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Callfor Proposals in Area of Therapeutics Vaccines and Diagnostic Research For TB 17052021

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0% found this document useful (0 votes)
15 views37 pages

Callfor Proposals in Area of Therapeutics Vaccines and Diagnostic Research For TB 17052021

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Indian Council of Medical Research

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

1. Development/validation of newer diagnostics for detection of MTB/MDR/XDR-TB preferably


with detection of resistance for complete first line or second line injectables and Fluoroquinolone
anti-TB drugs
2. Development /validation of Point of care diagnostic tests for extra pulmonary TB (EPTB).
3. Development /validation of Point of care diagnostic tests for paediatric TB
4. Diagnostic algorithm for latent TB (Incipient TB) diagnosis in adults and pediatric age group.

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:

1. Organization and contact details


2. PI and Co-PI: Name and designation of co-investigators and intra and inter institutional
collaborations, educational qualifications and experience (along with time commitment for the
research) and relevant publications (to be attached along with CV)
3. Strength of site PIs: Describe academic qualifications, employment details, previous experience
of handling research projects specially clinical trial (past and ongoing) and the scientific
contributions made from these projects. Enumerate 10 relevant publications
4. Key Research area (1-17 as mentioned above)
5. Category (Therapeutics/vaccines/diagnostics)
6. Title of the proposed research project: Should be concise and informative.
7. Rationale (up to 250 words): Describe the current, critical gaps in knowledge, current
requirements in NTEP and its implementation challenges, the national relevance.
8. Novelty/Innovation (up to 100 words): Describe how the proposal challenges and seeks to shift
the current research/knowledge/clinical practice paradigms by utilizing novel theoretical
concepts, methodologies, instrumentation or interventions.
9. Project description: objectives, study population, sample size (statistically calculated), study
area, proposed intervention/solution to address the problem, study design, detailed methodology,
SOPs for the conduct of trial, FU mechanism, implementing institutes. The proposal should also
contain as to how the proposed project is applicable, sustainable, cost effective and feasible and
could be implemented under existing systems of NTEP.
10. Mention the preliminary work done by the applicant, if any.
11. Previous experience of working on clinical studies
12. Collaborating institutes and justification
13. Timelines for conducting the study to submission of report
14. Budget requirements with justifications for each budget line.
15. Institutional support (up to 200 words): Mention the institutional support in terms of basic
infrastructure, Manpower, departments and laboratories with equipment required for the
proposed research work. The organizations should have basic infrastructure, skilled manpower
preferably prior experience in clinical studies, Commitment of time of Principal Investigator (PI)
and co-principal investigator (Co-PI) will be considered as one of the key factors while short
listing the proposals.

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.

FURTHER INFORMATION CONTACTS


Programme officer: Dr. Manjula Singh,
Scientist E,
Division of Epidemiology and Communicable Diseases
Indian Council of Medical Research
V. Ramalingaswami Bhavan
Ansari Nagar, New Delhi- 110029
Email: [email protected]
Telephone: 011-26589699
PABX: 011-26588895 (Extn-284)

IMPORTANT TIMELINES : Last date of submission extended


Extended date and time for submission of proposal: 31st May, 2021 till 24.00h
Review process:
The applications will be reviewed for technical and scientific quality, robustness and originality,
translational and completeness of the project/intervention, adequate project plan (sample quality,
experimental design, statistics, data analysis and management plan, Patient information sheet, consent
forms, proforma) and budget with justification. Clarity in experimental design, demonstration of prior
experience/preliminary data, achievable milestones and timelines and alternate plan in cases of slow
recruitments would also carry weightage.
Please Note: All proposals under ITRC would be coordinated by ICMR- ITRC and the short-listed
proposals would require detailed discussion for finalization of the proposal in collaboration with
ITRC team with close monitoring by ITRC team. Pre-submission meetings may be convened for
investigators by ITRC secretariat for discussion on proposals.
(ICMR Format for proposal submission given below)
Format for Application for Ad-hoc Research Projects

and

Guidelines for Operation of Extramural Projects

Indian Council of Medical Research

V. Ramalingaswami Bhawan, Ansari Nagar, P.Box No. 4911

New Delhi – 110029


Tel. : 26588895, 26588980, GRAM :SCIENTIFIC

26589794, 26589336 FAX :011-26588662

Email: [email protected]

