Announcements

We remain committed to sharing real time updates with our research community in regards to ongoing changes/ enhancements.
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  • 9/9/2020 - RCQA Educational Program

    Please note there has been and date/time change to Compliance with the Informed Consent Process class.  The new date is 9/15/2020 at 10:00am.  Please see updated schedule below-

    For any questions, please contact Patty Tate at plt18@miami.edu

    rcqa-sep

  • 8/7/2020- Increase to External IRB Administrative Review Fees

    fees

  • 7/16/2020- Solving the Challenges to Behavioral Research during the COVID-19 Pandemic

    The Center for HIV and Research in Mental Health (CHARM) invites you to participate in our Seminar on Solving the Challenges to Behavioral Research during the COVID-19 Pandemic. Register in advance by clicking on the image below or here: https://miami.zoom.us/webinar/register/WN_rGUEvN4WSIO16HamF0sK-g .

    You can add this event to your calendar directly from the registration website. After registering, you will receive a confirmation email with the necessary information to access the meeting. If you have questions, please contact Andrés Vázquez at ( axv830@med.miami.edu ) or 305-243-7447

     charm

  • 7/15/2020- RCQA - Education Program

    Dear Researchers,

     

    We are pleased to announce that starting next week, we will provide our training classes via zoom. Please see below flyer with all necessary information and share this announcement with your colleagues and team members. Please remember that we provide CEUs for most of our training classes and that you can use these CEUs for professional certifications and some license requirements (nurses, social-workers, psychologists).

     rcqa

    Please be safe.

     

    With best regards,

     

    Johanna Stamates

    Executive Director RCQA

  • 7/13/2020- NEW Registration Link for the Seminar on Community-Based Participatory Research (CBPR) and Ethics

    The Center for HIV and Research in Mental Health (CHARM) invites you to participate in our Seminar on Community-Based Participatory Research (CBPR) and Ethics. Register in advance by clicking here:  https://miami.zoom.us/webinar/register/WN_oyjv-2qxSj6QnZFWQdr1zA  . You can add this event to your calendar directly from the registration website. After registering, you will receive a confirmation email with the necessary information to access the meeting. If you have questions, please contact Andrés Vázquez at ( axv830@med.miami.edu ) or 305-243-7447.

     

     cbpr

     

  • 7/7/2020- Updated FDA Guidance on Conducting Clinical Trials During COVID-19

    Good afternoon,

     The FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”  

     

    The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation.  (See Questions 10 and 11)  

     

    In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. (See Question 12) 

     

    Finally, the guidance clarifies recommendations on documenting details when PI’s use video conferencing for remote trial visits. (See Question 20)

     

    Warm regards,

    Cindy

  • 6/17/2020- Updated Biomedical Consent Documents - Combined document for UM/JHS now available

    Good evening,

    I am pleased to announce the availability of three new versions of the biomedical research consent template:

    1.       HRP 502a1 – Biomedical Consent for use when the research will be conducted only at the University of Miami;

    2.       HRP 502a2 – Biomedical Consent for use when the research will be conducted only at Jackson Health System facilities; and

    3.       HRP 502a3 – Biomedical Consent for use when the research will be conducted at both the University of Miami and Jackson Health System facilities. 

    Also available are FAQs relating to the three documents above.  Researchers may not obtain IRB approval on HRP 502a3 and obtain consent from participants on only the one document, even when research procedures will be done at both facilities.

    The FAQs provide more information about the documents and when to use them.   

    Join me in thanking Katuska Barbery, who provided tremendous help with finalizing these documents. 

    Warm regards,

    Cindy

    Cynthia Gates, J.D., A.D.N, C.I.P.
    Associate Vice President, Regulatory Affairs and Assessment
    Office of Vice Provost for Research
    University of Miami
    1400 NW 10th Ave
    Dominion Tower, 12th Floor, Room 1206
    Miami, FL  33136
    305.243.7943

  • 6/15/2020 - Agreement Reached for Access to Health Information at Jackson Health Systems

    Good afternoon,

    I am pleased to inform you that the University of Miami (UM) and Jackson Health Systems (JHS) reached an agreement to restart research involving access to health information at JHS. 

    UM researchers who want to access JHS health information for research must complete and submit the HRP-503d  protocol template.  

    Please remember that researchers must record any health information collected from JHS or the UM anonymously. The updated template includes a list of identifiers that investigators must not record (write down) on the data collection document used to abstract the health information.  Investigators may record an identifier on a document or file that is separate from the data collection document and apply a code to link the health information to the identifier.  This process will create a de-identified, coded data set.  Investigators must maintain the link between the code and the data set on a separate document or file. 

    This updated template requires researchers to agree to:

    (1)    Maintain health information collected from JHS only on the secured JHS SharePoint environment;

    (2)    Also maintain the link between the health information collected from JHS and a code used to identify the individual on the JHS SharePoint environment; and

    (3)    Confirm that the researcher or study team will not reuse or disclose any health information collected from JHS, whether identifiable, coded, or anonymous, without first obtaining written permission from JHS. 

    Please read the updated template carefully and comply with the requirements.  You may need to develop new procedures to ensure compliance.

