Thursday, November 3, 2011

PRIM&R: IRBs Don't Write Consent Forms

PRIM&R's ANPRM comments make the helpful concession that "consent forms have become longer, more complicated, more 'legalistic,' and less useful as sources of information to potential subjects." But PRIM&R does not wish its members blamed for this trend, and claims that IRBs do not write consent forms. While this may be true in a technical sense, I believe it fails to acknowledge IRBs' share of responsibility for the problem.

Here's PRIM&R's version:

IRBs neither interact with subjects nor write consent forms. Rather, consent forms are often written by sponsors and sometimes by investigators, who then present them to an IRB as part of its review of the research. IRBs work with what is submitted to them, so we strongly urge that OHRP remind sponsors and investigators that they have an obligation to create clear and understandable consent forms prior to submitting them to IRBs for review, and that they are the entities that actually design and conduct research which makes them primarily responsible for protecting human subjects. As discussed below, we recognize that consent forms have become increasingly legalistic documents designed to protect institutions and sponsors rather than to protect human subjects. This is not, though, a problem created by IRBs, and often there is little an IRB can do to correct this in the face of institutional and sponsor pressure.

I think this would surprise Lee A. Green, Julie C. Lowery, Christine P. Kowalski, and Leon Wyszewianski:

Most IRBs returned applications for revision, requiring changes to consent procedures, study protocols, and forms. Especially in the beginning of the study, this feedback was often helpful in refining the protocol and clarifying the consent form. However, revisions continued to be requested at an undiminished rate even late in the recruitment phase of the study, when the study protocols and consent forms had been refined through revisions at multiple previous centers. At least one resubmission was required at 76 percent (31 of 41) of the sites, and three or more (up to six) resubmissions were needed to secure IRB approval from 15 percent (6 of 41) of the sites. The types of revisions required by the sites were categorized into editorial versus procedural revisions. Editorial revisions include changes in wording to the consent or clarifications in the protocol, while procedural revisions include changes in the actual procedures described in the protocol. All sites that requested revisions requested editorial revisions; indeed, nine sites each requested more than 10 editorial revisions apiece. Procedural revisions were required in only 12 percent (5 of 41) of the sites. Of the five procedural revisions requested, three were requests to eliminate the consent form and use a cover letter instead. No discernible patterns in the specifics of the editorial revisions emerged; they comprised a wide range of requests for deleting or adding sentences or paragraphs, phrasing, tense, and word choice.

Or Jim Vander Putten:

You can imagine my surprise when several of the IRBs rejected the proposals on the basis of an inconsistent array of style issues, such as consent forms not cumulatively paginated (e.g., 1 of 3, 2 of 3, etc) and either written or not written in the past tense. The time delays associated with revision and re-submission of these IRB proposals (some of which were rejected a second time) were measured in months, and would have been even longer had we been required to complete each institution’s responsible conduct of research training program. These delays began a chain reaction of subsequent delays in data collection, research conference proposal submissions and presentations, and manuscript submissions for publication consideration. For untenured faculty, these delays can present formidable obstacles to meeting institutional expectations for scholarly productivity leading to tenure and promotion.

Or the various communication scholars who described their experiences in 2005:

We once submitted an informed consent form that had previously been approved. It was virtually identical to the previous one except for minor wording and title changes. The IRB came back with eleven major changes required before it could be approved . . .

We had intentionally prepared a very clear, concise, non-academic script and consent form for the subjects explaining the study’s nature, goals, procedures, etc. However, the IRB did not approve of the script or consent form we prepared because they said that these respondents would include some illiterate or marginally educated individuals. They assumed the factory workers were not educated enough to read and understand our forms. Even though we informed the IRB that all employees at this factory were required to have a minimum of a high school diploma for employment, the IRB provided us with a script and consent form they created. Their materials were clearly written by a committee of academics; longer sentences, more polysyllabic words, more complex sentence structures. We were very surprised that they preferred their form over our own. While the IRB’s goal may have been to protect human subjects from harm, we did not see how their more complex script and consent form helped accomplish this objective.

Or, for that matter, AAHRPP:

IRBs are too rigid in consent document development, often using the precise wording in the 45 CFR 46.116 required elements of informed consent. In fact, many use even the exact order of the elements as written in 45 CFR 46.116. Guidance about elements that are optional, elements that are more important than others, or formatting sections would be helpful to the research community.

I would be curious to know what evidence PRIM&R has that "institutional and sponsor pressure" is behind this.

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