Treatment studies that provide essential therapeutic support for patients, or where cessation of treatment may negatively impact outcomes, may continue with in-person visits, though study teams should contact patients before visits to confirm that patients are not displaying COVID-19 symptoms. Non-essential treatment studies or observational studies should be discontinued.
The Research Management Group will continue budget and contract negotiations to prepare new studies for activation, and will process active study amendments. Please submit requests to rmg_ct_Intake@stanford.edu. Activation of new treatment studies or clinical observation studies will be evaluated and require approval by the Chair and Senior Associate Dean for Research. Studies deemed essential (e.g. for COVID – 19, cancer treatment) will be prioritized.
Other non-essential treatment studies should not initiate patient or in-person visits or enrollment during the COVID-19 pandemic to comply with CDC and FDA recommendations as well as local ordinances designed to protect participants, researchers and the community from risk of infection. We are committed to ensuring ongoing access to research that provides essential care to participants.
COVID STUDIES: Researchers considering any COVID-19 clinical research, including studies that require Institutional Review Board (IRB) approval as well as quality improvement projects, are required to complete a short survey at COVID-19 Clinical Research Review. More information on this process is on the IRB Website: https://researchcompliance.stanford.edu/panels/hs
#1 What is essential and non-essential research?
Memo from Ruth O’Hara, Senior Associate Dean for Research
In general, “essential” clinical research involves
- ongoing treatment studies that provide essential therapeutic support for our patients, or
- where cessation of the treatment could negatively impact patient outcomes and
- clinical research that obtains critical, in-person observations or laboratory measures on vulnerable patients or populations where not obtaining these observations could negatively impact patient safety
Even for “essential” clinical research, non-essential visits or follow-up visits for these essential treatment trials or clinical observational studies should be postponed or conducted virtually where possible.
Determination of which treatment trials or clinical observation studies can continue as usual with in-person visits should be made in consultation with your Department Chair, Division Chief, or your Institute Director. In addition, Ruth O’Hara, Senior Associate Dean for Research must review and approve. All necessary safety precautions should be taken for all in-person visits.
#2 The Shelter-in-Place ordinance limits the type of work we can do on our active industry sponsored clinical trials and we have not received any communication from the study sponsor, what steps do we need to take?
We suggest you contact the study’s Medical Monitor and/or directly reach out to the Sponsor and communicate our institution’s current position regarding on-going studies (option to use applicable language provided above) and request their guidance. If you are conducting a study that provides essential therapeutic support, you will need to request specific guidance from Sponsor (see below) on how to continue and then before proceeding discuss with SOM leadership, as noted above in FAQ #1. :
- determine clinical necessity of each in-person clinic visit and if applicable, options for study subjects to receive investigational drug or have blood samples taken etc. (i.e. use of 3rd party Home Health provider)
- discuss option of using telehealth visits (phone, video) to replace in-person visits or other required changes to protocol protect participant safety
- discuss FDA’s regulatory guidance
- review and follow Stanford IRB’s guidance as provided on their website
#3 We are spending a lot of additional unbudgeted time to manage new study logistics required due to COVID-19. What is required to request additional funding from Sponsor?
Although due to Stanford’s accounting practices we will not invoice sponsor on an hourly basis, it is important to track effort and specific activities required during the upcoming months so a budget amendment request with justification can be prepared and submitted to the sponsor.
If you have questions or need additional consultation, please submit to your questions/concerns by completing the COVID-19 Sponsor Notification and Request Form. Submit the form by attaching it to the Central Office Request in the SeRA system.To request a budget amendment, when you have a solid estimate of the total additional funding required with a justification document, submit to CT RMG Intake Team using our standard Amendment request process: http://med.stanford.edu/rmg/clinical-trials/post-award-management/amendments.html
#4 As a Clinical Research Coordinator, I know my salary is dependent on funding received from sponsors for clinical study activities. Since I am unable to conduct most of these activities, will I get laid off?
Stanford University has committed to pay employees, see online posts below and please contact your supervisor for additional information.
#5 Salary support for my entire research team is dependent on funding received from sponsors for clinical study activities. Since we are unable to conduct most of these activities, will I need to lay off my team?
Stanford University has committed to pay employees, see online posts below and please consult with your DFA or HR Manger so they can coordinate staffing and resources.
#6 Since I’m required to work remotely, may I take study binders home?
Please review and follow Stanford Medicine’s Policy for the Removal and Transport of PHI: http://med.stanford.edu/md/mdhandbook/section-3-15-stanford-medicine-policy-for-the-removal-and-transport-of-phi.html
Regulatory and Research Compliance
For all questions related to human subject research, please contact the IRB:
Contact IRB education via email / (650) 724-7141 or your Panel Manager for questions and refer to Stanford Health Alerts and Stanford Health Care webpages for updates.
Stanford RCO Response to COVID-19
The Research Compliance Office (IRB, SCRO, APLAC) is operating with a full staff and conducting protocol review business as usual. Incoming questions, help tickets or other support services are also being maintained.
In an effort to eliminate apparent immediate hazards to subjects (45 CFR 46.108(3)(iii)) and the Stanford community, all in-person visits for non-essential human research activities must be postponed, while preserving critical activity on interventional treatment trials or critical clinical research. In light of this urgency around COVID-19, Stanford’s IRB is not requiring prior review of some protocol changes, e.g., implementing video/phone visits, mailing of study medications, or other changes designed to protect participant safety. Understanding that resources must be prioritized, please track these changes and file a modification in eProtocol when your schedule allows. The IRB is available to assist you with these modifications.
Per FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic:
- "Sponsors and clinical investigators are encouraged to engage with IRBs/IEC 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 minimize 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 IRB approval or before filing an amendment to the IND or IDE, but are required to be reported afterwards."
- "If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.