the provisions of these SOPs, they may formally complain to the HDEC secretariat in
p.000033: writing. Formal complaints must cite the paragraph(s) of these SOPs that the applicant considers were not followed by
p.000033: the HDEC in making its decision, and provide reasons for this view.
p.000033: 156. When it receives a formal complaint, the secretariat must inform the chair of the relevant HDEC as soon as
p.000033: possible. It must then advise the chair and the applicant
p.000033:
p.000033:
p.000033:
p.000033: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000034: 34
p.000034:
p.000034: within 20 working days as to whether, in its view, the aspects of the decision-making process identified by the
p.000034: applicant accorded with these SOPs. However, the secretariat has no power to annul or amend decisions taken by HDECs,
p.000034: or to require them to reconsider a decision.
p.000034: 157. An HDEC may reconsider a decision to decline, suspend or cancel approval where an applicant has made a formal
p.000034: complaint regardless of the content or timing of the secretariat’s advice. The HDEC may not ask for additional
p.000034: information or assurances in reconsidering its original decision. The HDEC should formally advise the applicant of its
p.000034: intention to reconsider the decision, and invite them to attend the meeting at which this will occur.
p.000034: 158. Following reconsideration, the HDEC must either:
p.000034: 158.1. reaffirm its original decision to decline, suspend or cancel approval, or
p.000034: 158.2. where the original decision was to decline approval: approve or provisionally approve the application (where
p.000034: the decision is to provisionally approve, the HDEC must make a final decision as soon as possible and in any case
p.000034: within five working days of submission of further information), or
p.000034: 158.3. where the original decision was to suspend approval: allow the study to continue as normal, or
p.000034: 158.4. where the original decision was to cancel approval: either allow the study to continue as normal or suspend
p.000034: approval (in which case the provisions of section 12 apply).
p.000034: Second opinion on the merits of the decision
p.000034: 159. Where an applicant considers that a decision to decline, suspend or cancel approval was not one that was
p.000034: reasonably open to the HDEC in the circumstances, they may contact the secretariat to ask that a second opinion be
p.000034: obtained from another HDEC (‘the second HDEC’).
p.000034: 160. When it receives a request for a second opinion, the secretariat must:
p.000034: 160.1. inform the chair of the relevant HDEC as soon as possible, and
p.000034: 160.2. advise the chair and the applicant within 20 working days as to which HDEC will act as the second HDEC, and
p.000034: 160.3. supply the second HDEC with the application or substantial amendment and all associated documentation and
p.000034: correspondence.
p.000034: 161. The second HDEC should discuss the matter at its next meeting, and provide written advice as soon as possible
p.000034: to the original HDEC specifying the decision that it would have taken on the application or substantial amendment.
p.000034: However, the second HDEC has no power to annul the original decision.
p.000034: 162. Following receipt of a second opinion, the original HDEC must make one of the decisions outlined above in this
p.000034: section, and communicate this decision to both the applicant and the second HDEC.
p.000034: Appeal
p.000034: 163. Applicants may appeal any HDEC decision to decline, suspend or cancel approval to the HRCEC. Appeal decisions
p.000034: of the HRCEC are final and binding on HDECs.
p.000034:
p.000034:
p.000034:
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p.000035: 164. Applicants who wish to appeal HDEC decisions should contact the HRCEC for further details of the process.
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p.000035: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000036:
p.000036: 10. Locality authorisation
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Introduction
p.000036: The Government’s response to the Health Committee’s clinical trials report requires updated SOPs for HDECs to clarify
p.000036: that localities (such as district health boards (DHBs)), rather than HDECs, are responsible for checking local
p.000036: governance issues that may arise from the conduct of a study at a given locality. This section addresses that
p.000036: requirement. It replaces the current ‘locality assessment’ process described at section 7 of the Operational Standard
p.000036: for Ethics Committees.
p.000036: Key changes and clarifications include:
p.000036: • defining ‘locality’ more narrowly, to include only a subset of the organisations involved in the conduct of
p.000036: studies
p.000036: • making the DHB the natural unit for locality review within the public health system
p.000036: • allowing one locality review to cover multiple sites (for example hospitals or departments) within a single
p.000036: locality
p.000036: • clarifying and expanding the issues relevant to locality review; for example, to include issues relevant to a
p.000036: locality’s ability to meet its potential liabilities in intervention studies for which compensation is not available
p.000036: under the ACC Act.
p.000036: Key changes to this section following consultation include:
p.000036: • expanding the definition of ‘locality’ to include organisations involved in the conduct of observational studies
p.000036: (while recognising that not all such studies will involve localities)
p.000036: • clarifying that the study team as a whole (rather than the study sponsor) is responsible for ensuring that
p.000036: locality review is conducted by the appropriate individuals at a locality
p.000036: • more clearly requiring that a locality’s chief executive officer authorise the person completing a locality
p.000036: review
p.000036: • requiring locality review to be conducted afresh as soon as possible, rather than immediately following a change
p.000036: of the lead/principal investigator at a particular locality.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: HDEC approval and locality authorisation are separate processes
p.000036: 165. HDEC review is the process by which an HDEC checks that a study meets or exceeds established ethical
p.000036: standards. If an HDEC is satisfied that this is the case, it approves the study.
p.000036: 166. Locality review is the process by which a locality assesses its suitability for the safe and effective conduct
p.000036: of a study. If a locality is satisfied that this is the case, it authorises the study.
p.000036:
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p.000037:
p.000037: What is a locality?
p.000037: 167. For the purposes of these SOPs, a locality is an organisation responsible for a hospital, health centre,
p.000037: surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a
p.000037: study are to be conducted.
p.000037: 168. Almost all intervention studies and many observational studies will involve at least one locality.
p.000037: 169. Localities for studies within the New Zealand public health system will usually be DHBs. Examples of
p.000037: localities outside the public health system may include:
p.000037: 169.1. academic institutions (such as universities)
p.000037: 169.2. private companies (such as clinical trial units)
p.000037: 169.3. private hospitals or clinical practices
p.000037: 169.4. other health and disability research centres.
p.000037: 170. The following are not localities:
p.000037: 170.1. clinicians, clinical units or other organisations making referrals to a research team
p.000037: 170.2. clinicians, clinical units or other organisations involved only in identifying potential participants or
p.000037: facilitating recruitment by the research team, and not responsible for informed consent or any other procedures set out
p.000037: in the study protocol
p.000037: 170.3. research units undertaking support functions such as project management, site monitoring, data analysis or
p.000037: report writing.
p.000037: 171. Where a study will be conducted at more than one site within the same locality (for example, at multiple
p.000037: hospitals within the same DHB), locality review should be carried out just once to cover all sites within that
p.000037: locality.
p.000037: 172. Where a third party under contract to a locality is to undertake any procedures outlined in the protocol of a
p.000037: study, issues specific to the third party should be considered as part of the locality review.
p.000037: Who should complete locality review?
p.000037: 173. Locality review must be completed by either:
p.000037: 173.1. the locality’s chief executive officer, or
p.000037: 173.2. an individual to whom the chief executive officer has delegated responsibility for conducting locality review.
p.000037: 174. It is not the role of the HDEC to ensure that the person who carries out locality review has been
p.000037: appropriately authorised to do so. This is the responsibility of the study team of the study in question.
p.000037: Issues relevant to locality review
p.000037: 175. The central issue relevant to locality review is its suitability for the safe and effective conduct of the
p.000037: study in question. This involves checking that:
p.000037:
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p.000037:
p.000037: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000038: 38
p.000038:
p.000038: 175.1. the lead/principal investigator(s) at the locality is/are suitably qualified, experienced, registered and
p.000038: indemnified to take professional responsibility (under the direction of the CI) for the conduct of the study at the
p.000038: locality
p.000038: 175.2. the locality’s physical facilities are adequate for the conduct of the study
p.000038: 175.3. conducting the study at the locality would have no adverse effect on the provision of publicly funded health
p.000038: care at that locality
p.000038: 175.4. applicants have taken reasonable steps (particularly consultation with Māori, where appropriate) to ensure that
p.000038: they have identified and adequately addressed local cultural issues that may arise from the study
p.000038: 175.5. appropriate arrangements are in place for notifying other relevant local health or social care staff about the
p.000038: study, and for making available any extra support that might be required by participants
p.000038: 175.6. appropriate arrangements are in place for providing information to potential participants in the study who may
p.000038: not adequately understand information in English
p.000038: 175.7. applicants have included relevant locality-specific information and contact details in the local version of the
p.000038: participant information sheet and consent form
p.000038: 175.8. where participants injured as a result of treatment received as part of the study will not have access to ACC
p.000038: (see section 8):
p.000038: 175.8.1. members of the local research team hold appropriate professional indemnities, and
p.000038: 175.8.2. the locality itself understands the potential liabilities that may arise for it as a result of taking part
p.000038: in the study (for example, through the use of formal contracts and indemnity and compensation agreements, such as those
p.000038: developed by the New Zealand Association of Clinical Research), and has the ability to meet these liabilities
p.000038: 175.9. where the study involves the administration of a new medicine to participants who are in residence at sites
p.000038: within the locality, these sites are registered with Medsafe’s Clinical Trial Site Self-Certification scheme.
p.000038: 176. The checks above are not intended to be exhaustive, or to limit the ability of localities to implement more
p.000038: detailed research governance processes that require additional information and assurances from sponsors and CIs.
p.000038: Locality authorisation is a standard condition of HDEC approval
p.000038: 177. Locality authorisation is a standard condition of HDEC approval for the conduct of a study at a given
p.000038: locality. Once applicants have obtained HDEC approval for a study, and locality authorisation for the locality in which
p.000038: that study is to be conducted, the study may commence immediately. There is no need for the outcome of each locality
p.000038: review to be notified to the HDEC, or for the HDEC to confirm its approval for each locality.
p.000038: 178. Applicants must record locality authorisations in the electronic application system for HDEC review, allowing
p.000038: HDECs access to this information if they require.
p.000038:
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p.000039: 39
p.000039:
p.000039: 179. Locality review and authorisation may occur at any stage of the HDEC review process. However, it is generally
p.000039: desirable that it occur at the same time as or as close as possible to HDEC review.
p.000039: Cancellation of locality authorisation
p.000039: 180. Any locality may cancel locality authorisation for any study at any time at its sole discretion. If this
p.000039: occurs, the study may continue at all other localities for which applicants have obtained locality authorisation.
p.000039: 181. Where a locality cancels authorisation for reasons that may give the HDEC grounds to reconsider the approval
p.000039: in place for the study as a whole (in accordance with section 12), the locality should notify the HDEC of this as soon
p.000039: as possible.
p.000039: 182. There is no requirement for applicants to notify the HDEC of the routine closure of localities (or any sites
p.000039: within localities) used in a study. However, they must notify the HDEC of the conclusion or early termination of the
p.000039: study as a whole in New Zealand, in accordance with section 12.
p.000039: Appointment of a new lead/principal investigator at a locality, or addition of new localities
p.000039: 183. The suitability of the lead/principal investigator(s) at a locality is a matter that is relevant to locality
p.000039: review. Localities should therefore conduct locality review again when a new lead/principal investigator is appointed,
p.000039: as soon as practical in the circumstances. There will usually be no need in such cases to notify the HDEC, since the
p.000039: appointment of a new lead/principal investigator does not in itself constitute a substantial amendment (see section
p.000039: 11).
p.000039: 184. Similarly, the addition to a study of a locality not listed in the original application for HDEC approval does
p.000039: not in itself constitute a substantial amendment, except where it is related to other amendments that are substantial.
p.000039: However, whether or not the addition of a new locality in a study comprises a substantial amendment, applicants must
p.000039: obtain locality authorisation before the study commences at each locality.
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p.000040:
p.000040: 11. Amendments to approved studies
p.000040:
p.000040:
p.000040:
p.000040: Introduction
p.000040: The Government response to the Health Committee’s clinical trials inquiry requires updated SOPs for HDECs to clarify
p.000040: when amendments to approved studies themselves require HDEC review. This section addresses that requirement, while
p.000040: sections 5 and 6 clarify the review pathways by which different types of substantial amendment are to be reviewed.
p.000040: Key changes and clarifications include:
p.000040: • following European clinical trial rules in distinguishing between substantial and non- substantial amendments to
p.000040: approved studies, providing criteria and examples of each
p.000040: • allowing non-substantial amendments to be made to any study at any time without approval from or notification to
p.000040: an HDEC
p.000040: • allowing for HDECs to exercise discretion regarding whether amendments submitted for review meet the test of
p.000040: substantiality.
p.000040: Key changes to this section following consultation include:
p.000040: • requiring amendments to be submitted through the HDECs’ electronic submission system
p.000040: • clarifying that non-substantial amendments may continue to be submitted to HDECs for review
p.000040: • clarifying that responsibility for deciding whether an amendment is substantial rests with the study team as a
p.000040: whole, rather than the CI
p.000040: • confirming that details of documents submitted with amendments will continue to be noted in HDEC letters.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 185. An amendment to an approved study only requires HDEC review if it is substantial. Applicants may make
p.000040: non-substantial (‘minor’) amendments to any approved study at any time without approval from or notification to the
p.000040: HDEC.
p.000040: 186. Applicants must submit all substantial amendments through the HDEC’s online submission system, accompanied by
p.000040: copies of relevant study documents.
p.000040: Definition of ‘substantial amendment’
p.000040: 187. A substantial amendment is an amendment that is likely to affect to a significant degree any of the following:
p.000040: 187.1. the safety or physical or mental integrity of participants
p.000040: 187.2. the scientific value of the study
p.000040: 187.3. the conduct or management of the study
p.000040: 187.4. the quality or safety of any medicine or item used in the study.
p.000040: 188. The following should normally be regarded as substantial amendments:
p.000040:
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p.000041: 41
p.000041:
p.000041: 188.1. significant changes to the design/methodology of the study
p.000041: 188.2. significant changes to the type or number of procedures participants will undertake in the study
p.000041: 188.3. changes relating to the safety of the physical or mental integrity of participants, or to the risk/benefit
p.000041: assessment for the study
p.000041: 188.4. significant changes to the study’s documentation (such as participant information sheets)
p.000041: 188.5. the appointment of a new CI for the study
p.000041: 188.6. any other significant change to the study protocol or the information provided in the application for approval.
p.000041: 189. In themselves, the following should usually be regarded as minor amendments:
p.000041: 189.1. minor or administrative changes to study documentation
p.000041: 189.2. updated versions of the investigator’s brochure (where the study involves a new medicine)
p.000041: 189.3. changes to the research team other than the appointment of a new CI
p.000041: 189.4. changes in funding arrangements, except where these may alter the ability of participants to access publicly
p.000041: funded compensation in the event of injury
p.000041: 189.5. changes in arrangements for recording or analysing study data, or for storing or transporting samples
p.000041: 189.6. extension of the study beyond the expected end date given in the application form, except where this is related
p.000041: to other changes that are substantial.
p.000041: Deciding whether an amendment is substantial
p.000041: 190. In the first instance, it is the responsibility of the study team to decide whether or not a given amendment
p.000041: to a study is substantial. In making this decision, applicants should consider whether the amendment will change the
p.000041: study to a ‘significant degree’. Applicants should take particular account of any implications for the safety or
p.000041: welfare of participants, and of any information that participants might require to give informed consent to continue to
p.000041: participate in the amended research.
p.000041: 191. Where there is doubt as to whether an amendment is substantial, applicants may submit it for review. Where an
p.000041: amendment submitted for review is not validated as substantial, the secretariat should communicate this decision to the
p.000041: CI within two working days. This confirmation must contain details of all documents submitted with the amendment.
p.000041: Review pathways for substantial amendments
p.000041: 192. Substantial amendments to studies reviewed through the expedited review pathway must themselves be reviewed
p.000041: through this pathway. Substantial amendments to studies reviewed through the full review pathway may also be reviewed
p.000041: through expedited review, at the discretion of the chair.
p.000041: Changes in CI
p.000041: 193. The appointment of a new CI for a study is always a substantial amendment.
p.000041:
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p.000042: 42
p.000042:
p.000042: 194. However, where the CI for a study is to be absent for any reason for a period of less than 90 calendar days,
p.000042: any other investigator on the study may act in his or her place during this period. Such interim arrangements are not
p.000042: substantial amendments and do not require HDEC approval. The named CI remains responsible for the conduct of the study
p.000042: while such interim arrangements are in place.
p.000042: 195. The addition of investigators (including lead/principal investigators at particular localities) is not a
p.000042: substantial amendment. This is because the CI himself or herself is responsible to the HDEC for the ethical conduct of
p.000042: the entire research team at all localities.
p.000042: Addition of new localities
p.000042: 196. The addition of new localities to a study is not in itself a substantial amendment. However, the addition of
p.000042: new localities may be related to other amendments that are substantial, such as significant increases in recruitment
p.000042: targets or other significant changes to the study design. Applicants should submit such amendments to an HDEC for
p.000042: review in the normal way.
