Face-to-Face Human Subjects Research
During the current phase (Phase 4), the following guidance applies for face-to-face human subjects research:
- Notre Dame students and employees, as well as members of the general public, are eligible for inclusion in face-to-face human subjects research without restrictions beyond those outlined on the Research Continuity pages and those normally established by the IRB and University policies.
- Face-to-face human-subjects research must conform with the University's Visitor Policy and Gathering Policy.
- Research teams may, at their discretion, screen for and exclude a) individuals considered to be high-risk by the CDC or b) individuals not vaccinated against COVID-19. IRB approval or amendment is not needed in these cases provided the research team considers the exclusion temporary based on local health conditions and corresponding COVID-19 related University policies.
- A potential participant cannot be compelled to provide vaccine information nor documentation of vaccination. Thus, researchers will ultimately be taking any response at face value.
- Consent forms may state the potential consequences of providing vaccine information that is not accurate. A sample statement is as follows:
- "Because this research requires that you meet with study personnel in a lab, we will be asking if you have received a COVID vaccination. We will not ask you to provide specific health information or to provide copies of your vaccination record. The only purpose of this question is to ensure your safety as a research participant and the safety of our study personnel. We may ask that you postpone study visits or remove yourself from the study if you do not confirm that you have received full COVID vaccination. Providing inaccurate information may increase the risk of infection to yourself and others."
- It is important to communicate selection criteria as early as possible, what information is needed, and how it will be used. There is a significant likelihood that the question itself will elicit strong reactions from some participants and it needs to be clearly explained that the question is not being asked in order to collect health information about the individual themself beyond screening for their own safety.
- For studies already underway, if a principal investigator (PI) wants to now exclude subjects who are unvaccinated, a re-consent process that clearly explains that failure to confirm vaccinated status will (or may) result in removal from the study will be necessary.
- Prior to scheduled sessions researchers must screen participants for COVID-19 symptoms (fever, cough, shortness of breath, sore throat, loss of taste or smell, etc.) and if they have had 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 has had close contact with a person suspected of contracting COVID-19.
- Research teams should ensure that they are able to meet any local requirements that might apply, particularly when conducting face-to-face human subjects research off-campus. This includes potential requirements to use of face masks, social distancing, and more.
- 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.
NEED MORE INFORMATION?
For more information about face-to-face human subjects research or resuming a specific IRB protocol, please contact firstname.lastname@example.org.