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Education and Training
** Ongoing education and training in protection of human subjects is a federal requirement. **
The HRPO takes a proactive approach and works collaboratively with other research entities to provide ongoing education and training. To ensure the safe conduct of all individuals engaged in human subjects research, the following education/training programs are required and/or offered at UMB:
Required Education and Training
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.
A refresher course must be completed EVERY THREE YEARS to continue conducting human participant research at UMB.
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.nihtraining.com. 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.
For general questions regarding the UMB training, please contact Tom Fladland at 410-706-3864 or via email at firstname.lastname@example.org
For general questions regarding the VA training, please contact Yolanda Gayden at 410-605-7130 or via email at email@example.com
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 and your password is your first name.
* For assistance logging into the HIPAA training, please contact the School of Medicine (SOM) help desk at 410-706-3998 for assistance.
Center for Clinical Trials: Amshu Siddalingaswamy; phone: 410-706-1932
School of Dentistry: Kent Buckingham; phone: 410-706-0343
Optional Education and Training
- Additional CITI Courses:
- Responsible Conduct of Research (RCR): The RCR series has six basic courses that cover core RCR topics. Five of the basic courses have a disciplinary focus on the Biomedical Sciences, Engineering, Humanities, Physical Sciences, and Social, Behavioral, and Education (SBE) Sciences. Each of these five courses is suitable for any person involved in research, ranging from upper-level undergraduates to established faculty. The sixth basic course is tailored specifically toward Research Administration.
- Conflicts of Interest (COI)
- UM SOM Clinical Research Billing: View this online training on the Center for Clinical Trials website
- On Being a Scientist: A Guide to Responsible Conduct in Research