The Importance of Informed Consent

Informed consent is one of the most important things to consider when conducting a research project. After all, if someone is interviewed or tested without giving consent, the study could be deemed unreliable and the researchers could land in a messy legal battle.

Basically, informed consent is something that was created to protect the participants in a biomedical research study. What this means is that no researcher can include a person in a research project without getting approval from them first. This protects the individual from harm and protects the researchers from being sued or having their project deemed invalid or unethical.

Informed consent can be granted in a couple of different ways. For example, the individual can give his or her consent, or that of  their legal guardian or representative. The consent needs to be written down on a form that includes everything from the details of the study to its possible risks and benefits. The form not only needs to be signed but needs to be looked over with participants to ensure that it is clear so that they understand its contents before signing.

Informed consent is also a way for individuals to receive valuable information about the study in which they will participate. This is not a one-shot deal. For as long as the study continues, the researchers need to provide participants with information about the study. For example, if volunteers have questions or concerns about what is going on, researchers have to take the time to address such inquiries. If new components are added to a study as time goes on, participants are allowed to ask about additional risks and benefits. It is important to know that participants can leave a study at any time and can even withdraw their earlier consent forms.

Consent forms have to be given to the IRB for approval to ensure that the information about the research was as specific as possible. The informed consent forms are supposed to be clear enough so that even folks without medical training should be able to understand them. Basically, informed consent is something used to not only protect participants from harm, but also to give them as much information as possible about a study so that they know exactly what they are getting into before they sign up.

If you are a researcher, you need to be thorough when it comes todrafting a consent form. You do not want to go through with a study only for the form to be rejected by IRB. Thus, ask friends and colleagues to read over your form to ensure that it is as informative as possible. Have these readers ask you questions so that you can be sure that all necessary information is included in this document.

If you want to safeguard a study, researchers can also include additional materials to help participants understand the extent and purpose of a study. For example, some researchers may include videotapes documenting the illness that it is at the heart of the study. The more a researcher works with participants to ensure their complete understanding of the project, the more likely it is that the participants will give and continue to give their informed consent to a project.

This post is made possible by Argosy University, where getting a degree is one thing. Succeeding, quite another.