Guidance for Cerebral Palsy Alliance Funded Studies Affected by COVID-19

17th March 2020

The safety of research participants and research staff is our highest priority and will guide all of our decision-making in the event that COVID-19 affects funded research study operations.

The COVID-19 situation is unprecedented and plans are constantly updated to reflect the best-available information.

Purpose

The purpose of this notice is to provide guidance outlining the flexibilities available to recipients conducting Cerebral Palsy Alliance Research Foundation funded research trials and human studies, that are impacted by the COVID-19 public health emergency.

Safety Principles

Researchers and Institutions should take all measures necessary to ensure the safety of all human participants and research staff involved in Cerebral Palsy Alliance Research Foundation funded research trials and human studies. We recommend consultation with your Human Research Ethics Committee/IRB.

Examples of recommended safety measures include:

• Limiting study visits to those needed for participant safety
• Converting all face-to-face study visits to virtual study visits where feasible
• Cancelling data collection procedures in hospitals for out-patients and community members, and converting these study visits to virtual study visits where feasible, to promote infection control
• Cancelling conferences/ gatherings / data collection procedures of 10 or more people
• Arranging flexibilities for required medication prescription/administration over the phone and via delivery services
• Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
• Allowing adverse event data collection over the phone
• Cancelling all international travel
• Suspending non-essential domestic travel

Unanticipated Costs

As a result of COVID-19, Cerebral Palsy Alliance Research Foundation grant recipients may incur unanticipated research costs. For example:

• Costs incurred to arrange for participants to receive care at their local sites or virtually, rather than the study site, for required visits
• Supply chain disruptions
• Personnel disruptions due to illness or closure of facilities
• Additional lab testing (e.g. for COVID-19)
• Increased transportation costs

We grant researcher’s permission to redirect their existing budget to improve the safety of enrolled participants due to impacts of COVID-19. We do not require you to submit a protocol revision to our funding agency to enact urgent public health safety precautions.

If you need to cancel travel it is unlikely that you will be covered for coronavirus-related medical or cancellation expenses, apart from a few exceptions. Cerebral Palsy Alliance is a not-for-profit organisation and is unable to financially under right travel cancellation losses.

Delays in Research Progress

To promote participant health and safety, and continuity of research during this public health emergency, Cerebral Palsy Alliance Research Foundation will allow a no-cost extension to a grant as research timelines will inevitably lengthen.

Grant recipients may extend the duration of their approved project on active grants for up to 12 months by submitting a letter of variation outlining the new timeline to Cerebral Palsy Alliance Research Foundation.

We anticipate many researchers will need to make research protocol variations to improve participant’s safety, which may limit their ability to answer their original research questions. Progress reports should outline:

• proposed date of effect of protocol changes
• reason for the proposed changes
• impact on study viability and rigour

In cases where the original question can no longer be answered, decisions to continue scheduled grant payments will be considered on a case-by-case basis.

Payment schedules

We intend to honor existing financial commitments to funded grants. However, to reflect the impact of COVID-19 on the global research landscape and inevitable delays in study progress, Cerebral Palsy Alliance Research Foundation will automatically assume a six month delay in payment schedules unless there are extenuating circumstances, which will be assessed on a case by case basis.

Relinquish a Grant

In some circumstances research studies will need to be suspended or closed due to impacts of COVID-19.

If you decide to close a research project due to impacts of COVID-19, you can relinquish the unspent funds to Cerebral Palsy Alliance Research Foundation by providing a letter of termination, that includes:

• proposed date of effect
• reason for the termination

Unspent returned funds will be redirected to other projects that meet people with cerebral palsy’s research priorities.