xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018233</url>
    </required_header>
    <id_info>
      <org_study_id>2-010-23</org_study_id>
      <nct_id>NCT06018233</nct_id>
    </id_info>
    <brief_title>Role of Technology in Addressing Societal Challenges - New Governance</brief_title>
    <official_title>The Role Of Technology In Addressing Societal Challenges: A New Regime For The Law And Governance Of Innovation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aberdeen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Aberdeen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Technology and data can bring opportunities for increased societal benefits for example&#xD;
        regarding health, environmental sustainability and energy. There can be clashes between&#xD;
        regimes which aim to bring these benefits about, and the outcomes which are dictated if one&#xD;
        looks to only laws and regimes with a focus on technology and data, notably information and&#xD;
        intellectual property (IP) laws. A recent example of a clash was seen between IP, human&#xD;
        rights and health in relation to COVID-19.&#xD;
  &#xD;
        This study is part of a project exploring the place and impact of clashes on the operation of&#xD;
        regimes and possible new potential forms of governance, structure and regime creation which&#xD;
        could be developed. The project will explore the establishment and operation of the Scottish&#xD;
        Public Benefit and Privacy Panel for Health and Social Care. It will also explore approaches&#xD;
        to data and technology in the UK oil and gas licensing framework; a developing new&#xD;
        international regime in relation to marine biodiversity, benefit sharing and technology&#xD;
        transfer; and approaches in Scotland and in England to private or public ownership and&#xD;
        licensing of soil and environmental data, including those funded by research councils. It may&#xD;
        also include the European data strategy and the development of the pan African free trade&#xD;
        agreement and its approach to IP. Some of these regimes engage directly with laws relating to&#xD;
        data and technology, notably private rights, information control and IP; some do not.&#xD;
  &#xD;
        The study will interrogate, through qualitative research with key figures who and are&#xD;
        involved, the drivers for structural approaches being taken; levels of engagement in creating&#xD;
        and operating new regimes with regime and laws focussed on data and technology; and the&#xD;
        possible impact of data and technology regimes on the new regimes' wider goals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The project explores the different frameworks, and the possible consequences of limited&#xD;
        engagement with data and technology, for delivery of the ultimate societal goals. Proposals&#xD;
        are then developed for more holistic and pluralist engagement when new regimes, in their&#xD;
        different forms, are created.&#xD;
  &#xD;
        This project will make an important contribution to scholarship regarding legal policy&#xD;
        making, governance, regulation, legal theory, pluralism, private and public intersections and&#xD;
        &quot;wicked problems&quot;. The findings of this project will be of value to scholars, policy makers&#xD;
        and activists in developing a more open and informed approach to choices which could be made,&#xD;
        means by which they could be delivered, and to reaching more effective solutions to address&#xD;
        societal challenges through a lens - direct or indirect - of data and technology.&#xD;
  &#xD;
        The project's principal objective is to develop new theoretical approaches and practical&#xD;
        paths which could be applied, at national and international level, substantively and&#xD;
        structurally, to creating and operating regimes which address key societal challenges using&#xD;
        data and technology.&#xD;
  &#xD;
        The project's proposals will enable decision makers - irrespective of subject matter or&#xD;
        starting point - to take a wide view of relevance, to engage widely with stakeholders and&#xD;
        experts and to see nothing as unchallengeable or as the responsibility of another regime. The&#xD;
        project will also explore the extent to which a hierarchy or overarching common goals could&#xD;
        be created, such as stewardship and respect for the commons (or indeed private property),&#xD;
        within which governance of data, technology and also ultimate societal goals could and should&#xD;
        be delivered.&#xD;
  &#xD;
        Much of the project is based on theory and desk based reviews of scholarship and of publicly&#xD;
        available sources. It will consider legislation, treaties, case law, policy and activist work&#xD;
        and governance and regulatory frameworks. It will engage with ongoing developments in&#xD;
        judicial innovation, interpretation of legislation and application of regulatory approaches,&#xD;
        notably regarding precaution and certainty. It will draw on the intersection between law,&#xD;
        philosophy and science and the extent to which different approaches could and should be taken&#xD;
        to rawer information and that which has been the subject of processing and refinement.&#xD;
  &#xD;
        Complementing this, the study will carry out semi-structured qualitative interviews with&#xD;
        research participants.&#xD;
  &#xD;
        Interviews will be carried out online via TEAMS, and the interviews will be recorded using an&#xD;
