This section of the Investigator Manual details consent requirements, including: the consent document, assent processes, remote consent, electronic consent, waivers of consent, and enrolling patients with limited English proficiency.

Assent Process and Documentation

Assent is defined as “a child’s affirmative agreement to participate in research.” Passive resignation to submit to an intervention or procedure is not considered assent. Federal regulations do not specify any of the elements of informed assent and do not provide an age at which assent ought to be possible. In determining whether children are capable of assenting, the IRB takes into account the ages, maturity, and psychological state of the children involved. The IRB determines whether all or some of the children are capable of assenting. The IRB also determines if written documentation of assent is required. The study team may document assent using the signature block for studies enrolling children in the HRP-502 TEMPLATE CONSENT DOCUMENT. The IRB also assess when parental permission is required, whether by one or both parents.

The assent of the children is not a necessary condition for proceeding with the research if the IRB determines that the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation. For more information on requirements for assent for children, see HRP 416 – CHECKLIST – Children, HRP-090 – SOP – Informed Consent Process for Research, HRP-091 – SOP – Written Documentation of Consent, and the Research with Children section.

As a general rule, all adults, regardless of their diagnosis or condition, are presumed competent to consent to participate in research unless there is evidence to the contrary. When investigators propose to include individuals with questionable capacity, you must provide a plan for assessing the participants’ decision-making capacity. Assessment is done on an individual basis and should determine the potential participants’ ability to understand and express a reasoned choice based on:

  • The voluntary nature of research participation and the information relevant to their participation (research procedures);
  • Consequences of participation for the participant’s own situation, especially with regard to the participant’s health condition;
  • Consequences of the alternatives to participation;
  • Potential risks and benefits involved in the study; and
  • Procedures to follow if the participant experiences discomfort or wishes to withdraw.

If the assessment shows evidence that the participant is competent to consent, you must obtain valid informed consent directly from the participant. If the assessment determines that the potential participant does not have sufficient capacity to consent, you must do the following:

  • Document the participant is incapable of understanding the information presented regarding the research in the participant’s research record;
  • Document the information provided to the participant’s legally authorized representative regarding the cognitive and health status of the participant, the risks and benefits of the research, and the role of the legally authorized representative in the research record;
  • Obtain the consent and signature of the participant’s legally authorized representative; and
  • If ICH-GCP compliance is required, obtain and document the participant’s assent if the person with decisional impairment is capable of exercising some judgment concerning the nature of the research.

The verbal objection of an adult with decisional impairment is binding. If the participant, at any time, objects to continuing in the research study, they cannot participate in the research study. Situations may arise in which you could legitimately return to the participant at a later point to ascertain whether the previous objection still stands. The only exception will be research providing direct benefit only available in the context of the research, in which case you must submit a request to the IRB to enroll or continue the participant and provide written documentation of the agreement of the participant’s legally authorized representative. In this instance, the IRB may solicit advice of experts.

When appropriate, the consent process may be altered to allow for non-verbal or other alternative consent methods. Proposed alterations to the consent process are submitted for IRB review and approval.

For more information on consent and related requirements for enrolling adults with impaired decision-making, see HRP 013 – SOP – Legally Authorized Representatives, Children, and Guardians and HRP 417 – CHECKLIST – Adults with Impaired Decision-Making Capacity, HRP-090 – SOP – Informed Consent Process for Research, and HRP-091 – SOP – Written Documentation of Consent.

Enrolling Participants with Limited English Proficiency

Subjects who have limited English proficiency should be presented with informed consent information in a language understandable to them that includes all the required and additional elements for disclosure. Persons with limited English proficiency are individuals who do not speak English as their primary language and/or who have a limited ability to read, speak, write, or understand English.

For research involving targeted populations that have limited English proficiency, the use of a written translation of the approved long form consent document is required. With prior IRB approval, a short form consent documentation process is available for documenting consent when an individual with limited English proficiency is encountered unexpectedly and an IRB-approved translated long form consent document is not available. If unexpected enrollment of these subjects happens repeatedly, the IRB may require translation of the long form consent document / translation of the long form consent should be considered. Review the HRP-317 – WORKSHEET: Short Form of Consent Documentation.

  • Written translation of long form documents: The IRB must review and approve all non-English language versions of long form consent documents for a particular study prior to use.
    • For long form consent document translations, the investigator may wish to delay translation service until IRB approval is granted for the English version to avoid extra translation costs. The IRB must have all versions of the research materials (e.g., recruitment informed consent form(s), instruments) in both English and Non-English on file.
    • The translation of a consent document must be made by a reliable source.
    • The IRB may request verification of a back-translation process by an individual who is not associated with the research to confirm the accuracy of the translated document.
    • The investigator must provide the credentials (qualifications, skills or experience for carrying out this role) of the individual(s) or service(s) that were used to translate (and back translate, if applicable) the consent documents.
  • Written translation of short form documents:
    • If you will use the translated short forms posted in the Toolkit Library, you do not need to submit these forms for IRB approval.
    • Translated short forms from the following sites also do not need to be submitted for IRB approval, unless the study is approved for subjects lacking consent capacity (in which case, you should submit the short form to the IRB):
    • Translated short forms not from the IRB website or the other approved sites above must be submitted for IRB approval prior to use.
    • If you are not using a translated short form from UW’s Toolkit library, you must include within the English summary that is provided to participants contact information for the study team and the HRPP’s confidential compliance hotline (see the UW’s English short form under Who can I talk to? for example language).
  • Short form consent documentation process: The short form documentation process may be used when an individual with limited English proficiency is encountered unexpectedly, and no translated long form is available. For this process the following are required:
    • Include potential enrollment of participants with limited English proficiency in your protocol or IRB application at the time of initial submission to the IRB.
    • Submit a change of protocol application in ARROW for IRB review. You can submit this as an expedited change, as long as there’s no increased risk and the change meets criteria in HRP-313 – Worksheet – Expedited Review for a minor modification to previously approved research. The change of protocol application and revised protocols/applications should describe safeguards and accommodations for the added population(s) as well as the consent process for the population. If the change is time-sensitive, please indicate this in the change workspace when submitting and email to inform the IRB of the forthcoming time-sensitive submission.
    • Oral presentation of the research in a language understandable to the subject or the subject’s Legally Authorized Representative (LAR) by an interpreter
    • A short form consent document in the subject’s or LAR’s language
    • A written summary of the information that is presented orally (the IRB-approved English language long form consent document may serve as a summary).
    • If HIPAA applies to the study, oral presentation of HIPAA authorization elements, as well as a request for Altered Authorization to present the information orally and not obtain signature from the subject or subject’s LAR. (except no altered authorization is needed when using the stand-alone HIPAA Authorization that has been translated to Spanish). See: Authorization & Participants with Limited English Proficiency.
    • A witness fluent in both English and the language of the subject or subject’s LAR is present for the oral presentation. The witness is someone who is not involved in the research. When the person obtaining consent is assisted by a qualified interpreter or translator, that individual may serve as the witness if they are not involved in the research.
  • Signatures required for the short form consent documents:
    • The subject or representative signs and dates the short form consent document.
    • The individual obtaining consent signs and dates the summary.
    • The witness to the oral presentation signs and dates the short form consent document and the summary.
    • Copies of the signed and dated consent document and summary are provided to the subject or representative.

For more information, refer to HRP 090-SOP-Informed Consent Process for Research, HRP 091-SOP-Written Documentation of Consent, and HRP-317-WORKSHEET-Short Form of Consent Documentation.