Oregon Tech's Institutional Review Board (IRB) reviews research projects that involve human subjects, to protect the right and welfare of individuals recruited to participate in research activities conducted under the auspices of the Oregon Institute of Technology. All research conducted by any Oregon Tech faculty member, staff member, or student using human subjects must have prior approval from the Oregon Tech IRB before the research is initiated. Additionally, all human subjects research at OIT is conducted subject to relevant federal guidelines and policies. The IRB is a federally mandated body established under the US Department of Health and Human Services (DHHS) regulations for the protection of human subjects 45 CFR 46 (Protection of Human Subjects). Please contact the Oregon Tech IRB regarding animal subject research protocols as well.
*Prior to submitting a new IRB application watch the three IRB training videos (found under IRB Application Forms on the IRB SharePoint) and read the entire IRB SharePoint home page. New IRB application submissions should include three forms (found under IRB Application Forms on the SharePoint): 1) the official IRB Application, 2) the IRB Application Supplemental Questions, and 3) the Oregon Tech IRB Consent Form.
Once you have submitted all your application materials to the New Submissions folder, the IRB chair will then move your application to the Under Review folder where the IRB committee will provide feedback and applicants can provide their response/revisions. Once the IRB review process is complete and your application has been approved it will then be moved to the Approved folder and archived. While you can submit an application during summer break the IRB only operates during the 9-month academic year and will therefore review your materials when fall term starts.
Research is a systematic investigation designed to test hypotheses, evaluate programs, draw conclusions, or contribute to generalizable knowledge. Research is usually described in a formal protocol that sets forth objectives and a set of procedures designed to reach those objectives.
Human Subjects in research are living individuals about whom investigators (professionals or students) conducting research obtain (1) data through intervention or interaction with individuals, or (2) identifiable private information. Identifiable private information includes any acquired information via self-report, behavior, or observation in which the identity of research subjects is or may readily be ascertained by the investigators or be associated with the information.
Minimal Risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46.102(j)).
The purpose of the IRB is to protect the rights and welfare of research subjects and to ensure that such research is conducted in full compliance with both the letter and the spirit of applicable regulations.
Failure to obtain IRB approval or to follow approved protocols may result in disciplinary action as described in OIT IRB Procedures.
The IRB shall apply the following principles in the review of all research involving human subjects:
Participation of human beings in research must be voluntary as indicated by free and informed consent.
- Participants must be protected where possible from physical and emotional discomfort, harm, or danger.
- Research projects must be designed to benefit participants and/or a larger community whenever possible.
- The research must be designed to treat all individuals fairly.
- Commitments made to research subjects must be honored.
The Provost is the signatory official who is legally authorized to represent OIT. The Provost appoints IRB members and is responsible for overseeing activities performed by the IRB in accordance with the OIT Federalwide Assurance and Section 45 Part 46 of the Code of Federal Regulations. The Vice Provost for Research serves as the Human Protections Administrator who is responsible for interface with the DHHS Office for Human Research Protections. The IRB is authorized to revise and update this URP and associated IRB Procedures as needed to reflect new standards, regulations, and University URPs.
All research involving human subjects must be reviewed by the IRB to determine whether they merit being granted exempt status, expedited status, or full review status. To have your study reviewed by the IRB you must complete and submit the official IRB Application, IRB Application Supplemental Questions, and Oregon Tech IRB Consent Form (if a consent form is required) through the Microsoft SharePoint portal. The IRB determines the status of your study based on the human participant risks involved and the nature of the study as indicated below:
Granted by the IRB to research projects that (a) pose little or no risks to participants; and (b) do not involve a sensitive topic (i.e., a topic which could cause a participant distress); and (c) do not involve vulnerable populations; and (d) collect anonymous information (i.e., no names or other identifying information will be collected or recorded) including research using questionnaires or surveys, research conducted in educational settings involving normal curriculum (even if minors are involved), and research conducted using archival data.
