If you’re thinking of volunteering to be in a research study, the people doing the study will usually ask you to sign a form saying that you’re agreeing to be in the study. This form is called an ‘informed consent form’.

By signing this form, you are saying that you have made a free and informed decision to participate in this study. Consent is considered free when it was given voluntarily without any coercion or undue influence (no one forcing you to say yes). Consent is “informed” when you are able to fully understand the consequences of being in a study and make a decision about your participation.

An ‘assent form’ is for people who might have trouble understanding the longer – and often more detailed – ‘informed consent form’. It’s also for people who haven’t reached the legal age for consent or do not have the capacity to decide for themselves. The ‘assent form’ allows them to say ‘yes’ or ‘no’ to the research, even if they don’t understand everything about it.

For example, if a research study is about people who are 10 years old, then all these children would sign an ‘assent form’. Their parents or guardians would sign an ‘informed consent form’. And if a research study was about adults with advanced Alzheimer’s Disease, some of these adults might not be able to understand the ‘informed consent form’. So each of them would sign an ‘assent form’, and their relatives or legal representative would sign an ‘informed consent form’.

You never have to be in a study; it’s your right to say no. And saying ‘no’ to a research study should never mean that you won’t get the medical care that you need. Even children who are too young to understand about research, and adults with limited abilities, have the right to say ‘no’ to research.

If someone asks to you sign an ‘informed consent form’ or an ‘assent form’, you should read the form carefully before you sign it. Be sure to ask the study team questions if there’s anything you’re not sure about. You can ask to take the form home with you, to talk about it with your family and friends, before you decide if you want to be in the study.

Even if you sign the form, you can stop being in the study whenever you want.

The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.