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
For Researchers Sections
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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. HRPP Plan
* All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual
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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
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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
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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.* All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual.
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Required Training
Contains training requirements information for researchers conducting human subjects research:
- CITI training
- GCP training
- HIPAA training -
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
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Investigational New Drug Application
Includes requirements for IND submissions and FDA contact information for pre-IND consultation program for sponsor-investigators. FDA Application
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CT.GOV Information
Contains information, resources, and contacts for investigators conducting human subjects research that requires registration with clinicaltrials.gov.
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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
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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. -
Researcher Information
Researcher Information:
- HRP-106 - Unaffiliate IRB Flyer PDF
- HRP-107 - PI Basics for Conducting Research PDF
- Office 365 Security (OneDrive) DOCXRecorded OHRP webinars:
- All Education and Outreach RecordingsOHRP 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.
Researcher News
February 2025 - FDA Guidance for Institutional Review Boards and Clinical Investigators
The following is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research.
This is an opportunity for the research community to speak directly to the IRB Chair and a member of the HRPO/IRB staff!! The 2nd Monday of every month from 12n to 1pm.
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)
Communication from IRB Chair to Principal Investigators with expired studies about required training on their responsibilities for maintaining study approval and the consequences for allowing IRB approval to expire.
Expand to Register
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 Secure Research Environment (SRE) is a new University virtual environment designed to protect sensitive and restricted research data from misuse and unauthorized access.
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
Held March 2, 2023 1:00 - 2:00 PM, A Review of the Federal Regulations Pertaining to Research with Prisoners presented by Julia Gorey, JD, Department of Health and Human Services (HHS).
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
Research Community, Please see the attached quarterly Research Fact Sheet from the UMMS Human Protections Administrator/ Office of Corporate Research Compliance.
FY2021 Q3 Fact Sheet: FY2021-Q3 UMMS.UMB Research Fact Sheet
OHRP - New Lecture Video on e-Consent
OHRP Newsletter February 2020.
OHRP is excited to announce that a new informative video on e-Consent is now available to the research community!
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.
Contact
Human Research Protections Office
620 W. Lexington Street
Second Floor
Baltimore, MD 21201