        encrypted dictaphone and then transcribed by the researcher. Before the transcribing is&#xD;
        carried it, each participant will be accorded a legend (eg participant 1) and the transcript&#xD;
        will be prepared on this basis. The transcripts will be provided to the interviewees via&#xD;
        TEAMS in private subchannels for confirmation of accuracy before the data analysis stage&#xD;
        commences.&#xD;
  &#xD;
        Research participants will be individuals involved in creating and operating the regimes&#xD;
        which are used as case studies. Abbe Brown anticipates interviewing each research participant&#xD;
        once, although she will indicate that if future issues arise she may ask to speak to them&#xD;
        again if they would be willing to do so, for clarification purposes.&#xD;
  &#xD;
        Then, the data analysis phase will involve key word analysis of the transcripts based on&#xD;
        questions asked, issues explored in the book, and from points arising in interview, in a&#xD;
        grounded theory approach.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">November 27, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 27, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>New approaches to regime creation</measure>
      <time_frame>2 years 6 months project as whole. Interview phase as a whole, 4 months, each interview 1 hour, possible follow up.</time_frame>
      <description>Interviews carried out, transcribed and shared with individual participants. Thereafter, by researcher, analysed, and considered although theoretical research. Proposals developed for more holistic and pluralist engagement and book written</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Power</condition>
    <arm_group>
      <arm_group_label>People involved with creating and operating regimes which address key societal challenges.</arm_group_label>
      <description>Qualitative semi-structured interviews to explore approaches taken to regimes, including one case study group regarding the Public Benefit and Privacy Panel in Scotland. No use of drugs and no personal health related interventions. Same approaches taken to 3 other case study groups which do not involve health.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>New proposal for regime creation</intervention_name>
      <description>Interviews and building of proposals in the light of the information obtained and desk based research</description>
      <arm_group_label>People involved with creating and operating regimes which address key societal challenges.</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Group 1 - People involved in creation and operation of Scottish panel to grant access to&#xD;
          data for re-use in health and social care research (Public Benefit and Privacy Panel for&#xD;
          Health and Social Care of NHS Scotland).&#xD;
  &#xD;
          Group 2 - People involved in creation and operation of approaches to data and technology in&#xD;
          a UK framework based on the grant of an oil and gas licence.&#xD;
  &#xD;
          Group 3 - People involved in developing new international regime in relation to marine&#xD;
          biodiversity, benefit sharing and technology transfer.&#xD;
  &#xD;
          Group 4 - People involved in creation and operation of different approaches in Scotland and&#xD;
          in England to private or public ownership and licensing of soil and environmental data,&#xD;
          including those funded by a research council.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  involved in the development or operation of one of the relevant governance and regime&#xD;
               structures listed.&#xD;
  &#xD;
            -  able to communicate in English&#xD;
  &#xD;
            -  no communication needs.&#xD;
  &#xD;
            -  able to give informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not involved in the development or operation of one of the relevant governance and&#xD;
               regime structures listed.&#xD;
  &#xD;
            -  unable to communicate in English&#xD;
  &#xD;
            -  has communication needs&#xD;
  &#xD;
            -  is unable to give informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Miss King</last_name>
      <role>Study Director</role>
      <affiliation>University of Aberdeen and NHS Grampian</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abbe Brown, PhD</last_name>
      <phone>01224 273129</phone>
      <email>abbe.brown@abdn.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Aberdeen</name>
        <address>
          <city>Aberdeen</city>
          <state>Scotland</state>
          <zip>AB24</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abbe Brown</last_name>
        <email>abbe.brown@abdn.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Governance</keyword>
    <keyword>Technology</keyword>
    <keyword>Data</keyword>
    <keyword>Intersection</keyword>
    <keyword>Intellectual Property</keyword>
    <keyword>Regulation</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018233
  org study id: 2-010-23
  nct id: NCT06018233
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Technology and data can bring opportunities for increased societal benefits for example
        regarding health, environmental sustainability and energy. There can be clashes between
        regimes which aim to bring these benefits about, and the outcomes which are dictated if one
        looks to only laws and regimes with a focus on technology and data, notably information and
        intellectual property (IP) laws. A recent example of a clash was seen between IP, human
        rights and health in relation to COVID-19.
  
