17
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Germline Genome Editing Research: What Are Gamete Donors (Not) Informed About in Consent Forms?

      research-article
      * ,
      The CRISPR Journal
      Mary Ann Liebert, Inc., publishers

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.

          Related collections

          Most cited references24

          • Record: found
          • Abstract: found
          • Article: not found

          Cornerstones of CRISPR–Cas in drug discovery and therapy

          The use of CRISPR–Cas technology for gene editing has rapidly become widespread. Here, Corn and colleagues discuss the applications of this revolutionary tool in drug discovery and development, describing how it could make substantial contributions to target identification and validation, animal models and cell-based therapies.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Readability standards for informed-consent forms as compared with actual readability.

            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
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Progress and prospects in plant genome editing

                Bookmark

                Author and article information

                Journal
                CRISPR J
                CRISPR J
                crispr
                The CRISPR Journal
                Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA )
                2573-1599
                2573-1602
                February 2020
                17 February 2020
                17 February 2020
                : 3
                : 1
                : 52-63
                Affiliations
                [1]Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
                Author notes
                [*] [ * ]Address correspondence to: Emilia Niemiec, PhD, Centre for Research Ethics and Bioethics, Uppsala University, Box 564, 751 22 Uppsala, Sweden, Emilia.niemiec@ 123456crb.uu.se
                Article
                10.1089/crispr.2019.0043
                10.1089/crispr.2019.0043
                7047087
                32091253
                fd760274-b19f-4267-a958-07329d41ec4d
                © Emilia Niemiec and Heidi Carmen Howard 2020; Published by Mary Ann Liebert, Inc.

                This Open Access article is distributed under the terms of the Creative Commons Attribution Noncommercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are cited.

                History
                Page count
                Tables: 3, References: 35, Pages: 12
                Categories
                Research Article

                Comments

                Comment on this article