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About the IRB
What does the IRB need to review?
45 CFR 46 defines research as a "systematic investigation designed to contribute to generalizable knowledge." Human subject is defined as "an individual about whom an investigator conducting research obtains data through intervention or interaction, OR identifiable private information." Investigators must submit an application for all projects that involve "research" and "human subject" per the federal definition.
The IRB at American University also requires review of projects that may not meet the definition of research under two other circumstances.
- If the study involves children, prisoners, or mentally disabled participants or
- If the study involves more than minimal risk to the participants.
Use our Determination Tool if you are unsure if you need to submit an application or not. Applications should be submitted at least one month prior to the planned start of the research.
Please review our page detailing activities that do not require review for more information on which classroom projects.In general, if you are collecting new information and:
- That information will be collected and stored without direct identifiers;
- You will not be sharing the results outside of your class;
- You will not be using individuals under the age of 18 in your sample;
- You will not be asking any sensitive questions; and
- You will not be including any “vulnerable populations” in your study
In general, if you are analyzing pre-existing data and your analysis file has no direct identifiers and the possibility of passive identification has been minimized, a project conducted for a class will not require the IRB review.
Perhaps. The number of participants does not determine whether review is needed. The determining factor is whether or not human subjects are involved in research per the federal definition.
There is no allowance for retroactive approval in the federal regulations. There are conditions where the IRB can approve continued analysis of data collected for non-research purposes (eg: data collected for an undergraduate classroom assignment). Willful avoidance of IRB review can lead to a noncompliance investigation or a complaint of scholarly misconduct.
IRB Submissions and Review
The Research Compliance Office will triage a project into one of the four categories:
- Not human subjects research—The project is not research on human subjects (per the federal definitions above) and thus does not need to be reviewed by the Research Compliance Office/the IRB.
- Exempt human subjects research—The project involves research on human subjects per the federal definition, but falls into one of the exemption categories listed in the regulations.
- Human subjects research subject to expedited review—The project involves research on human subjects and requires review. However, the project does not require review by the full IRB (likely because it poses no more than minimal risk to research participants).
- Human subjects research subject to full IRB review—The project involves research on human subjects and must be reviewed by the full IRB.
The review processes time will vary based on several factors. The quality of the application, complexity of research methods, risk to participants, and the load of protocols pending review can all lead to longer approval times.
The IRB has monthly scheduled protocol review meetings. Protocols requiring full board review must be submitted in Cayuse IRB and certified by the faculty Principal Investigator (PI) two weeks prior to a posted meeting in order to meet the deadline for a given meeting.
All complete applications will receive an initial response with feedback from the IRB within two weeks of certification in Cayuse IRB.
The following is a description of the types of attachments you should include. Remember, the attachments will change depending on the type of project that you are doing:
- Proposed Consent Form (See Template Consent and Consent Guidelines)– All instructional language removed, written at the appropriate reading level for participants
- Proposed Assent Form (If minors are involved) – Written at the appropriate reading level for the age group (Contact the Research Compliance Office for a sample of a 6th grade Assent Form)
- Instrumentation – All surveys, questionnaires, standardized assessment tools, interview questions, focus group questions/prompts or other instruments of data collection
- Recruitment Materials – Letters to potential participants, advertisements, flyers, listserv postings, emails, brochures, telephone scripts, presentation scripts, etc.
- Debriefing Form – If the study proposes to use deception or incomplete information to participants
- Supplemental application forms as appropriate
- A description of the study itself and the study population
- Approximately how long participating in the activity will take
- How the data be used
- A statement that the activity is voluntary and that subjects may withdraw at any time
- A statement of the risks and benefits of participation
- PI (and other research team members as appropriate) contact information
- The Research Compliance Office contact information
- A statement confirming that the individual gives their consent to participate
- A signature line (unless documentation of informed consent is being waived)
For research involving minors, the consent form must be signed by the parent or guardian of the minor, and the minor should (when possible or appropriate) sign a separate assent form. The assent form does not have to include all of the elements of an informed consent document, but it must give the participant enough information about the project that he or she can make an informed choice about whether to participate. The assent form should also be written in a way appropriate to the age of the participant.
The submission form will prompt you for necessary components if you will be working with minors.
After IRB Approval
Once a project has been approved, you must communicate to the Research Compliance Office in the following circumstances:
- If you make any changes to the protocol or the instrumentation or recruitment materials associated with the project (using the Modification submission form in Cayuse IRB). You must also use the Modification submission form to alert the Research Compliance Office/the IRB to changes in funding source or of changes in research personnel.
- If a research participant experiences an unexpected problem related to the research activity (using the Incident Report submission form)
- When you have completed the project and are no longer recruiting participants or doing analysis (using the Closure Application submission form)
- If your project was reviewed via the full IRB board or through the expedited review procedure: you must complete the continuation/renewal submission form at least annually updating the Research Compliance Office and the IRB of the progress you have made with your project. the Cayuse IRB system will send reminders about this requirement via email.
There are specific circumstances in which the Research Compliance Office must be informed of research related problems. Specifically, if:
- A problem occurs that is directly related to the research activity; AND
- The problem was not anticipated by the research team and thus not listed in the protocol document reviewed by the Research Compliance Office/the IRB or the consent form given to participants; OR
- The problem experienced was listed in the protocol document and the consent form, but the magnitude/severity that a research participant experienced was not anticipated then the Incident Report submission must be entered into Cayuse IRB promptly. Depending on the funding source of the project, a formal report of the incident may need to be submitted to a federal funding agency.
External Researchers and Collaborations
The Research Compliance Office handles all requests from external researchers. The IRB at AU will not review external researcher's protocols. External researchers should provide to the Research Compliance office
- A memorandum of support from an AU staff or faculty member who will act as a sponsor and provide access to the campus and AU population
- A copy of the research protocol that has been approved by another institution's with an FWA number
- If you will be collaborating with AU affiliated faculty, staff, or students (where they are also engaged in the research,) they must submit the appropriate applications for approval before the research can begin.
Each collaboration is different, and other institutions each have unique requirements. Please check with the Research Compliance Office to discuss your circumstance. Generally, a reliance agreement will be drafted and signed by officials of each institution's IRB.