IRB is the acronym for Institutional Review Board. According to the provisions of the Federal Wide Assurance filed by Linfield University, federally-funded research involving human participants sponsored by Linfield must be reviewed according to the regulations set forth in 45 CFR 46. Linfield also certifies that all research involving human participants at Linfield University, independent of funding source, will be conducted in accordance with the ethical principles enunciated in the Belmont Report. The University has committed itself to a process of internal review of all research involving human participants.

To accomplish this purpose, IRB committees use a group process to review research protocols and related materials to ensure protection of the rights and welfare of human subjects of research.

The IRB for Human Participants has the authority to review, approve, reject or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review by officials at Linfield University; however, rejected applications may not be overturned by any other officials at Linfield University. The IRB committee’s primary role is to ensure the protection of human participants as subjects of research at Linfield University.

Studies that meet the definition of Human Subject Research must be submitted to the IRB and must receive IRB approval BEFORE any study activities take place. Please note that applications must be submitted in a timely fashion (see review timeline).

All research personnel who are responsible for the design, conduct and/or reporting of your project must complete an IRB training prior to submitting an IRB application. The course is accessible at CITI Program website and you should attach certificates of completion for all researchers along with your IRB application.

If the proposed activity is “research” and it involves “human participants” then YES you MUST obtain IRB approval unless it meets one of the following categories of investigation NOT considered to be research (see below). If you have any questions about whether you are doing research that requires an application please review the decision trees and/or contact the IRB chair before initiating what you believe may or may not be research.

Research is defined as:

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [DHHS 45 CFR 46.102(d)]

“testing of concepts by the scientific method of formulating a hypothesis or research question, systematically collecting and recording relevant data, and interpreting the results in terms of the hypothesis or question.” [VA 38 CFR 16; VHA Handbook 1200.5]

Human participants:

A human participant is a living individual about whom an investigator (whether professional or student) obtains either (1) data information or biospecimens through intervention (i.e, includes both physical procedures by which information or biospecimens are gathered (e.g., drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes) or interaction (i.e., communication or interpersonal contact between investigator and subject) with the individual or (2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens (i.e., biospecimens for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimens). Note that interaction includes communication or direct interpersonal contact between investigator and subject (e.g., surveys, looking at stimuli, interviews, etc.). Private information includes information about behavior that occurs in a context in which an individual can reasonably expect privacy (i.e., no observation or recording) and information which has been provided for specific purposes by an individual whereby s/he can reasonably expect that the information provided will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.

As of January 21, 2019 the following activities are NOT considered to be research:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Yes, if the study meets the definition for research with human participants, as explained above and is not one of four activities considered NOT to be research. Note that depending on the questions being asked, the population being surveyed, and whether the surveys can be linked to the participants, the level of review (i.e., exempt, expedited, limited, full) may vary and it may be exempt (see decision trees and application for more information).

It depends. If the project is to be used in for learning purposes only, the project may not constitute human participant research. In this case, while students may complete an IRB application for practice, they should NOT submit  an IRB application to the committee. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, if the data that students collect as a part of a class project fit the definition of “research” and “human participants” as described above then they MUST obtain IRB approval. For example, honor’s theses and senior capstone research projects should be submitted to IRB as they fit the definition of research and there is a greater chance that the student may wish to present and/or publish the findings. Additionally, if the project involves more than minimal risk (e.g., interacting with vulnerable populations, asking about sensitive topics, etc.) the project must be submitted to the IRB.

In cases when a classroom-based project is not submitted to the IRB it is assumed that the professor is supervising the project in accord with ethical guidelines. For example, professors may require students to complete the online tutorial. They may also require students to complete an IRB application, including a consent form as a means of improving students' knowledge and appreciation of ways to minimize risk, protect privacy and confidentiality.  To further educate students about the IRB process instructors may set up “mock” IRB committees so that groups of students "review" each other's applications.

Even though some classroom-initiated research is not reviewed by the IRB, it is the instructor's responsibility to work with students to review guidelines and ethics for protection of research participants and make sure they incorporate these into their methodology. Particular emphasis should be placed on:

• Developing an awareness of the types of risk participants may be exposed to in various types of research projects (i.e., physical, psychological, social, and legal).
• Obtaining voluntary informed consent to participate in a way that honestly informs participants of the purpose and potential risks and benefits of the research.
• Strategies to minimize potential risks to participants.
• Weighing risks and benefits for all populations, with special consideration given to populations who are vulnerable to coercion and undue influence (e.g., individuals with impaired decision-making ability, prisoners, children, and economically or educationally disadvantaged persons.).
• Protection of privacy and confidentiality of the participants.

Yes, if your research project involves active data collection. Federal regulations and Linfield policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study. It is likely that the project will be considered exempt, however, it is not up to the researcher to determine the status of review. However, if your research project is using archived data or existing information collected from human participants (e.g., secondary datasets, existing biological samples), and the data are not linked to individuals in any way, then the activity may not require IRB review. If you are unsure please see the IRB’s decision trees, and/or email the IRB chair for clarification.

Certain activities are not deemed research and require no IRB application (see FAQ #4 and decision trees for guidance). Under other circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations.

The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

In order to have a research project recognized as exempt, investigators will need to submit an IRB application checking the exemption categories which are applicable, along with other study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.) to the IRB. The IRB chair will evaluate exemption requests and notify investigators if their projects are eligible.

Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator may need to consult with IRB to determine if the change affects the eligibility of the research activity to continue to be exempt from IRB review and approval.

No. The Federal Regulations do make certain categories of research exempt from IRB review. However, Linfield University policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB.

If you think your research may be exempt from IRB review, you will indicate which categories of exemption apply to the proposed project when you submit your IRB application. The IRB staff will review the information submitted and make a determination as to whether the exemption can be granted. If your study is considered exempt from review the IRB will issue the PI a formal written notice via email. Protocols that are recognized as exempt from IRB review do not require continuing review (i.e., annual renewal of exemption is not necessary), nor do most studies with no more than minimal risk. However, for each change that is proposed or may need to be made while conducting the research, the PI should submit an amendment request so IRB staff can evaluate whether the change affects the research project’s eligibility for exemption from IRB review. The PI must receive a written notice confirming that the project remains exempt before implementing the change in the research activities.

As discussed above, classroom-based research projects the results of which will not be disseminated and which pose no risk to participants do not need to be reviewed. Oral histories, legal research, workshop/classroom evaluations, and administrative review projects need not be reviewed by the IRB if they are not research (i.e., the purpose is to NOT generalize beyond the individual, classroom or institution) (see FAQ #4).

If there is at least minimal risk to the participants (note that risk may be physical, social, psychological or legal in nature) or there are plans to disseminate the research beyond the immediate campus community and your proposed activities are not one of the four new categories of non-research (see FAQ #4), then you must submit an application to the IRB. The IRB is unable to give post facto approval, therefore if in doubt, it is wise to have your research approved (or reviewed and considered exempt). Even if your application is categorized as “exempt” it still requires initial review but is exempted from continuing review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.  

For more information please see IRB’s Decision Tree for information regarding exempt status.

If you are a member of the Linfield University faculty or staff, or a Linfield University student, and you are the person responsible for the conduct of the study (PI), you must get Linfield IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Both Federal and University policies encourage the completion of an IRB Authorization Agreement to be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.