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:

Request a Consult or Primary Review of Your Project

For any IRB and regulatory questions or concerns or to request training and/or a quality assurance assessment please contact casey.jackson@umaryland.edu or 410-706-1611.


Training Requirements

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:

  1. Collaborative Institutional Training Initiative (CITI) training
  2. Health Insurance Portability and Accountability Act (HIPAA) trainings
  3. 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:


Oversight Requirements

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
Existing PI x     x
New PI** x x   x
PhD Students x x x x
DNP/NHSR       x

ORS QA Review Requirements* 

 Primary & Departmental Review  Pre-Enrollment/ Regulatory Binder QA  <6 Month Post Enrollment QAAnnual QA/ Study Status Report As Needed/ Upon Request
Existing PI x       x
New PI** x x R   x
PhD Students x x R R x
DNP/NHSR        

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 (nrs-research@umaryland.edu), noting the IRB study number and the PI of the study in the subject line. 


Additional Resources