Three people sit on a bench near a railroad track. Each of the people wears and orange vest and holds multiple clipboards and pens. A fourth person, who seems not to be affiliated with the other three is walking away from the bench, presumably after talking to one of the three seated people.

Office of Research Compliance updates procedures and materials

Many cups of water sit on a table. Someone is sitting in one of the chairs pulled up to the table.
Food taste tests, like this one for bottled water, are a Level 1 Research activity.

The Office of Research Compliance has refined administrative procedures for institutional review of human subjects research. There are now three levels of research, as described below.

  • Level 1 Research (formerly “exemption screening”) correlates to activities listed in one of the “exempt” categories in Federal regulations (45 CFR 46). These include:
    • Minimal risk surveys, interviews, or observations of public behavior with subjects over the age of 18.
    • Research with subjects under the age of 18 conducted in a normal classroom setting using materials collected as part of the normal curriculum.
    • Research with anonymous data or biospecimens that have already been collected, provided Miami researchers have not been involved in the design of the project or the collection of the data.
    • Food taste testing.

Download the Level 1 Research application form here. Guidance for completing the application form can be found here.

  • Level 2 Research correlates to activities that qualify for “expedited review” according to Federal regulations. Specifically, this is minimal risk research involving a vulnerable population or manipulated subjects. Review is conducted by a sub-committee of the Institutional Review Board (IRB).Download the Level 2 Research application form for general subjects here. Download the Level 2 Research application form for student (K-12 or post-secondary) subjects here.
  • Level 3 Research is that which a member of the Level 2 review IRB sub-committee has determined warrants further review. This research is subject to full IRB review and majority approval. No application form is required.

To aid researchers in complying with regulations and standards for ethical practice, the following consent templates are now available on the Research Compliance website:

  • Interviews
    • Formal — Use when meeting a subject at an agreed-upon location for an in-depth interview
    • Informal — Use when recruiting and interviewing at a public place, such as a city street or a zoo.
    • Skype/phone — Use when calling subjects on a member list or  when calling subjects who have responded to an online invitation.
  • Surveys
    • Online — Use when recruiting via email or online invitation, or when accessing an instrument in a computer lab.
    • Paper — Use when distributing a survey card to patrons or program participants.
  • Classrooms
    • Use of materials (FERPA) — Use when requesting to use assignments or grades for use in pedagogy research.
    • Observation — Use to request minor assent and parental consent.
  • Courtesy/debriefing card — Use to thank subjects and to provide contact information for post-participation follow-up.

Written by Jennifer Sutton, Associate Director of Research Compliance, Miami University.

Survey photo by Richard Masoner via Flickr. Bottled water taste test photo by tiarescott via Flickr. Both used under Creative Commons license.

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