Phase

Interaction

Activity

Facility

Requirements

Phase Status

   0

Remote

No Direct Contact

Remote Research Activity/Study Visits

N/A

IRB Approval:

• To modify study visit interaction, as needed.

Active

Phase

Interaction

Activity

Facility

Requirements

Phase Status

1

Direct Person to Person Interaction

Research with the Potential for Direct Benefit

Clinical Care Site

Clinical Care Site approval, if applicable

IRB Notification:

• At next Continuation/Amendment

Active

Research visit (with or without direct benefit) that coincides with Clinical Care Visit

Direct Person to Person Interaction

Research with the Potential for Direct Benefit

Wayne State Site

OVPR Approval:

• WSU Site Plan

IRB Approval:

• Appendix N
• Participant COVID-19 Information Form
• COVID-19 Phone Script

Active

Direct Person to Person Interaction

Research with the Potential for Direct Benefit

Participant's Home

IRB Approval:

• Appendix N
• Participant COVID-19 Information Form
• COVID-19 Phone Script

**Allowable only in extenuating circumstances for  the safety of the participant

Phase

Interaction

Activity

Facility

Requirements

Phase Status

2

Direct Person to Person Interaction

Research without the Potential for Direct Benefit,

that does not coincide with a clinical care visit.

Clinical Care Site

Clinical Care Site approval, if applicable

IRB Approval:

• Participant COVID-19 Information Form
• COVID-19 Phone Script
• Consent Addendum:

to describe, in general, that in-person interactions may potentially increase the participant's exposure to COVID-19

• • to describe the PI/Site plan to minimize COVID-19 exposure

Not Active

Direct Person to Person Interaction

Research without the Potential for Direct Benefit

Wayne State Site

OVPR Approval:

• WSU Site Plan

IRB Approval:

• Appendix N
• Participant COVID-19 Information Form
• COVID-19 Phone Script
• Consent Addendum:
  • to describe, in general, that in-person interactions may potentially increase the participant's exposure to COVID-19
  • to describe the PI/Site plan to minimize COVID-19 exposure

Not Active

Phase

Interaction

Activity

Facility

Requirements

Phase Status

3

Direct Person to Person Interaction

Research without the Potential for Direct Benefit

Off Campus Site:

For example:

Schools

Churches

Community

Centers

Clinics

OVPR Approval:

Site Plan Approval as described in WSU policy

Site Approval:

• Letter of Support
• Site Plan to mitigate COVID-19 risks

IRB Approval:

• Appendix N
  • Site Letter of Support
  • Site Plan to mitigate COVID-19 risks

• Participant COVID-19 Information Form
• COVID-19 Phone Script
• Consent Addendum

• to describe, in general, that in-person interactions may potentially increase the participant's exposure to COVID-19
  • to describe the PI/Site plan to minimize COVID-19 exposure

Not Active

Phase

Interaction

Activity

Facility

Requirements

Phase Status

4

Direct Person to Person Interaction

Research without the Potential for Direct Benefit

Participant's Home

OVPR Approval:

Site Plan Approval as described in WSU policy

IRB Approval:

• Appendix N

• Participant COVID-19 Information Form
• COVID-19 Phone Script
• Consent Addendum:

• To describe, in general, that in-person interactions may potentially increase the participant's exposure to COVID-19
  • To describe the PI/Site plan to minimize COVID-19 exposure

Not Active