INDIAN COUNCIL OF MEDICAL RESEARCH


V. Ramalingaswami Bhawan, Ansari Nagar, Post Box Bo. 4911
New Delhi - 110029

APPLICATION FOR GRANT-IN-AID OF AD-HOC RESEARCH PROJECT

Indian Council of Medical Research

APPLICATION FORM FOR AD-HOC PROPOSAL


Name (IN BLOCK LETTERS):

Gender (tick any one): Male/Female

Type of Institute Govt / Private/ NGO / Other

Upload Valid DSIR Certificate if not a Govt Institute

Date of Birth of PI: DD-MM-YYYY

Age (calculate age automatically in completed years)

Date of Superannuation of DD-MM-YYYY


PI

Nature of Employment Permanent / Ad-hoc/Contractual

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]

Title of proposed research project:

Duration of project proposed (Maximum 36 months):

Six Keywords: [place six boxes for entry]

Broad Area [Choose from drop down menu]

Major Discipline [Choose from drop down menu]

General Information of Principal Investigator

Name Designation Department Institute/Organization’s Email Mobile


address No.

Academic details of Principal Investigator (Beginning from most recent)

S.No. Academic Qualifications Year Institute


Details of Research Experience as Principal Investigator during the last 10 years
(not for novice applicants)

Title From To funding Gran Grant Status: UPLOAD Project No. of


of Agency t ID Amount Completed/ Summary in 500 publications/
study words indicating patents/
ongoing significant copyrights)
scientific from this
contribution in project if
case of completed any
project

OR

Background,
objectives,
Methodology,
Results in case of
ongoing projects

Have you received any advanced training relevant to this project: Yes/no/ Not applicable.

If yes, enter details below:

S.N. Nature of From To Name of training institute/organization


training (MM/YYYY) (MM/YYYY
)

Total number of publications:


Enter details of ten best publications during the last 5 years including those related to the
topic of proposed research if any:

Publications

S.N. Authors Title of Journal Year Indexed Impact No. of ISSN


article Name / Non- factor citations No.
Indexed

Any Books/Chapters in book: Yes/ No

S.N. Title of Year of Name of Publisher


book/Chapter publication

Any patents/copyrights: Yes/ No

If yes, enter number of patents/copyrights:

Enter details of patents/copyrights

S.N. Title Year Patent/Copyright Number

Have you received any Awards and/or Honours: Yes/No. If yes, enter details below

S.N. Awards and honours Year


Number of Co-Investigators in the study

(It is Mandatory to have at least one Co-Investigator having permanent position from the same institute)

Details of Co-Investigators

S. Name Designation Department/ Email Mobile Academic Total


No. No. Qualifications number of
Institute/ publications

Organization’s
address

Duration and budget of project


Research Related other Information

Duration of Project (Maximum 36 months: 1. D


o
e
s
Budget Heads Year 1 Year 2 Year 3 Total

Salary

Equipments

Recurring

Travel

Overhead

Total (in Rupees)

the project involve use of?


a. Human subjects: Yes No if yes, Upload IEC approval
b. Animals: Yes No if yes, Upload IAEC approval
c. Stem Cells: Yes No if yes, Upload ICSCR approval
d. Radio-isotopes: Yes No if yes, Upload IBSC approval
e. Recombinant DNA technology: Yes No if yes, Upload RCGM approval

IEC = Institutional Ethics Committee

IAEC = Institutional Animal Ethics Committee

ICSCR = Institutional Committee for Stem Cell Research

IBSC = Institutional Bio-safety Committee

RCGM = Review Committee on Genetic Manipulation

If any of the above is Yes, appropriate approval to be obtained. Upload approval document or proof
of submission to the appropriate committee.

