Information in consent form in Biomedical Research that research Participants would Like to Know.

Recruiting

Conditions: 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: The study is multicentre, questionnaire based survey which would besimultaneously carried out in 10 member countries of Forum for Ethical ReviewCommittees in the Asian and Western Pacific region (FERCAP). ICMR BioethicsUnit, NCDIR, Bangalore has been identified to be the Country Coordinator for thesurvey at four sites in India. Data will be collected through an anonymous,self-administered, structured, paper-based questionnaire. The questionnaireregarding the contents of ICF would be given to the research participants toanswer the questions. The study results may provide important insights aboutthe contents of the ICF which would be beneficial to both Investigators andEthics Committees. The data obtained from the survey will be analyzed at theNational and International level (FERCAP member countries) which would help usto develop standard format for ICF across the country as well as in South EastAsia Region.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 3000

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
national level (in each country), and	June to November 2017
Results may provide important insights about the Informed Consent Form that will guide	June to November 2017
The outcomes will be beneficial to investigators and EC members at three levels:	June to November 2017
regional level (in the FERCAP region).	June to November 2017
iThe investigators to develop better and suitable ICFs for their biomedical research studies.	June to November 2017
iiThe ethics committee members when they assess ICFs during the ethical review and approval process.	June to November 2017
local level (at each particular study site),	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 implications	June to November 2017

Trial Locations

Locations (5): National Centre for Disease Informatics and Research (NCDIR)
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Rural, KARNATAKA, India
National Institute for Research in Reproductive Health (NIRRH)
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Mumbai, MAHARASHTRA, India
National Institute for Research in Tuberculosis (NIRT)
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Madurai, TAMIL NADU, India
National Institute of Cholera & Enteric Diseases (NICED)
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Kolkata, WEST BENGAL, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI)
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Lucknow, UTTAR PRADESH, India
National Centre for Disease Informatics and Research (NCDIR)
🇮🇳Rural, KARNATAKA, India
Dr Roli Mathur Country Coordinator
Principal investigator
80-22176301
icmr.bioethics@gmail.com