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 a document or single event.

An investigator should 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.

• Elements and Disclosures of the Informed Consent Process
  • Basic Elements
  • Disclosures
  • Additional Elements
• Requirement to Obtain Signature
• Requirement to Use Understandable Language
• Requirements When a Participant or the Legally Authorized Representative is Unable to Read
• Requirements for Cooperative Group Studies
• GINA – Genetic Information Nondiscrimination Act
• Additional Elements That May Be Included in the Consent Form
• Future Use Of Biological Specimens Collected Under Clinical Protocols

Several sections under General Information contain guidance about consent and assent:

• IRB-Review—Outcomes-and-Approval-Details
• Conducting the Protocol
• Participant Populations

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 on the Forms page​.