Human Subjects Research

Face-to-Face Human Subjects Research: Current COVID-19 Policies and Procedures

Last updated December 14, 2021

 

The OVPR policies and procedures below describe COVID-19 related requirements for conducting Face-to-Face Human Subjects Research. These policies and procedures are updated as the University announces changes to COVID-19 Campus Policies, Requirements & Recommendations. All changes are effective immediately. 

 

On Campus Research

  • There are no restrictions on occupancy of research spaces by faculty, students or staff.
  • 3-ply surgical masks must be worn in all Tufts spaces by research team members and participants. Cloth masks are prohibited in research spaces. Research teams must remind participants to wear a mask when they come on campus and must provide new 3-ply masks to all participants upon entry to the research space. 
  • Surveillance testing for COVID-19 continue for Tufts personnel.
  • All study staff are encouraged to screen research participants with the COVID-19 questionnaire at the beginning of each research visit or face-to-face interaction for their own protection. Use of the COVID-19 screening questionnaire (paper or mobile app) is required only for Dental School clinical patients, per university policy.
  • If research involved shared vehicle travel between individuals who are not from the same household, masks must be worn. Windows should be open if possible.
  • When conducting research in Tufts spaces/on-campus, Tufts researchers and research participants must follow all requirements described above and the University’s Campus Policies, Requirements & Recommendations.

Off-Campus Research, US-Based and International

  • U.S-Based Research
    • Tufts personnel or those working on behalf of Tufts who intercept participants on the street or conduct research in indoor settings must wear face masks. 
    • Research participants are expected to abide by the rules governing the spaces in which the research activities take place (e.g. prisons, schools).
    • All study staff are encouraged to screen research participants with the COVID-19 questionnaire at the beginning of each research visit or face-to-face interaction for their own protection.
    • Off-campus, US-Based research does not require Integrative Safety Committee (ISC) review unless categorized as having a Higher Risk of COVID-19 Infection (see list below).
  • International Research 
    • Tufts personnel and those working on behalf of Tufts must wear a face mask and follow any local COVID-19 policies.
    • Research participants are expected to follow local COVID-19 policies.
    • All study staff are encouraged to screen research participants with the COVID-19 questionnaire at the beginning of each research visit or face-to-face interaction for their own protection.
    • All international face-to-face human subjects research must be reviewed by the ISC, even if travel by Tufts personnel is not required.
    • Given the wide variation in COVID-19 conditions internationally, COVID-19 mitigation plans submitted to the ISC are likely to vary depending on research site.

Research-related Travel 

  • All Tufts-related international travel must follow the current review process, including approval by the dean or division VP’s office, review by the International Travel Review Committee (ITRC) for students, and review by the ISC for research-related travel
  • ISC approval of research travel in the United States is no longer required.
  • All travelers should be familiar with and follow local guidance at their destination.
  • Even if fully vaccinated, travelers should follow safe travel guidelines to protect themselves and others.
  • Upon return to Tufts, all travelers must follow arrival quarantine protocols according to their vaccination status, whether the travel was personal or Tufts-related.
  • For details on arrival testing for both domestic and international travelers, see Testing at Tufts.

Face-to-Face Human Subjects Research with a Higher Risk of COVID-19 Infection 

ISC review and approval is required for all face-to-face human subjects research with a higher risk of COVID-19 Infection. The following features are considered Higher Risk:

  • Research with participants who have had a positive COVID-19 test result in the past 14 days or are currently positive for COVID-19 symptoms/exposure in the past 14 days
  • The target population is unvaccinated individuals or immunocompromised populations
  • Research activities that require the removal a participant’s face mask while indoors 
  • Research conducted indoors that involves physical exertion by participants (running, strength/resistance exercises, etc.)
  • Research activities that involve the use of shared equipment that is invasive or in contact with a participant’s nose or mouth, outside of a medical/clinical setting
  • Researchers will collect human specimens (saliva, blood, stool, etc.) outside of a medical/clinical setting*
  • Research activities will involve gatherings of more than 10 people, including study staff (e.g., focus groups)
  • Research that involves bringing onto a Tufts campus more than 5 participants per day who are not in Tufts' COVID-19 surveillance testing program
  • Research conducted in an international setting

*Collection of human specimens must be registered with the Tufts Institutional Biosafety Committee prior to beginning the work.

 

COVID-19 Participant Screening Questionnaire

All study staff are encouraged to screen research participants with the COVID-19 questionnaire at the beginning of each research visit or face-to-face interaction for their own protection. Use of the COVID-19 screening questionnaire (paper or mobile app) is required only for Dental School clinical patients, per university policy.

 

Integrative Safety Committee (ISC) Review Process

ISC review and approval is required for all international research and research with higher risk of COVID-19 Infection. Submit requests to resume/begin face-to-face research activities to your respective Research/School Dean or Designee using the Ramp Up Request Form. The Dean or Designee will forward the request to the ISC for review.