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The Importance Of Valid Informed Consent

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Valid informed consent (IC) is a vital component of asthma research, yet research participants are frequently confused during the consenting process [5] [6], and often are uninformed about study objectives, risk and benefits of the research [5]. Information required in the consenting process has grown substantially which may pose challenges for researchers to balance convenience, full disclosure, and understanding [6] [7]. Over recent decades, informed consent documents have increased in length and complexity for transparency’s sake [8] [9], however this may threaten both feasibility and understanding [7]. We write to describe our asthma networks recent evaluation of the length and complexity of consent documentation. IC is a …show more content…

Without substantive changes in study complexity, there was a doubling of the mean consent form length, with the most recent consents approaching 15 pages. This increase in length may undermine true informed consent for some participants since consent forms longer than four pages [8] [10] are unlikely to be read completely. We speculate that accumulation of mandated language by review boards and subject protection committees has contributed to the large increase consent length. Though intended to optimize the informed consent process (i.e., provide more detailed information to volunteers to allow an informed decision), the burden of more detailed information may pose a challenge to many participants. The language used is important as well; our data shows that option to opt-out in the primary consent statement as opposed to having an additional consent was associated with a marked increase in consent rates (Fig 3) Widespread reports suggest that many participants entering clinical trials may not have the intended understanding of all facets of the research process [11] [12]. However, there may be some solutions to this problem. A recent review of 22 large trial consents [5] found that shorter consents relying on discussions with study personnel improved understanding. In addition, participants of focus groups complain that consent forms contain too much information that is unhelpful for decision-making, and are intimidated by overly technical language [13]. Our study

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