Our consent procedures and all research protocols have been approved by the Johns Hopkins Committee for Clinical Investigations and all aspects are reviewed annually. Informed consent is a process that involves the exchange of information between the researcher(s) and the potential subject. The purpose of the informed consent process is to make sure that participants understand the goals, risks, and benefits of participating in the research. This process is designed to protect the research participants by making sure that they understand the research before they agree to get involved. An informed participant also protects the researcher and the study.
Before an individual agrees to join a research study (or to have a non-routine medical procedure or test,) they are asked to sign an informed consent form. This form is a legal document that helps to ensure that the informed consent process has taken place. By reading the informed consent form and discussing the study with the researcher(s), a potential participant should understand what is involved with participation and the potential benefits and risks of the study.
A typical informed consent form will have the following elements:
Informed consent forms can be long and difficult to read. However, it is important to read the forms and talk to the researchers before agreeing to join a study. Read through the forms at your own pace. If you have questions about anything you read, ask the researcher.
Links for more information on Informed Consent:
The US Department of Health and Human Services Office of Human Research Protections,
The Office of Human Research Protections provides tips for researchers who are developing their informed consent process on what the process should entail.
American Society of Human Genetics (ASHG)
This document is the ASHG Position Statement on informed consent(back)