Helpful Hints
When Submitting Consent Forms for Review

• Please add a footer to each page of your consent form which indicates the version number and date of the consent form. These should change each time you modify the consent form. Remember that each new version of the consent form must be reviewed and approved by the Human Subjects Division. Indicating the version number and date on the consent form helps both the investigator and the Human Subjects Division keep track of which is the most current consent form.
• Please check the grammar and grade level of your consent form(s). If you have Microsoft Word, you will find the grammar function under the Tools menu. After the program checks the grammar and makes editorial and spelling suggestions, it will give you "readability statistics," including the grade level of your consent form. Because subjects come from a wide range of educational and socioeconomic backgrounds, we recommend that you write your consent forms at a level no higher than eighth grade.
• The heading "Investigators' Statement" or "Researcher's Statement" should be formatted to parallel the heading "Subject's Statement". The heading "Investigators' Statement" (and its analogues) applies to the entire consent form up to and including the investigator's signature line -- not simply to the initial paragraph. The formatting should make this clear.
• Attestations of understanding (e,g,. "I understand that") should not be put into the mouths of the subjects. One of the most common forms of misunderstanding is supposing that one understands when one does not, and requiring subjects to attest to their understanding of a particular point is thus at best a meaningless exercise. Furthermore, the phrase can carry an exculpatory weight that is quite at odds with the nature of a consent form. Finally, because consent documents must not state, suggest or imply that subjects give up any legal rights, or have entered into contractual obligations abridging their rights, phrasings of this sort, which occur in contracts and waivers, have no place in the subject's statement of a consent form.
• If you intend to make exceptions to confidentiality, state them clearly and directly in lay terms. Statements like "as provided by law", or "in accordance with law", or worse, statements citing specific statutory provisions, have no place in a consent form, unless knowledge of the relevant statutes is one of the eligibility requirements. The purpose of a consent form is to be informative. Such phrases and citations are not informative to anyone who does not have a thorough grounding in the relevant law and precedents. Except under unusual circumstances, no consent form containing such statements can be approved.
• Statements like, "You don't have to answer any question that makes you feel uncomfortable" should be avoided. Subjects are always free not to answer any question (or questions) at any time, for any reason whatsoever, and must not be told otherwise, or subjected to the insinuation that their refusal to answer will be taken as a sign of special sensitivity to the subject of the question. "You don't have to answer any questions you don't want to answer," is more accurate.
• The standard subject's statement text contains a bracketed statement consisting of a sentence and instructions on when to include that sentence. That bracketed statement appears just below.

  [If relevant, add: I give permission to use my medical records as described in this consent form.]

  This bracketed statement should never be included as it appears in the standard consent forms. Instead,

  • If medical records are being used, omit the brackets and the instructional clause, but retain the main embedded sentence
  • If confidential records (e.g., academic records or counseling records) other than medical records are being used, omit the brackets and instructional sentence, and retain the embedded sentence, but replace the qualifier "medical" with one appropriate to the study (e.g., "academic").
  • If no confidential records of any sort are being used, omit the entire bracketed passage -- and the brackets as well.
  • If some other combination of circumstances pertains (e.g. both medical and academic records are being used), it is that particular configuration of circumstances and no other that should be described.

General Information Archive
Consent Form Readability
Main Human Subjects Division Page