    The UM HSRO is accepting modification and new submissions of research involving medical record review at JHS.  Investigators must use the updated protocol for this purpose.  You may contact the UM HSRO or the JHS Clinical Trials Office for questions.

    Warm regards,

    Cindy

    Cynthia Gates, J.D., A.D.N, C.I.P.
    Associate Vice President, Regulatory Affairs and Assessment
    Office of Vice Provost for Research

  • 5/27/2020- Clinical Trial Disclosure: Determination and Protocol Registration Policy Training

    Please direct all replies and questions to Yolanda Davis at y.p.davis@med.miami.edu

    Dear Research Community,

    The Office of Research Compliance and Quality Assurance is offering several  Webinars (20 minutes) to enhance awareness for the revisions of the following  policy: Clinical Trial Disclosure: Determination and Protocol Registration (https://umiami.policystat.com/policy/token_access/628beb33-c8ef-422e-b7f2-f79acb2dbe1e/)

    The revised policy will be effective on June 1, 2020 

     

    The webinar will focus on:

    •       Changes to the existing policy

    •       Studies requiring registration on ClinicalTrials.gov in order to comply with the policy

    •       Responsibility for ensuring that studies are registered on ClinicalTrials.gov

    •       Required procedures  for protocol registration

    •       Contact for assistance

     

    Avoid being unaware of the new protocol requirements and attend one of these short Webinar sessions offered.  You can sign up in ULearn by searching for “Disclosure” and clicking on the class Clinical Trial Disclosure: Determination and Protocol Registration 2020.”  The first Webinar will take place on April 3, 2020 at 10:00 am and the final Webinar will be offered on May 29. 2020 at 4:00 pm.

    We understand that during the time of the COVID-19 pandemic, not everyone will be able to attend one of these webinars.  For those unable to attend at this time, a recording of the training will be made available on June 5, 2020 at ctd.uresearch.miami.edu/ policies and procedures.

    Regards,

    Yolanda P. Davis, CCRP

    Clinical Trial Disclosure Manager

    Office of Research Compliance and Quality Assurance University of Miami

  • 5/19/2020 - DRM Open Office Hours!

    UDisclose System Open Office Hours

    For immediate assistance with the UDisclose System, please call the DRM at (305) 243-9898.

    Do you have questions about how to navigate the UDisclose system? Are you unsure of what to disclose, or how to get started?

    Not to worry! The DRM is offering open hours four days a week via Zoom for all questions or concerns
    .

    Choose the day and time you want to "visit" our Zoom office hour and simply click on the link below!

    Monday

    Tuesday

    Thursday

    Friday

    8 – 9 AM join via Zoom

    11 AM – noon    join via Zoom

    2 – 3 PM join via Zoom

    10 – 11 AM join via Zoom

     

                Starting:

    Monday, May

    18th

    For immediate assistance outside of Open Office Hours or if you prefer assistance over the phone, please call the DRM at

    (305) 243-9898.

    DRM Open Office Hours:
    Answering your Questions
    We’re always looking for ways to reach out to our research community and faculty with information on UDisclose. During this time where in-office visits aren’t possible, it’s more important than ever to make sure we’re accessible to serve your needs. Office hours are staggered throughout the week to accommodate the varying schedules of our community members.

  • 5/15/2020 - Take the Survey - Electronic Consent and Remote Research Visits

    The Miami CTSI and the research enterprise are jointly exploring options for electronic consent, and conducting remote procedures using Zoom for Healthcare for research involving human subjects. Please complete the survey below to help us gauge your needs for this purpose. The purpose of this survey is to assess the research community’s needs in using an electronic consent platform and means to conduct research visits virtually.

    Click on the link to take the surveyhttps://redcap.miami.edu/surveys/?s=JKL8AX3YCR

    Short survey linkhttps://j.mp/3eZt5Y1

    Thank you,

    Miami CTSI

    Website: www.miamictsi.org

    Email: CTSIServices@med.miami.edu

  • 5/14/2020 - Updated Research Frequently Asked Questions

    Sent on Behalf of John Bixby, PhD, Vice Provost for Research and Erin Kobetz, PhD, MPH, Co-Vice Provost for Research

    Dear Colleagues,

    During our live research forums, as well as in the interim between the last forum and now, UM’s Office of the Vice Provost for Research has received a number of questions related to the current pandemic and its effects on research. Click here for an updated set of responses to those asked most often. A recording of the latest Q&A can be accessed at this page.

    John Bixby and Erin Kobetz

  • 5/11/2020 - Clinical Trial Disclosure: Determination and Protocol Registration Policy Training

    Dear Research Community,

    The Office of Research Compliance and Quality Assurance is offering several  Webinars (20 minutes) to enhance awareness for the revisions of the following  policy: Clinical Trial Disclosure: Determination and Protocol Registration (https://umiami.policystat.com/policy/token_access/628beb33-c8ef-422e-b7f2-f79acb2dbe1e/)

    The revised policy will be effective on June 1, 2020 

     

    The webinar will focus on:

    •       Changes to the existing policy

    •       Studies requiring registration on ClinicalTrials.gov in order to comply with the policy

    •       Responsibility for ensuring that studies are registered on ClinicalTrials.gov

    •       Required procedures  for protocol registration

    •       Contact for assistance

     

    Avoid being unaware of the new protocol requirements and attend one of these short Webinar sessions offered.  You can sign up in ULearn by searching for “Disclosure” and clicking on the class Clinical Trial Disclosure: Determination and Protocol Registration 2020.”  The first Webinar will take place on April 3, 2020 at 10:00 am and the final Webinar will be offered on May 29. 2020 at 4:00 pm.

