Health Condition 1: null- None, study is to understand what information is relevant to participants in the informed consent process.
Conditions
Interventions
None listed
Sponsors
Study funded by ICMR in India Internationally coordinated by FERCAP without financial support
Eligibility
Inclusion criteria
Inclusion criteria: The target populations are individuals participating in any ongoing biomedical research at study sites.
Exclusion criteria
Exclusion criteria: Individuals who refuse to answer the questionnaire for any reason or have communication difficulties due to language problems or cognitive disabilities will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Results may provide important insights about the Informed Consent Form that will guide i The investigators to develop better and suitable ICFs for their biomedical research studies. ii The ethics committee members when they assess ICFs during the ethical review and approval process. The outcomes will be beneficial to investigators and EC members at three levels: local level (at each particular study site), national level (in each country), and regional level (in the FERCAP region).Timepoint: June to November 2017 | — |
Secondary
| Measure | Time frame |
|---|---|
| The study could provide solutions to address the challenges to determine the extent of adequate information required in biomedical research conducted at different settings involving various groups of populations. It would also help understand the requirement of informed consent in India and to compare them with those in other countries of the South East Asia Region. Information received would also help us in refining the informed consent requirements as the results may have policy implicationsTimepoint: June to November 2017 | — |
Countries
China, India, Indonesia, Japan, Malaysia, Philippines, Republic of Korea, Sri Lanka, Taiwan, Thailand
Contacts
Public ContactDr Roli Mathur
National Centre for Disease Informatics and Research
Outcome results
None listed