Callfor Proposals in Area of Therapeutics Vaccines and Diagnostic Research For TB 17052021
Callfor Proposals in Area of Therapeutics Vaccines and Diagnostic Research For TB 17052021
Division of ECD
India TB Research Consortium (ITRC)
Date extended for call for full Research Proposal in area of Therapeutics, Vaccines and
Diagnostics in Tuberculosis
Background
One quarter of the global population is infected with Mycobacterium tuberculosis. India accounts for
27% of the global TB burden. The world cannot defeat tuberculosis unless India eliminates TB hence
highlighting the crucial role of India. In this regard, Government of India has pledged to eliminate TB
by 2025 – 5 years ahead of SDG goal and 10 years before the WHO’s END TB target. The centre and
state government are working in close co-ordination with National TB Elimination Programme
(NTEP) to achieve this ambitious target. Indian Council of Medical Research (ICMR) took an
initiative by setting up of India TB Research Consortium (ITRC) to address TB research-innovations
through consortium approach for innovation, research, new strategies and development of new tools
by adopting a mission mode approach by streamlining all the research related to TB in the country.
Despite prevention efforts, some groups of people (children, HIV positive patients, healthcare
personnel’s, prisoners, miners, person exposed to silica dust etc.) are more prone for developing
tuberculosis. Although NSP has included strategies to focus on vulnerable groups, however it still
remains a challenge. Pulmonary tuberculosis accounts for major load of TB burden but extra-
pulmonary tuberculosis cannot be neglected and needs special focus. Tuberculosis (TB) is associated
with frequent pulmonary damages despite microbiological cure. Patients with treated TB may remain
lifelong sufferers of disabling sequelae of the disease which subsequently impair their quality of life
and this area needs further research.
The India TB Research Consortium, Indian Council of Medical Research, New Delhi solicits research
proposals from Institutes/research organizations that are innovative and spells out newer diagnostics
and therapeutic intervention methods(Diagnostics and therapeutics) for achieving end TB 2025
targets of GOI .
Proposals (Multicentric study to be preferred) are solicited for the following areas of diagnostics,
therapeutics including newer chemical entities.
Diagnostics
5. Validation of new available test for the diagnosis of latent TB or subclinical TB in children/adults.
6. Development of a diagnostic algorithm for Non tubercular Mycobacterium (NTM) diagnosis in
Indian setting.
7. Study of newer non-sputum diagnostic test for TB/M/XDR-TB
8. Development-standardization/feasibility studies for in house/indigenous Molecular detection of
AFB from stool/urine or other biological specimen.
9. Studies on biomarkers of TB for diagnosis; prognosis and cure
10. Feasibility studies for newer diagnostic tests for TB/M/XDR-TB.
11. Diagnosis of Drug Resistant TB by cost effective genome sequencing method and its culture
correlation and clinico-epidemiological significance and development of a database of mutants
12. Development of a system (database/registry) to identify hot spots for TB transmission–using
molecular epidemiological methods
13. Studies on baseline INH resistance in community and its relevance in relation to INH prophylaxis.
14. Development/Validation/feasibility of AI software using X-ray images/other imaging techniques
for diagnosis of TB in varied Indian population
15. Refining or development of AI software for deciphering and differentiating Pulmonary TB using
chest radiographs for pulmonary TB in varied Indian organized and unorganized setting (silicosis;
miners etc.)
Therapeutics/Vaccines
1. Clinical trials for shorter efficacious treatment regimen/Host directed therapy (HDT) for
MDR_XDR TB using newer/ repurposed drugs/vaccines/immumomodulators
2. Clinical trials with new drugs for shorter efficacious treatment regimen all forms of paediatrics
and adult TB
3. Clinical trials with new/repurposed drugs/immunomodulators/vaccines for prevention of TB
4. Clinical trials with new/repurposed drugs/immunomodulators/vaccines for prevention of
recurrence
5. Clinical trial with immunomodulators/vaccines as adjunct to ATT for TB/MDR/XDR-TB
6. Newer non-therapeutic Interventional studies along with conventional drug treatment for better-
earlier treatment outcomes and amelioration of drug induced effect
7. Studies related to post TB sequelae and suggestive intervention methods for prevention.
8. Role of balanced nutrition including trace elements/vitamins; in overall outcome of TB patients
on anti TB treatment.
