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.
Informed Consent Document
Use HRP-502 – TEMPLATE CONSENT DOCUMENT to create a consent document. You may continue to use your own consent template if it includes the elements found in HRP-502. For social, behavioral, and educational studies and other appropriate minimal risk research, a consent wizard is available.
The consent document should be uploaded to the application in Word format, as this allows for reviewer edits and comments to be easily placed in the document.
Note that all long form consent documents and all summaries for short form consent documents must contain all of the required and all additional appropriate elements of informed consent disclosure. Review the “Long Form of Consent Documentation” section in HRP 314 – WORKSHEET – Criteria for Approval, to ensure that these elements are addressed. When using the short form of consent documentation, the appropriate signature block from HRP-502 – TEMPLATE CONSENT DOCUMENT should be used on the short form.
If your research study meets the requirements for an exemption and there are interactions with subjects, you may use an abbreviated process for obtaining consent as noted in the Preparing Supporting Materials section.
We recommend that you date the revisions of your consent documents to ensure that you use the most recent version approved by the IRB.
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.
Remote Consent Processes
Any method of obtaining informed consent other than a face-to-face consent interview must allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject.:
- A consent form may be sent to the subject or the subject’s legally authorized representative by mail, facsimile or e-mail, and the consent interview may then be conducted by telephone or via a UW-approved videoconferencing platform (i.e., WebEx, Secure Zoom). This process allows the subject or subject’s legally authorized representative to read the consent form before or during the consent discussion. After the consent discussion, the subject or the subject’s legally authorized representative can sign and date the consent form. If the signed informed consent document cannot be mailed or collected from the participant’s location and included in the study records, subjects or their LAR may scan the document or take a picture of each page via a smartphone or camera and send the document back to the study team via a UW approved document sharing option (e.g., uploads to Secure Box Folder, WebEx) or via email or fax. If a picture is used, the subject should email a picture of the entire consent form so you have a record of what information the subject received, and the full document that was signed. If the entire form cannot be sent back, the subject should email the signature page(s) as well as any pages requiring subject responses, such as checkboxes or initials. In cases where the entire form is not received from the subject, you should document that the entire document was provided to the subject and you should confirm that the version date and IRB stamp is visible on the page(s) received, to document that the subject signed the correct version. The email conversation with the subject can also provide documentation of timing of receipt and should be retained in the research records.
- Finally, the person signing the consent form must receive a copy of the consent form. Although FDA regulations do not require the subject’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.
Research records should clearly document what method was used to conduct the consent process and document that informed consent was obtained prior to beginning study procedures.
For studies subject to HIPAA regulations in which electronic protected health information (e-PHI) is being accessed, collected, or used during a remote consent process, please refer to the document Approved Tools for Exchanging and/or Storing Protected Health Information (PHI) for additional guidance.
Documenting Consent Electronically
“Digital signatures” may be acceptable forms of documentation of written informed consent. Electronic, computer, or tablet-based consent documents may facilitate record keeping even when an individual is present and could sign a paper form. Digital signatures may be considered for face-to-face and remote consent, but the technologies and processes used must be described in the protocol or application.
Digital signature generally take three forms:
- Actual signatures on tablets or computers (where an individual uses a stylus or finger to make a representation of their signature, as available in many retail stores) ,
- Validated electronic signatures on platforms with password entry (such as those used to sign medical notes or electronically write prescriptions) or
- Typing one’s name with an accompanying check box and statement noting an intent to affix a legal signature (e.g., “By checking this box and typing my name below, I am electronically signing this consent form”); this method is not allowable for FDA-regulated research.
Validated electronic signatures typically require one to “set up” an identity and password within an electronic system and may not be easily and rapidly activated. All forms of digital signature may be used in research in certain settings, but because of tracking, privacy, and identity validation issues, this may be more challenging than it initially appears.
‘Digital signature’ methodologies, if used entirely remotely, are generally approved only for low risk research or other circumstances (i.e., time of national emergencies, pandemics, natural disasters) because it is not always possible to validate the identity of the individual. When a stylus is used to collect a signature in person, the usual methods of identity validation should be used.
For FDA-regulated research, the digital signature platform and process must be 21 CFR part 11 compliant. In addition, the research team must verify the participant’s identity.
Waivers of Signed Consent
A researcher may request that the IRB waive the requirement to obtain a signed informed consent form for some or all subjects. For the IRB to waive this requirement, at least one of the following criteria must be met:
- The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
- 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; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
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. Review the HRP-317 – WORKSHEET: Short Form of Consent Documentation.
Some subjects with limited English proficiency may require alternative consent processes, such as subjects who are blind, deaf, or illiterate. A short form consent process may be appropriate in these cases, but there are times where the long form consent document can be used to document consent with some special provisions in place, such as larger font (visually impaired), use of an assistive reading device, or an ASL interpreter in the case of deaf subjects. IRB approval is required prior to enrolling these and any other special population and any alternative consent process should be described in the protocol.
- 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 or short forms translated by UWHC, you do not need to submit these forms for IRB approval.
- Studies enrolling UW Health patients must use the translated short forms from the IRB website (which are provided by UWHC). If you need a short form in a language not yet posted on the website, please contact the UW/UWHC Clinical Research Office.
- Studies not enrolling UW Health patients may use the translated short forms from the IRB website as well as translate short forms into additional languages. Short forms not translated by UWHC must be submitted for IRB approval prior to use.
- The UW-Madison Cultural Linguistic Services (CLS) is a resource that can be used to help with translations.
- Short form consent documentation process:The short form documentation process may should 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 AsktheIRB@hsirb.wisc.edu 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.
- 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.