How to apply
Instructions for researchers
ALL Human Subject Research must be approved by the IRB.
The following types of research involving human subjects must be submitted for IRB review prior to data collection:
- Research that is federally-funded, either through agency funding, or via state-level “flow through” funding (i.e. state programs that are funded via federal block grants) or a commercial entity receiving government funding that is passed on to UD via subcontract or service agreement;
- Student or faculty/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 master’s thesis or doctoral dissertation research (e.g. pilot studies, instrument validation procedures, etc.).
Reviews and Deadlines - Deadlines are the first of each month.
All proposals requiring full committee review received after the first of the month will be held until the next month. Once received, all proposals will be screened to determine whether or not they can be expedited and/or exempted*, or whether or not they will require full committee review. Those that require full committee review will be disseminated to committee members for review, and will be discussed at the full committee meeting held during last week of each month.
Each research proposal submitted to the IRB for review must include all of the following information:
- The Non-Exempt Application. If you are applying for a renewal of an already approved protocol, complete the Request for Renewal. If you believe your research qualifies for exemption (see below**), please use the Exempt Application.
- The text of all recruiting materials to be used.
- The text of any questionnaire, evaluative or diagnostic instrument, or debriefing protocol designed specifically for this research.
- The text of an informed consent form to be signed by each subject before participation. (see Forms page)
- Documentation of faculty approval** (only applies to student research; sent by faculty advisor directly to IRB@notes.udayton.edu)
- Documentation of off-site approvals, if data collection will occur off-campus. (sent by agency administrator directly to IRB@notes.udayton.edu).
- If data collection will occur on another college campus, you must also seek approval from that institution’s IRB.
THE IRB CANNOT REVIEW APPLICATIONS UNLESS ALL OF THE ABOVE HAVE BEEN SUBMITTED.
All applications should be submitted electronically to firstname.lastname@example.org. Hard copies of applications are not accepted. All files should be in Microsoft Word or PDF format.
**IMPORTANT NOTE FOR STUDENTS: All student applications must be accompanied by a statement from your faculty sponsor verifying that the faculty member has reviewed the proposal and attests to its scientific validity. In the case of theses or dissertations, this email should come from the Chair of the committee. In other cases, the statement should come from your faculty advisor or the professor for whom the project is being completed.
* REQUEST FOR EXPEDITED REVIEW and EXEMPTION DETERMINATIONS
Under federal regulations certain types of research may qualify for an ‘expedited’ review, meaning that full committee review is not required, at the discretion of the IRB Chair. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.110
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 federal regulations describing 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.
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. At the University of Dayton, the determination of exempt status must be made by the IRB on an individual project basis. 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)]:
Restrictions apply to exemption determinations for research with children, prisoners, pregnant women, and other vulnerable populations (including students). The IRB makes the official determination as to whether or not a particular research design is exempt. The researcher cannot make this official determination. The researcher should complete the Exempt Application, noting which exemption category is relevant (Category 1 through 5).