Exempt applications will be reviewed by at least one IRB member (usually the chair), and the principal investigator can expect to receive a response from the IRB within two weeks.*
Granted by the IRB to research projects that (a) involve minimal risks to the participants; and (b) do not involve sensitive topics; and (c) do not utilize vulnerable populations; and (d) include research using questionnaires, surveys, and interviews that are not anonymous (i.e., participants can be identified).
Expedited applications will be reviewed by three IRB members, and the principal investigator can expect to receive a response from the IRB within three weeks.*
Full Review Status
Granted by the IRB to research projects that (a) involve more than minimal risks to the participants, or (b) involve a sensitive topic, or (c) involve a vulnerable population.
Full review applications are reviewed by the entire IRB at their monthly meetings which are held on the second Tuesday of each month, except for when the second Tuesday of the month falls on a term break or holiday, in which case the IRB meets on the following Tuesday. Principal investigators can expect to receive a response within two weeks of the IRB meeting which followed the submission of their IRB application. Your application should be submitted a week prior (i.e., by the first Tuesday of the month) to the scheduled IRB meeting so the committee members have time to review it before meeting to discuss it together.*
*These times are estimates and may require additional time during certain periods of the academic calendar such as term breaks and holidays. The IRB does not operate during summer break so all IRB applications should be submitted two months prior to summer break. Importantly, before the IRB approves a research project and it can begin, the IRB will often have additional questions about the study for the principal investigator to answer, and potentially require modifications to the study protocol to ensure the protection of study participants. Accordingly, the amount of time necessary for a study to be approved by the IRB can vary significantly. The times listed above are for initial IRB feedback, not for when final IRB approval can be expected.
The Council for International Organizations of Medical Sciences' definition: "Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests." Vulnerable populations can include children, pregnant women, human fetuses and neonates, prisoners, veterans, adults with diminished cognitive capacity or who are educationally disadvantaged, and employees or students under the authority/evaluative power of the study investigators.
Projects Not Requiring IRB Review
Certain Educational Activities - Course-related activities/class projects in which data are gathered and analyzed strictly for educational purposes, and human subjects are only exposed to minimal risk, do not require IRB review. Such data cannot be reported in any thesis, dissertation, presentation, publication, or other professional venue without IRB review. If there is a possibility that researchers may use these data for the above purposes, IRB review is required prior to initiating the project.
Program Evaluation - Similarly, data gathering and analysis strictly for internal program evaluation purposes does not require IRB approval. If this information will also be shared outside of the university to contribute to generalizable knowledge, then IRB review is required prior to initiating the project.
Oral Histories and Biographies which are not intended to produce generalizable conclusions.
Journalism and Documentation Production which does not meet the definition of human subjects research
Responsibilities of Oregon Tech Researchers
All OIT faculty, staff, and students, on- and off-campus conducting research using human subjects must have prior approval from the OIT IRB before the research can begin.
Responsibilities of Oregon Tech IRB
The IRB is responsible for ensuring compliance with the federal regulations set forth in 45 CFR 46, and charged with the review and approval of all research involving human subjects conducted by faculty, staff, and students, on-and off-campus, regardless of funding source, prior to initiation of the research. The IRB is registered with the US Office of Human Research Protections (OHRP). The IRB reviews and approves any changes to approved research projects before implementation. Additionally, the IRB is tasked with monitoring ongoing research for adherence to federal regulations and institutional policies and procedures. The IRB reports to the Associate Provost of Research and Academic Affairs (APRAA) and follows a membership composition to comply with 45 CFR 46.107 (IRB Membership).
Responsibilities of the Associate Provost of Research and Academic Affairs
The Associate Provost of Research and Academic Affairs, Provost and Deans jointly appoint the IRB members for a term of 3 years. The Associate Provost of Research and Academic Affairs is responsible for submitting, updating, and renewing the Federalwide Assurances (FWAs).
Oregon Tech students, faculty, staff, and guests.