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Instructions for Researchers 

The following types of research involving human subjects must be submitted for IRB review prior to data collection:

(1)    Research that is federally-funded, either via a federal discretionary grant program, 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; 

(2)    Student or faculty/UDRI personnel research yielding results that the researcher may want to present to an academic journal or similar professional publication; 

(3)    Student or faculty/UDRI personnel research yielding results that the researcher may want to present at an academic conference; and 

(4)    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 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 on the last Thursday of each month. All researchers will be notified by email when their proposal has been screened and assigned to a review category.

Each research proposal submitted to the IRB for review must include all of the following information:

  1. The standard application form. If you are applying for a renewal of an already approved protocol, complete the renewal form.
  2. A research question or hypothesis.
  3. A review of the relevant literature. The literature review should include coverage of the problem to be addressed, should provide support for the methods and instruments used in the research, and should demonstrate the project's potential impact on the knowledge base.
  4. An experimental or research design which will answer the research question or hypothesis. Because all research potentially places subjects at some level of risk, no improperly designed research can be ethically acceptable. If the design cannot answer the research question or hypothesis, either because of confounds or other design errors, then the potential gain in knowledge cannot outweigh the potential risk to the participant.
  5. The method for determining sample size, for selecting participants, and for communicating with participants. How will data be collected?
  6. How the data will be used to answer the research question or hypothesis. This should include a description of data analysis procedures to be used.
  7. Statement of anticipated risks to the physical and mental health, comfort, and privacy of experimental subjects.
  8. A description of measures that will be taken to minimize risks and to ensure confidentiality of sensitive personal data during and after the research.
  9. The text of any questionnaire, evaluative or diagnostic instrument, or debriefing protocol designed specifically for this research.
  10. The text of an informed consent form to be signed by each subject before participation.

        If your proposal involves data collection at another site, you must include documentation of approval to conduct research there. For example, if you are collecting data at a public school, you should include a letter of approval from the building principal. If your proposal involves collection of data at other universities, you must submit to those IRBs as well. In many cases, these IRBs will not require much, if you have been approved by the UD IRB; however, professional courtesy is expected. If you have questions about how to deal with this issue, contact Jon Nieberding, IRB Chair.

        When submitting research proposals for review, include a printed copy of the proposal and associated material and an electronic copy via email. A less desirable alternative is to provide all on a CD. All electronic files submitted should be scanned for viruses. Electronic files should be in Microsoft Word or PDF format. Complete and include a standard application form with your submissions.

       *Important note for students*: All student applications should 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 letter (emails are also acceptable) 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.

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Research eligible for expedited review and/or exemption

        Expedited review. 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. Typically, these are activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures specified in federal regulations.

  1. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, specifically 46.101(b)(4).  This listing refers only to research that is not exempt.)

  2. Collection of data from voice, video, digital, or image recordings made for research purposes

  3. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.

  4. Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

  5. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

The activities listed should not be deemed to be of minimal risk simply because they are included on this list.  Inclusion on the list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. In these cases, what constitutes minimal risk is defined by the IRB but is subject to discussion with the researcher(s) if requested.

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            Exempt from review. 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 federal Policy for Protection of Human Research Subjects. At the University of Dayton, the determination of exempt status is made by the IRB on an individual project basis. Restrictions outlined below apply and the research must fall into one or more of the following exemption categories as described in federal regulations [excerpt from 45 CFR 46.101(b)]:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures, or observation of public behavior, unless (1) information obtained is records in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

  3. Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

  4. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is records by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

  5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefits or service programs; (ii) procedures for obtaining benefits or services under these programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

 

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         Restrictions: An exemption cannot be designated for research involving the following:

The IRB makes the official determination as to whether or not a particular research design is exempt. The researcher cannot make this official determination. A researcher may have a compelling case for arguing that his/her research is exempt from the regulations and can present his/her case for exemption to the IRB.

Additional Training

Free, online training modules are available at www.citiprogram.org. Select "University of Dayton" from the drop box and sign up for a user name and password.

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