Covid 19

 Dear Research Community-

 We understand the challenges you are faced with during this
unprecedented time in the wake of the COVID-19 pandemic.  

Know that the work you carry out is now more important than ever.  

With that in mind, attached you will find additional tools and guidance 
that will assist you when conducting your ongoing studies.

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  • SOP's

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

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

  • COVID-19 Risk Mitigation Planning

     Flowchart- Study Specific COVID-19 Risk Mitigation Planning

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

  • Modification & HIPAA Waiver Request

    -*HRP 219- Modification Form

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

    *Only required when the protocol is NOT being revised

     

  • Obtaining Informed Consent & HIPAA Authorization Remotely

    1. 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.

    2. 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)

    3. 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. 

    4. 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.

    5. Follow the steps in #4 to obtain authorization from the participant.

    6. 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.

    7. If the person is unable to take a picture, you will document the circumstances. 

    8. The person conducting the consent process should sign and date a copy of the consent document.

    9. The witness should sign & date on the witness line of a copy of the consent document.

    10. 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.

     

    Informed consent was obtained on Date at Time.  The participant could not come to the site for the consent process due to COVID-19 social distancing requirements.  A copy of the consent document was emailed to the prospective participant before the consent discussion

    The consent process was performed by phone/ZOOM.  The individuals attending the discussion were: (list the names of the individuals). The person obtaining consent explained the research to the participant and answered the participant’s questions.  The person obtaining consent asked the participant questions to ascertain whether the s/he understood the study, and the participant was able to answer the questions.  The participant voluntarily agreed to participate.  The subjest/LAR signed and dated the consent document. The research was not able to obtain a copy of the signed original consent document because consent was obtained remotely, and the document may transmit the COVID-19 infection.   

    After signing the consent document, the participant took a picture and sent it to the research team/ OR The participant was unable to send a picture of the document. A witness observed the entire process.
    The consenter should then add similar documentation about the HIPAA authorization.

  • Administering IP at an Alternate Location

    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.

  • Replacing IP With a Commercial Product When the Participant Cannot Obtain the Drug from the Site

    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. 

  • Research Visits guidance

    Interim University of Miami Guidelines for Human Subjects-Related Research Visits During the COVID-19 Outbreak

    Background

    The University of Miami (UM) is implementing this guideline to protect research participants, researchers, and the larger South Florida community from risk of infection with COVID-19 as well as to ensure ongoing access to research, which may provide essential support and care to participants. This policy will be revised as needed, based on new information, and circulated to the UM research community. It will also be available on the UM coronavirus website. Please send questions and comments on this policy to hsro@miami.edu. 

    Interim Guideline (Effective March 16th, 2020)                      

    Participants                                                                                                    

    Research visits should be performed remotely (e.g., by phone, Skype, Zoom, Microsoft Teams, or other means) whenever possible.

    Nonessential Research Visits (see examples below)

    Until further notice, you should postpone visits that are not essential to a participant's health and/or well-being when you cannot perform the visit remotely.  The determination of whether or not the research visit is "essential to the health and/or well-being” of the participant should be informed by the principal investigator of the study, the participant, the participant’s care provider, and should be informed by current public health guidance regarding the COVID-19 outbreak.

     

    Essential Research Visits (see examples below)

    If you cannot perform a research visit that is essential to a participant's health and/or well-being remotely, you can perform the visit in-person, with the following additional guidance:

    a)      Participants should be provided with information regarding the current COVID-19 epidemic and how best to reduce their risk of infection. You can provide this information in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. If possible, you should share this before the research visit. See the following CDC COVID-19 link for reference and materials: https://www.cdc.gov/coronavirus/2019-ncov/index.html.

    b)      Research staff should verbally screen all research participants via phone for fever, cough, and flu-like symptoms before the research visit, if possible. Research staff should re-screen participants when they arrive for the in-person visit.

    Participants who screen positive will require triage according to your institution’s clinical screening and triage protocols. 

    University of Miami

    Jackson Health Systems (requires JHS network access) 

    Enrollment of new patients on a clinical trial or other human subject-related research should be allowed only if:

    •    Participation in the trial is essential to a participant's health and/or well-being, as determined as above; or

    •    The enrollment and longitudinal participant management can be conducted remotely for the duration of the COVID-19 outbreak.

    Research Personnel                                                   

    All study personnel (faculty and staff) should receive appropriate training regarding proper research participant screening (e.g., masking protocols) and participant triage should they encounter a research participant who is at risk for COVID-19 infection during an in-person research visit screening. Please refer to your institution’s clinical screening and triage protocols. 

    Until further notice, track missed, remote, and out of window study visits due to COVID-19 as protocol deviations on a Deviation Log and report the deviations to the IRB within 30 days.

    Study Sponsors                                                       

    Principal investigators or their designees should contact study sponsors to notify them of this guideline and make appropriate arrangements. You should postpone all sponsor visits for clinical trials or other human subject-related research, whether for site qualification, site initiation, or monitoring visits, whenever feasible. You should base considerations for remote monitoring on study needs and resource availability.

    When is a Study Visit "Essential to the health and/or well-being" for Human Subject Research Visits During the COVID-19 outbreak

     

    The following examples are provided as a guide to help principal investigators, participants, and participant care providers determine the suitability of in-person research visits. These determinations and the balance of potential benefits and harms will vary by study objectives, target patient population, and may change as the COVID-19 outbreak evolves. The following examples are not intended to be comprehensive of all study types.

     

    For these study designs:

    Is the specific research visit "essential to the health and/or well- being" of the participant, thus supporting in-person visits?

     

     

    These visit types are LIKELY "essential" (supports an in-person visit)

    These visit types may or may not be "essential"

    (Support for in-person visit will depend on

    specifics of the study)

    These visit types are LIKELY not "essential" (does not support an in-person visit)

    Randomized controlled efficacy trial (e.g., phase IIb or III) of a potential drug or device or other intervention

    ·       New enrollments

    ·       Follow-ups

     

     

    Post-approval trial (e.g., phase IV) of a therapeutic drug, device, or other intervention to assess tolerability and/or

    long-term benefit

    ·       Follow-ups

    ·       New enrollments

     

    Early phase (e.g., phase I or IIa) pharmacodynamic, safety, tolerability or feasibility trial a potential drug or device

    or other intervention

    ·       Follow-ups

    ·       New enrollments

     

    Non-randomized interventional trial of a drug, device, or other intervention

    requiring safety monitoring

    ·       Follow-ups

    ·       New enrollments

     

    Non-randomized interventional trial of a drug, device, or other intervention not requiring safety monitoring

     

    ·       New enrollments

    ·       Follow-ups

     

    Comparative effectiveness studies or other study types describing the natural history of a disease or other clinical

    outcomes

     

    ·       Follow-ups

    ·       New enrollments

    Non-interventional qualitative study

     

     

    ·       New enrollments

    ·       Follow-ups

    Non-interventional study with collection of clinical data and/or biological specimens for future research

     

     

    ·       New enrollments

    ·       Follow-ups

     

     

  • Things to think about

    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.

  • COVID-19 Related Research Studies at UM

    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.

    View list