     

    We understand that during the time of the COVID-19 pandemic, not everyone will be able to attend one of these webinars.  For those unable to attend at this time, a recording of the training will be made available on June 5, 2020 at ctd.uresearch.miami.edu/ policies and procedures.

    Yolanda P. Davis
    Clinical Trial Disclosure Manager
    Office of Research Compliance and Quality Assurance University of Miami

     Please direct all replies and questions to Yolanda Davis at y.p.davis@med.miami.edu

  • 5/7/2020- Electronic Consent and Participant Visits with Conferencing Applications

    The Miami CTSI and the research enterprise are jointly exploring options for electronic consent and conducting remote procedures in human subject research.  

    Please complete the survey below to help us assess the research community’s needs in using an electronic consent platform and electronic means to conduct research procedures virtually.

    Click on the link to take the surveyhttps://redcap.miami.edu/surveys/?s=JKL8AX3YCR

    Short survey linkhttps://j.mp/3eZt5Y1

    Thank you,

    Miami CTSI

    Website: www.miamictsi.org

    Email: CTSIServices@med.miami.edu

     

  • 5/1/2020: REMINDER: Q&A with Research Leadership Today

    Virtual Forum: Q&A with Research Leadership

    Dear Colleagues:

    The University of Miami research community has had to adapt rapidly to new rules and new processes during the COVID-19 pandemic. One of our most important jobs during this time is communication.

    Join the University’s research leadership in a second Question & Answer session on the university’s plan for research in the coronavirus era. We hope to address questions that remain or have arisen since our first conversation, continuing our discussion on how your research and funding are affected by the COVID-19 epidemic and what you might expect from us moving forward.

    WHAT AND WHEN

    • Forum for faculty, research staff, and graduate students
      Friday, May 1st, 4 p.m. via zoom
    • Register HERE to participate (zoom link provided with registration)

    The forum will be recorded and archived at uresearch.miami.edu for later viewing by individuals who are not able to access the live events.

    PARTICIPANTS

    • John Bixby, PhD – Vice Provost for Research
    • Erin Kobetz, PhD, MPH – co-Vice Provost for Research
    • Barbara Cole – Associate Vice President, Research Administration
    • Cindy Gates, JD – Executive Director, Human Subjects Research Office

    Moderated by Ali Mosser, PhD  Senior Manager, Research Development and Strategy

  • 4/24/2020- Research Frequently Asked Questions

    Sent on Behalf of John Bixby, PhD, Vice Provost for Research and Erin Kobetz, PhD, MPH, Co-Vice Provost for Research

    Dear Colleagues,

    During our last research forum, as well as in the interim between then and now, we received a number of questions related to the current pandemic and its effects on research. Responses to some of those asked most often can be found here. A recording of the April 13th forum can be accessed at this page.

    John Bixby and Erin Kobetz

  • 4/23/2020 - Second Q&A with Research Leadership on May 1st

    Virtual Forum: Q&A with Research Leadership

    Dear Colleagues:

    The University of Miami research community has had to adapt rapidly to new rules and new processes during the COVID-19 pandemic. One of our most important jobs during this time is communication.

    Join the University’s research leadership in a second Question & Answer session on the university’s plan for research in the coronavirus era. We hope to address questions that remain or have arisen since our first conversation, continuing our discussion on how your research and funding are affected by the COVID-19 epidemic and what you might expect from us moving forward.

    WHAT AND WHEN

    • Forum for faculty, research staff, and graduate students
      Friday, May 1st, 4 p.m. via zoom
    • Register HERE to participate (zoom link provided with registration)

    ·         SUBMIT YOUR QUESTIONS NOWYou are invited to submit questions in advance using this link

    The forum will be recorded and archived at uresearch.miami.edu for later viewing by individuals who are not able to access the live events.

    PARTICIPANTS

    • John Bixby, PhD – Vice Provost for Research
    • Erin Kobetz, PhD, MPH – co-Vice Provost for Research
    • Barbara Cole – Associate Vice President, Research Administration
    • Cindy Gates, JD – Executive Director, Human Subjects Research Office

    Moderated by Ali Mosser, PhD  Senior Manager, Research Development and Strategy

  • 4/20/2020- COVID-19 & Remote Consent providing access to drugs when participants cannot come to the research site - Updated FDA Guidance

    Good morning,

    Below is updated guidance on conducting research during the COVID-19 pandemic.  The updated guidance includes additional Q&As.

    Conducting Research During the COVID-19 Pandemic 

    Conduct of Clinical Trials With Q&A - Revised Version 

    Also attached is information from the guidance to help researchers:

    1.       Obtain remote consent;

    2.       Administer the study drug at an external location when participants cannot come to the research site; and

    3.       Prescribe the study drug when the drug is approved, and participants cannot come to the research site.

     

  • 4/6/2020 - Important: Updated Biomedical Consent Template Consent Document

    Dear Research Community-

    The University of Miami HSRO is pleased to announce that we have an updated consent document for biomedical studies.  

