Informed consent

Definition

Informed consent is the process by which a patient or participant voluntarily confirms their willingness to participate in a particular procedure, after being informed of all the potential risks, benefits, and alternatives. It is essential for ethical practices in clinical research and medical treatments.

5 Must Know Facts For Your Next Test

1. Informed consent must include detailed information about the potential risks and benefits of gene therapy.
2. The process ensures that participants understand how gene therapy works and what it aims to achieve.
3. Participants must be informed about alternative treatments available before consenting to gene therapy.
4. Consent forms should be written in clear, non-technical language to ensure comprehension.
5. Informed consent is an ongoing process; participants can withdraw from the study at any time.

Review Questions

• What key elements must be included in an informed consent form for gene therapy?
• Why is it important for informed consent forms to be written in non-technical language?
• What rights do participants have after giving informed consent for a gene therapy study?

Related terms

Autonomy: The right of patients or participants to make their own decisions regarding healthcare interventions.

Gene Therapy:

A medical technique that involves modifying genes to treat or prevent disease.

Clinical Trial: A research study conducted with human participants aimed at evaluating a medical, surgical, or behavioral intervention.