Academic journal article
By Ballard, Hubert Otho; Shook, Lori Ann; Iocono, Joseph; Bernard, Philip; Hayes, Don, Jr.
IRB: Ethics & Human Research , Vol. 33, No. 3
Numerous studies have shown that research participants often fail to understand important core requirements of informed consent: the purpose of the study, its risks and benefits, that participation is voluntary, and that they have the right to discontinue participation. (1) For instance, studies have shown that the core requirements for informed consent in the perinatal and neonatal settings were only understood by 3-30% of parents. (2) In one study involving 200 parents who agreed to enroll their newborns in a randomized controlled trial, 70% had difficulty in one or more areas of the consent process. (3)
Our previous research of the informed consent process in the neonatal setting demonstrated that parents' recall of the study in which their newborn was enrolled was marginal, with only 3% of parents able to fulfill knowledge of all the core elements of informed consent. (4) This was in spite of stringent criteria for all key personnel who participated in obtaining informed consent. All key personnel were required to complete a continuing education course about the protection of human subjects. In addition, key personnel received training from the institutional principal investigator about the focus of the study and about the content of the consent form. Moreover, they observed the principal investigator obtain parental consent during a consent process at least once before they conducted a consent process on their own. Additionally, a certified clinical research coordinator (CCRC) met with parents before and after they had agreed to enroll their newborn in a clinical trial to answer questions and ensure they had received a copy of their signed consent forms.
With previous studies demonstrating that many parents of neonates do not fully understand the key information provided to them in the consent process, (5) we developed an enhanced consent process to measure parents' understanding and recall of key information for a phase II clinical trial in the neonatal setting.
Study Participants and Methods
Parents eligible to participate in the informed consent study had to meet two enrollment criteria: they had enrolled their newborn in a specific phase II study in the Neonatal Intensive Care Unit at the University of Kentucky from September 2004 through December 2007, and their newborn survived to discharge. The phase II study included critically ill neonates who weighed less than 1,250 grams at birth and required mechanical ventilation during the first 72 hours of life. Infants with major congenital anomalies, rupture of membrane for more than seven days, or intrauterine growth retardation (birth weight less than fifth percentile for gestational age) were excluded. The phase II study was a double-blind, placebo-controlled trial designed to evaluate the effect of azithromycin for the prevention of bronchopulmonary dysplasia. For the phase II study, either the investigators and/or the CCRC assigned to the study approached parents about enrolling their newborn. Everyone on the research team who sought informed consent for the phase II study had completed an educational program on human subjects protection.
For the informed consent study parents were assigned to standard consent or enhanced groups in alternating blocks of 30, with a total of 60 parents in each group. The initial block was the enhanced consent group and alternated thereafter. This type of block design was chosen due to the investigators' concern over possible "contamination" of study results that might result if participants discussed what group they were in while sitting in family waiting rooms or other common areas. This type of contamination has been reported previously by other investigators, and we attempted to minimize its effects through our larger block design. (6) We collected demographic data including maternal age, gestational age, birth weight, ethnicity, sex, and marital status, as well as details about the infant's delivery, including maternal medication history. …