Research Compliance and Education
The Office of Research and Scholarship:
- manages the pre-institutional review board (IRB) process
- is available to help investigators in developing preliminary strategies for IRB submissions
- provides consultation regarding human subjects research regulatory and compliance issues
- assists in responding to IRB inquires during the review process.
Assistance is also available to help researchers navigate and complete the electronic online application for the University of Maryland, Baltimore IRB (CICERO), and prepare the application for continuing review, protocol amendments, and Reportable New Information (RNI).
Research Quality Improvement Manager
Casey Jackson, MS, CCRP, is UMSON's research quality improvement manager. She can:
- assist with the pre-approval process
- conduct quality assurance assessments and pre-IRB reviews
- provide consultation and advice regarding regulatory and compliance issues
- administer training and education.
For any IRB and regulatory questions or concerns or to request training and/or a quality assurance assessment please contact email@example.com or 410-706-1611.
All University of Maryland, Baltimore (UMB) employees (including faculty, staff, post-docs, and students) participating in the design, conduct, or reporting of research funded by Public Health Service (PHS) agencies are required to complete PHS Conflict of Interest training through CITI.
Please see the UMSON Human Subjects Research Training Guide for additional guidance.
When conducting human subjects research at UMSON, you are required to complete:
- Collaborative Institutional Training Initiative (CITI) training
- Health Insurance Portability and Accountability Act (HIPAA) trainings
- Good Clinical Practice (GCP) training
All employees that work in a laboratory are required to complete Environmental Health and Safety training (EHS).
Research team members must keep Basic CITI, HIPAA, and GCP completion reports/certificates on file. These records should be placed in appropriate study binders, if applicable. Students involved in human subjects research are required to submit completion reports to the principal investigator of the study and to the associate dean of their degree program.
UMSON employees and affiliates actively engaged in human subjects research are required to submit documentation of GCP training to:
- the Office of Research and Scholarship at firstname.lastname@example.org
- Human Research Protections Office (HRPO) at email@example.com, when applicable.
To supplement the training requirements of the University of Maryland Human Research Protections Program, maintain protections for human subjects, and adhere to high quality research standards, the UMSON requires Quality Assurance (QA) reviews for students, staff, and faculty engaged in all human subjects research. QA reviews are conducted by Principal Investigators (PI) and the Office of Research and Scholarship Research Quality Manager. Timing and responsibility of QA reviews are noted in the tables below.
PI Self-QA Review Requirements*
|Regulatory Binder QA||<6 Month Post Enrollment QA||Annual QA/Study Status Report||Continuous QC|
ORS QA Review Requirements*
|Primary & Departmental Review||Pre-Enrollment/ Regulatory Binder QA||<6 Month Post Enrollment QA||Annual QA/ Study Status Report||As Needed/ Upon Request|
R = Recommended
*Greater than Minimal Risk Research has additional requirements for all PIs
**First study as an SON PI only
It is the responsibility of the PI to request QA reviews with the ORS. Requests are to be made via email (firstname.lastname@example.org), noting the IRB study number and the PI of the study in the subject line.
- UMSON Researcher Toolkit: regulatory documents, templates, and checklists
- Clinical Research Training and Mentoring Program (CRTMP)
- University of Maryland, Baltimore Human Research Protections Office
- University of Maryland, Baltimore Human Research Protections Lecture Series
- University of Maryland, Baltimore Environmental Health and Safety
- University of Maryland, Baltimore Center for Clinical Trials
- Office of Accountability and Compliance Lecture Series