Face-to-Face Human Subjects Research

As research activities continue to ramp up, the University aims to begin a phased reopening of face-to-face human subjects research within its four-phase Lab and Studio Reopening Plan. The goal is to undertake vital research in the social sciences involving human participants, insofar as possible, while protecting the health and safety of all staff, trainees, and research participants. 

The guidance below is intended to assist researchers in their planning for a gradual expansion of human subjects research.

Lab Reopening Phases 1 & 2

  • Face-to-face human subjects research is prohibited in Phases 1 and 2 of the University’s Lab and Studio Reopening Plan.
    • Human subjects research conducted via remote means of data collection (e.g., video conferencing, phone, electronic surveys, or online experiments) may be undertaken.
      •  If not already approved, Institutional Review Board (IRB) protocols must be amended to include the option of remote data collection.
  • During Phase 2, research teams may come to campus to carry out laboratory-based research activities that do not include face-to-face interactions with research participants provided a laboratory reopening plan has been submitted and approved by the Vice President for Research.

Lab Reopening Phase 3

  • Researchers may undertake limited face-to-face human subjects research.
    • Human subjects research should continue to be conducted remotely whenever possible. 
    • Face-to-face research activities should only be considered when participant samples, research questions, study methods, and/or ethical concerns (e.g., privacy, access to the benefits of research participation, etc.) do not allow for remote interaction with participants.
  • No face-to-face human subjects research can begin until approved by the researcher’s department chair and college dean (or designee), Office of Risk Management and Safety, as well as the vice president for research.
  • All face-to-face human subjects research activities must conform with the University’s return to campus and research continuity policies.
  • For existing research protocols, a risk evaluation must be completed by the study team to determine whether additional review and approval of the IRB is required (view the Research Protocol Changes and Modifications section below).
  • Participant recruitment and engagement may be limited:
    • Individuals who are considered high-risk by the CDC should only be included in face-to-face human subjects research if they are critical to the research question(s) being addressed in a study. 
      • In these cases, the research project will be deemed to have elevated risk and hence researchers are required to submit an IRB protocol (or amendment thereof) that provides justification for the inclusion of these individuals and describes safety measures commensurate with the health risks they may have.
      • The exclusion of high-risk individuals from a research study does not require IRB approval or amendment, provided the research team considers the exclusion temporary based on local health conditions and corresponding COVID-19 related University policies.
    • Notre Dame students and employees are eligible for inclusion in face-to-face human subjects research without restrictions beyond those outlined here and those normally established by the IRB and University policies.
    • Community members should only be included in face-to-face human subjects research if they are critical to the research question(s) being addressed in a study and it is safe for both them and the researchers to come to the site of the research study.  
      • In accordance with the University's general policy on campus visitors, the use of community participants in research at Notre Dame’s on- and off-campus (e.g., Shaw Center) research sites must be deemed essential and approved by the principal investigator's (PI) dean. This evaluation will be part of the normal process by which lab/community/field-work reopening plans, which must include a complete description of the research participants and safety protocols.  
    • Face-to-face human subjects research conducted at non-University research sites is subject to the University’s policies on general travel and travel-based research, as well as applicable government restrictions on gatherings.
  • Face-to-face human subjects research may not be undertaken if masks, face shields, and/or Plexiglas barriers cannot be used to prevent transmission of the virus.  
    • Research settings that do not additionally permit six feet of social distancing in both waiting and data-collection areas will require a comprehensive plan for mitigating risks of virus transmission (e.g., enhanced personal protective equipment (PPE)).
      • In such cases, alternate research sites should be considered in consultation with college/school dean’s offices.
    • All research spaces should be considered “public,” with PPE in use even if/when such spaces are only occupied by a participant and their caregiver(s)/family member(s).   
      • In situations where participants (and caregivers/family members) are isolated from others and the use of PPE would significantly hinder examination of the research question(s), the PI may consult with the College of Arts and Letters Associate Dean for Research James Brockmole to discuss a possible exception to this policy.
  • When recruiting participants and scheduling sessions, researchers must provide general information about the anticipated risks of participating in research as they relate to viral transmission as well as the safety procedures in place for each study (view Guidance on Resuming In-Person Human Research).
    • Unless inclusion has been approved by the IRB, researchers should also verify that potential participants are not members of high-risk groups prior to scheduling sessions.
  • The day prior to scheduled sessions researchers must screen participants by phone or email for COVID-19 symptoms (fever, cough, shortness of breath, sore throat, loss of taste or smell) and close contact with a person who is under suspicion of having contracted COVID-19. 
    • Researchers should instruct participants that they must not attend face-to-face data collection sessions if they or anyone in their household are experiencing COVID-19 symptoms or have had close contact with a person suspected of contracting COVID-19.
    • Researchers may give their contact information to participants and encourage participants to call or email to cancel/reschedule their session if they develop symptoms. Participants are not, however, required to contact researchers in these cases.
  • Researchers are to ensure that they have adequate PPE and hand washing/sanitizing supplies for both study participants and research staff, as well as cleaning supplies to disinfect equipment, surfaces, and other touch points that will be necessary throughout the day.
    • The research team bears the responsibility for the procurement and funding of supplies beyond those provided in common spaces of research buildings (e.g., disinfectant and hand sanitizer). Procurement Services can assist (for PPE contact RaSheda Humphrey).
  • While participating in research at Notre Dame, participants (and accompanying caregivers) are expected to conform to campus health and safety protocols including, but not limited to, wearing masks/face shields, the washing/sanitizing of hands, completing health screenings, and honoring social distancing. 
    • Non-University community member participants should be met outside of the research building and escorted to the lab. 
    • Participants who arrive at a session without a mask will need to be provided with one or dismissed from the session.
      • All school-age children must wear masks when participating in research. Based on CDC guidance, children two years of age and older must wear face masks in public spaces where it is difficult to practice social distancing. 
  • Between participant sessions, all equipment and other touch points must be disinfected with an ethanol (70% min.), isopropanol (70% min.), or 0.12% sodium hypochlorite (i.e., bleach) solution.
    • Where possible, doorways should be opened to allow maximal airflow through the research space.
  • A log of each participant’s entry and exit from the research site must be maintained. These logs will be used for contact tracing in the event a researcher or participant is known to become ill. 
    • Because logs will contain identifiable information, they must be maintained in a secure location. 
    • Logs are to be maintained for three weeks and then destroyed. 
  • If anyone associated with a face-to-face human subject research study tests positive for COVID-19, several actions on the part of the researchers are necessary:
    • If a member of the research team tests positive for COVID-19 they must immediately discontinue participation of in-person research activities. Student researchers should contact University Health Services and staff, faculty, and postdoctoral researchers should contact the Wellness Center to obtain medical advice and to determine what measures are required to protect themselves and the community.
    • If a member of the participant sample discloses a COVID-19 infection to the research team subsequent to participating in research, the PI must contact the Wellness Center. Researchers should not communicate with participants themselves unless instructed to do so by the Wellness Center.  
    • If PI becomes aware of a COVID-19 positive test result from a member of the research team or the participant sample, they must inform the director of Notre Dame's research compliance in order to determine if a review by the IRB is necessary, if the research protocol should be modified, or if any other actions on the part of the research team are required to satisfy research compliance requirements. 

