Human Subjects Research Compliance and Education

HomeResearchResearch ResourcesHuman Subjects 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).

Director of Research Quality Improvement and Compliance

Casey Jackson, MS, CCRP, is UMSON's director, research quality improvement and compliance. 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 casey.jackson@umaryland.edu or 410-706-1611.

Training Requirements

When conducting human subjects research at UMSON, you are required to complete:

  1. Collaborative Institutional Training Initiative (CITI) Protection of Human Subjects (PHS) training
  2. Health Insurance Portability and Accountability Act (HIPAA) training: 
    1. HIPAA 125 training
      AND
    2. HIPAA 201 training
  3. Good Clinical Practice (GCP) training

Please see the links above for additional guidance.

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 nrs-research@umaryland.edu prior to submitting research applications/engaging in research.

Principal Investigators must keep all CITI PHS, HIPAA, and GCP completion certificates on file for themselves and their research team. These records should be placed in appropriate study binders, if applicable. The ORS does not serve as a repository of certificates for investigators. Students involved in human subjects research are required to submit training completion reports to the principal investigator of the study and to the associate dean of their degree program.

All 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 the Conflicts of Interest training through CITI as well.

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 x         

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.