- Verbal Consent Process
- Written Consent Process
- Reconsent and Significant New Findings
- English-Speaking Subjects Unable to Read and Write
- Resources for Deaf or Hard-of-Hearing Subjects
- Consenting Non-English Speaking Participants
- Important Informed Consent Process and HIPAA Research Authorization Reminders
- Educational Resources
Informed Consent Overview
Both written and verbal consent for participation in research must involve an informed consent process. Informed consent involves an education and information exchange that takes place between the researcher and the potential subject.
Sometimes the information to be imparted to potential subjects is complex or possibly distressful and may require some time for it to be absorbed and appreciated. In these circumstances, the researcher should present the information and discuss the issues with potential subjects on more than one occasion, or allow a period of time to elapse between imparting the information and requesting a signature on the consent form. During this waiting period, potential subjects should be encouraged to discuss their possible participation with family members, close friends, or trusted advisors. With IRB approval, other approaches to communicating complex information can be used, including the use of audio-visual materials and brochures.
Definitions for this Webpage
- Investigators are those individuals approved by the IRB to be listed on the consent form and to obtain consent from a subject.
- Designees are those individuals approved by the IRB as part of the study team, but are not qualified through their education, training or experience to obtain the legally-effective informed consent from a subject. Designees are not listed on the consent form and cannot obtain consent from a subject. Designees may orient potential subjects, but investigators are responsible for completing the consent process.
Verbal Consent Process
In most cases the federal regulations require that informed consent be documented (i.e., signed consent form), but they also provide for some important exceptions. In some circumstances, the IRB may waive the requirement for written consent and allow researchers to obtain verbal consent. If the IRB grants a waiver of documentation of informed consent, the Investigator should follow the steps below:
- Step One: The Investigator (or an IRB approved designee), must explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and must allow the potential subject ample opportunity to ask questions.
- Step Two: Following this verbal explanation, the potential subject may be provided with a study information sheet (written summary - if required by the IRB) and must be afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from minutes to hours, dependent on how long it reasonably takes to evaluate the procedures, risks, potential benefits, and potential alternatives.
- Step Three: After allowing the potential subject time to read the study information sheet, the Investigator must answer any additional questions the potential subject may have and may obtain verbal agreement to participate in the research.
A waiver of documentation of informed consent must be approved by the IRB in order to obtain verbal consent from potential subjects.
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:
- Step One: The Investigator (or IRB approved designee) must explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and must allow the potential subject ample opportunity to ask questions.
- Step Two: Following this verbal explanation, the potential subject should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from hours to days, depending on how long it reasonably takes to evaluate the procedures, risks, potential benefits, and alternative treatments.
- Step Three: After allowing the potential subject time to read the consent form, an Investigator listed on the consent form should meet with the potential subject and answer any additional questions s/he may have.
NOTE: Designees may orient potential subjects, but an Investigator listed on the consent form is responsible for completing the consent process.
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, close-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?"
- 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.
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).
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.
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 a modification 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).
English-Speaking Subjects Unable to Read and Write
A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the English consent document.
A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be enrolled in a study using an English consent form if they are competent and are able to indicate approval or disapproval by other means. The subject must:
- retain the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally, and
- be able to indicate approval or disapproval to study entry.
The consent form (or research record) should document the method used for communication with the potential subject and the specific means by which the potential subject communicated agreement to participate in the study.
- An impartial witness must be present for the entire consent process and should sign and date the consent document.
- The FDA recommends that the Investigator provide the subject with a video tape recording of the consent process.
Note: English-speaking subjects who are unable to read and write must not be confused with non-English speaking subjects who are able to read and write in another language. A certified translation of the English consent form must be used to consent non-English speaking subjects.
Resources for Communicating Informed Consent to Deaf or Hard-of-Hearing Subjects
- National Institute on Deafness and Other Communication Disorders
- Alexander Graham Bell Association for the Deaf and Hard of Hearing
Important Informed Consent Process Reminders:
- Use the IRB approved consent form. The IRB approved consent form must be "stamped" and contain the UCI seal and a current IRB approval period in the footer of the document.
- Do not use an expired consent form. Confirm the approval and expiration date within the stamp on the consent document.
- Changes will be made to the informed consent document during the course of the study. It is the Lead Researcher's responsibility to ensure that the individual signs the latest version of the consent document.
- Do not verbally interpret the English version of the consent form into other languages. Investigators must use an IRB-stamped, translated consent form or the short form consent process (requires prior IRB approval). Subjects cannot waive their right to receive a translated informed consent document.
- Make sure to provide the subject with the Subject’s Bill of Rights (required for studies involving medical experimentation as defined by State law; all clinical investigations).
- An impartial witness does not simply the sign the consent document. If a witness is required (e.g., short form consent process), the witness must view the informed consent process and sign the consent form after the subject signs.
Important HIPAA Research Authorization Reminders:
- Requirements for HIPAA Research Authorization are noted on the IRB approval letter. If a written HIPAA Research Authorization is required, make sure that the investigator completes the blank sections (i.e., Study Title, Sponsor, and Section B) and that the individual and an impartial witness (when required) sign the form. For Section B, avoid checking "entire medical record" as a matter of convenience; only the minimum PHI necessary for study should be accessed. The reviewed HIPAA Research Authorization Form will be uploaded in the "Docs Depot", along with the IRB-approved (stamped) documents, ready for your use.
- For non-English speaking subjects researchers should download the appropriate translated language version. Researchers can access the HIPAA research authorization forms in several languages by clicking, "ORA Applications and Forms" and then "IRB Translated Forms."
- The HIPAA Research Authorization language cannot be altered. The form has received extensive review by the UC campus IRB offices, UC legal counsel, the UC Office of the President, and several major research sponsors to make sure it is in compliance with Federal and State regulations governing the privacy of medical information.
- Researchers can access the HIPAA Research Authorization form in Chinese (traditional), Farsi, Korean, Spanish and Vietnamese by clicking, the Applications and Forms webpage and then "IRB Forms Foreign Language Translations." The English version of the HIPAA Form can be found by clicking, the Applications and Forms webpage and then "IRB Forms."
For more information about HIPAA, protected health information (PHI) and when HIPAA Research Authorization is indicated, proceed to the Protected Health Information page.