Coronavirus: COVID-19 - Updates from the IRB

Human Research Protection Program

Institutional Review Board

COVID-19 precautions and considerations to protect participants of Human Subject Research

The Wayne State University (WSU) Human Research Protection Program (HRPP) remains in line with the University's COVID-19 policies. You can view the most up-to-date university-wide COVID-19 policies at https://wayne.edu/coronavirus

The final restrictions for conducting in-person research visits with participants were lifted on July 1, 2021. There are no restrictions for in-person research activities when conducted in accordance with IRB approval, WSU's COVID-19 policies, and all other applicable institutional and departmental policies.

Additional Requirements:

Investigators must have an IRB approved plan to inform research participants of what to expect before the in-person research visit such as procedures for completing the WSU Guest Campus Screener, and any masking guidelines based on the WSU policy and any other applicable department policy.
- A COVID-19 Phone Script template and COVID-19 Participant Information Sheet template is available on the IRB Informed Consent/Assent Templates Website (Updated 10/2022)
All researchers must comply with all applicable institutional & departmental COVID-19 policies.
In accordance with WSU policy, all researchers must complete the WSU Campus Screener each day before arriving on campus.
- Investigators should have a plan in place should a research participant, or investigator fail the COVID-19 screener prior to the scheduled in-person research visit.
  - WSU Campus Health Policies, and any other applicable departmental/ institution policies must be followed when someone fails a COVID-19 screener.
  - CDC quarantine guidelines must be followed whenever an investigator or participant tests positive for COVID-19.
In accordance with WSU policy, all research participants must complete the WSU Guest Campus Screener on the day of the scheduled campus visit and before arriving on campus.

Vaccination Requirements:

Researchers affiliated with any of WSU's affiliate institutions must follow their institutional vaccination requirements. It is important to be familiar with the COVID-19 policies for your study sites.

Vaccination does not eliminate the requirement for strict adherence to COVID-19 risk mitigation procedures.

WSU Vaccine Policy:

Details about the WSU Vaccine Mandate is available on the WSU Vaccine Mandate Website:

https://wayne.edu/coronavirus/vaccine-mandate

Vaccines for Research Participants:

Restricting access to human participant research based on an individual's vaccination status raises ethical concerns pertaining to the equitable selection of subjects which is a requirement of the Belmont Report described by the Ethical Principle of Justice. Therefore, investigators cannot include COVID-19 vaccination in their inclusion criteria for the enrollment of research participants.

IRB Training Requests & IRB Questions:

IRBQuestions@wayne.edu

https://research.wayne.edu/irb/education.

Key Considerations for In-Person Interactions with Research Participants:

It is important to be mindful that research participants are volunteers who must be afforded all reasonable protections to mitigate risk while participating in research including COVID-19 related risks. Some key considerations to reduce COVID-19 related risks when conducting in-person research activities include:

Whenever possible, research should maintain remote study interventions/visits, as per IRB approval.
- Investigators are encouraged to limit in-person research activities to the minimum necessary. Any interaction that can be conducted virtually should be offered to participants in the virtual format.
Discuss with the Department chair the capacity to resume human participant research that requires in-person contact.
Discuss options with the sponsor for alternatives to in-person study visits.
Consider whether the in-person study visit could coincide with a standard of care visit.
Develop comprehensive procedures to mitigate the risks of exposure to COVID-19. Such operational parameters may include but are not limited to the following:
- masking, social distancing, screening, vaccination of study personnel interacting with participants, consideration of the duration of in-person contact with participants and staff, an established scheduling structure for coordinating participant visits and cleaning procedures between participant visits
Develop a procedural checklist checklist to ensure adherence to the mitigation procedures developed.
All changes made to the research protocol and procedures to conduct study interventions/visits remotely must be submitted to the IRB in an amendment before those changes can be implemented.

Appendix N: Resumption of Research Plan and PI Attestation:

As of December 1, 2022, the WSU IRB will no longer require the submission of Appendix N:

Resumption of In Person Research and PI Attestation.

This form was a useful tool to help investigators describe COVID-19 precautions, and the IRB reviewers to assess risk to participants during the height of the pandemic. With more widely available options for treatment, vaccines and testing, the IRB no longer requires the additional information that Appendix N provided to assess risks to participants.

HRPP/IRB Operations - General Information

The IRB office is operating in accordance with WSU's return to campus requirements.
Meetings and training events will be conducted virtually as much as possible.

ClinicalTrials.gov Registration Updates

Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified. The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study's ClinicalTrials.gov registration with 30 days after IRB approval of the modification.