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What is informed consent?
Reviewed by Medicinsk Expert•Last updated: 2026-10-22•Testing

What is informed consent?

Informed consent is the essential process of educating a patient about a genetic test's benefits, limitations, and potential consequences to ensure they can make an educated, voluntary decision.

Understanding the Process

Before a person undergoes genetic testing, it is vital to understand the procedure, the benefits and limitations of the test, and the possible consequences of the results. The process of educating a person and obtaining their permission is called informed consent. "Informed" signifies that the person has sufficient information to make an educated decision, while "consent" refers to the voluntary agreement to proceed.

Who Provides Consent

Generally, informed consent is provided by adults who are competent to make their own medical decisions. For children or individuals unable to make their own medical decisions—such as those with impaired mental status—consent may be provided by a parent, guardian, or other legally responsible party.

This process is typically conducted by a doctor or genetic counselor during an office visit. The provider discusses the test, answers questions, and the patient usually reads and signs a consent form if they wish to proceed.

Key Elements of Informed Consent Forms

While requirements may vary by state, informed consent forms typically include the following:

  • A general description and purpose of the test, including the condition being evaluated.
  • The method by which the test will be performed (e.g., a blood sample).
  • An explanation of what results mean, including positive, negative, uninformative, or incorrect results (false positives/negatives).
  • Physical or emotional risks associated with the test.
  • Whether results may be used for research purposes.
  • Whether results might provide information about the health of other family members.
  • How and to whom results will be reported, including disclosure to health insurance providers.
  • The disposition of the test specimen after completion.
  • Acknowledgement that the patient had the opportunity to discuss the test with a provider.
  • The individual's signature and potentially that of a witness.

Changing Your Mind

Informed consent is not a contract. A person can change their mind at any time, even after a sample has been collected. To stop the process, the individual simply needs to notify their health care provider.

Frequently Asked Questions

No, your results are confidential. They will only be shared with family members if you explicitly consent to that sharing. Some tests may provide information that could be relevant to relatives, so your provider may discuss the possibility of sharing with family, but it requires your permission.
n inconclusive result means the test did not provide a clear answer about the presence or absence of the genetic variant. In such cases, your provider may recommend additional testing, a repeat sample, or alternative diagnostic approaches. They will explain the next steps and any implications for your health management.===
Before signing, you should be told the test’s purpose, the condition it examines, how the sample will be collected, what possible results mean (positive, negative, inconclusive, or false results), any physical or emotional risks, whether the results could reveal information about relatives, if the data might be used for research, and how the results will be communicated to you and possibly to your healthcare team. You should also have the chance to ask questions and receive clear answers about each point.
Yes, you can withdraw consent at any time before the results are released. However, once the test results are processed and reported, the provider may not be able to retract them. It is best to discuss withdrawal options with your clinician or genetic counselor before the test is completed.
Source: MedlinePlus, National Library of Medicine

MedlinePlus brings together authoritative health information from the National Library of Medicine (NLM), the National Institutes of Health (NIH), and other government agencies and health-related organizations.

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