    This consent form includes several parts: 

    Ø  -Part 1 – Consent for the research 

    Ø  -Part 2 – HIPAA Authorization 

    Ø  -Part 3 – Genetic/Genomic Sharing Consent 

    Ø  -Part 4 – Notice and Consent for GDPR*  
                       (*studies obtaining data about people in Europe)

    Ø  -Part 5 – Template language for risks 

     

    When this consent form is used, investigators:

    No longer need to obtain an authorization with HIPAA Form B  

     Participants will instead sign the authorization section of the consent document 

     No longer need to obtain a signature on separate consent document to test participants for HIV 

     The language is now included in the main consent document 

     Please start using this template immediately when you submit new studies.  Remove Part 5 (template risk language) and any other parts of the document that are not applicable to your research (e.g. GDPR, Genetic/Genomic sharing) before submitting the document.

    We remain committed to sharing real time updates with you.

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

  • 4/6/2020- Guidance for Electronic Signatures in Research During COVID-19

    Please direct all questions and replies to Helen Miletic at hmiletic@med.miami.edu

    Dear Human Subject Research Community,

    Please see the document “Guideline for Electronic Signatures in the Conduct of Human Subject Research During COVID-19 Pandemic.”

    This guidance document provides a standard process for applying electronic signatures in human subject research:

    • during the COVID-19 pandemic
    • when wet signatures cannot be obtained
    • for studies conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application, in the absence of a 21 CFR Part 11 compliant system

    • This guidance does not apply to the informed consent process.
    • This process is not intended to obtain electronic signatures from non-researchers such as research participants.

     

    Regards,

    Helen

    Helen Miletic, MA, CHRC, RQAP-GCP

    Director, GxP Compliance

    Research Compliance and Quality Assurance

    University of Miami

    Ph: (305) 243-4306 (direct line)

    hmiletic@med.miami.edu

     

  • 3/31/2020 - COVID-19 HRPP Guidance Documents

    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 in risk mitigation planning when conducting your ongoing studies:

    Flowchart- Study Specific COVID-19 Risk Mitigation Planning

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

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

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

    -HRP 219- Modification Form

    The safety of our research participants and of our study teams is tantamount.

    We remain committed to sharing real time updates with you

     in regards to ongoing changes and how we can best support your research needs during this time and beyond.  

    We thank you for your ongoing support. 

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

  • 3/31/2020- IRB/eProst & UDisclose Weekly Scheduled Maintenance: Every Thursday

     

    Systems Unavailable for Weekly Thursday Maintenance 

    IRB/eProst and UDisclose will be unavailable due to scheduled maintenance every Thursday, from 5:30 p.m. to 8 p.m. Once maintenance is complete, access to the systems will resume automatically. We apologize for any inconvenience.

     Have Questions?

    If you have any questions or IRB/eProst System feedback, please contact the HSRO by calling 305-243-3195 or emailing hsro@miami.edu. If you have any UDisclose System questions, please contact the DRM by calling 305-243-0877 or emailing to DRM@miami.edu.

     

    For 24/7 assistance, please contact the UHealth IT Help Desk by emailing help@med.miami.edu or calling 305-243-5999, Option 4.

     

    Thank you,

    The UHealth IT Research Team

  • 3/30/2020 - Updated FDA Guidance on Conduct of Clinical Trials

    Good afternoon,

    Please review the FDA Guidance on Conduct of Clinical Trials during the COVID-19 Pandemic.  The body of the guidance is essentially the same as the previous version that I shared with you earlier this month.  This version includes an appendix of Questions and Answers, including:

    (1)    Issues to consider when deciding whether to continue a trial;

    (2)    Whether and when to submit modifications to the FDA;

    (3)    Virtual study monitoring;

    (4)    Managing protocol deviations;

    (5)    Capturing data when protocol deviations are necessary to protect subject safety;

    (6)    Changes to processes for delivering and administering the test article; and

    (7)    Requirements for informed consent from individuals in isolation.    

    Please review the document and contact the HSRO if you have any questions. 

  • 3/24/2020 - UM Central IRB Fees

    Central IRB (sIRB) for Multi-site Research

    Effective June 1, 2020, the University of Miami will charge to serve as Central IRB for multi-site research. These fees must be incorporated into the grant or contract budget when conducting multi-site trials where UM will be the IRB of record.  The new fees associated with these types of submissions are provided below.

    For more information on Single IRB and Reliance see the single IRB and reliances section on the HSRO website.

    Type of Submission

    Review Fee Per Site

    Initial Review

    $1,200

    Continuing Review

    $700

    Modifications

    -0-

  • 3/16/2020 - Important Information - Human Subject Research During COVID-19

    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

     

     

  • 3/12/2020: Conducting Research During a COVID-19 Pandemic

    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.

  • 3/3/2020: HSRO Update

    Dear stakeholder-

    Over the past year, we have been diligently working on a variety of ways to improve upon the services we offer.

    During the next few months, we will experience temporary staffing shortages which may impact the overall turnaround time for submissions. 

