Ethical Challenges of Consent in Data Sharing

Completed

• Conditions: Data Sharing
• Interventions: Other: Semi-structured interviews; Other: Focus group discussions (FGDs)

• Registration Number: NCT03346720
• Lead Sponsor: University of Oxford

Brief 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. 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-08-07
• Study Completion: 2017-08-07
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

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Exclusion Criteria

• Lack of relevant experience or expertise

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants recruited into biomedical research	Focus group discussions (FGDs)	Participants recruited into biomedical research where data collected may be shared with the wider research community.
Frontline research staff	Semi-structured interviews	Frontline research staff directly involved in obtaining consent from participants in the above studies e.g. study nurses, investigators
Frontline research staff	Focus group discussions (FGDs)	Frontline research staff directly involved in obtaining consent from participants in the above studies e.g. study nurses, investigators
Community advisory board members	Focus group discussions (FGDs)	Community advisory board members and other community members
Participants recruited into biomedical research	Semi-structured interviews	Participants recruited into biomedical research where data collected may be shared with the wider research community.
Research related staff and other stakeholders	Semi-structured interviews	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	Semi-structured interviews	Community advisory board members and other community members
Research related staff and other stakeholders	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.

Primary Outcome Measures

Name	Time	Method
The opinion of ethical challenges in consent process under a new data sharing policy	1 year

Secondary Outcome Measures

Name	Time	Method
The opinion of participants recruited in primary research with information presented to potential participations in future research studies about data sharing	1 year
The views of stakeholders with broad consent	1 year

Trial Locations

Locations (3)

Mahidol-Oxford Tropical Medicine Research Unit (MORU) Office; 🇹🇭 Bangkok, Thailand

Hospital for tropical diseases, Faculty of Tropical Medicine, Mahidol University; 🇹🇭 Bangkok, Thailand

Shoklo Malaria Research Unit, Mae Sot; 🇹🇭 Mae Sot, Tak, Thailand