How to avoid problems with consent forms

Consent forms with these problems cannot be approved; consent forms with several of them may be returned for rewriting and thus delay an application's scheduling for committee consideration.

• Consent forms should not be entitled, "Informed Consent." Informed consent is a process and a state one strives to approximate; it is not a piece of paper. The title tends to obscure the nature of the process, and carries some risk by implying a degree of completeness that the form may not have.
• Strike out formats ("You/Your spouse/your child"). These should not be used where they make the form difficult to read.
• Where children or vulnerable adults are among the subjects, appropriate consent forms should be prepared:
  • a fairly standard consent form for the competent adult subject (18 years or older)
  • a simplified statement a fairly standard consent form for the guardian or parent
  • of assent for the 8-17 year old, or
  • assent for the adult who is not competent to give consent alone.
• Consent forms should not begin with a statement advertising the service or group conducting the study. This is coercive. A simple, factual statement of who's running the study may be inserted in the text of the document.
• Consent forms should not indicate that the patient's physician recommends participation; nor should they "offer the opportunity" (as opposed to "invite") to participate. These are considered coercive.
• Fill-in-the-blank formats, in which the features of a given study are "plugged in" to a stock format are discouraged.
• The clause "only aggregate data will be presented" should be used only when it is true.
• Statements summarizing foregoing consent information should be used only when they genuinely clarify; they should be avoided particularly when they suggest a warning or limitation of liability or opportunity for redress. Problem Examples:
  • The possible risks associated with this study have been presented.
  • The method and purpose of administration of this study have been explained to you. (Also objectional for lack of clarity.)
  • You have been made aware of certain risks and consequences...
• Assertions that drugs or studies have been approved for human use by the FDA may not be in the consent form if any part of the study is outside the licensed and approved indications of the drugs or devices used. Patients interpret this to mean "licensed and approved as given," not "has granted permission for experimentation."
• The patient/subject should not be asked to affirm that the physician will do something, i.e. "My doctors will watch for this problem".
• It is appropriate to point out adverse consequences of study withdrawal. It is not, however, appropriate to point out, in the right-to-withdraw part of the consent form, risks that are not known but might conceivably turn out to be the case if the study works out as the investigators hope. That's coercive.

In treatment studies, a clear distinction must be drawn between consent for the study and consent for the treatment. If the consent form is complex enough that the two may be confused, they should be presented in separate consent forms as described below:

• The benefits described should be those of the study, and should usually include a clear disclaimer that there may be no benefit of getting treated "on study" as opposed to "off study". The benefits of being treated are a different issue;
• The risks described should be those of the study, and should usually include a statement that there are or are not risks of getting treated on study that are not present if treated off study.
• The alternatives described should be those of being on the study, and should usually include a statement whether the study treatment is or is not available outside of the study context.

Where a consent form lists procedures or drugs used in a study, they should make clear the investigational/regulatory status:

• standard
• standard, but being used in a non-standard manner (such as unapproved dose, route, or indication for a licensed drug)
• experimental
• do not say "new" or "improved"

When the list of drugs' and procedures' risks is long, it may often be preferable to list only the major risks in the body of the consent form, and remove the others to a treatment consent form or to an appendix.

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