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
|
|
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
|
|
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
|
|
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. |