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In some types of studies (e.g., mail-out surveys), the investigator may request a waiver of the subject’s signature when submitting the New Project Application. In such cases, the conclusion of the Informed Consent Document (which could be formatted as a letter to the subject) should inform the subject that returning the survey will be considered evidence of consent.
The HIPAA Privacy Rule does not permit a waiver of documentation of authorization if the study data include protected health information. Thus, studies which utilize mailed surveys and wish to obtain HIPAA authorization to access medical record information must include a process for obtaining a signed combined consent and HIPAA authorization.
When there is no verbal communication with potential subjects (e.g., mail-out surveys), the signature of the person who obtained consent may also be deleted.
An auditor/witness signature line is needed only if specifically required by the IRB or the funding agency/company. However, if this line is included on the consent, the consent must always be witnessed and this line signed.
Except in certain minimal risk studies, the Informed Consent Document:
- is typically signed after the investigator has verbally explained the purpose and procedures involved in the study, answered questions, and otherwise provided information that permits the subject to make a prospective, informed decision.
- must be signed and dated before any study data collection procedures begin.
- must be obtained using only the methods described and IRB approved within the HawkIRB application
- serves as a written source of information for the subject and documents the fact that the process of consent occurred.