Informed Consent

When children are the participants the consent process becomes two-fold. Since children are not able to legally give consent on their own behalf, researchers must gather consent from their parents or guardians. If the child is old enough, they must also assent. Without both consent and assent the research cannot proceed.

When writing assent documents it is important to make sure that the language is easily understood by the child. If your study populations involves children of different ages, you may need more than one assent - a document that is comprehensive and easy to understand for a thirteen year-old may be confusing for a seven year-old. See our templates section for guidance.

When audio and/or video recordings are part of the data collection process, it is important that the consent materials clearly state that. It is also important to discuss how the recordings will be used, a participants who would be fine with video being used as a tool for analysis, may not be okay with the same video being used in a public presentation.

It is a good idea to have participants affirmatively consent to being audio or video recorded in the consent form. Some researchers may also want to offer participants the choice of opting out of being recorded, or offer participants the chance to select the ways in which their recordings can be used (e.g. for analysis only, for conference presentations, in public settings).

If recordings will be kept past the study or archived, that should also be made clear to participants and the IRB may require a secondary permission process for the sharing or archiving of audio/visual materials.

In some, limited cases the IRB can grant a waiver of consent. It must be integral to the study design that participants cannot be informed, not merely a matter of convenience for the researcher.

This only applies in cases where the study presents no more than minimal risk to participants, AND the study could not be carried out without the waiver, AND the waiver will not adversely effect the rights and welfare of the participants, AND, if possible, the participants will be informed of the study afterward. See this flow chart to determine if this might apply to your study.

When a waiver of documentation of consent is granted, the participants still experience most of the consent process discussed above. The only difference is that they do not legally document their consent (typically, in the form of a signed consent form). They will receive all the same information, but the researcher will not collect documentation (signatures).

The IRB can grant a waiver of documentation of consent for studies that present more than minimal risk to participants only when no other identifiable information is being collected and it is the signed document that presents the main risk. This is typically in cases where information that could have negative legal consequences is being collected (e.g. drug use, immigration status, etc.).

For studies that present no more than minimal risk, the IRB has more flexibility. As long as the study involves no procedures for which written consent would be required outside of the research context the IRB can grant a waiver of documented consent. See this flowchart for help figuring out if your study meets the requirements.

In some cultural contexts signed consent forms are a barrier to research. In places where legal documents are uncommon, a signed consent form could be inappropriate. If the study presents no more than minimal risk then a waiver of documentation of consent may be appropriate and verbal consent can be used.

When designing a verbal consent procedure, it is important to build a script that is easy to understand, but includes all the same points that would be included in a consent form. See our templates for guidance.

Some information, such as contact information, may not be easily conveyed in a verbal script. It may be useful to have contact cards (with researcher and IRB contact information) that are given to participants as part of the consent process.

Many studies take place online. For online studies that present no more than minimal risk, a waiver of documentation of consent may be appropriate since most common methods of noting consent online (check boxes, clicking 'I agree,' drawing a signature, etc.) do not meet the standards of legal documentation. Most online surveys, experiments and interviews fall into this category.

For online studies that present more than minimal risk, a consent procedure will need to be designed that allows participants to ask all the clarifying questions they need (which may involve a phone or video call) as well as legal documentation of consent (often using a service such as DocuSign).

Federal regulations state that consent must be presented to participants in a language understandable to the subject. When participants do not speak English, the IRB will require consent forms to be translated.

If consent materials will be translated then you need to describe the qualifications of the translator(s). Although translated forms must be submitted to the IRB, it is recommended that English versions of the consent forms be approved prior to translating, minimizing the number of translations needed. Later, the translations can be submitted through an amendment.

For studies that are more than minimal risk, the Board requires that the researchers either use certified translators (with a letter of certification from the translator or translation service) or that a “back-translation” by a different translator than the one who performed the original translation be provided. The translated documents (forward and back), as well as documentation of the qualifications of each translator, must be submitted to the IRB for final approval.

In studies where deception takes place the consent process is altered.

Deception can include giving participants false information (pretending a researcher is a fellow-participant, or presenting participants with false or altered media), or withholding information (not revealing the true topic of the study).

For such studies, the initial consent process is incomplete as these deceptions are not revealed as part of the study procedures. That is why the IRB will usually require a debrief. If a debrief cannot be offered, then you will need to request a waiver of consent as the consent process cannot be completed.

A debrief should explain what deception took place and the true purpose of the study. In some cases, the IRB may require that participants be offered the chance to withdraw their data at this time, or actively re-consent to the study now that they understand the true scope. See the templates page for guidance on debriefing documents.