Appendix B: WHO MUST USE THIS FORM?

1) If humans at CCSU (faculty, staff, or students) are to be involved in any way and/or are to be placed at risk¹ directly or indirectly, in any research project; or 2) if CCSU faculty, staff, and/or students are conducting research in which humans are to be involved in any way (regardless of location of the research) and/or are to be placed at risk¹ directly or indirectly please read this notice carefully.

HHS regulations require that all applications for support of research² or training projects which use human subjects or human materials, or place humans at risk in any way, should have the prior approval³ of the Central Connecticut State University Human Studies Council. The HSC operates under strict HHS guidelines. Each principal investigator is expected to submit to the HSC, copies of his or her proposal, or that portion with the research methodology that will involve humans, for HSC review and approval.⁴

If you have any questions, contact the Office of Sponsored Programs and

Research Services (832-2366) for directions as to the steps that must be taken with your application at CCSU and with State and Federal agencies.

A complete copy of the HSC policy is on file in the Office of Sponsored

Programs, Barnard Hall, Room 102.

NOTE: HSC APPROVAL MUST BE RENEWED ANNUALLY

All graduate level theses and similar projects involving human research must be reviewed and approved (or exempted) prior to any data collection. Prior review of non-sponsored research by the HSC is strongly encouraged. If a project is not reviewed and approved, CCSU is not liable for any legal action resulting from the research. In addition, many journals and conference organizers now require proof of human subject review. It is in everyone’s best interest to have research reviewed.

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1 The following extract is taken from HHS regulations:

"Subject at risk means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service."

2 Research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” If you have any question about the status of your project, CCSU strongly urges you to submit it for review or discuss possible review or exemption status with the HSC chair or administrator.

3 Prior approval means that this form has been submitted with all supporting documentation and has been reviewed and approved before the onset of any data or information collection from human research participants. The HSC cannot approve projects after they have begun. Researchers should build in to their research plan time for the HSC to do its job of review and time for possible protocol revisions.

4 Certain kinds of research may qualify as "exempt from HSC review." This exemption status should be determined by the HSC Chair or designate, not by individual researchers. Please note that student research projects are not automatically exempt simply because they function as a class assignment.

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