    To this end, we will be tweaking our workflow to better support your needs as well as train/ recruit accordingly.

    What you can do:

    • Submit continuing reviews at least 45 days in advance of expiration
    • Timely submittal of personnel changes
    • Prompt/ thorough responses to requests for changes

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

    We thank you for your patience and ongoing support.

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

  • 12/19/2019: eProst "Update" Feature Limitations (External IRB's)

    For Studies using External IRBs DO NOT use the eProst “Update” Feature for UM specific documents

    • If you use this feature to upload revised documents, those documents will not transfer into Velos.

    • HSRO staff do not “approve” information uploaded through an update.

    • Use of this feature could lead to compliance issues.

    • This feature should only be used for non-UM specific changes (i.e., New study-wide PI, study funding, study scope-drugs and devices, template ICF, etc…).

    • This feature appears in submissions related to sites using external IRB and is part of the “base product” from Huron. Research IT cannot remove it.

    DO submit a modification to upload UM specific documents

     

     

  • 12/4/2019: Revised Common Rule - Single IRB Requirement: Effective January 2020

    Revised Common Rule Single IRB (sIRB) Policy – Effective January 2020

    The revised Common Rule requires use of a single IRB for all federally-funded, domestic, multi-site or collaborative research, effective January 20, 2020.

    New grant applications to federal agencies submitted on or after this date must include a plan for use of a sIRB including identification of the sIRB.  For more information on Single IRB and Reliance see the single IRB and reliances section on the HSRO website.

    Choosing the single IRB for the study

    The sIRB will be proposed by the lead institution submitting the federal grant application or in rare cases, identified by the federal funding agency. UM will serve as the single IRB for research where a UM investigator is collaborating on the study. 

    Exceptions to the requirement

    sIRB is not required for non-US sites, sites involving tribal nations and studies for which the federal funding agency says sIRB review isn’t appropriate

    Cost of single IRB review

    The policy allows sIRBs to charge for review of external sites. The costs of these reviews will come from the grant and should be included in the budget.  If UM relies on the IRB of another institution or on a commercial IRB as the single IRB, their reviewing IRB will probably charge for the review.  PIs will need to work directly with the sIRB to get information about their fees. 

    Grant submission inquiries can be directed to the Office of Research  Administration’s application team or Lionel Vera: Lvera@med.Miami.edu

  • 11/27/2019: PES Updates

    Important Information on the PRMC Electronic System (PES) Upgrade:

    • PES login has been moved and can now be accessed at https://scccapps.cgcent.miami.edu/PES/login.htm

    • The system is now faster in order to facilitate your submission needs.

    • It is now mobile friendly.  

    • Additional information will be available to the study teams regarding where a submission is in the PRMC review process.

    Should you experience any difficulties or notice any discrepancies, please do not hesitate to reach out to us at Informatics@med.miami.edu

    We are continuing to improve the system for effective usability. Please feel free to provide feedback as you continue to utilize the system.

  • 11/20/2019: Federally Funded Studies Under External IRB Oversight

    Are you conducting a federally-funded study under external IRB oversight?

     If yes, please read the following information:

    On January 21, 2019, the 2018 Common Rule became effective.  Protocols approved on after this date must follow the 2018 Common Rule.  Studies approved before that date can follow the old Common Rule or the 2018 Common Rule.  In these instances, the IRB decides which version to apply.

    The eProst system requires the IRB to enter the Common Rule version that applies to this research.  You must review letter and/or contact the reviewing IRB to see which version applies and provide this the approval the version  with the next eProst submission. 

  • 11/19/2019: eProst Error:  Notices on Continuing Review Deadline for Closed Studies

    Many closed studies that are under external IRB oversight are receiving erroneous automatic communications from eProst. If an external IRB reviewed your study that is closed in eProst, please disregard the notice.  This error is a technical issue that Research IT is working to correct.

  • 11/1/2019: Time Sensitive- Postupgrade

    Important Information on eProst Upgrade

    Action Required on Existing Submissions before the upgrade: Submissions that were sent back to study teams as “clarification requested” or “modifications required” must be sent back to the HSRO to continue the review process. 

    Once you send them back, the HSRO will continue with the review.

    CITI dates displayed: Note that the new dates displayed in the Study Team Member section in eProst are reflecting the CITI courses’ completion date (not the expiration date as the label indicates). For HSR and ICH GCP courses, approval is valid for 3 years from completion date. For COI course, approval is valid for 4 years from completion date.

    Should you experience any difficulties or notice any discrepancies, please do not hesitate to reach out to us at hsro@miami.edu.

  • 10/29/2019: Submitting New External IRB Studies

     Instructions are Avaliable for Submitting
    New External IRB Studies in eProst IRB 8.2.4

    Below are instructions for new studies that will be reviewed by an external IRB. When eProst 8.2.4 is avalibale, these are the instructions you need to follow to submit these studies to the HSRO. The HSRO must administratively approve the study before you can start studies reviewed and approved by an external IRB.

