INSTITUTIONAL REVIEW BOARD (IRB) APPLICATION
Application for the Review of Research
This form should be completed by any individual associated with California Southern University who is planning to conduct a research project. For any section that does not apply, please mark NA.
Submission Instructions: Doctoral Learners should email the completed IRB application to their Mentor/Chair for approval. The Mentor/Chair will then forward the application to the Dean of the appropriate school for review and forwarding to the IRB. Faculty who are doing research should email a completed application to their appropriate Dean for review and forwarding to the IRB. Non-faculty and others who are doing research should submit a completed application to the CAO for review and forwarding to the IRB.
The IRB meets the second and fourth Monday’s of every month and applications must be submitted to the IRB two weeks prior to this date for consideration by the full IRB.
Section I: Type of IRB Review
Category 1: Exempt Category 2: Expedited Review Category 3: Full Review
1. Name of Principal Investigator:
2. School: ☐Business ☐Education ☐Behavioral Science
3. Responsible Supervising Faculty Member:
4. Title of Project: _____________________________________________________________
Project Start Date: Planned End Date:
Section III Selection of Subjects
5. Age Range of Participants:
6. Estimated Number of Participants: _____
7. Type of Subject: Adult Protected Class Non-Student Minor College Student Other (Describe Protected Class or Other):_____________________
8. Yes No Will access to subjects be gained through a cooperating institution? If yes, indicate institution and attach copy of approval letter from that institution.
9. Yes No Will subjects receive payment or extra credit point compensation for participation? If yes, detail amount form and conditions of award.
10. Yes No Will the subjects be deceived, misled, or have information about the project withheld? If so, identify the information involved, justify the deception, and describe the debriefing plan.
Response to Reviewer Comments:
Section IV – Research Design, Protocols, Risk, Confidentiality and Consent Forms (Please attach applicable protocols such as surveys and other instruments to the IRB Application).
Directions: In a total of no more than 6 pages, please answer the following questions. Please be brief and concise in your responses to each of these questions. Failure to respond to any questions will cause significant delays.
Research Design and Protocol Description
11. Type of Study:
☐Theoretical ☐Qualitative ☐Quantitative ☐Mixed Methods
12. Research Question (s):
13. Describe the research problem (s):
14. Describe the aim and objectives:
15. Describe the significance of the proposed research:
16. Describe the Research Design Methodology (Theoretical, Qualitative, Quantitative, or Mixed Methods as well as protocols).
17. Describe how you will access the subjects and/or organizations for participation (Data Collection Procedures).
18. Describe participant selection criteria:
Risk, Benefits, Privacy and Confidentiality
19. Attach a copy of the consent form that will be used. If no consent form will be used, explain the procedures used to ensure that participation is voluntary/with permission. Note: This information is particularly important in determining that there is no actual or implied coercion to participate.
20. Describe the methods that will be used to ensure the confidentiality of all subjects and/or organizations identities and the safeguarding of data. Include how data will be handled after research is completed and the destruction of the data. Confidentiality of data is required.
21. Describe the risks to the subjects/organization and precautions that will be taken to minimize the risks to the participants. Risk goes beyond physical risk and includes risk to the subject’s dignity and self-respect as well as psychological, emotional, employment, legal, and/or behavioral risk or harm. (Note: there is always minimal risk(s) associated with a project).
22. Describe the benefits of the project to business and/or society. Also describe benefits to the subject, if any exist. The IRB must have sufficient information to make a determination that the benefits outweigh the risks of the project.
Response to Reviewer Comments:
Section V – Investigator Assurances
This protocol review form has been completed and typed. I am familiar with the ethical and legal guidelines and regulations (i.e. the Belmont Report, The Code of Federal Regulations Title 45 Part 46, and California Southern University Policy) and will adhere to them. Should material changes in procedure become advisable, I will submit them to the IRB for review prior to initiation the change. If any problems involving human subjects occur, I will immediately notify the IRB. I understand the IRB review must be conducted biennial and that continuation of the project beyond two year requires resubmission and review.
Principal Investigator Date
Supervising Faculty Mentor (if appropriate) Date
End of Application
California Southern University
Institutional Review Board
Date of Submission:
Date of Initial Review:
Determination of Review:
· Approved [Study meets requirements. Study meets criteria in 45 CFR 46.111 where applicable.]: You can collect data. Please see IRB approval below.
· Approved with Conditions: You cannot collect data. Minor modifications to procedures or forms must be made and approved before you can proceed. Please answer the reviewer’s questions and submit a revised application and supplemental form. If you are a student, please submit through your dissertation chair.
· Deferred: You cannot collect data. The reviewer has some questions about procedures, some procedures need to be changed, and/or several changes are needed to forms. Please answer the reviewer’s questions and submit a revised application and supplemental form. If you are a student, please submit through your doctoral project chair.
Please fill in and explain all of your changes in the “Responses to Reviewer Comments”. Please revise the original information in each section.
Please also revise the check boxes as needed, and include updated materials with your next submission. Please do not submit a partial application.
Approval from Chair, Institutional Review Board
The signature of the Chair of the Institutional Review Board, when affixed below, indicates that the activity identified in the enclosed application has been approved with the conditions and restrictions noted here.
Restrictions and Conditions: (please attach a note)
Chair, Institutional Review Board Date