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      Informed consent process: A step further towards making it meaningful!

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          Abstract

          Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process.

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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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            Quality of informed consent in cancer clinical trials: a cross-sectional survey.

            Luna S. Joffe, Scarla J. Weeks, Charles Cook … (2001)
            Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.
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              Improvement of informed consent and the quality of consent documents.

              Michael Jefford, Rosemary Moore (2008)
              Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Perspect Clin Res
                Journal ID (iso-abbrev): Perspect Clin Res
                Journal ID (publisher-id): PCR
                Title: Perspectives in Clinical Research
                Publisher: Medknow Publications & Media Pvt Ltd (India )
                ISSN (Print): 2229-3485
                ISSN (Electronic): 2229-5488
                Publication date (Print): Jul-Sep 2017
                Volume: 8
                Issue: 3
                Pages: 107-112
                Affiliations
                [1]Quality Assurance Manager, Chest Research Foundation, Pune, Maharashtra, India
                Author notes
                Address for correspondence: Ms. Rashmi Ashish Kadam, Chest Research Foundation, Marigold Premises, Kalyani Nagar, Pune - 411 014, Maharashtra, India. E-mail: rashmipatkar@ 123456gmail.com
                Article
                Publisher ID: PCR-8-107
                DOI: 10.4103/picr.PICR_147_16
                PMC ID: 5543760
                PubMed ID: 28828304
                SO-VID: 6193a78b-adf0-4cec-bcb1-afac488f9c48
                Copyright © Copyright: © 2017 Perspectives in Clinical Research
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

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                Subject: Review Article

                ScienceOpen disciplines: Medicine
                Keywords: clinical trials,comprehension,informed consent,strategies,understanding,competence
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: clinical trials, comprehension, informed consent, strategies, understanding, competence

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