    Submitting New External IRB Studies in eProst IRB 8.2.4

  • 10/23/2019: ePROST Upgrade - REMINDER

    Important Information: eProst Upgrade & Submission Deadlines 

    The HSRO’s eProst System is undergoing an upgrade from 10/24/2019 - 10/27/2019

    From 10/24/2019 until 10/27/2019

    • No one will be able to use eProst or submit information to the HSRO or to the UDisclose system

    • You will not be able to access IRB-approved study documents in Velos

    • The HSRO will not be conducting IRB meetings (Meeting scheduled for 10/28 is cancelled)
    • Existing Submissions: Right before the upgrade HSRO staff will be kicking back any existing submissions as they will need to be in one of the following states before the system goes down: Clarifications Requested or Modifications Required.

      Please DO NOT resubmit until AFTER the upgrade

     

    WHAT'S NEW IN ePROST 8.2? 

  • 10/22/2019: Medical Campus Training today- in advance of eProst upgrade

    The HSRO’s eProst System is undergoing an upgrade from

    10/24/2019 - 10/27/2019

    Upgrade training (focus on external and Central IRB)

    • Tuesday, 10/22, from 10:30 a.m. to 12:00 p.m., Lois Pope Life Center Auditorium (Medical Campus)

    Walk-ins welcome.  Hope to see you there!

    In the event you cannot attend in person, please note the session will also be recorded.

    Join Skype Meeting 

    Trouble Joining? Try Skype Web App

    Join by phone

     +17866361461 (Dial-in Number) English (United States)

     Find a local number

     Conference ID: 364379943

     Forgot your dial-in PIN? |Help    

  • 10/21/2019: Upgrade training notification

    Upgrade training (focus on external and Central IRB)

    • Monday, 10/21, from 1:30 p.m. to 3:00 p.m., Flipse Building, Room 502 (Gables Campus)
    • Tuesday, 10/22, from 10:30 a.m. to 12:00 p.m., Lois Pope Life Center Auditorium (Medical Campus)

    Walk-ins welcome.  Hope to see you there!

    In the event you cannot attend in person, please note the session will also be recorded.

    Join Skype Meeting 

    Trouble Joining? Try Skype Web App

    Join by phone

     +17866361461 (Dial-in Number) English (United States)

     Find a local number

     Conference ID: 78905781

     Forgot your dial-in PIN? |Help    

  • 10/21/2019: IRB 8.2.4 Upgrade, What is changing?
  • 10/18/2019: TIME SENSITIVE-REMINDER: In advance of the eprost upgrade

    From 10/24/2019 until 10/27/2019

    • No one will be able to use eProst or submit information to the HSRO or to the UDisclose system
    • You will not be able to access IRB-approved study documents in Velos
    • The HSRO will not be conducting IRB meetings (Meeting scheduled for 10/28 is cancelled)
       

    Please note…

    • Deadline for initial review submissions: The HSRO will not accept submissions for new studies between 10/14/2019-10/27/2019

    • Deadline for continuing review reports: If your study will be expiring within the next (45) days – on or before 11/30, deadline to do so was 10/14/2019

    • Studies using an external IRB: Deadline for submissions of modifications was 10/16/2019.  The HSRO will discard all submissions that have not been completely reviewed before the upgrade because this part of eProst will be significantly upgraded 

    • Existing Submissions: Right before the upgrade HSRO staff will be kicking back any existing submissions as they will need to be in one of the following states before the system goes down: Clarifications Requested or Modifications Required. Please DO NOT resubmit until AFTER the upgrade

    • Upgrade training (focus on external and Central IRB)
      • Monday, 10/21, from 1:30 p.m. to 3:00 p.m., Flipse Building, Room 502 (Gables Campus)
      • Tuesday, 10/22, from 10:30 a.m. to 12:00 p.m., Lois Pope Life Center Auditorium (Medical Campus)

  • 10/17/2019: External IRB Upgrade Training

    You are invited to attend training to learn about the External IRB upgrade features. No registration required. Walk-ins welcome.  

    • Monday, October 21, from 1:30 p.m. to 3:00 p.m., Flipse Building, Room 502 (Gables Campus)

    • Tuesday, October 22, from 10:30 a.m. to 12:00 p.m., Lois Pope Life Center Auditorium 7th floor Auditorium (Medical Campus)

    Have Questions?

    If you have any questions or IRB/eProst System feedback, please contact the HSRO by calling 305-243-3195 or emailing hsro@miami.edu.

  • 10/3/2019: NEW DATES for submission deadlines: In advance of the eprost upgrade

    From 10/24/2019 until 10/27/2019

    • No one will be able to use eProst or submit information to the HSRO or to the UDisclose system
    • You will not be able to access IRB-approved study documents in Velos
    • The HSRO will not be conducting IRB meetings (Meeting scheduled for 10/28 is cancelled)

     

    Deadlines for eProst Submissions October

    • Deadline for initial review submissions: The HSRO will not accept submissions for new studies between 10/14/2019-10/27/2019
    • Deadline for continuing review reports: If your study will be expiring within the next (45) days – on or before November 30th, and you have not yet submitted, please do so no later than 10/14/2019
    • Studies using an external IRB: Deadline for submissions of modifications is 10/16/2019.  The HSRO will discard all submissions that have not been completely reviewed before the upgrade because this part of eProst will be significantly upgraded 

