Final answer:
To prove lack of informed consent, a plaintiff must demonstrate that an undisclosed or inadequately explained material risk was not made known to the patient, which could have influenced the patient's decision regarding their care. This principle of informed consent is crucial for patient autonomy and ethical medical and research practices. Violations include not fully disclosing study information, influencing participant decision-making, or using one's biological materials without consent.
Step-by-step explanation:
To prove lack of informed consent, a plaintiff must show that a material risk existed that was unknown to the patient and that the risk was undisclosed or inadequately explained. If a healthcare provider fails to disclose a material risk that is not common knowledge or that the patient was not fully aware of, and the patient would have made a different decision about their care had they been informed, this can be a violation of informed consent. This ethical principle is essential in both clinical and research settings, ensuring that patients and participants are protected and are making their health decisions based on all necessary information.
Examples of potential violations of informed consent include offering incentives to prisoners that might influence their ability to make a free choice, not fully informing participants about the structure of a clinical trial such as the use of placebos, or using someone’s biological material without their consent, as in the historical case of Henrietta Lacks. The requirement to obtain informed consent is governed by the autonomy principle, ensuring that individuals have the right to self-determination regarding their participation in medical treatments or research studies.
Every research study must have an Institutional Review Board (IRB) approval, which among other things, ensures that a detailed informed consent form is signed by the participant or their legal guardian if the participant is under 18. This form explains the nature of the research, any risks involved, and upholds the participant's right to confidentiality and voluntary participation.