The informed consent process is a basic ethical obligation for researchers. Informed consent is more than just obtaining a signature on a form. It is an active process of sharing information between researchers and potential subjects. The exchange of information can occur by various modes of communication including face-to-face contact, postal or email, telephone or internet calls, video, or through a shared drive.

The informed consent process must contain the Elements of Informed Consent (45 CFR 46.116) and comply with the regulatory requirements for Documentation of Informed Consent (45 CFR 46.117).

The consent process should include all the key features:

  • Conducted by someone listed in the HawkIRB application as being involved in the consent process
  • Provides necessary information about the research for potential subjects to make an informed decision
  • The researcher has a mechanism to assess whether potential subjects understand the procedures and risks of the study
  • Potential subjects make a voluntary decision to participate in the study, free from coercion or undue influence, and they can choose to withdraw from the study at any time.

More information about the informed consent process can be found in the UI IRB Standard Operating Procedures and Researcher Guide

  • Section II, Part 11.B (The Full Informed Consent Process)
  • Section II, Part 5.C (Waiver of Informed Consent
  • Section II, Part (Exception from Informed Consent Requirements, 21 CFR 50.24(a)(1))
  • Section II, Part 9.A.iii.a.ix (Informed Consent, 21 CFR 812.150(b))

FDA Informed Consent Guidance

If the study is conducted or supported by HHS and involves an FDA-regulated product, the study is subject to both 45 CFR part 46 and 21 CFR parts 50 and 56, meaning that both sets of regulations must be followed.

Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.

Research subject to 21 CFR parts 50 and 56 is typically subject to 21 CFR part 11 (FDA regulations regarding electronic records and electronic signatures) which affects the use of eConsent.

FDA-regulated studies must utilize an electronic informed consent tool that complies with Part 11 regulations (21 CFR 11). The University of Iowa does not currently have a tool meeting these requirements, but a study sponsor may supply one. 

Educational Tools:

  • Informed Consent Document Checklist
  • Informed Consent Document Checklist for Social, Behavioral, and Educational Research
  • Short Form Consent Document and Process Guidance

Related Topics

Please click on the links below to learn more about other topics related to the informed consent process: