Meeting date: / 14 February 2017
Meeting venue: / Sudima Hotel, Christchurch Airport, 550 Memorial Drive, Christchurch
Time / Item of business
12:00pm / Welcome
12:05pm / Confirmation of minutes of meeting of 24 January 2017
12:30pm / New applications (see over for details)
i 17/STH/6
ii 17/STH/7
iii 17/STH/19
iv 17/STH/11
v 17/STH/13
vi 17/STH/14
vii 17/STH/17
viii 17/STH/9
2:50pm / General business:
· Noting section of agenda
3:00pm / Meeting ends
Member Name / Member Category / Appointed / Term Expires / Apologies?
Ms Raewyn Idoine / Lay (consumer/community perspectives) / 27/10/2015 / 27/10/2018 / Present
Mrs Angelika Frank-Alexander / Lay (consumer/community perspectives) / 27/10/2015 / 27/10/2018 / Present
Dr Sarah Gunningham / Non-lay (intervention studies) / 27/10/2015 / 27/10/2018 / Present
Dr Nicola Swain / Non-lay (observational studies) / 27/10/2015 / 27/10/2018 / Present
Dr Mathew Zacharias / Non-lay (health/disability service provision) / 27/10/2015 / 27/10/2018 / Apologies
Dr Devonie Eglinton / Non-lay (intervention studies) / 13/05/2016 / 13/05/2019 / Present
Assc Prof Mira Harrison-Woolrych / Non-lay (intervention studies) / 27/10/2015 / 27/10/2018 / Present
Dr Fiona McCrimmon / Lay (the law) / 27/10/2015 / 27/10/2018 / Present
Welcome
The Chair opened the meeting at 12:00pm and welcomed Committee members, noting that apologies had been received from Dr Mathew Zacharias.
The Chair noted that the meeting was quorate.
The Committee noted and agreed the agenda for the meeting.
Confirmation of previous minutes
The minutes of the meeting of 24 January 2017 were confirmed.
New applications
1 / Ethics ref: / 17/STH/6Title: / A longitudinal study of dental health status of New Zealand children
Principal Investigator: / Associate Professor John Thompson
Sponsor:
Clock Start Date: / 27 January 2017
No member of the research team was present for discussion of this application.
Potential conflicts of interest
The Chair asked members to declare any potential conflicts of interest related to this application.
No potential conflicts of interest related to this application were declared by any member.
Summary of Study
1. The Committee stated that this study may be valuable and provide useful information to improve dental health, however, a number of ethical concerns have not been sufficiently addressed in the application.
Summary of ethical issues (outstanding)
The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows.
2. The Committee noted that in the application form the researcher had not identified any ethical concerns, however, this application involves a number of concerns including the use of health information from a vulnerable population group (children) without informed consent.
3. The Committee stated that this application was confusing and it was unclear whether participants would provide informed consent. The application form indicates that participants have already provided informed consent, however, no Participant Information Sheet was provided. The Committee stated that it appeared that the Researcher may be indicating that consent to their child’s enrolment in the dental programme should be considered consent to their data being used for research, however, the statement in the application form indicates that participants’ parents were told that data may be accessed by other health care professionals, but not that it may be used for research. The Committee stated that insufficient information regarding this has been provided.
4. If the Researcher believes that the form used to enrol children in the dental programme provides sufficient information for the parents to make an informed decision regarding their child’s data being used in research, the Committee requested that this form is provided with any future application to allow this to be assessed by the Committee.
5. Based on the information provided in the application, the Committee continued to assess this application on the basis that it involves the use of health information without informed consent.
6. The Committee noted that participants have a right to know that their health information is being used in research. Right 6(1)(d) of the HDC Code of Rights states:
o Every consumer has the right to information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including … notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval.
