IRBs help make research ethical. But what is an IRB?

Last month, we were proud to announce the launch of our research initiative, the Helix DNA Discovery Project, which aims to expand our knowledge of genetics and how it relates to everyday life. This initiative was reviewed and approved by an institutional review board (IRB). IRBs are a crucial part of the research process, so we wanted to explain some of what makes them important and relevant to users participating in the project.

IRBs exist to ensure that research studies and projects meet bioethical standards. They are composed of experts on topics ranging from research ethics to scientific research and medical practice, and they include non-experts who represent research participants, the local community, and/or affected groups. IRBs are convened to review and oversee the ethical conduct of research projects—before, during, and after the course of the project. Research projects that meet an IRB’s standards will be approved and allowed to proceed; research projects that don’t will get feedback on how to improve before they come back to the IRB for further review.

IRB ethical standards focus on protecting the study participants. Modern IRBs use standards established in documents like the Belmont Report, which outlines basic ethical principles that guide the IRBs’ research project evaluations.

At a basic level, IRBs evaluate research to make sure the benefits and risks of participating are balanced. The greater the risk to participants, the more the risks need to be offset or justified.

IRBs consider some research to be minimal risk. In minimal risk research, the chance and severity of harm to participants is about the same as they’d face in their normal lives. As such, it doesn’t take much to offset the risks of minimal risk research projects. (The Helix DNA Discovery Project is an example of a minimal risk project.) As research projects get further and further from minimal risk, they have more work to do to convince IRBs that they have balanced their risks. How much the results of the research will benefit society at large can help research projects do so. However, IRBs will give a special focus to how much the research benefits participants.

IRBs will also base their evaluations of a research project’s ethics on the kinds of people that it hopes to recruit as participants—particularly if a project wants to recruit people from groups known as vulnerable populations. These populations are vulnerable in the sense that they are more susceptible than others to harms from research. Some of these groups have historically borne a disproportionate amount of risk and harm from research, while others are particularly susceptible to coercion or other harm. Because of these participants’ vulnerability, IRBs will try to make sure that extra precautions are taken to protect them.

In most cases, the main vulnerable populations that IRBs pay attention to are people who are pregnant, imprisoned, or under the age of 18. People who are disabled or who are cognitively impaired are also often considered vulnerable. The specific details of a research project may make other groups vulnerable, so IRBs also take care to understand those details.

Additionally, IRBs make sure that researchers explain those details to their participants. The main way to do so is through a research project’s informed consent process. IRBs typically have predetermined requirements for what informed consent documents have to describe, such as the likely risks and benefits of the project. They also review how researchers present those documents in person or online.

Meeting all of these expectations and standards that IRBs have for research can be challenging—and rightfully so! Passing IRB scrutiny is a crucial part of keeping research participants safe and making sure that they are being treated ethically. We are proud to be working to advance the field of personal genomics, our understanding of DNA, and its impact on everyday life—and we are especially proud to have a research project that has met these high standards.

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