Data Sharing Clinical Trial
— Data SharingOfficial title:
Ethical Challenges Related to Consent Following Implementation of a New Data Sharing Policy
NCT number | NCT03346720 |
Other study ID # | BE1601 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2017 |
Est. completion date | August 7, 2017 |
Verified date | June 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | August 7, 2017 |
Est. primary completion date | August 7, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 Exclusion Criteria: - Lack of relevant experience or expertise |
Country | Name | City | State |
---|---|---|---|
Thailand | Hospital for tropical diseases, Faculty of Tropical Medicine, Mahidol University | Bangkok | |
Thailand | Mahidol-Oxford Tropical Medicine Research Unit (MORU) Office | Bangkok | |
Thailand | Shoklo Malaria Research Unit, Mae Sot | Mae Sot | Tak |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The opinion of ethical challenges in consent process under a new data sharing policy | 1 year | ||
Secondary | The opinion of participants recruited in primary research with information presented to potential participations in future research studies about data sharing | 1 year | ||
Secondary | The views of stakeholders with broad consent | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05298514 -
Data Sharing Project Part 2
|