Frequently Asked Questions (FAQs)
► 1. Why should I complete an Institutional Review Board (IRB) application?
► 2. Does my study require IRB approval?
► 3. How long will it take to get my application approved?
Exempt Applications: Approximately 2-4 weeks
Expedited Applications: Approximately 4-6 weeks
Full Board Applications: Approximately 4-8 weeks
Review Times are estimates based upon the following factors:
- The Quality and completeness of the submission.
- The number of studies in the queue at the time of submission (studies are processed in the order in which they are received).
- The length of time it takes applicants to respond to pending items and questions for the IRB committee.
- The availability of the IRB members (all members are volunteers
► 4. What are the responsibilities of the Principal Investigator (PI)?
► 5. Do all PIs and faculty advisors have to complete human subjects training?
► 6. What is the definition of research?
The Code of Federal Regulations (45 CFR 46.102 (d)) defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A Systematic investigation means an activity that may include:
- Collection of observational or qualitative data
- Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
- Collection of data using experimental designs such as clinical trials; or
- Some demonstration and service activities.
Contributions to generalizable knowledge means public presentation of the study data through any of the following:
- Meetings, conferences, seminars, poster presentations, and similar venues;
- Publications distributed beyond WOU including evaluation reports, journal articles, papers, dissertations; and,
- Master’s Theses and Projects
► 7. What is the definition of human subject?
Federal Regulations state that a human subject is a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Manipulations of the subject’s environment; or
- Applications of procedures or treatments, such as drugs, devices, or biologics; or
- Administration of psychological therapies or counseling to change behavior or promote well-being
- Communication with the subject; or
- Interpersonal contact with the subject; or
- Physical procedures to collect data, such as taking blood samples
Private information must be individually identifiable and includes:
- Information about behavior that the subject expects will not be observed or recorded
- Specific information about the individual that the individual can reasonably expect will not be made public
► 8. What do I have to do to obtain IRB approval?
A basic IRB application packet for WOU-affiliated researchers must be completed and submitted. It includes:
- Evidence of human subjects research training. Every individual listed on the IRB application must submit a certificate of successful completion of the CITI human subjects research training course.
- A completed and signed WOU IRB Proposal Application Signatures are required for all members listed on the IRB application.
- Documentation of Consent Procedures which includes one or more of the following:
- Written Consent Form, or
- Verbal Consent Script, or
- Letter indicating why consent is not needed
- In the case of minor subjects (not of legal age), a written Assent Form or verbal Assent Script should also be included.
- Any survey instruments or questionnaires to be used
- A detailed list of interview questions and/or topics.
Please note that applications for other types of projects (e.g., those involving collaborative research with individuals from other institutions) may require additional documentation. Please see the Preparing Submissions page for more information.
► 9. What are common mistakes made that I can avoid to get my application approved faster?
- Submitting applications before all principal investigators have completed the CITI Training.
- Providing poorly written materials. Contact the Writing Center if you would like help with improving the quality of your application and additional paperwork.
- Writing consent forms in language which will not be understood by the target population.
- Submitting the IRB application as a blank document. Be sure that all materials are legible before sending.
- Missing documents, such as a sample of the survey you will be using, consent/assent forms, etc.
- Not including accurate contact information. NEVER use “Dr. Researcher” but rather include you and the IRB’s actual contact information in your documents.
- Not being proactive. If you are concerned with the amount of time that it is taking to get your application approved contact the IRB to ensure they received your application.
► 10. How do I know if my project is exempt, expedited or full board?
► 11. Do I need to go through the IRB process if my project is exempt?
► 12. Do I need to get consent from my participants if my project is exempt?
Yes, all research requires that participants be informed of their rights and the nature of the study. For more information about consent requirements, please refer to the WOU IRB website (https://wou.edu/irb) or contact an IRB member.
► 13. Can the IRB give approval once data collection has begun?
► 14. How do I renew my study?
