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 Collaborative Institutional Training Initiative (CITI) (online): Investigator & Key Personnel Training on the Protection of Human Subjects for Exempt and Non-Exempt Research Projects. Necessary training modules vary dependent on type of research. See guidance below.
- NIH awardees: The NIH Clinical Research Training site (online) course may be substituted for the equivalent CITI course for NIH funded projects.
- NOTE: Documentation of completion of the educational requirement for each investigator involved in the design and conduct of NIH-funded human subjects research must be submitted prior to award. (NOTE: As of September 30, 2018, NIH is no longer offering this online training. UH will accept existing NIH training documentation. Otherwise, researchers will need to complete the CITI training.)
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.
What rules, regulations, mandates, policies, etc. are associated with HRP training requirements?
More information on the regulations and policies governing the University of Hawaii's HRP requirements may be found here.
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.
Registering for UH HRP Training on CITI
It may be helpful to print this page for reference, when navigating the CITI site.
- Go to the CITI website. Select Register. Under "Select your Organization Affiliation", type University of Hawaii. If you have a UH email and username, you may select "University of Hawaii (SSO)" from the drop down list. If you do not have a UH username, select "University of Hawaii" (without the SSO).
- Read through the CITI terms service, and select the appropriate checkbox, and also the checkbox verifying you are affiliated with the University of Hawaii. If you are using your UH username for your CITI account, select "Continue to SSO Login / Instructions". 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". (Using your UH username will allow your CITI account to link to your account in the HSP online application system, and automatically update your CITI training records.) Follow the subsequent instructions to create your CITI account.
NOTE: If you already have a CITI account (either personal, of from a previous institution) you may continue using your existing account. Log in to your existing account as usual. On your "Main Menu" page, scroll to the bottom of the page and select "Affiliate with another Institution". Type (and select) "University of Hawaii". Follow the subsequent instructions.
Once you have created your University of Hawaii account/profile on CITI, you will need to select the appropriate curriculum.
At the Main Menu page, click Add a course of update your learner groups under the University of Hawaii Courses section.
Use the following table for the "Select Curriculum - University of Hawaii" page.
|Type of Research
CITI Course Name
|Exempt||Exempt, but working ONLY with existing biomedical data or biospecimen||Non-Exempt Biomedical/ Clinical Research||Non-Exempt Social or Behavioral Sciences Research|
|Question 1: Conflicts of Interest||No (not required for HRP)|
|Question 2: Responsible Conduct of Research||Not at this time (Not required for HRP)|
|Question 3: Human Subjects Research (select one from this section, as appropriate to your project)||Exempt Researchers and Key Personnel||Exempt Researchers and Key Personnel -- Biomedical Data and Specimens Only||Non-Exempt Biomedical Researchers and Key Personnel||Non-Exempt Social & Behavioral Sciences Researchers and Key Personnel|
|Question 4: Supplemental Courses for the following vulnerable populations and settings||Please select one or more of the supplemental courses if you are going to be working with any of the listed vulnerable populations and/or settings. These courses are optional but highly recommended for those whose research is applicable.|
Question 5: Information Privacy and Security (IPS)
(select one from this section, as appropriate to your project)
|Exempt Researchers and Key Personnel||Exempt Researchers and Key Personnel -- Biomedical Data and Specimens Only||Non-Exempt Biomedical Researchers and Key Personnel||Non-Exempt Social & Behavioral Sciences Researchers and Key Personnel|
|Question 6: Good Clinical Practice course||Skip||Skip||
For clinical trial involving IDE select
GCP Course for clinical trials involvling medical devices
For clinical trial involving IND select
GCP for clinical trials involving investigational drugs
|Question 7: Laboratory Animal Welfare||Skip||Skip||Skip||Skip|
Click the Submit button at the bottom of the page; you will be returned to the previous CITI Main Menu, which should now list the courses that you selected.
NOTE: HRP educational requirements include one Human Subjects Research course, and one Information Privacy and Security (IPS) Course. If you find your course selection does not include at least one of each, you will need to return to the course selection page and add the missing course.
Click on the first course listed and complete 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 Hawaii 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 requested date of presentation for consideration. Please note our office's ability to fulfill your request for particular date and time may be affected by prior HSP commitments and the availability of staff and perhaps other resources.