Data SharingData SharingNCT03346720
Ethical Challenges of Consent in Data Sharing
An observational study of Data Sharing, run by University of Oxford at 3 sites in Thailand.
Trial summary
In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Data Sharing
- What is being tested?
- Semi-structured interviews and Focus group discussions (FGDs)
- How many people
- 40 participants
- Where
- 3 sitesThailand
- Study dates
- 1 Feb 2017to 7 Aug 2017
- 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: Four groups of participants will be recruited. Group 1. Participants recruited into biomedical research where data collected may be shared with the wider research community. Group 2. Frontline research staff directly involved in obtaining consent from participants in the above studies e.g. study nurses, investigators. Group 3. Research related staff and other stakeholders involved in the implementation of the data sharing policy e.g. study managers, data access committee members, ethics committee members, study nurses, investigators, research collaborators, data managers and other clinical trials support staff. Group 4. Community advisory board members and other community members.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Able to speak and understand Thai, English, Burmese or Karen
Who cannot join
- Lack of relevant experience or expertise
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Hospital for tropical diseases, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
Mahidol-Oxford Tropical Medicine Research Unit (MORU) Office
Bangkok, 10400
Shoklo Malaria Research Unit, Mae Sot
Mae Sot, Changwat Tak
About this study
Official title: Ethical Challenges Related to Consent Following Implementation of a New Data Sharing Policy
In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings. It has been our policy for many years to support sharing of data across collaborative research networks in order to maximize their utility. However there is increasing support from research funders, regulatory agencies and journals for sharing individual-level data from genomic, medical and public health research beyond research collaborations. A number of potential advantages of sharing individual level data from clinical and public health research have been identified in the literature. These include maximizing the utility of data, allowing verification of research results, and minimizing the burdens and costs of unnecessary duplication of research. In low- and middle-income settings it may be particularly important to effectively share data to maximize its utility and enable timely responses to important public health issues such as resistance to antimalarial treatments. Many authors have called for data sharing to be carefully curated, to minimize potential harms including breaches of privacy, the publication of poor quality or biased secondary research, and insufficient acknowledgment of the contribution of researchers generating datasets. In low- and middle-income settings, the need for data sharing policies and processes to promote equitable use of data, including the development of sustainable capacity to both share and analyse datasets, has been recognized.
It is foreseeable that the impact of this policy will be significant both practically and ethically. In the practical sense, there have already been changes in our data management processes and resources, clinical trial agreements and negotiations with collaborators. Ethically, this policy has impact on the consent process which includes the increasing use of broad consent, the changes in the language of information sheets, study protocols and ethics application documents and the actual consent taking by research staff.
Now that that these new data-sharing mechanisms have been put in place there is a need to evaluate their impact on practice. The aim of this study is to identify and analyse ethical challenges related to consent following implementation of a new data sharing policy with the aim of refining the data sharing policy and its related consent processes
- Conditions
- Data Sharing
- Being tested
- Semi-structured interviews, Focus group discussions (FGDs)
- Keywords
- Data Sharing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
These interviews will be conducted following an interview guide. Interviews will be conducted in English or Thai at a place convenient and familiar to the interviewee. It is estimated that each interview will last between 45 minutes to an hour.
Focus group discussions (FGDs)Other
These will be conducted following an interview guide. FGDs will be conducted in English or Thai. In addition, a note taker will be present to take notes. FGDs will take place at a place convenient and familiar to the participants. It is estimated that each FGD will last between 1 to 1.5 hours. FGDs will typically consist of homogenous groups e.g. study nurses.
| Study group | Role | What they receive |
|---|---|---|
| Participants recruited into biomedical research | Participants recruited into biomedical research where data collected may be shared with the wider research community. Receives: Other: Semi-structured interviews; Other: Focus group discussions (FGDs) | |
| Frontline research staff | Frontline research staff directly involved in obtaining consent from participants in the above studies e.g. study nurses, investigators Receives: Other: Semi-structured interviews; Other: Focus group discussions (FGDs) | |
| Research related staff and other stakeholders | Research related staff and other stakeholders involved in the implementation of the data sharing policy e.g. study managers, data access committee members, ethics committee members, study nurses, investigators, research collaborators, data managers and other clinical trials support staff. Receives: Other: Semi-structured interviews; Other: Focus group discussions (FGDs) | |
| Community advisory board members | Community advisory board members and other community members Receives: Other: Semi-structured interviews; Other: Focus group discussions (FGDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The opinion of ethical challenges in consent process under a new data sharing policy
Measured: 1 year
Secondary outcomes (2)
The opinion of participants recruited in primary research with information presented to potential participations in future research studies about data sharing
Measured: 1 year
The views of stakeholders with broad consent
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2017
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data SharingStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346720
- Sponsor's protocol ID
- BE1601
- Acronym
- Data Sharing
- Status last verified
- Jun 2018
- First submitted
- 3 Nov 2017
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for this study will be de-identified and may be shared with other groups of researchers in accordance with the current MORU Data Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethical Challenges Related to Consent Following Implementation of a New Data Sharing Policy
- ClinicalTrials.gov ID
- NCT03346720
- Acronym / sponsor ID
- Data Sharing / BE1601
- Conditions
- Data Sharing
- Keywords
- Data Sharing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 17 Nov 2017 (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.