9. Preclinical studies for new/repurposed chemical (drugs and vaccine candidates) entities for all
forms of paediatrics and adult TB
10. Prophylactic clinical trial with new/repurposed drugs/imunomodulators/vaccines for latent TB
11. Standardized Pharmacokinetic (PK) and pharmacodynamics (PD) studies in relation to program
daily FDC (emphasizing under dosing of INH in different weight bands, overdoing of Rifampicin
in >70kg and in HIV and pediatric age group ).
12. Studies on standardization of Pharmacokinetic (PK) and pharmacodynamics (PD) for all TB
drugs including newer and repurposed ATT drugs.
CATEGORY:
Kindly mention the category clearly
1. Diagnostic
2. Therapeutic
3. Vaccine research
ELIGIBILITY
Individuals holding permanent positions in Medical colleges/Universities, educational and research
institutes, NGOs (possessing DSIR certificate).
HOW TO APPLY
Duration of the research proposals could be maximum three years. All projects involving research on
human beings/animals must be cleared by the Human Ethics Committee of the respective institute.
Applicants may submit full-length proposal via email to [email protected]. The format
for preparing the full proposal is available on ICMR website www.icmr.nic.in (also given at the end
of this call document) and should also include the following details.
The proposal should be submitted in Adhoc form (attached) and should clearly provide
following details:
16. Roles, responsibilities and accountability for the activities assigned to each of the
investigators should be clearly defined in the end of the protocol
Shortlisted proposals addressing similar issues may be merged to form a single multicentric
proposal.
and
Email: [email protected]
Check eligibility Eligible / Not eligible (system to generate eligibility check based on
above criteria)
If eligible, continue to fill the form: [PI should be permanent employee with at least 3 years of
service left at the time of grant application]
Have you received any funding for research project from ICMR as Principal Investigator: Yes/No
Have you received any funding for research projects as Principal Investigator from any other Govt
agency/Private Organization either national or international: Yes/No
[Novice Applicant: Not received funding grant till date as Principal Investigator]
OR
Background,
objectives,
Methodology,
Results in case of
ongoing projects
Have you received any advanced training relevant to this project: Yes/no/ Not applicable.
Publications
Have you received any Awards and/or Honours: Yes/No. If yes, enter details below
(It is Mandatory to have at least one Co-Investigator having permanent position from the same institute)
Details of Co-Investigators
Organization’s
address
Salary
Equipments
Recurring
Travel
Overhead
If any of the above is Yes, appropriate approval to be obtained. Upload approval document or proof
of submission to the appropriate committee.
1. Title: Should be concise and yet sufficiently descriptive and informative. Title may include study
design such as a randomized controlled trial; an observational study; a case-control study etc.
2. Summary (up to 250 words): A structured summary should contain the following subheadings:
Background, Novelty, Objectives, Methods, and Expected Outcomes.
3. Keywords: Six keywords separated by comma which best describe your project may be provided
4. Abbreviations: Only standard abbreviations should be used in the text. List of abbreviations
maximum of ten may be given as a list.
5. Background (up to 500 words): State the background information to adequately present the
problem, mention how the research question addresses the critical barrier(s) in scientific knowledge,
technical capability, and/or programmatic/clinical/lab practice and its relevance to local, national and
international context.
6. Literature review (up to 1000 words): Review to be written cohesively to build justification for the
research question to be addressed with reference of key publications in the field. References up to
20 in Vancouver style may be provided at the end of literature review. (References will not be
included in the word count)
7. Novelty/Innovation (up to 250 words): Describe how the proposal challenges and seeks to shift
current research/knowledge/clinical practice paradigms by utilizing novel theoretical concepts,
approaches or methodologies, instrumentation, or interventions. Mention if there is a refinement,
improvement, or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions in the proposed study.
8. Study objectives: Define the objectives clearly and in measurable terms; mention as primary and
secondary objectives if necessary. Do not write too many objectives.
i. Study design: Proposed study design should be appropriate to fulfill all the objectives;
details of study design whether descriptive, analytical, experimental, operational, a
combination of these or any other; and adequate description of study population should be
provided. Explain the rationale of selection of the research participants and controls (humans
or laboratory animals), whether chosen randomly, consecutively etc. with inclusion and
exclusion criteria, rules for discontinuation, definitions of cases, controls and lost to follow up
etc.; in case of Intervention studies a detailed description of Intervention
(drug/device/behavioral intervention) should be given. The use of quantitative and qualitative
methods may be specified if any.
