The IRB application is used to provide information to the IRB, whose responsibility it is to ensure the university adheres to federal regulations in the protection of human participants in research. No recruitment or data can be collected until an application is approved by the IRB.
Embry-Riddle Training Requirement: Prior to applying, all investigators (researchers) must have completed CITI Training. Previous/prior training is good for three years. For further information, see Mandatory Training.
Before completing the IRB application form, you must know:
- The identity of all of the investigators who will be working on the project.
- Who will be recruited to participate and how they will be recruited.
- Where the research will be conducted.
- What data will be collected and what will happen to that data.
- How the research will be conducted.
- How the participants will be protected from emotional or physical harm.
Use the IRB Application Checklist to be sure you have everything you need before starting the online application.
Important: Listed below are common omissions and application problems that could cause a delay in your IRB review and approval.
Applicant Information
If the applicant is a student, a Faculty Advisor must be included. The Faculty Advisor listed receives a copy of the application and materials to review, makes comments and approves the project prior to forwarding on through the IRB review process.
Project Information
Type of Project: Select the type of project you are doing from the dropdown list provided. If you are using several different research methods, it may be helpful to contact the IRB Office for assistance in completing the application by emailing teri.gabriel@erau.edu.
Project Title: It should be unique to your project. It should be consistent with the focus of the project and why you are collecting data using human participants. The title should be consistent across all documents. Do not include the words "Capstone project" anywhere in the title or within the IRB application. A Capstone project is a project you do to achieve an academic goal. It is not a reason to do research using human participants.
Principal Investigator (PI): Is the primary researcher/investigator in charge of the project.
- Undergraduate Students: Cannot be a PI. If you are an undergraduate student, you must include your faculty advisor as PI. All correspondence concerning the IRB application will go through your faculty advisor, so he/she can confirm approval of the project.
- Graduate Students: May list your name as the PI, but you must list your faculty advisor under "List all Other Investigators." The IRB requires that all student IRB applications go through a faculty advisor to ensure he/she has approved the project prior to IRB review.
Degree Level of Principal Investigator: Refers to the level of degree the PI has attained. For students, the degree program you are working on. For faculty, the level of degree.
List all Other Investigators: Any and all individuals who are working on the project and/or interacting with the participant needs to be listed, and they must also have taken the required CITI Training.
Expected Beginning Date: A project cannot begin until IRB approval is obtained. Approval may take 2-8 weeks depending on the type of review (see Categories of Research).
The IRB Application’s 10 Questions
The answers to the questions need not be overly long, but they should be sufficiently detailed so that the IRB reviewer can accurately assess the risks and benefits associated with your study. IRB members have various types of experience and expertise but may not be an expert in the type of research you are undertaking. Therefore, construct your application so that an intelligent, nonexpert can understand your research project.
Important: Carefully proofread your application. This application is subject to federal review. It must not contain typos and grammatical errors.
- Background and Purpose
- How does the study contribute to existing knowledge?
- Spell out acronyms the first time they are used.
- Need not be overly long but long enough so that an "educated non-expert" can understand.
- Use consistent terminology.
- Design, Procedures and Methods: The IRB will need to know
- Describe what will be done in the study to collect the data (i.e., surveys, interviews).
- How the data collection method (survey, etc.) will be provided to the participant (i.e., through the Internet via email with a link attached, hand delivered, etc.).
- If video/audio recording, describe:
- How it is being recorded.
- What device will be used to record the data.
- The exact location of where the research is being conducted.
- If using an external organization, provide documentation of permission to use their facility.
- Time
- Enter the amount of time that will be asked of the participant.
- The amount of time must match what was entered on the consent form.
- Do not include the time needed for the participant to read the Informed Consent Form.
- Measures and Data to be Collected
- What data is being collected, what will it measure, and how will it be collected?
- The IRB must review anything that is provided to the participant including:
- Questionnaires
- Surveys
- Interview questions
- Do not include your master’s or doctoral thesis. All information must be included on the IRB application, and IRB reviewers will not read it.
- Participant Population and Recruitment Procedures
- Who will be recruited?
- How many participants do you hope to recruit?
- How will participants be recruited?
- The IRB must review any recruitment invitations, flyers, posters, emails or any other materials that will be provided to the participant.
- If you are recruiting participants through an online system, you must include the system and the verbiage you will use to do so.
- If you are recruiting participants at an airport, company or a branch of the military, you will need to obtain permission from the airport, company or branch of the military to conduct the research and provide the IRB with the approval document.
- For research using military personnel, written permission must be obtained from the applicable command. The written authorization should include reference to the non-existence of any conflicting military branch IRBs. Note: Some branches not only have branch-specific IRBs but also may have base or region IRBs as well.
- For research being conducted outside of the US:
- An entity similar to an IRB needs to review and approve the research prior to Embry-Riddle’s IRB, and
- Investigators must take an additional CITI Training module under the "Human Subjects: Researcher" basic course titled "International Research."
- Risks or Discomforts
- There are risks to all research even if the risks are no greater than what is experienced in daily life.
- The risks should be spelled out:
- Example: This study could cause motion sickness. Motion sickness can cause fatigue, dizziness and nausea.
- An explanation of how the risks will be mitigated to protect the participant must be included.
- Example: Should a participant experience the symptoms of motion sickness, the study will be discontinued and the participant will be provided a comfortable place to rest for at least 30 minutes.
- It is incumbent upon the researcher/investigator to demonstrate that every possible step has been taken to reduce risk to the participants.
- The risks on the IRB application must match what is written on the consent form. (Written to the IRB Reviewer on the IRB Application and to the participant on the consent form.)
- Benefits
- What are the benefits to the participant? If there are no benefits to the participant, this needs to be stated.
- What are the benefits to others (society)?
- The benefits on the IRB application must match what is written on the consent form. (Written to the IRB Reviewer on the IRB Application and to the participant on the consent form.)
- Note: Extra credit is considered an incentive and not a benefit.
- Informed Consent
- The consent document is the most important part of the process. It must be clear to the IRB.
- How informed consent will be obtained.
- Upload the informed consent document (see Example Informed Consent Forms).
- For more details, please see the Obtaining Participant Consent.
- It is not necessary to obtain a signature for survey research. However, there should be a place for the participant to indicate agreement (or disagreement) to participate (see Example Survey Research Informed Consent Form).
- Use of existing data does not require a consent form. However, permission from the source of the data is necessary, unless the data is publicly available.
- Confidentiality of Records/Data and Privacy
- If you are interacting with the participant in any way (interviews), the study is considered "Confidential," although information collected must remain anonymous.
- Explain how the participant’s information and privacy will be protected.
- Indicate what will happen to the data collected from participants who choose to "opt out" or stop participating during the research process.
- Will the data collected up to that point be destroyed?
- Or will a portion of it be used in your study?
- Indicate when the data will be destroyed. Stating that the data will be destroyed when the Capstone project is completed is not acceptable. A specific time period must be indicated.
- Example: Data will be destroyed three years after the completion of the research
- Economic Considerations/Incentives
- If you are providing "extra credit," alternative opportunities to achieve the same extra credit based on a comparable commitment of effort to that required for the proposed research activity must be offered to any student who prefers not to participate in the research.
- The amount of inducement to conduct research should be commensurate with what the participants are being asked to do; it should be enough to entice individuals to participate but not be so extravagant as to seem coercive.
After you have completed and uploaded all necessary documents, read the disclaimer at the bottom and enter your full name, then click the "Submit" button. If you are a student, the application and all materials will be sent to the Faculty Advisor listed on the application. Otherwise, the IRB Application and all materials are sent directly to the IRB Office to continue with the IRB review process.