Clinical Research: How We Keep Volunteers Safe

Clinical research is a type of research that involves people. Research participants help researchers to study new types of treatments, like new medicines or medical devices. It might even include changes in how people live or act, such as different ways to eat or exercise. Researchers ask healthy people, called healthy controls, as well as people who have the condition they are studying to participate.

How do we know clinical research is safe? There are several steps researchers must follow to make sure all volunteers are as safe as possible. There are review boards at the research institution, and national offices all the way up to the federal government, with rules and laws in place to ensure safety and ethical standards are followed.

Office for Human Research Protections

There are national government offices to help make sure clinical research remains as safe as possible. The two main offices are the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). These offices have many regulations telling researchers how to perform research with people. The main regulation is called “The Common Rule”. This rule tells researchers that they need to have approval of their projects by an ethics board; that they need to ask people before they put them in a research study; and that they need to weigh the risks and benefits of research to make sure they are okay for the people in the studies.

Institutional Review Boards (IRBs)

An institutional review board (IRB) is a committee of people that review and approve a study before people can enroll in the research. They make sure the research meets ethical standards and federal regulations to protect the people who would be involved.  An IRB includes at least five people and is made up of doctors, nurses, scientists, members of the communities they serve, and others. Places where research is done, like Nationwide Children’s Hospital, usually have their own IRB, but the IRB reviewing a study can be at other institutions or in stand-alone companies too.

What Does the IRB Require?

The IRB makes sure clinical studies meet certain standards. These include:

• Risks to join the study are low by using well-designed research methods.
• Any risks are acceptable compared to benefits of joining the study.
• Selecting people to join the study is done fairly.
• The research team will get informed consent from each person in the study.
• The research team will keep a record of each informed consent.
• There are enough measures in place to monitor data and ensure participants' safety.
• There are enough measures to protect participants' privacy and confidentiality.
• Extra protections are in place for especially vulnerable participants (e.g., children, those with less education).

Informed Consent and Children’s Assent

When a research team asks someone to join a study, they have a conversation called informed consent. The team explains what the research study is about. This is called the study purpose. They go over the risks and benefits of participating in the study and discuss all the things the study participant will be asked to do. Finally, they tell study volunteers that if they participate, they can leave the study at any time without affecting their care at Nationwide Children's.  Volunteers can ask questions. Parents or legal guardians give permission for children under age 18. Once the parent or legal guardian gives permission, children under age 18 give their assent (agreement) to join.

To keep up to date on the latest clinical research at Nationwide Children’s, follow @NCHClinicalResearch on Instagram.