Information in consent form in Biomedical Research that research Participants would Like to Know.
Not Applicable
- Conditions
- Health Condition 1: null- None, study is to understand what information is relevant to participants in the informed consent process.
- Registration Number
- CTRI/2017/07/009043
- Lead Sponsor
- Study funded by ICMR in India Internationally coordinated by FERCAP without financial support
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
The target populations are individuals participating in any ongoing biomedical research at study sites.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Results may provide important insights about the Informed Consent Form that will guide <br/ ><br>iThe investigators to develop better and suitable ICFs for their biomedical research studies. <br/ ><br>iiThe ethics committee members when they assess ICFs during the ethical review and approval process. <br/ ><br>The outcomes will be beneficial to investigators and EC members at three levels: <br/ ><br>local level (at each particular study site), <br/ ><br>national level (in each country), and <br/ ><br>regional level (in the FERCAP region).Timepoint: June to November 2017
- Secondary Outcome Measures
Name Time Method 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