- What is the IRB?
- Why does Willamette University have an IRB?
- What are the specific concerns of the IRB when reviewing proposed research?
- Do I need to have my research reviewed by the IRB?
- What are the differences in the types of reviews the IRB conducts?
- What do I need to do to submit an IRB proposal?
- Do I always need an Informed Consent form and what should be included in this?
- When do I need to submit an IRB proposal and when are the proposals reviewed?
- Do I need to submit a Willamette University IRB proposal if I'm conducting my research through another agency that has already done its own IRB review of the proposed research and has approved it?
- If I'm a student, what do I do with my original data once my research is completed?
- Do surveys or interviews require IRB approval?
- If I make a change to my design or research materials after my research has been approved by the IRB, do I need to submit another IRB proposal?
- If my research will continue for more than one academic year, do I need to have continuing review of my research project?
- What do I need to to do if my research involves collaboration with another agency?
The Willamette University Institutional Review Board (IRB) is charged with the responsibility of reviewing research proposed at Willamette University that will involve human or non-human animal participants prior to the initiation of the research. The purpose of these reviews is to ensure for the protection of human and non-human animals who participate in research. Research involving non-human animals is reviewed by the Institutional Animal Care and Use Committee (IACUC), a sub-committee under the IRB.[back to top]
The IRB and the IACUC comply with federal regulations for the protection of human and non-human animal participants involved in research. Larger institutions are required to have an IRB. Willamette University has a voluntary IRB and IACUC.[back to top]
When evaluating research, the IRB utilizes the following criteria in determining whether or not to approve the proposal.
The goal of research is to contribute to the general knowledge base. Proposed research will be evaluated with regard to whether or not the proposed research accomplishes this. Benefits of the research need to justify any potential risks; the riskier the research project is to the participants, the greater the amount of knowledge gained should be. Therefore, the specific research design, procedures, and materials need to be clearly articulated in the proposal so that the IRB can make a determination regarding the overall contributions of the research in light of potential risks to participants. Replication of previous research that has been done often and that has potential risks to the participants is not justified.
Research projects should not harm participants. The primary mandate of the IRB is to protect participants from harm. Harm can include physical as well as psychological or emotional harm. Moreover, harm can be immediate or delayed. The IRB will require evidence from the researcher that participants will not be harmed in any way by participating in the research study.
Research participants need to be adequately informed of the possible benefits/risks should they participate in research. They need to know they have the right to discontinue participation at any time, they need to acknowledge these risks and benefits by signing an Informed Consent form, and must be debriefed after the study if appropriate. Those unable to legally provide their own consent must have a parent/guardian provide consent on their behalf. In these instances, those who able to should sign an Assent form acknowledging their understanding of the benefits/risks of participation. The IRB will weigh the relative benefits and risks to the participants and will review the Informed Consent and Assent forms to ensure that the researcher has adequately explained these.
The confidentiality of the participants needs to be protected. The researcher must demonstrate sufficiently how the confidentiality of the participants will be maintained; this is especially critical whenever there is video- or audio-recording of participants. The IRB will require evidence from the researcher that there is adequate protection of the participants' confidentiality.[back to top]
Any research involving human participants that involves at least minimal risk to the participants or where the researcher plans to disseminate the results of the study (through either presentation or publication) needs to be reviewed by the IRB. Class research projects that do not meet either of these criteria do not need to be reviewed. Please refer to the Exceptions to Review section of this website to determine whether or not your research study must have IRB approval. Any questions about whether or not a particular research project needs an IRB review can be directed to the IRB Chair at firstname.lastname@example.org. If a researcher is not sure whether his/her research must be reviewed by the IRB, it is the responsibility of the researcher to make the necessary inquiries regarding this prior to the initiation of the research project. The IRB cannot give post facto approval of a research study.[back to top]
There are three types of IRB Review: Exempt Reviews, Minimal Risk Reviews, and Full Board Reviews. The type of review the IRB conducts depends upon the potential risk to the participants. The greater the potential risk to the participants, the more involved the IRB review will be and the longer it will take. For a detailed description of each type of review, please refer to the Review Criteria section of this website.[back to top]
It's easy to submit an IRB proposal. All you need to do is submit an application. (A Willamette username and password are required to submit an application.) This form allows you to submit an IRB application. On that form, you will be given some general instructions about how to submit an IRB application, and the application itself will follow. You need to complete all relevant parts of the application as well as the checklist at the bottom of the application. Only web IRB proposals are now accepted.[back to top]
For research involving human participants, there needs to be an Informed Consent form. Additionally, there are some required elements that each Informed Consent form must have. Please consult the Informed Consent Issues section of this website to see what the components of the Informed Consent form should be and for links to examples of specific types of Informed Consent forms.[back to top]
IRB proposals need to be submitted before the research process begins. Therefore, researchers need to allow themselves enough time in advance of conducting their research to obtain IRB approval.
