Continuing Research Guidelines

Updated 01/24/2021

University and divisional guidelines

Indoor research spaces

  1. While on campus, all persons must wear face coverings, except when in offices alone.
  2. At least six feet of distance must be maintained between people at all times.
  3. Persons on campus must be free of recognized COVID-19 symptoms including: a new continuous cough, fever, sore throat, generalized muscle pain, loss or change to sense of smell or taste, unusual fatigue, chills, or shortness of breath.
  4. Persons with concerns about returning to laboratories/studios or shared offices due to health reasons should contact Academic Personnel to seek appropriate accommodations.
  5. Persons must use the CampusClear app before coming to campus.

Outdoor research spaces

  1. Employ methods that are consistent with social distancing guidelines and while on campus, indoors and outdoors, must wear a face mask.

Libraries

  1. Patrons of the libraries must follow research space requirements.
  2. Patrons must follow the protocols as stipulated by library staff.

Infection flare-up

  1. If another infection flare-up or surge occurs, we can expect to see a renewed action on the part of public-health authorities to further restrict social interactions. If we experience another infection flare-up or surge with public health restrictions, the University research programs will consider moving in reverse to a more enhanced restriction on social interaction and, if necessary, full cessation of research activities.
  2. All researchers should plan for a quick reduction for shut-down of research or creative activities.

Building guidelines

  1. Guidelines for buildings can augment, but cannot be less restrictive than, University & Divisional Guidelines.
  2. Shared offices and research spaces must follow social distancing guidelines.
  3. Additional restrictions or guidelines should be set by the relevant department chair(s), program director(s), facility director, and building manager.
    • These restrictions should be sent by email to all employees and researchers who typically occupy the building and should be posted at designated entrances and in a central location (e.g., outside the department main office).
  4. Ventilation of shared spaces must be maintained to reduce aerosol concentration.
  5. Each building should have designated entrances (one-way, if possible) with a hand-washing or hand-sanitizing station available at the entrance.
  6. Hallways should be marked in such a way as to minimize cross-traffic.

Individual laboratory/studio or group guidelines

  1. Guidelines for individual laboratories/studios or research groups can augment, but cannot be less restrictive than, university and divisional guidelines and building guidelines.
  2. Additional restrictions must include:
    • Timing and assignment of work shifts to ensure all individuals have an opportunity to access physical spaces.
    • Requirements for PPE to be worn during research activities where more than one person is present in the same room.
  3. Activities that involve multiple researchers or researchers and human research subjects working in close proximity (closer than 6 feet) will require additional mitigation strategies that must be approved on a case-by-case basis by Environmental Health & Safety. Examples include:
    • Wearing of enhanced PPE (N95 masks, face shields, etc.).
    • Additional engineering controls to isolate the airspace, such as a Plexiglas partitions, between researchers and subjects.
  4. Each laboratory/studio director should develop a safety plan that accounts for the physical layout of each laboratory/studio and all infection control measures.
    • Templates for laboratory/studio plans and suggested signage are in Guidance on Individual Return to Research Plans.
    • In addition to general distancing guidelines, also consider how to minimize cross traffic (e.g., one-way aisles) and take advantage of physical barriers, such as curtains or Plexiglas, to help further minimize potential exposure of individuals.
    • All plans require the approval of the department chair, any relevant compliance committee, and are subject to review by the VPRI. These plans should be saved in the ORI R2R Google folder.
  5. All external grant expenditures must be reviewed and approved through normal channels. All internally funded research expenditures must be reviewed and approved by the PI's chair and dean, as well as the provost. Travel must follow guidelines as indicated below.

Space inventory and utilization, including use of teaching labs

Whenever possible, additional spaces should be used
  1. Laboratory/Studio/Office
    • Explore the use of teaching labs during the winter break and spring (if available) as extra space to provide work areas for research while maintaining distance between researchers.
  2. Office
    • Explore the use of classrooms (if available) as overflow spaces to allow researchers to conduct office work, while maintaining distance between researchers.
    • Note: Suitable separation is not possible in most current graduate student office configurations or office cubicles without staggered shifts or additional space utilization.

