Announcements

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

  • 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.