Informed Consent Frequently Asked Questions

The member(s) of the research team who conduct the consent discussion and obtain informed consent from participants are qualified researchers identified in the consenting plan approved by the IRB.

Fred Hutch IRB expects professionals with certain credentials to obtain informed consent, depending on the type of study and the level of risk involved for participants. Refer to Appendix A of IRB Policy 2.11 Informed Consent for guidelines.

The principal investigator must sign the consent form when:

1. the PI conducts the consent discussion, and
2. there is a Researcher's Statement signature line on the consent form.

Often the person who conducts the consent discussion will sign the consent form immediately after the participant (or legally authorized representative or parent/guardian) because they are in the room with the participant. However, there is no regulatory requirement that the signatures occur at the same time or even place. If circumstances prevent the person who conducted the consent discussion from signing right after the participant, the signature should be executed as soon as feasible, and, if applicable, the research staff should make a note to the study file documenting why the signature dates differ.

For example, after the consent discussion, a potential participant returns home to consider her options. Later, she decides to participate in the research. The participant signs the consent form at home and mails the consent form back to the study staff. After the study staff receive the participant's signed consent form, the person who conducted the consent discussion with the participant should sign the consent form as soon as practical. The person who conducted the consent discussion dates the form with the date they sign; do not back-date to the date that the consent discussion occurred.

Consenting in the Fred Hutch clinic: Providers should refer to policy ADM601 Informed Consent: Research Consenting Guidelines (available via PolicyStat) for research consent documentation requirements at the clinic.

The person obtaining consent should record in the electronic medical record, case history, or study file (as applicable) a description of how, where, and when the consent discussion took place with the participant or participant’s legally authorized representative, and who was involved (for example, in addition to the participant and person obtaining consent, if there was a LAR, a witness to the consent discussion, an interpreter, etc.). The record should also describe how informed consent is documented (who signed and when).

If the study procedures begin on the same day that informed consent is provided (i.e., the date on the consent form), the electronic medical records or research records must indicate that informed consent was obtained prior to the start of any study procedures.

If the participant’s (or LAR’s) signature on the consent form is on a different date from the signature of the person who obtained consent (for example, if the participant took the consent form home and signed it, and returned it to the study staff later), this difference should also be documented with a note to file (either subject- or protocol-level depending on circumstances and IRB-approved consenting plan).

A witness is generally required only in certain situations:

• when there are English-speaking participants who cannot read, either due to low literacy or physical reasons;
• when a participant comprehends English, but is unable to speak or physically unable to sign the consent form; or
• when a short form consent process is being employed to enroll unplanned participants with limited English proficiency. Review the page on enrollment of Non-English Speaking Participants for more information.

There may be other situations in which a witness is needed, such as in specific jurisdictions (e.g., if state law requires a witness), or if a sponsor requires a witness.

The witness should be present for the entire consent discussion.

Note: if a consent form has a witness signature line, this does not necessarily mean a witness must sign for all participants, but rather it is a place for a witness to sign when needed.

Fred Hutch IRB expects a witness to be an impartial witness, that is, not a member of the study staff or clinic team. A witness can be a family member of the participant, an interpreter assisting with the consent discussion if in person or via video conferencing, or other person independent of the study.

Potential participants should be given opportunity to carefully consider joining a study and to discuss their options with others. If a person takes the consent form home and then decides to join the study, he/she can:

• return to the study location where the consent discussion took place and sign the consent form in person; or
• sign the consent form at home and return it to the study team. The original signed consent form can be mailed, faxed, sent via secure email or web portal, or handed to the study staff in person. If the signed consent form is faxed or sent via secure email or web portal, the study staff should make arrangements to obtain the original signed consent document as soon as possible for retention in the study records.

If there is a signature line for the person obtaining consent, the person who obtained consent should sign the returned consent form, dating it the day they signed, and provide the participant with a copy for their records.

Document why the person conducting the consent discussion signed on a different date in the electronic medical record, case history, or study file (as applicable).

Unless justified by exceptional circumstances, the consent process should take place in person, especially for research studies involving more than minimal risk. To conduct a remote consent discussion, an investigator must have approval from the IRB, and specific safeguards need to be in place. Refer to IRB Policy 2.11 Informed Consent for further details.

