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All institutions that receive federal funding for research are required to comply with certain regulations regarding the treatment of people in research activities. These regulations can be found at 45 CFR 46. In order to comply with these regulations, research activities at American University involving humans must undergo some level of ethical review by the Research Compliance Office or the IRB.
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. Applications should be submitted at least one month prior to the planned start of the research.
The Research Compliance Office will triage a project into one of the four categories:
1. 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.
2. 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.
3. 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).
4. Human subjects research subject to full IRB review—The project involves research on human subjects and must be reviewed by the full IRB.
You may discuss your proposed project with the Research Compliance Office, or the IRB member associated with your college or department.
Meetings for the IRB are held once a month. See the IRB meeting schedule for IRB meetings for protocols requiring full board review. For review at a full board meeting, you must submit your completed protocol by the listed deadline (approximately three weeks prior to the board meeting).
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 received in the Research Compliance Office by the due date listed on the IRB meeting schedule in order to meet the deadline for a given meeting.
All complete applications will receive an initial response within two weeks of receipt by the Research Compliance Office.
An email will be sent to the principal investigator and the student researchers, if appropriate, regarding the status of the protocol after it has been reviewed initially. The IRB can issue an approval, a request for minor revisions, a tabling of the protocol, or a disapproval of the protocol.
Yes, exemption is research with human subjects that fits one of six categories in the federal regulations. Only the IRB or Research Compliance Office may determine if a protocol qualifies for exemption. To apply for exemption, submit a Request for Exemption application before your work can begin.
After you have submitted your application to the Research Compliance Office and the staff has had a chance to review it, someone will let you know if your project requires full board review. You may contact the Research Compliance Office staff at any time before you submit an application to discuss your project and understand beforehand how the Research Compliance Office will triage your project. If you know you need a project reviewed by a certain time, it is best to check the IRB meeting schedule and make sure that you submit a completed application prior to the submission deadline for the meeting date that best suits your needs.
No, your project will not be reviewed immediately. IRB members need time to review materials before they meet to discuss specific projects. We have a strict policy that only projects submitted by a deadline listed on the IRB meeting schedule page will be reviewed at the corresponding meeting.
The Determination Form is primarily used to help researchers decide if their project will not require review by the IRB. You need only submit this form if you would like a letter from the Research Compliance Office indicating that your project is not human subjects research (typically either for a sponsor or for an eventual journal publication). Any questions may be directed to an the Research Compliance Office compliance specialist.
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, today@AU postings, telephone scripts, presentation scripts, etc.
- Debriefing Form – If the study proposes to use deception or incomplete information to participants
- Supplemental application forms as appropriate
Yes. All informed consent documents must include:
1.A description of the study itself and the study population
2. Approximately how long participating in the activity will take
3. How the data be used
4. A statement that the activity is voluntary and that subjects may withdraw at any time
5. A statement of the risks and benefits of participation
6. PI (and other research team members as appropriate) contact information
7. The Research Compliance Office contact information
8. A statement confirming that the individual gives their consent to participate
9. A signature line (unless documentation of informed consent is being waived)Additional information is required in specific circumstances. Please review our informed consent guidelines and template for more information.
No. On the human subjects application, there is a section where one may apply for a “waiver of documentation of informed consent.” In certain minimal risk circumstances where it would either be impractical to collect signatures or the only record linking an individual to his or her responses would be the signature on the consent form, the Research Compliance Office/the IRB will waive the requirement for signature. Typically, waivers are granted for electronic surveys. If you do not specifically request a waiver of documentation of informed consent, you are required to obtain signature on the consent form of each participant of a project.
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.
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 Request form). You must also use the amendment form to alert the Research Compliance Office/the IRB to changes in funding source.
- If a research participant experiences an unexpected problem related to the research activity (using the Unanticipated Problem Report form)
- When you have completed the project and are no longer recruiting participants or doing analysis (using the Continuation/ Termination request form) If your project was reviewed via the full IRB board or through the expedited review procedure: you must complete the continuing review form at least annually updating the Research Compliance Office and the IRB of the progress you have made with your project. the Research Compliance Office will send reminders about this requirement via email.
Students may be listed as a PI, but a responsible faculty member must endorse the application before the IRB can begin review of a protocol. Faculty advisors should email their endorsement to firstname.lastname@example.org using the same study title as listed in the application. Faculty advisors will be included in all communications with student investigators.
Please review our Classroom Projects SOP for more information on which classroom projects require IRB review and which do not.
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,
then a project conducted for a class will not require the Research Compliance Office/IRB review. 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 Research Compliance Office/IRB review.
The Research Compliance Office has not exempted specific disciplines from undergoing ethical review. In any discipline, if a project does not meet the definition of research or the definition of human subjects, it is not required to be reviewed by this office.
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 Unanticipated Problem Report must be filled out and submitted to the Research Compliance Office 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.
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.
All application forms found on the IRB website have been tested and verified to work across multiple platforms. Forms are dynamic .pdf files which will require Adobe Reader to operate properly. The following steps should allow you to open the forms and save your progress.
- The forms have not been tested nor verified on tablets or smartphones -- Use a computer to complete the forms.
- Download the newest version of the free Adobe Reader software.
- Save the application form you wish to use to your computer in a location that you will easily locate it.
- Open the Adobe Reader software.
- Open the form file from within Adobe Reader.
- Do not attempt to open the form from a link within your web browser.
If you still have difficulty using the form, please contact the Research Compliance Office.
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 (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.