Informed Consent

Informed Consent

Informed consent is one of the primary requirements of research involving human participants. It is important to remember that informed consent is an ongoing process, not an event.

An investigator shall seek informed consent only under circumstances that

  • provide the prospective participant or the participant’s representative sufficient opportunity to consider whether or not to participate and
  • minimize the possibility of coercion or undue influence.

The plan for obtaining consent must be included in the Human Subjects Protocol.

Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, provided the conditions described on the waiver form are fulfilled.

Several sections under General Information contain guidance about consent and assent: The UAB IRB also offers a sample consent form written for a fictitious protocol. In most places, the sample demonstrates effective use of language at an 8th-grade reading level. It also includes reminders for the person writing the document. The sample is available online as an MS Word file.

Page updated: May 8, 2013