- About IRB
- Policy & Procedures
- Membership list
- Continuing Education and Training
OHRP FAQs on informed consent This web site from the federal Office for Human Research Protections offers information about the consent and assent processes.
Consent forms: A quote from the Wall Street Journal:
"Informed consent may be the biggest misnomer in medicine: Studies show that most patients [subjects] don't read the forms they sign before undergoing surgery or medical treatment. More than half of those who do read the forms don't understand them, and only a quarter of forms include all of the data patients [subjects] need to make an informed decision." This is a concern of the Cal Poly Pomona IRB as well. It requires a detailed and informative consent as part of your IRB protocol submission. Model yours from these samples of standard consent forms: for an anonymous and non-intrusive study, for a confidential study, to obtain consent for multiple specific uses of videotape, for a minimal risk psychology study (more to come). The NIH Clinical Research Policy Analysis and Coordination Program has released a compendium of current ('07), publicly available NIH resources on informed consent.
Experimental subject's bill of rights for medical research This consent form is to be used as well for clinical procedures.
Anonymous versus Confidential Often the difference between the terms anonymous and confidential is not well understood when applied to research studies involving human participants. Yet, these concepts are very important for the protection of the subjects, and they need to be considered by researchers when designing a study and writing the protocol. During protocol review, the level of protection described will be evaluated by the IRB.
Protocols: Samples of written and IRB-approved protocols representing various risks and data privacy are available at these links:
Cold Pressor study - invasive, physiological study but neglible confidentiality risks
Minimal risk behavioral science studies - psychology study and sociology study
Education (CEIS) protocol with older minors, teachers, and anonymous survey
Questions about research data? Review this publication on "Access to and Retention of Reseach Data: Rights and Responsiblities" 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
