Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT03346720
Status:
COMPLETED
Last Update Posted:
2018-06-20
First Post:
2017-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ethical Challenges of Consent in Data Sharing
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Ethical Challenges Related to Consent Following Implementation of a New Data Sharing Policy
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Data Sharing
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: