Parents' Understanding and Recall of Informed Consent Information for Neonatal Research

By Ballard, Hubert Otho; Shook, Lori Ann et al. | IRB: Ethics & Human Research, May-June 2011 | Go to article overview

Parents' Understanding and Recall of Informed Consent Information for Neonatal Research


Ballard, Hubert Otho, Shook, Lori Ann, Iocono, Joseph, Bernard, Philip, Hayes, Don, Jr., IRB: Ethics & Human Research


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.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Parents' Understanding and Recall of Informed Consent Information for Neonatal Research
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.