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p.000043:
p.000043: 12. Post-approval processes
p.000043:
p.000043:
p.000043:
p.000043: Introduction
p.000043: This section sets out the limited role of HDECs in monitoring approved studies, and contains details of the reports and
p.000043: information that applicants need to submit to ensure HDECs can carry out that role.
p.000043: Key changes and clarifications include:
p.000043: • clarifying that, while HDECs must keep approvals under review, responsibility for proactively monitoring a study
p.000043: remains at all times with the CI and sponsor of that study
p.000043: • removing the requirement for researchers to submit individual reports of serious adverse events (SAEs) to HDECs,
p.000043: and replacing it with a requirement that, in the case of intervention studies involving a new medicine, they submit an
p.000043: annual summary of safety information
p.000043: • removing the need for HDEC approval to be reconfirmed following receipt of annual progress reports
p.000043: • clarifying the process to be followed by HDECs in reconsidering the approval in place for a study with a view to
p.000043: suspending or cancelling that approval.
p.000043: Key changes to this section following consultation include:
p.000043: • requiring applicants to submit annual progress reports, final reports, protocol deviations/violations and
p.000043: notifications of conclusion of study through HDECs’ electronic submission system
p.000043: • clarifying that annual progress reports must be submitted at least yearly, to allow for alignment of annual
p.000043: reporting cycles in international studies, and clarifying that summaries of safety information produced for
p.000043: international regulators may serve as annual safety reports
p.000043: • more clearly defining ‘protocol deviation/violation’, and clarifying that the same definition of ‘substantiality’
p.000043: as for amendments applies in deciding whether HDEC review is required in this situation
p.000043: • requiring HDECs to inform CIs within 15 (rather than 20) calendar days of receipt of a document of a decision to
p.000043: reconsider approval for the study on the basis of that document.
p.000043:
p.000043:
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p.000043:
p.000043: Commencement
p.000043: 197. A study commences when any of the procedures set out in its protocol are initiated.
p.000043: 198. Studies should commence within 12 months of the date on which they receive approval from an HDEC, and must
p.000043: commence within 24 months of approval. Where a study has not commenced within 12 months, the CI must give reasons for
p.000043: this in the first annual progress report.
p.000043: 199. Where a study is abandoned before it commences, the CI should notify the HDEC of the conclusion of the study.
p.000043:
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p.000044:
p.000044: Annual progress reports
p.000044: 200. Applicants must submit annual progress reports for all approved studies to the HDEC at least yearly, using
p.000044: HDECs’ electronic submission system. It may be desirable in some cases to submit the first annual progress report
p.000044: early, in order to align with annual reporting cycles for the study in other countries.
p.000044: 201. The HDEC secretariat must acknowledge annual progress reports, then assign them for review through the
p.000044: expedited review pathway. The secretariat must formally notify the full HDEC itself of the receipt of the report
p.000044: through the noting section of the agenda of its next meeting (see section 4).
p.000044: 202. It is not necessary for an HDEC to reconfirm approval for a study following receipt and review of an annual
p.000044: progress report. The presumption is that approval remains valid for the duration of the study, unless the report gives
p.000044: grounds to reconsider approval.
p.000044: 203. The HDEC secretariat should send a reminder to the applicant about one month before an annual progress report
p.000044: is due. Where it does not receive an annual progress report by the due date, it must send a second reminder as soon as
p.000044: possible. Where it does not receive an annual progress report within one month of a second reminder being sent, it may
p.000044: cancel approval for the study. However, the secretariat should make all reasonable efforts to contact the applicant
p.000044: before cancelling approval for a study, and may extend the due date for an annual progress report for up to 90 calendar
p.000044: days from the date of the second reminder letter.
p.000044: 204. Where HDEC approval is cancelled for failure to submit an annual progress report, applicants must submit a new
p.000044: application to reactivate the study.
p.000044:
p.000044: Annual safety reports
p.000044: 205. An annual safety report must be attached to each annual progress report for an intervention study involving a
p.000044: new medicine. While there is no prescribed format for annual safety reports, they must be no longer than two pages in
p.000044: length, written in lay language, and include:
p.000044: 205.1. a brief description and analysis of new and relevant findings that may have a significant impact on the safety
p.000044: of participants
p.000044: 205.2. a brief analysis of the safety profile of the new medicine and its implications for participants, taking into
p.000044: account all safety data as well as the results of any relevant non-clinical studies
p.000044: 205.3. an brief discussion of the implications of safety data to the risk-benefit ratio for the intervention study,
p.000044: and whether study documentation has been or will be updated
p.000044: 205.4. a description of any measures taken or proposed to minimise risks. (Where such a proposed measure would be a
p.000044: substantial amendment, it must be submitted to the HDEC for review in the normal way.)
p.000044: 206. Summaries of safety information such as Development Safety Update Reports may serve as annual safety reports
p.000044: to HDECs provided that they contain the information outlined above. These summaries should usually be accompanied by
p.000044: comment from the CI of the study in New Zealand.
p.000044:
p.000044:
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p.000045: 207. There is no general requirement for applicants to submit individual or expedited reports of SAEs or suspected
p.000045: unexpected serious adverse reactions (SUSARs) to HDECs, who do not have the expertise or resources to review them.
p.000045: Further, annual safety reports should not in any circumstances be accompanied by line listings of global or local SAEs
p.000045: or SUSARs.
p.000045: Urgent safety measures
p.000045: 208. It may sometimes be necessary for investigators to take urgent safety measures in order to protect
p.000045: participants in an intervention study from a significant, immediate hazard to their health or safety. If this occurs
p.000045: the applicant must notify the HDEC immediately and in any case within seven calendar days of taking any such measures.
p.000045: 209. Notifications of urgent safety measures are considered to be a type of amendment, and applicants should submit
p.000045: them as such to the HDEC for review.
p.000045: Temporary halts
p.000045: 210. Where a study is halted temporarily (for example for reasons of participant safety), applicants must notify
p.000045: the HDEC of this as soon as possible but in any case within seven calendar days.
p.000045: 211. Temporary halts are considered to be a type of amendment, and applicants should submit them as such to the
p.000045: HDEC for review. Similarly, the recommencement of a study following a temporary halt is considered to be a type of
p.000045: amendment. If a study that has been temporarily halted concludes or is terminated early, applicants should notify the
p.000045: HDEC in the normal way (see below).
p.000045: Protocol deviations/violations
p.000045: 212. A protocol deviation is any change, divergence or departure from the study design or procedures of a research
p.000045: protocol that is under the investigator’s control and that has not been approved by an HDEC. A protocol violation is a
p.000045: deviation that may affect participants’ rights, safety or well-being, or the completeness, accuracy and reliability of
p.000045: the study data. Deviations/violations may occur without the knowledge or permission of the sponsor or the CI, and may
p.000045: constitute fraud or misconduct.
p.000045: 213. Where a protocol deviation/violation meets the definition of ‘substantial’ set out at section 11 of these
p.000045: SOPs, applicants must submit it to the HDEC for review.
p.000045: 214. As is the case for amendments, it is in the first instance the responsibility of the study team to decide
p.000045: whether a protocol deviation/violation is substantial. Where there is doubt as to whether a protocol
p.000045: deviation/violation is substantial, the study team may submit it to an HDEC. Once validated, an HDEC must review a
p.000045: protocol deviation/violation through the expedited review pathway.
p.000045: 215. Where a protocol deviation/violation is necessary to protect participants from an immediate hazard to their
p.000045: health and safety, the study team should notify the HDEC as an urgent safety measure (see above).
p.000045: 216. Where a protocol deviation/violation is necessary due to errors, omissions or inadequacies in the protocol or
p.000045: other study documents, the sponsor and CI are responsible for making appropriate amendments. If the amendments are
p.000045: substantial,
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p.000046: the HDEC must review and approve them in the normal way before they are implemented.
p.000046: Reconsideration of HDEC approval
p.000046: 217. HDECs should keep all approvals for all studies under review at all times. However, other than by means of the
p.000046: documents applicants are required to submit under this section, HDECs are not themselves responsible for proactively
p.000046: monitoring approved studies. Primary responsibility for such monitoring lies at all times with the study sponsor and
p.000046: the CI.
p.000046: 218. An HDEC may reconsider the approval in place for any study at any time on the basis of information contained
p.000046: in:
p.000046: 218.1. an annual progress report
p.000046: 218.2. a notification of an urgent safety measure or temporary halt of the study
p.000046: 218.3. a substantial protocol violation or deviation
p.000046: 218.4. the cancelation of locality approval for a locality in the study (see section 10)
p.000046: 218.5. any other information received by the HDEC in writing from any party which the chair considers, on reasonable
p.000046: grounds, may give grounds for suspending or cancelling approval.
p.000046: 219. An HDEC may only reconsider approval for a study through the full review pathway. Where the chair considers
p.000046: that one of the documents above may give grounds for suspending or cancelling approval, he or she must place the matter
p.000046: on the agenda of the next meeting of the HDEC (under ‘review of approved studies’). The HDEC must notify the applicant
p.000046: of its intention to reconsider approval, and the reasons for this, and invite them to provide a written response and
p.000046: attend the meeting.
p.000046: 220. Consistent with the fact that the HDEC must review items of business mentioned in this section through the
p.000046: expedited review pathway, an HDEC must notify the applicant of a decision to reconsider approval for a study on the
p.000046: basis of information contained in a document within 15 calendar days of the document’s having been submitted.
p.000046: Suspension or cancelation of HDEC approval
p.000046: 221. Following reconsideration, HDEC approval may be suspended or cancelled due to serious concerns about one or
p.000046: more of the following:
p.000046: 221.1. the health and safety of participants
p.000046: 221.2. the competence or conduct of the CI, sponsor, or other investigator
p.000046: 221.3. the feasibility of the study
p.000046: 221.4. suspension or cancelation of regulatory approval for the study.
p.000046: 222. Letters communicating an HDEC’s decision to suspend or cancel approval for a study must detail:
p.000046: 222.1. whether approval is suspended or cancelled
p.000046: 222.2. the reasons for the suspension or cancellation
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p.000047: 222.3. the date from which approval is suspended or cancelled (which will usually be the date of the letter)
p.000047: 222.4. any action that the HDEC recommends the CI take to inform participants or arrange for their continuing
p.000047: treatment outside the trial protocol
p.000047: 222.5. where approval is suspended: any conditions which must be satisfied before the HDEC will consider lifting the
p.000047: suspension.
p.000047: 223. An HDEC may only take a decision to lift suspension for a previously approved study through the full pathway.
p.000047: Conclusion or early termination of a study
p.000047: 224. The definition of the conclusion of a study should be included in its protocol. In most cases, an intervention
p.000047: study will conclude on the date of the last visit of the last participant, or the completion of any follow-up
p.000047: monitoring and data collection specified in the protocol. Any change to this definition is a substantial amendment
p.000047: requiring HDEC approval.
p.000047: 225. Applicants must notify the HDEC (through the electronic submission system) within 90 calendar days of the
p.000047: conclusion of an approved study, and as soon as possible but within 15 calendar days of the early termination of an
p.000047: approved study.
p.000047: 226. All notifications of conclusion or early termination should be acknowledged and reviewed through the expedited
p.000047: review pathway. No further review is required, unless the reviewing members wish to discuss any matters raised by the
p.000047: report at a meeting of the HDEC (under ‘general business’).
p.000047: 227. There is no requirement for applicants to submit annual progress reports following the conclusion or early
p.000047: termination of a study.
p.000047: Final reports
p.000047: 228. Applicants should submit a summary of the final report of a study to the HDEC within one year of its
p.000047: conclusion or early termination, through the HDECs’ electronic submission system.
p.000047: 229. There is no standard format for final reports. However, they should include information on whether the study
p.000047: achieved its objectives, the main findings and arrangements for the publication or dissemination of results.
p.000047: 230. The secretariat should acknowledge final reports and the HDEC review them through the expedited review
p.000047: pathway. No further action is necessary, unless the chair wishes to discuss any matter arising from information
p.000047: contained in a final report at an HDEC meeting.
p.000047: 231. Where an HDEC does not receive a final report within one year of the conclusion or early termination of a
p.000047: study, the secretariat should send a reminder.
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p.000048: 13. HDEC review of tissue banks
p.000048:
p.000048:
p.000048:
p.000048: Introduction
p.000048: This section provides more detail of the process by which HDECs review application involvement the establishment or
p.000048: maintenance of tissue banks.
p.000048: Key changes to this section following consultation include:
p.000048: • requiring HDEC approval to establish and manage a tissue bank, rather than simply allowing
p.000048: such approval to be applied for
p.000048: • expanding the matters that applicants must address in such applications to include cultural issues.
p.000048:
p.000048:
p.000048:
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p.000048: 232. A tissue bank is a collection of human tissue samples stored for potential use in research beyond the life of
p.000048: a specific research project.
p.000048: 233. The establishment and management of a tissue bank is not research, and it is not necessarily the case that all
p.000048: individual research projects using banked tissue will themselves fall within the scope of HDEC review set out in these
p.000048: SOPs. Nevertheless, organisations responsible for the establishment and management of a research tissue bank are
p.000048: required to apply for HDEC approval for this.
p.000048: Review process for tissue bank application
p.000048: 234. The HDEC must review tissue bank applications through the full review pathway. The relevant provisions of
p.000048: these SOPs therefore apply in full to tissue bank applications, except as modified below.
p.000048: Matters relevant to HDEC review of tissue bank applications
p.000048: 235. Because establishing or managing a tissue bank is not itself research, the established ethical standards for
p.000048: health and disability research do not apply directly to tissue bank applications. HDEC review of tissue bank
p.000048: applications should focus on:
p.000048: 235.1. how the governance arrangements for the tissue bank ensure that robust and appropriate processes are in place
p.000048: for all aspects of tissue storage, management and use
p.000048: 235.2. how consent will be sought from donors9
p.000048: 235.3. how tissue samples will be collected, transported and stored
p.000048: 235.4. how applicants will address cultural issues associated with the storage and use of tissue that may arise for
p.000048: Māori (and other relevant population groups)
p.000048:
p.000048:
p.000048: 9 In this section, ‘donor’ refers to any person who can give consent for the use of tissue for the purposes of the
p.000048: Human Tissue Act 2008.
p.000048:
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p.000049: 235.5. the circumstances in which tissue stored in the tissue bank may be provided to researchers, including:
p.000049: 235.5.1. the types of activity for which tissue may potentially be made available
p.000049: 235.5.2. how the organisation will check that research projects using the tissue bank samples are scientifically
p.000049: valid
p.000049: 235.5.3. any other conditions under which tissue samples will be made available
p.000049: 235.6. where relevant, details of whether and how donors and their relatives will be provided with clinically
p.000049: significant information obtained as a result of research on their tissue.
p.000049: 236. There is no standard application form for tissue bank applications. Applicants should provide information that
p.000049: addresses the matters listed above, in a form and of a nature that is reasonably likely to allow the HDEC that reviews
p.000049: the application to come to a final decision on it at first review.
p.000049: 237. Tissue bank applications must be submitted or authorised by a representative of the tissue bank organisation,
p.000049: and accompanied by copies of any participant information sheets and consent forms to be used in obtaining consent from
p.000049: donors.
p.000049: 238. Where an HDEC has declined approval of a previous application in respect of the same tissue bank, the
p.000049: additional validation criteria in section 4 also apply.
p.000049: Approval conditions
p.000049: 239. HDEC approval for tissue banks is given for a period of ten years, subject to the submission of annual
p.000049: progress reports within the timeframes set out in section 12. Annual progress reports should contain a brief summary of
p.000049: the research projects for which tissue has been made available during the year.
p.000049: 240. Applicants may not make tissue samples available under the terms of a tissue bank approval to any research
p.000049: project that, in the view of the tissue bank organisation:
p.000049: 240.1. is not within the fields of research described in its application to the HDEC, or
p.000049: 240.2. does not comply with the terms of the consent obtained from donors for the use of their tissue in research, or
p.000049: 240.3. has not been subjected to peer review of an appropriate standard, or
p.000049: 240.4. involves the collection of further data or tissue from donors, or any other contact with donors other than
p.000049: where this is necessary in order to communicate clinically significant information.
p.000049: 241. HDEC approval for a tissue bank does not override the need for any study using tissue from the bank that falls
p.000049: within the scope of HDEC review to be reviewed in accordance with these SOPs.
p.000049: Substantial amendments, deviations and violations
p.000049: 242. Changes to any of the matters relevant to HDEC review of tissue bank proposals should normally be considered
p.000049: to be substantial amendments, and submitted for
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p.000050: review in the normal way. Applicants should also notify the HDEC of breaches of approval as protocol
p.000050: deviations/violations where they are substantial.
p.000050: Closure of tissue banks
p.000050: 243. Applicants should notify the HDEC of any intention to close an approved tissue bank, and inform them of
p.000050: arrangements for the disposal of tissue samples or their transfer to another tissue bank.
p.000050: 244. Where tissue samples are transferred to another organisation, HDEC approval of the tissue bank is not
p.000050: transferable.
