JDRF Australia and T1DCRN Research Support for COVID-19

The COVID-19 pandemic is having an unprecedented impact on all areas of healthcare, medicine and research. In response, JDRF Australia is aiming to minimise the impact for our award recipients and ongoing projects as much as possible, while prioritising the safety of patients, healthcare providers and the community. We are committed to engaging closely with our recipients during this time, and plan to work with individual research teams to identify and successfully address specific challenges being faced in the current environment.

Please note that this information is intended to provide guidance and recommendations for award recipients of funding from JDRF Australia via the Type 1 Diabetes Clinical Research Network and does not imply contractual changes between JDRF Australia and the institution. It does not apply to research contracted directly between an Australian institution and JDRF International – any implications for such research will be communicated separately.

Contingency planning and project continuity

JDRF Australia is aware that study teams are undertaking contingency planning to address the potential impacts of COVID-19 across their projects. These impacts include:

        – Participant and staff availability, including as a result of quarantine restrictions or reallocation to other projects

        – Institute, site and laboratory closures

        – Travel bans

        – Supply issues

        – Animal study issues

        – Access to clinical samples

        – Subcontractor commitment

        – Quarantine of bio-samples by customs

 We recommend that the following steps are considered by study teams:

1. Review existing policies and procedures and update these in line with changes in government policy, public health advice and the needs of those conducting or participating in the research project. In some cases, new policies may need to be implemented.

2. Teams should have a research contingency plan that documents the approach that will be taken to ensure continuity of projects, minimise impact, and manage study conduct and participant safety where relevant.

3. Changes may be required to policies and procedures around supply of study materials, laboratory or site closures, the informed consent process, study visits and procedures, data collection, study monitoring, ethics approval, or adverse event reporting. Any changes should be compliant with current government restrictions.

Protocol variations

At JDRF Australia we understand that some contingency plans will impact on the current study plans and design. We will be as pragmatic as possible during this period and will consider variation requests for the following:

       – Deferral of project commencement
       – Deferral of milestones
       – No cost extensions
       – Protocol amendments (such as remote monitoring, phone follow-up, reduction in monitoring visits, changes in statistical analysis)
       – Change of investigator(s)
       – Extension of project end date

If your research has been impacted in a manner such as those above please contact JDRF Australia or identify the impact when JDRF Australia contacts you.

Recruitment for clinical studies and remote visits

JDRF Australia supports remote recruitment and monitoring where possible. However, we advise staff to be aware of the ethics and privacy implications if medical records are accessed remotely or in public areas. Trial participants may need to provide additional prior consent to remote sharing of their information and be assured that confidentiality be maintained.

Budgets

We recognise that there may be implications to project budgets or the achievement of milestone payments. We encourage project teams to contact us to discuss individual situations.

Safety and reporting

Many clinical research projects are being put on hold or deferring follow-up visits. We ask that during this time clinical trials continue to monitor the safety of participants and continue to report according to the requirements of the HREC/RGO.

Additionally, protocol amendments, such as changes to the way participant visits occur, may need to be reported to the HREC. Please check with your governing HREC to find out what circumstances require notification.

Significant protocol deviations

In the event that a protocol amendment impacts or may impact significantly on the original study design such as but not limited to power calculations due to a change in sample size, the statistical analysis plan, change in the primary outcome, change in the number of participants, change in the sample collection, duration of treatment etc, please consult JDRF Australia as soon as possible to discuss the impact.

Investigational product

For trials involving an investigational product, please be mindful of the requirements to ensure participants receive the product and measures are in place to document receipt. For further guidance on clinical trial management and continuity, please refer to the current guidelines from the Department of Health here. 

JDRF Australia Travel Grants Program

Due to global travel restrictions, JDRF has extended the deadline for travel grant applications for the current round to Monday 2 November 2020. Applicants are eligible to apply to for travel which occurs from Monday 2 November 2020 to Monday 17 May 2021.

Communication

We encourage you to consult with or inform JDRF Australia of any current or potential changes or impacts to your research projects at the earliest opportunity.

Please do not hesitate to contact us on crn@jdrf.org.au at any stage for further support or information.  

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