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 & Electronic Consent Processes
Study teams must describe both the consent process and documentation of consent in IRB submissions.
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 research study or is the legally authorized representative of the subject.
Some minimal risk research may qualify for a waiver of written documentation of consent and an altered HIPAA authorization. In determining how to document informed consent, researchers may request that the IRB waive the requirement to obtain a signed form from some or all subjects.
In all cases, research records should clearly document what method was used to conduct the consent process and document that informed consent was obtained, if required, prior to beginning study procedures.
Any use of email as described below must comply with the IRB’s Email Recruitment Guidelines.
For research using a “wet signature”:
- 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, brought to the next study visit, 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 an appropriate mechanism based on the sensitivity of the study, such as 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 send 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 send 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, document that the entire consent form was provided to the subject and 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.
For research using an electronic signature:
“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.
Researchers conducting FDA regulated research may also use the University’s instance of DocuSign that is Part 11 Compliant to obtain an electronic signature on the consent/authorization form.
See HRP 314-WORKSHEET- Criteria for Approval; HRP 090-SOP-Informed Process for Research, and HRP 091-SOP-Written Documentation Consent.
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.
Waivers & Alterations of Informed Consent
When a research study or component of a research study meets specific criteria, a researcher may request that the IRB waive the requirement for informed consent or approve a consent procedure that omits or alters elements of informed consent.
A waiver of informed consent allows a researcher to conduct human subjects research without obtaining informed consent from participants. The waiver may apply to an entire study or to particular study components; it may apply to all participants or only some participants. Situations in which a waiver of consent may be approved include:
- Collection and analysis of medical record information, with no participant interaction.
- Secondary analyses of existing datasets or specimens.
- FDA regulated investigation of in vitro diagnostic devices using anonymous tissue specimens
An alteration of informed consent allows a researcher to omit some or alter some or all elements of informed consent. Situations in which an alteration of consent may be approved include:
- Asking participants to do specific research activities, such as fasting or completing baseline questionnaires, before they provide consent to take part in the study as a whole.
- Requesting consent to retain identifiable information for research analysis from individuals who respond to eligibility screening questions but do not participate in the study. (See Eligibility Screening and Recruitment Elements and Scripts.)
- Omitting or altering certain consent information for scientific design reasons, such as omitting or altering the description of a study’s purpose to avoid expectation bias. (See Deception.)
Requesting a waiver or alteration of informed consent
To waive or alter informed consent, the IRB must find that all of the following criteria are met:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
To request a waiver or alteration of consent, the ARROW application or study protocol should specify whether the waiver/alteration is requested for the study as a whole or for certain study activities or participants. The application or protocol should also describe how the research or research activities meet each of the criteria above. When requesting an alteration of consent, also submit the altered consent text for IRB review.
The IRB uses HRP-410 – CHECKLIST – Waiver or Alteration of Consent Process when reviewing such requests. Researchers can use this checklist for reference, to ensure that their application or protocol includes the information needed for IRB review.
Additional information
- Waiving the requirement for participant signatures to document informed consent (i.e., waiver of written documentation, waiver of signed consent) is separate from waiver/alteration of consent, with a different set of criteria. See Waivers of Signed Consent for more information.
- If HIPAA applies to a study that is requesting a waiver or alteration of informed consent, the ARROW application should also request a waiver, partial waiver, or alteration of HIPAA authorization. See Partial and Full Waivers of Authorization and Altered Authorization for more information.
- For FDA regulated studies, FDA guidance allows approval of waivers and alterations of informed consent when criteria (1), (2), (4), and (5) above are met, and for clinical investigations of in vitro diagnostic devices using anonymous tissue.
- Studies approved under the 2018 Common Rule may obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility without informed consent, if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
- Studies approved under the pre-2018 Common Rule (before 1/21/2019) must have an approved waiver of consent to access records for screening purposes and a waiver or alteration of consent to obtain recruitment and screening information through oral or written communication with prospective participants.
Reconsenting Participants
Federal regulations for obtaining informed consent of research participants require that, when appropriate, “significant new findings developed during the course of the research that may relate to the participant’s willingness to continue participation will be provided to subjects”. The regulations do not, however, stipulate what qualifies as a significant new finding that may relate to a participant’s willingness to continue participation or how the new information should be conveyed.