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p.000051:
p.000051: Glossary and references
p.000051:
p.000051:
p.000051: Glossary
p.000051: ACC Accident Compensation Corporation
p.000051: ACC Act Accident Compensation Act 2001
p.000051: Amendment Any change to the terms of a study, including to the protocol or other supporting
p.000051: documentation, made after an HDEC has approved the study
p.000051: Appeal A review by the HRCEC of the process and/or merits of an HDEC decision that
p.000051: produces a binding decision
p.000051: Applicant The person who submits an application to an HDEC. Where the applicant is not
p.000051: also the CI for the study, the CI must have authorised the application
p.000051: Approval conditions Conditions to be met by an applicant prior to commencement of the study. There are
p.000051: three types of approval condition:
p.000051: standard conditions, which apply to all HDEC approvals
p.000051: minor conditions, which HDECs may impose in giving approval to a study
p.000051: non-minor conditions, which HDECs may impose in giving provisional approval to a study
p.000051: Audit or related activity Has the meaning given to it by the Ethical Guidelines for Observational Studies
p.000051: Calendar day Any day that is not a day between 25 December and 15 January
p.000051: Chair The member of an HDEC appointed to the chair. Where the chair is unavailable
p.000051: for any reason, his or her duties may be performed by any other member of the HDEC, lay or non-lay, at the discretion
p.000051: of the chair
p.000051: Clinical trial An intervention study
p.000051: Commercially sponsored study A clinical trial that is conducted principally for the benefit of the
p.000051: manufacturer or distributor of the medicine or item being trialled. Also known as a ‘form B’ study
p.000051: Co-ordinating investigator (CI) Formerly known as the ‘principal investigator’; the chief investigator of a study in
p.000051: the New Zealand, or the investigator assigned responsibility for the co-ordination of investigators at different
p.000051: centres participating in a multi-centre study. In New Zealand, the CI has primary responsibility for the design and
p.000051: conduct of the study in New Zealand, including compliance with all relevant legal and ethical standards. All
p.000051: applications for HDEC review of a study must be submitted or authorised by the study’s CI
p.000051: Ethical standards Standards for the ethical conduct of health and disability research
p.000051: contained in the Ethical Guidelines for Intervention Studies and the
p.000051: Ethical Guidelines for Observational Studies
p.000051:
p.000051:
p.000051:
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p.000052: 52
p.000052:
p.000052: Ethics committee Health and Disability Ethics Committee (HDEC)
p.000052: Expedited review pathway The HDEC decision-making process set out at section 6 of these SOPs Form A study
p.000052: A clinical trial that is not conducted principally for the benefit of the
p.000052: manufacturer or distributor of the medicine or item being trialled
p.000052: Form B study A clinical trial that is conducted principally for the benefit of the
p.000052: manufacturer or distributor of the medicine or item being trialled
p.000052: Full review pathway The HDEC decision-making process set out at section 5 of these SOPs GCP
p.000052: Guidelines for Good Clinical Practice
p.000052: HDEC Health and Disability Ethics Committee
p.000052: HDEC review The process by which an HDEC checks, in accordance with these SOPs, that a new
p.000052: application (or substantial amendment to a previously approved application) meets or exceeds established ethical
p.000052: standards
p.000052: Health information Has the meaning given to it by the Health Information Privacy Code 1994 HRC
p.000052: Health Research Council
p.000052: HRCEC Health Research Council Ethics Committee
p.000052: Human tissue Has the meaning given to it by the Human Tissue Act 2008
p.000052: ICH International Conference on Harmonisation of Technical Requirements for
p.000052: Registration of Pharmaceuticals for Human Use
p.000052: Intervention study Has the meaning given to it by the Ethical Guidelines for Intervention Studies;
p.000052: namely, a study in which investigators control and study the intervention(s) provided to participants
p.000052: Investigator Any investigator on a study who is not the CI. This includes investigators who
p.000052: are responsible for the conduct of a study at a given locality (or at a site within that locality). A study may have
p.000052: any number of investigators. The CI of a study may also be the lead/principal investigator at one or more localities
p.000052: Investigator’s brochure A document summarising the clinical and other data relating to a new medicine that are
p.000052: relevant to the study of the product in human participants
p.000052: Locality An organisation responsible for a hospital, health centre, surgery or other
p.000052: establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be
p.000052: conducted
p.000052: Locality review The process by which a locality assesses its suitability for the safe and
p.000052: effective conduct of an intervention study
p.000052: Medical device Has the meaning given to it by the Medicines Act 1981 Medicine
p.000052: Has the meaning given to it by the Medicines Act 1981
p.000052: Medsafe New Zealand Medicines and Medical Devices Safety Authority
p.000052: Minor amendment Any amendment to a previously approved study that is not a substantial amendment
p.000052: NEAC National Ethics Advisory Committee
p.000052:
p.000052:
p.000052:
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p.000053: 53
p.000053:
p.000053: New medicine Has the meaning given to it by the Medicines Act 1981
p.000053: Observational research Has the meaning given to it by the Ethical Guidelines for Observational Studies; namely,
p.000053: an observational study that involves participants but in which investigators do not control and study the
p.000053: intervention(s) provided to them, if any
p.000053: Observational study Has the meaning given to it by the Ethical Guidelines for Observational Studies;
p.000053: namely, a study in which investigators do not control and study the intervention(s) provided to participants, if any
p.000053: Participant An individual who actively participates in a study. HDEC review of a study may
p.000053: be required where participants are recruited in their capacity as:
p.000053: consumers of health and disability support services, or
p.000053: relatives or caregivers of such consumers, or
p.000053: healthy volunteers in clinical trials
p.000053: Post-approval item An item of business (such as an amendment, annual progress report, final report,
p.000053: protocol deviation/violation, or notification of conclusion of study) submitted for review following HDEC approval for
p.000053: a study.
p.000053: Principal Investigator (PI) The investigator with primary responsibility for the design and conduct of a study,
p.000053: including compliance with all relevant legal and ethical standards. All applications for ethics committee review of a
p.000053: study must be submitted by its PI.
p.000053: Protocol A document describing the objectives, design, methodology, analysis and
p.000053: organisation of a study
p.000053: Reference number A unique identifier assigned to an application for HDEC review
p.000053: Review clock The timeframe within which an HDEC must give a final opinion on a new application
p.000053: or a substantial amendment to a previously approved application
p.000053: SAE Serious adverse event; an untoward occurrence at any dose that:
p.000053: results in death, or
p.000053: is life-threatening, or
p.000053: requires inpatient hospitalisation or prolongs hospitalisation, or
p.000053: results in a persistent or significant disability or incapacity, or
p.000053: is a congenital anomaly or birth defect
p.000053: SCOTT Standing Committee on Therapeutic Trials; a standing committee of the HRC whose
p.000053: function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section
p.000053: 30 of the Medicines Act 1981
p.000053: Sponsor The person or organisation with responsibility for the initiation, management
p.000053: and financing arrangements of a study
p.000053: Study An intervention study or an observational study
p.000053: Study start Commencement of the procedures set out in the study protocol
p.000053:
p.000053:
p.000053:
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p.000054:
p.000054: Substantial amendment Any amendment to a study that is likely to affect to a significant degree:
p.000054: the safety or physical integrity of participants
p.000054: the scientific value of the study
p.000054: the conduct or management of the study
p.000054: the quality or safety of any medicine or device used in the study
p.000054: SUSAR Suspected unexpected serious adverse reaction; an SAE that is suspected to be
p.000054: linked to the medical product being investigated, and the nature or severity of which is not consistent with the
p.000054: applicable product information (for example as provided in the investigator’s brochure)
p.000054: Tissue bank A collection of human tissue or other biological material derived from humans that
p.000054: is stored for potential use in research beyond the life of a specific research project
p.000054: Validation An administrative check carried out by the HDEC secretariat to verify that an
p.000054: application or other item of business is complete and may be assigned for review through the full or expedited review
p.000054: pathway
p.000054: Working day Any day that is not a Saturday or Sunday, a public holiday (excluding regional
p.000054: anniversary days) or a day between 25 December and 15 January inclusive in any year
p.000054:
p.000054:
p.000054: References
p.000054: Health Research Council of New Zealand. 2008. Guidelines for an Accredited Institutional Ethics Committee to refer
p.000054: Studies to an Accredited Health and Disability Ethics Committee (“Referral Guidelines”). Auckland: Health Research
p.000054: Council. Available online at http://hrc.govt.nz/sites/default/files/Referral%20Guidelines.pdf.
p.000054: Health Research Council of New Zealand. 2010. Guidelines for Researchers on Health Research Involving Māori.
p.000054: Auckland: Health Research Council. Available online at http://hrc.govt.nz/ethics-
p.000054: and-regulatory/applying-ethical-approval/specific-considerations.
p.000054: Ministry of Health. 2006. Operational Standard for Ethics Committees: Updated edition. Wellington: Ministry of
p.000054: Health. Available online through http://www.ethics.health.govt.nz, or
p.000054: http://www.ethicscommittees.health.govt.nz/moh.nsf/pagescm/6777/$File/OperationalStandard20 06.pdf.
p.000054: National Ethics Advisory Committee. 2006. Ethical Guidelines for Observational Studies. Wellington: National
p.000054: Ethics Advisory Committee. Available online at
p.000054: http://www.neac.health.govt.nz/moh.nsf/indexcm/neac-resources-publications-ethicalguidelines.
p.000054: National Ethics Advisory Committee. 2009. Ethical Guidelines for Intervention Studies. Wellington: National
p.000054: Ethics Advisory Committee. Available online at
p.000054: http://www.neac.health.govt.nz/moh.nsf/indexcm/neac-resources-ethical-guidelines-for- intervention-studies.
p.000054:
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p.000006: particular aspects of the study’s design, it should be specific about these.
p.000006: 12. Where a study involves the administration of a new medicine, HDECs can expect issues of scientific validity
p.000006: to have been satisfactorily addressed as part of that study’s being approved by SCOTT under section 30 of the Medicines
p.000006: Act 1981. Accordingly, HDECs may not usually require that additional peer review be carried out in respect of such
p.000006: studies.
p.000006: HDECs do not address locality-specific governance issues.
p.000006: 13. HDEC review concerns ethical issues relating to studies. Localities themselves, rather than HDECs, consider
p.000006: locality-specific research governance issues.
p.000006: 14. It is a standard condition of HDEC approval that locality authorisation, which focusses on these
p.000006: locality-specific research governance issues, be obtained before a study commences at that locality. Section 10
p.000006: describes the locality authorisation process in more detail.
p.000006: HDECs do not provide legal advice.
p.000006: 15. Researchers and sponsors are responsible for ensuring that their health and disability research is conducted
p.000006: lawfully. Where an HDEC suspects that a research proposal is not lawful, it should advise the applicant of its
p.000006: concerns, and may suggest that they seek formal legal advice. However, HDECs are not themselves responsible for
p.000006: providing such legal advice.
p.000006: 16. However, New Zealand law gives HDECs responsibility for decisions that may have legal consequences. Most
p.000006: obviously, the Accident Compensation Act 2001 (the ACC Act) requires HDECs to determine whether publicly funded
p.000006: no-fault compensation will be available to participants injured in a clinical trial. Section 8 explains the statutory
p.000006: role of HDECs under the ACC Act in more detail.
p.000006: HDEC review does not constitute consultation with Māori, or other population groups.
p.000006: 17. Researchers are responsible for ensuring that Māori (and, where relevant, other population groups) are
p.000006: consulted in the development and conduct of studies that are of relevance to them. Where formal consultation with
p.000006: Māori is required by the Guidelines for Researchers on Health Research Involving Māori, HDECs should
p.000006:
p.000006: 1 Ethical Guidelines for Observational Studies, para 5.7, Ethical Guidelines for Intervention Studies, para 5.5.
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p.000007: check that this consultation has been or will be carried out appropriately. However, HDEC review does not constitute
p.000007: or replace such consultation.
p.000007: 18. Localities, rather than HDECs, are responsible for checking that studies appropriately address local cultural
p.000007: issues (including by formal consultation with Māori, where required).
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p.000028: 28
p.000028:
p.000028: 119. For the purposes of the 35- and 15-day review clocks, the date of decision is the date on which the HDEC sends
p.000028: the decision letter.
p.000028: 120. HDECs should formally communicate all decisions on new applications and substantial amendments to applicants
p.000028: within four working days of their being made. This four-day timeframe applies to decisions made at HDEC meetings as
p.000028: well as to decisions made within the expedited review pathway.
p.000028: 121. All decision letters should be in the name of the chair of the HDEC.
p.000028: 122. All decision letters must include the following information:
p.000028: 122.1. a brief summary of the main ethical issues considered by the HDEC in making the decision
p.000028: 122.2. the decision
p.000028: 122.3. a list of study documents, including version numbers and dates
p.000028: 122.4. where the decision was made through the full review pathway: a list of HDEC members, indicating their
p.000028: membership category, whether they were present at the meeting at which the matter was discussed and, if so, whether
p.000028: they declared a potential conflict of interest.
p.000028: 123. Decision letters should not attribute particular comments, questions or concerns to individual HDEC members.
p.000028: Similarly, where a decision was made through the expedited review pathway, decision letters must not reveal the names
p.000028: of the members of the subcommittee involved.
p.000028: Letters communicating a decision to approve
p.000028: 124. In addition to the information specified at paragraph 122, approval letters must confirm:
p.000028: 124.1. that the HDEC operates in accordance with these SOPs and with the principles of international good clinical
p.000028: practice
p.000028: 124.2. whether participants injured as a result of treatment received in the study will be eligible for publicly
p.000028: funded compensation through ACC (see also section 8).
p.000028: Conditions of HDEC approval
p.000028: 125. All HDEC approvals are subject to the following standard conditions.
p.000028: 125.1. Applicants must obtain all necessary regulatory approvals and authorisations before the study commences in New
p.000028: Zealand.
p.000028: 125.2. Applicants must obtain locality authorisation before the study commences at a given locality (see section 10).
p.000028: 125.3. If the study is an intervention study, it must be registered in a clinical trials registry approved by the
p.000028: World Health Organisation before it commences in New Zealand.
p.000028: 126. HDECs may also impose minor conditions on approval. By way of example, such conditions might include minor
p.000028: corrections or changes to study documentation. However, where the changes required would necessitate further ethical
p.000028: consideration (for example, significant or unspecified revision of study documentation), the HDEC
p.000028:
p.000028:
p.000028:
p.000028: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000029: 29
p.000029:
p.000029: should provisionally approve the study and formally review these revisions before giving final approval.
p.000029: 127. The approval letter must clearly state both standard and minor conditions of approval, and applicants must
p.000029: fully meet these in order for HDEC approval to be effective. Until the conditions are met, the study cannot commence
...
p.000030: information requested or conditions imposed. If the requirement is straightforward or administrative, the secretariat
p.000030: may take responsibility for it. However, the chair (and, potentially, other members) should review the response if
p.000030: substantive questions of ethical judgement are likely to arise.
p.000030: 140. Notwithstanding the above, the chair may make a final decision on any provisionally approved application or
p.000030: substantial amendment where he or she believes, on reasonable grounds, that this is necessary to ensure respect for the
p.000030: 35-day review clock. This might be the case, for example, if other members became unavailable at short notice.
p.000030: Authority for considering further information – expedited review
p.000030: 141. Where the expedited review pathway results in a grant of provisional appeal, the subcommittee responsible for
p.000030: the original decision should usually consider any further information submitted. Where this is not possible, the chair
p.000030: (or acting chair) should consider the information and make a final decision.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000031: 31
p.000031:
p.000031: 8. HDECs and the Accident Compensation Act 2001
p.000031:
p.000031:
p.000031:
p.000031: Introduction
p.000031: This section explains the statutory role of HDECs under the Accident Compensation Act 2001 (‘the ACC Act’). This Act
p.000031: excludes participants injured as a result of treatment received as part of some clinical trials from access to
p.000031: compensation through New Zealand’s no-fault compensation scheme.
p.000031: In this section, the role of HDECs is interpreted consistently with the Government response to the Health Committee’s
p.000031: clinical trials inquiry. This response provided that HDECs are not responsible for considering local research
p.000031: governance issues (such as locality-specific insurance and indemnity arrangements).
p.000031: No major changes have been made to this section following consultation.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 142. HDECs have two roles with regard to compensation arrangements for participants who are injured as a result of
p.000031: treatment given as part of an intervention study. These roles derive from the ACC Act.
p.000031: Determining the principal benefactor of the study
p.000031: 143. First, HDECs must determine whether the intervention study is to be conducted principally for the benefit of
p.000031: the manufacturer or distributor of the medicine or item being trialled. Such studies are often referred to simply as
p.000031: commercially sponsored (or ‘form B’) studies, since the relevant manufacturer or distributor will normally (but not
p.000031: necessarily) also be the study’s sponsor.
p.000031: 144. The provision of financial or material support alone is not determinative of whether a study is conducted
p.000031: principally for the benefit of a particular manufacturer or distributor. In making this determination, HDECs should
p.000031: ask:
p.000031: 144.1. who is initiating the study?
p.000031: 144.2. who is designing and planning the research questions that the study will ask?
p.000031: 144.3. will the CI or other investigators receive remuneration from the manufacturer or distributor?
p.000031: 144.4. is the manufacturer or distributor putting any unreasonable restrictions or delays on the timely publication of
p.000031: the results of the study?
p.000031: 144.5. is the manufacturer or distributor providing any funding or materials for the study?
p.000031: If the study is ‘commercially sponsored’, checking that compensation would be available to at least ACC-equivalent
p.000031: standard
p.000031: 145. Section 32 of the ACC Act provides that participants injured as a result of treatment given as part of
p.000031: ‘commercially sponsored’ intervention studies are not eligible for publicly funded compensation through ACC.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000032: 32
p.000032:
p.000032: 146. Investigators and sponsors of ‘commercially sponsored’ intervention studies are therefore responsible for
p.000032: ensuring that compensation for such injuries would be available to at least ACC-equivalent standard.8 HDECs are
p.000032: responsible for checking that such arrangements are in place.
p.000032: 147. In so checking, HDECs are not expected or resourced to undertake detailed expert scrutiny of insurance
p.000032: policies held by the sponsor or any other parties to a ‘commercially sponsored’ intervention study, or to examine the
p.000032: indemnity agreements that may exist between them and localities. HDECs can expect to rely on localities to ensure that
p.000032: these arrangements are robust and appropriate.
p.000032: 148. Given the limited information and resources available to them, and the complexity of determining entitlements
p.000032: under the ACC scheme, HDECs should interpret ACC- equivalence in terms of parity of entitlements available.
p.000032: 149. As evidence that ACC-equivalent compensation would be available, it will be sufficient for HDECs to be
p.000032: provided with copies of the following documents:
p.000032: 149.1. in the case of the CI: evidence of appropriate professional indemnity, for example through membership of the
p.000032: Medical Protection Society
...
p.000037: study in question. This involves checking that:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000038: 38
p.000038:
p.000038: 175.1. the lead/principal investigator(s) at the locality is/are suitably qualified, experienced, registered and
p.000038: indemnified to take professional responsibility (under the direction of the CI) for the conduct of the study at the
p.000038: locality
p.000038: 175.2. the locality’s physical facilities are adequate for the conduct of the study
p.000038: 175.3. conducting the study at the locality would have no adverse effect on the provision of publicly funded health
p.000038: care at that locality
p.000038: 175.4. applicants have taken reasonable steps (particularly consultation with Māori, where appropriate) to ensure that
p.000038: they have identified and adequately addressed local cultural issues that may arise from the study
p.000038: 175.5. appropriate arrangements are in place for notifying other relevant local health or social care staff about the
p.000038: study, and for making available any extra support that might be required by participants
p.000038: 175.6. appropriate arrangements are in place for providing information to potential participants in the study who may
p.000038: not adequately understand information in English
p.000038: 175.7. applicants have included relevant locality-specific information and contact details in the local version of the
p.000038: participant information sheet and consent form
p.000038: 175.8. where participants injured as a result of treatment received as part of the study will not have access to ACC
p.000038: (see section 8):
p.000038: 175.8.1. members of the local research team hold appropriate professional indemnities, and
p.000038: 175.8.2. the locality itself understands the potential liabilities that may arise for it as a result of taking part
p.000038: in the study (for example, through the use of formal contracts and indemnity and compensation agreements, such as those
p.000038: developed by the New Zealand Association of Clinical Research), and has the ability to meet these liabilities
p.000038: 175.9. where the study involves the administration of a new medicine to participants who are in residence at sites
p.000038: within the locality, these sites are registered with Medsafe’s Clinical Trial Site Self-Certification scheme.
p.000038: 176. The checks above are not intended to be exhaustive, or to limit the ability of localities to implement more
p.000038: detailed research governance processes that require additional information and assurances from sponsors and CIs.
p.000038: Locality authorisation is a standard condition of HDEC approval
p.000038: 177. Locality authorisation is a standard condition of HDEC approval for the conduct of a study at a given
p.000038: locality. Once applicants have obtained HDEC approval for a study, and locality authorisation for the locality in which
p.000038: that study is to be conducted, the study may commence immediately. There is no need for the outcome of each locality
p.000038: review to be notified to the HDEC, or for the HDEC to confirm its approval for each locality.
p.000038: 178. Applicants must record locality authorisations in the electronic application system for HDEC review, allowing
p.000038: HDECs access to this information if they require.
