For Researchers
For Researchers
This resource helps Investigators:
  • Design, write, and organize research protocols
  • Maintain compliance with UMB HRPP, IRB, and federal policies, procedures, and regulations
  • Create and submit IRB applications via CICERO
  • Ensure protection of human research participants
  • Investigator Manual
    This document will guide Investigators through:
  • Policies, procedures and resources related to the conduct of Human Research that are specific to UMB
  • Information regarding Human Research protections
  • Relevant federal regulations and guidance

  • The manual will answer questions such as:
  • Can I be a principal investigator for a study?
  • When am I engaged in research?
  • What is UMB's Institutional Review Board (IRB)?

  • * All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual
    Click Here to access the Full Manual
    Study Conduct
    Contains information and documents for investigators conducting human subjects research, such as:
  • Continuing Review Table to Report SAE's
  • Reportable New Information (RNI) bulletin

  • Click Here to access All Study Conduct Tools
    General Tools
    Contains links, documents, and general tools covering regulations, policies, and guidance, such as:
  • DHHS Regulations
  • VA - Maryland Research and Development

  • Click Here to access All General Tools
    Required Training
    Contains training requirements information for researchers conducting human subjects research:
  • CITI Training
  • HIPAA Training

  • Click Here to access Full Requirements
    Clinical Research Training Mentoring Program
    The Program provides the following support services:
  • Assist investigators in designing, submitting, and or revising IRB protocols
  • Assist investigators with scientific and regulatory issues unique to their research protocols
  • Meet personally with investigators and research team to provide instruction to facilitate the submission of protocols through CICERO
  • Advise how to strengthen the design and conduct of their studies
  • Attempt to identify other faculty and staff experienced in clinical research that can help the investigator
  • Provide assistance until protocols are either approved or withdrawn

  • Click to request CRTMP Support   (UMVibe Site)



    Program Director, Robert Edelman, MD
    Associate Program Director, James Campbell, MD, MS
    Program Manager, Karen Stewart (send email)
    Video of the Week
    UMB Human Research Protection Program Plan
    This short document describes the roles and responsibilities of key individuals, organizations, and committees within the HRPP, such as:
  • Definitions
  • Human Research Protections Office (HRPO)
  • Institutional Review Board (IRB)
  • Office of Research and Development (ORD)
  • Conflict of Interest Officer and Advisory Committee
  • Institutional Biosafety Committee (IBC)
  • Radiation Safety Committee(RSC)

  • * All individuals involved in research are expected to be knowledgeable of the guidance outlined in the Plan
    Click Here to Download the HRPP Plan
    Consent Form Templates
    Instructional Videos
    These short videos will answer common researcher questions, such as:
  • Accessing and navigating the CICERO system:
  • Creating and Submitting an IRB Apllication
  • What is Non Human Subject Research

  • Click Here to access All Videos
    HRPP Education and Training Program
    Coordinates overall program content and delivery methods for the daily operations and events within the HRPP components, specific to:
  • Individuals
  • Groups
  • Educational resources
  • Other research programs

  • Educate and train researchers involved with human research participants; specifically focusing on:
  • Study design
  • The review process
  • Study conduct
  • Study oversight
  • Monitoring of human subject research

  • Click to request HRPP Education/Training   (UMVibe Site)



    Program Director, Karen Stewart (send email)

    UMVibe

    Access to UMVibe is granted via your MyUM credentials. You will need to know your MyUMID and password.
    If you do not know your MyUMID or password go to https://directory.umaryland.edu to find your MyUMID or change your password.