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Phase 1 Guidance for American University Researchers Human Subjects Research in the Context of COVID-19

The fundamental consideration for the decision on how and when to restart human subjects research is the protection of research participants. A significant part of ensuring the safety of participants in a pandemic is also to protect the safety of the researchers. The scientific understanding of the virus, its transmission, and effective mitigations is still emergent. The situation “on the ground” is highly variable by location and the local contexts are subject to rapid change. All of these conditions make it difficult to assess and mitigate risk to research participants.  

However, it is also clear that we are in a critically important period of time in this country and in the world and that there is also risk of harm by omission in stopping the creation of some knowledge. While the IRB has focused on helping researchers modify their protocols to conduct their research online, it is important to note that there are certain populations, topics, and methodologies where online research is not feasible (e.g. populations that do not have access to technology, sensitive topics where remote data collection may inhibit participation, or methodologies that cannot be approximated remotely).

Therefore, the IRB will offer the opportunity for researchers to petition for an exception to the current suspension of in-person, human subjects research. Petitions will be considered on a case-by-case basis.

We will employ a phased approach to restarting human subjects research. Phase 1 guidance is outlined below. Phase 1 will begin with the publication of this guidance document and continue until conditions dictate an adjustment – loosening or expanding based on emerging science, the spread of the pandemic, and overall environmental conditions.

Types of Research

Researchers may petition the IRB for an exception to the suspension of in-person research for the following types of research:

  1. 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.
  2. Research conducted in hospitals or other facilities in which there are rigorous protocols in place related to COVID-19.
  3. 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.

Approval Process

Please email the IRB detailing the exception request with the safety protocol as listed above to irb@american.edu.  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 must be resubmitted for renewal six-months from the date of approval.   

Safety Protocol for 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:

  1. 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).
  2. Personal Protective Equipment for both the researcher and the participants, including face coverings, gloves, hand sanitizer.
  3. Cleansing protocols
  4. Attestation of wellness on the part of both the researcher and the participant.
  5. 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.
  6. The context of the research setting related to COVID-19, such as local infection rates, etc.

Additional Notes

  • 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.