  • 9/27/2019: JHS CRRC ancillary reminder

    If your study includes research activities at any Jackson Health System (JHS) facility or if you are accessing JHS patient information:

    To see if Jackson’s Clinical Research Review Committee has approved your submission- please refer to ‘Reviews Tab’ for ancillary reviews

    Reference the Accepted column (indicating Yes for Accepted, or No for Not Accepted) to know whether the review group has accepted the review

    For more information on our standard operating procedures, please visit Jackson CRRC ancillary

  • 9/12/2019: eProst Upgrade - Deadlines & other important information

    The HSRO’s eProst System is undergoing an upgrade from 10/10/2019 through 10/13/2019

    From 10/10/2019 until 10/14/2019

    • No one will be able to use eProst or submit information to the HSRO or to the Udisclose system

    • You will not be able to access IRB-approved study documents in Velos

    • The HSRO will not be conducting IRB meetings (Meetings scheduled 10/14 and 10/15 are cancelled)

     

    Deadlines for eProst Submissions: September – October

    • Deadline for initial review submissions:
      The HSRO will not accept submissions for new studies from 9/23/2019 - 10/14/2019

    • Deadline for continuing review reports:
      If your study will be expiring within the next 45 days - on or before October 31st, and you have not yet submitted, please do so no later than 9/25/2019

    • Studies using an external IRB:
      Deadline for submissions of modifications is 10/01/2019.
      The HSRO will discard all submissions that have not been completely reviewed before the upgrade because this part of eProst will be significantly upgraded 

  • 9/12/2019: Cancer-related Research FAQ and Protocol Submission and Review Process Flows

    Here are 5 things you need to know about the Protocol Review and Monitoring Committee (PRMC):

    1. PRMC approval is required for all human subject research that:
    • Involves cancer patients;
    • Has cancer-related objectives or endpoints; and/or
    • Is aimed at preventing, treating or diagnosing cancer.
    1. PRMC approval is required even when the research involves only a chart review or a registry.
    2. To obtain PRMC approval, you must follow one of the review process listed below as described in the attached documents.
      1. Population Science/Social and Behavioral Science (SBS) Interventional Study Process Flow
      2. Population Science/SBS Observational Study Process Flow
      3. Clinical Trials Coordination Unit (CTCU) Interventional Study Process Flow
      4. Non-CTCU Interventional Study Process Flow
      5. Observational, Basic Science, Ancillary/Correlative Study Process Flow
      6. Chart Review, Registry, Bio Repository, HUD, Compassionate Use Process Flow
    3. The Sylvester Cancer Center is a National Cancer Center (NCI) Designated Cancer Center and PRMC review is part of the requirements the NCI. 
    4. You can find more information at:  

    PES - https://bbcapps.ad.med.miami.edu:8443/PES/login.htm

    PRMC SharePoint - https://miamiedu.sharepoint.com/sites/scccshare/ResearchInf/scccprc/SitePages/Home.aspx

    Support - https://umiamihealth.org/sylvester-comprehensive-cancer-center/research/research-resources/clinical-research-services/research-committees-support-unit

    Sylvester is South Florida’s only NCI-Designated Cancer Center!!

  • 8/30/2019: Using the "Consent to Contact" Process for Recruitment - What you need to Know

    Consent to Contact is a process that helps investigators meet recruitment goals. Investigators who complete the requirements can obtain a list of names and contact information of individuals who may meet eligibility requirements for their study. These individuals agreed to allow investigators contact them for recruitment purposes.  

    The first step is to follow the process outlined by the CTSI, the organization facilitating the “Consent to Contact” program.  

     Click on this link to the CTSI webpage  to obtain information on the actions you need to take to obtain a list of potential subjects. 

    After you start the procedures above, you will also need to obtain IRB approval of the process.

    Below is a summary of the steps you should take to obtain IRB approval: 

    1.    Include a description of your plan to use “Consent to Contact” in your local protocol. 

    2.    Provide information needed to obtain a waiver of authorization from the IRB. You will need this waiver to receive the list of potential subjects. To approve the waiver, the IRB must have “written confirmation” from the recipient of the waiver indicating (1) the recipient will destroy the identifiable information at the earliest opportunity, and (2) the recipient will not re-use or re-disclose the information received for any purpose except purposes allowed by the HIPAA Privacy Rule.

    To meet this requirement, you need to include in your protocol the following language with both of the checkboxes checked.  

    •  I confirm that you will destroy or de-identify the information you collect at the earliest opportunity.
    •  I confirm that the information you collect will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study or for other research for which the use or disclosure of PHI is permissible.  
            

    3.      You also need to include in your IRB submission the approved Consent to Contact Script template with the questions you will ask potential subjects included.  You should include questions on the basic eligibility criteria found in your protocol. You may also include language in the script to schedule an appointment for an in-person visit to confirm eligibility and to obtain the subject’s consent and authorization (if required).  Please note:  When you use the Consent to Contact process, you can ask for only the minimum information necessary to conduct a basic screening for your study. 

    4.    Additional requirements must be met if your research involves sensitive matters or if you will ask potential subjects for sensitive information such as:

    • HIV status
    • Sexually transmitted diseases (STD's)
    • Hepatitis infections
    • A mental health diagnosis
    • Substance abuse 
    • Sexual assault

    If your research involves this sensitive information, you will need to ensure the person you speak with on the phone is the patient who agreed to be contacted. 

