How to apply
All Human Subject Research must be approved by the IRB. Any questions can be directed to email@example.com.
What types of human research must be submitted for IRB review prior to data collection?
- Human research that is federally-funded, either through direct federal agency funding, or via state-level “flow through” funding (via federal block grants), or a commercial entity receiving government funding (via subcontract or service agreement);
- Student, faculty, and staff research yielding results that the researcher may want to submit to an academic journal or similar professional publication, or present at an academic or technical conference; and
- Student research yielding results that the researcher may want to use later as part of his/her honor’s or master’s thesis or doctoral dissertation (e.g., pilot studies, instrument validation procedures, etc.).
As a general rule, if in doubt, it is better to seek IRB approval as more journals are asking for documentation of IRB approval before accepting manuscripts for publication.
**IMPORTANT NOTE FOR STUDENTS** All student applications must be accompanied by a statement from your faculty sponsor verifying that they have reviewed the proposal and attest to its scientific validity. It is important for students to work closely with their faculty advisors in developing their research methods so that risk is minimized and the application and review process go smoothly.
Does my project qualify as “human research”?
Federal regulations 45CFR46.102(f) define a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information. Some common examples of human research include surveys, interviews, health information collection/analysis, physical performance tests, aptitude tests, classroom methods, and psychological tests.
What should I do if I am not sure if my project is human research?
Contact the firstname.lastname@example.org with a brief paragraph describing your study and ask for a determination.
How do I know if my research qualifies as EXEMPT research?
Only the IRB can make a final determination on whether your project is exempt. However, you can use the same guidance the IRB uses to determine which application form to use:
Exempt research is a subset of research involving human subjects that falls within a short list of categories determined by federal regulations as “exempt” from continuing oversight by the IRB. Restrictions apply and the research must fall into one or more of the exemption categories as described in federal regulations [excerpt from 45 CFR 46.101(b), see exemptions (b)(1) through (b)(6)]:
Restrictions apply to exemption determinations for research with children, prisoners, pregnant women, and other vulnerable populations. The IRB must make the official determination as to whether or not a particular research design is exempt. The researcher cannot make this official determination. Please see the FORMS page for the exempt application forms. If you are not sure which form to use, please contact us at email@example.com.
If my project does not qualify for an exemption, it is considered NON-EXEMPT research. How do I know if my project qualifies for “expedited review”, or if it must go to the full IRB for committee review?
Under federal regulations certain types of non-exempt research may qualify for an ‘expedited’ review, meaning that full committee review is not required, and one or more IRB members will be assigned the review at the discretion of the IRB Chair. Typically, these are activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures specified in federal regulations. The expedited review process is described in the federal regulations at:
The federal regulations describe 9 categories of research that are eligible for EXPEDITED REVIEW. The research categories (1 through 9) eligible for expedited review can be found at:
If you feel that your research qualifies for an expedited review, please note this in your e-mail application and refer to the relevant specific research category (1 through 9). The request will be reviewed by the IRB Chair and you will be notified of the outcome.
What happens if my project is not eligible for exemption and not eligible for an expedited review?
Any research that does not qualify for exemption or expedited review must go to the full IRB committee for review and approval. Please see below for details on this process. If you would like to adjust your research methods to qualify for exemption or expedited review, the IRB can help you with those adjustments. Please contact us at firstname.lastname@example.org.
Is there a deadline for applications to be reviewed?
Only applications requiring full committee review have a timeline. Such studies are non-exempt and do not qualify for expedited review. Such studies carry greater than minimal risk and should be submitted with all appropriate accompanying documentation by the first of the month. Applications that require full committee review will be disseminated to committee members for review, and will be discussed at the full committee meeting held during the last week of each month. This full committee review process can last 45 days or more, depending on the level of risk to the participants. We encourage you to contact us during your experimental design phase to discuss ways to minimize risk, which will ease the approval process.
Research studies that qualify for an EXEMPTION or that qualify for EXPEDITED REVIEW are reviewed on a rolling basis and can be submitted at any time to email@example.com. Such reviews can take 1 to 30 days, depending on caseload. If you have any questions on application review turnaround time, please e-mail firstname.lastname@example.org for an estimate. Please note that the timeliness of application review depends upon timely submission of all required documents to the IRB. For a list of required documents, please see the FORMS page.
What should I do if I want to conduct research at another college or university?
You should contact the IRB on that campus for guidance on how to get your study approved. The University of Dayton’s IRB is happy to collaborate with other IRBs to determine which campus should maintain oversight of such research. Regardless of which IRB has oversight of your project, you must contact UD’s IRB to let us know you are conducting human research.
How do I apply for Renewal of Approval of a study that has an IRB approval that will expire soon?
All approved non-exempt research protocols are under “continuing review” by the IRB. This means the IRB retains oversight of the study until the study is officially closed. The IRB can request study updates or make changes to a study’s protocol, if necessary. A researcher with a non-exempt study will receive an approval that has an expiration date. It is the researcher’s responsibility to apply for continuing approval prior to the expiration date of their current approval. It is against federal regulations to continue human research once the IRB approval has expired. If your IRB approval has expired and you have not completed a study closure report, please contact the IRB immediately for resolution (IRB@udayton,edu).
If you are applying for a renewal of an already approved protocol, see the FORMS page for the Request for Renewal application form. If you plan to close your study soon, see the FORMS page for the Closure of Study form to report the closure to the IRB.
What do I need to do if I want to use a drawing or raffle as an incentive to participate in my study?
State law and University policies require you to follow the IRB Guidance on the Use of Drawings if you plan to use a drawing or raffle in your study. Please contact email@example.com if you have any questions.
If I want to offer compensation or a financial incentive to people to participate in my study, how do I go about this?
All applications should be submitted electronically to irb@ udayton.edu. Hard copies of applications are not accepted. All files should be in Microsoft Word or PDF format.
All QUESTIONS should be directed to: Mary Connolly, Ph.D., IRB Chair, at firstname.lastname@example.org;
Phone: (937) 229-3493.