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Portland State University's Human Research Protection Program (HRPP) is a comprehensive approach to protecting the rights, safety, and welfare of human research subjects recruited to participate in research activities conducted under the auspices of PSU. The HRPP pertains to all human subjects research conducted under the direction of any employee or student, regardless of sponsorship.
Review and approval of all human subjects research at PSU is required prior to initiating a study. A study is considered subject to review by the HRPP if it meets the federal definition of both research and human subject, as provided in the HHS Common Rule:
Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject: a living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Human Subjects Review & Oversight
Human Subjects Review & Oversight
Protocol Submission
Protocol Submission
The PSU HRPP uses Kuali Protocols to manage all protocol submissions for review, with submissions typically requiring 2-4 weeks for review and approval. To submit an application, or to amend, renew or close an existing protocol, please login to Kuali Protocols.
Kuali Protocols User Guide & Other Resources
Kuali Protocols User Guide & Other Resources
For assistance accessing and navigating the system, refer to this IRB/HRPP Investigator User Guide.
If you're unable to access the Kuali Protocols using your PSU Odin ID, please submit a Kuali Protocols User Access Request.
To provide Kuali Protocols user feedback, please submit our Kuali Feedback Form.
Principal Investigator Policy: A faculty member is required to be identified as Principal Investigator (PI) for IRB/HRPP submissions. All student-initiated research must list the faculty advisor in the PI role.
CITI Training:
PSU faculty or employees: Kuali Protocols connects to the required CITI training records through PSU's single-sign on (SSO). In order for Kuali to reflect training for PSU-affiliated researchers, ensure the CITI account is linked using these CITI SSO instructions, under the Human Subjects Research Training section.
PSU students: CITI training records are not connected to Kuali at this time. Please upload completion certificates in the Personnel table for each student.
Email [email protected] with questions about submitting an application using Kuali Protocols or to connect with an HRPP Administrator about your project.
Office Hours
Office Hours
HRPP staff offer the following drop-in Zoom office hours to help with navigating Kuali Protocols submissions (click the office hour link below to join the Zoom meeting at the scheduled day/time, please note that office hours are cancelled on University holidays):
Consent & Assent Templates
Consent & Assent Templates
To design and develop study consent or assent materials, begin with one of our provided templates and customize to fit the needs of your project:
Consent - Online Survey (Adults, no signature)
Consent - No Signature (Adults)
Consent - Signature (Adults)
Consent - Verbal Script (Adults)
Assent - No Signature (Youth up to age 17 & Cognitively Impaired Adults)
Assent - Signature (Youth up to age 17 & Cognitively Impaired Adults)
Assent - Verbal Script (Youth up to age 17 & Cognitively Impaired Adults)
Parental Consent - Signature (Adults consenting for children)
Required Human Subjects Training (CITI)
Required Human Subjects Training (CITI)
Faculty, staff and students conducting human subjects research are required to complete the Protection of Human Subjects research training available via the Collaborative Institutional Training Initiative (CITI). All personnel engaged in human subjects research must complete Human Subjects CITI training prior to engaging in human subjects research activities (CITI training must be completed within the last three years).
Visit our Training page for specific human subjects login and completion instructions.
Conducting Collaborative Research
Conducting Collaborative Research
Non-exempt collaborative research projects involving a PSU investigator and an external collaborator who is engaged in human subjects research may choose one IRB to provide IRB review and oversight of the project. PSU may serve as the IRB of record, or cede IRB review and therefore rely on the external collaborator's home IRB for review and oversight. This determination is formally documented through the use of an IRB Authorization Agreement (IAA).
External collaborators who are engaged in human subjects research activities but are not associated with an external IRB may be added to PSU-led protocols through the use of an Individual Investigator Agreement (IIA).
To request an IAA or an IAA to conduct collaborative research with external organizations or individuals, please login to Kuali Protocols to submit a request.
Future Human Subjects Research Requests
Future Human Subjects Research Requests
PSU investigators who receive new external funding (e.g., NSF or NIH JIT funding) that is subject to documentation of human subjects approval but are not yet prepared to submit a complete HRPP application for approval (e.g., recruitment, consent materials and/or instruments are still under development) may request a "Future Human Subjects" review and approval from the PSU HRPP. These requests typically take about a week to process.
To request a Future Human Subjects review, please login to Kuali Protocols to submit a request.
Outside Research Requests
Outside Research Requests
Investigators external to Portland State University who wish to recruit participants from PSU may do so with permission. PSU requires all external researchers to obtain IRB approval through their home institution in order to recruit participants at PSU.
Please submit a local IRB approval letter, IRB approved protocol, and approved study materials with a request to perform recruitment at PSU to [email protected].
Human Subjects Research Resources
Human Subjects Research Resources
PSU Guidance: FERPA & Conducting Human Subjects Research
Decision Tool: Am I Doing Human Subjects Research?
Decision Tool: Am I Doing Human Subjects Research?
There is now a convenient online tool to help investigators determine whether their research involves human subjects. The tool may be accessed here: OHRP Decision Tool
Important Note: This tool may not be used to document whether a project qualifies for an Exemption Determination; only staff with the HRPP may formally document an Exemption Determination for research.
Federal Agencies & Organizations
Federal Agencies & Organizations
Regulations, Guidelines & Other Useful Links
Regulations, Guidelines & Other Useful Links
History of Human Subjects in Research
History of Human Subjects in Research
Diversity, Equity & Inclusion in Human Research
Diversity, Equity & Inclusion in Human Research
The PSU Institutional Review Board (IRB) program upholds a deep commitment to diversity, equity, inclusion, and social justice in the conduct of research with human participants. The PSU IRB Statement on Diversity, Equity and Inclusion affirms this commitment and outlines the IRB's means of protecting marginalized individuals and communities participating in PSU research.
Institutional Review Board (IRB) Meetings & Roster
Institutional Review Board (IRB) Meetings & Roster
Meeting Dates, Time & Location
Meeting Dates, Time & Location
The Institutional Review Board (IRB) meets approximately once a term. Meetings are subject to re-scheduling due to holidays, university closures, no meeting quorum, etc. At this time, all IRB meetings are hosted virtually, using an online meeting platform. Meetings are scheduled on an as-needed basis. Please note that the majority of HRPP submissions at PSU do not require Full Review and are reviewed on a rolling basis, in the order they are received.
This site is updated with a meeting agenda at least one week in advance of a scheduled meeting. The next IRB meeting is scheduled for:
TBD
Please contact the HRPP at [email protected] with any questions.
IRB Roster
IRB Roster
About the Human Research Protection Program
About the Human Research Protection Program
About the Human Research Protection Program
About the Human Research Protection Program
The Human Research Protection Program consists of administrative program staff and the Institutional Review Board (IRB). The IRB is an research ethics review committee comprised of PSU faculty, staff, and community members. The HRPP focuses on:
educating investigators, research staff, and IRB members;
providing ethical review of human subjects research;
making research protocol development assistance available to investigators and research staff;
monitoring research activities and improving compliance;
providing a resource for research subjects; and
continuously assessing and improving the quality, efficiency, and effectiveness of the program.
PSU Federalwide Assurance & IRB Registration Numbers
PSU Federalwide Assurance & IRB Registration Numbers
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
Contact Us
Contact Us
For additional questions related to conducting human subjects research, please contact the Human Research Protection Program at [email protected] or (503) 725-5484.
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