Resuming Face-to-Face Human Participant Research

*** Please visit Return to Face-to-Face Participant Research Q&A Session to view the recording of the session held Friday, September 6, 2020

Effective August 31, 2020, research involving human participants that was halted by the COVID-19 emergency may resume and new human participant research may begin.

Researchers resuming or beginning on-campus and off-campus research with human participants must submit a Return to Face-To-Face Research Plan (RF2FRP) in the Syracuse University Application Portal. The RF2FRP includes the following:

If you are an External PI (ESF), please follow these instructions on how to register an account in the Syracuse University Application Portal.

All new studies and study modifications require IRB approval prior to submitting a RF2FRP. See the Human Research Forms for required IRB submissions for amendments and reporting study deviations. Please send questions to orip@syr.edu. Procedures to add safety precautions due to COVID-19 (e.g. face coverings, cleaning, physical distancing, health screening, see Important Information about COVID-19 and Research Participation Sheet) do not require an amendment to the IRB protocol.

The present uncertainty about the impact of the recent state-wide relaxation of earlier restrictions and the rapidly-evolving understanding about factors that affect transmission of the SARS-CoV-2 virus determine the current and future changes in Syracuse University policy and allowable activities for research involving human subjects.

Other form:

Checklist for Reviewing Human Participant Research Resumption

This checklist is used to help guide reviewers, but submission of form is not required

Research on Syracuse University Campus.

For research conducted on campus with non-SU participants (individuals who are not matriculated students, faculty, or staff), the research team is responsible for ensuring that Requirements for Visitors to Campus for Limited Research Purposes is followed by all campus visitors.

Other form:

Human Participant Health and Safety Screening

Research outside of New York State.

Research allowable in New York State as described below may not be appropriate in other locations – other states or internationally. Researchers should consult the local public health and pandemic context, as well as local requirements. If local requirements are more relaxed than Syracuse University requirements, the Syracuse University requirements of what is allowable should be followed. For example, face masks should be worn even if not required in the local jurisdiction. If travel is involved (traveling more than 100 mile from Syracuse, NY), nationally or internationally, Syracuse University Travel Safety  is required to be followed.

Process. Use the RF2FRP to submit your operating plan for human participants research. Procedures to add safety precautions due to COVID-19 (e.g. masks, cleaning, social distancing, health screening, Important Information about COVID-19 and Research Participation Sheet) do not require an amendment to the IRB protocol.

Note: Research with human participants falling under Research Activity C below cannot resume or start until your Return to Face-to-Face Research Plan (RF2FRP) have been reviewed by Environmental Health and Safety Services (EH&SS) and an Institutional Review Board designated member.

Guard against stigma. Please remind your team that the risk of infection by the novel coronavirus is not connected with age, race, ethnicity, or nationality. Do not make determinations of risk of transmission based on any of these factors. Be sure to maintain the confidentiality of people with confirmed coronavirus infection. Also, keep in mind that some may perceive that there is a stigma associated with identifying as having COVID-19. Work to create an environment that prioritizes sharing accurate information. For additional information about COVID-19, contact the New York State Department of Health at: https://coronavirus.health.ny.gov/home.

Research Activities

A: NO in-person interactions

 “In-person” means the study participant and study team members are physically in the same space, wherever that space is located.

Studies with NO in-person interactions may continue or begin.
Examples:
  • All interactions with study participants happen remotely (e.g., via zoom meetings)
  • No equipment is needed or equipment has been dropped off or mailed to participants; no face-to-face interactions. Specific cleaning and disinfecting requirements apply for equipment that has been dropped off and picked up.

B: In-Person but with appropriate physical distancing at all times

Physical distancing means a minimum of 6 ft. between researcher and research participants throughout the interaction.

Studies falling under this category may continue or begin with review and approval of the Return to Face-To-Face Research Plan. On- and off-campus in-person data collection with appropriate physical distancing, use of face covering, personal protective equipment (PPE), if needed, and enhanced cleaning/disinfection protocol is allowed.

If the research does not take place on campus, the researchers should provide details in their RF2FRP on the travel and the local public health conditions

  • Appropriate country, state and field site location webpages should be consulted for COVID-19 information, and policies.
  • For all fieldwork, researchers should use best public health practices recommended by the CDC (https://www.cdc.gov/coronavirus/2019-ncov/index.html), and follow all state and field location specific policies and requirements.
  • Some off-campus work may require two weeks of self-quarantine when returning to campus.
Examples:
  • Interview, behavioral, or observational* studies that allow for 6 ft. physical distancing throughout the data collection period.
  • Practice-based and practice-led research activities within a performance space or makerspace with appropriate physical distancing such as:
    • visual, theatre arts, and dance research with no shared theatrical properties, no indoor moderate-to-vigorous physical activity;
    • small musical ensembles rehearsing/performing in appropriately de-densified spaces with no indoor vocal performance or wind instruments.

* Investigators must weigh the need for self-quarantine or testing and self-quarantine before returning to campus after completing observational research in large crowds or crowded spaces, through immersion in crowded spaces, or in an area that does not require face coverings.

C: In-person interactions that do not allow physical distancing to be maintained at all times (e.g., for the purpose of measurement or exam).

Studies falling under the following criteria will be reviewed on a case-by-case basis by members of the Syracuse University Institutional Review Board, and Environmental Health and Safety Services.

Studies that include in-person interactions without continuous physical distancing must result in benefits for the mental or physical health of the participants that outweigh the coronavirus risks.

Studies falling under this category may continue or begin with review and approval of the Return to Face-To-Face Research Plan.
Examples:
  • Exercise, hearing and speech studies.

Other Forms:

Checklist for Reviewing Human Participant Research Resumption

Human Participant Health and Safety Screening

 

Resources used from the following institutions:

University of Washington

Penn State University

University of Colorado Boulder

University of Denver, Colorado

University of North Carolina- Greensboro

University of West Virginia

University of Massachusetts at Amherst

Harvard University