When informed consent is required for a procedure which of the following steps should occur?

Written Consent Process

Obtaining written informed consent from a potential subject is more than just a signature on a form. The consent document is to be used as a guide for the verbal explanation of the study. The consent document should be the basis for a meaningful exchange between the Investigator and the subject. The subject's signature provides documentation of agreement to participate in a study, but is only one part of the consent process. The consent document must not serve as a substitute for discussion.

The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the Investigator and the subject to exchange information and ask questions.

Documentation involves the use of a written consent form containing all the information to be disclosed and signed by the subject or the subject's legally authorized representative (LAR)*. The subject or LAR who signed the consent form must be given a copy as a reference and reminder of the information conveyed.

*Use of a Legally Authorized Representative (surrogate) for obtaining consent for minors or subjects who are cognitively or medically incapacitated requires prior IRB approval.

Explanation of the Research

Investigators (or IRB approved designees) must use the following steps in order to orient the potential subject to the purpose of the research and why they might wish to participate:

Subject Comprehension Assessment

The responsibility of ensuring that a potential subject understands the research and the risks and benefits involved falls upon the Investigator and not upon the potential subject. It is critical to the consent process that the Investigator not only field questions but also asks questions. Asking questions can further the discussion, elicit questions from the potential subject, prompt the potential subject to think more carefully about the study, and help the Investigator decide whether the person has adequately understood the study. Useful questions will be open-ended and non-directive. Rather than asking for yes or no answers, they ask for explanation because these questions often can be answered in a variety of ways, and do not already contain the correct answer. Open-ended questions are often introduced with "what," "where," "how often," "when," and "please describe."

Examples of open-ended questions are:

• "Just so that I'm sure you understand what is expected of you, would you please explain to me what you think we're asking you to do?"
• "Describe in your own words the purpose of the study."
• "What more would you like to know?"
• "What is the possible benefit to you of participating in this study? What are the possible risks?"
• "Can you describe what the alternatives to participation in this study are?”

The IRB suggests that investigators use the decision-making capacity tool as needed to assess subject comprehension.

In contrast, closed-ended questions do not further discussion and tend to bring it to a stop, so they should be avoided. Examples of closed-ended questions are:

• "Do you understand?"
• "Do you have any questions?"
• "Do you see that there are some risks to taking this drug?"

Required Signatures

Once an individual has had all his/her questions answered and has agreed to participate in the study, the subject should sign and date the consent form. If the IRB requires a HIPAA Research Authorization this must also be signed and dated at the time written consent for participation in the study is obtained. The Investigator who has oriented and consented the subject also must sign and date the consent form. Usually, the Investigator, subject and impartial witness (when required—see below) sign at the same time. The Investigator's signature cannot pre-date the subject's signature. It may be appropriate for the Investigator to sign after the subject if the Investigator needs to verify that basic eligibility criteria have been met. The subject should always be provided with a copy of the consent form to use as continual reference for items such as scheduling of procedures and for emergency contact information. NOTE: The subject is not technically enrolled until both the subject and the Investigator have signed.

The Investigator’s signature means that the informed consent process has taken place with the subject and that the subject:

• meets all study inclusion criteria;
• was appropriately consented (as described above);
• understands the requirements of the study; and
• has received a copy of the informed consent document.

Obtaining Electronic Signatures on the Consent Form:

Per UCI Health IT,  FDA-Regulated Studiesmust use DocuSign Part 11 for obtaining electronic signatures on the Informed Consent Form. Please see the related guidance for a complete list of documents that require the use of DocuSign Part 11 for obtaining electronic signatures.

When is a Witness Signature Required?

Observation of the consent process by a witness is required in the following situations:

• When using the IRB-approved foreign language short form process for participants who do not speak English;
• When obtaining informed consent from a participant (or the participant's parent/guardian or surrogate decision maker) who can understand and comprehend the language, but is physically unable to read, write, talk or is blind.
  • The individual providing informed consent must be competent and able to indicate approval or disapproval by other means.
  • The method by which the individual indicated consent must be noted on the consent form (blinking of eyes, raising arm, etc).

The witness must be impartial, such as an adult who is not a member of the study team (i.e., is not listed on the protocol narrative) and who is not a family member of the subject. For additional information about who should be listed on the protocol as part of the research team go to Frequently Asked Questions (FAQs). In addition, for any exceptions, refer to HRPP Policy.

The witness must sign and date the consent form attesting that the requirements for informed consent have been satisfied; that consent is voluntary and freely given by the subject, guardian, or surrogate, without any element of force, fraud, deceit, duress, coercion, or undue influence.

Requirements of the California Medical Experiment Act

When meeting the requirement to attest that informed consent to the California Medical Experiment Act has been satisfied, the consent form is signed and dated by any person other than the subject or the subject's guardian or legally authorized representative who can attest that the requirements for informed consent has been met, as specified in Section 24175 of the California Health and Safety Code. At UCI, the investigator's signature serves this purpose.

Subject Advocates

When a subject population is especially vulnerable, the IRB may require use of an impartial third party to observe the consent process and verify subject comprehension. The advocate is more than a witness, rather an independent monitor charged with protecting a subject’s rights.

Reconsent and Significant New Findings

Obtaining a signature on a consent form does not complete the consent process. Maintaining informed consent requires that subjects be provided with any new information that arises during the course of the study (such as changes to the research plan, change in risk/benefit profile, the results of related research, etc.) that may affect a subject’s decision whether or not to continue participation in the study.

When such information arises, the investigator may submit an amendment request to revise the consent form and submit a re-consent cover letter that briefly describes what changes have been made since the subjects last provided informed consent. The re-consent memo should be attached to the front of the consent form. The memo is designed to facilitate the re-consent process by emphasizing the revisions. Subjects must sign the updated consent form. A re-consent cover memo template is available on the Applications and Forms webpage.

Examples of when re-consenting is required:

• Change in the risk/benefit profile
  • New risks identified
  • Increase in risk
  • Decrease in expected benefit
• Change in research procedures

The IRB will consider other situations where re-consenting may be required (e.g., change in Lead Researcher).

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