Basics of Human Research Protection (HRP) Education
Who must complete training?
Human Subject Research Principal Investigators, Co-Investigators, Student Investigators, and Key Personnel. Key Personnel include those who will interact with participants for the research project or who will work with identifiable participant data.
When does training need to be completed?
Personnel included on the protocol should complete training prior to submission of an application for IRB review. Documentation of training for all investigators and key personnel listed on a protocol, must be submitted with the initial IRB application. Personnel joining an approved protocol, must likewise complete training prior to being added. Protocol revisions adding new personnel should include documentation of HRP education requirements.
How is training provided?
- UH provides access to required HRP educational materials through the CITI Program(CITI) web site. The required training modules vary, dependent on type of research. CITI HRP training certification is valid for three years following completion of the curriculum. Researchers and key personnel will need to redo the CITI training if their research project extends past the three year time period.
- For NIH funded projects, legacy NIH training documentation will be accepted in place of CITI training.
How is training tracked and verified?
The Investigator is responsible for ensuring that those involved with the research project fulfill training requirements. Principal Investigators must submit the names of all Co-Investigators and Key Personnel with the IRB application. HSP staff will use this list to verify training requirements are satisfied. CITI provides email notifications of impending expiration.
The eProtocol application system will upload CITI training information for users that registered on the CITI website using the UH Single Sign On. This will only apply to users listed on the personnel page of the application form. You will need to print out and separately upload training documentation for research personnel not listed on the personnel page.
Registering for a CITI account for the first time
- Go to the CITI website (www.citiprogram.org)
- Select Register.
- In the Select your Organization Affiliation box, type University of Hawaiʻi.
- If you have a UH email and username, select University of Hawaiʻi (SSO) from the drop down list.
- If you do not have a UH username, select University of Hawaiʻi (without the ‘SSO’).
- Select the checkbox verifying you are an affiliate of University of Hawaiʻi.
- Continue to…
- If you are using your UH username for your CITI account, select Continue to SSO Login / Instructions. Using your UH username will allow your CITI account to link to your eProtocol account, and automatically update your CITI training records in eProtocol.
- If you do not have a UH username, or do not wish to use it for CITI, select Continue to create your CITI Username/Password.
- Follow the subsequent instructions to complete your registration.
NOTE: Do not use the Independent Learner Registration section when registering for CITI.
Previously existing accounts
If you already have a personal CITI account or one from a previous institution, you may continue using your existing account.
- Log in to your existing account.
- On the Main Menu page, scroll to the bottom and select Affiliate with another Institution.
- Type (and select) University of Hawaiʻi.
- Follow the subsequent instructions.
Selecting courses in CITI
- On the Courses tab in the Institutional Courses section, select the University of Hawaiʻi View Courses button.
- In the Learner Tools for University of Hawaiʻi section, select Add a Course.
- Use the guidance below to answer the questions:
Question 1: Do you conduct research in any of the following settings?
For your Human Studies Program/IRB application, Human Subjects Research (HSR) is the only module required for the UH Human Research Protection Program. All the other selections (GCP, RCR, etc.) are to fulfill the requirements of other programs.
Question 2: Please advise if you need to complete a Basic Course in the Protection of Human Research Subjects or any supplementary Human Subjects modules.
For the required modules of the Human Studies Program, select I would like to complete a Basic Course in the Protection of Human Research Subjects, and click Next.
Choose supplementary module, if you are interested in modules on additional topics (i.e. Children, Prisoners, Pregnant women). You will have the opportunity to review these options later, so it is safe to skip this option in your initial registration.
Question 3: Please choose one learner group below based on your role and the type of Human Subjects Research activities you will conduct. You will be enrolled in the Basic Course for that group.
Researchers should have a basic idea of whether their research will qualify as exempt, or non-exempt. If you are not sure, please refer to the HSP website page here for more guidance. You may also contact the HSP office for guidance.
If your project qualifies for exempt status, choose one of the two exempt options that is most relevant to your type of research (biomedical versus social/behavioral). Otherwise, choose one of the two non-exempt options that is most relevant to your type of research. Then click Next.
Do not select one of the two IRB members options, unless you are interested in becoming an IRB member, as these modules are more extensive than the researcher modules.
Question 4: Please make any additional selections below if you wish to complete any supplementary Human Subjects Research modules.
Question 4 appears only if you opted to include a supplementary human subjects research module in Question 2. All selections under this question are optional. You do not need to complete these to meet basic Human Studies Program requirements. These supplemental courses are recommended if you will be working with any of these vulnerable populations. You may, however, click Next to advance past this question without making a selection.
In the Courses Ready to Begin section, click Start Course. Each course consists of a list of Required, Elective and Supplemental modules. Complete all of the Required Modules listed under each selected course.
Print out the Completion Report from the Main Menu once all courses have been completed. The course is not complete until “Print Report” is shown under the Completion Report column for the course listed in your main menu. The completion reports are to be submitted with the IRB application as required material.
- Non-Exempt CITI required training may be used in lieu of exempt CITI required training, specifically:
- non-exempt biomedical covers exempt biomedical data and specimen
- non-exempt social and behavioral covers exempt
- Per BOR policy, students cannot be the sole Principal Investigator for their project (See policy), and therefore faculty advisors must be listed as PIs for their student-led research. This means that faculty must complete required human subjects research training (and include their completion report) for their students’ research.
- Investigators and key personnel who have completed CITI training from another institution may use the training they have completed from that institution given that the modules completed are the same and have been completed within the last 3 years. By adding University of Hawai‘i as a participating institution to their existing CITI account, the unexpired training will automatically be credited once the user’s UH courses have been selected as instructed above.
The Human Studies Program provides a select number of group presentations to faculty, students and staff who plan to conduct research involving human participants. Interested parties may complete a Lecture Request form and submit it to the Human Studies Program at email@example.com at least two weeks prior to the requested date of presentation for consideration. Please note our office’s ability to fulfill your request for a particular date and time may be affected by prior HSP commitments and the availability of staff and perhaps other resources.
- Lecture Request Form
- How we can improve? Please submit completed anonymous feedback to our office via campus mail. (Lecture Feedback Form)