COVID-19 and Human Subjects Research Guidance for Preparing to Resume In-Person Research

The situation involving coronavirus is rapidly changing, please visit Clemson University’s official COVID-19 webpage for current information. You may also visit the IRB FAQs page for additional IRB related COVID-19 information.

All research involving human participants must maintain an ethically appropriate standard, which serves to protect the rights and welfare of the participants. The Office of Research Compliance is providing this information to assist researchers with managing their research activities. This page is being updated regularly as new information emerges.

As we have learned more about COVID-19 and about our communities’ ability to face this challenge, we are now in a position to begin the thoughtful, phased restart of in-person research. Doing so safely and effectively will require the concerted, coordinated efforts of many parts of the university, a close adherence to university guidelines and a keen awareness that our actions affect not only ourselves as individuals but our colleagues and our entire state.

Resuming in-person research will also require patience and flexibility because we cannot simply return to how things were before COVID-19. Moreover, we will make changes as we go along in response to new information, new outbreaks and changes in the capacity of our communities to respond.

Resuming in-person research is guided by these goals and principles:

  • Seek to return research back to full strength while being consistent with the university’s goals and implementation principles
  • Protect our researchers, students, research participants and community partners
  • Respect the specific health conditions and other risks factors of every individual involved
  • Protect and enhance the quality and impact of the university’s research and teaching
  • Maintain compliance with all federal, state and local requirements
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    • Research activities that can be conducted remotely, should continue remotely for the foreseeable future. This includes multi-institutional and international research projects. Whenever possible, research involving human participants should be conducted using methods that remove or diminish contact between researchers and participants.

    • Researchers should be aware that there may be a need to pause or wind down in-person research in the future in response to new information about COVID-19, new outbreaks or changes in the capacity of our communities to respond. PIs resuming research under these guidelines should have a plan in place for the orderly reduction or cessation of in-person research on a temporary or long-term basis.

    • Researchers must follow university policies for all university-related travel. University-related travel is not permitted until restrictions are lifted. More information is available on the Procurement and Business Services webpage.

    • Researchers are required to notify the IRB office if a Clemson employee or student is involved or will be involved with an international project, even if the Clemson researcher will not interact with research participants. 

      An amendment request is required to resume all international projects involving in-person interactions.

    • If the protocol was reviewed and approved at Clemson, in-person interactions at Clemson may resume when the university returns to normal operations. 

      If the partnering institution is the lead IRB on the approved study, then follow their guidelines for resuming in-person research and notify the IRB office if there are any concerns or conflict. A deferral request must be on file with the Clemson IRB office.

    • With guidance from a task force comprised of Clemson researchers and staff from the Office of Research Compliance and Occupational and Environmental Safety, a checklist was developed to guide researchers with developing their safety protocol before resuming in-person research. PIs are asked to use the checklist to assess the team’s resources before resuming in-person research activities. 

      A reference table was developed to assist researches with determining what information is required by the IRB.

    • In an attempt to protect the community, all study personnel and research participants (except participants in K-12 school settings) are required to complete the COVID-19 screening questions on the IRB webpage within 24 hours before every in-person session. 

      For K-12 school settings, study personnel are required to follow school districts’ safety protocol for in-person interactions. 

      Screening for symptoms and risk factors prior to a research visit is not considered a research procedure and, therefore, does not require an amendment. However, the results of such screenings should not be kept as part of your research files or used for research purposes. An amendment is required and the informed consent form will have to be updated If you want to use the screening information as research data.  Study personnel experiencing COVID-19 symptoms must follow the university reporting guidelines.

      If a research participant is experiencing COVID-19 symptoms, postpone the in-person session for a minimum of 14 days and refer them to the S.C. Department of Health and Environmental Control (DHEC) webpage for monitoring requirements. 

    • Research study personnel are required to provide the safety notification developed by the IRB office and the guidance task force to research participants before the first in-person interaction. The notification may not be modified. 

      The notification is intended to provide context for a conversation with prospective participants about what Clemson University researchers are doing to protect both participants and staff. 

      Study personnel may supplement the safety notification with additional information on what the study team is doing to minimize the risk of contracting the virus. The supplemental safety information does not require IRB approval. 

      For K-12 school settings, the safety notification is not required for research participants in school settings. Study personnel are required to follow school district safety protocol.

    • Study personnel is not required to provide the safety notification or screening questions to research participants in K-12 classrooms but required to follow the school district’s safety protocol and provide documentation of site approval to the IRB office.

      Study personnel visiting classrooms for in-person activities are required to complete the COVID-19 screening questions before each in-person session.

    • An amendment request is required before resuming in-person research for all Full Board protocols and international studies, regardless of review level. 

      An amendment is not required to resume in-person research for previously approved Exempt and Expedited IRB protocols. An amendment is still required for all changes that were not previously reviewed and/or approved by the IRB. 

      Study personnel is required to provide updated documentation of site approval for all off-campus locations. Submit the amendment request and/or updated site approval to IRB@clemson.edu.
    • If you are proposing to conduct in-person research, provide the information from the in-person research checklist on the IRB application and describe why the study cannot be conducted remotely. Use the current application and templates on the forms page.

    • Clemson employees are required to complete the “United as Tigers - Return to Workplace Training” developed by the university. The training is available on Tiger Training. 

      The COVID-19 training does not replace the CITI human subjects training required for IRB approval.

    • When on-campus instruction resumes, in-person research may continue under the requirements outlined in this guidance.

      Review the university’s Health & Safety Directives for University Visitors before inviting external participants to campus.

    • Off-campus in-person research may resume for IRB approved studies with an updated site approval on file with the IRB office. An amendment request is required if you are adding new research sites to the protocol. An amendment is not required for previously approved sites; only an updated site letter is required. 

      Site documentation must include a statement that appropriate safety protocols are agreed to and in place as a condition of resuming the research. Guidance on research site letters is available on the resources page. 

      Study personnel is required to follow the university and off-campus sites’ safety protocol. The university’s safety protocol is available on the COVID-19 resource webpage.

    • Please follow CU guidelines regarding testing and reporting for study personnel who may have been exposed to the virus. 

    • Clemson University expects all researchers to comply fully with university guidelines to protect the health of each other and our broader communities. PIs bear additional responsibility for compliance with these guidelines throughout their research teams and facilities. Academic units (e.g., schools, departments, centers, institutes) also have additional responsibility for oversight and support. 

      If the research team is found to be conducting human subjects research without IRB approval, the research will be halted pending an investigation and a proper course of action will be pursued, which may include suspending all funds and research associated with the project. 

      Persons observing non-compliance with research guidelines should address this, as appropriate, with the individual(s) involved, the PI or study personnel, and notify the IRB office at IRB@clemson.edu. Complaints may also be made anonymously through the ethics/safety hotline.