ii. Sample size: Details of sample size and/or power calculation should be described with
references where needed. [Please note: the sample size calculation should provide adequate
power to the study to satisfactorily answer all the primary objectives, data from pilot studies
can also be used for sample size calculation]. Operational definitions for key variables should
be presented. A flow chart indicating study design with number of participants should be
given where applicable.
iii. Project implementation plan: Describe the overall strategy for enrollment of participants
including collaboration with other departments where applicable, process of enrollment of
participants - how, where and by whom will the participants be enrolled, how and when and
where will they be followed up; collection, storage and testing of samples; if new tests are
being done describe the process of standardization etc. Describe quality assurance
processes to accomplish the study objectives
iv. Ethics review: Address review requirements including ethics review [human or animal],
approval for use of stem cells, biologicals etc. and other regulatory reviews/approvals as
applicable. Details of obtaining informed consent and its documentation should be described
along with risks and benefits to the participants. [Ethics and other regulatory guidelines
related to Bio-medical research are available on ICMR website]
v. Data collection & statistical analysis plan: Describe the key variables of the study, how
will they be measured and unit of measurement. Specify comprehensively the data collection
methods and tools as relevant to the study objectives and study design and provide structural
components like data entry and analytical platforms to be used for analysis. Present data
analysis plan comprehensively mentioning appropriate statistical methods to be used in order
to answer/ achieve the study objectives.
14. Institutional support: Mention the efforts made to achieve inter-departmental or inter-
institutional collaboration needed for study implementation, details of coordination between
clinical, laboratory and data management procedures, mention the institutional resources
such as equipment and other physical resources available for use in the project proposed.
15. Budget: Should be appropriate and as per ICMR guidelines available on the website.
Justification for staff along with their roles and responsibilities in the project to be
provided.
Provide additional information as per the ‘’Call for proposals’’ wherever appropriate or as an
additional attachment.
DECLARATION AND ATTESTATION
i. I/We have read the terms and conditions for ICMR Research Grant. All necessary
Institutional facilities will be provided if the research project is approved for financial
assistance.
ii. I/We agree to submit within one month from the date of termination of the project the
final report and a list of articles, both expendable and non-expendable, left on the closure
of the project.
iii. I/We agree to submit audited statement of accounts duly audited by the auditors as
stipulated by the ICMR.
iv. It is certified that the equipment(s) is/are not available in the Institute/Department or
these are available but cannot be spared for the project
v. It is further certified that the equipment(s) required for the project have not been
purchased from the funds provided by ICMR for another project(s) in the Institute.
vi. I/We agree to submit (online) all the raw data (along with descriptions) generated
from the project to the ICMR Data Repository within one month from the date of
completion /termination of the project.
If any equipment already exists with the Department/Institute, the investigator should justify
purchase of the another equipment.
Signature of the:
a) Principal Investigator _______________________________
b) Co-Investigator(s) _______________________________
c) Head of the Department _______________________________
Signature of the Head of the Institution with seal
Date:
Check list of documents to be uploaded in PDF format along with application
_________________________________________________________________________________________
_
* This information must be given, otherwise the application will be returned. In case no financial assistance
has been received, nil should be stated. Indicate titles of the projects and reference number, if available, for
ICMR grants.
Guidelines for Operation of Projects for Grantees of ICMR’s Extramural Research Projects
The Indian Council of Medical Research provides financial assistance to promote health
research. The assistance is provided by way of grants to scientists/professionals who have a
regular employment in the universities, medical colleges, postgraduate institutions,
recognized research and development laboratories and NGOs (documentary evidence of the
recognition should be enclosed with the application).
2. Research grants from ICMR are intended to supplement research facilities available at the
host institutions.
3. Staff: For staff to be recruited in the projects, all the guidelines issued by ICMR
(Admn.II) from time to time will be followed (e.g. Order No. 16/107/2008- Admn. II
dated 24.08.2016, 4.10.2016 and 7.11.2016). All the subsequent orders will be
automatically applicable.
4. Sanction of Projects
Once a project is approved for funding, the concerned Technical Division would inform
the Principal Investigator (PI) that the project has been technically approved for funding and
communicate the budget including the details of the staff, equipment, contingencies, travel
grants etc.
4. a. Budget
The PI is expected to inform the concerned Technical Division about the following:
On receipt of the above information from the PI, the Division will process the release of
grant.
