The following provides an update to researchers who have studies impacted by Alert Level 3 and 4.
During Levels 3 and 4, the HDECs acknowledge that studies may need to deviate from their approved protocols. The HDEC Emergency Standard Operating Procedures (ESOP) outlines the process that should be followed for amendments to approved studies.
Please note that the recent Level 4 lockdown coincided with the roll over from Online Forms to the Ethics Review Manager (ETHICS RM)(external link). New post approval forms can be created in ETHICS RM from 1 September 2021 onwards. Unless the amendment is high risk or related to participant safety, we ask that you record any amendments or deviations and submit them from 1 September, following the guidance below.
If you are unsure, please contact the HDECs Secretariat at HDECS@health.govt.nz
The following applies to any studies which require amendment due to impacts caused by COVID-19.
Guidance for Amendments to Existing Approved Studies Impacted by Wider COVID -19 Response
- Ensuring the safety of trial participants and study staff is paramount.
Co-ordinating Investigators should consider each circumstance, focusing on the potential impact on the safety of trial participants and staff, and modify study conduct accordingly.
- Study decisions may include those regarding continuing trial recruitment, continuing use of the investigational product for patients already participating in the trial, and the need to change participant monitoring during the trial. In all cases, it is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.
- It may be the case that a participant’s safety, welfare, and rights are best served by continuing their participation in the trial as per the protocol or by discontinuing the administration or use of the investigational product or even their participation in the trial. Such decisions will depend on specific circumstances, including the nature of the investigational product, the ability to conduct appropriate safety monitoring, the potential impact on the investigational product supply chain, and the nature of the disease under study in the trial.
- Since trial participants may not be able to come to the investigational site for protocol-specified visits, sponsors, researchers and sites should evaluate whether alternative methods for safety assessments (e.g. phone contact, virtual visit, alternative location for assessment, including local labs, imaging centres) could be implemented when necessary and feasible, and would be sufficient to ensure the safety of trial participants.
- Co-ordinating Investigators should determine if in-person visits are necessary to fully assure the safety of trial participants (for example, to carry out procedures necessary to assess safety or to ensure the safe use of the investigational product) and should follow hospital policy in doing so. In making the decision to continue the use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach.
- In some cases, trial participants who no longer have access to the investigational product or the investigational site may need additional safety monitoring (e.g. withdrawal of an active investigational treatment).
- The need to put new processes in place or to modify existing processes will vary by the protocol and local situation. For example, this assessment could include consideration of whether it is appropriate to delay some assessments for ongoing trials, or, if the study cannot be properly conducted under the existing protocol, whether to stop ongoing recruitment, or even withdraw trial participants.
Amendment Requirements and Process
- Substantial study amendments are typically not implemented before review and approval by the HDECs. Co-ordinating Investigators are encouraged to engage with the HDECs as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19.
- Such changes to the protocol or investigational plan to minimise or eliminate immediate hazards or to protect the life and well-being of research participants (e.g. to limit exposure to COVID-19) may be implemented without HDEC approval or before filing an amendment to the HDECs but are required to be reported afterwards as protocol deviations or violations.
- The HDECs encourage sponsors and Co-ordinating Investigators to establish procedures to prioritise the reporting of deviations that may impact the safety of trial participants.
- The implementation of alternative processes should be consistent with the protocol to the greatest extent possible. Sponsors and Co-ordinating Investigators should document the reason for any contingency measures implemented.
- Sponsors, researchers, and sites should document how restrictions related to COVID-19 led to the changes in study conduct and the duration of those changes and indicate which trial participants were impacted and how those trial participants were impacted.
- If researchers have submitted and received approval for an amendment of protocol under Alert Level 3 or 4 of the (and have since reverted back to the pre COVID-19 approved protocol in Alert Level 1 or 2) you are not required to submit an amendment again if the National COVID-19 alert level increases. Instead, the HDECs ask that this this be communicated in the next annual progress report.
Reporting Requirements for Substantial Changes
- Current studies requiring a substantial amendment in accordance with Section 11 of the HDEC SOPs will be expedited under the Emergency Meeting pathway.
- A risk-based approach must be used to determine whether a change is so significant that it requires ethics review prior to implementation. This is likely to apply to prepared changes to studies that will add a COVID-19 element to their conduct.
- If the research team fails to submit a substantial amendment prior to implementation this will be treated as a substantial protocol deviation or violation and will require submission as soon as practicable.
- It may be appropriate for some deviations to the study protocols to occur without prior notification to the HDECs. Where they are required for urgent safety measures, they must be reported to the HDECs as soon as practicable but must be reported within a month of the deviation. However, where the deviations are due to government requirements and do not significantly impact on participant safety (such as verbal/electronic consent, remote check-ups etc.), these can be reported as a summary as part of the annual progress report process.
Reporting Requirements for Non-substantial Changes
- Notification to the HDECs is not required for non-substantial amendments as defined in Section 11 of the HDEC SOPs. All cases of minor changes must be reported to the HDECs in the next annual progress report.