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CTRI Number  CTRI/2017/07/009043 [Registered on: 14/07/2017] Trial Registered Retrospectively
Last Modified On: 31/08/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Information in consent form in Biomedical Research that research Participants would Like to Know.  
Scientific Title of Study   A Survey of What Information Research Participants Would Like to Know in Informed Consent Forms in Biomedical Research  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roli Mathur  
Designation  Scientist E & Head 
Affiliation  National Centre for Disease Informatics and Research  
Address  ICMR Bioethics Unit National Centre for Disease Informatics and Research (ICMR), II Floor of Nirmal Bhawan, ICMR Complex, Poojanhalli Road, Off NH-7, Kannamangala Post Bangalore

Bangalore Rural
KARNATAKA
562110
India 
Phone  91-80-22176301  
Fax    
Email  icmr.bioethics@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roli Mathur  
Designation  Scientist E & Head 
Affiliation  National Centre for Disease Informatics and Research  
Address  ICMR Bioethics Unit National Centre for Disease Informatics and Research (ICMR), II Floor of Nirmal Bhawan, ICMR Complex, Poojanhalli Road, Off NH-7, Kannamangala Post Bangalore

Bangalore Rural
KARNATAKA
562110
India 
Phone  91-80-22176301  
Fax    
Email  icmr.bioethics@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roli Mathur  
Designation  Scientist E & Head 
Affiliation  National Centre for Disease Informatics and Research  
Address  ICMR Bioethics Unit National Centre for Disease Informatics and Research (ICMR), II Floor of Nirmal Bhawan, ICMR Complex, Poojanhalli Road, Off NH-7, Kannamangala Post Bangalore

Bangalore Rural
KARNATAKA
562110
India 
Phone  91-80-22176301  
Fax    
Email  icmr.bioethics@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
 
Primary Sponsor  
Name  Study funded by ICMR in India Internationally coordinated by FERCAP without financial support 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     China
India
Indonesia
Japan
Malaysia
Philippines
Republic of Korea
Sri Lanka
Taiwan
Thailand  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roli Mathur Country Coordinator  National Centre for Disease Informatics and Research (NCDIR)  ICMR Bioethics Unit, II Floor of Nirmal Bhawan, ICMR Complex, Poojanhalli Road, Off NH-7, Kannamangala Post Bangalore - 562 110
Bangalore Rural
KARNATAKA 
91-80-22176301

icmr.bioethics@gmail.com 
Dr Ragini Kulkarni  National Institute for Research in Reproductive Health (NIRRH)  Department of Operational Research Jehangir Merwanji Street, Parel, Mumbai-400 012
Mumbai
MAHARASHTRA 
91-22-24192043

kulkarnir@nirrh.res.in 
Dr P Paul Kumaran  National Institute for Research in Tuberculosis (NIRT)  Scientist E (Deputy Director-Medical) National Institute for Research in Tuberculosis (ICMR) Madurai Unit @ GRH, Madurai,
Madurai
TAMIL NADU 
91-9443224962

ppaulkumaran@nirt.res.in 
Dr Suman Kanungo  National Institute of Cholera & Enteric Diseases (NICED)  Division of Epidemiology, National Institute of Cholera & Enteric Diseases, P-33 CIT Road, Scheme XM, Beliaghata, P.O. Box 177, Pin 700010, Kolkata
Kolkata
WEST BENGAL 
91-9903824322

sumankanungo@gmail.com 
Dr Subhash Yadav  Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI)  Department of Endocrinology, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), Rae Bareli Road, Lucknow, UP, Pin-226014
Lucknow
UTTAR PRADESH 
91-9415770502

subhash70@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee Sanjay Gandhi Postgraduate Institute of Medical Sciences  Approved 
Institutional Ethics committee, National Institute of Cholera and Enteric Diseases  Approved 
National Institute for Research in Tuberculosis Institutional Ethics Committee  Approved 
NCDIR-Institutional Ethics Committee  Approved 
NIRRH Ethics committee for clinical studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  None, study is to understand what information is relevant to participants in the informed consent process.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The target populations are individuals participating in any ongoing biomedical research at study sites.

 
 
ExclusionCriteria 
Details  Individuals who refuse to answer the questionnaire for any reason or have communication difficulties due to language problems or cognitive disabilities will be excluded. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
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).  
June to November 2017 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/06/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The manuscript(s) for publication in international journals will be prepared after the completion of the study. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study is multicentre, questionnaire based survey which would be simultaneously carried out in 10 member countries of Forum for Ethical Review Committees in the Asian and Western Pacific region (FERCAP). ICMR Bioethics Unit, NCDIR, Bangalore has been identified to be the Country Coordinator for the survey at four sites in India. Data will be collected through an anonymous, self-administered, structured, paper-based questionnaire. The questionnaire regarding the contents of ICF would be given to the research participants to answer the questions. The study results may provide important insights about the contents of the ICF which would be beneficial to both Investigators and Ethics Committees. The data obtained from the survey will be analyzed at the National and International level (FERCAP member countries) which would help us to develop standard format for ICF across the country as well as in South East Asia Region. 
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