Minutes - National Institute of Nursing Research - National Institutes ...

The majority of Dr. Menikoff’s presentation focused on improving informed consent,particularly the consent form. He emphasized that the consent form is an important part of theconsent process because it serves as documentation that volunteers received the key pieces ofinformation they needed when deciding whether to participate in a study. Thus the consent formshould be clear and understandable to potential research subjects. However, investigators andstudy participants have often complained that consent forms are too long (sometimes as many as30 pages), that the language is often too legalistic, that consent forms often function more assales documents than as decision aids, and that the forms frequently fail to include the mostimportant pieces of information that could help someone make an enlightened decision. Thus theproposed rules aim to:• Prescribe the appropriate content that must be included in the form, perhaps with greaterdetail and specificity than the current regulations provide.• Restrict the content that would be inappropriate to include.• Limit the acceptable length of various sections of the form.• Prescribe how information should be presented, for example what information should bepresented at the beginning of the form and the type of information that should be included inappendices.• Reduce institutional boilerplate language that is usually included to protect institutions fromlitigation, rather than to inform study subjects.• Provide standard consent form templates that could be used to satisfy the new regulations.17