Social distancing

  1. Centers for Disease Control (CDC) and Ohio Department of Health (ODH) guidelines recommend a minimum of 6 feet spacing between individuals.
  2. A typical science lab has close to 50% of floor space dedicated to laboratory benches.
    • Laboratory bench space can be used as buffer zones and aisles can be used as one-way traffic lanes to facilitate social distancing.

Infection control

  1. Health monitoring:
    • Personnel should check their temperature at home prior to coming to campus.
    • Personnel should also monitor other characteristic symptoms of COVID-19, including: a new continuous cough, fever, sore throat, generalized muscle pain, loss or change to sense of smell or taste, unusual fatigue, chills, or shortness of breath.
    • Personnel with fever or other symptoms should not report to work and should notify their supervisor.
    • Face coverings must be worn in all public and shared spaces at all times to contain respiratory droplets from individuals that may be asymptomatic carriers of the COVID virus. Follow guidance from ODH
    • Before coming to campus, personnel should use the CampusClear app.
  2. Post signs on laboratory/studios doors, and in laboratories/studios.

Undergraduate research students and undergraduates in studios

Each faculty member or director will need to evaluate if undergraduate research or work can be safely conducted in their lab, research facility, or studio. If a mentor or director believes that undergraduate research or work can be safely conducted in the lab or studio, the following policies must be followed:
  1. All undergraduate students who will be on campus for any activities are required to sign the Healthy Together Pledge. Undergraduate students who have externally-funded research fellowships, are working on externally-funded research projects, need to complete critical lab or studio requirements for graduation, or have required honors or research capstone projects should be given priority in the labs or studios.
  2. Before any research or work in the lab or studio is conducted, the research mentor will meet with the undergraduate student and explain all building and lab policies regarding face masks, distancing, cleaning, self-health monitoring, and, of course, any lab-related safety issues. The mentor should also discuss safe behavior (no attendance at large gatherings where social distancing is not possible, wearing face masks in public places, etc.) outside of the lab or studio to reduce exposure to COVID-19 and its introduction into the lab or studio. The student must comply with these policies. The undergraduate student should be listed on all relevant room policy forms, and the mentor should resubmit these revised forms to the Chair for approval and for uploading in the Return to Research Google folder. The university’s policies regarding continuing return to research can be found on the ORI website.

Failure to follow these policies will result in the loss of research lab or studio privileges.

Personal protective equipment (PPE)

  1. Definition: PPE is specialized clothing or equipment worn by an employee for protection against infectious material. These are items approved by OSHA and/or FDA.
  2. Minimum PPE in line with the research should be used at all times. More stringent PPE requirements necessitated by the research should always supersede the minimal COVID-19 related infection control requirements.
  3. The PI is responsible for the purchase of required PPE for researchers and, for human subjects research, participants.
  4. If research activities must be conducted face-to-face, there must be a protocol for PPE and social distancing for researchers and, for human subjects research, for the participants/subjects.
  5. Competencies for correct use of PPE can be found in PPE Competency and PPE guidance from the CDC.
  6. Additional considerations for human subjects’ research:
    • Space/equipment sterilization: See CDC’s “Personal Protective Equipment (PPE) Competency for Human Subjects Research” document for more information.
    • Include plan for PPE/social distancing/sanitizing equipment in IRB modification
    • Assign equipment to one person when possible, e.g. each researcher should have own audio recorder; camera should be used by only one individual.