All studies must be reviewed and approved every five years (annually for studies involving more than minimal risk). It is the responsibility of the principal investigator to be aware of when their study expires and submit a renewal request to the IRB at least 30 days prior to the study expiration date. When submitting a renewal request you must provide the IRB with;
- Your IRB approval number (as indicated in the approval letter)
- The complete title of your study
- Date of most recent IRB approval
- A brief protocol summary. Include in this section information regarding any deviations from the approved protocol since the last approval.
- A copy of the current informed consent document(s) (i.e., informed consent, parental permission, and children’s assent or waiver documents as appropriate).
- A brief status report including number of participants accrued, summary of unanticipated problems (e.g., withdrawal of subjects), and summary of any new information identified (e.g., risks or benefits) which may affect the willingness of current or future research participants to participate in the study.
- Evidence that the CITI training requirement is met for all listed on IRB application, if not already on file (including faculty sponsors).
► 15. How long can I conduct my approved study?
IRB approval lasts five years for studies involving only minimal risk and one year for studies involving more than minimal risk. The PI is responsible for informing the IRB when the study is complete, or applying for an extension. (See renewal instructions above)
► 16. What if I want to make a change to my previously approved study?
You must contact the IRB and provide them with;
- Your IRB approval number
- The complete title of your study
- Complete explanation of the changes you would like to make
- Any additional paperwork that is relevant to the changes you are requesting
► 17. If I am collaborating with researchers at external institutions, which IRB reviews my study?
► 18. Do I need IRB approval for research that will use secondary/archival data (i.e., data that someone else collected or that I collected for a different purpose)?
- Is it possible to identify any individual person in the data through any of the following means: personal information, context, or a key to any codes or pseudonyms even if you don’t possess the key?
- Answer: Yes, you need to submit an application to the IRB for review.
- I collected the data for a previous study, but now I want to use it to answer new research questions that are different from what the participants initially consented to.
- Answer: Yes; however, under acceptable circumstances, the IRB may issue a waiver that allows the repurposing of the data. Consult with your IRB.
- Does the data include participants who are/were prisoners, HIPAA-covered entities, or is it FDA-regulated research?
- Answer: Yes. You need IRB approval.
- I want to collect data that is publicly available, but before being made public, it was obtained illegally (stolen, hacked, accidentally released, etc.), and the individuals who the data is from had expected it to remain private.
- Answer: Yes. You need IRB approval.
Otherwise, you may not need IRB approval for your project. For more specific information and additional examples, see the Secondary/Archival Research section on the Forms, Guidance, and Other Resources page.
Faculty oversight of student research
► 1. Do I need to require my students to get IRB approval for class research projects? What is the responsibility of the WOU instructor with regard to student research?
► 2. What types of student research activities DO require direct review by the IRB?
► 3. What types of student research activities DO NOT require direct review by the IRB?
IRB approval is typically not required for a student research project involving human subjects when the primary objective is for the student researcher to learn research methods and procedures. Specifically, it is not necessary for the IRB to review these projects when the all of following conditions are met:
- Research involves minimal or no risk to participants; and
- Participants do not include members of vulnerable populations such as children and/or impaired adults; and
- Research findings are only to be distributed within the classroom and/or institutional setting (not outside of WOU).
Although research projects meeting the aforementioned conditions do not require IRB approval, instructors are expected to actively supervise student research projects and to educate their students about the ethical guidelines related to the protection of human subjects.
Yes and No. Yes, if human subjects are involved, the primary objective is the development of new knowledge (e.g., a thesis), and students wish to present and/or publish their research outside of the Academic Excellence Showcase. No, if the primary objective for the research was for the student researcher to learn research methods and procedures and the student only plans to present their research at the showcase. Additionally, such student research must meet all of the following conditions:
► 4. Are IRB applications required for students participating in the Academic Excellence Showcase?
Yes and No.
Yes, if human subjects are involved, the primary objective is the development of new knowledge (e.g., a thesis), and students wish to present and/or publish their research outside of the Academic Excellence Showcase.
No, if the primary objective for the research was for the student researcher to learn research methods and procedures and the student only plans to present their research at the showcase. Additionally, such student research must meet all of the following conditions: