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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/07/009043
• Date of registration: 14-07-2017
• Prospective Registration: No
• Primary sponsor: Study funded by ICMR in India Internationally coordinated by FERCAP without financial support
• Public title: Information in consent form in Biomedical Research that research Participants would Like to Know.
• Scientific title: A Survey of What Information Research Participants Would Like to Know in Informed Consent Forms in Biomedical Research
• Date of first enrolment: 12-06-2017
• Target sample size: 3000
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19467
• Study type: Observational
• Study design: Other; Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:
• Phase: N/A

Countries of recruitment

China, India, Indonesia, Japan, Malaysia, Philippines, Republic of Korea, Sri Lanka, Taiwan, Thailand

Contacts

• Name: Dr Roli Mathur
• Affiliation: National Centre for Disease Informatics and Research

• Name: Dr Roli Mathur
• Affiliation: National Centre for Disease Informatics and Research

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- None, study is to understand what information is relevant to participants in the informed consent process.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India

Ethics review

Status: Approved
Approval date: 15/02/2017
Contact:

Institutional Ethics committee, National Institute of Cholera and Enteric Diseases

Status: Approved
Approval date: 01/03/2017
Contact:

NCDIR-Institutional Ethics Committee

Status: Approved
Approval date: 10/03/2017
Contact:

NIRRH Ethics committee for clinical studies

Status: Approved
Approval date: 17/04/2017
Contact:

Institutional Ethics Committee Sanjay Gandhi Postgraduate Institute of Medical Sciences

Status: Approved
Approval date: 14/08/2017
Contact:

National Institute for Research in Tuberculosis Institutional Ethics Committee