COVID-19 Guidance for Researchers
Published July 31, 2020 (HSR updated 8/27/2020)
An update regarding on the University’s Plan for Phased Continuity of the Research Enterprise (PDF), and regarding the submission and approval of research and scholarly activity requests. We will be moving to Phase 3 of the plan as of August 1st.
Phase 3 involves an increase in on-site research and scholarly activity and an expansion of allowable activity (limited to work that cannot be done remotely and is able to be done safely). During this phase we will continue to require submission of your not-previously submitted research and scholarly activity for approval using the request form which has been in place since March 24th. No previously approved research and scholarly activity needs to be resubmitted. Also, facilities and labs with approved reopening plans do not need to submit projects for approval, but must track and maintain records of their research activity internally as described in the Plan for Phased Continuity of the Research Enterprise (PDF).
As a reminder, additional COVID-19 Research Guidelines are available at the links below:
- Guidance for Research
- Graduate School Community Guidelines
- Office of Research Development Guidelines
- Office of Research Administration Guidelines
The response to COVID-19 continues to be a rapidly evolving situation even at this stage of the pandemic and this guidance is subject to change. Please be sure to regularly review available Research Guidelines at the above links. Also, please continue to regularly check the UMS Information page (https://www.maine.edu/health-advisory/) and the UMaine Information page (https://umaine.edu/coronavirus/).
Field Research – Updated 7/31/2020
Faculty and staff are encouraged to discuss proposed field work plans with their college or center prior to submitting a request. Specific guidance for field research (PDF) has been developed to provide an overview of key review criteria and safety considerations for fieldwork activity during the COVID-19 pandemic.
Human Subjects Research – Updated 8/27/2020
Effective 8/27/2020, we are entering a phased plan to resume Face-to-Face human subjects research (HSR). Restarting of any Face-to-Face HSR study will be based on the ability to abide by current COVID-19 restrictions in place and the risk for exposure or transmission as it relates to the in-person interaction necessary to conduct the study. As with all research, those that can continue their work effectively remotely should continue to do so, all others should review the table in the Human Subject Research Ramp Up Guidance (PDF) to determine when their study may be allowed to restart.
The University is currently in Research Activity Category ‘Medium Level’ for HSR.
Key steps for restarting Face-to-Face HSR include:
- HSR studies that require modifications to an IRB approved protocol need to submit an amendment package to the UMaine IRB for review and approval.
- Along with any application modifications, research teams will need to develop plans for safety [Hierarchy of Controls (HOC) Task Assessment (Excel) and a signed Hierarchy of Controls Checklist (Word)] and submit a Research & Scholarly Activity Request for review and approval.
- Key safety requirements which must be addressed in the HOC:
- Social distancing plans (both throughout the in-person session and between appointments)
- Mandatory face covering for research team and participants
- Increased disinfecting procedures
Additional COVID Requirements for Face-to-Face HSR in Research Activity Category ‘Medium Level’:
- All research personnel must complete UMS Return to Campus: UMS Plan to Reopen for Fall 2020 (in UMS Academy; requires @maine.edu log in) which includes COVID-19 safety precautions (PI is responsible for ensuring all project personnel complete the appropriate training).
- Research team and participant screening must be completed prior to any in-person interaction. The screening information should be collected from any new or returning participants via phone, email, or other virtual method within 24 hours of the participant’s planned study-related visit or interaction and immediately before in-person interaction. The screening questions to be utilized can be found in the COVID-19 Participant Screening (Word).
- Research team must track activity that can be used for contact tracing in the event of a report of illness or exposure (In the study’s informed consent, ensure that you tell participants that information collected for contact tracing may need to be shared with UMaine/UMS Administration and/or Maine CDC).
- Supply all potential participants with the handout COVID-19 Information for Participants (PDF) which includes information about COVID-19, additional measures implemented to reduce risk of COVID-19 exposure, and their responsibilities if they choose to participate.
Need help preparing a Hierarchy of Control (HOC) for your project?
- Watch UMS Safety Management’s video on the hierarchy of controls (requires @maine.edu log in)
- Download the task assessment and edit the document to include your tasks involving human subjects. (The task assessment includes examples to assist in evaluation of your research tasks).
- Contact UMS Safety Management (SEM@maine.edu) to schedule a 1 hour HOC session and walk through your project’s tasks.
Please contact the IRB office at firstname.lastname@example.org if you have any questions about this guidance or need more information.
Animal Research – Updated 7/31/2020
In addition to requiring IACUC approval, all not-previously approved research and scholarly activity requires approval using the request form which has been in place since March 24th.
Before initiating an approved research & scholarly activity which involves animals, please note that permission by the applicable lab manager must be obtained prior to performing any experiments in close quarters. Please email your request to the appropriate lab manager with copy to ORC (email@example.com). Your request should include applicable IACUC protocol number(s), a description of the experiment, and date of approval by the OVPRDGS.
We ask that you remain flexible as Animal Facility ramp-up is also dependent on all of the following:
- Appropriate animal care staffing levels
- Personal Protective Equipment (PPE) required for entry to the facility as well as any additional protocol-specific PPE (i.e. for handling hazardous agents)
- Disinfectants required for use on surfaces within the facilities
Please contact the Office of Research Compliance for assistance (firstname.lastname@example.org).
Be prepared: Plan for Contingencies
If and when UMS and/or State health officials provide limiting/restrictive guidance that are out of alignment with current research activities, research efforts will drop back to lower phases as appropriate and will be ramped up when the guidance changes. Thus, researchers must maintain contingency plans and be prepared to halt all activities on short notice in case this becomes necessary. ORC’s Guidance for Research Ramp-Down (PDF) includes information to help you prepare, or update, your contingency plans.