Ramping up Research and Creative Activities at App

Updated November 15, 2021

As of August 26, 2021, the requirement for in person human subjects research to receive COVID-19 related approval is lifted for most types of research. Some types of human subjects research protocols still require approval by the vice provost for research to start or resume. Please see the information below to determine if your protocol requires approval.

Importantly, COVID-19 remains a risk; therefore, faculty, staff, and students conducting research with human participants must continue to put in place measures that will mitigate the risk of transmission of SARS-CoV-2.  All researchers and participants must abide by the university policy on face coverings, which requires face covering to be worn in all indoor spaces on campus. Researchers must practice proper hand washing or use hand sanitizer throughout the day as well as before, and after working with each research participant, disinfect surfaces, especially high touch surfaces and shared items, and use additional PPE appropriate for the research study. 

Researchers are allowed to incorporate stricter risk mitigation measures (requirement for double masking, physical distancing etc.) into their research protocols beyond the requirements listed above as long as they are consistent with the current university policies. 

All researchers performing human subjects research must also continue to assemble the following documents in order to proceed with their studies (please note that these are minimum requirements, additional requirements for protocols that must be approved centrally for COVID-19 risk mitigation are listed at the end of this page). The documents listed below need to be stored by the PI and separately from the consent forms. Researchers do not need to submit these forms.

  • Daily checks for research personnel taking part in the study: Researchers must not take part in the “in-person” portion of the study if they don’t feel well and follow university guidelines to isolate and get COVID tested as appropriate.
  • Student certification forms: Undergraduate and graduate students are eligible to participate as researchers. Students involved must continue to fill out the undergraduate and graduate student certification forms. These must be approved by the department chairs (or the dean, in case of the school of music) and the faculty supervisor must collect and store digital or hard copies of the forms. 
  • COVID-19 information sheet for participants: Participants must be provided with this document describing risk mitigation measures the research team is taking to minimize transmission risk. This information must be delivered verbally by the research team in addition to providing the written information. Exemption: Research, which solely involves protocols similar to what students attending in person classes experience, is exempt from this requirement.
  • COVID-19 symptom screening questionnaire: This document must be filled out for all participants. Exemption: Research, which solely involves protocols similar to what students attending in person classes experience, is exempt from this requirement.

Researchers DO NOT need to obtain additional COVID-19 related approval for their protocol if:

  • the protocol does not involve aerosol generating procedures greater than normal talking (e.g., coughing, sneezing, singing, procedures that require forceful exhalation, or increased breathing depth and frequency such as physical exercise) 
  • the protocol does not involve populations at higher risk of complications from COVID-19, or
  • the protocol does not involve children under the age of 12.

 Researchers DO need to receive COVID-19 related approval to start or resume their in-person human subjects research if:

  • the protocol involves aerosol generating procedures greater than normal talking (e.g., coughing, sneezing, singing, procedures that require forceful exhalation, or increased breathing depth and frequency such as physical exercise) 
  • the protocol involves populations at higher risk of complications from COVID-19, or
  • the protocol involves children under the age of 12.

Researchers whose protocols fall into one of these three categories are required to submit a brief risk mitigation plan to be approved by the vice provost for research. The vice provost for research will consult with the chairs and deans/associate deans of the relevant departments and colleges, respectively, and members of the human subjects research task force, as needed.

Risk Mitigation Plan submission:

  1. Please submit your risk mitigation plan for approval in InfoReady using this link.
  2. Approvals are project specific. Please submit a new request for each project.
  3. Only the research team leader should submit a plan.
  4. Research team leaders must certify in the submission that all personnel (faculty, staff, and students involved) will abide by the safety precautions within the risk mitigation plan.

Approval: Please allow 1-2 weeks for processing.  If a decision regarding approval has not been received within this timeframe, please contact vpr@appstate.edu.

Please email Ece Karatan at vpr@appstate.edu with any questions about the plan or the registration. For technical help with the submission, email Katie Schoaf at shoafkm@appstate.edu. If you have questions about your IRB protocol including modifications that need to be made, please contact irb@appstate.edu.