The resumption of human subjects research will occur in stages and will be linked to the university’s resumption of research and other activities more generally. Researchers should monitor Office of the Vice President for Research and Human Subjects Office communications and websites to determine the restrictions or requirements currently in place for human subjects research. All research visits should continue to be conducted by virtual means whenever possible.
Human Subjects Guidance
The following guiding principles should be applied to all research conducted by UI researchers as restrictions are slowly lifted:
- Health and safety of research participants and study teams remain the priority
- Research study visits should continue to occur remotely whenever possible
- All UI, UIHC and state/local public health guidelines must be followed
- PPE must be available for a study before work begins. Please adhere to the PPE guidance in place at the location where the research is performed.
- COVID-19 Research will continue to be prioritized, but care must be taken not to overburden subjects or put them at unnecessary risk.
- Health care systems, schools and other off-campus agencies/facilities must not be overburdened with research requests. The study teams must work closely with these entities to ensure that the research teams abide by all policies in place at each facility.
- Virtual consenting and monitoring processes should be followed whenever possible.
- Participant research visits must be performed remotely (e.g., by phone, Zoom, or other means) whenever possible.
- Except for researchers involved in approved pilot ramp-up activities and COVID-19-related research, visits that cannot be performed remotely and are not essential to a participant’s health and/or well-being should be postponed until further notice.
- Research visits that cannot be performed remotely and are essential to a participant’s health and/or well-being may be performed in person, following all relevant guidance.
Note: Stage 2 of Human Subjects research follows Stage 1 restrictions, which were announced on March 16.
- As UIHC and other health care systems resume some non-essential health care activities, study visits coincident with clinical care may be allowed to resume.
- Participation in study must not increase the risk that the participant has greater exposure to COVID-19.
- Study teams must work with the health care system or clinic on appropriate scheduling. Patience will be required to not overburden clinics and other units.
- In some settings, study teams may need to provide their own PPE.
- Patients may be uncomfortable returning to the health care setting. Study team members must be respectful of their concerns should be prepared to modify study visit activities with input from the subject, sponsor and IRB.
- Most participant research visits will continue to be performed remotely (e.g., by phone, Zoom, or other means).
- For non-essential research, i.e., research that is not essential to the health and/or well-being of a participant, face-to-face research visits may resume during regular standard of care medical visits. Participants may not enter UI facilities solely for research purposes.
Note: Stage 3 of Human Subjects research follows Stage 1 restrictions, which were announced on March 16, and Stage 2, which allowed research coincident with clinical care to resume.
Effective immediately (June 16, 2020), Stage 3 of Human Subjects research allows in-person research study visits to resume outside of clinical care settings under the following conditions:
- Research may resume in university buildings and off-campus locations and facilities (schools, nursing homes, etc.) as they are brought online, following the health and safety guidelines in place at each location.
- Situation-specific research ramp-up plans for activities involving human subjects must be approved by the respective associate dean for research or their designee.
- Associate deans for research will have specific instructions for research ramp up plans and implementation schedule.
- A sample Research Ramp-up checklist and Research Ramp-up plan can be found on the VPR COVID Ramp Up Website, under the top-center box called Resources.
- Study teams should consider Potential Sources of COVID-19 Related Risks for Research Participants while preparing ramp-up plans.
- Researchers will follow the Guidelines for All Research Study Teams, Guidelines for In Person Research Study Visits and the Guidelines for Maintaining Healthy Research Environments as well as additional direction provided by their department, college or study location.
- Care must be taken not to overburden newly opened facilities.
- Study teams must work with each participating facility/agency to develop a study plan that incorporates updated safety and operational requirements. For previously approved studies, the teams may be required to update operational plans.
- Appropriate PPE must be available before for both researchers and research participants prior to when the research work begins, following the guidance in place at the location where the research is performed.
Study teams should consider potential sources of COVID-19 related risks for research participants:
- Requirements for close interaction or physical contact between study participants and the study team and/or with other participants.
- The feasibility of social distancing
- Likelihood that study team members might be infectious.
- The availability of appropriate personal protective equipment (PPE), if required, and the availability of face coverings for source control, i.e. face shields and/or face masks intended to help prevent the spread of the virus to others.
- The availability of viral testing, symptom checks and health screening before participant enters a research space.
- Equipment or other items that may be used/touched by multiple participants.
- Surfaces that may be touched by multiple participants.
- The availability and frequency of disinfection and cleaning procedures for surfaces, hands, etc.
- The number and frequency of interactions with each participant.
- Whether the potential benefits of the research outweigh the risk of participation.
- Older adults and individuals of any age with serious underlying medical conditions are at higher risk for serious illness from COVID-19. Research visits should not resume unless there is a direct benefit to these populations.
