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      Informed Consent in Biomedical Research

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          Abstract

          Informed consent is the result of tumultuous events in both the clinical and research arenas over the last 100 years. Throughout this time, the notion of informed consent has shifted tremendously, both due to advances in medicine, as well as the type of data being gathered. As such, informed consent has misaligned with the goals of medical research. It is becoming more and more vital to address this chasm, and begin building new frameworks to link this disconnect. Thus, we address three goals in this paper. First, we discuss the history of informed consent and unify the varying definitions of the term. Second, we evaluate the current research on the topic, classify them into themes, and attend to the problems therein. Lastly, we employ these themes of informed consent research mentioned previously to provide guidance and insight for future research in the arena.

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          Identifying personal genomes by surname inference.

          Melissa Gymrek, Amy McGuire, David Golan … (2013)
          Sharing sequencing data sets without identifiers has become a common practice in genomics. Here, we report that surnames can be recovered from personal genomes by profiling short tandem repeats on the Y chromosome (Y-STRs) and querying recreational genetic genealogy databases. We show that a combination of a surname with other types of metadata, such as age and state, can be used to triangulate the identity of the target. A key feature of this technique is that it entirely relies on free, publicly accessible Internet resources. We quantitatively analyze the probability of identification for U.S. males. We further demonstrate the feasibility of this technique by tracing back with high probability the identities of multiple participants in public sequencing projects.
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            Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

            Adam Nishimura, Jantey Carey, Patricia Erwin … (2013)
            Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.
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              Readability standards for informed-consent forms as compared with actual readability.

              Michael Paasche-Orlow, Holly Taylor, Frederick Brancati (2003)
              Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight. To test these hypotheses, we conducted a cross-sectional study linking data from several public-use sources. A total of 114 Web sites of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form templates. Actual readability was measured with the Flesch-Kincaid scale, which assigns a score on the basis of the minimal grade level required to read and understand English text (range, 0 to 12). Data on the level of research activity, local literacy rates, and federal oversight were obtained from organizational Web sites. The average readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 10.8) on the Flesch-Kincaid scale. Specific readability standards, found on 61 Web sites (54 percent), ranged from a 5th-grade reading level to a 10th-grade reading level. The mean Flesch-Kincaid scores for the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (95 percent confidence interval, 2.4 to 3.2; P<0.001). Readability was not associated with either the level of research funding (P=0.89) or local rates of literacy (P=0.92). However, the 52 schools that had been made subject to oversight by the Office for Human Research Protections (46 percent) had lower Flesch-Kincaid scores than the other schools (10.2 vs. 10.9, P=0.005). IRBs commonly provide text for informed-consent forms that falls short of their own readability standards. Federal oversight is associated with better readability. Copyright 2003 Massachusetts Medical Society
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                Author and article information

                Contributors
                Fida K. Dankar
                Marton Gergely
                Samar K. Dankar
                Journal
                Journal ID (nlm-ta): Comput Struct Biotechnol J
                Journal ID (iso-abbrev): Comput Struct Biotechnol J
                Title: Computational and Structural Biotechnology Journal
                Publisher: Research Network of Computational and Structural Biotechnology
                ISSN (Electronic): 2001-0370
                Publication date PMC-release: 25 March 2019
                Publication date Collection: 2019
                Publication date (Electronic): 25 March 2019
                Volume: 17
                Pages: 463-474
                Affiliations
                [a ]College of IT, UAEU, Al Ain, P.O.Box 15551, United Arab Emirates
                [b ]Independent Scientist, Ottawa, Canada
                Author notes
                [* ]Corresponding author. fida.dankar@ 123456uaeu.ac.ae
                Article
                Publisher ID: S2001-0370(18)30348-9
                DOI: 10.1016/j.csbj.2019.03.010
                PMC ID: 6458444
                PubMed ID: 31007872
                SO-VID: 1b6b14b0-b935-4ed5-911e-4bfe7b67a6ca
                Copyright © © 2019 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 19 December 2018
                Date revision received : 19 March 2019
                Date accepted : 21 March 2019
                Categories
                Subject: Review Article

                Keywords: informed consent,privacy,biomedical research,biomedical data,medical care
                Data availability:
                Keywords: informed consent, privacy, biomedical research, biomedical data, medical care

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