Required Training

ALL individuals (including IRB members) engaged in human participant research at the University of Maryland, Baltimore (UMB) are required to complete.

Protection of Human Subjects Training

The University of Miami's Collaborative IRB Training Initiative (CITI) provides a comprehensive selection of educational modules appropriate for the nature of research with which an investigator is engaged. The Human Research Protections Office (HRPO) requires ALL individuals (including IRB members) engaged in human participant research at the University of Maryland, Baltimore (UMB) to take the UMB-specific CITI Training human participant protections training.

Individuals are required to only take the modules most related to the type of research in which they are engaged.

• 18 basic modules, Course Title: Group 1. Biomedical Research Investigators and Key Personnel   or
• 17 basic modules, Course Title: Group 2. Social / Behavioral Research Investigators and Key Personnel

* You must affiliate with “University of Maryland Baltimore” (NOT “University of Maryland Baltimore, School of Medicine”) to access the correct course for the protection of human subjects in research.

** You can now log on to CITI Training using your SOM/UMID. (From the logon page, select “Log in Through My Institution” and scroll down until you find and select University of Maryland Baltimore.  Log on using your SOM/UMID credentials.   You will be prompted to enter your local CITI training credentials to link to your SOMID/UMID.  If you are not able to access your training records, please email the, CITI Program help desk at support@citiprogram.org.)

*** A refresher course must be completed EVERY THREE YEARS to continue conducting human participant research at UMB. 

**** CITI Program Content is Current with the Revised Common Rule that went into effect 21 January 2019.

Instructions to access CITI training courses

Access the CITI Training website 

NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management, and oversight of NIH-funded clinical trials are required to be trained in Good Clinical Practice.

Good Clinical Practice Training

NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management, and oversight of NIH-funded clinical trials are required to be trained in Good Clinical Practice. GCP training must be refreshed at least every three years to remain current with regulations, standards, and guidelines.

Courses that will be accepted at University of Maryland, Baltimore are:

• CITI Good Clinical Practice and ICH, completed under University of Maryland Baltimore or Baltimore VA affiliation;
• CITI Good Clinical Practice (US FDA Drug and Device Focus), completed under University of Maryland Baltimore affiliation;
• CITI GCP-Social and Behavioral Research Best Practices for Clinical Research, completed under University of Maryland Baltimore affiliation;
• Good Clinical Practice for Social and Behavioral Research, eLearning Course;
• National Drug Abuse Treatment Clinical Trials Network Good Clinical Practice course, gcp.nidatraining.org/. This course can be completed by those who conduct NIH-funded social/behavioral research even without a drug abuse focus; OR 
• Other GCP training will be accepted as meeting the requirement if the course is approved by TransCelerate

      * Recipients of GCP training are expected to retain documentation of their training.

CITI GCP training access instructions

 

For general questions regarding the UMB training, please contact Tom Fladland at 410-706-3864 or via email at tfladland@umaryland.edu 

UMB policy requires that all individuals employed at UMB must take HIPAA 125 (HIPAA 101 and HIPAA 120), regardless of whether they are engaging in research. Additionally, all individuals engaging in research at UMB are also required to complete HIPAA 201.

HIPAA Training

National health information privacy standards have been issued by the U.S. Department of Health and Human Services (DHHS), pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The HIPAA Privacy Rule is the first comprehensive federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. Covered entities may use and disclose protected health information (PHI) for research with authorization or without individual authorization under limited circumstances. 

UMB policy requires that all individuals employed at UMB must take HIPAA 125 (HIPAA 101 and HIPAA 120), regardless of whether they are engaging in research. Additionally, all individuals engaging in research at UMB are also required to complete HIPAA 201. 

Log on to HIPAA Training/Access Courses. Your user name is your six-digit employee ID number, which can be found on the top right hand corner of your UMB Timesheet.  The password is your first name.   If you are not a UMB employee, please click the link that provides instructions for creating a new account. 
* For assistance logging into the HIPAA training, please contact the School of Medicine (SOM) help desk at 410-706-3998 for assistance. 

Principal Investigators (PIs) are required to take training on their responsibilities as it relates to maintaining IRB approval and the consequences for allowing IRB approval to expire.

The Office of Accountability and Compliance (OAC) has set up a Blackboard site for you to receive this training. If you have been granted PI privileges in CICERO you are required to complete this training before submitting protocols or continuing reviews for approval. To access the training, please complete the following:

1. Go to blackboard.umaryland.edu.
2. Log in with your UMB credentials.
3. Click on “Courses” from the left hand menu.
4. If you have many courses, in the search bar, type in “PI Responsibilities – Human”.
5. Click on “PI Responsibilities – Human”.
6. Once you are in the course, click on “Content” in the left hand menu.
7. Click on the folder titled “Expired Protocols Training”.
8. Next, click on “Expired Protocols – Pre-test”.
9. Answer the questions in the pre-test and submit.
10. Scroll to the bottom and select “Click OK to review results” in the bottom right corner.
11. Once you have submitted the pretest, you will receive access to the “Expired Protocols” training video and the “Expired Protocols – Post-Test”.
12. Watch the Expired Protocols training video.
13. Complete the “Expired Protocols – Post-Test” and submit.
14. Scroll to the bottom and select “Click OK to review results” in the bottom right corner to review your answers.

You must score at least 80% on the posttest.

If you have questions about the content of the training, please contact the Human Research Protections Office (HRPO) at hrpo@umaryland.edu. If you are having trouble accessing the course on the Blackboard site, please contact Thomas O. Cole at thomascole@umaryland.edu.