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Getting Started
A
Guide for Investigators and Research Staff
What is informed consent?
Informed consent is the process by which potential participants are provided key information about the research study.
Human subjects can only be involved in your study if they voluntarily agree to participate after having been adequately informed about the research.
If the human subjects in your study are part of a vulnerable population (children, students, prisoners), special protections may be required. For more information on vulnerable populations, please consult the OPRS website or office (312) 996-1711.
Consent documents must be clearly written and understandable to subjects. The language must be non-technical (comparable to the language in a newspaper or general circulation magazine). Scientific, technical, and medical terms must be plainly defined. The reading level of the consent document should be appropriate to your targeted subject population. The same recommendation applies to the assent forms for minors and study recruitment materials. Informed consent may not include language that appears to waive subjects’ legal rights or appears to release the investigator or anyone else involved in the study from liability or negligence.
Templates and model consent forms are available on the OPRS website at: http://www.uic.edu/depts/ovcr/research/protocolreview/irb/forms/index.shtml
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