Portland State University (PSU) is responsible for the rights and welfare of human subjects involved in research sponsored or conducted by the university. In order to meet this responsibility, the University established the Human Subjects Research Review Committee (referred to hereafter as the Institutional Review Board or IRB). Members are charged with reviewing all human subjects research (as defined by federal guidelines) conducted under the auspices of PSU to ensure adequate protections are in place.
All faculty, other employees and students at PSU who propose to use humans as subjects in research and related activities must have approval from the IRB prior to conducting the research. In addition, these policies apply to any entity who contracts with PSU for services or who wishes to conduct research on PSU property or that involves students and/or employees.
Portland State University has an assurance to conduct human subjects research in accordance with regulations set forth by the United States Department of Health and Human Services Office of Human Research Protections Federal wide assurance: FWA00000091.
FWA expires: 2/15/2021
Research is defined as any systematic investigation designed to develop or contribute to generalizable knowledge.
A systematic investigation is one that applies a defined set of questions or steps across a number of individuals or points in time in order to answer a research question. Systematic investigation may be a characteristic of both research and non research projects. For example, a quality improvement process may be a systematic investigation but may not meet the criteria of resulting in generalizable knowledge.
Generalizable knowledge refers to knowledge that is intended to be applied beyond the research setting (program) or individual. Findings that are intended to be published or presented to audiences outside of the research setting are considered research for the purpose of human subjects review.
The IRB may be composed of faculty, research staff, graduate students and community members. The IRB may use, as necessary, non-voting members and consultant reviewers to provide specific expertise needed for the review of an application. PSU and federal regulations require that there be a minimum of 5 regular voting members. The IRB will have at least one member unaffiliated with the University (community member). At least one member on the IRB must have primarily non-scientific concerns; this is someone not primarily functioning as an investigator, such as a lawyer, ethicist or member of the clergy; thus this individual may also fulfill the role of community member. The IRB may also include a graduate student member. The IRB will be appointed such that the members have varying backgrounds based on experience, disciplinary expertise and diversity in terms of gender, racial and cultural background.
The Director of the Office of Research Integrity and the Associate Vice President for Research and Strategic Partnerships will annually review existing IRB membership and provide recommendations to the Vice President for Research and Strategic Partnerships regarding recruitment, retention or dismissal of members. This review includes examination of attendance, expertise, affiliation and diversity. Thus the membership and composition of the IRB is periodically reviewed and adjusted to meet regulatory and or organizational requirements.
The IRB will include an individual with competence in special areas to assist in the review of complex issues that require expertise beyond that available on the board (e.g. research with prisoners). A prisoner advocate is used by PSU as an outside reviewer. This position does not serve as a voting member of the IRB. Every attempt is made to have a member of the IRB who has expertise in reviewing research with indigenous populations. If however, there is no such voting member available then this is another time when an outside review by an individual with competence to review these activities would be sought.
IRB members will be nominated through the University’s procedure for committee assignments. All new or continuing members and Chairperson are appointed by the Vice President of Research and Strategic Partnerships. Members are appointed for three years. Members may be asked to serve a longer term at the recommendation of the Director of Research Integrity. Each appointed IRB member will complete an on-line Human Subjects Training program before participating in a review. They will also be provided a book of training materials and provided a mentor, as appropriate.
Each IRB member is expected to attend IRB meetings regularly, read and analyze all applications sent prior to the meeting, and serve as primary reviewer as assigned. Acting as primary reviewer includes preparing a thorough critique of the application, contacting the investigator for additional information prior to the meeting and presenting the application to other members of the IRB at the meeting.
Members may be asked to perform expedited reviews outside of the IRB meetings.They are given two weeks to review an application and are expected to do so in a timely manner.
IRB members will recuse themselves from discussion of any application in which they have a vested interest (e.g. principal investigator or other affiliation with the project) except to provide information as requested by the IRB.
Investigators may not request a specific IRB member as primary reviewer, although they may comment on which reviewer may have related expertise.
The IRB will review all research involving human subjects conducted by faculty, other employees and students of PSU, or conducted on PSU property, or under PSU affiliation. The IRB may also review applications from non PSU entities at the discretion of the Director of the Office of Research Integrity. A fee is charged for these non-PSU reviews.
Applications will be submitted to the Office of Research Integrity and reviewed by ORI IRB staff for completeness and to determine if the proposed project constitutes research involving human subjects. ORI IRB staff will also determine whether the application can be certified as exempt, qualifies for expedited review or requires full board review. Applications that require a full board review will be placed on the agenda of the next IRB meeting. Applications must be received at least two weeks prior to a meeting date to be placed on that agenda.
