Human Subjects Use Training

General Information

All investigators, advisors and research team personnel (staff, students, and volunteers) who participate in the design and/or the conduct of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. Note that external evaluators, consultants or transcriptionist who are involved research, but will not have any contact with human participants or identifiable data, are not required to take this training.

Research personnel must complete the below required modules before the IRB provides approval. Personnel may also choose to supplemental coursework in each module specific to research project needs. Training module descriptions are available here. Follow instructions below.  UMBC may accept evidence of training (e.g. certificate of completion) from another institution (see below). Upload Please forward these documents to compliance@umbc.edu for review.

CITI also offers Responsible Conduct of Research (RCR) Courses. While useful to inform on the aspects of RCR, these courses do not provide the content the IRB requires to fully inform investigators of the ethics and procedures of conducting human subjects research. These RCR modules cannot be substituted for the below training courses but are required for NSF, NIH, USDA funded research and some UMBC graduate Programs. Please be sure IRB training modules are only listed in the protocol application.

Questions or issues regarding training? Click this link: Research compliance feedback and reporting research concerns.

citi

CITI Program Human Subjects Use Training

IMPORTANT NOTE: ALL HUMAN SUBJECTS USE TRAINING MUST BE REPEATED EVERY 5 YEARS.

 First step:

  • Using your UMBC login credentials, click on the University of Maryland, Baltimore County Single Sign On (SSO) login link on the CITI Program’s website.  
  • Persons with a current CITI login will be directed to their current CITI course list.
  • If you do not have a current CITI login, you will see this screen. Click on the appropriate link and follow the below instructions
  • Click on Register link in top right.
  • Set up an account for yourself – in “Select Your Organization Affiliation” section, make sure to select “University of Maryland, Baltimore County” by typing it in box. Then follow the rest of the instructions to create your account.
  • When asked “Which courses do you plan to take”…
  • Scroll to “Question #1” and under “Human Subjects Courses” choose one of the following:

Students conducting less than minimal risk research – Appropriate for Undergraduate Students and their Faculty Advisors

Social/Behavioral Research Course Appropriate for Graduate Students, Faculty and Staff

Research with pre-existing data, records data or laboratory specimens – Appropriate for researchers with no direct contact with Human subjects and/or Secondary Data Use

GCP – Social and Behavioral Research Best Practices for Clinical Research – Appropriate for researchers conducting research in a clinical setting

GCP for Biomedical Research – Appropriate for researchers working with FDA regulated drug, device or biologic studies. 

  • Scroll to “Question #7” and under “Information Privacy and Security” choose one of the following:

Health Information Privacy – Required for those working with HIPAA protected Data

Information Security Course – Suggested for all UMBC Researchers

Family Educational Rights and Privacy Act (FERPA) – Suggested for those working with data that is protected under FERPA

  • Once courses selected, click “Submit”
  • Then complete the courses

Your CITI training record is automatically fed into the Kuali IRB protocol record.

Once the initial training period has ended, CITI will provide instruction to renew training modules with a refresher course.

Instructions for Non-UMBC affiliated users involved in human subjects research 

Key research team members (e.g., co-principal investigators) from other institutions who are engaged” in a UMBC IRB approved protocols must have a record of current human subjects protection training and recorded in the Kuali IRB protocol record. The IRB prefers members of the research team complete appropriate CITI training modules. Persons who have completed CITI training at another institution should affiliate their CITI account with UMBC. After affiliating with UMBC, CITI will ask you to complete any modules required by UMBC that may not have been required by the current research team member’s institution.  Review CITI’s guidance on how to add/change your affiliated institution or transfer completions for more information.

The IRB will also accept completion of the Office for Human Research Protections Human Research Protection Training module for non-UMBC affiliated investigators who participate in UMBC IRB approved protocols. UMBC PIs are required to upload evidence of training completion in the protocol.

Additional Training Opportunities

UMBC’s Office of Research Protections and Compliance provides a wide variety of training.  ORPC has presented to departments, labs and administrative groups on campus.  We would be more than happy to meet with you or your unit.  Please feel free to contact us at compliance@umbc.edu.

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