Human 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).
Casey Jackson, MS, CCRP, is UMSON's research quality 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 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) Protection of Human Subjects (PHS) training
- Health Insurance Portability and Accountability Act (HIPAA) training:
- HIPAA 125 training
- HIPAA 201 training
- HIPAA 125 training
- 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 email@example.com 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.
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