PSC Column: Part V of V Series: Understanding Informed Consent and Assent in Research

04/15/2026

By Jamie Saunders, M.S., Research Program Manager, MaineHealth Cancer Care Network NCORP

Informed consent is the process through which researchers ensure that an individual understands the nature of a study and makes an informed decision about participation. It involves more than obtaining a signature; it is an ongoing exchange of information that explains the study’s purpose, the procedures involved, potential risks and benefits, how personal information will be managed, and the voluntary nature of participation.

Only individuals who are legally permitted to make their own decisions can provide informed consent. When a person is unable to consent, most commonly because of age or cognitive limitations, a parent, guardian, or other legally authorized representative may provide permission on their behalf. In these circumstances, researchers should also seek the participant’s assent whenever it is appropriate to do so.

Assent serves a distinct but complementary role. It allows children and others who cannot legally consent to express their willingness—or reluctance—to participate. Although assent does not replace legal consent, it is an important means of respecting the individual’s autonomy. The approach used to obtain assent should reflect the participant’s age and ability to understand the study.

Assent may be demonstrated in several ways:

• Verbally: for example, by saying “yes” or otherwise agreeing to participate
• In writing: through simplified or age‑appropriate forms
• Behaviorally: such as cooperating with study procedures or, conversely, showing hesitation

Even when a parent or guardian has provided permission, any reluctance or refusal from the participant should be taken seriously whenever possible.

Key Differences Between Consent and Assent

• Legal Authority: Consent carries legal standing; assent does not and cannot serve as a substitute for consent.
• Who Provides It: Consent is given by individuals who can legally make decisions for themselves. Assent is used when the participant cannot legally consent because of age or cognitive ability.
• Documentation: Consent must be formally documented. Assent may be recorded in various ways, depending on what is appropriate for the participant and the study context.

Both processes support ethical research, but assent places particular emphasis on the participant’s willingness, even when another individual provides legal authorization.

When research involves minors or adults who cannot provide consent for themselves, both the legally authorized representative’s permission and the participant’s assent are typically required.

Informed consent and assent work together to protect participants and uphold ethical standards. Consent provides the legal basis for participation, while assent ensures that individuals who cannot legally consent still have an active and meaningful role in the decision to participate.

Additional resources: Research with Children FAQs | HHS.gov

Missed Parts I, II, III or IV? You can catch up here:

Part I of IV Part Series: Informed Consent Discussion & Documentation – NRG Oncology

Part II of IV Part Series: Informed Consent Discussion & Documentation Options – NRG Oncology

PSC – Part III of IV Series: Waivers – Documentation & Consent – NRG Oncology

Part IV of V Series: Recording the Consent Process – NRG Oncology