» Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what’s involved so the person can decide if they want to participate.  This process is one of the central components of the ethical conduct of research with human subjects.

The consent process typically includes providing a written consent document containing the required information (i.e., the elements of informed consent under the 2018 Common Rule) and the presentation of that information to prospective participants.

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document a person’s consent to participate) unless the IRB has waived the requirement to consent or the requirement to document consent (e.g., signature). (See Waiver of Informed Consent Guidelines)

Even in situations where the IRB may waive the documentation (signature) requirement (e.g., for a telephone interview or online survey), investigators must present participants with the required key elements of informed consent and with a copy of the written consent document (or a link to download/print the consent form).

General Information and Tips for Preparing a Consent Document

Reading Level

Informed consent documents should be written in plain language at a level appropriate to the participants, typically at an 8th grade level.  A best practice is to have a colleague or friend read the informed consent document for comprehension before submitting the IRB application.  Always:

  • Tailor the document to the participants
  • Avoid technical jargon or overly complex terms.
  • Use straightforward, understandable language.

Writing Tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

  • Use the second person (you) or third person (he/she/they) to present the study details. Avoid the use of the first person (I).  
  • Include a statement of agreement at the conclusion of the informed consent document. 
  • Be consistent with the information that is described in the IRB application.

Informed Consent Templates

Although the requirements set forth in the Common Rule provide the elements of informed consent, the research team must determine the most pertinent information about the study to provide, the most effective way to communicate that information, and the most accurate way to assess if the research participant understood the information. Additional information must be included in informed consent documents for clinical trials.

The IRB may make recommendations or edits to consent forms to ensure all identified risks are clearly stated. The IRB may also provide ideas of what a reasonable person would want to know and what might be the most helpful information for the person’s decision about whether or not to participate. Of course, the IRB must also help ensure all of the required elements are included per the federal regulations. The following templates should be used when researchers develop consent documents.


Under certain conditions (§46.116(d)), the IRB may approve a research study that involves deception or incomplete disclosure. In this case, participants must be “debriefed” or provided additional information about the study once it ends. The debriefing process should provide participants with an explanation of the study’s purpose, the procedures in which deception occurred, and why it was necessary for deception to occur.  Participants must also choose whether or not the researchers may use their data collected prior to debriefing.

Translation Certification

The Translation Certification Guidance and Form is to be used when any document(s) related to an IRB-approved study will be translated from English to other languages or other languages to English.

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