Informed Consent

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before subjects may be included in research.

The primary purpose of informed consent is to protect the prospective human subjects. Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. 

Keep in mind that obtaining informed consent is a continuous process throughout the research, not simply a one-time event when a subject signs a form.

To ensure informed consent, researchers should:

  • Work to communicate clearly and effectively with their participants and to build trust and cooperation.

  • Openly and willingly explain their research, answer questions, and be sensitive to the needs and concerns of their prospective research participants.

When using an informed consent form, a final version, as it will appear to your subjects (e.g., on letterhead), must be included in the application. 

If no informed consent form will be used, an information sheet and/or informed consent script may be required.

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The informed consent form

Obtaining informed consent is most often accomplished through an informed consent form that each investigator creates for his/her particular research project.

The informed consent form documents the information regarding the research which the subject has been given, and his/her agreement to participate in the research. For guidelines on how to create an informed consent form, see Elements of Informed Consent and Sample Informed Consent Form

Waiver of documented informed consent

When the use of an informed consent form would be impractical or detrimental to the study, a waiver may be requested. Federal regulations allow an IRB to waive the requirement to obtain written documentation of informed consent for some or all subjects under either of the following circumstances:

  1. When the consent document would provide the only link to the subject and the principal risk of the research would be a breach of confidentiality.

  2. When the risk to the subjects is minimal and consent would not be required outside the research context.

If you would like to request a waiver of documented informed consent, explain in your protocol how one or both of the above circumstances apply to your research. Be sure to clearly explain why you believe your research qualifies for the waiver.

Where the IRB waives the requirement for documented informed consent, investigators must understand that they are still required to communicate all the required elements of informed consent to their subjects and that the subject's active consent must be obtained before proceeding with the research.

Examples of projects that might qualify for a waiver of documented informed consent include online anonymous surveys, telephone surveys, and some group research.

Note that if documented informed consent is being waived, the IRB may require an information sheet be given to the subjects and/or an informed consent script be included in your application. 

Information sheets in lieu of documented informed consent

In cases where documentation of consent is waived, the IRB may require investigators to provide subjects with a written statement regarding the research called an Information Sheet.

The information sheet generally includes all the elements of informed consent and looks similar to an informed consent form, without requiring the subject's signature.

An Informed Consent Script

Keeping in mind that informed consent is more than a form, an informed consent script may be required.

An informed consent script outlines how the investigator will conduct the informed consent process and what s/he will say to the subjects to explain this process. 

An informed consent script is most often necessary when a waiver of documented informed consent is being requested. 

Waiver or alteration of informed consent

In rare instances the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent entirely provided it finds:

  1. The research could not practicably be carried out without the waiver.

  2. The research involves no more than minimal risk to the subjects.

  3. The waiver will not adversely affect the rights and welfare of the subjects.

  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Special Topics Involving Informed Consent

Research involving deception or incomplete disclosure

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research -- one of the essential ethical concerns in human subjects research -- and a waiver or alteration of informed consent must be requested of the IRB whenever deception or incomplete disclosure is planned.

Because subjects cannot be formally consented prior to the research, subjects must agree to participate in the research through the use of a consent to participate in lieu of formal informed consent. This agreement will include all of the elements of informed consent aside from a description of the actual purpose of the study. 

To mitigate the concern regarding the lack of informed consent, subjects should ideally be informed prospectively, via the consent to participate, of the use of deception/incomplete disclosure in the research in which they are being asked to participate, and consent to its use. 

Sample Consent Language:

Research sometimes requires that information regarding its purpose not be shared with the research participants because its knowledge could impact the results of the research. While the tasks you will be asked to perform for this research have been explained, the full intent of the research will not be provided until the completion of the study. At that time you will have the opportunity to ask questions, including about the purpose of the study and the procedures used, and withdraw your data if you so choose. Note that none of the aspects of the research being withheld are reasonably expected to affect your willingness to participate.

*Note that, in order for research to be exempt, the consent form must include such a statement of prospective agreement.

Once the subject’s participation in the research is complete, s/he must be debriefed regarding the true nature of the research. A debriefing and informed consent form giving the investigator permission to retain and use his/her data must be signed by the subject and attached to the consent to participate.

For additional important information regarding debriefing and the use of deception in human subjects research, see the IRB's Deception webpage.

Research involving children

Research involving minors (non-emancipated subjects < 18 of age) involves special considerations and federal regulations require certain additional protections for children involved as subjects in research.

For more information, see the IRB's Research with Children and Students webpage.

Research Involving Third Parties

When an investigator conducting research obtains identifiable private information about a living individual, that individual becomes a research subject, regardless of whether that person is the individual with whom the investigator is having an interaction.  For example, if the research involves asking the primary subject to provide identifiable private information about a third party, that third party then becomes a subject in the research. As such, all of the regulatory requirements for protecting that individual apply.

The IRB can determine whether informed consent needs to be sought from third party subjects, or whether it can be waived. In making this determination, the IRB relies on both the requirements for a waiver (noted earlier in this section) and the importance of the information to the research.  Investigators whose research may involve so-called “secondary subjects” are encouraged to contact the IRB Staff to discuss how to best protect the rights and welfare of these subjects in a given project.

Research involving a language other than English

Informed consent must always be obtained in a language in which the subject is comfortably fluent. In those instances where the subjects do not speak English, the informed consent form should be translated into the primary language spoken and understood by the subjects and, if the investigator is not fluent in this language, an interpreter hired to translate throughout the informed consent process.

It is important that the investigator not rely on family members or friends of the subjects. Instead, a professional should be hired with whom the investigator can discuss the study in detail. It is important that the interpreter fully understands the research or s/he may not communicate the information accurately. In addition, it is important that the subjects feel comfortable answering and/or asking questions freely.

In those instances where a subject has some competency in English, the investigator may be tempted to forgo the use of an interpreter. The investigator must be careful, however, to be sure the subject is truly proficient in English. There are often times when a subject believes s/he is proficient “enough” and so does not inform the investigator – or even realize – that both s/he and the interpreter would be better served by the use of an interpreter.

Note that for each language into which documents are translated, a Translation Certification must be submitted with the translated documents.