-HRP-092 - SOP – COVID-19 Risk Mitigation Planning

-HRP 092- SOP Appendix – COVID-19 Considerations for Investigators Conducting Human Research

 Flowchart- Study Specific COVID-19 Risk Mitigation Planning

HRP 350- Worksheet – Research Specific COVID-19 Risk Mitigation Plan

Entrance to Facilities Screening

-*HRP 219- Modification Form

-*HIPAA waiver form (to waive the requirement for signature and date)

*Only required when the protocol is NOT being revised

1. Review the Remote & Electronic Consent Guidance
2. Submit a modification to the IRB adding a remote consent process to the protocol:
   
   
   • If research involves only minimal risk, request a waiver of documentation of consent (waiver of the requirement for a signature on the consent document.)
   • If the research involves greater than minimal risk, the consent document must include a witness signature line for remote consent.
   • If a HIPAA Authorization (Form B) is needed, request a waiver of the signature requirement on the HIPAA Authorization.
     
     
3. Consider the technology you will use to conduct the consent process:
   
       UM IT recommends Zoom for Healthcare
   • To access this  HIPAA-compliant form of ZOOM, contact the TeleHealth team by emailing telehealth@miami.edu. 
     
     
   • If you cannot use Zoom, arrange a three-way call with the patient, an impartial witness, and if desired and feasible, additional participants requested by the patient, (e.g. next of kin)
     
     
4. Arrange the time and communication method for the consent process for participant, or an existing participant, if the process is for reconsent.
    
   
   • Send a copy of the consent document via secure email or U.S. Mail.
   • Arrange for a *witness to attend and witness the consent discussion.
   • Let the participant know that a witness will join the consent meeting.
   • Set up a Zoom meeting or 3-way call and send an invitation to the attendees.
     
     Per SOP-090:
     
     *The witness is an impartial third party, not otherwise connected with the study (for example, clinical staff not involved in the research or a patient advocate), serve as the witness. The witness must attest that the information in the consent form and any other information provided was accurately explained to, and apparently understood by, the subject/representative, and that consent was freely given. 
     
     *The witness may not be a person involved in the design, conduct, or reporting of the research study.
     
     *The witness may be a family member or friend. 
     
     
5. During meeting:
   
   
   • Identify everyone on the call.
   • Review the informed consent with the participant, answer the participant’s questions and ask questions of the participant to confirm comprehension.
   • Ask the participant if s/he consents to participate/continue participation.
   • If the participant agrees, ask him/her to sign and date the consent document.
   • If using 3-way call, ask the participant to confirm s/he signed & dated the document.
     
     
6. Follow the steps in #4 to obtain authorization from the participant.
   
   
7. Ask the participant to scan or take a picture of each page of the documents and email the signed/dated documents to the study team. As an alternative, the research could establish a "UM Box" location for uploading the consent document.
   
   
8. If the person is unable to take a picture, you will document the circumstances. 
   
   
9. The person conducting the consent process should sign and date a copy of the consent document.
   
   
10. The witness should sign & date on the witness line of a copy of the consent document.
    
    
11. The person conducting the consent process should document the purpose for the remote consent (COVID-19), and each step of the process.  The note should explain why the research team doesn’t have the signed and dated document. 

Documenting the Remote Consent process

• The originals of the informed consent document signed by the investigator and witness should be placed in the participant’s research record.
  
  
• The person obtaining consent should document how s/he confirmed that the patient consented and signed the consent form. The note should include a statement indicating why the informed consent document signed by the participant was not retained, (e.g., due to contamination of the document by infectious material.)
  
  
• If the participant cannot send a picture of the signed document, the person obtaining consent should document why a copy of the signed document is not available. See example below.

1. The FDA recommends that PIs contact the appropriate FDA review division to discuss IP administration at an alternate site 
   
   
2. PIS must obtain prior IRB approval for this revised procedure.
   
   
3. PIs must consider whether shipping the IP to the alternate location is safe & feasible.
   
   
4. Trained personnel must administer the IP under supervision of an MD with experience in the class of products involved and assure subject safety that is equal to administration at a trial site.
   
   
5. Local health care providers (HCPs) who are administering drugs in a manner that does not differ from their normal clinical practices are not sub investigators.
   
   
6. These HCPs should be listed in research site records, such as a log of activities delegated by the PI. 
   
   
7. HCPs performing study-specific research procedures or assessments that represent a direct and significant contribution to the clinical data are considered sub-PIs and must be listed on the 1572.
   
   
8. The PI must supervise shipping of the IP to assure accountability and quality.
   
   
9. The PI should ask participants to authorize access to medical records from the HCP to collect trial-related data pertaining to the IP administration.

1. A PI can prescribe the drug instead of shipping the product directly to the patient when: 
   
   
   • The participant cannot come to the trial site to obtain the investigational product.
   • The clinical trial is investigating an FDA-approved drug, and
   • The clinical trial does not require blinding.
     
     
2. The FDA recognizes that the commercial product will not have the following statement on the packaging: “Caution: New Drug--Limited by Federal (or United States) law to investigational use.”
   
   
3. During the COVID-19 Emergency, the FDA  intends to exercise flexibility without sponsors needing to seek a waiver of the investigational labeling requirements.
   
   
4. The FDA will not object if the sponsor reimburses the participant for the cost of the drug obtained from a commercial venue. 

Dear Research Community,

Over the past 24 hours, the World Health Organization declared the coronavirus outbreak a global pandemic, and Miami-Dade County recorded its first confirmed case.

The health and well-being of our research participants and research teams is our highest priority.

The University’s IRBs will continue to hold regularly scheduled meetings, and the HSRO team will continue to process submissions.  

Here are some things to think about: 

1. Your study participants’ health and welfare should be uppermost in any decisions made relating to clinical trial activities. Consider the health implications to participants, your research team, and the community before enrolling new participants in your studies. 
   
   
2. Talk with study sponsors to obtain advice on whether to continue enrollment to find creative methods to meet study requirements during this emergency.  For example, you may be able to conduct some visits by phone or via the Internet. If your protocol doesn’t provide for remote visits, you must submit a modification to the IRB before changing in-person visits to remote visits unless this change is necessary to prevent an imminent hazard to subjects.
   
   
3. A protocol deviation occurs when a participant is unable to complete a required study-related activity, even when the deviation is due to unavoidable circumstances.  Please ensure you report these deviations to the IRB and the sponsor per the protocol requirements

We remain committed to sharing real time updates with our research community in regards to ongoing changes. 

Should you have any questions, kindly direct these to hsro@miami.edu.

A list of approved and upcoming COVID-19 related studies is now available to the UM research community.

It was made possible through a collaboration between the Miami CTSI, the Office of the Executive Dean for Research and Office of the Vice Provost for Research to increase awareness, foster collaboration and maximize institutional resources and support.

It will be updated on a weekly basis and be accessible only to users with a Cane ID and password.

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