Click here for more details about what does and does not require IRB review. 

See the answer to the previous question. 

An NHSR determination is a formal finding that a project does not meet the definition of human subjects research requiring IRB review. 

⭐ At PSU, an NHSR determination is optional and is not required by PSU policy or federal regulations.

Investigators may request an NHSR determination when they need formal documentation for a sponsor, funder, publication, or other external requirement.

To request an NHSR determination in Kuali

1) Create a new submission

2) Answer Yes to the question: “Is this a request to determine if this project requires IRB review?” 

3) You will then complete a short form and submit it for review. 

Based on that review, you will either receive an NHSR determination or be instructed to submit a full IRB application.

A PSU faculty or staff member is required to be identified as Principal Investigator (PI) for IRB/HRPP submissions. All student-initiated research must list the PSU faculty advisor in the PI role.

The faculty advisor must serve as the PI for student-led research at PSU. As PI, the faculty advisor is responsible for reviewing and submitting the initial Kuali application and for providing oversight of the study in accordance with applicable regulations, PSU policies, and ethical standards.

Students may prepare the application and use Notify PI to Submit in Kuali when it is ready for faculty review. Before submitting, the PI is responsible for confirming that the application is complete, all questions are answered clearly, and all required study materials are attached.

Faculty advisors are expected to guide their students on IRB requirements and study-specific questions before submission. Students should work with their faculty advisor to address questions about the application, required materials, and IRB expectations. When additional support is needed, faculty advisors may schedule an HRPP consultation and attend with their advisee.

A person is considered engaged in human subjects research if they do any one of the following:

• Obtain consent from participants

• Collect data from participants

• Analyze identifiable data

If a PSU investigator performs any of these activities on behalf of PSU, whether as an employee or as a student conducting research for a degree requirement, they are considered engaged in research.

This must be requested in Kuali through the External Personnel Table within the standard protocol submission. Non-PSU personnel who are engaged in human subjects research may be added to a PSU-led study if they are not affiliated with PSU or another institution with an IRB. In those cases, PSU may use an Individual Investigator Agreement (IIA) to formally cover their involvement.

To request this in Kuali, complete the External Personnel table as part of the standard protocol submission. HRPP staff will begin the IIA process during review.

External collaborators must also complete the required PSU CITI training or provide documentation of equivalent training.

For non-exempt collaborative research involving more than one institution with an IRB, one IRB must be designated as the lead IRB (eCFR).

• The lead IRB is responsible for the primary review and oversight of the research. 

• The other institution or institutions rely on that review through a formal IRB Authorization Agreement (IAA), sometimes called ceding review or external reliance.

If PSU will serve as the lead IRB

The request is made through a standard IRB submission in Kuali. The PSU study team should identify any external personnel and outside research sites in the application.

If PSU will rely on another institution’s IRB

The request must be initiated in Kuali by the PSU Principal Investigator. Please refer to the Kuali User Guide for instructions on how to submit this type of reliance request.

Investigators are strongly encouraged to contact psuirb@pdx.edu for guidance on collaborative research or to schedule a consultation with an HRPP Program Manager.

Please note: PSU can serve as the lead IRB or cede review only for non-exempt research. 

For exempt research, a PSU exemption applies only to PSU personnel. Collaborators at other institutions may need to seek review from their own institutions.

Anyone involved in a human subjects study must complete PSU’s required CITI training before participating in the research. Training is completed online through the Collaborative Institutional Training Initiative (CITI).

CITI training is valid for three years. If training expires and the individual will continue working on the study, it must be completed again.

PSU-affiliated personnel can access CITI through single sign-on (SSO) using their PSU ODIN username and password. Non-PSU affiliated research personnel may create a CITI account directly, affiliate with PSU, and complete the required course at no cost.

When selecting a course in CITI, choose Protection of Human Subjects and then select the curriculum that matches your role:

• Group 1: Human Subjects Researcher — required for study personnel involved in human subjects research

• Group 2: Institutional Review Board (IRB) Member — required for IRB members only

• Group 3: Human Research Protection Program (HRPP) Administrator — required for HRPP staff only

PSU faculty, staff, and students must access CITI through Single Sign On (SSO) using their ODIN ID and password.

Previous CITI users

If you already have a CITI account, you may need to connect your PSU SSO account to your existing CITI account the first time you log in through SSO.

Before getting started:

• Have your existing CITI username and password available

• Make sure your first name, last name, and PSU email address in CITI match your ODIN account information

This helps ensure your CITI training records are correctly linked to your PSU account.

To log in:

• Go to the CITI Single Sign On page

• Log in using your ODIN ID and password

If CITI opens directly and shows Portland State University as your institution, your account is already associated and you can begin or continue your training.

If CITI does not open directly after logging in with your ODIN ID, follow CITI’s instructions to associate your PSU SSO account with your existing CITI account. Once that is complete, you will be able to log in using SSO.

New CITI users

If you are new to CITI:

1. Go to citiprogram.org

2. Select Register.

3. Under Select Your Organization Affiliation, enter Portland State University

4. Log in through Portland State University using your ODIN ID and password

Note: Research personnel who are not affiliated with PSU must create a CITI account directly and affiliate with Portland State University through CITI, rather than using SSO. Please see further guidance here.

Generally, no. Most investigators do not need to email their CITI training certificate to the IRB.

PSU faculty and staff

The required CITI Group 1: Human Subjects Researcher training is connected to Kuali and should appear there automatically.

PSU Students 

CITI training is not currently connected to Kuali. Students should upload their CITI completion certificate in the Personnel section of the protocol submission.

If a certificate is missing or training has expired, HRPP staff can retrieve training records directly from CITI if needed.

See the Kuali Investigator User Guide for assistance with most basic actions in Kuali. 

For further questions, email psuirb@pdx.edu for assistance. 

Possibly, but additional risks must be addressed first.
Generative AI may be a useful tool for transcription, but its use in human subjects research can raise important confidentiality and consent concerns. In some cases, participant data entered into AI tools may be used for additional training or other purposes that cannot be fully controlled by the researcher.

For that reason, study protocols and consent forms must clearly describe how AI software will be used. Researchers are also strongly encouraged to use only AI tools recommended by PSU OIT to help protect participant confidentiality and reduce the risk of data being used without consent.

PSU OIT’s guidance on generative AI is available here.

Yes, but there is an official process. PSU faculty who wish to include FERPA-protected data in their research must obtain active student consent AND institutional permissions. 

Click here for guidance on using FERPA-protected data in research

Yes. The HRPP is guided by its Federalwide Assurance (FWA) of compliance filed with the U.S. Department of Human Services (HHS). 

The FWA outlines PSU's commitment to comply with the requirements set forth in the Federal Policy for the Protection of Human Subjects (the Common Rule). 

• PSU Federalwide Assurance: FWA 00000091

• PSU IRB Registration: #00000903