Lab Reopening Phase 4

  • It is expected that face-to-face human subjects research will approximate near-normal levels in Phase 4 of the Lab and Studio Reopening Plan although several Phase 3 safeguards to health and safety will likely remain in place. Additional guidance on Phase 4 operations will be issued at a later date.

Research Protocol Changes & Modifications

  • Until updated guidance is issued by the IRB, new and existing research protocols are subject to COVID-19 related modifications to typical practice.
  • New research protocols:
  • Existing approved protocols:
    • Prior IRB approval does not grant permission to conduct research that does not fall within the current phase of the University’s Research Continuity Plan. Approval to conduct a study must also be granted by the researcher’s department chair and dean as well as the vice president for research.
    • All continuing studies must provide participants with pre-study communication about the existing risks and established protections related to participating in face-to-face research studies at this time (view Guidance on Resuming In-Person Human Research).
    • Researchers must evaluate whether current circumstances present an elevated risk to participants (view Human Research COVID-19 Risk Evaluation Checklist): 
      • If no elevated risk is identified, no amendment is needed.
      • If an elevated risk is identified, an amendment will be required to outline the risk and the mitigating steps being taken by the research team.
    • Informed consent forms must be updated to provide standard information about the fact that any activity which requires entering public spaces at this time carries a risk of COVID-19 infection (view Guidance on Revising Informed Consent Documents). Amendments are not required when implementing this language.
    • If new or elevated risks are identified, corresponding changes to the consent form must be made. These changes require IRB review as part of the amended protocol.
    • If remote data collection is not already approved, IRB protocols must be amended to include these procedures if they are to be implemented.
    • Expanded PPE, social distancing, health screenings, etc. do not require IRB approval or amendment.
      • Exception: If information collected during COVID-19 related health screening procedures is to be used as research data, IRB approval is required.
NEED MORE INFORMATION

For more information about face-to-face human subjects research or resuming a specific IRB protocol, please contact compliance@nd.edu.