- 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?
- 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?
- 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?
- What do I need to do if my research involves collaboration with another agency?
1. What is the IRB?
The Willamette University Institutional Review Board (IRB) is charged with the responsibility of reviewing research proposed at Willamette University that will involve humans or animal participants prior to the initiation of the research. The purpose of these reviews is to ensure the protection of humans and animals involved as participants in research. Research involving animals is reviewed by the Institutional Animal Care and Use Committee (IACUC), a sub-committee under the IRB.
2. Why does Willamette University have an IRB?
The IRB and the IACUC comply with federal regulations for the protection of humans and animal participants involved in research.
3. What are the specific concerns of the IRB when reviewing proposed research?
When evaluating research, the IRB utilizes the following criteria in determining whether to approve a proposal.
The goal of research is to contribute to the general knowledge base. Proposed research will be evaluated with regard to whether it accomplishes this. Benefits of the research need to justify any potential risks; the riskier the research project is for 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.
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 (e.g., individuals under the age of 18) must have a parent/guardian provide consent on their behalf. In these instances, researchers are required to obtain a signed Assent form from participants (e.g., children) who are able acknowledging their understanding of the benefits/risks of participation. The IRB will weigh the relative benefits and risks to 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 participant confidentiality.
4. Do I need to have my research reviewed by the IRB?
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 irbchair@willamette.edu. 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.
5. What are the differences in the types of reviews the IRB conducts?
There are three types of IRB Review: Exempt Reviews, Minimal Risk Reviews, and Full Board Reviews. The type of review depends upon the potential risk to participants. The greater the potential risk, the more involved the IRB review will be and the longer it may take. For a detailed description of each type of review, please refer to the Review Criteria section of this website.
6. What do I need to do to submit an IRB proposal?
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 accepted.
7. Do I always need an Informed Consent form and what should be included in this?
For research involving human participants, an Informed Consent form is generally required. 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.
8. When do I need to submit an IRB proposal and when are the proposals reviewed?
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 at 9 am every Monday during the academic year. Proposals received after 9am Monday of a given week will be sent out the subsequent Monday. Although the IRB reviews applications as expeditiously as possible, researchers should plan on exempt and minimal reviews to take 1-2 weeks; Full Board reviews may take up to 3 weeks after they are sent out for review to the committee.
Beginning with the 2019-2020 academic year, the IRB will be available to review applications throughout the calendar year. However, researchers need to be aware that the timelines for review of applications received during the end-of-year and summer breaks may be longer than that noted above, and to plan accordingly.
Thus, to ensure timely review, researchers are encouraged to submit applications prior to the end of each semester as listed below.
Fall: 2nd Friday in November
Spring: 1st Friday in April
NOTE: Researchers need to be aware that the IRB receives the greatest number of applications in late October/early November in Fall and in mid/late April in Spring. Therefore, early submission is encouraged to avoid any unnecessary delays in the review process due to the volume of applications received at this time.
9. If I'm a student, what do I do with my original data once my research is completed?
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.
10. Do surveys or interviews require IRB approval?
Surveys and interviews are a form of data collection may be subject to IRB review. Please refer to the question "Do I need to have my research reviewed by the IRB?" for more information.
11. 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 minor changes are made to a 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.
12. 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 researchers indicate that their projects 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 may 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.
13. 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 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.
14. What do I need to do if my research involves collaboration with another agency?
If you plan on collecting data in collaboration with another agency, 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 converted to an electronic .pdf file, and 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.