The process for obtaining consent includes the steps that will be followed and the resources/information that will be used to inform the participant. The process for obtaining consent should be customized to fit the needs of the participants, while considering a study's risks and procedures, as well as the study location and the study team's access to the participants.

When obtaining consent, the federal regulations require that the following elements be incorporated into the consent process:

1. Provide the participant with all of the required information about the study. See tab: What information will be provided to the participants during the consent process?
2. Give information in a language the participant understands. This means
   1. Use the language (English, Spanish, Vietnamese, etc.) that the participant speaks, reads, and understands; and
   2. Use terms that are appropriate for the participant's understanding. For the general population, this means simplifying scientific terms, using short sentences, etc.
3. Give the participant an opportunity to ask questions before providing consent. It is important that participants understand what you have told them about the study. If the participant has questions about the study, the study team should ensure an appropriate individual is available to answer those questions.
4. Give the participant enough time to consider being in the study.  It is important the participants not feel undue pressure to be in the study. Giving them enough time to think about their choice helps to reduce this pressure.  It is recognized that some studies have urgent timelines for enrolling in a study.  In these cases, the study team must consider additional ways to reduce the pressure.
5. Do not use exculpatory language in the consent process.  Exculpatory language is
   1. Any language that waives or appears to waive the rights of the participant
   2. Any language the waives or appears to waive the liability of those conducting the research (investigators, sponsors, institutions, etc.)
6. Document that the participant's consent was obtained before beginning study procedures. See tab: How will consent be documented in the research record?
7. Give a copy of the signed consent form to the participant. This is required in cases where consent is documented with a signature on a consent form.

Investigators must provide important information about the study to participants during the consent process, such that participants can make a decision about being in the study. This information is generally provided in a written consent form, but may also be given in another written format (a letter, an email), or may be provided verbally. The IRB provides consent document templates that include all of the required elements of consent for the following regulations:

• Department of Health and Human Services (DHHS) Common Rule
• Food and Drug Administration (FDA)
• Veterans Affairs (VA): Specific guidance for Research at the Salt Lake City VA
• Department of Defense (DoD): Specific guidance for Department of Defense Research
• HIPAA Authorization

These templates can be viewed on the IRB Forms pages. Using the templates will help to ensure that all consent elements are included. Study teams may design their own consent documents based on the consent elements in the regulations; these will be accepted by the IRB, so long as the required elements are included. These templates may also be used to design consent letters, consent emails, and verbal consent scripts, to ensure to that all consent elements are included. If you have justification for leaving out one or more of the consent elements that are applicable to your study, you must request an Alteration of Informed Consent in the IRB application. You will be asked to provide justification as part of the Alteration request.

A participant's consent must be documented in the research record as proof that the participant

1. was given the choice to participate,
2. was given the necessary information about the study, and
3. gave his/her affirmative consent before beginning the study.

Consent (and authorization) are commonly documented by obtaining a signature from the participant and then keeping the signed document in the research record. A copy of the signed document must also be given to the participant.

There are instances when the participant cannot give legally effective consent for him/herself, such as when the participant is under the age of 18 or is cognitively impaired. There are also instances when getting a signature is not reasonable or practical.

The sections below describe instances when the common method of documenting consent with a signature requires additional considerations or is not reasonable or practical.

Parental Permission and Assent

When a participant is a child, under the age of 18, documentation of consent must be obtained from the parent(s). Additionally, assent may be required for children ages 7-17. Please review the following Investigator Guidance Series documents that provide in depth information about the parental permission and assent processes:

• Research Involving Children
• Parental Permission
• Assent
• Wards of State

Consent from a Legally Authorized Representative (LAR)

When a participant is cognitively or decisionally impaired, he/she may not be able to understand the study information and consent process presented. In these cases, documentation of consent must be obtained a legally authorized representative of the participant. Additionally, assent may be required for adults who are cognitively/decisionally impaired but can understand the study well enough to provide assent.  Please review the following Investigator Guidance Series documents that provide in depth information about the LAR consent and participant assent processes:

• • Research Involving Individuals with Decisional Impairment
  • Assent

Consent for Non-English Speaking Participants

When a participant does not speak English, consent documentation must include proof that the consent process and elements were provided in the participant's language. This means that consent documents must be translated into the language understood by the participant.

A translator with appropriate language expertise must translate the consent documents. The translator certifies his/her translation by writing a letter to describe his/her qualifications for the translation.  A template Translation Certification Letter can be found on the IRB Forms pages.

There are situations when a translation of the consent document cannot be obtained. In these cases, the IRB may consider it appropriate to use a translated short form in combination with an oral interpretation of the full English consent document. A short form is like a cover letter to the full consent form, telling the participant what to expect during the oral consent process discussion of the study. When using the short form process to obtain and document consent, strict rules must be followed according to the federal regulations.  Pre-translated short forms are available on the IRB Forms pages.

In most cases, and in all cases when using the short form, a qualified interpreter must assist in the consent process. Members of the study team who are fluent in a participant's language may also provide interpretation. Investigators must be sure that the individuals providing interpretation and translation services have appropriate medical/scientific language skills to accurately communicate the details of the study.

Consent Without a Signature

Consent without a signature can only be approved by an IRB in the following situations:

• • The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
    • In this scenario, each participant must be asked whether he/she would like to sign a consent document. If the participant declines to sign, but voices consent verbally, he/she can still be in the study.
  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Consent without a signature requires that a waiver of documentation of consent be requested in the IRB application. The IRB application asks for justification according to the situations above.

In many cases, it is still appropriate to provide the participant with written information about the study, discussing the required consent elements.  This is often done using a consent cover letter; a template for the consent cover letter can be found on the IRB Forms pages.

When a signature is not obtained, another method must be used to document consent in the research record. Consider the consent process example scenarios below for additional methods of consent documentation.

Opt-In and Opt-Out Consent Models

An opt-in model is one where the participant must affirm his/her consent before the study team may begin procedures. A participant may opt in by signing a consent form, verbally consenting, or using another acceptable method.

An opt-out model is one where the participant does not have to affirm consent before his/her inclusion in the study begins, but must affirm dissent if he/she wishes to be excluded from the study.  Opt-out models are often used when the participant does not have to physically engage in any study procedures; for example, when existing data about the participant will be analyzed for the research.