7. The Committee noted that they can approve access to identifiable health information without consent for research in certain circumstances. The Ethical Guidelines for Observational Studies states at Paragraph 6.43:
o Access to identified or potentially identifiable data for research without the consent of the people the data identifies or makes potentially identifiable may be justifiable when:
§ the procedures required to obtain consent are likely to cause unnecessary anxiety for those whose consent would be sought; or the requirement for consent would prejudice the scientific value of the study; or it is impossible in practice to obtain consent due to the quantity or age of the records; and
§ there would be no disadvantage to the participants or their relatives or to any collectives involved; and
§ the public interest in the study outweighs the public interest in privacy.
8. To approve a study involving access to health information without consent the Committee must be satisfied that these requirements are met by the study concerned. The Committee stated that this application does not provide sufficient justification.
9. The Committee were unsatisfied with the quality and independence of the peer review provided, please provide further evidence of review.
10. The Committee noted that the applicant has indicated that this research area is of specific concern for Māori, however, they have not indicated that formal Māori cultural consultation will be obtained. The Guidelines for Researchers on Health Research Involving Māori state that as a general rule, consultation should take place if Māori are to be involved as participants in a project or the project relates to a health issue of importance to Māori.
Decision
This application was declined by consensus, as the Committee did not consider that the study would meet the following ethical standards.
· Please provide information regarding the proposed cultural consultation process for this study.
· Please provide evidence of favourable independent peer review of the study protocol (Ethical Guidelines for Observational Studies Appendix).
· The Committee were not satisfied with the justification provided for the use of health information without consent. The Ethical Guidelines for Observational Studies states at Paragraph 6.43:
o Access to identified or potentially identifiable data for research without the consent of the people the data identifies or makes potentially identifiable may be justifiable when:
§ the procedures required to obtain consent are likely to cause unnecessary anxiety for those whose consent would be sought; or the requirement for consent would prejudice the scientific value of the study; or it is impossible in practice to obtain consent due to the quantity or age of the records; and
§ there would be no disadvantage to the participants or their relatives or to any collectives involved; and
§ the public interest in the study outweighs the public interest in privacy.
Title: / The pathway of stroke survivor's transfer to aged residential care after first ever stroke
Principal Investigator: / Dr Julia Slark
Sponsor:
Clock Start Date: / 02 February 2017
No member of the research team was present for discussion of this application.
Potential conflicts of interest
The Chair asked members to declare any potential conflicts of interest related to this application.
No potential conflicts of interest related to this application were declared by any member.
Summary of Study
1. The Committee noted that despite references to the participant’s family members being involved in this study, the Researcher had clarified prior to the meeting that no family members of participants were intended to be involved, and all participants would provide their own informed consent. These references to family members were accidentally left over from earlier versions of study documents.
Summary of ethical issues (outstanding)
The Committee requested the following changes to the Participant Information Sheet and Consent Form:
2. The Committee requested that the Participant Information Sheet is revised to not refer to participants as ‘stroke survivors’ they consider that ‘people recovering from a stroke’ is a more suitable term.
3. Please reformat the Participant Information Sheet to increase the white space and improve readability.
4. The Committee suggested that it may be beneficial to clarify in the Participant Information Sheet what kind of information about their stroke may be accessed by researchers.
5. Please state in the benefits section of the Participant Information Sheet that there are no expected benefits.
6. Please add a Māori cultural support contact number.
7. The Committee questioned the statement in the Consent Form where participants can agree or not agree to being digitally recorded, they stated that their understanding was that if participants wanted to be in the study they must agree to being recorded. If this is optional please explain in the Participant Information Sheet what the options are, in addition to this statement in the Consent Form, if it is not optional please revise this statement in the Consent Form for clarity.
8. Please add a header and footer to the Participant Information Sheet, the footer should include page numbers.
Decision
This application was approved by consensus, subject to the following non-standard conditions:
· Please amend the information sheet and consent forms, taking into account the suggestions made by the committee (Ethical Guidelines for Observational Studies para 6.10)
Title: / HARPE
Principal Investigator: / Dr Barney Montgomery
Sponsor:
Clock Start Date: / 02 February 2017
Dr Barney Montgomery was present by teleconference for discussion of this application.
