A consent form cover sheet should be included at the front of all more than minimal risk studies’ consent forms. This allows prospective participants to get a quick look at the basics of what the study entails, what their choices are, and what the risks and benefits are, without having to read a lengthy, in-depth description. It allows them to determine quickly if they think they will be interested in participating. It also assists them in understanding the more complex consent discussion.
Sample Consent Form Summary Page
Title of Study
Below is a summary of the study that you are asked to participate in. This outline is meant to be a guide for you to use while considering the study and reading the consent form. It is not meant to replace the consent form, which you will have to sign if you decide to participate in the study. The consent form contains detailed information about the study and about the risks which you will need to consider before making your decision. Read the consent form carefully and discuss it with others before deciding to take part. And remember that, even if you agree to participate, you can change your mind at any time.
Participation is Voluntary
As with all research, this is a voluntary study, and you do not have to participate if you do not want to. Also, you may stop participating at any time
(This section is only required for treatment studies.) (Name available alternative treatments, including the option of not receiving treatment.)
(Describe the basic procedures only, not every blood test and questionnaire. Use a bulleted format):
This study includes some risks and discomforts (please refer to the consent form for further details and explanations of these risks). These include (list only the most important risks, in order of severity and frequency):
This research study is not meant to benefit you directly.*
You may contact the study doctor, ____________ at _________ with any questions.
* If true, you may add “although some benefit is possible,” and name the possible benefit(s).