This resource helps investigators design, write, and organize research protocols; maintain compliance with UMB, IRB, and federal policies, procedures, and regulations; create and submit IRB applications via CICERO; and ensure the protection of human research participants

For Researchers Sections

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.

 

Study Conduct

Contains information and documents for investigators conducting human subjects research, such as:

  • Continuing Review Table to Report SAEs
  • Reportable New Information (RNI) bulletin
  • Investigator Quality Improvement Assessment

 

CT.GOV Information

Contains information, resources, and contacts for investigators conducting human subjects research that requires registration with clinicaltrials.gov.

 

Investigational New Drug Application

Includes requirements for IND submissions and FDA contact information for pre-IND consultation program for sponsor-investigators.

 

General Tools and Links

Contains links, documents, and general tools covering regulations, policies, and guidance, such as:

  • DHHS Regulations and Information
  • FDA Regulations and Information
  • VA-Maryland Research and Development

 

Instructional Videos and Recorded Lectures

These short videos will deal with common researcher issues, such as:

  • NEW! - Common Rule Revisions - Courses for the Jan 2019 Changes
  • Accessing and navigating the CICERO system
  • Creating and submitting an IRB application
  • What is non-human subject research?
  • Recorded research seminars

 

Reseacher News
HHS Announcement, Single IRB and Cooperative Research

HHS Announcement Nov. 21st, 2019 - Determination of Exception to the Required Use of a Single IRB for Certain HHS Cooperative Research that is Subject to the 2018 Requirements.

Researcher Information:

 Recorded OHRP webinars:

OHRP Information:

 

HRPP Plan 

The UMB Human Research Protection Program Plan is a short document that describes the roles and responsibilities of key individuals, organizations, and committees within UMB's HRP.

* All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual

 

Consent Form Templates

Consent and Assent Form Templates used by UMB (Only the UMB IRB approved consent/assent templates [with the UMB logo] will be accepted when UMB IRB is the IRB of record):

  • Consent Form Template
  • Assent Form Template
  • HIPAA Authorization Form

 

Required Training

Contains training requirements information for researchers conducting human subjects research:

  • CITI training
  • GCP training
  • HIPAA training

 

Clinical Research Training Mentoring Program

Program Director: James Campbell, MD, MS
Associate Program Director: Robert Rosenthal, MD
Contact the HRPO (send email)

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 approved or withdrawn.

Click to Request CRTMP Support