Steps to IRB Review
The IRB meets monthly to review proposals received during the previous month.
** The IRB does not meet in the month of August.**
Step 1: Determine if your project requires IRB approval
Step 2: Complete the Mandatory Online Certification for Researchers
Mandatory online certification is required for all researchers, investigators, faculty advisors (if applicable for student conducted research) who submit a proposal to the IRB.
Save a copy of the certification as a pdf to submit as part of the research proposal.
Step 3: Complete the IRB Research Project Application
Complete the Research Project Application.
Step 4: Prepare the Informed Consent Document(s)
Research projects involving human participants require informed consent from the participants.
If the research study has human subjects under the age of 18 as participants, additional informed consent forms are required.
Informed consent should include the following information:
- The document describes, briefly and simply, what the research is about.
- It tells the subjects what they will be asked to do and for how long.
- It explains any risks and benefits. If there is no direct benefit to the subject, the document should explain what the study hopes to discover and why.
- If you promise to protect your subjects’ identity, you must describe how you will do this. If it is impossible for you or anyone else to link the data you collect to a specific person, then you may promise to guarantee your subjects’ anonymity. However, in most cases it will be possible to use your records to identify a subject. In that case, the most you can promise is to keep the subjects’ personal information private to the extent allowed by law.
- The document describes any compensation the subject will receive and conditions under which no payment or partial payment will be made.
- The document makes it clear that participation is voluntary.
- It tells subjects that they may skip questions or withdraw from the study at any point without penalty.
- It gives the subjects the names, addresses, telephone numbers and e-mail addresses of persons to contact if they have questions or concerns about the study. The IRB asks that name, address, telephone number and e-mail address be included for the investigator and his or her faculty advisor (if the investigator is a student).
- It tells subjects that if they have questions or concerns about their rights as a participant in the research study, they may also contact the IRB chair.
- It does not contain “exculpatory language.” Subjects must not be asked to waive (or appear to waive) any of their legal rights, nor may they be asked to release the investigator, any funding organization, or Bellevue College from liability for negligence. By signing the consent document, the subject is not “signing away” any rights. Their signature merely indicates that the subject has read the document or has had it read to him/her, has had a chance to discuss it with the investigator, and understands it.
Examples and templates of Informed Consent Documents can be found here.
Step 5: Submit Proposal Form
Review the previous steps and ensure that each step has been completed. Proposal will go through this process.
E-mail completed proposal with labeled appendices as a pdf to the IRB Chair.
Or mail to:
IRB, Office of Effectiveness and Strategic Planning
3000 Landerholm Circle SE
Bellevue, WA 98007-6484
Communications regarding proposals are conducted via e-mail.
Step 6: Make adjustments as necessitated by IRB Review until approved
The IRB meets on a monthly basis to review proposals submitted during the previous month.
Prior to submitting the proposal to the board or reviewers, the IRB Chair will review the proposal for completeness and will provide feedback on enhancements and clarifications needed prior to determining the type of review necessary for the proposal.
During the submittal process, if a PI does not follow up on a request within 90 days, the application will be considered abandoned. The application process would start again from the beginning.
Step 7: Report Changes and Annually Renew Authorization (if needed)
If there are changes to your proposal after it has been approved, you need to notify the IRB using the Research Project Modification Form. For more information, refer to FAQ’s Research Modification.
If in the course of the study something negative happens to the subject then you must notify the IRB using the Adverse Incident Reporting Form. The IRB will then notify the Federal Office of Human Protection as required by law. Please note that this process must be followed regardless of the perceived seriousness of the incident, or whether or not you agree with the subject that something negative has occurred. If the subject reports an incident, then you must follow up within 48 hours of learning of the incident.
If your research duration is long than one year, you will need to submit an Annual Review Form prior to the anniversary of your research project application’s approval.
Step 8: Submit a Close-Out Form
Once you have finished gathering data, you will need to submit a Research Project Closure Form to the IRB. This notifies the IRB that its oversight responsibilities are over. Studies classified as “Exempt” do not require submission of this form.