The IRB can take one of four actions: approve, approve with modifications (conditional), deny, or return the application to the investigator for more information before making a decision (incomplete).
Investigators will receive written documentation regarding the decision made about their application. Any conditions or modifications required will be sent to investigators by email typically within 3-4 weeks after submission of the application. The time between submission to approval is generally 4-6 weeks. Approval letters will be sent by e-mail. Approval is for one year unless stipulated otherwise.
In order to continue a project, a Continuation Review Report is required at least annually, however, the IRB can require continuing review more frequently for high risk research.
The IRB may also review reports of unanticipated problems at the request of the Director of Research Integrity. A full committee must review and approve the decision to suspend or terminate an IRB approval.
Quorum is defined as a simple majority with one more than half of the voting members present either in person or on the phone at the time of the meeting. Quorum also requires that at least one voting member in attendance is a non-scientist member. If a quorum is not present, the IRB cannot make a determination about an application.
IRB meetings are scheduled once a month. The meeting is cancelled at the joint discretion of the IRB Chair and Director of ORI when there is no IRB business.
IRB members will be notified of the schedule of meetings at the beginning of the academic year. Time and place of meeting, as well as agenda and applications to be reviewed will typically be delivered to each member a week prior to the scheduled meeting.
All research that involves human subjects conducted by faculty, other employees and students at PSU must have prior review and approval by the IRB. The IRB Administrator or other IRB staff will determine the level of risk involved and the type of review needed: Exempt, Expedited or Full Committee review. The determination of the type of review is based on an assessment of the level of risk. Research of no greater than minimal risk can be reviewed at the exempt or expedited level, while research of greater than minimal risk will be reviewed at the full committee level.
Minimal risk is defined as the probability that the magnitude of harm or discomfort anticipated in the proposed research is no greater in and of itself than those ordinarily encountered in everyday life, or during the performance of routine physical or psychological examinations or tests. All investigators must submit a complete IRB application, even if they believe that their research falls under one of the exemption categories.
Research that involves human subjects may be determined to meet one of the six categories for exemption. This determination is made by the ORI IRB staff in consultation with the Chairperson of the IRB as appropriate. To be considered exempt, the PSU IRB must find the research to be both minimal risk and to fit into one of the following exemption categories. PSU’s IRB policy requires a consent process even if the research falls under one of the exemption categories and the IRB may require changes to a protocol even though it may fall under one of the exemption categories. Even if a research project appears to fit under an exemption category, the ORI IRB staff may determine that the risk to subjects is too high to be waived.
Exempt categories: (Quoted from 45 CFR 46.101)
Research activity that involves no greater than minimal risk to subjects may be eligible for expedited review.
Expedited reviews are conducted by one or more voting IRB members who have knowledge in the area of research provide this review. For example, studies that include minors are reviewed by a child specialist voting member of the IRB.
The expedited review process can be applied to new applications with minimal risk or minor changes in previously approved research (also called amendments).
Under the expedited review procedure, the Chairperson or his/her designee examines the expedited review reports and has the authority as the IRB to make a determination to approve or request modifications. However, research cannot be disapproved through the expedited process as a majority of members must vote to disapprove an application.
Upon evaluation of the application, the reviewers may request review by a full committee.
Expedited categories (Quoted from 45 CFR 46.110)
Researchers, including graduate students working on thesis, dissertations or master’s projects, whose project meets all four of the following criteria need to complete the form titled “Review Not Required” (if the project involves secondary data but does not meet all four criteria, a complete application must be submitted):
The Review Not Required form is also used when an investigator believes a project does not require IRB review and approval because the activities do not meet the definition of "human subjects" or "research."
A majority of the regular membership who are in attendance in person or by phone constitute a quorum. A majority of persons present (in person or by phone) at the meeting is required to approve and/or disapprove an application.
If an investigator disagrees with either the IRB’s decision or the conditions placed on the protocol, they may request to meet with the ORI Director and the Chairperson of the IRB. The purpose of this meeting will be to review the decisions and discuss possible alternative resolution. If the investigator is not satisfied with the outcome of this meeting he or she can appeal to the Associate Vice President for Research and Strategic Partnerships and subsequently to the Vice President of Research and Strategic Partnerships. No other University official has the authority to override or disapprove an IRB decision. However, by regulation, while the Vice President of Research and Strategic Partnerships cannot approve research that the IRB has disapproved, the VP of Research and Strategic Partnerships can deny research the IRB has approved.
The initial application requires submitting information on each of the following:
For research that will be conducted with vulnerable populations, the IRB Administrator or the IRB may ask for verification of the investigator’s qualifications to work with the population.