    For these types of studies, you must include the following language in the script:

    Before I tell you about the study, I need to confirm that you are (subject’s name).  Please provide your birthdate and zip code.  (When the potential subject provides the information, check the record to see if the information provided is accurate.)

  • 8/8/2019: Foreign Engagement Guidelines

    Dear Colleagues,

    Recent communications from federal agencies have made it clear that there is increased scrutiny from our research sponsors regarding our relationships with foreign entities. As a result, a number of investigators, here and at other universities, have asked for guidelines in this area. Here is some guidance that we hope will help clarify UM’s position on various activities relating to foreign entities.

    Please contact the Office of Research Administration, the Office of the Vice Provost for Research, the Office of Faculty Affairs, and/or the Office of Technology Transfer if you desire further information.
    Yours,


    John L. Bixby, PhD
    Professor of Pharmacology and Neurological Surgery
    Vice Provost for Research

     

  • 8/7/2019: Upcoming workshop

    Study Start-Up Workshop offered by RCQA on August 30, 2019

    Too little preparation for complex studies is a recipe for non-compliance. This 3.5-hours workshop will provide you with information and tools to be prepared prior to enrolling the first subject. You will learn how efforts put towards the start-up phase of your studies can save you time and frustration, leaving you with the wonderful feeling of “being prepared.”

    When: 8/30/2019 from 9:00 am to 12:30 pm

    Where: Don Soffer Clinical Research Center, CTSI Training Center, room 710

    Two (2) CEUs will be provided to all attendees

    Please sign up at ULearn – Study Start-Up Workshop. 

    Who should attend?

    • Study Coordinators
    • Principal Investigators
    • Sub-Investigators
    • Research Nurses
    • Research Managers
    • Regulatory Coordinators
    • Data Coordinators
    • Quality Assurance professionals
    • Quality Control Professionals
    • Anyone who is involved in the conduct of human subject research

    Workshop Objectives

    • Identify project requirements for Study Start-Up preparation and assessment for Investigator-Initiated studies
    • Demonstrate methods and tools for conducting a Study Start-Up assessment
    • Provide hands-on learning experience in group exercise
    • Discuss common pitfalls and recommendations

    If you have questions, please do not reply to this listserv. Instead, contact Patty Tate at plt18@miami.edu or 305-243-9740.

    With kind regards,

    Johanna Stamates
    Executive Director, RCQA

  • 8/6/2019: Signatures on IRB Notifications

    Please note that IRB notifications generated from eProst will no longer include a signature. 

    The HSRO continuously takes steps to reduce administrative burden and improve our services.  We recently noted that the regulations do not require a signature on IRB notifications.  In fact, many IRBs issue approval notifications without signatures.  We revised our processes accordingly. 

    This change will be effective immediately.    

  • 7/25/2019: Investigator Manual

    The UM HSRO created an Investigator Manual  that outlines the duties and responsibilities of investigators engaged in human subject research at the University of Miami. 

    The HSRO requires that all first time and current principal investigators review and comply with this manual before and during their research.

    For more information on our standard operating procedures, please visit HSRO

  • 7/25/2019: NIH notice on delayed reporting in ClinicalTrials.gov for basic research studies

    Dear Colleagues,

    We have some good news from NIH.

    NIH issued a notice yesterday delaying the requirement for institutions to report the results of basic research on human studies in ClinicalTrials.gov until September 2021.  The delay applies only to basic experimental studies with humans (BESH) studies submitted to funding opportunities designated as “basic experimental studies with humans” in the title.  Applicants must identify alternative platforms for reporting the research results and include the information in the Dissemination Plan attachment of the application.

    In a November 2018 letter, COGR, many other organizations, and many of our member institutions strongly urged the NIH to separate the reporting of clinical trial studies from basic research and consider a more appropriate reporting mechanism for basic research studies.

    See the full notice at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-126.html

    Please contact me with any questions. 

    Michelle D. Christy
    Council on Governmental Relations
    1200 New York Ave NW Suite 460
    Washington DC 20005
    Cell: 617-223-1551
    www.cogr.edu

     

     

  • 7/16/2019: HSRO Website & Items in Pre-submission

    Quick reminders:

    • Look on the HSRO website for Forms, Checklists, Templates, SOPs, etc. (Not eProst)

    • All submissions that are in pre-submission state and are > than 6 months old are being withdrawn

  • 7/12/2019: Protocol templates

    To help you move your study through the review process quickly, we developed three protocol templates that are easy to complete and easy to review because they ask for all of the information we need to complete the process:

    • Chart review
    • Research with Existing Biospecimens
    • Research Involving Surveys, Questionnaires, Focus Groups, & Observations

    These templates are located on the HSRO Website.

    When researchers don’t use the template, it takes us longer to review the submission because the protocol doesn’t include all of the information we need.  

    When this happens, we have to ask a lot of questions and require a lot of revisions.

    If you choose not to use the template, we may require to you to transfer the information in your protocol to the template protocol if you haven’t submitted sufficient information.