Protocol Design – Sections of the consent form

Example - Waiver of Informed Consent

A investigator plans to review the medical records of all children ages 3 to 16 years to determine the risk factors for a ruptured appendix. Searching a database containing diagnostic related groups of children admitted to a local pediatric hospital, the investigator finds that approximately 200 children with a ruptured appendix have been admitted to this large, tertiary care children’s hospital over the past five years. The investigator will collect limited data for this research, including the following: vital signs at time of admission to the emergency department and during the immediate preoperative period, level of activity prior to emergency department admission, complete blood count and electrolyte values at emergency department admission, and level of abdominal pain as per age-appropriate pain assessment scale. The investigator will code the data, so that confidentiality is achieved. The results of the research (i.e., any newfound risk factors) will not affect the clinical care of these subjects, since their treatment (removal of appendix) has already occurred, but might affect other children.

This project meets three of the four criteria necessary for a waiver of informed consent: (1) the research will not expose subjects to more than minimal risk, (2) the waiver will not adversely affect the participants, and (3) the research would not be feasible to carry out without the waiver. The fourth criterion, regarding the provision of additional information to the subjects after participation in the study, does not apply since information about clinical care, as related to the prediction of a ruptured appendix, no longer applies to these children.