5
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Broad consent for biobanks is best – provided it is also deep

      research-article

      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

          Background

          As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent.

          Main text

          In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication.

          Conclusion

          We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

          Related collections

          Most cited references22

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

          Should donors be allowed to give broad consent to future biobank research?

          Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Dynamic consent: a patient interface for twenty-first century research networks

            Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Broad Consent for Research With Biological Samples: Workshop Conclusions.

              Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.
                Bookmark

                Author and article information

                Contributors
                rbm@ifro.ku.dk
                mgj@ifro.ku.dk
                Gunhild.Waldemar.01@regionh.dk
                pes@sund.ku.dk
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central (London )
                1472-6939
                15 October 2019
                15 October 2019
                2019
                : 20
                : 71
                Affiliations
                [1 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Dept. of Food and Resource Economics, , University of Copenhagen, ; Copenhagen, Denmark
                [2 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Danish Dementia Research Centre, Dept. of Neurology, Rigshospitalet, , University of Copenhagen, ; Copenhagen, Denmark
                [3 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Dept. of Food and Resource Economics and Dept. of Veterinary and Animal Sciences, , University of Copenhagen, ; Rolighedsvej 25, 1958 Frederiksberg C, Copenhagen, Denmark
                Author information
                http://orcid.org/0000-0002-3453-5287
                http://orcid.org/0000-0001-5739-5988
                http://orcid.org/0000-0003-0397-3273
                Article
                414
                10.1186/s12910-019-0414-6
                6794864
                31615491
                e5efe098-dbf1-4adb-9289-449549718fa7
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 August 2018
                : 1 October 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100012774, Innovationsfonden;
                Award ID: 4108-00008B
                Categories
                Debate
                Custom metadata
                © The Author(s) 2019

                Medicine
                informed consent,biobank research,autonomy,consent models,risks,ethics
                Medicine
                informed consent, biobank research, autonomy, consent models, risks, ethics

                Comments

                Comment on this article