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p.000030: may take responsibility for it. However, the chair (and, potentially, other members) should review the response if
p.000030: substantive questions of ethical judgement are likely to arise.
p.000030: 140. Notwithstanding the above, the chair may make a final decision on any provisionally approved application or
p.000030: substantial amendment where he or she believes, on reasonable grounds, that this is necessary to ensure respect for the
p.000030: 35-day review clock. This might be the case, for example, if other members became unavailable at short notice.
p.000030: Authority for considering further information – expedited review
p.000030: 141. Where the expedited review pathway results in a grant of provisional appeal, the subcommittee responsible for
p.000030: the original decision should usually consider any further information submitted. Where this is not possible, the chair
p.000030: (or acting chair) should consider the information and make a final decision.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000031: 31
p.000031:
p.000031: 8. HDECs and the Accident Compensation Act 2001
p.000031:
p.000031:
p.000031:
p.000031: Introduction
p.000031: This section explains the statutory role of HDECs under the Accident Compensation Act 2001 (‘the ACC Act’). This Act
p.000031: excludes participants injured as a result of treatment received as part of some clinical trials from access to
p.000031: compensation through New Zealand’s no-fault compensation scheme.
p.000031: In this section, the role of HDECs is interpreted consistently with the Government response to the Health Committee’s
p.000031: clinical trials inquiry. This response provided that HDECs are not responsible for considering local research
p.000031: governance issues (such as locality-specific insurance and indemnity arrangements).
p.000031: No major changes have been made to this section following consultation.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 142. HDECs have two roles with regard to compensation arrangements for participants who are injured as a result of
p.000031: treatment given as part of an intervention study. These roles derive from the ACC Act.
p.000031: Determining the principal benefactor of the study
p.000031: 143. First, HDECs must determine whether the intervention study is to be conducted principally for the benefit of
p.000031: the manufacturer or distributor of the medicine or item being trialled. Such studies are often referred to simply as
p.000031: commercially sponsored (or ‘form B’) studies, since the relevant manufacturer or distributor will normally (but not
p.000031: necessarily) also be the study’s sponsor.
p.000031: 144. The provision of financial or material support alone is not determinative of whether a study is conducted
p.000031: principally for the benefit of a particular manufacturer or distributor. In making this determination, HDECs should
p.000031: ask:
p.000031: 144.1. who is initiating the study?
p.000031: 144.2. who is designing and planning the research questions that the study will ask?
p.000031: 144.3. will the CI or other investigators receive remuneration from the manufacturer or distributor?
...
p.000037: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000038: 38
p.000038:
p.000038: 175.1. the lead/principal investigator(s) at the locality is/are suitably qualified, experienced, registered and
p.000038: indemnified to take professional responsibility (under the direction of the CI) for the conduct of the study at the
p.000038: locality
p.000038: 175.2. the locality’s physical facilities are adequate for the conduct of the study
p.000038: 175.3. conducting the study at the locality would have no adverse effect on the provision of publicly funded health
p.000038: care at that locality
p.000038: 175.4. applicants have taken reasonable steps (particularly consultation with Māori, where appropriate) to ensure that
p.000038: they have identified and adequately addressed local cultural issues that may arise from the study
p.000038: 175.5. appropriate arrangements are in place for notifying other relevant local health or social care staff about the
p.000038: study, and for making available any extra support that might be required by participants
p.000038: 175.6. appropriate arrangements are in place for providing information to potential participants in the study who may
p.000038: not adequately understand information in English
p.000038: 175.7. applicants have included relevant locality-specific information and contact details in the local version of the
p.000038: participant information sheet and consent form
p.000038: 175.8. where participants injured as a result of treatment received as part of the study will not have access to ACC
p.000038: (see section 8):
p.000038: 175.8.1. members of the local research team hold appropriate professional indemnities, and
p.000038: 175.8.2. the locality itself understands the potential liabilities that may arise for it as a result of taking part
p.000038: in the study (for example, through the use of formal contracts and indemnity and compensation agreements, such as those
p.000038: developed by the New Zealand Association of Clinical Research), and has the ability to meet these liabilities
p.000038: 175.9. where the study involves the administration of a new medicine to participants who are in residence at sites
p.000038: within the locality, these sites are registered with Medsafe’s Clinical Trial Site Self-Certification scheme.
p.000038: 176. The checks above are not intended to be exhaustive, or to limit the ability of localities to implement more
p.000038: detailed research governance processes that require additional information and assurances from sponsors and CIs.
p.000038: Locality authorisation is a standard condition of HDEC approval
p.000038: 177. Locality authorisation is a standard condition of HDEC approval for the conduct of a study at a given
p.000038: locality. Once applicants have obtained HDEC approval for a study, and locality authorisation for the locality in which
p.000038: that study is to be conducted, the study may commence immediately. There is no need for the outcome of each locality
p.000038: review to be notified to the HDEC, or for the HDEC to confirm its approval for each locality.
p.000038: 178. Applicants must record locality authorisations in the electronic application system for HDEC review, allowing
p.000038: HDECs access to this information if they require.
p.000038:
p.000038:
p.000038:
p.000038: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000039: 39
p.000039:
p.000039: 179. Locality review and authorisation may occur at any stage of the HDEC review process. However, it is generally
p.000039: desirable that it occur at the same time as or as close as possible to HDEC review.
p.000039: Cancellation of locality authorisation
p.000039: 180. Any locality may cancel locality authorisation for any study at any time at its sole discretion. If this
p.000039: occurs, the study may continue at all other localities for which applicants have obtained locality authorisation.
p.000039: 181. Where a locality cancels authorisation for reasons that may give the HDEC grounds to reconsider the approval
p.000039: in place for the study as a whole (in accordance with section 12), the locality should notify the HDEC of this as soon
p.000039: as possible.
p.000039: 182. There is no requirement for applicants to notify the HDEC of the routine closure of localities (or any sites
p.000039: within localities) used in a study. However, they must notify the HDEC of the conclusion or early termination of the
p.000039: study as a whole in New Zealand, in accordance with section 12.
p.000039: Appointment of a new lead/principal investigator at a locality, or addition of new localities
p.000039: 183. The suitability of the lead/principal investigator(s) at a locality is a matter that is relevant to locality
p.000039: review. Localities should therefore conduct locality review again when a new lead/principal investigator is appointed,
p.000039: as soon as practical in the circumstances. There will usually be no need in such cases to notify the HDEC, since the
...
p.000040: 187.2. the scientific value of the study
p.000040: 187.3. the conduct or management of the study
p.000040: 187.4. the quality or safety of any medicine or item used in the study.
p.000040: 188. The following should normally be regarded as substantial amendments:
p.000040:
p.000040:
p.000040:
p.000040: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000041: 41
p.000041:
p.000041: 188.1. significant changes to the design/methodology of the study
p.000041: 188.2. significant changes to the type or number of procedures participants will undertake in the study
p.000041: 188.3. changes relating to the safety of the physical or mental integrity of participants, or to the risk/benefit
p.000041: assessment for the study
p.000041: 188.4. significant changes to the study’s documentation (such as participant information sheets)
p.000041: 188.5. the appointment of a new CI for the study
p.000041: 188.6. any other significant change to the study protocol or the information provided in the application for approval.
p.000041: 189. In themselves, the following should usually be regarded as minor amendments:
p.000041: 189.1. minor or administrative changes to study documentation
p.000041: 189.2. updated versions of the investigator’s brochure (where the study involves a new medicine)
p.000041: 189.3. changes to the research team other than the appointment of a new CI
p.000041: 189.4. changes in funding arrangements, except where these may alter the ability of participants to access publicly
p.000041: funded compensation in the event of injury
p.000041: 189.5. changes in arrangements for recording or analysing study data, or for storing or transporting samples
p.000041: 189.6. extension of the study beyond the expected end date given in the application form, except where this is related
p.000041: to other changes that are substantial.
p.000041: Deciding whether an amendment is substantial
p.000041: 190. In the first instance, it is the responsibility of the study team to decide whether or not a given amendment
p.000041: to a study is substantial. In making this decision, applicants should consider whether the amendment will change the
p.000041: study to a ‘significant degree’. Applicants should take particular account of any implications for the safety or
p.000041: welfare of participants, and of any information that participants might require to give informed consent to continue to
p.000041: participate in the amended research.
p.000041: 191. Where there is doubt as to whether an amendment is substantial, applicants may submit it for review. Where an
p.000041: amendment submitted for review is not validated as substantial, the secretariat should communicate this decision to the
p.000041: CI within two working days. This confirmation must contain details of all documents submitted with the amendment.
p.000041: Review pathways for substantial amendments
p.000041: 192. Substantial amendments to studies reviewed through the expedited review pathway must themselves be reviewed
p.000041: through this pathway. Substantial amendments to studies reviewed through the full review pathway may also be reviewed
p.000041: through expedited review, at the discretion of the chair.
p.000041: Changes in CI
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p.000010: 27.3.2. health information will not be disclosed to researchers in a form that:
p.000010: 27.3.3. could identify, or could reasonably be expected to identify, the individual(s) concerned, or
p.000010: 27.3.4. would allow for the information to be matched with other data sets (for example, through the use of
p.000010: non-encrypted identifiers such as National Health Index numbers).
p.000010: Exemptions to main criteria
p.000010: 28. Studies on low-risk devices: A study involving a medical device does not require HDEC review if the device is
p.000010: (or would be) classified as a low-risk (class I) medical device by Australia’s Therapeutic Goods Administration (TGA).2
p.000010: 29. Minimal-risk observational studies: An observational study requires HDEC review only if the study involves
p.000010: more than minimal risk (that is, potential participants could reasonably be expected to regard the probability and
p.000010: magnitude of possible harms resulting from their participation in the study to be greater than those encountered in
p.000010: those aspects of their everyday life that relate to the study).
p.000010: 30. For the avoidance of doubt, an observational study always involves more than minimal risk if it involves one
p.000010: or more of the following:
p.000010: 30.1. one or more participants who will not have given informed consent to participate, or
p.000010: 30.2. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000010: decisions about their participation in the study),3 or
p.000010:
p.000010:
p.000010: 2 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
p.000010: Australian regulatory guidelines for medical devices, available from the TGA’s website at
p.000010: http://tga.gov.au/pdf/devices-argmd.pdf.
p.000010:
p.000010:
p.000010:
p.000010: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000011: 11
p.000011:
p.000011: 30.3. standard treatment being withheld from one or more participants, or
p.000011: 30.4. the storage, preservation or use of human tissue without consent, or
p.000011: 30.5. the disclosure of health information without authorisation.
p.000011: 31. Audits and related activities: An audit or related activity requires HDEC review only if it involves the use,
p.000011: collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at
p.000011: section 20(f) of the Human Tissue Act 2008 and Right 7(10)(c) of the Code of Health and Disability Services Consumers’
p.000011: Rights 1996).
p.000011: 32. Student-led research: From 1 January 2013, a study conducted wholly or principally for the purposes of an
p.000011: educational qualification requires HDEC review only if it:
p.000011: 32.1. is an intervention study, or
p.000011: 32.2. is not conducted at or below Master’s level.
p.000011:
...
p.000016: interventions
p.000016: • clarifying that HDECs should allow at least 30 minutes for discussion of new applications
p.000016: • providing for researchers to attend HDEC meetings with other parties involved in the study, such as
p.000016: representatives of sponsors or localities.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: What is the full review pathway, and what should be reviewed by it?
p.000016: 49. The full review pathway involves an HDEC reviewing a new application, substantial amendment or other item of
p.000016: business at a meeting held in accordance with the provisions set out in this section.
p.000016:
p.000016:
p.000016: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000017: 17
p.000017:
p.000017: 50. The full review pathway is appropriate for any intervention or observational study that is within the scope
p.000017: of HDEC review and that involves one or more of the following:
p.000017: 50.1. a new medicine (as defined by the Medicines Act 1981), or
p.000017: 50.2. an approved medicine being used for a new indication or through a new mode of administration, or
p.000017: 50.3. a medical device that is or would be classified as a class IIb, class III or active implantable medical device
p.000017: by the TGA,6 or
p.000017: 50.4. a new surgical intervention, or
p.000017: 50.5. one or more participants who will not have given informed consent to participate, or
p.000017: 50.6. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000017: decisions about their participation in the study),7 or
p.000017: 50.7. standard treatment being withheld from one or more participants, or
p.000017: 50.8. the storage, preservation or use of human tissue without consent.
p.000017: 51. Full review is also appropriate for substantial amendments to previously approved studies that were
p.000017: themselves reviewed by this pathway. However, the chair of an HDEC may direct that the HDEC review any such amendments
p.000017: through the expedited review pathway.
p.000017: Natural justice
p.000017: 52. As public administrative bodies, HDECs must act in accordance with the principles of natural justice. In
p.000017: particular, they must ensure that:
p.000017: 52.1. their decision-making is impartial and transparent, following the processes defined by these SOPs, and
p.000017: 52.2. they give applicants fair opportunity to be heard and to hear the deliberations of the HDEC.
p.000017: Meeting dates and cut-off dates
p.000017: 53. HDECs must make public the dates, times and locations of HDEC meetings sufficiently in advance to give
p.000017: interested members of the public a reasonable chance to organise their attendance as observers.
p.000017: 54. HDECs must also clearly publicise, for each meeting, the last date on which applications and substantial
p.000017: amendments may be received for consideration at that meeting (the ‘cut-off date’). The cut-off date may not be more
p.000017: than 12 calendar days before the date of the meeting.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 6 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
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p.000044: 201. The HDEC secretariat must acknowledge annual progress reports, then assign them for review through the
p.000044: expedited review pathway. The secretariat must formally notify the full HDEC itself of the receipt of the report
p.000044: through the noting section of the agenda of its next meeting (see section 4).
p.000044: 202. It is not necessary for an HDEC to reconfirm approval for a study following receipt and review of an annual
p.000044: progress report. The presumption is that approval remains valid for the duration of the study, unless the report gives
p.000044: grounds to reconsider approval.
p.000044: 203. The HDEC secretariat should send a reminder to the applicant about one month before an annual progress report
p.000044: is due. Where it does not receive an annual progress report by the due date, it must send a second reminder as soon as
p.000044: possible. Where it does not receive an annual progress report within one month of a second reminder being sent, it may
p.000044: cancel approval for the study. However, the secretariat should make all reasonable efforts to contact the applicant
p.000044: before cancelling approval for a study, and may extend the due date for an annual progress report for up to 90 calendar
p.000044: days from the date of the second reminder letter.
p.000044: 204. Where HDEC approval is cancelled for failure to submit an annual progress report, applicants must submit a new
p.000044: application to reactivate the study.
p.000044:
p.000044: Annual safety reports
p.000044: 205. An annual safety report must be attached to each annual progress report for an intervention study involving a
p.000044: new medicine. While there is no prescribed format for annual safety reports, they must be no longer than two pages in
p.000044: length, written in lay language, and include:
p.000044: 205.1. a brief description and analysis of new and relevant findings that may have a significant impact on the safety
p.000044: of participants
p.000044: 205.2. a brief analysis of the safety profile of the new medicine and its implications for participants, taking into
p.000044: account all safety data as well as the results of any relevant non-clinical studies
p.000044: 205.3. an brief discussion of the implications of safety data to the risk-benefit ratio for the intervention study,
p.000044: and whether study documentation has been or will be updated
p.000044: 205.4. a description of any measures taken or proposed to minimise risks. (Where such a proposed measure would be a
p.000044: substantial amendment, it must be submitted to the HDEC for review in the normal way.)
p.000044: 206. Summaries of safety information such as Development Safety Update Reports may serve as annual safety reports
p.000044: to HDECs provided that they contain the information outlined above. These summaries should usually be accompanied by
p.000044: comment from the CI of the study in New Zealand.
