Boilerplate Explanation of Randomization with Blinded Assignment

You can use this boilerplate explanation of randomization with blinded assignment in your own consent forms for similar studies.

If your study has 2 randomized groups:

We will assign you to 1 of the 2 study groups by chance, like flipping a coin. Your group is not based on what you want or what seems best for you. You will have an equal chance of being in either group. You will not be told which group you are in during the study. The study researchers also will not know which group you’re in. So, if you agree to participate, you will need to be okay with being in either group and not knowing which group you’re in.

If your study has more than 2 randomized groups:

We will assign you to 1 of [X] study groups by chance, like drawing from a hat. Your group is not based on what you want or what seems best for you. You will have a 1 in [Y] chance of being in either group. You will not be told which group you are in during the study. The study researchers also will not know which group you’re in. So, if you agree to participate, you will need to be okay with being in either group and not knowing which group you’re in.

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