Please fill out all sections completely and accurately by adding the requested information. Notes and guidelines for preparing this application are in RED TEXT below or next to each question. PLEASE DELETE AND REPLACE the text in red before submitting your application.
After completing this document, save a PDF copy using the following naming convention:
IRB_Application_[LAST NAME]_[FIRST NAME]
(example: IRB_Application_Smith_Sawyer.pdf)
Prepare any appendices required (See “Preparing Appendices and Supporting Documents”) and add them to the saved PDF.
Support instructions for combining multiple files into a single PDF can be found here.
Completed Applications and Appendices should be uploaded to this form. DO NOT email this to the IRB or the Office of Research unless specifically instructed to do so. Incomplete or mislabeled applications or forms will require resubmission and will delay review time.
1. General Information
You will be asked to provide the following information:
• Project Title
• Principal Investigator First Name
• Principal Investigator Last Name
• PI's Phone Number
• PI's Email
• Co-Investigator(s) Name(s)
• Academic Department or Program
Course (If Applicable)
• Funding Agency (If Applicable)
• Date of Project Initiation
• Date
• Type of Review: Noted in Email Correspondence from the IRB Decision Tree
-Limited IRB Review (Only Complete Sections 1 and 10)
-Full IRB Review (Complete all Sections)
2. Abstract
Provide no more than a one-page research abstract briefly stating the problem, the research hypothesis, and the importance of the research.
3. Objectives of Proposed Project
What is the goal of the research (Primary Objective)? Are there any steps that need to be accomplished (Secondary Objectives) leading up to the Primary Objective?
4. Background
Some projects may benefit from having additional context on past research or past methodology. Briefly describe existing data, previous experience with procedures and practices, and any other relevant information to justify the research. This is particularly useful if risks are anticipated, but have been explored in past research.
5. Description of Human Participants
Information about potential participants is key information effecting how the IRB evaluates the ethical considerations of a research project. Please be as detailed as possible on numbers, criteria for participant selection, mechanisms by which you intend to recruit these participants, and any recruitment incentives.
If you plan to use prisoners as your research population, you must indicate that clearly here. You must also indicate clearly if your research involves the recruitment or use of minors (persons under the age of 18) or a vulnerable adult population (the elderly, some adults with disabilities or mental health issues) where you may need permission of a parent/guardian or a Legally Authorized Representative.
Note that in some research designs (e.g., naturalistic observation, ethnography) it may be impossible to specify exactly who the participants will be. In these cases it is appropriate to give a more general description (e.g., people who will interact with a librarian at the circulation desk).
6. Summary of Research and Data Gathering Procedures
Include a detailed explanation of the procedure you will follow for collecting data and interactions with participants. Provide a description in language that someone who is not an expert in your field could understand. Include a detailed explanation of the procedure you will follow in collecting data and interacting with participants. The IRB should clearly understand the method you will utilize and how the data will be recorded/collected.
7. Location of Project
Provide a brief statement of where the research project will take place. For some research projects a description of that location may be important (e.g., the location of the project influences who participates in the project).
8. Confidentiality Safeguards
Describe whether data are anonymous or if they are confidential; if they are confidential, describes steps taken to protect participant confidentiality.
If participants will be anonymous state that here; anonymous means that it is impossible to identify any particular individual’s data. Signed consent forms must be collected and stored separately from data to ensure anonymity.
If the participants will not be anonymous, describe how the confidentiality of the participants’ responses will be maintained. If confidentiality cannot be safeguarded, please explain. If responses are to be audio or video recorded, this must be clearly described and how those recordings will be gathered, stored, and destroyed should be described.
If participants will not be anonymized, nor will their identity be kept confidential, please explain why this is necessary for your research design.
9. Description and Assessment of Any Potential Risks
Assess the likelihood and seriousness of any potential risks—physical, psychological, social, legal, or other—and describe the procedures that will be used to minimize the risks that have been identified.
If your methodology involves potential risks, describe alternative methods, if any, that were considered and why they will not be used.
10. Description of Consent Procedures
Describe the consent process and debriefing procedures used in your research. Include how and where informed consent will be obtained. Take care to make sure the procedures you describe align with any consent forms you attach in the appendix.
If the researcher wants to request a waiver of documented consent or a waiver of consent entirely, justification for this wavier must be clearly stated.
Limited Review Applicants MUST specifically provide the following:
• A general description of the types of research that may be conducted with the identifiable private information. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
• A description of the identifiable private information that might be used in research, whether sharing of identifiable private information might occur, and the types of institutions or researchers that might conduct research with the identifiable private information;
• A description of the period of time that the identifiable private information or may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information may be used for research purposes (which period of time could be indefinite);
• Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
• Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
• An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of research-related harm.
11. Description of the Potential Benefits
Describe the benefits to the individual participant, investigator(s), and to society in general which may result from this research. The benefit of the research is weighed against the risks of the research to determine a cost-benefit assessment of the project.