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IRB Study Personnel
[D28.0000] Study personnel on a protocol involving human subjects
A study personnel is an individual who engages in human subjects research by:
- Interacting or intervening with research participants.
- Accessing "Personally Identifiable Information (PII)" of participants or research data collected from participants.
- Taking part in the informed consent process.
Any individual meeting any of the criteria above is required to be listed in the Study Personnel section of the IRB application.
In some cases, individuals may be involved in the research as both subjects and study personnel.
Note: Funding agencies may have their own definition of study personnel as it applies to grant or other funding applications.
Training Requirements
UK Study Personnel listed in the IRB application must complete Responsible Conduct of Research (RCR) training before the IRB application may be submitted to the IRB for review.
All study personnel listed in the IRB application are required to complete Human Subject Protection (HSP) training before the IRB may approve the application.
- UK Study Personnel HSP FAQs (Required once every three years)
- Non-UK Training Options (Includes community-based (CBPR) personnel training options; only required when initially added as study personnel)
- The IRB does not mandate the type of completion date of the HSP training for individuals who are not UK employees or students.
- To confirm the equivalency of HSP training taken outside of UK, please email the document to the HSP Training Support Team.
- Non-UK study personnel may complete publicly available HSP training courses. Courses are also available for non-research individuals from the community who assist with or partner with researchers to provide input to community needs or engage participants via their role in the community.
- Non-UK individuals should adhere to their institutional policy for HSP training; UK does not require ongoing HSP training from Non-UK individuals.
At Continuation Review (CR), all study personnel listed in/added to the IRB application must have up-to-date HSP training before the IRB may approve the CR. If this is not possible, any study personnel who do not have up-to-date HSP training must be removed from the protocol before IRB approval.
If study personnel are added to an IRB-approved protocol via a modification request (MR) will only be approved if they have completed the required HSP training. (UK study personnel added via an MR must also complete the RCR training as mandated by the Office of the Vice President for Research.)
Minors as Study Personnel
High school students who participate as study personnel are subject to the UK "Minors Involved in University-Sponsored Programs or Programs Held at the University" policy.
The policy includes a "Programs Involving Minors Notification Form" and a mandatory parental "Informed Consent, Voluntary Waiver, Release of Liability and Assumption of Risk Form."
UK Risk Management may require training for supervisors of minors. Contact UK Risk Management at (859) 257-3708 for guidance.
The student may also need to sign an IRB Individual Investigator Agreement (IIA) to abide by all applicable human subject regulations and institutional requirements.
[D163.0000] Non-UK Study Personnel
Non-UK individuals assisting an investigator with their research may need to be added as non-UK study personnel on the research protocol.
STEP ONE: Criteria for study personnel
Determine whether the individual meets the criteria for study personnel.
Exception: If an IRB Authorization Agreement (IAA) is in place and the other institution (reviewing institution) is the responsible party, agreeing to confirm the training for study personnel from their institution.
STEP TWO: Determine if an Individual Investigator Agreement (IIA) is required
Most Non-UK individuals must sign an Individual Investigator Agreement (IIA).
An IIA is an agreement that the non-UK study personnel sign, agreeing to follow relevant institutional policies and procedures for the protection of human subjects.
- The investigator will fill out the protocol information section of the IIA before giving it to the non-UK individual to sign.
- The non-UK individual must sign the IIA in Adobe Digital Signature or in ink and return it to the investigator.
- The investigator will need to email the signed IIA to the IRB Reliance Team.
- The IRB Reliance Team will obtain the signature of the Vice President for Research (VPR) and return the IIA to the investigator.
The process will take about a week.
STEP THREE: Add the Non-UK individual to the IRB application
To add Non-UK individuals to the IRB draft application, view E-IRB Video Tutorial, or follow the instructions below.
Add each Non-UK individual to the E-IRB system.
- On the main E-IRB dashboard, click "Manage Study Personnel" and choose the "Non-UK Personnel" option.
- Check to see if the individual has already been added to the system. Best Practice:
- Use different filters
- Do multiple searches
- Ensure correct spelling
- If there is no record, click "Insert New."
- Complete the record fields as fully and accurately as possible before submitting.
- Add each Non-UK individual to the draft application via the Study Personnel section.
STEP FOUR: Attach the Non-UK Human Subject Protection (HSP) training certificate to the protocol application
Attach each Non-UK individual's Human Subject Protection training in the "Additional Information/Materials" section of the IRB application. (View video example of attaching a document)
If you cannot attach the training document to the IRB application, you may email the document to the HSP Training Support Team for manual entry. Include the individual's name and email address used in E-IRB.