- Do NOT return to work if you are experiencing any COVID-19 symptoms. Your own department or college may have specific procedures for daily attestations of wellness. In particular, no one should come to work if they are beginning to experience any of the following symptoms:
- All personnel should follow the current rules from the Iowa Department of Public Health. As of 5/4/20, individuals experiencing COVID-19 symptoms must stay home, contact their healthcare provider, and self-isolate for a minimum of 10 days and at least 72 hours of being free of fever without the aid of any fever-reducing medication, provided that other symptoms have also improved. Individuals who live with someone who has COVID-19 symptoms or tested positive for COVID-19 should self-isolate at home for 14 days (download IDPH's guidelines here).
- If you come to work and start showing any possible symptoms of illness, you must leave as soon as possible and inform your PI and/or local HR leader.
- Develop a personal transportation plan that minimizes proximity to other people.
- Communicate COVID mitigation plans with all research team members interacting with research participants.
- Researchers must adhere to the health and safety guidance in place at the location where the research is performed.
- For study visits that will be conducted in person, study teams should contact participants within 24 hours prior to the visit.
- Staff should verbally confirm that the participant is well and explain the screening procedures, if any.
- For research occurring on campus or in institutional settings, screening procedures in place at the relevant location will be followed.
- The participant and any participating caregiver must be informed that they will be required to wear a mask throughout the visit (except when removal of the mask/covering is necessary for the research procedure), and whether the mask will be provided by the study team. Individuals at higher risk for serious illness from COVID-19 may also be asked to wear a face shield.
- Participants should be advised to wash their hands before and after entering the research space. Hand sanitizer should be available if a restroom isn’t nearby.
- Participants should be asked to report a COVID positive diagnosis to the research team within 14 days from a research visit.
- Research participants should be advised not to bring guests to the visit. Children and adults who require assistance may be accompanied by one caregiver. If a caregiver is present, the caregiver should also be screened.
- Throughout the study visit, including during the screening process, research personnel should follow physical distancing guidelines (i.e., 6 feet of physical distancing), except as necessary to complete required procedures.
- Research related activities should be conducted by a minimum number of necessary people, with time limitations and minimal personnel density.
- Researchers should eliminate traditional waiting and common seating areas and utilize non-traditional alternatives, e.g., call ahead registration, waiting in car until called, moving participant directly to research room, etc.
- Ensure adequate supplies to minimize sharing of high-touch material to the extent possible. Discourage sharing of items that are difficult to clean or disinfect.
- Establish a cleaning procedure between research participants.
- If possible, maintain records of study visits to assist public health authorities with contact tracing.
- Create a plan to administer a healthy research environment for the resumption of research related activities. All plans should be approved by departmental or Org leadership (e.g. Research Deans, DEOs, etc.) Update the IRB application for plans that may intersect with research related activities. Information and virtual tools for researchers can be accessed on the HSO Website under COVID-19 Information and Human Subjects Research.
- Researchers should continue to maintain ramp down plans in the event of sudden spikes in cases.
- Use of paper to gather research related data (i.e. informed consent, questionnaires, surveys, etc.) should be avoided when possible to limit the potential spread of COVID.
- Identify one point person as part of each research team to maintain the research guidelines and ensure all components are routinely addressed. (e.g. social distancing, use of PPE, disinfecting, etc.)
- Consider whether other safeguards or changes to the research plan may be necessary to prevent additional risks to researchers and participants. Such as
- Whether compensation may coerce those that may be economically challenged in to participating when they otherwise would not.
- Whether researchers feel additional pressure to resume research in order to graduate.
- Whether research conducted internationally can continue as originally intended (e.g. Travel restrictions, in country restrictions, etc.)
- What steps will be taken if a member of the research team or a participant is quarantined due to potential exposure.
- Create a schedule for research spaces and adhere to it. This schedule should minimize the number of people in each room at any one time and may require staggering work shifts. A Sharepoint site or other secure online tool can be used to identify who is present in the space at any given time and be used as a mechanism for controlling the number of people in the space at the same time. Open areas will require a communication system that spans all research groups within the shared area.
- Distribute a list of duties to be performed by critical personnel with location and designated time of day.
- Stagger break times to minimize contact between people in rooms used for eating or drinking.
- Be sure to disinfect surfaces such as tables and chairs before and after use.
- Wash your hands after using a break room.
- Create safe spaces to maintain at least 6 feet of distance between researchers and research participants at all times.
- Post a lab map inside the entryway with maximum room/bay occupancy to maintain social distancing.
- Small, narrow rooms on the order of 100-150 square feet (sf) can likely only accommodate one person at a time. Consider whether research related activities could be conducted safely and confidentially in a larger space.
- Square or rectangle rooms larger than 200 sf can possibly accommodate more, but keep the number to a minimum. If you cannot maintain at least 6 feet of social distance in any direction, revise the schedule and/or reconfigure the room.
- To the extent possible, move equipment to create at least 6 feet between users.
- Use tape to mark out 6-foot spaces for high traffic areas or bottlenecks. If possible, set up one- way traffic zones to minimize interactions.
- Avoid having individual workstations in areas of high traffic or frequently used shared equipment.
- Create a plan for safe practices.
- Do not begin any research related activities without an adequate stock of personal protective equipment (PPE). There are significant disruptions in the PPE supply chain during the COVID-19 outbreak.