This guidance provides study teams with points to consider when determining if new information should be presented to participants and how the new information should be presented.
What information should be provided to already enrolled participants during the course of the study?
Most frequently, information provided to participants during the course of their participation relates to new or updated risk information, changes to study procedures/interventions or to the time commitment required of participants, or updates to how their data or samples may be used or shared. Less frequently, information pertaining to alternatives to participation (e.g. approval of a new medication for the treatment of the disease under study) may arise. New information may apply to subjects who are actively participating and/or to subjects who have already completed their participation.
Information related to reportable events may also impact a participant’s willingness to continue participation and in those cases, should be conveyed to participants. Examples include breaches of confidentiality or other information related to unanticipated problems posing risks to subjects or others.
There is also information that typically does not need to be communicated to already-enrolled research participants. Examples include changes to the inclusion criteria that have no impact on previously enrolled participants (e.g., increase to upper age limit from 60 to 70), an increase in the overall number of participants, or revised procedures that will affect only newly enrolled participants.
How will the information be communicated?
There are generally three pathways in which to provide participants with new information, and the choice of pathway may be influenced by factors including the nature of the new information, its perceived impact on currently enrolled participants, and the status of the research (e.g., enrolling, long term follow-up only, near completion).
Full consent form: Consent documents are revised to include the new information. Participants go through a complete consent process that supersedes the original consent using a document or oral process that contains all required elements of consent and is documented in accordance with the federal regulations. This is often referred to as “reconsent.” The consent process includes highlighting the changes for existing participants and obtaining a signature on the revised form or obtaining oral consent as allowable under federal regulations. Typically recommended when:
- The information affects both current participants and participants enrolled in the future.
- The information is significant or complex in nature (e.g. substantive new risk information, new or changing procedures or visits scheduled)
Information sheet/letter/Consent addendum: The new information is communicated through a written document that is not a full consent form. Consent addendums require a signature, while a mailed letter or information sheet may not. The document should include enough detail to provide context to the new information so that participants can evaluate their continued participation. It is acceptable to cite portions of the original consent that are still valid, but study teams should consider providing a reference copy of the consent form, especially if it has been some time since the subject was enrolled. This method may be appropriate when:
- Participants are in long-term follow-up or not being actively seen
- There is no need to revise the consent form (the study is permanently closed to enrollment)
- The new information is straightforward and does not require revisions to the main consent form to provide context.
Verbal communication with documentation in the study record: New information is communicated orally to participants. Participants are provided with an opportunity to consider the information and reaffirm their willingness to continue participating in the research. Typically recommended when:
- The information is urgent in nature and requires timely disclosure to participants (may be necessary to follow-up with written documentation using one of the methods described above, particularly when new risks are involved)
- The information is easily conveyed verbally, does not include additional risks, and does not require revision to the full consent form (e.g., adding a short questionnaire to a visit that is consistent with those already described in the consent and that doesn’t add significant time to participation).
The choice of pathway should focus on the most effective way to communicate the new information to participants considering the status of the participant and the nature of the new information.
Who should be provided with new information and when?
Study teams should consider the status of the study when deciding which participants need to be informed and how. Different methods may be appropriate for participants who have completed participation, those who are in follow-up, and those who are still actively participating. Also important is whether the study is still enrolling new participants.
When presenting a process to the IRB, study teams should describe the following:
- The nature of the changes or new information.
- The urgency of the information and timeline for informing participants. Please see the reporting guidance on when a New Information report may also be necessary.
- Which participants will be informed (e.g. all participants, current participants only)
- How will they be informed (e.g. reconsented with revised consent forms, use of consent addendum, provision of an information sheet, telephone call).
Resources
The Secretary’s Advisory Committee for Human Research Protections provides a Table of Options based on the significance of the change and whether the information is time-sensitive, also taking into account the recruitment status of the study. SACHRP Reconsent Appendix 2
Other Consent Considerations
Some consent scenarios may require alternative consent processes, such as enrollment of 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.
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.