Bioethics Consultants' Roles on IRBsAuthor(s): Bioethics Consultant GroupSource: IRB: Ethics and Human Research, Vol. 12, No. 6 (Nov. - Dec., 1990), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564545 .

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'3Holder, Angela R. and Levine, Robert J.: Informed consent for research on specimens obtained at autopsy or surgery: A case study in the overprotection of human subjects. Clinical Research 1976; 24: 68.

'4See, e.g., Karr, "Comment"; Culliton, "Patient sues UCLA"; and Specter, "When doctors profit."

'5Levine, Robert J.: Ethics and Regulation of Clinical Research, 2nd ed. Baltimore: Urban and Schwar- zenburg, 1986, p. 194-199.

16Barinaga, "A muted victory." '7For a general discussion of one institution's

response to this problem, see Prentice, Ernest D., Wiltse, John C., Sharp, John G., and Antonson, Dean L.: An institutional policy on the right to benefit from the commercialization of human biological material. Law, Medicine and Health Care 1990; 18:162-67.

1845 CFR Section 46.116 (a). 19Levine, "Research that could yield marketable

profits."

November/December 1990

?- ETRS-

Bioethics Consultants' Roles on IRBs

In this month's IRB, we present the evaluation study data of our pilot project of bioethics consultants participating in the IRB process of the NIH Clinical Center. We are interested in learning about how bioethics consultants to IRBs across the country view their role(s) and responsibilities. We are interested, also, in your thoughts on how other members of the IRB perceive the bioethics con- sultant's contributions to the review process.

While we begin attempting to answer these questions, perhaps for an article on this topic to appear in a future issue of IRB, we would greatly appreciate hearing from IRB readers who have experience or thoughts in this area. Please address your correspondence to Evan DeRenzo as listed below. Thank you, we look forward to hearing from you.

Bioethics Consultant Group Michele Carter, PhD

Evan G. DeRenzo, PhD Chris Grady, RN, MS

Sandy Leikin, MD George Patrick, PhD

Janicemarie Vinicky, MA Ernie Wallwork, PhD Alison Wichman, MD

Bioethics Program, CC, c/o Evan G. DeRenzo, PhD, National Institutes of Health, 10/1C116, 9000 Rockville Pike, Bethesda, MD 20892, (301) 496-2429

The Problems of Consent Documents Lie with Writers, Not Readers

The article by Young, Hooker, and Freeberg on increasing comprehension by reducing the reading level of informed consent documents (Informed consent documents: increasing compre- hension by reducing reading level, IRB, May/June 1990) reaches some admira- ble conclusions, but perpetuates some mistaken notions along the way.

The real issue is not reducing the reading level, but raising the writing level. The authors imply that the "High Reading Level Consent Form" was produced for people who read well ("at about the college graduate level"), when in fact it was produced by people who write poorly. For example, the opening sentence-"Preceding your agreement to participation in this experimental investigation, it is important that the following explanation of the investiga- tion be read in its entirety and signed"-- violates at least two basic principles of clear writing at any level. It buries potential verbs within nouns ("agree" in

"agreement"; "participate" in "participa- tion"; "investigate" in "investigation"; "explain" in "explanation") and forces the remaining verbs ("be read....and signed") into the passive voice by the awkward use of "it is important that." By contrast, the "Low Reading Level Consent Form" uses strong, active verbs: "Before you agree to take part in this study, you must read and sign the following." (Both versions, incidentally, are inaccurate, since signing the docu- ment does not precede agreement.)

The authors' recommendation-that researchers and IRBs "increase the comprehensibility of their consent documents" (that is, write them more clearly)-is laudable. But let's not fool ourselves that we are "reducing the reading level" when we write clearly. The problem is indeed a lack of verbal skills, but the lack is in the writers, not the readers.

Gary Miranda Technical Editor/Writer

Kaiser Permanente Center for Health Research

Portland, OR

Fl

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