Potential conflicts of interest
The Chair asked members to declare any potential conflicts of interest related to this application.
No potential conflicts of interest related to this application were declared by any member.
Summary of ethical issues (resolved)
The main ethical issues considered by the Committee and addressed by the Researcher are as follows.
1. The Committee questioned when Māori consultation would be undertaken. The Researcher explained that they have been undertaking consultation throughout the process of developing this application. The Committee noted that the application states that consultation will be sought and no indication has been given that consultation is currently happening.
Summary of ethical issues (outstanding)
The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows.
2. The Committee questioned whether this study was being conducted principally for the benefit of the manufacturer of the study device. The Committee noted that the company conducting the study is a commercial clinical trial unit and they would not expect them to be conducting an investigator initiated trial, additionally the manufacturer is fully funding this trial. The Researcher explained that they had initiated this study and approached the manufacturer for a grant, further, the manufacturer will have no control over the conduct of this study or the publication of the results.
3. The Committee expressed their reservations regarding whether this study is not being conducted principally for the benefit of the manufacturer, and, consequently, whether participants would be eligible for compensation for ACC. HDECs have a responsibility to check that at least ACC-equivalent compensation is available to participants in clinical trials that are not covered by the accident compensation scheme (paragraph 8.5 of the Ethical Guidelines for Intervention Studies).
4. The Researcher indicated that they have written the study protocol, rather than the manufacturer, and have consulted with some tobacco researchers to ensure a suitable study design. The Committee noted that it appeared that the protocol was in fact written by Pharmaceutical Solutions Ltd.
5. The Committee questioned whether the researchers have a clinical trial agreement with the manufacturer and whether the manufacturer will have any access to study results or data. The Researcher explained that the manufacturer will only have access to the study data that will be publically available following the study. The Committee stated that they would like to see the clinical trial agreement that documents the manufacturer’s involvement in the study, as they still have reservations regarding whether the study is conducted principally for the benefit of the manufacturer.
6. The Committee requested that the Researchers obtain an independent legal opinion regarding whether this study is being conducted principally for the benefit of the manufacturer of the device being tested. The Committee stated that evidence of suitable insurance and indemnity to provide at least ACC equivalent compensation to participants will need to be provided if it is determined that this study is being conducted principally for the benefit of the manufacturer of the product being tested.
7. The Committee stated that the information they have available regarding the legality of the study product indicates that the distribution of this product is prohibited in New Zealand. This is because “heat not burn” products are considered tobacco products for oral use, and as they are not smoked their sale and distribution in New Zealand is prohibited under Section 29(2) of the Smoke-free Environments Act 1990.
8. Section 29(2) provides:
o “Tobacco product not to be advertised or labelled as suitable for chewing, etc
No person shall import for sale, sell, pack, or distribute any tobacco product labelled or otherwise described as suitable for chewing, or for any other oral use (other than smoking).”
9. Paragraph 15 of the HDEC Standard Operating Procedures states:
o "Researchers and sponsors are responsible for ensuring that their health and disability research is conducted lawfully. HDECs need to be satisfied that any research approved by the Committee is consistent with NZ law. An HDEC may not approve an application that is inconsistent with NZ law, even if that application is consistent with ethical guidelines."
10. The Researcher responded that their view is that the device is not prohibited under this section of this act, the Researcher indicated that they have received legal advice that this product does not fall inside Section 29 of the Smoke-free Environments Act 1990. The Committee stated that the information available from the Ministry of Health clearly states that “heat not burn” tobacco products are included under Section 29 and their distribution is prohibited in New Zealand. The Researcher explained that the manufacturer is currently disputing this with the Ministry of Health. The Committee responded that they may be able to reconsider their view that the distribution of this product for the purposes of this study is prohibited if independent legal advice is provided indicating that this device can be legally distributed in New Zealand, the Committee also stated that they may need to seek their own legal advice in this case.