Graduate students must provide a description of the research support they will have available including the involvement of an advisor (e.g. Dissertation chair).
Investigators are required to complete a continuing review report annually if they wish to continue the study past one year. The report must include a description of the status of the project including information on enrollment numbers, adverse events, changes to consent documentation, etc. The IRB Administrator or other ORI IRB staff will determine if the Continuing Review Report will be reviewed in full committee or if it can be reviewed through an expedited process.
Amendments to an approved protocol may be submitted at any time. Details of the proposed changes are to be sent to the IRB Administrator along with any revised forms. The IRB Administrator will determine whether the amendment needs full committee review or can be reviewed through an expedited process. If the amendment significantly changes the protocol or increases the risks to subjects, the IRB Administrator can require a new application. Amendments cannot be implemented until they are approved. If there is a need to avoid immediate risks to subjects, researchers should contact the IRB Administrator to discuss any immediate changes to a protocol.
A pilot study is defined as 1) a study that tests the effectiveness or applicability of an already existing research instrument on a new population or 2) a study that tests the effectiveness or applicability of a new research protocol (i.e. interview schedule) on a new population. The researcher must consult the IRB Administrator to determine if the pilot study will require IRB review. The decision will depend on 1) the type and number of subjects; 2) that data will not be used in any analysis other than the pilot test; 3) the pilot test results will not be published; 4) there is no greater than minimal risk to the subjects in the pilot test.
Link to unanticipated event form
Unanticipated problems or adverse events are those which cause unanticipated harm or increased risk to subjects or others, specifically problems not explained in the consent form. An example of an unanticipated problem is loss of data files containing personal information about participants.
The Research Integrity Director will review the report and determine if the event was (a) unforeseen (b) caused harm or placed a person at increased risk of harm and (c) was directly related to the research procedures. The Research Integrity Director will take action which may include but is not limited to: requiring a modification of the research protocol, requiring additional information on the informed consent, requiring that all affected participants be notified of the increased risk. The Research Integrity Director may also refer the report to a full committee for review and recommendation for action. The decision to suspend or terminate a research project because of an unanticipated problem or adverse event must be made by the full committee.
An IRB membership roster will be available on the ORI website and updated at least annually.
Written minutes of the IRB meetings are kept by the IRB Administrator. The minutes will document members present, summary of discussion on debated issues, the record of IRB decisions and the record of voting. IRB meeting minutes are retained for three years.
Written or electronic records of study protocols, approved consent forms, written communication to and from the IRB, adverse reaction reports, and continuing review reports will be kept under the supervision of the IRB Administrator for three years.
A thesis or dissertation is automatically considered to be adding to generalizable knowledge because the University intends to disseminate its contents for the use of others. Therefore, students completing a master’s thesis or doctoral dissertation that involve the use of human subjects must submit an IRB application for review and approval.
If a student’s master’s project meets the federal definition of research and involves human subjects as defined by federal guidelines, a review is needed.
Similarly, research conducted as part of a classroom assignment will not routinely be reviewed by the IRB. Usually, this type of research is conducted under the purview of the classroom instructor who is responsible for assuring that human subjects are adequately protected. A research paper written as a class assignment only within the classroom setting is an example.The classroom instructor is responsible for determining the risks to subjects and may wish to consult with the IRB Administrator.
In the case of research conducted as coursework, faculty and students have an ethical responsibility to inform participants of the purpose of the project, the scope and duration of each activity in which they are expected to take part, and the expected outcomes—in essence, to obtain informed consent. The IRB Administrator is available for consultation in drawing up informed consents or cover letters. In addition, if any data collection of a sensitive nature is to take place, it is recommended that the investigator work with the IRB Administrator to incorporate appropriate protections for those involved in the project.
The IRB will review projects in which no greater than minimal risk to children is presented, only if adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
The IRB will review projects in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, only if:
Unless permission to forgo obtaining either assent by the child or permission from his or her parents or guardian is explicitly granted by the IRB, both are required in research that will involve children.
The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, we may still waive the assent requirement under circumstances in which consent may be waived in accordance with general informed consent provisions. When the IRB determines that assent is required, it shall also determine how assent must be documented.
In addition, the IRB shall determine that adequate provisions are made for soliciting the permission of each child’s parents or guardian. Where parental permission is to be obtained, the IRB may find that permission of one parent is sufficient for research involving minimal risk or for research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. For research involving greater risk and no prospect of direct benefit to subjects, permission is to be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects--for example, neglected or abused children--it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as subjects is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law.
The IRB shall review research only if it finds that:
Permitted Research Involving Prisoners
Biomedical and behavioral research may involve prisoners as subjects only if the proposed research involves the following: