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Writing Your Protocol

The task of writing a protocol might seem difficult to some, but please do not feel discouraged. Here are some samples of written and IRB-approved protocols representing various risks and data privacy. Use them as examples and look for updates to the current protocol version.

College of Science:

Cold Pressor study (PDF) - invasive, physiological study but negligible confidentiality risks.  This link to the informed consent form (PDF) shows comments about the original one in the protocol.

C.L.A.S.S:

Minimal risk behavioral science studies - a psychology study (DOC) on charismatic speech and its informed consent form (PDF) with comments

sociology study (DOC) on responding and its informed consent form (PDF) with comments.

College of Education and Integrated Studies:

Education (CEIS) protocol (DOC) with older minors, teachers, and anonymous survey.  This link provides constructive comments about the consent, assent, and recruitment (PDF) letter in the protocol.

 Other sample protocol #1(m) (PDF).  

Other sample protocol #2(a) (PDF).

College of Business Administration:

Business research protocol (DOC), student PI protocol (PDF) with an anonymous on-line survey, other business anonymous survey protocol (PDF)

Questions about research data?  

Review this publication on "Access to and Retention of Research Data: Rights and Responsibilities" Council on Governmental Relations, 2006.

Renewals and changes to methods:  

Protocols are generally approved for conduct for one year. They may be renewed if interaction with subjects will continue. They may be changed, known as being amended. Send an email to the IRB administrator describing in detail the reason for the renewal (e.g., collection of additional data from more subjects) or proposed change (e.g., recruiting men as well as women in the study).  Completion of a de novo protocol in either circumstance may be requested by the IRB.

Using copyrighted materials:  

The CSU Office of General Counsel has a manual on the Fundamentals of Copyright and Fair Use. See: http://www.calstate.edu/gc/Docs/Fair_Use.doc

Web sites and such to assist with international human subjects research:

In conjunction with the IRB policy on conducting research, individually or collaboratively, outside of America.