HDEC Chairs' Message to Sector – July 2019
Following a recent meeting of the Health and Disability Ethics Committee chairpersons, HDEC would like to communicate the following to the heath research sector.
Gaps in current guidance: HDEC acknowledges that there are ethical gaps and grey areas posed by current guidance and legislation. Cluster randomised trials, for example, are restricted by the difficulty in obtaining individual informed consent and the provisions of Right 7(4) (Code of Health and Disability Consumers’ Rights). Use of Statistics New Zealand’s Integrated Data Infrastructure also remains a point of ethical discussion, which involves the secondary use of increasing quantities of increasingly identifiable health data with no ethics oversight.
Standards of peer review: The quality of scientific peer reviews submitted to HDEC varies across applications. This is due to a lack of understanding as to what constitutes sufficient peer review. HDEC wishes to make it clear that review templates which have had their fields simply ticked will not be accepted. Additionally, researchers should not submit funding letters which provide committees with no assurance of sound peer review. It is acknowledged that the current ethics application form is ambiguous as to what is acceptable, and this will be updated to give better guidance once the change to a new IT system is complete. While it is not the job of an HDEC to assess the scientific validity of a study, it should be noted that committees reserve the right to request additional peer review on safety, and therefore ethical, grounds. So long as they remain the remit of HDEC, the need for strong peer review is emphasised for medical device trials. Researchers should refer to the appendices of the NEAC Ethical Guidelines.
Tissue samples sent overseas: In order to obtain informed consent, PISCFs must narrow the storage location to city. For future unspecified research, the time length of retention must be stated. As an important note, no information should appear in the CF which was not in the PIS. HDECs will also insist on samples being de-identified; date of birth is not acceptable, and if formatting requirements demand DOB a sham day/month can be used. For tissue stored within New Zealand, PISCFs should clearly state the tissue bank (name of the facility, etc).
Phase 1 study registration: Despite the conflict with FDA waivers, in the interest of transparency HDEC will require that all phase 1 clinical trials are registered.
Mother consenting for child after birth: This is a non-negotiable legal requirement, though committees will accept oral consent post birth, not exclusively written consent.
Internet of things: When studies involve devices which involve both the active and passive collection of data, researchers must include in the PISCF who is holding these data and where these are going (for example, relevant third parties must be disclosed).
Demarcating investigator-led from commercial studies: HDEC has judged that if datasets are to be sent to the sponsor (ie, the sponsor has privileged access to data), then the study will be considered ‘commercially sponsored’. The criterion of control over the publication of results is sufficient but not necessary to make this determination.
Sufficient compensation: Sponsor insurance must not be companywide but study-specific (insurance certificate names the protocol), and signed.
Requesting a closed HDEC meeting: The starting point for considering any request to close an HDEC meeting are the principles of availability and a presumption of openness. That is, information must be made available unless there is a good reason for withholding it. See section 9(2)(b)(ii) of the Official Information Act, where withholding is necessary to:
(b) protect information where the making available of the information—
(ii) would be likely unreasonably to prejudice the commercial position of the person who supplied or who is the subject of the information.
The test under section 9(2)(b)(ii) is whether release of the information at issue would be likely to unreasonably prejudice the third party’s commercial position. A mere assertion of prejudice will not be sufficient; nor will vague and unsubstantiated references to ‘commercial sensitivity’ or ‘confidentiality’. Any request by an applicant or sponsor to close an HDEC meeting discussion and minutes must be accompanied by evidence that:
- demonstrates that the Applicant or Sponsor has a commercial position; and
- explains how release of the information at issue would be likely to unreasonably prejudice that position.
Before making the decision on a request, HDEC may consult the Applicant or Sponsor in advance of the meeting.
As an aside on the Official Information Act, HDEC is administered by the Ministry of Health and all documents submitted as part of ethics applications are deemed ‘official information’. Any OIA request pertaining to these must therefore be considered. However, section 9(2)(ba)(i) and (ii) of the Act also allows for the withholding of this information if it is necessary to:
(ba) protect information which is subject to an obligation of confidence or which any person has been or could be compelled to provide under the authority of any enactment, where the making available of the information—
(i) would be likely to prejudice the supply of similar information, or information from the same source, and it is in the public interest that such information should continue to be supplied; or
(ii) would be likely otherwise to damage the public interest