Biological and physical sciences fieldwork

  1. Definitions:
    • Pod - A pod is a small group of 2-4 field researchers who travel, live, and work together in cases where social distancing cannot be maintained. No PPE is necessary when members of a pod are together. Contact with people outside the pod should be minimized and care taken to maintain social distance or wear PPE when engaged in essential activities such as shopping or travel. A Pod Communicator must be identified and correspond regularly with the principal investigator on health-related issues.
    • Field team - A field team is a group that contains more than one pod and/or field researchers who commute to field sites while continuing to live with others outside the team. Members of a field team must maintain social distancing and use appropriate PPE unless they are only working with members of their own pod. Pods must maintain social distance or wear appropriate PPE when working with other pods or commuters.
  2. Procedures:
    • Please see travel section for general guidelines for travel. All research-related travel requires prior approval (chair, dean, VPRI) and must be deemed essential research travel.
    • Pods are only relevant to groups of researchers are traveling, working, and living together. The pod concept is not relevant for groups of researchers who work together during work hours and then go home to separate locations with family members or house/roommates.
    • To create a system that allows research collaborations to function safely, field scientists who will travel, work and live together (students and researchers) will be organized into “pods” of 4 or fewer people. Pod members will live in shared housing units, and will cook, eat, and work together as household members around the world have been doing for months.
    • If a new pod member is needed due to illness, change of job, or other reason, then the new member must certify that they have been asymptomatic and not in direct prolonged contact with any known symptomatic individuals within the last 14 days.
    • Anyone exhibiting any symptoms of COVID-19, or who has spent time in confined indoor environments in the past 72 hours where others outside of their family group have congregated without maintaining social distancing or wearing appropriate PPE, must not join a research pod. If a member of a potential pod member’s household develops symptoms of illness, that potential pod member must self-quarantine before joining the pod.
    • Before traveling to the field site, the PI or host institution must have an approved plan for individual isolation should a member show symptoms of COVID-19.
    • If any member of a pod begins experiencing symptoms they must (1) notify their Miami University supervisor, (2) seek medical advice from an appropriate health care provider, and (3) self-isolate in a designated living space separate from other pod members until no fever is present for 72 hours and at least 10 days after onset of symptoms.
    • Anyone who develops a suspected or confirmed case of COVID-19 must (1) notify their Miami University supervisor as well as the Miami University Health Center, (2) if out of Oxford, notify the local health district, (3) seek medical advice from an appropriate health care provider, and (4) self-isolate in a predesignated, living space separate from other pod members until no fever is present for 72 hours and at least 10 days after onset of symptoms.
    • Asymptomatic members of the pod can continue to work together, but must quarantine, minimizing contact with people outside of the pod.
    • Pods that must interact with others outside of their pod become part of a Field Team. Members of a field team must maintain social distancing and use appropriate PPE unless they are only working with members of their own pod. Pods must maintain social distance or wear appropriate PPE when working with other pods or commuters.