- In order to help slow the spread of COVID-19 and protect research participants, all research personnel should wear face shields whenever possible when working in research areas, in a common space, and when interacting with research participants.
- To doff: remove gloves, wash hands, remove face shield-do not touch front: grab the face shield from the top or the bands on the side and lift it off the head, place on horizontal surface, wash hands.
- To decontaminate re-usable face shield: Don gloves, carefully wipe the inside, followed by the outside of the face shield using an approved cleaner/disinfectant, inspect for damage; if damaged dispose, fully air dry, remove gloves and wash hands, place in clean location, wash hands.
- Employees are permitted to wear cloth face masks throughout the workday in accordance with CDC guidelines. N95 respirators should be reserved for healthcare providers; there are shortages of these masks, and it is critically important that healthcare workers have the equipment they need.
- To doff: remove gloves, wash hands, remove face mask-do not touch front. If disposable, properly dispose. If reusable, launder regularly; transport in a bag if necessary. Wash hands after removal.
- Don the appropriate PPE when entering a laboratory or research space, including a lab coat and gloves. PPE hazard assessment tools/risk assessments which outlined required PPE prior to the outbreak must still be followed. A cloth mask is not adequate PPE for laboratory safety and cannot be substituted for an isolation mask; a face shield does not replace safety glasses/goggles.
- Do not wear potentially contaminated PPE outside of the lab. Always wash your hands with soap and water after removing gloves and before leaving the lab. In addition, wash hands after touching shared accessory devices like phones.
- To the extent possible, minimize shared items (pens, notebooks, frequently used reagent bottles, computers, desks, etc.).
- Create an enhanced cleaning schedule; see the enhanced cleaning section at the end of this document.
- Create a plan for shared equipment, e.g. computer keyboards, headphones, etc. All shared equipment must be disinfected before and after each use.
- Wear disposable gloves when cleaning and disinfecting.
- Special care should be taken to disinfect equipment that makes direct physical contact with skin, including eyepieces for microscopes, touch pads, etc. To the extent possible, don gloves prior to touching equipment surfaces that cannot be disinfected.
- Wash your hands immediately after gloves are removed and after any surface contact.
- Create a plan for interactions with others outside the research space.
- Contact with other researchers should be made via phone or electronic means.
- Transfer of non-hazardous items should be arranged by leaving them in the hallway or other designated area rather than handing them over in person. Transfer of any hazardous item should be done in person while maintaining social distancing between individuals.
- Use of shared facilities and other research equipment should be pre-arranged in order to minimize contact. Establish and communicate sign-in/sign-out procedures.
- Use precautions when entering a restroom, shared core facility, or other common areas. Wash your hands upon entering and leaving such areas.
- Create a plan in the event of a possible or confirmed case of COVID-19 among research personnel and research participants.
The efficacy of disinfectants is evaluated on pre-cleaned surfaces. Thus, surfaces that are visibly dirty should be cleaned with soap and water prior to disinfection. Disinfection of work and common areas can be achieved with an EPA approved disinfectant. EPA List N covers disinfectants approved for coronavirus. Follow disinfectant label instructions for adequate contact time to disinfect. If possible, wet towels or wipes with disinfectant rather than spraying; spraying may aerosolize anything that is on surfaces. Do not mix different types of disinfectants and/or cleaning solutions; some may react with each other and may produce dangerous fumes.
- Increase the frequency of cleaning and disinfecting, focusing on high-touch surfaces.
- Practice good hand hygiene after cleaning (and always):
- Wash hands often with soap and warm water for at least 20 seconds.
- Hand sanitizer (at least 60% alcohol) should only be used if soap and water are not available.
- Cleaning chemicals should only be used by staff trained on the hazards of those cleaning chemicals.
- Wear disposable gloves when cleaning and disinfecting. Wash hands immediately after gloves are removed.
- Wear eye protection when there is a potential for splash or splatter to the face.
- Lab coats are recommended to protect personal clothing.
- Store chemicals in labeled, closed containers. Store them in a manner that prevents tipping or spilling.
Cleaning and disinfection of surfaces:
Examples of Work Areas (offices, shared core areas, etc.):
- Benchtops, fume hood and biosafety cabinet sashes and work surfaces, waste container lids and handles, etc.
- Handheld devices (pipettors, pipetman, etc.) and other commonly used items.
- Shared PPE (laser goggles, safety glasses, etc.).
- Frequently touched surfaces, such as light switches, door handles, knobs and push plates, refrigerator and freezer handles, equipment touch screens, elevator buttons, etc.
- Clean electronics according to manufacturer instructions.
Examples of Common areas (lunchrooms, offices, etc.):
- Refrigerator/freezer handles and shelves.
- Microwave keypad and handle.
- Sink faucets and surrounding surfaces.
- Tables and chairs
- Door handles, knobs, and push plates.
- Clean electronics according to manufacturer instructions.
- Information on Facilities Management’s COVID-19 operational response and custodial services can be found here: https://www.facilities.uiowa.edu/coronavirus