        This study is part of a project exploring the place and impact of clashes on the operation of
        regimes and possible new potential forms of governance, structure and regime creation which
        could be developed. The project will explore the establishment and operation of the Scottish
        Public Benefit and Privacy Panel for Health and Social Care. It will also explore approaches
        to data and technology in the UK oil and gas licensing framework; a developing new
        international regime in relation to marine biodiversity, benefit sharing and technology
        transfer; and approaches in Scotland and in England to private or public ownership and
        licensing of soil and environmental data, including those funded by research councils. It may
        also include the European data strategy and the development of the pan African free trade
        agreement and its approach to IP. Some of these regimes engage directly with laws relating to
        data and technology, notably private rights, information control and IP; some do not.
  
        The study will interrogate, through qualitative research with key figures who and are
        involved, the drivers for structural approaches being taken; levels of engagement in creating
        and operating new regimes with regime and laws focussed on data and technology; and the
        possible impact of data and technology regimes on the new regimes' wider goals.
  The project explores the different frameworks, and the possible consequences of limited
        engagement with data and technology, for delivery of the ultimate societal goals. Proposals
        are then developed for more holistic and pluralist engagement when new regimes, in their
        different forms, are created.
  
        This project will make an important contribution to scholarship regarding legal policy
        making, governance, regulation, legal theory, pluralism, private and public intersections and
        "wicked problems". The findings of this project will be of value to scholars, policy makers
        and activists in developing a more open and informed approach to choices which could be made,
        means by which they could be delivered, and to reaching more effective solutions to address
        societal challenges through a lens - direct or indirect - of data and technology.
  
        The project's principal objective is to develop new theoretical approaches and practical
        paths which could be applied, at national and international level, substantively and
        structurally, to creating and operating regimes which address key societal challenges using
        data and technology.
  
        The project's proposals will enable decision makers - irrespective of subject matter or
        starting point - to take a wide view of relevance, to engage widely with stakeholders and
        experts and to see nothing as unchallengeable or as the responsibility of another regime. The
        project will also explore the extent to which a hierarchy or overarching common goals could
        be created, such as stewardship and respect for the commons (or indeed private property),
        within which governance of data, technology and also ultimate societal goals could and should
        be delivered.
  
        Much of the project is based on theory and desk based reviews of scholarship and of publicly
        available sources. It will consider legislation, treaties, case law, policy and activist work
        and governance and regulatory frameworks. It will engage with ongoing developments in
        judicial innovation, interpretation of legislation and application of regulatory approaches,
        notably regarding precaution and certainty. It will draw on the intersection between law,
        philosophy and science and the extent to which different approaches could and should be taken
        to rawer information and that which has been the subject of processing and refinement.
  
        Complementing this, the study will carry out semi-structured qualitative interviews with
        research participants.
  
        Interviews will be carried out online via TEAMS, and the interviews will be recorded using an
        encrypted dictaphone and then transcribed by the researcher. Before the transcribing is
        carried it, each participant will be accorded a legend (eg participant 1) and the transcript
        will be prepared on this basis. The transcripts will be provided to the interviewees via
        TEAMS in private subchannels for confirmation of accuracy before the data analysis stage
        commences.
  
        Research participants will be individuals involved in creating and operating the regimes
        which are used as case studies. Abbe Brown anticipates interviewing each research participant
        once, although she will indicate that if future issues arise she may ask to speak to them
        again if they would be willing to do so, for clarification purposes.
  
        Then, the data analysis phase will involve key word analysis of the transcripts based on
        questions asked, issues explored in the book, and from points arising in interview, in a
        grounded theory approach.
  observational model: Other
  time perspective: Retrospective
  measure: New approaches to regime creation
  time frame: 2 years 6 months project as whole. Interview phase as a whole, 4 months, each interview 1 hour, possible follow up.
  description: Interviews carried out, transcribed and shared with individual participants. Thereafter, by researcher, analysed, and considered although theoretical research. Proposals developed for more holistic and pluralist engagement and book written
  arm group label: People involved with creating and operating regimes which address key societal challenges.
  description: Qualitative semi-structured interviews to explore approaches taken to regimes, including one case study group regarding the Public Benefit and Privacy Panel in Scotland. No use of drugs and no personal health related interventions. Same approaches taken to 3 other case study groups which do not involve health.
  intervention type: Other
  intervention name: New proposal for regime creation
  description: Interviews and building of proposals in the light of the information obtained and desk based research
  arm group label: People involved with creating and operating regimes which address key societal challenges.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Miss King
  role: Study Director
  affiliation: University of Aberdeen and NHS Grampian
  last name: Abbe Brown, PhD
  phone: 01224 273129
  email: abbe.brown@abdn.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No