PowerNCT06018233
Role of Technology in Addressing Societal Challenges - New Governance
An observational study of Power, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Power
- What is being tested?
- New proposal for regime creation
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 - People involved in creation and operation of Scottish panel to grant access to data for re-use in health and social care research (Public Benefit and Privacy Panel for Health and Social Care of NHS Scotland). Group 2 - People involved in creation and operation of approaches to data and technology in a UK framework based on the grant of an oil and gas licence. Group 3 - People involved in developing new international regime in relation to marine biodiversity, benefit sharing and technology transfer. Group 4 - People involved in creation and operation of different approaches in Scotland and in England to private or public ownership and licensing of soil and environmental data, including those funded by a research council.
Who may be able to join
- involved in the development or operation of one of the relevant governance and regime structures listed.
- able to communicate in English
- no communication needs.
- able to give informed consent.
Who cannot join
- not involved in the development or operation of one of the relevant governance and regime structures listed.
- unable to communicate in English
- has communication needs
- is unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role Of Technology In Addressing Societal Challenges: A New Regime For The Law And Governance Of Innovation
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.
Read the detailed description
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.
- Conditions
- Power
- Being tested
- New proposal for regime creation
- Keywords
- Governance, Technology, Data, Intersection, Intellectual Property, Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New proposal for regime creationOther
Interviews and building of proposals in the light of the information obtained and desk based research
| Study group | Role | What they receive |
|---|---|---|
| People involved with creating and operating regimes which address key societal challenges. | 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. Receives: Other: New proposal for regime creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
New approaches to regime creation
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
Measured: 2 years 6 months project as whole. Interview phase as a whole, 4 months, each interview 1 hour, possible follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start3 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PowerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miss King, Study director, University of Aberdeen and NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018233
- Sponsor's protocol ID
- 2-010-23
- Status last verified
- Dec 2024
- First submitted
- 11 Aug 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Technology In Addressing Societal Challenges: A New Regime For The Law And Governance Of Innovation
- ClinicalTrials.gov ID
- NCT06018233
- Acronym / sponsor ID
- 2-010-23
- Conditions
- Power
- Keywords
- Governance, Technology, Data, Intersection, Intellectual Property, Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People involved with creating and operating regimes which address key societal challenges. | – | Other: New proposal for regime creationQualitative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 - People involved in creation and operation of Scottish panel to grant access to data for re-use in health and social care research (Public Benefit and Privacy Panel for Health and Social Care of NHS Scotland). Group 2 - People involved in creation and operation of approaches to data and technology in a UK framework based on the grant of an oil and gas licence. Group 3 - People involved in developing new international regime in relation to marine biodiversity, benefit sharing and technology transfer. Group 4 - People involved in creation and operation of different approaches in Scotland and in England to private or public ownership and licensing of soil and environmental data, including those funded by a research council.
Key inclusion criteria (4 listed)
- involved in the development or operation of one of the relevant governance and regime structures listed.
- able to communicate in English
- no communication needs.
- able to give informed consent.
Key exclusion criteria (4 listed)
- not involved in the development or operation of one of the relevant governance and regime structures listed.
- unable to communicate in English
- has communication needs
- is unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New proposal for regime creationInterviews and building of proposals in the light of the information obtained and desk based research | Other | People involved with creating and operating regimes which address key societal challenges. |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miss King study director
University of Aberdeen and NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Power, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.