In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings. It has been our policy for many years to support sharing of data across collaborative research networks in order to maximize their utility. However there is increasing support from research funders, regulatory agencies and journals for sharing individual-level data from genomic, medical and public health research beyond research collaborations. A number of potential advantages of sharing individual level data from clinical and public health research have been identified in the literature. These include maximizing the utility of data, allowing verification of research results, and minimizing the burdens and costs of unnecessary duplication of research. In low- and middle-income settings it may be particularly important to effectively share data to maximize its utility and enable timely responses to important public health issues such as resistance to antimalarial treatments. Many authors have called for data sharing to be carefully curated, to minimize potential harms including breaches of privacy, the publication of poor quality or biased secondary research, and insufficient acknowledgment of the contribution of researchers generating datasets. In low- and middle-income settings, the need for data sharing policies and processes to promote equitable use of data, including the development of sustainable capacity to both share and analyse datasets, has been recognized.
It is foreseeable that the impact of this policy will be significant both practically and ethically. In the practical sense, there have already been changes in our data management processes and resources, clinical trial agreements and negotiations with collaborators. Ethically, this policy has impact on the consent process which includes the increasing use of broad consent, the changes in the language of information sheets, study protocols and ethics application documents and the actual consent taking by research staff.
Now that that these new data-sharing mechanisms have been put in place there is a need to evaluate their impact on practice. The aim of this study is to identify and analyse ethical challenges related to consent following implementation of a new data sharing policy with the aim of refining the data sharing policy and its related consent processes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants recruited into biomedical research | – | Other: Semi-structured interviews, Other: Focus group discussions (FGDs)Participants recruited into biomedical research where data collected may be shared with the wider research community. |
| Frontline research staff | – | Other: Semi-structured interviews, Other: Focus group discussions (FGDs)Frontline research staff directly involved in obtaining consent from participants in the above studies e.g. study nurses, investigators |
| Research related staff and other stakeholders | – | Other: Semi-structured interviews, Other: Focus group discussions (FGDs)Research related staff and other stakeholders involved in the implementation of the data sharing policy e.g. study managers, data access committee members, ethics committee members, study nurses, investigators, research collaborators, data managers and other clinical trials support staff. |
| Community advisory board members | – | Other: Semi-structured interviews, Other: Focus group discussions (FGDs)Community advisory board members and other community members |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Four groups of participants will be recruited. Group 1. Participants recruited into biomedical research where data collected may be shared with the wider research community. Group 2. Frontline research staff directly involved in obtaining consent from participants in the above studies e.g. study nurses, investigators. Group 3. Research related staff and other stakeholders involved in the implementation of the data sharing policy e.g. study managers, data access committee members, ethics committee members, study nurses, investigators, research collaborators, data managers and other clinical trials support staff. Group 4. Community advisory board members and other community members.
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Able to speak and understand Thai, English, Burmese or Karen
Key exclusion criteria (1 listed)
- Lack of relevant experience or expertise
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 |
|---|---|---|
| Semi-structured interviewsThese interviews will be conducted following an interview guide. Interviews will be conducted in English or Thai at a place convenient and familiar to the interviewee. It is estimated that each interview will last between 45 minutes to an hour. | Other | Community advisory board members, Frontline research staff, Participants recruited into biomedical research, Research related staff and other stakeholders |
| Focus group discussions (FGDs)These will be conducted following an interview guide. FGDs will be conducted in English or Thai. In addition, a note taker will be present to take notes. FGDs will take place at a place convenient and familiar to the participants. It is estimated that each FGD will last between 1 to 1.5 hours. FGDs will typically consist of homogenous groups e.g. study nurses. | Other | Community advisory board members, Frontline research staff, Participants recruited into biomedical research, Research related staff and other stakeholders |
Primary outcome
The opinion of ethical challenges in consent process under a new data sharing policy
Time frame: 1 year
2 secondary outcomes
The opinion of participants recruited in primary research with information presented to potential participations in future research studies about data sharing
Time frame: 1 year
The views of stakeholders with broad consent
Time frame: 1 year
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 20 Jun 2018.
- Individual participant dataSharing planned: Yes. Data collected for this study will be de-identified and may be shared with other groups of researchers in accordance with the current MORU Data Sharing Policy.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Sharing, run by University of Oxford at 3 sites in Thailand.
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 3 inclusion and 1 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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?
The opinion of ethical challenges in consent process under a new data sharing policy (time frame: 1 year). 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 20 Jun 2018; AzTrials last refreshed its copy on 30 Oct 2026.