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 informed consent is conducted.
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. For a model of how to provide this information at the beginning of a study, use the Study Information Sheet in Consent Templates section. 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 Exempt Protocols.
The Board can alter or waive the general requirements for consent when the following apply:
The research involves no more than minimal risk to the subjects;
The research could not practicably be carried out without the requested waiver or alteration;
If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
The Board can waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if any of the following apply:
- That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In cases in which the documentation requirement is waived, the Board may require the researcher to provide participants or the legally authorized representatives with a written statement regarding the research.
Please see Minors in Research: Consent.