People who participate in research, from observational studies to clinical trials, are crucial to moving science forward. These volunteers are essential to helping biomedical researchers understand what causes diseases, how they might be treated, and whether new treatments are effective and safe.

It is essential that the health and well-being of research participants are prioritized in these studies. To make sure that researchers are adhering to legal and ethical guidelines, any such study in the US, including those involving people with ALS, must seek the input of an Institutional Review Board (IRB). An IRB is a committee of experts that considers the interests of people participating in a research study and is empowered to approve – or reject – the methods and practices of that study.

Who serves on an IRB?

An individual or group of researchers that aims to conduct studies with human participants must assemble an IRB that meets these requirements.

  • According to FDA regulations, an IRB must include at least five members.
  • These members may include other researchers with expertise in the study’s field, legal experts, and bioethicists.
  • The FDA also requires that the IRB must include at least one person with a nonscientific background to serve as a community representative.
  • If the research group is part of a larger institution such as a biotech company or university, at least one member must have no association with that institution.

These individuals who serve on an IRB provide independent oversight for the study and make sure that participants’ interests are being fully considered.

What does an IRB do?

After assembling the IRB, the researchers must then submit their study design to the IRB for comment and approval, and they must address any concerns or feedback they receive from the IRB members. This is required for any study that involves people as research participants – from a simple survey to a longitudinal observational study or even a clinical trial.

An IRB will consider questions such as:

  • Does the study adequately minimize any risks to the participants?
  • Do the study’s risks, if any, justify its potential benefits for participants?
  • Will the participants be well-informed about the study’s requirements and potential risks or benefits?
  • Does the study protect the privacy of participants?
  • Does the study meet all legal and regulatory requirements?

If the IRB feels any of these requirements are not met, they will ask for changes to the study design to resolve any potential issues. Once the researchers have submitted an acceptable study design, they will vote to approve it, and the research can move forward. As the study continues, any further changes to its design or protocols must be submitted and approved by the IRB in the same manner. An IRB may only approve a study for up to one year ­– researchers conducting a study lasting longer than this must seek reapproval from their IRB annually.

While an IRB is responsible for reviewing and approving a study’s design, in the case of a clinical trial, they are not the only group charged with ensuring participants’ safety. Another independent board of scientific and medical experts, a Data and Safety Monitoring Board (DSMB), will periodically review the data generated by clinical trial, as well as any issues that may arise among participants, while the study is ongoing. Unlike an IRB, all members of the DSMB must be completely independent of the institution running the trial. It is this group’s responsibility to advise the trial sponsor as to any changes that need to be made if participant safety issues arise – and, in some cases, to recommend ending the trial if the treatment appears to be unsafe or ineffective.

The IRB and Research at ALS TDI

At the ALS Therapy Development Institute (ALS TDI), our ALS Research Collaborative (ARC) study gathers data from people around the world to learn more about ALS and accelerate drug discovery. These data inform research at ALS TDI and is shared with other ALS researchers throughout the space through the ARC Data Commons.

To make sure the people who generously share their data with us are adequately protected, ALS TDI’s IRB reviews and approves every aspect of the ARC study. This includes an annual evaluation of the program, as well as reviews of any new aspects that are introduced. In June 2023, the IRB approved a plan to greatly expand the study, signing off on the recruitment of 1000 new participants, the introduction of participant’s medical record data, and the inclusion of asymptomatic ALS-related gene carriers.

To learn more about the ALS Research Collaborative (ARC), click here.

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