Informed consent is almost always required of studies, but there are instances in which all or part of the consent can be waived. Today’s tip focuses on the signed consent form and guidelines the Institutional Review Board (IRB) will consider when reviewing a waiver.
According to the Code of Federal Regulations, 45 CFR 46.117(c), an IRB has the authority to waive the requirement for signed consent if one of the following two is true:
- That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern; or
- 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 (e.g., drawing a blood sample, or asking shoppers in a mall about the ambient lighting or temperature).
The IRB may still require that participants are provided a copy of an informed consent form. However, if there is documentation of potential harm to the participants as a result of having the consent form, this too can be waived. An example of this might include participants who are involved in instances of domestic abuse. If they are living in an environment where the abuse occurs, having an informed consent or any study related materials might pose a risk. The IRB will carefully consider the merits of the request for waiver of each study to make the appropriate determination.
For additional information about the CFR visit: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117