Research Involving Human Subjects

The purpose of this page is to familiarize the Regis Community with the review policies of the Regis IRB so that individuals will have a better understanding of the types of research involving human subjects that need IRB approval. For approval purposes, there are three types of research activities involving human subjects: projects that are exempt from review, projects that qualify for an expedited review process (by chairperson) and projects that require a full review of the entire IRB. Examples of research exempt from the approval processes of the IRB follow:

1. Research conducted in an educational setting involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) 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 confidentiality is not protected and any exposure of the subjects' responses outside the research could 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 collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

4. Research and demonstration projects designed to study or evaluate public benefit or service programs.

5. Taste and food quality evaluation and consumer acceptance studies.

The IRB may use the expedited review process if the proposed research involves no more than minimal risk. A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Please Note: Even if your project falls into a category above designated as exempt, you still need to submit an IRB form to the IRB committee. The committee decides the status of an IRB, exempt, expedited or full board. All research or projects being done that involve the use of human subjects must submit an IRB application.

One last note of importance: There are additional considerations when children are used as subjects in research projects. If children are involved in your research (or if you have any other questions), please call the Director for Academic Grants, Bud May (x4206) emay@regis.edu

In order to receive an application form for IRB approval, please contact Laura Padgett at 303-964-3616, or e-mail her at lpadgett@regis.edu

The following guidelines provide an example of material you may wish to include in your informed consent. Some of these items may apply to your project and some may not.
Checklist for Informed Consent

The following document is one example of an informed consent and there are others. Please contact Bud May if you feel you would like to see some other examples of informed consent documents for your particular project.
Informed Consent Example 1 - Health and Biological Sciences

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