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

    PRMC SharePoint -

    Support -

    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.

    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 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 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 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

    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



  • 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.