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When Will We Learn?Author(s): Alan MeiselSource: IRB: Ethics and Human Research, Vol. 32, No. 5 (September-October 2010), p. 9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/25766156 .
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13. See ref. 11, Hoffman-LaRoche Lim ited 2006, p. 5.
14. Anderson JR, Schonfeld TL, Kelso
TK, Prentice ED. Women in early phase trials: An IRB's deliberations. IRB: Ethics &
Human Research 2oo3;25(4):7-n, p. 8.
15. See ref. 3, U.S. Food and Drug Ad ministration 2008.
16. Lyerly AD, Little MO, Faden R. The second wave. Toward responsible inclusion
of pregnant women in research. The Inter national Journal of Feminist Approaches to
Bioethics 20o8;i(z):5-22.
Letters : :
When Will We Learn?
\ f y reaction to "The Evolu .a V1 tion of Consent Forms for
Research: A Quarter Century of
Changes," by Ilene Albala, Marga ret Doyle, and Paul S. Appelbaum (May-Jun 2010), can be summed
up this way: after a quarter cen
tury, how can we still have so little
understanding of informed consent?
Yes, it is very interesting to do a
multivariate regression analysis and all those other sophisticated statistical analyses and to find that consent forms have gotten longer and understanding hasn't improved (though I'm not sure those who are
familiar with informed consent to
research needed a study to be con
vinced of this). Let's get back to basics. The
problem is not the length or com
plexity of consent forms; it is the undue?and sometimes exclusive?
reliance on consent forms to obtain informed consent. Informed consent is?or is supposed to be?the disclo sure to patients (or in the research
context, potential subjects) of material information about what a
physician (or investigator) proposes to do, in a comprehensible manner, so that the potential subjects can
make decisions about participating in research in a manner shaped by their own values, preferences, goals, and interests.
If that is what we seek to pro mote?and it certainly is what
the law says it seeks to promote, and what the consensus among bioethicists seeks to promote, and
what policy-makers (including NIH
officials) seek to promote?why do we rely on the written word to
impart information? Why, after all this time, do we not realize that the consent form is intended primarily to serve two functions: to memorial ize what the subject has been told, and to confirm through the subject's signature that this information has been provided?
Consent forms are?how best to put it??formalistic. While this satisfies institutional review boards
(IRBs)?and, judging from the content of the federal regulations governing research with human
subjects, the relevant federal of
ficials, too?it should not satisfy anyone concerned with promoting the goals of informed consent. If that is what we are truly interested
in, we would not support a one
size-fits-all rule. We would require methods of informing potential subjects geared to each person's needs and learning styles. A 10-page written form might actually be best for some potential subjects (though probably few). Good, old-fashioned conversations with?depending on the research project and the research personnel?the principal investigator, the project coordinator, or some other knowledgeable staff
person would be the starting point, possibly supplemented by audiovi sual materials (DVDs, audiotapes, interactive Web sites) if the potential subject wants them. Some type of test of understanding would also be
required, and the type of test, too, would be geared to various needs and learning styles.
So why after a quarter century do we persist in doing something that rarely works and is frequently counterproductive? Some would
respond that there will be legal
trouble if we don't. But, as some
judges have pointed out, a consent form provides no legal protection if there hasn't been informed consent. Others will point out that we con tinue to do this because the federal
government requires it, and thus, we need it to get research funding.
A signed consent form is not
informed consent. When are federal officials going to wake up and put the emphasis on informed consent rather than on consent forms, and thus on educating subjects as well as
promoting research? Alan Meisel
University of Pittsburgh School of Law
IRB: Ethics & Human Research September-October 2010
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