COVID-19 Reporting and Information

Office of Research

Tennessee Tech COVID-19 Human Subject Research Recommendations

This statement provides guidance to researchers as TTU engages in research using human subjects during the current COVID-19 pandemic. We recommend that researchers take extra steps to decrease the likelihood that they will put their study participants, members of their study teams, or themselves at risk of becoming infected with or spreading the novel coronavirus.

These recommendations are put forth for research being conducted in person with human subjects. Research not conducted in person (e.g. online, telephone) do not need to consider these protocols.

PIs are recommended to implement COVID-19 pre-screening procedures with any potential in-person research participants and may only enroll participants that are presumed COVID-19 negative.

In accordance with CDC guidelines, research participants must agree to appropriate PPE before arriving to the research visit. Additionally, research study staff should self-screen for COVID-19 symptoms and implement appropriate safety measures.

PIs and Co-PIs must comply with COVID-19 protocols of research sites that have mandated specific COVID-19 directives (e.g., masks, social distancing).

Student researchers should work closely with their Faculty Advisors to determine whether any changes are needed to facilitate their research.

Investigators should establish plans
All studies should have a contingency plan detailing how the study is being conducted during the pandemic. This plan should be in writing and distributed to the entire research team. The plan should be maintained with the research records and made available upon request to the IRB, compliance agencies, or sponsors.

All investigators engaging in human subjects research should develop concrete and actionable plans for:

  • Continuing or halting data collection.
  • Modifying the protocol to decrease or eliminate in-person study interactions or implement remote visits or procedures.
  • Regularly communicating with the research team, sponsor, study sites, and participants and their caregivers to ensure safety and compliance.
  • Managing data accessibility and storage to facilitate ongoing research as the situation changes.
  • Coordinating with data collection sites to follow any new guidelines or procedures for interacting with subjects and determining whether any coronavirus cases have been identified at the site.
  • Ensuring that research study staff is healthy and that provisions are in place to handle a reduction in study staff

Screening study participants

  • Follow directives from TTU in accordance with guidance from the CDC, Tennessee Department of Health, and local county health departments.
  • Follow instructions from the specific facility where participation interaction would occur.
  • Consider the participant population (e.g., are they at risk for COVID-19) and the setting in which the interaction would occur.
  • Develop possible alternatives to in-person study visits that are important for subject safety and monitoring.

Modifying study procedures to occur remotely
Research studies may consider modifying their procedures to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening, and consenting. Researchers may consider alternatives to in-person research or monitoring visits, such as email, telephone or videoconference interactions.

Please also keep in mind that any changes to approved IRB applications require review and approval prior to implementation. Changes can be requested using the Request for Continuation/Change Form.

Contact us with questions
The IRB Chair and faculty are available to discuss human subject research concerns and offer advice on how to handle modifications. Please do not hesitate to reach us via email. Please continue to visit the TTU IRB website for the most up-to-date information.

 

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