Human subjects research

An IRB Modification must be submitted and approved, including protocol for:
  • For remote research: Any changes to procedure, materials, method, informed consent, data security, etc. as a result to COVID-19
  • For face-to-face research:
    • Plan for procurement and effective use of PPE (for researchers and subjects/participants)
    • Plan to implement social distancing within the research space(s) including at field sites and in public settings
    • Proof of completion of PPE competencies (see PPE section for more description)
  • Remote research
    • If it is possible to conduct the human subjects work remotely, submit an IRB modification to revise protocol and do so.
    • Considerations for remote research (if possible; must be approved by IRB).
    • Use of Phone/Webex/Zoom to conduct interviews/observations/screening/questionnaires.
    • Use of Qualtrics and other survey software to administer surveys.
    • Use of e-gift cards for compensation (e.g., Tango gift cards).
    • Modifications to consent procedures.
    • Methods to ensure data security in a virtual environment.
  • Human subjects field work
    • Please see travel section for general guidelines for travel. All research-related travel requires prior approval (Chair, Dean, VPRI) and must be deemed essential research travel.
    • Researchers need to consider local rules and restrictions, general travel plans, alternative routing in case of resurgence of travel restrictions, shared equipment, personnel health, number of personnel within modes of transportation (i.e., automobiles), use of masks and gloves when traveling and onsite, transport of equipment or specimens, IACUC protocols, IBC, and IRB protocols.
  • Human subjects field work - site requirements
    • Field work that involves human subjects is inherently limited by COVID-19 because events, gatherings, and service buildings are largely cancelled/closed to the public at the present.
    • Any field work that can be done remotely should submit an IRB modification, but can proceed if meeting the requirements of the university/state.
    • Schools, businesses, public and governmental agencies, health care facilities and other organizations provide settings for conducting field research. At the fieldwork sites, researchers may engage with students, employees, or clients. Each site is likely to have requirements for visitors, and has the ultimate authority for whether researchers may enter, and what protections are required. Researchers and organizational hosts should agree on protocols such as requiring face masks or PPE. Written guidelines provided by the organization should be reviewed and signed by researchers.
    • In the absence of written policies, guidelines should be prepared by the researcher based on their understanding of current practices, and agreed to with signatures from the PI and a representative of the host organization. All agreed upon guidelines should adhere to the requirements of the county and state where the organization is located and/or the state of Ohio, if Ohio’s requirements are more stringent. If the organization is not meeting governmental guidance (e.g. not observing social distancing) Miami researchers should not begin or should discontinue fieldwork until it is deemed safe to continue.
    • Use hospital/site guidelines for maintaining healthy/best practices.
    • Limit number of people in the room to no more than 1 person per 150 sq. ft.
  • For approved in-person research
    • COVID-19 screening of participants and staff, and other preparations, before in-person interactions. All studies that meet the criteria to continue must include the following procedures.
    • Avoid all participants with confirmed or presumptive positive COVID-19 infection or requiring potentially aerosolizing procedures, unless this is the focus of the study. Ask the following questions:
      • Have you, someone living in your household, someone with whom you have been in close or frequent contact, or someone you are caring for been diagnosed with COVID-19 (coronavirus) or had any contact with a confirmed case of COVID-19?
      • In the last 14 days, have you or someone living in your household, or someone with whom you have been in close or frequent contact, or someone you are caring for returned from, or made a travel connection through a CDC Level 3 or Level 2 country or State Department Level 3 or Level 4 country?
      • Do you currently have, or have you had within the last 24 hours, any cold or flu symptoms with a fever greater than 100.4 F or acute respiratory distress (e.g., shortness of breath or new continuous cough)? Sore throat? Chills? Generalized muscle pain? New loss of or change in sense of taste or smell? Unusual fatigue?
    • Have a protocol for non-contact screening of participants and study staff for active symptoms of acute respiratory infection possibly related to COVID-19 or high risk of infection. This may be accomplished by communication with participants or care providers, chart review, screening surveys, or other options prior to approaching potential research participants. Individuals with active symptoms or in social isolation (e.g., due to travel history or exposure to someone with COVID-19 symptoms) should be avoided.
    • Reduce face-to-face contact with research participants. For example, this may be accomplished by including barriers between research personnel and participants, and/or using technology (e.g., telephone, Facetime, email, intercoms) to conduct interviews and obtain data.
    • If a study participant has a 100.4° F (38°C) or above temperature (no meds in past 24 hours) or other symptoms of COVID-19, that individual must not participate in the research and must leave the site. The incident must be reported to your supervisor. Self-quarantine of all individuals who had contact with the individual may be required.
    • Face-to-face research
      • Follow university timeline/protocol for phasing researchers back into their research duties.
      • Subject status/characteristics (by CDC or other health entities).
      • Research with vulnerable populations should be limited until it is safe to do so.
      • Age of the individual is a risk factor; studies show that 8 out of 10 deaths are in individuals 65 years old and older.
      • Individuals of any age group that have one of the following underlying health conditions:
        • Chronic lung disease or moderate to severe asthma
        • Serious heart conditions
        • Immunocompromised due to many reasons including but not limited to cancer, smoking, HIV, immune deficiencies, prolonged use of medications that impact immune weakening medications
        • Severe obesity (BMI >40)
        • Diabetes (type I or 2)
        • Chronic kidney disease (undergoing dialysis)
        • Liver disease
        • NOTE: Individuals should consult with their physician to discuss their risk.
      • Consider living environments (for example: nursing home, children living with elders, etc.)
    • Special considerations for human subjects research
      • Long-term protection
        • Protective equipment such as gloves and face masks are required for the normal safety, and typical operations of the laboratory shall always be a requirement of employment and safe operations. It is the responsibility of all laboratory authorities and laboratory managers to ensure proper equipment is always used.
        • At all times during this crisis, materials including face masks at a minimum, are a part of required personal equipment and must always be carried and worn as a part of normal dress for employment when interacting with other employees in laboratory or public places. Normal laboratory safety procedures that require specialized personal protection equipment will not be affected by the current crisis.
        • Special planning will be required for those researchers involved in face-to-face research with human subjects. Under these conditions, researchers will be required to have on hand enough disposable gloves, masks and other needed materials to allow for a change of these materials after each subject and take responsibility for proper disinfecting procedures of research spaces visited by participants.
      • Burden on caregivers
        • The independent school districts, preschool programs, summer childcare/activity programs, and childcare facilities have closed. Elder-care facilities may be closed. This puts an extra workload on caregivers. There is discussion at the national level within scientific societies and supporting organizations that this challenge may disproportionately impact researchers who carry these obligations, no matter their gender or marital status.
        • We know that, as our population has aged, more elderly persons need care; in many situations, younger family members are taking on that care-giving role. COVID-19 closures are potentially impacting caregivers differently.
        • Additionally, experimental researchers and lab researchers may also be impacted because much of their work is conducted within a setting that children cannot enter. Solutions for these issues should allow flexible work hours and the continuation of remote work as discussed with the supervisor. Research supervisors are encouraged to open dialogue with all direct reports to explore where employees are being affected and how flexibility in terms of work hours, schedule of work, and assignment of duties can help relieve the burden during this crisis.
    • New research studies
      • Researchers should carefully consider whether new enrollment is advisable on a study-by-study basis. Factors to consider include:
      • The nature of the study population (e.g., high risk for COVID-19)
      • Whether the possible risk of COVID-19 infection is outweighed by the probable direct and meaningful benefit to individual participants.
      • The impact on clinical resources, facilities, and supplies that may be or become limited.