All proposals will be sent out for review to the IRB committee every Monday during the academic year. Proposals received after Monday of a given week will be sent out the subsequent Monday. Exempt and minimal reviews should take 2-3 weeks and Full Board reviews should take approximately 1 month after they are sent out for review to the committee.
No proposals will be reviewed over University breaks, between semesters, or over the summer except under exceptional circumstances on an ad-hoc basis.
No proposals will be reviewed after the dates listed below until the next academic semester's weekly reviews begin.
Fall Deadline: 2nd Friday in November
The final date that proposals will be accepted for review in the fall is the 2nd Friday in November. All fall research and early spring semester research proposals must be submitted to the IRB by that day.
Spring Deadline: 1st Friday in April
The final date proposals will be accepted for review in the spring is the 1st Friday in April. All spring semester and summer research proposals must be submitted to the IRB by that day.
Carson & Lilly Grants
Students receiving Carson Grants, Lilly Grants, or participating in formalized summer research programs such as SCRP may submit proposals for their summer research up until the last day of finals of the spring semester.[back to top]
9. Do I need to submit a Willamette University IRB proposal if I'm conducting my research through another agency that has already done its own IRB review of the proposed research and has approved it?
Researchers who have already obtained approval through another agency's IRB do not need to additionally submit a proposal to the Willamette University IRB. However, individuals must provide a copy of the IRB application and notice of approval from the other agency to Willamette's IRB so that we can document that IRB approval was sought and obtained by another agency. If no documentation is provided, the researcher will need to go through the Willamette IRB review process.[back to top]
Hardcopy data from student research projects should go to faculty advisor for storage when the research project is completed. These data should be housed by the faculty for at least 3 years per IRB Federal Guidelines (and possibly longer depending on the guidelines for each discipline). Any audio- or video-recording of participants should be destroyed as soon as these data are coded (except when needed for documentary or other purposes). Special Informed Consent and Release forms for creating and using recordings of participants need to be part of these research studies.[back to top]
Surveys and interviews are a form of data collection and, as such, are subject to the same conditions for possible IRB review as other forms of research involving human participants. Whether or not data collected via a survey or interview requires IRB review will depend on whether or not there is any risk to individuals for participating and whether the data will be disseminated. Please refer to the question "Do I need to have my research reviewed by the IRB?" for more information.[back to top]
12. If I make a change to my design or research materials after my research has been approved by the IRB, do I need to submit another IRB proposal?
If a researcher makes minor changes to their research design or research materials after IRB approval, the researcher does not need to resubmit another IRB proposal as long as the changes do not affect the potential risk to the participants or the general design of the study. However, if changes to the research design or research materials are significant or if these changes increase the risk of potential harm to the participants, then another IRB application will need to be submitted prior to the commencement of the research.[back to top]
13. If my research will continue for more than one academic year, do I need to have continuing review of my research project?
On the application form, the researcher is asked to include the length of the proposed research project. In its initial review of a proposal, the IRB will consider the extent of continuing review needed for research projects that are likely to continue for more than one year. If the researcher indicates that his/her project will continue beyond one academic year, the IRB will review the research on an annual basis. However, in research studies where the participants are exposed to more than minimal risk, such proposals will be reviewed at more frequent intervals appropriate to the research. This review interval will be determined at the time the research is approved and may be changed at the discretion of the IRB. During a continuing review, the principal investigator will be required to promptly report the status of the research activity, and any proposed changes in the research activity. If the research is still in progress, the investigator will affirm that the approved research protocol involving human participants is being followed and that no significant changes to the design of the research has occurred which affected risk to the participants.[back to top]
If you plan on collecting data in collaboration with another agency, then you need to provide documentation to the IRB that the agency is supportive of the research relationship. In order to provide this documentation, you will need to obtain a signed letter on the agency's letterhead from an authorized agency representative that attests to the fact that the research relationship between you and the agency has been reviewed and approved by the agency. The letter should be scanned into the computer and converted to an electronic .pdf file, and should then be uploaded as part of your IRB proposal. The IRB will not be able to approve proposals that involve collaboration with outside agencies without this documentation.[back to top]