All investigators and research personnel listed on a human subjects application submitted to the Institutional Review Board Committee (IRB) are required to complete a training course prior to protocol approval.
This requirement was first mandated by the National Institutes of Health in 2000 for individuals considered to be "key personnel" on research studies involving human subjects. The University of Houston, in its written agreement with the federal government, has indicated that it has elected to apply the same high-quality standards and requirements to all human subjects research regardless of the source of support. Because of this agreement and our commitment to high-quality, ethical research, the education requirement is extended to the following individuals:
- Principal Investigator(s) on all projects that include research involving human subjects
- All individuals responsible for the design or conduct human subjects research
- Those individuals identified as key personnel of consortium participants or alternate performance sites if they are participating in research that involves human subjects
- Those serving as voting members of the IRB
Investigators who conduct human subjects research that is exempt from full IRB review and approval must also comply with the education requirement; this became mandated by NIH in 2005. (The six exempt categories are defined in 45 CFR part 46.101(b). Exempt protocols must still be submitted into ICON for administrative review.)
Failure to assure the education component of our assurance is considered noncompliance, and has the potential to negatively affect funding opportunities for University of Houston faculty, staff, and students. It is the PI’s responsibility to ensure that all individuals engaged in research have been appropriately trained.
Two options are available to fulfill this requirement:
- (Recommended): The web-based Course in the Protection of Human Research Subjects through the Collaborative Institutional Training Initiative (CITI). IRB recommends this option as its primary one because IRB personnel are able to access individual transcripts and verify training, making this the most convenient option for the PI.
- The IRB will also accept NIH Human Subject Research training certificates.
- CITI training: To begin the online course, visit the CITI website and select “Register for the Course”. Select University of Houston as your institution, and a username and password (see detailed instructions (PDF)). For the training record to be automatically pulled into ICON, you must use your UH email address ending in uh.edu. There are four options for human subject research training based on the college you are located in, the level of student or faculty member, and the focus of your research:
- Group 1: Human Subject Research-Biomedical and Physical Science Research Investigators and Graduate Students
- Group 2: Human Subject Research-Social and Behavioral Research Investigators and Graduate Students
- Group 3: Human Subject Research-UH IRB Members and Staff
- Group 4: Human Subject Research-Undergraduate Students
- NIH training: This course is online. IRB personnel CANNOT access the transcripts for this course; a copy of the certificate must be attached in ICON prior to final approval.
The IRB reviews documentation for the education requirement prior to the initial approval of a IRB application, and when a revision is requested to add additional personnel. A refresher course is required every three years.
The CITI program provides a shorter version of the original training, listed as "Refresher Course." This will meet the training requirements for research personnel who have completed the original training course.
Remember, the University of Houston extends this training requirement to all research, regardless of funding source. For more information contact the IRB office at 713-743-9204 or visit http://grants.nih.gov/grants/policy/hs_educ_faq.htm.