What is Informed Consent?

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Informed consent is the process of obtaining a patient’s or participant’s permission prior to conducting a medical procedure or investigation on said person. It involves ensuring that the participant completely comprehends and agrees to the potential consequences of any procedures that they will undergo. Examples include, a health care provider asking their patient to consent to a surgical procedure before providing it, or a psychologist discussing information about the study with a future research participant prior to enrolling them into an experimental study. As such, informed consent is collected according to guidelines from the fields of medical ethics and research ethics, and centers around the protection of patient welfare and security.

When a healthcare provider recommends specific medical care, the provider must clearly outline all aspects of a given procedure to the patient, who has the option to agree to the entire proceeding or only parts of it. Beforehand, the patient must complete and sign a consent form, which serves as a legal document of agreement and participation. This form will most often contain essential information regarding a procedure, such as the name of the patient’s condition, the form of intervention that the provider recommends, risks and benefits of said intervention, as well as the risks and benefits of any other options (including not conducting the intervention). In order for consent to be properly given, the patient must have received all information about potential treatments, understood the information, had a chance to ask questions, used the information to decide if they wish to receive the recommended treatment options, and agreed to receive some or all of the treatment options. Only in completing these essential steps can informed consent be satisfactorily given in a medical context.

Meanwhile, the main purpose of clinical trials is to study new medical products in people. As such, informed consent for research or clinical trials is also required, as newly-developed medical products may contain unforeseen side effects or risks. It is therefore important for those considering participation in a clinical trial to understand their role as a research subject rather than a patient, allowing them to make educated decisions about their participation in a study. Participants must be informed about what will be done to them, how the research will proceed, what risks or discomforts they may experience, and that their participation is a completely voluntary decision. A potential research subject must also have had the opportunity to read the consent form, ask questions about anything they do not understand, and have had a sufficient amount of time to make an informed decision.

The processes for healthcare and research are similar in nature, with both having three main ideas that must be fulfilled in order for an individual to have given valid informed consent:

  1. Disclosure. The provider has supplied the subject with the information necessary to make an autonomous decision.

  2. Capacity. The subject has both understood the information provided and formed a reasonable judgment based on the potential consequences of their decision.

  3. Voluntariness. The subject has made an autonomous decision without being subjected to unfair external pressures.

In general, informed consent can only be given by adults who are capable of making their own medical decisions. Children and those who are unable to make their own medical decisions, such as individuals with mental disabilities, must have their informed consent given by a parent, guardian, or other surrogate: individuals who are legally responsible for making decisions on that person’s behalf. The duty of obtaining informed consent for participation within a research study by children, who are unable to provide full consent themselves, is endowed in the parents or guardians, who are thought to have the best interests of the child in mind. Issues can often arise, nonetheless. For instance, there is data supporting that informed consent for research by adults for themselves is often faulty, associated with a poor comprehension of the voluntary nature of study participation, or the meaning of language used in the trial, as well as other issues.

Institutional Review Boards (IRBs) have been put in place by the FDA to preserve the rights of human subjects in biomedical research. An IRB has the ability to review research and can request modifications, approve, and disapprove research to ensure the safety and wellbeing of the research’s subjects. However, an IRB is also able to grant complete waivers of informed consent in the case of research on medical records if it is not practical to obtain consent and as long as there are appropriate guidelines in place to protect the sensitive information. With institutions that serve as “learning healthcare systems,” such as Emory, people may be involved in research that will serve to benefit society, without knowing which studies their records are being utilized for specifically. However, the patient is able to request a record of all disclosures of their HIPAA-protected information for research purposes at any time.

One of the only exceptions to informed consent is in the context of medical emergencies, when a decision must be made urgently and the patient or their surrogate is unable to partake in decision making. Under such circumstances, physicians may initiate treatment without prior informed consent. Even then, the physician should seek to inform the patient or surrogate at the earliest opportunity and obtain consent for ongoing treatment in order to maintain ethical standards.

Overall, informed consent is a procedure that protects patients and participants from undergoing procedures that they may not completely understand nor agree to. Through the key points of disclosure, capacity, and voluntariness, informed consent can also protect individuals from potential mistreatment or falsified information. As a result, the process of informed consent ultimately plays a vital role in medical and research ethics, allowing for more transparency in operations that continue to improve our society and world.