1. What is an IRB?
2. What is the purpose of the IRB?
The purpose of an IRB review is to determine whether participants in a research study will be placed at physical or mental risk and, what risk is involved, and to certify that the following conditions have been met.
- Risks to participants are minimized.
- Participants in the study (and their guardians) are fully aware of the risks and that individuals may withdraw from the study at any time without any form of penalty.
- Research activities, designed to yield fruitful results for the benefit of individual participants or society in general, may incur risks to the participants provided such risks are outweighed by the benefit to be derived from those activities.
- Risks to the participants are so outweighed by the sum of the benefits to the participants and the importance of the knowledge to be gained as to warrant a decision to allow the participants to accept these risks voluntarily.
- The degree of risk involved in any activity should never exceed the humanitarian importance of the problems to be solved by that activity. Likewise, compensation to volunteers should never be such as to constitute an undue inducement to the participants.
- Rights and welfare of any such participants will be adequately protected.
- Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with the provisions of Westcliff University IRB Guide.
- Stored data or other information obtained for a different purpose is used within the scope of the original consent.
3. How do I know if I need IRB approval to conduct research?
IRB approval is needed if you are conducting Human Research. Human Research is any activity with the primary intent of securing information from or about human participants in a systematic investigation for the purpose of contributing to the generalized body of knowledge.
4. When should I submit an application?
Dissertation students should submit an application after a successful proposal defense. Refer to your faculty chair for assistance. The application must be submitted, and certification must be granted prior to participant recruitment and data collection begins.
5. Which application should I submit?
The principal investigator, in consultation with his or her faculty research supervisor, assesses the risk-to-benefit ratio of the research and completes an IRB application at the appropriate level (exempt, expedited, or full review) based on the following descriptions.
The exempt review is for research projects with minimal risk to human participants. Research projects for which there is no human participant interaction undergo this limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information.
The expedited review process is used to review certain categories of research involving minimal risk to human participants. Any research in which human participant interaction is anticipated falls under this level unless risk to participants is more than minimal.
A full IRB review is required for research projects that entail sensitive or risky research topics or methodologies or involve vulnerable participants (i.e., vulnerability to coercion and undue influence) in recognition that coercion or undue influence refers to the ability to make an informed decision about participating in research. Vulnerable participants (e.g., children, individuals with impaired decision-making ability, prisoners, and persons under court supervision) require full IRB review in a full board meeting.
6. Does the IRB approve research?
7. What is the timeline for application approval?
All approval timelines are based on the date the application is received.
8. What happens if an application is not approved?
Exempt and Expedited applications may be revised. Full applications may be appealed. If the appeal is not granted the research will be advised to revise the research design and resubmit the application.
9. How long does the IRB certification last?
IRB certification is typically valid for one year. It is the responsibility of the principal investigator to request an extension of certification in a timely manner.
10. I am just doing a simple survey. Do I need IRB approval?
Yes, IRB will need to determine the level of identifiable data that will be collected from participants and the sensitivity of the questions that will be asked.
11. I am just doing analytics on a publicly available database. Do I need IRB approval?
12. Do classroom research projects conducted by Westcliff students need IRB approval?
Most class assignments do not fall within the definition of research, because the focus is on gathering information for journalistic/educational purposes as opposed to collecting data for a research project that may lead to research publication or presentation.
On the contrary, some research conducted by students as part of their class assignments as well as class research conducted by professors in their work with students may be subject to IRB review.
The course instructor has the responsibility for ensuring that the student is educated on the general principles of research ethics, human participant protection, and investigator training. Faculty and students may contact the IRB to discuss the assignment and obtain assistance.
13. My research will be done in another country. Do I need IRB approval?
Yes, however in addition to Westcliff University IRB approval, in cases where international research will be conducted, the guidelines established by the OHRP at the U.S. Department of Health and Human Services are also followed. The guidelines can be found at: http://www.hhs.gov/ohrp/international/index.html.
14. I need to conduct a pilot study. Do I need IRB approval?
Each principal investigator proposing a research project involving human data, large or small, must request IRB review.
15. When may I begin recruiting my study participants?
Participant recruitment must not begin until the study has received IRB approval. All plans for recruitment and recruitment documents must be submitted with the application. Recruiting participants prior to approval may result in disapproval of the application and new participants will need to be determined.
16. When may I begin data collection?
Data collection must not begin prior to IRB approval. Data collection plans and all instrumentation must be submitted with the application. Data collected prior to approval may result in disapproval of the application and new data will need to be collected.
17. Can the IRB approve a project retroactively?
No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data were collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.
18. What about training requirements?
At Westcliff University, all investigators and research staff are required to successfully complete the CITI Program training and the IRB application training. The CITI program training must be updated at least once every three years. A completion certificate for each CITI program completed course is required from the principal investigator and any committee members or research advisors when submitting an application for review. The following CITI program courses are required:
Social and Behavioral Responsible Conduct of Research
Social – Behavioral – Educational Researchers
Students and Instructors
19. If my research plan changes, what should I do?
If any changes to the research plan the principal investigator must complete the Amendment to Original IRB Certification (Appendix J) and submit it prior to implementing any changes to the research plan.
20. Can I recruit Westcliff faculty or staff for participation in my research?
Westcliff University faculty, staff, and students may not be recruited for participation in dissertation research.
21. If my application is disapproved, is there an appeals process?
If a principal investigator wishes to contest an IRB decision, he or she may make a written request to the IRB chairperson to reconsider. No further appeal is available. No faculty member or administrator may conduct or approve a research project involving human participants that has not been certified by the IRB as in compliance with applicable ethical and legal standards.