Updated July 7, 2022
Update to human subjects research processes
The central oversight provided by the vice provost for research (vpr) and the human subjects research task force members will be discontinued. A separate COVID-19 review will no longer be required. All new studies will be reviewed by the human subjects research program and the institutional review board. Additional guidance will be available at this link soon. Please contact email@example.com for questions.
Information about existing studies that have already undergone approval by the vpr and human subjects task force
Existing protocols that are approved by the human subjects research task force and the IRB can continue as approved until IRB approval expires.
Any modifications to existing safety protocols should be submitted for review to the IRB.
Some documentation required by the human subjects task force does not need to be collected any further:
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/or develop any new symptoms that may be consistent with COVID-19 and follow university guidelines to isolate and get COVID tested as appropriate. However, this no longer needs to be documented.
Student certification forms are no longer needed. This is not considered a research protocol change and a modification to the IRB is not necessary.
Researchers who wish to stop using the COVID-19 symptom screening questionnaire should submit a modification to the IRB.
Studies for which a COVID-19 information sheet for participants is necessary should continue to use that form until the study is completed.
Any new protocol for human subjects research should be submitted for review to the IRB administration and should address precautions to minimize COVID -19 risks, if relevant. The IRB will consider COVID-19 as a risk factor in their review of the protocols.
Additional documentation related to COVID-19 which was required by the human subjects task force (daily checks for research personnel, student certification forms,COVID-19 symptom screening questionnaire), do not need to be collected for new studies.
Information about procedures to mitigate risks from COVID-19 will be included in the IRB application and protocol when appropriate (see categories below)
- All researchers should continue to be vigilant and follow CDC guidelines to minimize the risk of the spread of the virus that causes COVID-19 including hand washing frequently with soap and water or using alcohol-based hand sanitizers.
Researchers must not take part in the "in-person" portion of any study if they don't feel well or have any symptoms that may be consistent with COVID-19.
IRB review and requirements for COVID-19 - related precautions will depend on the study activity and fall into 4 categories. Regardless of the categories below, at any time the IRB may determine during its review of a study that additional protections are necessary.
Category 1 - No physical contact or face-to-face interaction
Studies which do not require any physical contact or face-to-face interaction For example online surveys or interviews conducted via zoom. No additional COVID-19-related precautions are necessary for this research.
Category 2 - Minimal physical contact or face-to-face interaction
Studies which involve some face-to-face interaction but the interaction does not involve close interaction, physical intervention, extended face-to-face contact, or does not differ from regular classroom or University activities. For example, classroom surveys or focus group discussions. No additional COVID-19-related precautions are necessary for this research.
Category 3 - Prolonged close or physical contact
Studies which involve prolonged, close and/or physical contact. For example, studies involving eye-tracking procedures or other physical interventions with participants. For these studies, researchers are allowed to use their discretion to require their research team and participants to wear face coverings during this interaction. These requirements do not need to be submitted to or reviewed by the IRB.
Category 4 - Studies with increased risk
Involve aerosol generating activities (e.g., coughing, sneezing, singing, procedures that require forceful exhalation, or increased breathing depth and frequency), or
Include populations that are at high risk for severe COVID-19 illness per CDC guidelines, or vulnerable populations, or
Require contact with nasal or oral cavities, or which break the skin
For studies in this category, additional requirements may be necessary depending on the research procedures and population. Researchers should include plans to mitigate risks from COVID - 19 in their IRB materials, for review by the IRB.