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000045: 45
p.000045:
p.000045: 207. There is no general requirement for applicants to submit individual or expedited reports of SAEs or suspected
p.000045: unexpected serious adverse reactions (SUSARs) to HDECs, who do not have the expertise or resources to review them.
p.000045: Further, annual safety reports should not in any circumstances be accompanied by line listings of global or local SAEs
p.000045: or SUSARs.
p.000045: Urgent safety measures
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000013: 37. Only one application may be submitted in relation to a study, including, generally, those that entail
p.000013: separate protocols governing sub-studies in addition to the main study. Applicants who intend to conduct related
p.000013: studies that are substantially similar to each other (for instance, studies that involve the administration of the same
p.000013: intervention for different indications) should contact the HDEC secretariat prior to submission to discuss how best to
p.000013: proceed.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000014: 14
p.000014:
p.000014: 38. Where an application will be reviewed by the full review pathway, the applicant may indicate at the time of
p.000014: submission that they would prefer their application to be considered by the closest possible HDEC (that is, the HDEC
p.000014: that meets closest to the address given by the CI in the application). Where such a preference has not been indicated,
p.000014: applications will be allocated for review to the next available HDEC meeting.
p.000014: Validation of new applications
p.000014: 39. HDECs must assign all new applications and substantial amendments a unique identifier (an ‘HDEC reference
p.000014: number’) upon submission. The secretariat must then validate applications before assigning them to an HDEC for review.
p.000014: 40. The HDEC secretariat may validate a new application only if:
p.000014: 40.1. the application is within the scope of HDEC review, and
p.000014: 40.2. the application is not similar enough to another application that it would be more appropriate for a single
p.000014: application to be made in respect of both studies, or for the application to be dealt with as a substantial amendment
p.000014: to an approved study, and
p.000014: 40.3. all relevant questions in the application form have been answered in a manner that is reasonably likely to
p.000014: allow the HDEC to make a final decision on the application the first time it is considered, and
p.000014: 40.4. the application is accompanied by the following mandatory documents:
p.000014: 40.4.1. a study protocol
p.000014: 40.4.2. a brief CV for the CI
p.000014: 40.4.3. in the case of studies that do not involve a new medicine, evidence of favourable peer review4
p.000014: 40.4.4. in the case of studies involving a new medicine, an investigator’s brochure
p.000014: 40.4.5. in the case of studies involving participants, a participation information sheet and consent form
p.000014: 40.4.6. in the case of studies involving the administration of surveys or questionnaires, copies of the surveys or
p.000014: questionnaires
p.000014: 40.4.7. in the case of ‘commercially sponsored’ studies (see section 9), evidence of the insurance held by the
p.000014: study sponsor and evidence of the professional indemnity held by the CI
p.000014: 40.4.8. in the case of studies where a previous application for the same study (or a substantially similar study)
p.000014: has been declined by an HDEC, a copy of the letter from the HDEC declining the previous application and a covering
p.000014: letter from the CI explaining how the new application addresses the reasons given by the HDEC to decline.
p.000014: 41. Applicants may attach other documents to their application at their discretion. This should normally include
p.000014: other written information to be provided to participants in the
p.000014:
...
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p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000036: 36
p.000036:
p.000036: 10. Locality authorisation
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Introduction
p.000036: The Government’s response to the Health Committee’s clinical trials report requires updated SOPs for HDECs to clarify
p.000036: that localities (such as district health boards (DHBs)), rather than HDECs, are responsible for checking local
p.000036: governance issues that may arise from the conduct of a study at a given locality. This section addresses that
p.000036: requirement. It replaces the current ‘locality assessment’ process described at section 7 of the Operational Standard
p.000036: for Ethics Committees.
p.000036: Key changes and clarifications include:
p.000036: • defining ‘locality’ more narrowly, to include only a subset of the organisations involved in the conduct of
p.000036: studies
p.000036: • making the DHB the natural unit for locality review within the public health system
p.000036: • allowing one locality review to cover multiple sites (for example hospitals or departments) within a single
p.000036: locality
p.000036: • clarifying and expanding the issues relevant to locality review; for example, to include issues relevant to a
p.000036: locality’s ability to meet its potential liabilities in intervention studies for which compensation is not available
p.000036: under the ACC Act.
p.000036: Key changes to this section following consultation include:
p.000036: • expanding the definition of ‘locality’ to include organisations involved in the conduct of observational studies
p.000036: (while recognising that not all such studies will involve localities)
p.000036: • clarifying that the study team as a whole (rather than the study sponsor) is responsible for ensuring that
p.000036: locality review is conducted by the appropriate individuals at a locality
p.000036: • more clearly requiring that a locality’s chief executive officer authorise the person completing a locality
p.000036: review
p.000036: • requiring locality review to be conducted afresh as soon as possible, rather than immediately following a change
p.000036: of the lead/principal investigator at a particular locality.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: HDEC approval and locality authorisation are separate processes
p.000036: 165. HDEC review is the process by which an HDEC checks that a study meets or exceeds established ethical
p.000036: standards. If an HDEC is satisfied that this is the case, it approves the study.
p.000036: 166. Locality review is the process by which a locality assesses its suitability for the safe and effective conduct
p.000036: of a study. If a locality is satisfied that this is the case, it authorises the study.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000036: that localities (such as district health boards (DHBs)), rather than HDECs, are responsible for checking local
p.000036: governance issues that may arise from the conduct of a study at a given locality. This section addresses that
p.000036: requirement. It replaces the current ‘locality assessment’ process described at section 7 of the Operational Standard
p.000036: for Ethics Committees.
p.000036: Key changes and clarifications include:
p.000036: • defining ‘locality’ more narrowly, to include only a subset of the organisations involved in the conduct of
p.000036: studies
p.000036: • making the DHB the natural unit for locality review within the public health system
p.000036: • allowing one locality review to cover multiple sites (for example hospitals or departments) within a single
p.000036: locality
p.000036: • clarifying and expanding the issues relevant to locality review; for example, to include issues relevant to a
p.000036: locality’s ability to meet its potential liabilities in intervention studies for which compensation is not available
p.000036: under the ACC Act.
p.000036: Key changes to this section following consultation include:
p.000036: • expanding the definition of ‘locality’ to include organisations involved in the conduct of observational studies
p.000036: (while recognising that not all such studies will involve localities)
p.000036: • clarifying that the study team as a whole (rather than the study sponsor) is responsible for ensuring that
p.000036: locality review is conducted by the appropriate individuals at a locality
p.000036: • more clearly requiring that a locality’s chief executive officer authorise the person completing a locality
p.000036: review
p.000036: • requiring locality review to be conducted afresh as soon as possible, rather than immediately following a change
p.000036: of the lead/principal investigator at a particular locality.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: HDEC approval and locality authorisation are separate processes
p.000036: 165. HDEC review is the process by which an HDEC checks that a study meets or exceeds established ethical
p.000036: standards. If an HDEC is satisfied that this is the case, it approves the study.
p.000036: 166. Locality review is the process by which a locality assesses its suitability for the safe and effective conduct
p.000036: of a study. If a locality is satisfied that this is the case, it authorises the study.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000037: 37
p.000037:
p.000037: What is a locality?
p.000037: 167. For the purposes of these SOPs, a locality is an organisation responsible for a hospital, health centre,
p.000037: surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a
p.000037: study are to be conducted.
p.000037: 168. Almost all intervention studies and many observational studies will involve at least one locality.
p.000037: 169. Localities for studies within the New Zealand public health system will usually be DHBs. Examples of
p.000037: localities outside the public health system may include:
p.000037: 169.1. academic institutions (such as universities)
p.000037: 169.2. private companies (such as clinical trial units)
p.000037: 169.3. private hospitals or clinical practices
p.000037: 169.4. other health and disability research centres.
p.000037: 170. The following are not localities:
p.000037: 170.1. clinicians, clinical units or other organisations making referrals to a research team
p.000037: 170.2. clinicians, clinical units or other organisations involved only in identifying potential participants or
p.000037: facilitating recruitment by the research team, and not responsible for informed consent or any other procedures set out
p.000037: in the study protocol
p.000037: 170.3. research units undertaking support functions such as project management, site monitoring, data analysis or
p.000037: report writing.
p.000037: 171. Where a study will be conducted at more than one site within the same locality (for example, at multiple
p.000037: hospitals within the same DHB), locality review should be carried out just once to cover all sites within that
p.000037: locality.
p.000037: 172. Where a third party under contract to a locality is to undertake any procedures outlined in the protocol of a
p.000037: study, issues specific to the third party should be considered as part of the locality review.
p.000037: Who should complete locality review?
p.000037: 173. Locality review must be completed by either:
p.000037: 173.1. the locality’s chief executive officer, or
p.000037: 173.2. an individual to whom the chief executive officer has delegated responsibility for conducting locality review.
p.000037: 174. It is not the role of the HDEC to ensure that the person who carries out locality review has been
p.000037: appropriately authorised to do so. This is the responsibility of the study team of the study in question.
p.000037: Issues relevant to locality review
p.000037: 175. The central issue relevant to locality review is its suitability for the safe and effective conduct of the
p.000037: study in question. This involves checking that:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000038: 38
p.000038:
p.000038: 175.1. the lead/principal investigator(s) at the locality is/are suitably qualified, experienced, registered and
p.000038: indemnified to take professional responsibility (under the direction of the CI) for the conduct of the study at the
p.000038: locality
p.000038: 175.2. the locality’s physical facilities are adequate for the conduct of the study
p.000038: 175.3. conducting the study at the locality would have no adverse effect on the provision of publicly funded health
p.000038: care at that locality
p.000038: 175.4. applicants have taken reasonable steps (particularly consultation with Māori, where appropriate) to ensure that
p.000038: they have identified and adequately addressed local cultural issues that may arise from the study
p.000038: 175.5. appropriate arrangements are in place for notifying other relevant local health or social care staff about the
p.000038: study, and for making available any extra support that might be required by participants
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000003: - how HDEC decisions may be challenged, and by whom (section 9)
p.000003: - the distinct role of localities in addressing local research governance issues (section 10)
p.000003: - HDEC review of amendments to approved studies (section 11)
p.000003: - the role of HDECs in monitoring approved studies, and the process for suspending or cancelling approval (section
p.000003: 12)
p.000003: - HDEC review of arrangements for establishing and managing tissue banks (section 13).
p.000003: Procedural guidance, not ethical standards
p.000003: 3. These SOPs contain procedural guidance on the HDEC review process. They do not set out the established
p.000003: ethical standards that must be met or exceeded in all health and disability research, regardless of whether or not HDEC
p.000003: review is required. These
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000004: 4
p.000004:
p.000004: ethical standards are set out in guidelines authored by the National Ethics Advisory Committee (NEAC), namely:
p.000004: - the Ethical Guidelines for Observational Studies and
p.000004: - the Ethical Guidelines for Intervention Studies.
p.000004: 4. For the avoidance of doubt, these SOPs do not in any way affect the rights of participants in health and
p.000004: disability research, including by way of example and without limitation rights under the:
p.000004: - Protection of Personal and Property Rights Act 1988
p.000004: - New Zealand Bill of Rights Act 1990
p.000004: - Privacy Act 1993
p.000004: - Health and Disability Commissioner Act 1994
p.000004: - Accident Compensation Act 2001
p.000004: - Human Tissue Act 2008
p.000004: - Treaty of Waitangi.
p.000004:
p.000004: Application
p.000004: 5. These SOPs come into force on 1 July 2012, and apply in full to all applications for HDEC review submitted
p.000004: on or after that date. They supersede all other process guidance for HDECs, including that contained in the Operational
p.000004: Standard for Ethics Committees.
p.000004: 6. Similarly, from 1 July 2012 the SOPs apply in full to all studies approved prior to 1 July 2012. They
p.000004: supersede all other process guidance for such studies, including that contained in the Operational Standard for Ethics
p.000004: Committees and approval letters. However, review timelines for amendments and other ‘post-approval’ items for studies
p.000004: approved prior to 1 July 2012 do not apply where these items are submitted other than through the HDECs’ online
p.000004: application system
p.000004:
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p.000004:
p.000004:
p.000004: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000005: 5
p.000005:
p.000005: 2. The role of HDECs
p.000005:
p.000005:
p.000005:
...
Social / Student
Searching for indicator student:
(return to top)
p.000008: relatives of consumers, or volunteers in early-phase clinical trials (for instance, health professionals or members of
p.000008: the general public)
p.000008: • involve the use of existing anonymised human tissue samples with consent
p.000008: • involve low-risk (class I) medical devices
p.000008: • are audits or related studies (except where HDEC review is required by law)
p.000008: • are observational studies that do not involve more than minimal risk
p.000008: • are to be conducted wholly or principally for the purposes of an educational qualification, in some
p.000008: circumstances.
p.000008: Regardless of whether HDEC approval is required, researchers in such studies will still be required by the Code of
p.000008: Health and Disability Services Consumers’ Rights 1996 to comply with the established ethical standards that apply to
p.000008: them.
p.000008: Key changes to this section following consultation include:
p.000008: • more clearly basing definitions of ‘intervention study’ and ‘observational study’ on relevant NEAC guidelines
p.000008: • dividing the scope of HDEC review into ‘main criteria’, ‘exemptions’ and ‘inclusions’
p.000008: • clarifying and restricting the types of observational study that may be considered to be of minimal risk, and
p.000008: therefore exempt from HDEC review
p.000008: • restricting the scope of the exemption from HDEC review for some student-led studies, and delaying the
p.000008: introduction of this exemption until 1 January 2013
p.000008: • requiring (rather than allowing) HDEC review for the establishment or maintenance of tissue banks.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000009: 9
p.000009:
p.000009: What is health and disability research?
p.000009: 19. Health and disability research is research that aims to generate knowledge for the purpose of improving
p.000009: health and independence outcomes.
p.000009: 20. ‘Health and disability research’, for the purposes of these SOPs, does not include research that creates or
p.000009: uses a human gamete, human embryo or hybrid embryo. The Human Assisted Reproductive Technology Act 2004 requires that
p.000009: such ‘human reproductive research’ be approved by the Ethics Committee on Assisted Reproductive Technology.
p.000009: Types of health and disability research
p.000009: 21. There are two main types of health and disability research: intervention studies and observational studies.
p.000009: Intervention studies
p.000009: 22. ‘Intervention study’ has the meaning given to it by the Ethical Guidelines for Intervention Studies; namely,
...
p.000010: 30.2. one or more participants who are vulnerable (that is, who have restricted capability to make independent
p.000010: decisions about their participation in the study),3 or
p.000010:
p.000010:
p.000010: 2 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
p.000010: Australian regulatory guidelines for medical devices, available from the TGA’s website at
p.000010: http://tga.gov.au/pdf/devices-argmd.pdf.
p.000010:
p.000010:
p.000010:
p.000010: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000011: 11
p.000011:
p.000011: 30.3. standard treatment being withheld from one or more participants, or
p.000011: 30.4. the storage, preservation or use of human tissue without consent, or
p.000011: 30.5. the disclosure of health information without authorisation.
p.000011: 31. Audits and related activities: An audit or related activity requires HDEC review only if it involves the use,
p.000011: collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at
p.000011: section 20(f) of the Human Tissue Act 2008 and Right 7(10)(c) of the Code of Health and Disability Services Consumers’
p.000011: Rights 1996).
p.000011: 32. Student-led research: From 1 January 2013, a study conducted wholly or principally for the purposes of an
p.000011: educational qualification requires HDEC review only if it:
p.000011: 32.1. is an intervention study, or
p.000011: 32.2. is not conducted at or below Master’s level.
p.000011:
p.000011: Inclusions
p.000011: 33. Regardless of the exemptions to the main criteria outlined above, a study requires HDEC review if it:
p.000011: 33.1. involves the use of human tissue samples taken as part of New Zealand’s Newborn Metabolic Screening Programme
p.000011: (known as ‘Guthrie cards’), or
p.000011: 33.2. is funded by the Health Research Council of New Zealand (HRC) and is not able to be reviewed by an
p.000011: institutional ethics committee approved by the HRC’s Ethics Committee (HRCEC).
p.000011: 33.3. involves the establishment or maintenance of a tissue bank (see section 13).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
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p.000011:
p.000011:
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p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 This term is defined more fully in the Ethical Guidelines for Intervention Studies.
p.000011:
p.000011:
p.000011:
p.000011: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000012: 12
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
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p.000012:
p.000012:
p.000012:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000022: at any time where they consider, on reasonable grounds, that that person’s behaviour is having an unduly adverse impact
p.000022: on the HDEC’s ability to perform its functions.
p.000022: The decision-making process
p.000022: 90. HDECs must reach one of the decisions listed in section 7 of these SOPs on every new application and
p.000022: substantial amendment they consider.
p.000022: 91. HDECs should reach decisions by consensus wherever possible. Where this is not possible, a formal vote should
p.000022: be taken by a counting of hands, the decision being determined by a simple majority of members present and the chair
p.000022: having a casting vote.
p.000022: 92. Where an HDEC decision is taken by vote, members who dissent from the decision may ask that the minutes note
p.000022: their dissent.
p.000022: Minutes
p.000022: 93. The minutes of an HDEC meeting must contain a true and accurate summary of the discussion that takes place
p.000022: during the meeting, and the decisions made at it.
p.000022: 94. For each application or substantial amendment reviewed at a meeting, the minutes must clearly record:
p.000022: 94.1. which members (if any) declared a potential conflict of interest, and the decision the HDEC took to manage
p.000022: these declarations (it is not necessary to record details of the potential conflict of interest; only that one was
p.000022: made)
p.000022: 94.2. a brief summary of the main ethical issues considered
p.000022: 94.3. the decision (see section 7)
p.000022: 94.4. whether the decision was reached by consensus or by vote; if by vote, the numbers for and against
p.000022: 94.5. any formal dissent from the decision by a named member
p.000022: 94.6. where the decision is to approve, any minor conditions applicants must meet prior to the start of the study
p.000022: 94.7. where the decision is to decline, reasons for this
p.000022: 94.8. where no decision is made pending receipt of further information:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000023: 23
p.000023:
p.000023: 94.8.1. details of the further information requested, and
p.000023: 94.8.2. the established ethical standard or standards in respect of which the HDEC requests the further
p.000023: information, and
p.000023: 94.8.3. who will have responsibility for considering this information and making a final decision.
p.000023: 95. The summary of ethical issues should set out the main issues considered in making the decision. It is not
p.000023: necessary to include requests for explanations of technical or non-ethical matters, or to record every aspect of the
p.000023: HDEC’s discussion. The summary should include, for example, substantive ethical issues discussed and resolved with the
p.000023: CI at an HDEC meeting, and any oral clarifications given of information contained in the application.
p.000023: 96. The secretariat should prepare draft minutes and the chair (or acting chair) agree to them as soon as
p.000023: possible after the meeting. The chair (or acting chair) may consult with other HDEC members at their sole discretion
p.000023: before agreeing to minutes. However, such consultation should not prevent the HDEC sending letters communicating
p.000023: decisions made at the meeting to the applicant within four working days of the decision being made (see section 7)
p.000023: 97. Except where a named member wishes to be named as dissenting from a decision taken by vote, the HDEC must
p.000023: present minutes entirely as the outcome of collective discussion. It should not attribute comments and questions to
p.000023: named members.
p.000023: 98. Draft minutes should be submitted to the following meeting of the HDEC for formal confirmation as a true and
p.000023: accurate record. Any minor changes necessary should be noted and the minutes amended accordingly after the meeting. The
p.000023: chair (or acting chair) should sign the final minutes, which should then be published electronically.
