Mitigation Plan for In-Person Human Subject Research

Research Involving In-Person Interactions

Researchers are encouraged to continue developing and modifying protocols to allow flexibility for conducting research activities remotely.

Researchers that need to conduct in-person activities with participants (activities that cannot reasonably be conducted remotely) will need to submit a mitigation plan to ORED for approval.  Examples of such in-person activities include, but are not limited to the following activities:

  • Biospecimen collection;
  • Physical examinations;
  • Diagnostic testing;
  • Use of pharmaceutical drugs;
  • Use of medical devices; or
  • Any other activities that require direct contact with participants

Our goal is to help ensure that you can conduct your in-person activities while ensuring the safety of the researchers, participants and community.

Minimum Requirements for a Mitigation Plan

  • Justification for In-Person Activities
    • Adequate justification as to why the specific activities need to be conducted in-person and cannot reasonably be conducted remotely.
  • Screening Procedures
    • Screening of participants for COVID-19 by administering the FIU P3 App Visitor Questionnaire
    • Following the COVID-19 screening requirements of external clinical facilities (other universities, hospitals or clinics) for off-campus research activities. The requirements will be reviewed by ORED to ensure they meet FIU’s minimum requirements.
    • Arrangements will be made for participants to come to FIU campus by appointment only.
  • Social Distancing
    • Maintaining the CDC recommended distancing between the participant and researcher whenever possible.
    • Minimizing the number of people in a room at a given time to ensure social distancing.
    • Ensuring that participants are scheduled at appropriate intervals to avoid participant overlap.
  • Personal Protective Equipment
    • Researchers and participants will be required to wear a facial covering (surgical or cloth mask) during all human subject interactions (and at all times while on the FIU campus). Researchers will need to supply a surgical mask if a participant does not have a facial covering.
  • Disinfecting Procedures
    • All high-touch points, equipment, and devices will be disinfected before and after each session with participants using an EPA approved disinfectant.
  • Personal Hygiene
    • Researchers will be required to wash hands or use hand sanitizer prior to interacting with any participants or using any equipment that will be touched by others.
  • Other Steps
    • Researchers will be required to minimize the amount of time needed for each in-person interaction.
    • Researchers are encouraged to escort participants to and from their vehicles while social distancing whenever possible.

How to Submit a Mitigation Plan for Approval

  1. Download the Mitigation Plan Request Form
  2. Complete the form and ensure that your mitigation plan meets the minimum requirements shown above.
  3. Email the completed form and any other applicable attachments to Dr. Luis Salas and Chris Grayson

Frequently Asked Questions

The document will be assessed by ORED to ensure that the in-person activities are necessary and that appropriate mitigation steps will be taken to minimize potential risks to the participants and researchers.

If revisions are required, the document will be sent back to the the researcher with comments and tracked changes. Plans may require a call with the researcher to discuss and clarify the proposed activities and mitigation plan.

Once all pending revisions have been addressed, the document is submitted to the Vice President for Research for final ORED approval.  When applicable, the document may also require approval by a Health Committee and the Repopulation Task Force.

The researcher will be notified in writing once final approval has been obtained.

The IRB does not need to approve your mitigation plan.  However, you will need to ensure that your approved mitigation plan does not conflict with any procedures from your IRB approved protocol.  Any discrepancies will need to be addressed via an IRB amendment submission. Researchers should wait to amend their IRB protocol until after their mitigation plan has received final approval.

Complete the PPE Request Form and submit it to Tonja Moore.

Please contact Dr. Luis Salas or Chris Grayson if you have any questions.