Overarching Goal
  • Research with human participants, both on- and off-campus can proceed only to the extent that it can be performed safely and all the proper approvals from the JMU Institutional Review Board (IRB) have been obtained.

  • JMU faculty, research team members and staff must continue to comply with executive orders and health authority guidance from national, state, local, and University authorities to protect the safety of research participants, staff, visitors, students and faculty.

  • Consistent with the Governor’s Phase 2 Reopening Plan, the approach outlined in these guidelines is based on established physical distancing requirements for our various research spaces, requiring the use of personal protective equipment (PPE) which remains a limited resource, and sound hygienic practices, such as recommended hand washing/use of hand gel, and routine sanitizing of work areas.

  • Under no circumstances should safety be sacrificed due to the lack of adequate supplies, such as the type and quantity of PPE. Plan in advance for PPE supply chain issues when reopening research. 

  • Failure to follow these guidelines will result in revocation of research approval.

Timeline for re-opening non-clinical research

Research off-campus with human subjects, which was not previously paused, may continue provided that face-to-face contact is not required.

Target date – July 6, 2020: Off-campus research with human subjects requiring face-to-face contact
Target date – July 13, 2020: On-campus research with human subjects requiring face-to-face contact  

  • The above target dates will be highly dependent upon ongoing updates to federal, state, local, and institutional policies related to physical distancing and allowed activities. We will be continuously monitoring these guidelines.  All safety measures (e.g. social distancing, wearing protective masks, etc.) are required and will continue until further notice.

  • If there are special circumstances (e.g., the need for certain procedures in restricted periods in a longitudinal study) you may request an earlier restart.  Please provide background information and justification to researchintegrity@jmu.edu.

  • Additionally, researchers must have a plan and be prepared to halt all activities on short notice, if necessary.

  • Students submitting IRB protocols should include a statement from their supervising faculty mentor about continued adherence to the JMU, Commonwealth, and National regulations. 

  • To submit a protocol, please go to https://era.jmu.edu (must be on the JMU network).  To connect to eRA off-campus, see the ORI website at https://www.jmu.edu/researchintegrity/irb/irbsubmit.shtml.

Off-Campus Research

In order for researcher/staff to initiate or resume off-campus research which does require face-to-face contact, the University will require: 1) approval for the required travel to the off-campus location, including adequate personnel procedures and PPE; and 2) project-specific approval or authorization from the site to conduct the research.

For domestic or international travel, care must be taken to protect the human subjects in keeping with local requirements as well as observation of any and all cultural restrictions. 

Researchers will require approval for off-campus research with human subjects from their AUH and Dean.  International and domestic travel may require a higher level of approval, but should be in conjunction with JMU, Commonwealth, and National guidance.

When developing the human participant research plan for on-campus or off-campus work, particular attention must be given to the following:

  • All research personnel must wear protective masks, which includes a personal cloth mask, surgical mask, or face covering, while working on-campus, including when in contact with research participants and/or staff.

    • Research participants and caregivers must wear either a surgical/procedural mask or a cloth mask/face covering throughout the visit, except when removal of the mask/covering is necessary (e.g., when required by the research procedure).

    • Research personnel must also wear a face shield, protective mask, or goggles if the recommended separation distance (6 feet) between the researcher and research participant cannot be maintained.

  • Research personnel must follow the recommendations on physical distancing and hygiene practices for staff and study participants as required for the specific locations being used.  

  • When moving around a minimum distance of 6 feet is recommended for social distancing. 

  • For prolonged work with others (e.g., in shared office or research space) a larger spacing (beyond the recommended 6 feet) should be considered. Considerations for time of contact and physical spacing between people should be sufficiently detailed in the protocol and receive IRB approval.

  • Supervisors must, to the extent practicable, make special accommodations for employees at higher risk for severe illness. Individuals in these high-risk categories have been identified by the Centers for Disease Control and Prevention. Such accommodations shall be coordinated through the Human Resources employee relations team, see this link for additional information.

  • Research personnel should contact participants within 24 hours of the face-to-face interactions. Research personnel should confirm and document that the participant is well and explain the procedures on site for screening. The participant should be informed to wear a protective mask to the visit and that they will be required to wear a protective mask throughout the visit.

  • Per the Governor’s Phase Guidance for Virginia Schools, researchers should encourage the use of protective masks in minors as developmentally appropriate in settings where physical distancing cannot be maintained.  Researchers should also strongly encourage older minors (e.g., middle or high school) to use protective masks in settings where physical distancing cannot be maintained.  (NOTE:  Until we move into a different phase, protective masks are required for participation in all face-to-face research.)

  • Upon arrival, research participants will be asked about symptoms consistent with COVID-19 (up-to-date symptom description from the CDC can be found here). If research is being conducted in facilities where this screening is conducted for everyone who enters the building, research personnel do not need to repeat the screening.

  • Research participants should not bring guests. Children and adults who require assistance may have one caregiver (unless the research protocol requires the presence of both parents). If a caregiver is present, the caregiver must also be screened as outlined above.

  • Throughout the research study, including during the screening process, research personnel should follow physical distancing guidelines, except as necessary to complete required procedures.

  • All research sites that are unable to follow physical distancing guidelines must eliminate traditional waiting and common seating areas and utilize non-traditional alternatives (e.g., call-ahead registration, waiting in car until called, take participant directly to the research room, etc.).

 


NOTE: If the facility in which this research occurs has stricter restrictions than outlined above, the facility guidance must be followed.  Failure to follow these guidelines will result in revocation of onsite privileges.


 

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