Guide :: Informed Consent :: Consent not required
When is consent not required?
For some studies, consent is not a requirement or it can be waived. However, depending on the study the Board may advise or require that some level of consent is conducted.
Exemption
If a study is granted exemption from IRB review, the Board determines if consent is necessary. For some exempt studies, consent is generally not necessary. Anonymous archival data, for example, does not require consent, though it usually requires permission from the data’s owner to access the data. Anonymous data collection such as using a blind survey does not require consent, but the Board may require that you provide an information sheet explaining the purpose of the study, how the data will be used, and stating that the data are anonymous (for a model of an information sheet, use the General Consent Template and simply remove the signature section at the bottom). Collecting consent documentation in this case would hamper the benefits of collecting the data anonymously. However, providing basic information about the study in the instruction sheet may make the participants feel more comfortable about participating. Studies that are classified as “normal educational practice” have specific requirements regarding consent; please see the Normal Educational Practice section for details on consent procedures. For more information about exemption categories, please see Exemption.
Waiver of consent
The Board can alter or waive the general requirements for consent (please see General Consent Template section) when the following apply:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
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Guide :: Informed Consent :: Consent not required |
