Human subjects research training
General guidelines for submitting a proposal
How to determine what category a submitted proposal is?
Classroom Based Student Research Projects
Submitting a category 1 proposal
Submitting a category 2 proposal
Submitting a category 3 proposal
Instructions for creating a consent form
Modifications and Amendments to protocols
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Institutional Review Board
Proposal Categories
Review the following guidelines to determine which of the three categories your proposal falls in. The method for review of your proposal depends upon the category. The Categories are 1 (exempt review), 2 (expedited), and 3 (requires full review by the IRB Board). You the researcher, and if appropriate your faculty advisor, makes the initial determination of the proposal's review category. The IRB makes the final decision. The IRB may require full review of any research submitted under either of the first two categories, or of any research previously approved under expedited review (if you seek approval beyond the initial 12 month approval period). The researcher can always request a higher level of review than that required if so desired.
The review categories are:
Category 1 (Exempt Review) - your proposal fits this category if the research presents no possible risk to subjects 18 years of age and older and is one of the following activities:
- anonymous, mailed (postal or email) survey on innocuous topics
- anonymous, non-interactive non-participating observation of public behavior
- secondary analysis of existing data (see definition in attached appendix).
Category 2 (Expedited Review) - your proposal fits this category if the research presents no more than minimal risk to subjects and is one of the following activities:
- research on educational curricula, records, or teaching methods involving normal educational practices
- research involving the use of educational tests if information taken from these sources is recorded in such a manner that subjects cannot be identified
- research on individual or group behavior of normal adults where there is no psychological intervention, physiological intervention or deception
- interviews and non-mailed surveys on non-sensitive topics
- minor changes in previously approved research (see appendix)
- continuations of approval for previously approved no-risk research with no more than minor changes in procedures (see appendix).
- research conducted on the Internet on non-sensitive topics (see appendix).
Category 3 (Full Review) - your proposal fits this category if the research has the potential for harming participants, violates their rights, or requires special protections for participants. Such research includes activities such as:
- research which might put participants at risk
- research involving psychological or physiological intervention
- non-curricular, interactive research in schools
- interviews or surveys on sensitive topics (e.g. sexual activity, alcohol or drug use, illegal behavior)
- research on special populations (e.g. prisoners, people with mental health issues or developmental delays) whether or not the research is covered by another assurance (see appendix)
- research involving deception (see appendix)
- research to be conducted on the Internet on sensitive topics (see appendix)
- international research, including class projects conducted in another country. International research requires additional approval from an IRB (or similar body) in that country and a copy of the translation of the informed consent document and any survey or interview questions (see appendix). Please contact the IRB Administrator at (585) 395-2779 for assistance prior to submitting your proposal.
