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.