Educational Requirements
All principal investigators, co-investigators, and research staff are required to receive training regarding the protection of human research subjects prior to beginning any human research-related activities. Training status will be verified prior to iRIS access being granted, when beginning a study and at the scheduled review period of active studies.
The minimum requirements to obtain an iRIS account and participate in any research involving human subjects are:
- Human Subject Research Course
- Conflict of Interest Course
- Submission of a Research Financial Disclosure
- Informed Consent Training (effective 9/1/2024)
Additional training courses may be required based on specific qualities of the research being conducted and your role within it. Please explore the tabs below or click here to download a full copy of the Educational Requirements guide.
Required Training
Each person conducting or assisting in the conduct of a research project that involves human participants is first required to complete training on ethical and regulatory issues. The course approved by TTUHSCEP is the web-based Course in the Protection of Human Research Subjects— Human Subjects Research administered by the University of Miami through the Collaborative IRB Training Initiative (CITI).
Training must be completed every 3 years. The ability to submit new projects, continuing reviews or amendments of ongoing projects will be limited if more than 3 years elapse between completion of the course. Renewal training is identical to the initial CITI course.
Training regarding financial conflicts of interest in research is required of all investigators and research personnel and applies to all research, regardless of funding. Training must be completed every 4 years. The ability to submit new projects, continuing reviews or amendments of ongoing projects will be limited if more than 4 years elapse between completion of the course. Renewal training is identical to the initial CITI course.
TTUHSC EP OP 73.09 requires that Investigators and research personnel update their Research Financial Disclosure forms on at least an annual basis, or within 30 days of a change in significant financial interests. The annual disclosure form is accessed through iRIS via the Conflict of Interest Module under "My Workspaces" at the top left of the iRIS dashboard.
To begin the on-line course, go to the following web site: www.citiprogram.org and select "Register." Next, enter “Texas Tech University Health Sciences Center-El Paso” as your organization affiliation. Continue through the multiple step process to establish your Username and Password. You do not need an eRaider account to complete the training. TTUHSCEP personnel must use their TTUHSCEP email address for registration. You may include a secondary email as well. On the CITI registration page you will need to select "Human Subjects Research Course” and “Conflict of Interest Course,” and any other training (as indicated previously) that may be required for the research that is being done.
To add a course to an existing account, log in, click on “View Courses” under Texas Tech University Health Sciences Center-El Paso, scroll down to the bottom of the page, and click on “Add a Course.” Respond with a “yes” to the questions related to the course you need to complete, and follow the prompts.
Upon successful completion of the course, you will be able to download a course transcript and print a certificate. Please keep for your records. TTUHSCEP is also notified of your successful completion of the course, but we are not provided with a copy of it. You will be required to achieve an overall score of at least 80% to successfully complete the course. You can also log back in at any time to print your completion report by clicking on “View previously completed coursework.”
All investigators and research staff are required to renew their training at regular intervals, training regarding the protection of human research subjects and most supplemental courses offered by CITI must be renewed at least once every three years. Conflict of Interest training must be renewed every four years.
The ability to submit new projects or continuing reviews of ongoing projects may be limited if required training items have lapsed. The renewal training is identical to the initially completed CITI course.
As part of the ongoing process to ensure that all TTUHSC El Paso research personnel involved in human subject research are appropriately informed and trained on informed consent procedures, beginning September 1, 2024, all will be required to complete Informed Consent Training as part of the minimum training requirements to open an iRIS account. For existing studies, this new requirement will need to be completed at the next continuing review or by December 1, 2024, whichever comes first.
Information about the training is available at: Training | Texas Tech Health El Paso. The training is available online through Tech Training. To obtain access to the online informed consent training, please click on the Training Request Form, Online Informed Consent Training, then Basic Informed Consent Training.
Please note that the training must be completed within 30 days of obtaining access. Trainings do expire after 30 days and participants only have three opportunities to pass the test.
For questions, email Barcaste@ttuhsc.edu. Certificates should be retained as proof that the training was completed.
The CRC course provides clinical research professionals with basic training tailored to the conduct of clinical trials. It includes the planning aspects of clinical trials, including the overall clinical trial process, associated activities, and the roles and responsibilities of the clinical team members. The CRC training is required of all research coordinators, and investigators/other research personnel who are performing the duties of a research coordinator. The ability to submit new projects, continuing reviews or amendments of ongoing projects will be limited if more than 3 years elapse between completion of the course. Renewal training is identical to the initial CITI course.
NIH guidelines now require Good Clinical Practice (GCP) training for NIH funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials.
All TTUHSC El Paso research personnel involved with drug and/or device studies will also be required to complete GCP training, regardless of funding. The ability to submit new projects, continuing reviews or amendments of ongoing projects will be limited if more than 3 years elapse between completion of the course. Renewal training is identical to the initial CITI course.
This in-depth course provides practical knowledge on how to develop, negotiate, and implement a clinical trial budget from the perspective of the clinical site. It details what goes into budget planning and reviews criteria for measuring direct and indirect costs. The course outlines how to assess clinical trial feasibility and calculate procedural costs, while offering a primer on negotiating study budgets in ways that produce fair and mutually acceptable outcomes.
If you are a Principal Investigator, Research Director, or Clinical Research Coordinator conducting industry sponsored clinical trials, this course is required. This training will need to be completed prior to submitting a clinical trial budget for review through Research Contracts and Agreements. Please visit https://www.citiprogram.org/ and use the “Add a Course” option under the TTUHSC El Paso affiliation; the course is listed as question number 10 on the enrollment page.
The ability to submit new clinical trial agreements, projects, continuing reviews or amendments of ongoing projects will be limited if this training is not on file and if more than 3 years elapse between completion of the course. Renewal training is identical to the initial CITI course.
What if I have completed this CITI training course previously?
Many institutions use the CITI program to administrate required training courses and the same course is often used between different institutions. If you have completed a specific course (or modules within a course) within the past two years then you will automatically receive credit for those portions when enrolling for the same course under the TTUHSC El Paso affiliation in CITI.
How do I transfer records of previous CITI course completions to TTUHSC El Paso?
Simply affiliate your CITI account with TTUHSC El Paso and enroll for the course under our section. Upon enrolling, you will automatically be granted credit for the courses or modules/portions of courses that you have completed in the past two years. Please note that the Course ID must match for credit to be transferred; similar training with different course numbers is not accepted and will not transfer.
Why did my CITI course completion from a different institution not transfer to TTUHSC El Paso?
If you have followed the steps above and credit has not transferred, it may be due
to the following
reasons:
- The course completed at the other institution is not compatible with the TTUHSC El
Paso
version. This occurs when an institution opts for a highly customized course with institution specific content rather than the base course offered by CITI or simply uses a different base course with similar content. You will need to enroll for and complete our required course(s) in their entirety as these have been approved by our institutional bodies to comply with local/state/federal regulations. - Not all modules required for the course by TTUHSC El Paso have been completed. For some courses, TTUHSC El Paso requires completion of supplementary modules beyond the base course offered by CITI. If you have completed the base course at another institution within the past two years you will receive credit for those portions upon enrollment and need only complete the additional modules. Upon completion of these, you will receive a new certificate for the entire course valid for the full renewal period.
- The course is expired or was completed more than two years ago. Due to the renewal periods set by our institution and federal regulations, training older than two years is not accepted for transfer to TTUHSC El Paso.