Human Research Protection Program
IMPACT OF COVID-19 ON THE HUMAN RESEARCH PROTECTION PROGRAM:
All in-person / face-to-face research activities with human subjects remain suspended. Due to current COVID-19 infection rates and orders issued by the Governor, the process to request an exception to conduct face-to-face research activities during the pandemic has been paused until further notice.
Human subjects research activities must be performed via remote data collection methods (online or mail surveys, Zoom or other online meeting platforms, telephone, etc.) until further notice. Please visit the RGS website for the most up-to-date information related to COVID-19 impacts on research at PSU.
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
To request HRPP review of research involving human subjects, investigators must prepare an HRPP protocol application. An HRPP protocol application consists of all applicable HRPP Initial Review Forms, as well as recruitment materials, consent and assent forms, and all study instruments.
Complete protocol applications must be submitted by email to firstname.lastname@example.org. Please allow 2-6 weeks for review and approval. Following approval, any proposed changes to an HRPP protocol must be submitted for review and approval prior to implementation.
Staff from the HRPP and/or members of the Institutional Review Board (IRB) will review the protocol to determine if the study constitutes Human Subjects Research; whether the study is Exempt from IRB review and approval; and/or approve, require modifications to secure approval of the protocol.
Human Subjects Training
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 listed personnel must complete Human Subjects CITI training prior to protocol approval or before 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.
Institutional Review Board (IRB) Meetings & Roster
Meeting Dates, Time & Location
The Institutional Review Board (IRB) meets approximately once a month. 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:
None scheduled at this time
To confirm upcoming meeting information, please contact the HRPP at email@example.com.
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.
Conducting Collaborative Research
Collaborative research projects involving a PSU investigator and an external investigator may choose one IRB to provide 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 not associated with an external IRB may be added to PSU-led HRPP 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 complete the Supplemental Form: IRB Authorization Agreement Request Form and send to IRB at firstname.lastname@example.org.
Future Human Subjects Research Approval
PSU investigators who receive new external funding subject to documentation of human subjects approval but who 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 email email@example.com with the following information:
Email title: Requesting Future Human Subjects Approval
Investigator name and department
Funding proposal number (PSU proposal number and/or grant agency proposal number)
Provide a brief description of planned activities with human subjects, including: whether there are any anticipated collaborations with external entities; a description of the target subject population(s); a timeline for beginning recruitment and consent; and description of research activities to be completed.
Outside Research Requests
Investigators external to Portland State University who wish to recruit participants from PSU may do so with permission. PSU requires 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 firstname.lastname@example.org.
Human Subjects Research Resources
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
Regulations, Guidelines & Other Useful Links
History of Human Subjects in Research
About the Human Research Protection Program
The HRPP is overseen by PSU's Research Integrity & Compliance and the Institutional Review Board (IRB). The IRB is an administrative 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
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