The UMB Human Research Protection Office (HRPO) is aware of a message currently posted on the CITI Program website regarding the UMB account. We are working with CITI to have the message removed. Access for learners and administrators remains available. We appreciate your patience.
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
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. HRPP Plan
* 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 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
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.
* All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual.
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:
- 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
Includes requirements for IND submissions and FDA contact information for pre-IND consultation program for sponsor-investigators. FDA Application
Contains information, resources, and contacts for investigators conducting human subjects research that requires registration with clinicaltrials.gov.
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
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.
Researcher Information:
- HRP-106 - Unaffiliate IRB Flyer
- HRP-107 - PI Basics for Conducting Research
- Office 365 Security (OneDrive)
Recorded OHRP webinars:
- All Education and Outreach Recordings
OHRP Information:
- OHRP Information Videos: Latest Video - Research with Children: What Parents Need to Know
- 2020 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 following is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research.
Questions??? Ask the Chair and HRPO Staff!
This is an opportunity for the research community to speak directly to the IRB Chair and a member of the HRPO/IRB staff!!
2nd Monday of every month from 12n to 1pm.
First session: This Monday, October 14, 2024
Link: https://umaryland.zoom.us/j/95695695923?pwd=RNkVmEbTox7fbjGaTqGORBojpXAGqJ.1
(no RSVP required)
Upcoming Training Sessions (all via Zoom):
TBD
To register for one of the above sessions, email with desired date.
To request a different date/time email the IRB Chair to arrange.
The SRE is different from the current UMB research computing environment in that the computing resources, data storage and software are not located on a local desktop or laptop computer but are available in a secure Cloud infrastructure. The SRE minimizes risk to the institution and to the principal investigator of an unlawful exposure of sensitive data.
See Guidebook
Title: A Review of the Federal Regulations Pertaining to Research with Prisoners.
Speaker: Julia Gorey, JD
Julia Gorey serves as a Policy Analyst in the Office for Human Research Protections, Division of Policy, Department of Health and Human Services (HHS), and is charged with writing and interpreting guidance and policy for 45 CFR part 46, the HHS regulations for the protection of human subjects in research. In addition to general responsibilities, she oversees the administration of subpart C and the review and authorization of human subject research involving prisoners; she also serves as Executive Director of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which provides expert advice and recommendations to the Secretary, HHS, on issues relevant to research involving human subjects with a particular emphasis on vulnerable populations. She is a University of Maryland Francis King Carey School of Law alumnus.
Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=b6625c743e2521293c0e43600ad584ab
620 W. Lexington Street
Second Floor
Baltimore, MD 21201
The University of Maryland, Baltimore is the founding campus of the University System of Maryland.
620 W. Lexington St., Baltimore, MD
21201 | 410-706-3100
