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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
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
Contact the HRPO to request HRPP education/training (send email)
Coordinates overall program content and delivery methods for the daily operations and events within the HRPP components, specific to:
- 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
- Assist in the implementation of the University of Maryland, Baltimore (UMB) HRPP and coordination of its components as set forth by the UMB Institutional Official (IO).
- Provide information, guidance, and assistance in ethics, regulations, and good clinical human participant research practices to all within the UMB HRPP.
- Provide training in research ethics and study conduct to investigators, study coordinators, administrators, and research support staff.
- Collaborate with and support research education initiatives both inter- and intra-departmentally and throughout the UMB campus.
- Assist with marketing, advertising, communication, and dissemination of information for research educational programs on the UMB campus.
- Create programs that are affordable and available to all staff involved in clinical research at UMB in a manner that can easily increase the information that can be learned and increases the ease in which the information is learned.
Recorded OHRP webinars:
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 (such as):
- 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
These short videos will deal with common researcher issues, such as:
- Accessing and navigating the CICERO system
- Creating and submitting an IRB application
- What is non-human subject research?
- Recorded research seminars
Program Director: Robert Edelman, MD
Associate Program Director: James Campbell, MD, MS
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.