6. Release of grants
The funds are released in 6/12 monthly installments. The first installment is released along
with the sanction letter. It would include the entire grant for purchase of equipment and
recurring grant for the period of six months. Next installment would be for the next 6/12
months or at the end of the project. Steps to procure the approved equipment should be
initiated immediately (to avoid escalation of cost) following the prescribed norms of the host
institution.
7. Re-appropriation of funds
Expenditure should on no account exceed the budget sanctioned for the project.
Expenditure incurred over and above the sanctioned amounts against one or more sub-
heads of expenditure such as pay & allowances, contingencies etc. shall be met without
references to ICMR. For re-appropriation of under savings and equipment, a request will
have to be sent to ICMR and Heads of Division can make the appropriate decisions. The PI
should take any action only after receiving approval from ICMR in such cases.
9. Date of start
The sanction letter would specify the date of start. It can only be a prospective date. If,
however, no date is mentioned in the sanction letter, the project will be considered as
initiated and operative from the day the grant is received by the investigator. This date
would have to be communicated by the host Institute to ICMR. It will in no case be later than
one month after the receipt of the draft by the Institute. The date of start of a project can be
changed following a request from the PI provided no expenditure has been incurred from
the grant released by the Council to the date of request.
b. Taking up field work/travel connected with the research work with sanction of TA/DA
as per entitlement
c. Visiting the ICMR Hqrs office for meetings related to the project
d. Attending a training course relevant to the project (mainly for project staff).
e. Travel grant cannot be used for foreign travel or related expenses for any reason.
This guideline is meant for recurring as well as non-recurring expenditure under the
contingency grant. The contingent grant can be utilized for purposes like, but not limited to:
a) Acquisition of books and documents of relevance to the research topic in case these are
not available in the library. These would be treated as the property of the Institution’s
library and after purchase and accession, may be issued to the concerned
Department/PI as per institutional rules.
c) Charges for specialized investigations for which facilities do not exist in the host
institute
f) Printing of questionnaire/s
k) Communication charges
12. Contingency grant: For expenditure under contingency grant exceeding Rs. 25000/- per
annum, detailed breakdown should be given.
All expenditure and non- expendable articles acquired for work of the project should be
purchased in accordance with the procedure in vogue in the host institutions. For
permanent and semi-permanent assets acquired solely or mainly out of the grant, a
separate audited record in the form of register shall be maintained by the Institute. The
term “assets” means movable property where the value exceed Rs.1000. Separate assets
registers for items costing more than Rs. 20,000/- and less than Rs. 20,000- may be
maintained.
13. Equipment
a. The Council would also provide equipment(s) for the conduct of the study provided it
has been approved by the appropriate Committee. There is no upper ceiling on the
amount to be sanctioned for purchase of equipment (s). This would vary on the nature,
scope and need of the Project.
b. All equipment should be purchased according to the rules and procedures of the
Institutions where the project is to be carried out.
c. Equipment procured through the ICMR grant should bear a label “ICMR funded”.
d. On completion of the study a list of all equipment procured from the project funds
along with cost, date of purchase, and suggestion for disposal of the items should be
sent to ICMR HQs
e. Equipment costing less than Rs. 20,000 are generally allowed to be retained by the
Institute, while in case of those costing more than Rs. 20000, the Council will take the
final decision after reviewing the request the request/ suggestions from the PI.
b. The progress of the project would be evaluated by ICMR either by peer review or by
an Expert Committee.
c. The scheme will not be renewed for the next financial year unless the Council receives
the progress report in time.
d. A delay in receipt of the report in time for consideration by the Committee may lead to
termination of the project.
e. The PI may be asked to present the progress at the meeting of the review/expert
committee, if considered necessary.
f. The suggestion and views of the committee and mid-course correction, if any, would
be conveyed to the PI from time to time for compliance and effective conduct of the
project.
a. Each year, a simple statement of accounts giving the funds received and expenditure
incurred as of end of March every year needs to be submitted for release of the first
and subsequent installments for the duration of the project.
b. Unspent balance would be adjusted in the first installment for the next year.
a. At the completion of the project, the final report in the prescribed format will have to
be submitted.
b. The report should be submitted not later than three months of the date of completion of
the project.
c. 10% grant would be withheld for release until the receipt of final project report.
The final settlement of the Accounts will be done at ICMR HQs only after the receipt of the
following:
19. Auditors
The Council would normally accept reports audited by statutary auditors. The Council may
also accept statement of accounts audited by Chartered Accountants approved by or
registered with CAG and/ or Ministry of Health & Family Welfare.
