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Informed Consent

Informed Consent is fundamental to ethical research. The informed consent process gives participants the information they need to chose whether or not they want to participate in research.

Because this is such a key part of the ethical research agenda, the federal regulations have specific guidelines about informed consent procedures in many different situations. This section will discuss both the typical process of informed consent, and special situations that may apply to your research.

The Consent Process

When thinking about the informed consent process, it is important to remember that it is an ongoing process that takes place from the very first interaction with a potential participant until their last interaction with the research.

This means that informed consent starts not with the consent document, but when participants first encounter information about the study. This is why it is important that recruitment materials are accurate and offer potential participants the information they need to know if they are eligible for the study.

If a potential participant is interested they may move into the next stage of the process. For some studies that might involve a conversation with the research team about the study. This gives the potential participants time to ask questions and review the study information. Typically a consent form is used to guide this conversation.

Consent Forms

Consent forms are only one part of the consent process, but they are an important part. It is in the consent form that all the relevant information about the study should be summarized. See our templates for guidance on what needs to be included.

Consent forms should be written in language that is easily understood by the average participant. Remember, that unless your sample will be fellow academics, most participants will not be familiar with the language used within your field. Typically, consent forms for adults should be written at a eighth grade reading level.

Documentation of Consent

At the bottom of a typical consent form is the signature line. This is where consent is documented by the participant's signature. For minors and others who are not legally able to offer their own consent, a parent or guardian's signature will be documented. These participants will be asked to document their assent.

It is important to understand that documentation of consent must meet certain legal standards of documentation. Many forms of electronic documentation will not meet this standard so you will need to check whether the method you plan to use is appropriate. Below is a discussion of when a waiver of documentation of consent may be applicable.

Ongoing Consent

The consent process does not stop once a participant has signed a consent form. As the study progresses, researchers should make sure that participants are fully informed about relevant information and answer questions as they arise. Participants also have the right to withdraw consent even after the study has started.

Record Keeping

The final step of the consent process, even once participants have finished their part, is record keeping. In adherence with LUC policy, researchers must keep signed consent forms indefinitely. This may be done physically or digitally.

Special Consent Situations

There are a variety of consent situations and contexts that may require alteration from the basic process discussed above. Below we will discuss some of the most common, and you can view federal guidance on even more situations here.

Parental Consent and Children's Assent

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.

Audio and Video Recordings

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.

Waiving Consent

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.

Waiving Documentation of Consent

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.

Verbal Consent

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.

Online Consent

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).

Translation of Consent Materials

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.

Deception

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.

Informed Consent is fundamental to ethical research. The informed consent process gives participants the information they need to chose whether or not they want to participate in research.

Because this is such a key part of the ethical research agenda, the federal regulations have specific guidelines about informed consent procedures in many different situations. This section will discuss both the typical process of informed consent, and special situations that may apply to your research.

The Consent Process

When thinking about the informed consent process, it is important to remember that it is an ongoing process that takes place from the very first interaction with a potential participant until their last interaction with the research.

This means that informed consent starts not with the consent document, but when participants first encounter information about the study. This is why it is important that recruitment materials are accurate and offer potential participants the information they need to know if they are eligible for the study.

If a potential participant is interested they may move into the next stage of the process. For some studies that might involve a conversation with the research team about the study. This gives the potential participants time to ask questions and review the study information. Typically a consent form is used to guide this conversation.

Consent Forms

Consent forms are only one part of the consent process, but they are an important part. It is in the consent form that all the relevant information about the study should be summarized. See our templates for guidance on what needs to be included.

Consent forms should be written in language that is easily understood by the average participant. Remember, that unless your sample will be fellow academics, most participants will not be familiar with the language used within your field. Typically, consent forms for adults should be written at a eighth grade reading level.

Documentation of Consent

At the bottom of a typical consent form is the signature line. This is where consent is documented by the participant's signature. For minors and others who are not legally able to offer their own consent, a parent or guardian's signature will be documented. These participants will be asked to document their assent.

It is important to understand that documentation of consent must meet certain legal standards of documentation. Many forms of electronic documentation will not meet this standard so you will need to check whether the method you plan to use is appropriate. Below is a discussion of when a waiver of documentation of consent may be applicable.

Ongoing Consent

The consent process does not stop once a participant has signed a consent form. As the study progresses, researchers should make sure that participants are fully informed about relevant information and answer questions as they arise. Participants also have the right to withdraw consent even after the study has started.

Record Keeping

The final step of the consent process, even once participants have finished their part, is record keeping. In adherence with LUC policy, researchers must keep signed consent forms indefinitely. This may be done physically or digitally.

Special Consent Situations

There are a variety of consent situations and contexts that may require alteration from the basic process discussed above. Below we will discuss some of the most common, and you can view federal guidance on even more situations here.