Researchers may petition the IRB for an exception to the suspension of in-person research for the following types of research:
- Ethnographic participant observation research in which the research participants are not asked to engage in any behaviors that are different than what their activities would be if they were not research participants. For example: if a researcher intends to participate in BLM protests as a participant observer they can petition for an exception.
- Individual face-to-face interviews and other types of human-subjects research when the researcher can demonstrate that the participants would not reasonably be able to participate.
- Research conducted in hospitals or other facilities in which there are rigorous protocols in place related to COVID-19.
In the application for an exception to the suspension of in-person research, the complete safety protocol for COVID-19 will need to be included and must cover both the recruitment of participants and the actual research.
- If the research was previously approved by the IRB, provide the approved protocol number
- On-campus research must adhere to all policies set by the AU Forward Return to Research plan
Off-campus research protocols should address:
- The setting with special attention to ventilation, methods for maintaining social distance, and sanitation. (Outdoors is generally considered safer than indoors. Indoors should have ample fresh air).
- Personal Protective Equipment for both the researcher and the participants, including face coverings, gloves, hand sanitizer.
- Cleansing protocols
- Attestation of wellness on the part of both the researcher and the participant.
- If the research is to be conducted in an institution that has its own COVID-19 related protocols, those should be appended and followed in addition to whatever additional protections are enacted. In some instances, a research site may have stricter requirements, which must be followed. In others, the IRB may require protections in addition to those required by a research site.
- The context of the research setting related to COVID-19, such as local infection rates, etc.
The risk of contracting COVID-19 as part of taking part in face to face research must be explicitly addressed in the informed consent process. Please use the informed consent addendum if you will be interacting face-to-face with research participants. Importantly, the public health mandate to reveal contact to contact tracers specified by government policies, supersedes confidentiality protections. Therefore, this exception to protecting confidentiality in the event of contact-tracing arising from Covid-19 needs to be included in the informed consent. If the researcher believes that the risk of this very specific breach of confidentiality is so great that it outweighs the danger from this public health crisis, then they should make this case and ensure their methodology does not collect any identifiable information.
If the protocol has not yet been reviewed and approved by the IRB, include the safety protocol as listed above in your Cayuse IRB submission, in the “Final Steps” section. If the protocol has been previously approved by the IRB, please email the IRB detailing the exception request with the safety protocol as listed above to firstname.lastname@example.org. Be sure to include the approved protocol number. The exception request will go to the chair of the IRB who may choose to escalate the decision to the full IRB. Because of the rapidly changing nature of these circumstances, in-person research will only be approved for a six-month period. All research protocols with approved exceptions must be resubmitted for renewal six-months from the date of approval.
- Research that is approved by another IRB of record through a reliance or authorization agreement must follow guidelines and policies of the IRB of record. Oversight of this research has been ceded to the other institution.
- Researchers are required to adhere to any mandates by government health authorities at the research site as well as any imposed by grant funders. As always, researchers are responsible for reporting any adverse events and the IRB may halt any approved research at any time.