Requests for project extension beyond approved duration would not be entertained
routinely. However, if interesting/important leads are likely to emerge that need to be
followed up, then a valid justification for an extension should be submitted by the PI three
months before the expected completion of the project clearly mentioning the period of
extension with justification.
21. Change of PI
b. In case the PI leaves the project an eligible co-investigator could be considered as the PI
subject to recommendation of the PI, the Head of the Institution and the approval of
ICMR. Such a request should be sent well in advance.
c. In case the PI is shifting to any other institution, the co-investigator could be made PI or
the project could be transferred to the new Institutions with prior approval from ICMR.
d. The host institution has an important role to play in the above. The institute/Principal
Investigator will have to inform ICMR of any changes and in consultation with ICMR
takes steps to ensure successful continuation completion of the project before relieving the
principal investigator.
All new intellectual property viz. patents, copyright, design, etc. generated as part of the
research supported by the ICMR would belong to the Council. All raw data (in all forms)
should be made available/accessible to ICMR at the completion of the project along with
submission of the final report.
The research papers and publications based on the result of the research project should
clearly acknowledge the assistance by the ICMR along with ID number. Copies/ reprints of
the papers published should be forwarded to ICMR as and when published.
Annexure-1
1. Name of equipment/ asset with model, name etc. and date of procurement
2. Sanctioned amount:
3. Actual expenditure (this should include only the cost of equipment, insurance, freight charges and
octroi etc.)
4. Other expenses, if any (expenses such Bank charges, agency commission etc., should be avoided
through appropriate negotiations. If unavoidable expenses incurred, the same may be indicated
5. Utilization rate (%)
Annexure-2
1. Project title
4. Date of start
5. Duration
7. Methodology
10. A summary sheet of not more than two pages under following heads (Title, Introduction,
Rationale, Objectives, Methodology, Results, Translational Potential)
15. If additional budget or staff is required for the remaining part of the research work, please
give justifications and details.
Date : Signature
Designation
Annexure-3
Format for Annual Statement of Accounts to accompany request for release of First Installment
(Year means Financial Year i.e. 1st April to 31st March of next year)
Check list for covering note to accompany Utilization Certificate of grant for the project for the period
ending 31st March, 20 __)
3) Principal Investigator
6) Amount received during the financial year (Please give No. & Date of ICMR's sanction letter for the
amount)
7) Total amount that was available for expenditure (excluding commitments) during the financial year
(SI.No.6+7)
8) Actual expenditure (excluding commitments) incurred during the financial year (upto 31st March).
11) Amount to be carried forward to the next financial year (if applicable). Indicate the amount already
committed with supporting documents.
FORMAT FOR UTILISATION CERTIFICATE
(ANNUAL/FINAL)
Certified that out of Rs................... of grants-in-aid sanctioned during the year ………............ in favour
of ............................………. under ICMR Letter No……….............................................. and
Rs . ................................................................ on account of unspent balance of the previous year, a sum of
Rs ...................................... has been utilized for the purpose of …………........................... for which it was
sanctioned and that the balance of Rs . ................................remaining unutilised at the end of the year has been
surrendered to ICMR (vide cheque No ........................... Dated…............ /will be adjusted towards the
grants-in-aid payable during the next year i.e ............................................
5. Date of commencement
6. Duration
7. Date of completion
8. Objectives as approved
9. Deviation made from original objectives if any, while implementing the project and reasons thereof.
13. Contributions made towards increasing the state of knowledge in the subject.
14. Conclusions summarizing the achievements and indication of scope for future work.
ii) Data base/s, Medical devices, Health Care System Processes etc. developed/generated from the
study
Sl. Name Brief Description Format of Database
No. (Database/excel/paper)
*would you like to have assistance from ICMR in patenting/copyright (Yes / No) :
1. __________________________
(Principal Investigator)
2. __________________________
(Co-Investigator)
Signature of Competent
Financial/audit authority
With date
To,
Director General
Indian council of Medical Research
Ansari Nager
New Delhi-110029
Dear Sir/Madam,
2. We certify that the equipment requested and approved in the project is neither
available nor accessible in our Institute.
3. We understand that our annual project accounts will have to be audited either by a
statutary auditor or a certified Chartered Accountant.
4. We undertake that the staff employed in the project will not be the responsibility of ICMR
(we will forward separate undertaking to ICMR from each project staff member).
5. We, also, undertake the responsibility to implement the project as per ICMR guidelines
issued from the to time.
Yours sincerely
(Name of PI)
*****