Many (but by no means all) human subject research studies require using a written informed consent form to document the subjects’ agreement to participate. Federal regulations and IRB policies have specific requirements for the information that must be conveyed during the informed consent process, and when you’re using a written consent form, that form should reflect what subjects are told during the process. Here are some tips for drafting a consent form that will meet the IRB’s consent form requirements:
- The consent process, including the language used in the consent form, must be presented using language understandable to the subject. This refers not only to the language used (English versus Spanish, say) but also to the reading level of the consent form. The simpler the language you can use, the better. Consent forms that incorporate language directly cut and pasted from the protocol almost always get sent back for revision, because protocols are written for scientists. Consent forms need to be written for people who haven’t spent half their lives in grad school. We recommend keeping that elderly relative that you only see during the holidays and who has never worked in a scientific field in mind as you’re drafting your consent form. When she asks you, “So, what’s that big project you’re working on right now? Something about curing cancer or something?”, what kind of vocabulary are you going to use to describe the project to her? Use that same level of vocabulary as you put your consent form together.
- Check that your consent form contains all required elements, but don’t include the optional elements that do not apply to your study. For example, if your project is not subject to FDA oversight, you don’t need to indicate that the FDA might look at study records. You don’t have to indicate that some side effects of treatment may be unknown if your study doesn’t involve treatment. See UAMS IRB Policy 15.1 for the required elements, and also use the checklist available on the Office of Research Compliance website to double-check.
- Have someone who is not familiar with your study read your consent form before you finalize it to make sure it fully explains the study procedures in an understandable way. (Maybe that elderly relative that you only see during the holidays.) Seriously. We’ve found that PIs who write their own consent forms are already so familiar with their study that they don’t recognize that the gaps in their explanations of study procedures are unclear.