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 issue
- assists in responding to IRB inquires during the review process.
Assistance is also available to help researchers navigate and complete the electronic online application – CICERO – and prepare the IRB application for continuing review, protocol amendments, and Reportable New Information (RNI).
Research Quality Improvement Manager
Jessica Rowe, MS, MA, 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.
Rowe also serves as the UMSON IRB signatory, conducting departmental reviews prior to IRB review. This includes reviewing all human subject research applications submitted via CICERO.
For any IRB and regulatory questions or concerns or to request training and/or a quality assurance assessment, please contact Jessica Rowe at firstname.lastname@example.org or 410-706-1611.
When conducting human subjects research at UMSON, you are required to complete:
- Collaborative Institutional Training Initiative (CITI)
- 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 initial documentation of GCP training to:
- the Office of Research and Scholarship at email@example.com
- Human Research Protections Office (HRPO) at firstname.lastname@example.org, when applicable.
- 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
Monthly Research Seminar Series
The Office of Research and Scholarship offers a Monthly Research Seminar Series on various topics.
Questions? Contact us.
|Jessica Rowe, MS, MA, CCRP
Research Quality Improvement Manager, RES
UMSON IRB Signatory/Departmental Reviewer
Phone Number: 410-706-1611