Note: An investigator is not prevented from answering a potential participant's questions remotely, before or after the consent discussion, if the person has questions about their participation.

Unless a waiver of documentation of consent has been granted by the IRB, no study procedures may start until the research staff has obtained and properly documented informed consent of the participant or the participant’s legally authorized representative. When there is a signature line for the person obtaining consent, the fully signed consent document must be in the study staff’s possession before any research procedures may begin.

If a waiver of documentation of consent has been approved by the IRB, study procedures may begin as soon as the participant or the participant’s legally authorized representative has verbally consented, and the study staff has recorded the participant or LAR’s consent to participate in the research in the electronic medical record, case history, or study file (as applicable).

With approval from the IRB, some studies may involve screening procedures to determine eligibility of potential participants without first obtaining consent from those individuals.

If the investigator anticipates encountering a population that does not understand English, the recruitment materials--including consent form--should be translated into the target language. The consent process should be conducted as normal, with the aid of an interpreter.

However, if a potential participant speaks/reads a language that was not planned for, a short form consent process can be used. For details about how this process works, refer to Non-English Speaking Participants.

The participant should sign the form indicated for their age group.

Requirements for obtaining assent are determined per research study; however, unless the requirement for assent is waived using the same criteria as waiver of consent, the IRB will generally apply the following regarding assent:

• Children age 0-6 generally are not required to assent because they lack age or maturity to provide assent.
• Children age 7-12 generally are required to provide assent if the research has no therapeutic intent, or there are alternative treatments outside the research context. 
• Children age 7-12 generally are not required to provide assent if the research holds the prospect of direct benefit and there are not alternatives outside the research context.
• Children age 13-17 are generally always required to provide assent. 

Study teams must describe how they plan to document consent and assent in the IRB application. If minors will be enrolled, the consent and assent forms should ideally indicate which age groups are expected to sign.

In general, re-consent is required any time a change occurs to the research, or new information comes to light, that could affect a participant's willingness to continue to participate in the research. The IRB will determine whether re-consent is required in each specific circumstance. In general, re-consent will be necessary when:

• There are significant changes to the research procedures, risks, potential benefits, or available alternatives;
• Informed consent was not properly obtained;
• There is a desire to use information and/or biospecimens for research not previously consented to;
• A participant's legal status changes, such as a minor becoming an adult, a previously incapacitated individual regaining autonomy, or a previously autonomous individual losing capacity;
• A translated informed consent document becomes available for a participant who was previously enrolled using a short form consent process.

An additional resource about re-consent is provided within Fred Hutch by Clinical Research Support: Recommendations for Timely Reconsent of Study Participants.

The person who conducts the re-consent discussion does not necessarily have to be the same person(s) who conducted the original consent discussion.

When re-consent is required, the PI may request in the Modification form to allow other members of the research staff than the person who originally obtained informed consent to conduct the reconsent discussion. In general, the circumstances that necessitate re-consent and the information that must be communicated will dictate the qualifications of the individual allowed to re-consent participants. For example, a medical professional would need to discuss with the participant new drug risks or new alternative medical treatments that become available. On the other hand, the PI may not need to be the individual to re-consent participants if a research modification adds another study visit to the planned schedule, or an additional research test is planned for already obtained biospecimens.

Fred Hutch IRB expects professionals with certain credentials to obtain informed consent, depending on the type of study and the level of risk involved for participants. Refer to IRB Policy 2.11 Informed Consent for guidelines.

An additional resource about re-consent is provided within Fred Hutch by Clinical Research Support: Recommendations for Timely Reconsent of Study Participants.

The re-consent discussion does not always have to be in person, but it depends on the information that needs to be communicated and why re-consent is being done as well as the context of the study. In general, if re-consent includes obtaining documentation of consent, the re-consent discussion should take place in person. The investigator should describe the re-consenting plan to the IRB, which should include details about whether participants will be asked to re-sign the consent form and whether the re-consenting will be done in-person or remotely.

An additional resource about re-consent is provided within Fred Hutch by Clinical Research Support: Recommendations for Timely Reconsent of Study Participants.