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p.000023: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000024:
p.000024: 6. The expedited review pathway
p.000024:
p.000024:
p.000024:
p.000024: Introduction
p.000024: The Government response to the Health Committee’s clinical trials inquiry requires that updated SOPs for HDECs impose a
p.000024: 15-day time limit for making final decisions on applications through the expedited review pathway. This section
p.000024: addresses that requirement, and defines the expedited review pathway in more detail.
p.000024: Key changes and clarifications include:
p.000024: • clarifying the items of business for which expedited review is appropriate, which may include some applications
p.000024: for low-risk clinical trials
p.000024: • allowing chairs to share the workload within the expedited review pathway by creating subcommittees consisting of
p.000024: up to three other members of the HDEC to advise them on their decisions.
p.000024: Key changes to this section following consultation include:
p.000024: • clarifying that studies of class IIa medical devices may qualify for expedited review, and that final reports
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p.000026: 117. Subcommittees should communicate decisions taken through the expedited review pathway to the full HDEC through
p.000026: meeting agendas. The full HDEC does not need to ratify these decisions.
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p.000026: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000027:
p.000027: 7. Decisions open to HDECs
p.000027:
p.000027:
p.000027:
p.000027: Introduction
p.000027: This section describes the decisions open to HDECs, and sets out in more detail the timeframes within which the HDEC
p.000027: must make and communicate those decisions. Consistent with the established practice of other jurisdictions in which
p.000027: ethics committees are expected to make decisions within a given timeframe, the 35- or 15-day review clock is able to be
p.000027: suspended once, where an application has been provisionally approved.
p.000027: Key changes and clarifications include:
p.000027: • removing the ability of HDECs to ‘defer’ consideration of an application through the full review pathway until
p.000027: their next meeting, since retaining this ability would be inconsistent with the 35-day review clock
p.000027: • allowing the 35- and 15-day review clocks to be suspended once, for up to 90 calendar days, where the HDEC gives
p.000027: provisional approval
p.000027: • making regulatory approval, locality approval and clinical trial registration standard conditions of HDEC
p.000027: approval, and allowing HDECs to impose other minor conditions of approval (such as corrections to study documents)
p.000027: • clarifying that researchers and sponsors, rather than HDECs, are responsible for ensuring that standard and minor
p.000027: conditions of HDEC approval are met before a study commences
p.000027: • clarifying that HDECs must provide reasons based on established ethical standards wherever they provisionally
p.000027: approve or decline a new application or substantial amendment.
p.000027: Key changes to this section following consultation include:
p.000027: • clarifying that HDECs should communicate decisions within four working days
p.000027: • consistent with changes to the definition of ‘locality’ in section 9, making locality authorisation a standard
p.000027: condition of all HDEC approvals, rather than just those involving intervention studies
p.000027: • clarifying standard and minor conditions of approval, and specifying that changes requiring reconsideration of
p.000027: ethical issues should be re-checked by HDECs after provisional approval.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Decisions
p.000027: 118. Chairs are responsible for ensuring that HDECs make one of the following decisions on all new applications and
p.000027: substantial amendments through the full and expedited review pathways:
p.000027: 118.1. approve
p.000027: 118.2. decline
p.000027: 118.3. provisionally approve.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000028:
p.000028: 119. For the purposes of the 35- and 15-day review clocks, the date of decision is the date on which the HDEC sends
p.000028: the decision letter.
p.000028: 120. HDECs should formally communicate all decisions on new applications and substantial amendments to applicants
p.000028: within four working days of their being made. This four-day timeframe applies to decisions made at HDEC meetings as
p.000028: well as to decisions made within the expedited review pathway.
p.000028: 121. All decision letters should be in the name of the chair of the HDEC.
p.000028: 122. All decision letters must include the following information:
p.000028: 122.1. a brief summary of the main ethical issues considered by the HDEC in making the decision
p.000028: 122.2. the decision
p.000028: 122.3. a list of study documents, including version numbers and dates
p.000028: 122.4. where the decision was made through the full review pathway: a list of HDEC members, indicating their
p.000028: membership category, whether they were present at the meeting at which the matter was discussed and, if so, whether
p.000028: they declared a potential conflict of interest.
p.000028: 123. Decision letters should not attribute particular comments, questions or concerns to individual HDEC members.
p.000028: Similarly, where a decision was made through the expedited review pathway, decision letters must not reveal the names
p.000028: of the members of the subcommittee involved.
p.000028: Letters communicating a decision to approve
p.000028: 124. In addition to the information specified at paragraph 122, approval letters must confirm:
p.000028: 124.1. that the HDEC operates in accordance with these SOPs and with the principles of international good clinical
p.000028: practice
p.000028: 124.2. whether participants injured as a result of treatment received in the study will be eligible for publicly
p.000028: funded compensation through ACC (see also section 8).
p.000028: Conditions of HDEC approval
p.000028: 125. All HDEC approvals are subject to the following standard conditions.
p.000028: 125.1. Applicants must obtain all necessary regulatory approvals and authorisations before the study commences in New
p.000028: Zealand.
p.000028: 125.2. Applicants must obtain locality authorisation before the study commences at a given locality (see section 10).
p.000028: 125.3. If the study is an intervention study, it must be registered in a clinical trials registry approved by the
p.000028: World Health Organisation before it commences in New Zealand.
p.000028: 126. HDECs may also impose minor conditions on approval. By way of example, such conditions might include minor
p.000028: corrections or changes to study documentation. However, where the changes required would necessitate further ethical
p.000028: consideration (for example, significant or unspecified revision of study documentation), the HDEC
p.000028:
p.000028:
p.000028:
p.000028: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000029: 29
p.000029:
p.000029: should provisionally approve the study and formally review these revisions before giving final approval.
p.000029: 127. The approval letter must clearly state both standard and minor conditions of approval, and applicants must
p.000029: fully meet these in order for HDEC approval to be effective. Until the conditions are met, the study cannot commence
p.000029: (or cannot commence at a given locality).
p.000029: 128. It is the responsibility of the CI and study sponsor to ensure that applicants meet all standard and minor
p.000029: conditions of HDEC approval before the study commences (or commences at a given locality). Neither the HDEC nor the
p.000029: secretariat is required to undertake any further review to ensure that this is the case, or to confirm approval.
p.000029: Duration of HDEC approval
p.000029: 129. HDEC approval applies for the duration of the study as specified in the original application, subject to
p.000029: approval being suspended or cancelled in accordance with the provisions of section 12.
p.000029: 130. Extension of the duration of a study beyond that specified in the original application is not in and of itself
p.000029: a substantial amendment to that study, except where it is related to other amendments that would be substantial (such
p.000029: as an increase in recruitment targets, the addition of new procedures, or an extension of follow-up activities).
p.000029: Consequently, applicants will usually not require an HDEC’s approval to extend a study’s duration (see section 11).
p.000029: Letters communicating a decision to decline
p.000029: 131. In addition to the information specified at paragraph 122, letters declining an application must clearly
p.000029: state:
p.000029: 131.1. the ethical standard(s) that the HDEC believes the study would not meet, with reasons
p.000029: 131.2. how the applicant may challenge the decision of the HDEC to decline (see section 9).
p.000029: 132. An applicant may make a second application in respect of a study that an HDEC has declined at any time. In
p.000029: such cases, the second application is considered to be a new application, and assigned a new reference number (in
p.000029: accordance with section 4).
p.000029: Letters communicating a decision to provisionally approve
p.000029: 133. An HDEC may provisionally approve a new application or substantial amendment pending receipt of further
p.000029: information or satisfaction of non-minor conditions. This decision may only be made once in respect of any new
p.000029: application or substantial amendment.
p.000029: 134. In addition to the information specified at paragraph 122, provisional approval letters must clearly state:
p.000029: 134.1. the established ethical standard(s) that the HDEC is not satisfied the study would meet on the basis of the
p.000029: information in the original application
p.000029: 134.2. the further information (or non-minor conditions) that the HDEC requires (or imposes) in order to make a final
p.000029: decision
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p.000029:
p.000029: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000030:
p.000030: 134.3. the number of days remaining on the 35- or 15-day review clock
p.000030: 134.4. the date by which the HDEC must receive a response from the applicant.
p.000030:
p.000030: Stopping and restarting the review clock
p.000030: 135. The 35- or 15-day review clock stops on the date of the provisional approval letter, and restarts on the date
p.000030: on which the HDEC receives a complete response. If an applicant submits an incomplete response, the review clock
p.000030: remains suspended. Where the HDEC receives a response that is incomplete, it should inform the applicant of this as
p.000030: soon as possible.
p.000030: 136. A complete response must be received within 90 calendar days of the date of the provisional approval letter.
p.000030: The secretariat should send a reminder of this request after 60 calendar days.
p.000030: 137. Where the HDEC does not receive a complete response after 90 calendar days, the application or substantial
p.000030: amendment will be considered to have been withdrawn. The secretariat must confirm this.
p.000030: Authority for considering further information – full review
p.000030: 138. In order to ensure compliance with the relevant review clock for making a final decision, an HDEC may not
p.000030: require that a response be considered by the full committee at a future meeting. Instead, the HDEC must clearly
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p.000040: 40
p.000040:
p.000040: 11. Amendments to approved studies
p.000040:
p.000040:
p.000040:
p.000040: Introduction
p.000040: The Government response to the Health Committee’s clinical trials inquiry requires updated SOPs for HDECs to clarify
p.000040: when amendments to approved studies themselves require HDEC review. This section addresses that requirement, while
p.000040: sections 5 and 6 clarify the review pathways by which different types of substantial amendment are to be reviewed.
p.000040: Key changes and clarifications include:
p.000040: • following European clinical trial rules in distinguishing between substantial and non- substantial amendments to
p.000040: approved studies, providing criteria and examples of each
p.000040: • allowing non-substantial amendments to be made to any study at any time without approval from or notification to
p.000040: an HDEC
p.000040: • allowing for HDECs to exercise discretion regarding whether amendments submitted for review meet the test of
p.000040: substantiality.
p.000040: Key changes to this section following consultation include:
p.000040: • requiring amendments to be submitted through the HDECs’ electronic submission system
p.000040: • clarifying that non-substantial amendments may continue to be submitted to HDECs for review
p.000040: • clarifying that responsibility for deciding whether an amendment is substantial rests with the study team as a
p.000040: whole, rather than the CI
p.000040: • confirming that details of documents submitted with amendments will continue to be noted in HDEC letters.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 185. An amendment to an approved study only requires HDEC review if it is substantial. Applicants may make
p.000040: non-substantial (‘minor’) amendments to any approved study at any time without approval from or notification to the
p.000040: HDEC.
p.000040: 186. Applicants must submit all substantial amendments through the HDEC’s online submission system, accompanied by
p.000040: copies of relevant study documents.
p.000040: Definition of ‘substantial amendment’
p.000040: 187. A substantial amendment is an amendment that is likely to affect to a significant degree any of the following:
p.000040: 187.1. the safety or physical or mental integrity of participants
p.000040: 187.2. the scientific value of the study
p.000040: 187.3. the conduct or management of the study
p.000040: 187.4. the quality or safety of any medicine or item used in the study.
p.000040: 188. The following should normally be regarded as substantial amendments:
p.000040:
p.000040:
p.000040:
p.000040: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000041: 41
p.000041:
p.000041: 188.1. significant changes to the design/methodology of the study
p.000041: 188.2. significant changes to the type or number of procedures participants will undertake in the study
p.000041: 188.3. changes relating to the safety of the physical or mental integrity of participants, or to the risk/benefit
p.000041: assessment for the study
p.000041: 188.4. significant changes to the study’s documentation (such as participant information sheets)
p.000041: 188.5. the appointment of a new CI for the study
p.000041: 188.6. any other significant change to the study protocol or the information provided in the application for approval.
p.000041: 189. In themselves, the following should usually be regarded as minor amendments:
p.000041: 189.1. minor or administrative changes to study documentation
p.000041: 189.2. updated versions of the investigator’s brochure (where the study involves a new medicine)
p.000041: 189.3. changes to the research team other than the appointment of a new CI
p.000041: 189.4. changes in funding arrangements, except where these may alter the ability of participants to access publicly
p.000041: funded compensation in the event of injury
p.000041: 189.5. changes in arrangements for recording or analysing study data, or for storing or transporting samples
p.000041: 189.6. extension of the study beyond the expected end date given in the application form, except where this is related
p.000041: to other changes that are substantial.
p.000041: Deciding whether an amendment is substantial
p.000041: 190. In the first instance, it is the responsibility of the study team to decide whether or not a given amendment
p.000041: to a study is substantial. In making this decision, applicants should consider whether the amendment will change the
p.000041: study to a ‘significant degree’. Applicants should take particular account of any implications for the safety or
p.000041: welfare of participants, and of any information that participants might require to give informed consent to continue to
p.000041: participate in the amended research.
p.000041: 191. Where there is doubt as to whether an amendment is substantial, applicants may submit it for review. Where an
p.000041: amendment submitted for review is not validated as substantial, the secretariat should communicate this decision to the
p.000041: CI within two working days. This confirmation must contain details of all documents submitted with the amendment.
p.000041: Review pathways for substantial amendments
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p.000050: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000051: 51
p.000051:
p.000051: Glossary and references
p.000051:
p.000051:
p.000051: Glossary
p.000051: ACC Accident Compensation Corporation
p.000051: ACC Act Accident Compensation Act 2001
p.000051: Amendment Any change to the terms of a study, including to the protocol or other supporting
p.000051: documentation, made after an HDEC has approved the study
p.000051: Appeal A review by the HRCEC of the process and/or merits of an HDEC decision that
p.000051: produces a binding decision
p.000051: Applicant The person who submits an application to an HDEC. Where the applicant is not
p.000051: also the CI for the study, the CI must have authorised the application
p.000051: Approval conditions Conditions to be met by an applicant prior to commencement of the study. There are
p.000051: three types of approval condition:
p.000051: standard conditions, which apply to all HDEC approvals
p.000051: minor conditions, which HDECs may impose in giving approval to a study
p.000051: non-minor conditions, which HDECs may impose in giving provisional approval to a study
p.000051: Audit or related activity Has the meaning given to it by the Ethical Guidelines for Observational Studies
p.000051: Calendar day Any day that is not a day between 25 December and 15 January
p.000051: Chair The member of an HDEC appointed to the chair. Where the chair is unavailable
p.000051: for any reason, his or her duties may be performed by any other member of the HDEC, lay or non-lay, at the discretion
p.000051: of the chair
p.000051: Clinical trial An intervention study
p.000051: Commercially sponsored study A clinical trial that is conducted principally for the benefit of the
p.000051: manufacturer or distributor of the medicine or item being trialled. Also known as a ‘form B’ study
p.000051: Co-ordinating investigator (CI) Formerly known as the ‘principal investigator’; the chief investigator of a study in
p.000051: the New Zealand, or the investigator assigned responsibility for the co-ordination of investigators at different
p.000051: centres participating in a multi-centre study. In New Zealand, the CI has primary responsibility for the design and
p.000051: conduct of the study in New Zealand, including compliance with all relevant legal and ethical standards. All
p.000051: applications for HDEC review of a study must be submitted or authorised by the study’s CI
p.000051: Ethical standards Standards for the ethical conduct of health and disability research
p.000051: contained in the Ethical Guidelines for Intervention Studies and the
p.000051: Ethical Guidelines for Observational Studies
p.000051:
p.000051:
p.000051:
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p.000052: ICH International Conference on Harmonisation of Technical Requirements for
p.000052: Registration of Pharmaceuticals for Human Use
p.000052: Intervention study Has the meaning given to it by the Ethical Guidelines for Intervention Studies;
p.000052: namely, a study in which investigators control and study the intervention(s) provided to participants
p.000052: Investigator Any investigator on a study who is not the CI. This includes investigators who
p.000052: are responsible for the conduct of a study at a given locality (or at a site within that locality). A study may have
p.000052: any number of investigators. The CI of a study may also be the lead/principal investigator at one or more localities
p.000052: Investigator’s brochure A document summarising the clinical and other data relating to a new medicine that are
p.000052: relevant to the study of the product in human participants
p.000052: Locality An organisation responsible for a hospital, health centre, surgery or other
p.000052: establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be
p.000052: conducted
p.000052: Locality review The process by which a locality assesses its suitability for the safe and
p.000052: effective conduct of an intervention study
p.000052: Medical device Has the meaning given to it by the Medicines Act 1981 Medicine
p.000052: Has the meaning given to it by the Medicines Act 1981
p.000052: Medsafe New Zealand Medicines and Medical Devices Safety Authority
p.000052: Minor amendment Any amendment to a previously approved study that is not a substantial amendment
p.000052: NEAC National Ethics Advisory Committee
p.000052:
p.000052:
p.000052:
p.000052: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000053: 53
p.000053:
p.000053: New medicine Has the meaning given to it by the Medicines Act 1981
p.000053: Observational research Has the meaning given to it by the Ethical Guidelines for Observational Studies; namely,
p.000053: an observational study that involves participants but in which investigators do not control and study the
p.000053: intervention(s) provided to them, if any
p.000053: Observational study Has the meaning given to it by the Ethical Guidelines for Observational Studies;
p.000053: namely, a study in which investigators do not control and study the intervention(s) provided to participants, if any
p.000053: Participant An individual who actively participates in a study. HDEC review of a study may
p.000053: be required where participants are recruited in their capacity as:
p.000053: consumers of health and disability support services, or
p.000053: relatives or caregivers of such consumers, or
p.000053: healthy volunteers in clinical trials
p.000053: Post-approval item An item of business (such as an amendment, annual progress report, final report,
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p.000008: and reduce the scope of HDEC review. This section gives effect to this requirement. It replaces the definition of scope
p.000008: contained in:
p.000008: • section 3 of the Operational Standard for Ethics Committees
p.000008: • chapter 11 of the Ethical Guidelines for Observational Studies
p.000008: • the Guidelines for an Accredited Institutional Ethics Committee to refer Studies to an Accredited Health and
p.000008: Disability Ethics Committee.
