This image is a banner for "Science Wednesdays" by Open Medicine Foundation. It has a blue background with hexagonal shapes and a DNA-like structure on the right, symbolizing scientific research.

What is an IRB or Ethics Board?

From the Desk of Dr. Danielle Meadows
Vice President of Research Programs & Operations

Professional headshot of Danielle Meadows smiling at the camera.

The IRB plays a central role in the first stage of the research process—linked here again if you missed it—so it’s probably about time I talk about what an IRB (or the non-US equivalent) actually is and does.

The image is a flowchart depicting the stages of a research study process with four connected arrows: "Study Design, IRB/Ethics Review," "Recruitment, Data Collection," "Data Analysis," and "Publication." The "Study Design, IRB/Ethics Review" arrow is highlighted, emphasizing this particular phase of the study.

In short, no formal research can be conducted on humans without receiving approval from an institution that has the authority to review the ethics of a study. So this part of the first stage of the research process is not only important, but required.

The Heart of the Matter

  • Having an ethics board review a study’s protocol is a necessary step before you are able to conduct human subject research, making it part of the first stage of the research process: “Study Design, IRB/Ethics Review”.
  • Different countries have different regulatory agencies that perform ethics reviews. These agencies are the Institutional Review Board (IRB), Research Ethics Board (REB), Swedish Ethical Review Authority, and Human Research Ethics Committee (HREC) in the United States, Canada, Sweden, and Australia, respectively.
  • Ethics review boards protect human subjects in research by ensuring that the information collected from them is necessary, that procedures done are safe, and that participants give informed consent.
  • The time it takes to do an ethics review depends on the complexity of the protocol, the kind of review being conducted (full vs. expedited), and the number of rounds of review required

Having a research protocol reviewed and approved by an ethics board (e.g., an IRB) is a crucial step in conducting any study on human subjects. 

What is an IRB or Ethics Board?

An ethics board’s primary objective is to protect human subjects during the conduct of research. In the United States, requiring an ethics review of a study traces back to something called the Belmont Report, released in 1971, which served as the foundation for existing regulations on the ethics of human subject research—now known as the Common Rule. Many other countries have their own version of the Common Rule. 

For countries where OMF has research centers, the institutions responsible for ensuring ethics regulations are followed in each and every study are: an Institutional Review Board (IRB) in the United States, a Research Ethics Board (REB) in Canada, a Swedish Ethical Review Authority in Sweden, and a Human Research Ethics Committee (HREC) in Australia. 

What kinds of things do review boards look at?

At its core, an ethics board checks for three major things:

  1. The information collected from participants in a research study is necessary to address the question being asked, 
  2. The processes performed as part of the study don’t put the participant at undue risk, 
  3. And each participant understands what is being asked of them and why and consents to participate.

How long does an IRB or Ethics review take?

As with many parts of research, the time required for a full protocol review can be unpredictable. In general, protocols are reviewed during meetings that occur on a specific cadence, and it typically takes at least three months to receive approval, though the process often lasts longer than that. More involved protocols—those that ask participants to do more things and have complex components—are more likely to take longer to get ethics approval. 

The time it takes for ethics review also depends on the type of feedback they provide, the number of rounds of review that are done, and the type of review requested. The first time a protocol is reviewed, it has to go through a full review by the ethics board—they provide feedback on the protocol, the researchers make revisions, and the protocol is resubmitted. This process can happen multiple times before getting approval. 

After a protocol has been approved, if any changes are made (called amendments), they also need to be reviewed and approved. For OMF’s Life Improvement Trial, for example, an amendment was submitted after the initial protocol was approved to make small updates, including the plan to share de-identified data in an open repository after the trial. Read more about the setup of the trial through the study’s protocol paper. For a minor change without any significant impact on participants, researchers can request an expedited review. Major amendments, however, need to go through a full review.

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia Leading Research. Delivering Hope.Open Medicine Foundation®

What are the advantages of giving from your Donor Advised Fund (DAF)?

  • Your gifts to your donor advised fund entitle you to an immediate income tax deduction at the time of contribution.
  • You avoid capital gains tax on appreciated assets you place in your donor advised fund.
  • Your fund’s investment gains accumulate tax free.
  • Funds are distributed to Open Medicine Foundation in your name and immediately put to use to support our worldwide research efforts.


How do I make a donation through my DAF?

Just click on the DAF widget below. It is simple and convenient to find your fund among the over 900 funds in our system.

Still can’t find your fund? 

  • Request a grant distribution through your Donor Advised Fund sponsor
  • Be sure to use OMF’s EIN #26-4712664
  • You can also designate OMF as a beneficiary for your Donor Advised Fund
  • Questions? Give us a call at 650-242-8669