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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
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.
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
Contains information, resources, and contacts for investigators conducting human subjects research that requires registration with clinicaltrials.gov.
Includes requirements for IND submissions and FDA contact information for pre-IND consultation program for sponsor-investigators.
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
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
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.
- HRP-106 - Unaffiliate IRB Flyer
- HRP-107 - PI Basics for Conducting Research
- Office 365 Security (OneDrive)
Recorded OHRP webinars:
- Back to Basics: Does my project fall within the scope of the regulations
- What you should know about IRB review of research
- 2019 Edition of International Compilation of Human Research Standards
- New! OHRP Spanish Resources on Protections for Research Participants. Trial coordinators and research staff can use these materials to facilitate and improve the informed consent process. https://hhs.gov/about-research-participation. From the main page, users can choose to view the site in English or Spanish.
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 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
Contains training requirements information for researchers conducting human subjects research:
- CITI training
- GCP training
- HIPAA training
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.