Iowa Exempt Survey
Description
How to fill out Exempt Survey?
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FAQ
Research regulated by the Food and Drug Administration (FDA): With the exception of Category 6, FDA-regulated research does not qualify for exempt status.
If a study is granted exemption from IRB review, the Board does not require consent documentation but the Board generally requires that participants receive information about the study.
Emergency research is the most often mentioned example in all contexts described, and it is the most notable research discipline in which practical problems are forwarded as the primary reason why the informed consent requirement should be waived.
The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject's legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents
Federal regulations outline formal informed consent requirements for non-exempt research. Research confirmed as meeting the criteria for exempt review (i.e. exempt research) is not subject to those formal requirements, allowing PIs flexibility in how informed consent is obtained.
All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent. Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process.
Yes, in some circumstances. The HHS regulations require that an investigator obtain legally effective informed consent from subjects or a legally authorized representative before the subjects may be involved in research (45 CFR 46.116), unless this requirement has been waived by an IRB.
An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.
As indicated above, use of a formal, signed consent form is not required by the IRB for studies under exempt review. For many benign surveys, a few simple paragraphs preceding the survey sufficiently meets the spirit of this ethical tenet.