Improving the Quality of Informed Consent to Research

By Schwartz, Victor; Appelbaum, Paul S. | IRB: Ethics & Human Research, September-October 2008 | Go to article overview

Improving the Quality of Informed Consent to Research


Schwartz, Victor, Appelbaum, Paul S., IRB: Ethics & Human Research


A substantial body of work has demonstrated that many research subjects have significant misunderstandings about the clinical trials in which they agreed to participate, despite lengthy informed consent documents and detailed explanation of the research during the informed consent process. (1) These failures of comprehension range from factual errors to misconceptions about the very nature of clinical research and how it differs from ordinary treatment. (2) Thus, a signature on an informed consent document does not guarantee that an individual understands or appreciates what it means to be a research subject in a clinical trial.

Although there has been broad awareness of this problem for the past 20 years, efforts to address it have been largely unavailing. Data on innovative approaches to obtaining informed consent show no consistent effects of these efforts. (3) Although well-intentioned investigators and Institutional Review Boards (IRBs) have developed more detailed consent forms, it has become clear that more information per se does not necessarily lead to better understanding. In fact, it may be that as the amount of information increases, prospective subjects may have more difficulty grasping essential information, (4) thus leaving the research community with a disturbing ethical dilemma.

Some researchers, recognizing that no approach to informed consent is perfect, have begun to use brief questionnaires during the consent process to assess the understanding of potential research participants. (5) This enables specific deficits to be identified and addressed. Potential participants can then be retested before being accepted into a study. Obviously, though, this approach is not perfect. Investigators must identify the truly crucial information to include in their few questions and must determine what constitutes a "passing grade"; over time, collaboration between investigators and IRBs may lead to an evolving consensus as to which information is the most important to include and how much of it potential subjects must grasp. And there is the risk that prospective subjects will simply be fed a script by the person conducting the consent process--often not the Principal Investigator (PI) but another member of the research team--resulting in no real increase in understanding or appreciation of the purpose and features of the clinical trial. Finally, IRBs concerned with ensuring that individuals enrolled in trials truly grasp the nature of the study have no way of monitoring the results of the educational process or the accuracy of the resulting scores.

Our contribution here is focused on the question of how investigators and IRBs might monitor the informed consent process--including the disclosure of information as well as the testing, reeducating, and retesting of prospective subjects--all with an eye to improving the quality of the consent process. One possibility is to record the consent process using inexpensive digital recorders (available for less than $100) that can fit into a pocket. The recorded conversations can be saved to a computer hard drive or compact disc and subsequently accessed when needed, thus minimizing storage costs. …

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

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 ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

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

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Improving the Quality of Informed Consent to Research
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
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?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
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.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, 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." (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

    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.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.