Notifying funders, sponsors, etc.

  • Requirements may rapidly change about whether/when PIs are required to notify entities about a pause in enrollment or ongoing procedures, or a change in procedures. Consult with the entity or its webpage about requirements and processes if requirements aren’t clear.
  • FDA: The PI that holds the IND or IDE for the study must notify the FDA if the study is paused or modified.
  • NIH and other federal funding agencies: Consult with your program officer or follow published NIH Guidance.
  • Industry sponsor: Inform the sponsor as soon as feasible, using the standard process for informing the sponsor of changes to the research. This includes information about delayed or missed study visits.
  • External IRBs: Studies that are reviewed by an external IRB instead of the MU IRB should consult with the IRB or (for multi-site studies) the lead PI or lead study team.

Travel

  • For all travelers:
    • Miami University’s policies on travel govern whether travel for research is possible. Geographic location of destinations will impact whether travel to field sites is advisable for the safety of researchers and participants. Resources developed by the National Governors’ Association provide up-to-date information to assist in determining whether travel is possible or advisable.
    • All research-related travel requires prior approval (chair, dean, VPRI) and must be deemed essential research travel. To request approval, complete the Request for Travel and Assumption of Risk form and submit it to your department chair. University-funded travel is not permitted at this time, although externally-funded travel may be, if approved as described above.
    • Pre-approved quarantine and isolation plans, with contingency back-up plans on both ends of the travel, will be required for overnight or out-of-state travel.
    • If research duties require travel, and you have pre-existing health conditions that contraindicate travel, you should contact your healthcare provider and Academic Personnel for accommodations.
    • No person should be compelled to travel, and all travelers will be asked to confirm that they are willing to travel and will adhere to all guidelines in accepted plans. If a person feels that they are being compelled and cannot address that with their supervisor, they should contact their chair or dean or the VPRI, or submit an Ethics Point report.
  • The remaining guidelines apply to all research travel except for members of a field research “pod.” (See biological and physical sciences fieldwork section).
    • If possible, vehicular occupancy should be limited to one person. Subject to approval, two persons maximum per vehicle may be allowed if both individuals wear facial covers and windows are lowered. This policy applies to travel using a University vehicle or a personal vehicle. The only exception to this rule is that researchers who live, or have self-quarantined, together may travel together in a shared vehicle.
    • If traveling long distances, stops should only be made for fuel and restrooms. Sanitize hands after these activities. High touch areas (i.e., keys, door handles and steering wheel) must be disinfected before and after the field day.
    • One person per room: Any overnight lodging must be one person per room.
    • Dining practices should observe current guidelines for maintaining social distancing. Food should not be shared and researchers at field sites should bring their own meals to the fieldwork site already prepared and labeled.

Contact Us: Ramp-Up

Alicia Knoedler
Vice President for Research & Innovation
102 Roudebush Hall
513-529-3600
knoedler@MiamiOH.edu