Why obtain informed consent

Let your health care provider know of your wishes. You have the right to refuse any and all treatment options. You may also choose other treatment options that have been presented to you by your health care provider, even if they are not as well proven as the one your health care provider recommends.

You may also refuse part of the treatment options, without refusing all care. For example, you may choose to refuse surgery, but still wish to be treated for pain. In this case, it may be up to you to find another health care provider or facility to treat you with such an approach if your health care provider is not comfortable with it. If you have decided to refuse treatment or diagnostic tests, your health care provider may tell you about the risks or likely outcomes of this choice, so you can make an informed refusal meaning, you understand what could happen to your health by refusing the recommended treatment but you still don't want the treatment.

In this case, you might be asked to sign a form to state that you received this information and that you still chose not to be treated. In order for individuals to participate in a study, they must receive information about what their involvement would include and voluntarily agree to participate, known as the informed consent process.

Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and start a relationship between researcher and participant based on communication and trust that continues throughout the trial.

Informed consent is defined as the process of providing participants important information pertaining to the clinical trial, including what procedures they will undergo and possible risks and benefits. The information is intended to help participants make an informed decision on whether or not they want to start or continue with a clinical trial.

The informed consent of the participant must be obtained before any research procedures start. This is documented by an informed consent form ICF signed by the participant.

This document is kept on file for the duration of the clinical trial, as well as a specified time period afterwards for auditing purposes. Participants must know key aspects of the protocol and understand their involvement in the trial is voluntary.

They can withdraw from the study at any given moment, without reason. Informed consent is not a one-time process; it is the start of a relationship based on communication.

Research staff should not only obtain informed consent before any trial-related procedures begin, but consistently throughout the trial. Conversely, there are times when informed consent is not needed, although these cases are rare. There are many reasons why a participant decides to join a clinical trial — they might want to advance science, or they may see it as their best option for treatment.

Regardless of their reasoning, participating is voluntary, and subjects can opt-out at any time without any given reason. Informed consent is obtained to assure the researcher that the participant knows every aspect of their participation in the trial — what the procedures or treatments are going to look like and the potential outcomes, including the benefits and the risks.

Obtaining informed consent also benefits the research staff. A good consent process means the participant understands what is being asked of them. Investigators or IRB approved designees must use the following steps in order to orient the potential subject to the purpose of the research and why they might wish to participate:.

The responsibility of ensuring that a potential subject understands the research and the risks and benefits involved falls upon the Investigator and not upon the potential subject. It is critical to the consent process that the Investigator not only field questions but also asks questions. Asking questions can further the discussion, elicit questions from the potential subject, prompt the potential subject to think more carefully about the study, and help the Investigator decide whether the person has adequately understood the study.

Useful questions will be open-ended and non-directive. Rather than asking for yes or no answers, they ask for explanation because these questions often can be answered in a variety of ways, and do not already contain the correct answer. Open-ended questions are often introduced with "what," "where," "how often," "when," and "please describe.

The IRB suggests that investigators use the decision-making capacity tool as needed to assess subject comprehension. In contrast, closed-ended questions do not further discussion and tend to bring it to a stop, so they should be avoided. Examples of closed-ended questions are:. The Investigator who has oriented and consented the subject also must sign and date the consent form. Usually, the Investigator, subject and impartial witness when required—see below sign at the same time.

The Investigator's signature cannot pre-date the subject's signature. It may be appropriate for the Investigator to sign after the subject if the Investigator needs to verify that basic eligibility criteria have been met. The subject should always be provided with a copy of the consent form to use as continual reference for items such as scheduling of procedures and for emergency contact information.

NOTE: The subject is not technically enrolled until both the subject and the Investigator have signed. The witness must be impartial, such as an adult who is not a member of the study team i. It informs the participants about the trial and lets them make educated decisions about taking part in the study.

The process is similar to informed consent in healthcare. In a research setting, it involves discussing the following:. In an emergency, your provider may look for your closest blood relatives for consent. When a healthcare provider recommends a specific procedure, you have the right to accept or refuse it. Informed consent means that you made a voluntary and educated decision.

It also means that your healthcare provider has fully explained the medical procedure, including its risks and benefits. Talk to your healthcare provider if you have questions or concerns about this process. As the patient, you have the right to make informed choices about your medical care and what works best for you. One in three women and one in six men in the United States experience sexual violence in their lifetime.

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