p.000008: The definition of scope in this section will reduce the scope of HDEC review, for example by excluding studies that:
p.000008: • involve participants recruited other than in their capacity as consumers of health and disability services,
p.000008: relatives of consumers, or volunteers in early-phase clinical trials (for instance, health professionals or members of
p.000008: the general public)
p.000008: • involve the use of existing anonymised human tissue samples with consent
p.000008: • involve low-risk (class I) medical devices
p.000008: • are audits or related studies (except where HDEC review is required by law)
p.000008: • are observational studies that do not involve more than minimal risk
p.000008: • are to be conducted wholly or principally for the purposes of an educational qualification, in some
p.000008: circumstances.
p.000008: Regardless of whether HDEC approval is required, researchers in such studies will still be required by the Code of
p.000008: Health and Disability Services Consumers’ Rights 1996 to comply with the established ethical standards that apply to
p.000008: them.
p.000008: Key changes to this section following consultation include:
p.000008: • more clearly basing definitions of ‘intervention study’ and ‘observational study’ on relevant NEAC guidelines
p.000008: • dividing the scope of HDEC review into ‘main criteria’, ‘exemptions’ and ‘inclusions’
p.000008: • clarifying and restricting the types of observational study that may be considered to be of minimal risk, and
p.000008: therefore exempt from HDEC review
p.000008: • restricting the scope of the exemption from HDEC review for some student-led studies, and delaying the
p.000008: introduction of this exemption until 1 January 2013
p.000008: • requiring (rather than allowing) HDEC review for the establishment or maintenance of tissue banks.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000009: 9
p.000009:
p.000009: What is health and disability research?
p.000009: 19. Health and disability research is research that aims to generate knowledge for the purpose of improving
p.000009: health and independence outcomes.
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p.000010: decisions about their participation in the study),3 or
p.000010:
p.000010:
p.000010: 2 The TGA’s guidance on device classification can be found from page 77 of the Therapeutic Goods Administration’s 2011
p.000010: Australian regulatory guidelines for medical devices, available from the TGA’s website at
p.000010: http://tga.gov.au/pdf/devices-argmd.pdf.
p.000010:
p.000010:
p.000010:
p.000010: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
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p.000011: 30.3. standard treatment being withheld from one or more participants, or
p.000011: 30.4. the storage, preservation or use of human tissue without consent, or
p.000011: 30.5. the disclosure of health information without authorisation.
p.000011: 31. Audits and related activities: An audit or related activity requires HDEC review only if it involves the use,
p.000011: collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at
p.000011: section 20(f) of the Human Tissue Act 2008 and Right 7(10)(c) of the Code of Health and Disability Services Consumers’
p.000011: Rights 1996).
p.000011: 32. Student-led research: From 1 January 2013, a study conducted wholly or principally for the purposes of an
p.000011: educational qualification requires HDEC review only if it:
p.000011: 32.1. is an intervention study, or
p.000011: 32.2. is not conducted at or below Master’s level.
p.000011:
p.000011: Inclusions
p.000011: 33. Regardless of the exemptions to the main criteria outlined above, a study requires HDEC review if it:
p.000011: 33.1. involves the use of human tissue samples taken as part of New Zealand’s Newborn Metabolic Screening Programme
p.000011: (known as ‘Guthrie cards’), or
p.000011: 33.2. is funded by the Health Research Council of New Zealand (HRC) and is not able to be reviewed by an
p.000011: institutional ethics committee approved by the HRC’s Ethics Committee (HRCEC).
p.000011: 33.3. involves the establishment or maintenance of a tissue bank (see section 13).
p.000011:
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p.000011:
p.000011: 3 This term is defined more fully in the Ethical Guidelines for Intervention Studies.
p.000011:
p.000011:
p.000011:
p.000011: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000012: 12
p.000012:
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...
Social / embryo
Searching for indicator embryo:
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p.000008: them.
p.000008: Key changes to this section following consultation include:
p.000008: • more clearly basing definitions of ‘intervention study’ and ‘observational study’ on relevant NEAC guidelines
p.000008: • dividing the scope of HDEC review into ‘main criteria’, ‘exemptions’ and ‘inclusions’
p.000008: • clarifying and restricting the types of observational study that may be considered to be of minimal risk, and
p.000008: therefore exempt from HDEC review
p.000008: • restricting the scope of the exemption from HDEC review for some student-led studies, and delaying the
p.000008: introduction of this exemption until 1 January 2013
p.000008: • requiring (rather than allowing) HDEC review for the establishment or maintenance of tissue banks.
p.000008:
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p.000008: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000009: 9
p.000009:
p.000009: What is health and disability research?
p.000009: 19. Health and disability research is research that aims to generate knowledge for the purpose of improving
p.000009: health and independence outcomes.
p.000009: 20. ‘Health and disability research’, for the purposes of these SOPs, does not include research that creates or
p.000009: uses a human gamete, human embryo or hybrid embryo. The Human Assisted Reproductive Technology Act 2004 requires that
p.000009: such ‘human reproductive research’ be approved by the Ethics Committee on Assisted Reproductive Technology.
p.000009: Types of health and disability research
p.000009: 21. There are two main types of health and disability research: intervention studies and observational studies.
p.000009: Intervention studies
p.000009: 22. ‘Intervention study’ has the meaning given to it by the Ethical Guidelines for Intervention Studies; namely,
p.000009: a study in which the investigator controls and studies the intervention(s) provided to participants for the purpose of
p.000009: adding to knowledge of the health effects of the intervention(s). The term ‘intervention study’ is often used
p.000009: interchangeably with the terms ‘experimental study’ and ‘clinical trial’.
p.000009: 23. The ethical standards that researchers must meet or exceed in conducting intervention studies are contained
p.000009: in the Ethical Guidelines for Intervention Studies.
p.000009:
p.000009: Observational studies
p.000009: 24. ‘Observational study’ has the meaning given to it by the Ethical Guidelines for Observational Studies. All
p.000009: health and disability research that is not an intervention study is an observational study. Like intervention studies,
p.000009: observational studies may involve looking at the health effects of interventions provided to human participants.
p.000009: However, researchers in such an observational study do not control these interventions, which would have been provided
p.000009: regardless of participation in the study.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000024: recognising that this may be continue to be necessary in exceptional circumstances, and requiring such decisions to be
p.000024: brought to the attention of the full HDEC.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: What is the expedited review pathway, and what should be reviewed by it?
p.000024: 99. In the expedited review pathway, a subcommittee of an HDEC reviews an application, substantial amendment or
p.000024: other item of business in accordance with the provisions set out in this section.
p.000024: 100. The expedited review pathway is appropriate for:
p.000024: 100.1. all new applications for which full review is not required (including studies of class IIa medical devices,
p.000024: where none of the other features making full review appropriate are present)
p.000024: 100.2. all substantial amendments to approved studies that were reviewed through the expedited review pathway
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000025: 25
p.000025:
p.000025: 100.3. any substantial amendments to other studies, at the discretion of the chair
p.000025: 100.4. all annual progress reports and final reports
p.000025: 100.5. all protocol deviations or violations
p.000025: 100.6. all notifications of the conclusion or early termination of a study.
p.000025:
p.000025: The 15-day review clock
p.000025: 101. The expedited review pathway does not involve physical meetings of HDECs. For this reason, the expedited
p.000025: review pathway entails a shorter review clock than the full review pathway.
p.000025: 102. In the expedited review pathway, HDECs must give a final opinion within 15 calendar days. They may suspend
p.000025: this timeframe once in the case of provisional approval of an application or substantial amendment (see section 7).
p.000025: 103. The 15-day review clock begins on the working day following submission of the application or substantial
p.000025: amendment.
p.000025: 104. Calendar days from 25 December to 15 January inclusive do not count for the purposes of the 15-day review
p.000025: clock.
p.000025: Declarations of conflict of interest
p.000025: 105. HDEC members must be mindful to avoid situations that might compromise the impartiality and integrity of the
p.000025: HDEC review process. This obligation is particularly strong in the context of the expedited review pathway.
p.000025: 106. An HDEC member who is assigned an item of business to review within the expedited review pathway must decline
p.000025: to review it if they believe they have (or might reasonably be perceived to have) a potential conflict of interest.
p.000025: 107. Where the chair believes that they personally have (or might reasonably be perceived to have) a potential
p.000025: conflict of interest on a new application, they may request the secretariat to assign the application to another HDEC.
p.000025: 108. The 15-day review clock for giving a final opinion does not stop when a chair or member declines to review an
p.000025: item of business due to a potential conflict of interest.
p.000025: Role of the chair
p.000025: 109. In the expedited review pathway, the chair is responsible for:
p.000025: 109.1. selecting the subcommittee members who will be involved in the review of items of business
p.000025: 109.2. ensuring that final decisions are made within the 15-day timeframe.
p.000025: 110. Where the chair is unavailable, any other member of the HDEC may act in their place for the purposes of the
p.000025: expedited review pathway, although this role should usually be taken by the member identified by the HDEC as a whole to
p.000025: act in the absence of the chair at meetings. The HDEC as a whole should usually choose this member at the meeting
p.000025: preceding the chair’s period of unavailability.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000026: 26
p.000026:
p.000026: Size and composition of subcommittees
p.000026: 111. A subcommittee consists of the chair plus up to three other appointed members. The size and composition of
p.000026: subcommittees is at the chair’s discretion, subject to the following rules.
p.000026: 111.1. A subcommittee reviewing a new application must consist of the chair plus at least one other member.
p.000026: 111.2. A subcommittee reviewing a new application for an intervention study must include at least one non-lay member.
p.000026: 111.3. A subcommittee composed of three or more members (including the chair) must include at least one lay member and
p.000026: at least one non-lay member.
...
p.000032: provided with copies of the following documents:
p.000032: 149.1. in the case of the CI: evidence of appropriate professional indemnity, for example through membership of the
p.000032: Medical Protection Society
p.000032: 149.2. in the case of the study sponsor: evidence of the insurance that will be in place for the study (for example, a
p.000032: certificate of insurance).
p.000032: 150. However, HDECs may not require documents relating to insurance or indemnity arrangements specific to
p.000032: localities in a ‘commercially sponsored’ intervention study, or specific to any individuals involved in the study other
p.000032: than the CI. This is because localities themselves are responsible for checking that they and relevant members of the
p.000032: local research team are appropriately indemnified and insured (see section 10).
p.000032:
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p.000032: 8 Ethical Guidelines for Intervention Studies , para 8.4.
p.000032:
p.000032:
p.000032:
p.000032: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000033: 33
p.000033:
p.000033: 9. Challenging HDEC decisions
p.000033:
p.000033:
p.000033:
p.000033: Introduction
p.000033: This section defines how applicants may challenge certain HDEC decisions. In addition to the complaint and
p.000033: second-opinion processes that are currently available, the option of appeal to the HRCEC has been added pursuant to
p.000033: ministerial decision in 2010.
p.000033: Key changes to this section following consultation include:
p.000033: • clarifying that the timeframe for formal complaint and second opinion is 20 working days.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: 151. An applicant may challenge an HDEC decision to:
p.000033: 151.1. decline to approve a new application or a substantial amendment to an approved study, or
p.000033: 151.2. suspend approval for a study, or
p.000033: 151.3. cancel approval for a study.
p.000033: 152. There are three options open to applicants who wish to challenge an HDEC decision to decline, suspend or
p.000033: cancel approval:
p.000033: 152.1. formal complaint about the decision-making process, or
p.000033: 152.2. second opinion on the merits of the decision, or
p.000033: 152.3. appeal.
p.000033: 153. While third parties (including members of the public) may not challenge HDEC decisions, they may submit
p.000033: information that they believe may give grounds for the HDEC to review approval for a study in accordance with the
p.000033: provisions of section 12.
p.000033: 154. The principles of natural justice underlie the process of challenging an HDEC decision. HDECs should advise
p.000033: all relevant parties of the process that it will follow, give them an opportunity to comment and respond, and keep them
p.000033: informed of progress. While there is no fixed timeframe within which reconsideration must occur, considerations of
p.000033: natural justice mean that the process should be completed as expeditiously as possible.
p.000033: Formal complaints about the decision-making process
p.000033: 155. Where an applicant considers that the process followed by an HDEC in making a decision to decline, suspend or
p.000033: cancel approval did not accord with the provisions of these SOPs, they may formally complain to the HDEC secretariat in
p.000033: writing. Formal complaints must cite the paragraph(s) of these SOPs that the applicant considers were not followed by
p.000033: the HDEC in making its decision, and provide reasons for this view.
p.000033: 156. When it receives a formal complaint, the secretariat must inform the chair of the relevant HDEC as soon as
p.000033: possible. It must then advise the chair and the applicant
p.000033:
p.000033:
p.000033:
p.000033: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000034: 34
p.000034:
p.000034: within 20 working days as to whether, in its view, the aspects of the decision-making process identified by the
p.000034: applicant accorded with these SOPs. However, the secretariat has no power to annul or amend decisions taken by HDECs,
p.000034: or to require them to reconsider a decision.
p.000034: 157. An HDEC may reconsider a decision to decline, suspend or cancel approval where an applicant has made a formal
p.000034: complaint regardless of the content or timing of the secretariat’s advice. The HDEC may not ask for additional
p.000034: information or assurances in reconsidering its original decision. The HDEC should formally advise the applicant of its
p.000034: intention to reconsider the decision, and invite them to attend the meeting at which this will occur.
p.000034: 158. Following reconsideration, the HDEC must either:
p.000034: 158.1. reaffirm its original decision to decline, suspend or cancel approval, or
p.000034: 158.2. where the original decision was to decline approval: approve or provisionally approve the application (where
p.000034: the decision is to provisionally approve, the HDEC must make a final decision as soon as possible and in any case
p.000034: within five working days of submission of further information), or
p.000034: 158.3. where the original decision was to suspend approval: allow the study to continue as normal, or
p.000034: 158.4. where the original decision was to cancel approval: either allow the study to continue as normal or suspend
p.000034: approval (in which case the provisions of section 12 apply).
p.000034: Second opinion on the merits of the decision
p.000034: 159. Where an applicant considers that a decision to decline, suspend or cancel approval was not one that was
p.000034: reasonably open to the HDEC in the circumstances, they may contact the secretariat to ask that a second opinion be
p.000034: obtained from another HDEC (‘the second HDEC’).
p.000034: 160. When it receives a request for a second opinion, the secretariat must:
p.000034: 160.1. inform the chair of the relevant HDEC as soon as possible, and
p.000034: 160.2. advise the chair and the applicant within 20 working days as to which HDEC will act as the second HDEC, and
p.000034: 160.3. supply the second HDEC with the application or substantial amendment and all associated documentation and
p.000034: correspondence.
p.000034: 161. The second HDEC should discuss the matter at its next meeting, and provide written advice as soon as possible
p.000034: to the original HDEC specifying the decision that it would have taken on the application or substantial amendment.
p.000034: However, the second HDEC has no power to annul the original decision.
p.000034: 162. Following receipt of a second opinion, the original HDEC must make one of the decisions outlined above in this
p.000034: section, and communicate this decision to both the applicant and the second HDEC.
p.000034: Appeal
p.000034: 163. Applicants may appeal any HDEC decision to decline, suspend or cancel approval to the HRCEC. Appeal decisions
p.000034: of the HRCEC are final and binding on HDECs.
p.000034:
p.000034:
p.000034:
p.000034: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000035: 35
p.000035:
p.000035: 164. Applicants who wish to appeal HDEC decisions should contact the HRCEC for further details of the process.
p.000035:
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p.000035:
p.000035:
p.000035: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000036: 36
p.000036:
p.000036: 10. Locality authorisation
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Introduction
...
