In order for the IRB to consider approval for waiving this requirement, checkmark the box for "Request for Waiver of Signatures in the Informed Consent Process" under the Informed Consent section of the E-IRB application, and answer the questions as prompted.

If you are requesting IRB approval for waiver of the requirement for signature in informed consent, your research activities must fit into one of three regulatory options:

1. The only record linking the participant and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent is normally required outside of the research context (i.e. a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which signing forms is not the norm, and the research presents no more than minimal risk to the subject and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Note: The IRB cannot waive the requirement for signatures or alter the consent form for FDA-regulated research unless the research presents no more than minimal risk to the participant and involves no procedures for which written consent is normally required outside of the research context (i.e., a cover letter on a survey or a phone script). *Option 1 below. 

Even if a waiver of the requirement for signatures is approved by the IRB, participants must be provided oral or written (e.g., cover letter) information including all required and appropriate elements of consent so they have the knowledge and opportunity to consider whether or not to participate. To help ensure required elements are included in your consent document, please use the Cover Letter Template (in sidebar on the right) as a guide. The cover letter template was developed specifically for survey/questionnaire research; however, it may be useful as a guide for developing a consent document for other types of research as well. 

In your E-IRB protocol application, you will select the option that best fits your study, and explain in the space provided how your study meets the criteria for the selected regulatory option.