p.000053: intervention(s) provided to them, if any
p.000053: Observational study Has the meaning given to it by the Ethical Guidelines for Observational Studies;
p.000053: namely, a study in which investigators do not control and study the intervention(s) provided to participants, if any
p.000053: Participant An individual who actively participates in a study. HDEC review of a study may
p.000053: be required where participants are recruited in their capacity as:
p.000053: consumers of health and disability support services, or
p.000053: relatives or caregivers of such consumers, or
p.000053: healthy volunteers in clinical trials
p.000053: Post-approval item An item of business (such as an amendment, annual progress report, final report,
p.000053: protocol deviation/violation, or notification of conclusion of study) submitted for review following HDEC approval for
p.000053: a study.
p.000053: Principal Investigator (PI) The investigator with primary responsibility for the design and conduct of a study,
p.000053: including compliance with all relevant legal and ethical standards. All applications for ethics committee review of a
p.000053: study must be submitted by its PI.
p.000053: Protocol A document describing the objectives, design, methodology, analysis and
p.000053: organisation of a study
p.000053: Reference number A unique identifier assigned to an application for HDEC review
p.000053: Review clock The timeframe within which an HDEC must give a final opinion on a new application
p.000053: or a substantial amendment to a previously approved application
p.000053: SAE Serious adverse event; an untoward occurrence at any dose that:
p.000053: results in death, or
p.000053: is life-threatening, or
p.000053: requires inpatient hospitalisation or prolongs hospitalisation, or
p.000053: results in a persistent or significant disability or incapacity, or
p.000053: is a congenital anomaly or birth defect
p.000053: SCOTT Standing Committee on Therapeutic Trials; a standing committee of the HRC whose
p.000053: function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section
p.000053: 30 of the Medicines Act 1981
p.000053: Sponsor The person or organisation with responsibility for the initiation, management
p.000053: and financing arrangements of a study
p.000053: Study An intervention study or an observational study
p.000053: Study start Commencement of the procedures set out in the study protocol
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000054: 54
p.000054:
p.000054: Substantial amendment Any amendment to a study that is likely to affect to a significant degree:
p.000054: the safety or physical integrity of participants
p.000054: the scientific value of the study
p.000054: the conduct or management of the study
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000053: consumers of health and disability support services, or
p.000053: relatives or caregivers of such consumers, or
p.000053: healthy volunteers in clinical trials
p.000053: Post-approval item An item of business (such as an amendment, annual progress report, final report,
p.000053: protocol deviation/violation, or notification of conclusion of study) submitted for review following HDEC approval for
p.000053: a study.
p.000053: Principal Investigator (PI) The investigator with primary responsibility for the design and conduct of a study,
p.000053: including compliance with all relevant legal and ethical standards. All applications for ethics committee review of a
p.000053: study must be submitted by its PI.
p.000053: Protocol A document describing the objectives, design, methodology, analysis and
p.000053: organisation of a study
p.000053: Reference number A unique identifier assigned to an application for HDEC review
p.000053: Review clock The timeframe within which an HDEC must give a final opinion on a new application
p.000053: or a substantial amendment to a previously approved application
p.000053: SAE Serious adverse event; an untoward occurrence at any dose that:
p.000053: results in death, or
p.000053: is life-threatening, or
p.000053: requires inpatient hospitalisation or prolongs hospitalisation, or
p.000053: results in a persistent or significant disability or incapacity, or
p.000053: is a congenital anomaly or birth defect
p.000053: SCOTT Standing Committee on Therapeutic Trials; a standing committee of the HRC whose
p.000053: function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section
p.000053: 30 of the Medicines Act 1981
p.000053: Sponsor The person or organisation with responsibility for the initiation, management
p.000053: and financing arrangements of a study
p.000053: Study An intervention study or an observational study
p.000053: Study start Commencement of the procedures set out in the study protocol
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000054: 54
p.000054:
p.000054: Substantial amendment Any amendment to a study that is likely to affect to a significant degree:
p.000054: the safety or physical integrity of participants
p.000054: the scientific value of the study
p.000054: the conduct or management of the study
p.000054: the quality or safety of any medicine or device used in the study
p.000054: SUSAR Suspected unexpected serious adverse reaction; an SAE that is suspected to be
p.000054: linked to the medical product being investigated, and the nature or severity of which is not consistent with the
p.000054: applicable product information (for example as provided in the investigator’s brochure)
p.000054: Tissue bank A collection of human tissue or other biological material derived from humans that
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000044: account all safety data as well as the results of any relevant non-clinical studies
p.000044: 205.3. an brief discussion of the implications of safety data to the risk-benefit ratio for the intervention study,
p.000044: and whether study documentation has been or will be updated
p.000044: 205.4. a description of any measures taken or proposed to minimise risks. (Where such a proposed measure would be a
p.000044: substantial amendment, it must be submitted to the HDEC for review in the normal way.)
p.000044: 206. Summaries of safety information such as Development Safety Update Reports may serve as annual safety reports
p.000044: to HDECs provided that they contain the information outlined above. These summaries should usually be accompanied by
p.000044: comment from the CI of the study in New Zealand.
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000045: 45
p.000045:
p.000045: 207. There is no general requirement for applicants to submit individual or expedited reports of SAEs or suspected
p.000045: unexpected serious adverse reactions (SUSARs) to HDECs, who do not have the expertise or resources to review them.
p.000045: Further, annual safety reports should not in any circumstances be accompanied by line listings of global or local SAEs
p.000045: or SUSARs.
p.000045: Urgent safety measures
p.000045: 208. It may sometimes be necessary for investigators to take urgent safety measures in order to protect
p.000045: participants in an intervention study from a significant, immediate hazard to their health or safety. If this occurs
p.000045: the applicant must notify the HDEC immediately and in any case within seven calendar days of taking any such measures.
p.000045: 209. Notifications of urgent safety measures are considered to be a type of amendment, and applicants should submit
p.000045: them as such to the HDEC for review.
p.000045: Temporary halts
p.000045: 210. Where a study is halted temporarily (for example for reasons of participant safety), applicants must notify
p.000045: the HDEC of this as soon as possible but in any case within seven calendar days.
p.000045: 211. Temporary halts are considered to be a type of amendment, and applicants should submit them as such to the
p.000045: HDEC for review. Similarly, the recommencement of a study following a temporary halt is considered to be a type of
p.000045: amendment. If a study that has been temporarily halted concludes or is terminated early, applicants should notify the
p.000045: HDEC in the normal way (see below).
p.000045: Protocol deviations/violations
p.000045: 212. A protocol deviation is any change, divergence or departure from the study design or procedures of a research
p.000045: protocol that is under the investigator’s control and that has not been approved by an HDEC. A protocol violation is a
p.000045: deviation that may affect participants’ rights, safety or well-being, or the completeness, accuracy and reliability of
p.000045: the study data. Deviations/violations may occur without the knowledge or permission of the sponsor or the CI, and may
p.000045: constitute fraud or misconduct.
p.000045: 213. Where a protocol deviation/violation meets the definition of ‘substantial’ set out at section 11 of these
p.000045: SOPs, applicants must submit it to the HDEC for review.
p.000045: 214. As is the case for amendments, it is in the first instance the responsibility of the study team to decide
p.000045: whether a protocol deviation/violation is substantial. Where there is doubt as to whether a protocol
p.000045: deviation/violation is substantial, the study team may submit it to an HDEC. Once validated, an HDEC must review a
p.000045: protocol deviation/violation through the expedited review pathway.
p.000045: 215. Where a protocol deviation/violation is necessary to protect participants from an immediate hazard to their
p.000045: health and safety, the study team should notify the HDEC as an urgent safety measure (see above).
p.000045: 216. Where a protocol deviation/violation is necessary due to errors, omissions or inadequacies in the protocol or
p.000045: other study documents, the sponsor and CI are responsible for making appropriate amendments. If the amendments are
p.000045: substantial,
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000046: 46
p.000046:
p.000046: the HDEC must review and approve them in the normal way before they are implemented.
p.000046: Reconsideration of HDEC approval
p.000046: 217. HDECs should keep all approvals for all studies under review at all times. However, other than by means of the
p.000046: documents applicants are required to submit under this section, HDECs are not themselves responsible for proactively
p.000046: monitoring approved studies. Primary responsibility for such monitoring lies at all times with the study sponsor and
p.000046: the CI.
p.000046: 218. An HDEC may reconsider the approval in place for any study at any time on the basis of information contained
p.000046: in:
p.000046: 218.1. an annual progress report
p.000046: 218.2. a notification of an urgent safety measure or temporary halt of the study
p.000046: 218.3. a substantial protocol violation or deviation
p.000046: 218.4. the cancelation of locality approval for a locality in the study (see section 10)
p.000046: 218.5. any other information received by the HDEC in writing from any party which the chair considers, on reasonable
p.000046: grounds, may give grounds for suspending or cancelling approval.
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000019: 65.2. the meeting follows and respects the agenda
p.000019: 65.3. the HDEC reaches clear decisions on all matters before it
p.000019: 65.4. the meeting allows all members present a reasonable opportunity to participate in discussion.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000020: 20
p.000020:
p.000020: 66. Where the chair is unable to attend a meeting, the HDEC must elect an acting chair at the start of the
p.000020: meeting by majority vote of appointed members present. While it may elect any appointed member for this purpose, it
p.000020: should usually identify in advance the member who will be expected to act in the absence of the chair.
p.000020: Quorum
p.000020: 67. The quorum for any HDEC meeting is five members (including the chair or acting chair), of whom at least two
p.000020: must be lay members and at least two non-lay members. Members should make all reasonable attempts to attend meetings in
p.000020: person, but may if necessary attend by video conference (or, exceptionally, teleconference).
p.000020: 68. Where there is no quorum, an HDEC may not commence, continue or conclude a discussion on any item of business
p.000020: relating to any application, and may not take any decision on any matter.
p.000020: Co-opted members
p.000020: 69. Where a meeting would otherwise be inquorate, the chair or acting chair may co-opt up to two appointed
p.000020: members of other HDECs for that meeting. Co-opted members count towards quorum and may participate fully in
p.000020: decision-making. However, the meeting may not elect them to act as chair, and may not delegate them with authority to
p.000020: make final decisions on items of business on which no final decision is made at the meeting.
p.000020: 70. The minutes for any HDEC meeting at which members have been co-opted must note that they have been co-opted
p.000020: before the meeting declares a quorum or discusses any substantive item of business.
p.000020: 71. Where the chair of an HDEC believes it will be necessary to co-opt members in order to meet quorum, the HDEC
p.000020: secretariat is responsible for contacting members of other HDECs to arrange this. Neither HDECs nor their chairs may
p.000020: insist on co-opting a named member of another HDEC.
p.000020: 72. An individual member may not be co-opted more than three times in any 12-month period.
p.000020: Potential conflicts of interest
p.000020: 73. HDEC members must be mindful to avoid situations that might compromise the impartiality and integrity of the
p.000020: HDEC review process.
p.000020: 74. In particular, members should declare any potential conflict of interests they have or may reasonably be
p.000020: perceived to have in relation to any item of business the HDEC is considering. The chair must remind all members
p.000020: present at a meeting to declare potential conflicts of interest prior to discussion of each item of business.
p.000020: 75. Where a member declares a potential conflict of interest, the HDEC may decide, by consensus or vote, to:
p.000020: 75.1. require that the member leave the meeting room and take no part in the discussion or decision relating to that
p.000020: item of business, or
p.000020: 75.2. allow the member to remain in the meeting room and take a full part in the discussion and decision relating to
p.000020: that item of business.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
...
p.000029: 134. In addition to the information specified at paragraph 122, provisional approval letters must clearly state:
p.000029: 134.1. the established ethical standard(s) that the HDEC is not satisfied the study would meet on the basis of the
p.000029: information in the original application
p.000029: 134.2. the further information (or non-minor conditions) that the HDEC requires (or imposes) in order to make a final
p.000029: decision
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000030: 30
p.000030:
p.000030: 134.3. the number of days remaining on the 35- or 15-day review clock
p.000030: 134.4. the date by which the HDEC must receive a response from the applicant.
p.000030:
p.000030: Stopping and restarting the review clock
p.000030: 135. The 35- or 15-day review clock stops on the date of the provisional approval letter, and restarts on the date
p.000030: on which the HDEC receives a complete response. If an applicant submits an incomplete response, the review clock
p.000030: remains suspended. Where the HDEC receives a response that is incomplete, it should inform the applicant of this as
p.000030: soon as possible.
p.000030: 136. A complete response must be received within 90 calendar days of the date of the provisional approval letter.
p.000030: The secretariat should send a reminder of this request after 60 calendar days.
p.000030: 137. Where the HDEC does not receive a complete response after 90 calendar days, the application or substantial
p.000030: amendment will be considered to have been withdrawn. The secretariat must confirm this.
p.000030: Authority for considering further information – full review
p.000030: 138. In order to ensure compliance with the relevant review clock for making a final decision, an HDEC may not
p.000030: require that a response be considered by the full committee at a future meeting. Instead, the HDEC must clearly
p.000030: delegate authority for checking the response and for making a final decision to either:
p.000030: 138.1. the chair (or acting chair) alone, or
p.000030: 138.2. the chair (or acting chair) in consultation with one or more named members who contributed to the decision to
p.000030: provisionally approve the application, or
p.000030: 138.3. the secretariat.
p.000030: 139. In delegating authority to make a final decision, the HDEC should consider the significance of the further
p.000030: information requested or conditions imposed. If the requirement is straightforward or administrative, the secretariat
p.000030: may take responsibility for it. However, the chair (and, potentially, other members) should review the response if
p.000030: substantive questions of ethical judgement are likely to arise.
p.000030: 140. Notwithstanding the above, the chair may make a final decision on any provisionally approved application or
p.000030: substantial amendment where he or she believes, on reasonable grounds, that this is necessary to ensure respect for the
p.000030: 35-day review clock. This might be the case, for example, if other members became unavailable at short notice.
p.000030: Authority for considering further information – expedited review
p.000030: 141. Where the expedited review pathway results in a grant of provisional appeal, the subcommittee responsible for
p.000030: the original decision should usually consider any further information submitted. Where this is not possible, the chair
p.000030: (or acting chair) should consider the information and make a final decision.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000031: 31
p.000031:
p.000031: 8. HDECs and the Accident Compensation Act 2001
p.000031:
p.000031:
p.000031:
p.000031: Introduction
p.000031: This section explains the statutory role of HDECs under the Accident Compensation Act 2001 (‘the ACC Act’). This Act
p.000031: excludes participants injured as a result of treatment received as part of some clinical trials from access to
p.000031: compensation through New Zealand’s no-fault compensation scheme.
p.000031: In this section, the role of HDECs is interpreted consistently with the Government response to the Health Committee’s
p.000031: clinical trials inquiry. This response provided that HDECs are not responsible for considering local research
p.000031: governance issues (such as locality-specific insurance and indemnity arrangements).
p.000031: No major changes have been made to this section following consultation.
p.000031:
p.000031:
p.000031:
p.000031:
...
p.000052: Human tissue Has the meaning given to it by the Human Tissue Act 2008
p.000052: ICH International Conference on Harmonisation of Technical Requirements for
p.000052: Registration of Pharmaceuticals for Human Use
p.000052: Intervention study Has the meaning given to it by the Ethical Guidelines for Intervention Studies;
p.000052: namely, a study in which investigators control and study the intervention(s) provided to participants
p.000052: Investigator Any investigator on a study who is not the CI. This includes investigators who
p.000052: are responsible for the conduct of a study at a given locality (or at a site within that locality). A study may have
p.000052: any number of investigators. The CI of a study may also be the lead/principal investigator at one or more localities
p.000052: Investigator’s brochure A document summarising the clinical and other data relating to a new medicine that are
p.000052: relevant to the study of the product in human participants
p.000052: Locality An organisation responsible for a hospital, health centre, surgery or other
p.000052: establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be
p.000052: conducted
p.000052: Locality review The process by which a locality assesses its suitability for the safe and
p.000052: effective conduct of an intervention study
p.000052: Medical device Has the meaning given to it by the Medicines Act 1981 Medicine
p.000052: Has the meaning given to it by the Medicines Act 1981
p.000052: Medsafe New Zealand Medicines and Medical Devices Safety Authority
p.000052: Minor amendment Any amendment to a previously approved study that is not a substantial amendment
p.000052: NEAC National Ethics Advisory Committee
p.000052:
p.000052:
p.000052:
p.000052: Standard Operating Procedures for Health and Disability Ethics Committees, version 1.0 (May 2012)
p.000053: 53
p.000053:
p.000053: New medicine Has the meaning given to it by the Medicines Act 1981
p.000053: Observational research Has the meaning given to it by the Ethical Guidelines for Observational Studies; namely,
p.000053: an observational study that involves participants but in which investigators do not control and study the
p.000053: intervention(s) provided to them, if any
p.000053: Observational study Has the meaning given to it by the Ethical Guidelines for Observational Studies;
p.000053: namely, a study in which investigators do not control and study the intervention(s) provided to participants, if any
p.000053: Participant An individual who actively participates in a study. HDEC review of a study may
p.000053: be required where participants are recruited in their capacity as:
p.000053: consumers of health and disability support services, or
p.000053: relatives or caregivers of such consumers, or
p.000053: healthy volunteers in clinical trials
p.000053: Post-approval item An item of business (such as an amendment, annual progress report, final report,
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| disability | Mentally Disabled |
| educational | education |
| embryo | embryo |
| hazard | Natural Hazards |
| healthy volunteers | Healthy People |
| incapacity | Incapacitated |
| injured | injured |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| student | Student |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| healthy volunteers | ['volunteers'] |
| volunteers | ['healthyXvolunteers'] |
Trigger Words
capacity
consent
cultural
ethics
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input