2. Is the project a new drug clinical trial? Yes/ No


3. If yes, DCGI Clearance: Obtained /Submitted for Review / Informed (upload document)
4. CTRI Registration Number Applied: Yes/No
5. If yes, CTRI Number: .........................
FORMAT OF RESEARCH PLAN

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.

9. Methodology (up to 2000 words): Include the following subheads

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.

10. Expected outcomes (up to 100 words)


11. Limitations of this study (up to 100 words)
12. Future plans based on expected outcomes if any (up to 100 words)
13. Timelines: Details of activities to be carried out along with timelines during
preparatory phase, data collection, analysis & report writing to be provided.

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

i. Vaild DSIR of Institute where applicable


ii. Format of research proposal
iii. Informed consent form where applicable
iv. Case record proforma, study instruments, questionnaires, scales, etc where applicable
v. Ethical approval / proof of submission to Ethics Committee (animal or human); regulatory approvals as
appropriate
vi. Declaration, attestation form

_________________________________________________________________________________________
_

* 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).

1. Proposals in fundamental/strategic research as well as development and evaluation


research in the form of Adhoc / task force projects including operational research are
considered for ICMR support.

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 budget would be sanctioned under broad sub-heads as under:

i. Staff -Pay and allowance of the staff


ii. Contingency -Recurring
-Non-recurring
iii. Travel (if approved)
iv. Equipment (if approved)
v. Overhead charges

4. b. Number of projects with the PI

Under normal conditions a PI should only be implementing five ICMR funded


research projects at a given point in time. While submitting an application for a
research project the PI should give in detail all the research projects (completed, on-
going). Fresh research proposal can be considered only when the on-going research
proposals are about to conclude.

5. After sanction of project

The PI is expected to inform the concerned Technical Division about the following:

a. Formal acceptance of the budget sanctioned.


b. For all equipment approved in the project, the PI is required to give a certificate to the
effect that either the equipment is not available or not accessible for the project work
in his/her institute.
c. The name of the statutory auditor.
d. An undertaking that the staff employed for the project would be the responsibility of
the host institution and would have no claim to a permanent employment with the
ICMR. The project staff would be governed by administrative and service rules of
host Institutes.

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.

8. Down gradation/Up-gradation of approved posts

For whatever reasons, if an investigator would like to downgrade or upgrade a post or


convert it to an equivalent post with another designation, the PI will have to send a request
to ICMR with adequate justification. The justification will be carefully examined by the
Technical Division and if approved, Heads of Divisions will communicate the same to the PI.
However, the PIs will have to manage such re-designations within the budget and only after
appropriate approvals.

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.

10. Utilization of the travel grant


The grant can be utilized for travel of the PI, co-investigator or of research fellow/associates
working on the scheme for:

a. Attending seminars/symposia/conferences within the county provided the PI himself or


the Fellow/Associate, is presenting, a research paper based on the project work (either
oral or poster presentation).

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.

11. Utilizing the contingent grant

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.

b) Chemicals/consumable items required for research work

c) Charges for specialized investigations for which facilities do not exist in the host
institute

d) Publication Charges/reprints/off-prints of research papers published as an outcome of


the research.
e) Data-entry charges

f) Printing of questionnaire/s

g) Computer utilities, charges for analysis of data (computer charges)

h) Typing of research reports

i) Expenses in connection with the preparation of the final report

j) Petrol, oil, lubricants (POL)

k) Communication charges

l) Grant cannot be used for purchase of furniture items/office equipment

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.

14. Annual Progress Report

a. Annual Report is to be submitted by the PI in the prescribed format(format is available


at ICMR web).The Annual Progress Report should be submitted about three months
prior to the completion of the financial year end to enable its evaluation and decisions
regarding subsequent grant release. The subsequent Annual Reports will have to be
submitted till the end of project period.

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.

15. Annual utilization certificate

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.

c. An audited statement would be essential for release of second installment and


subsequent installments of the annual grant from second onwards.

16. Final Project Completion Report

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.

17. Final settlement of the Accounts

The final settlement of the Accounts will be done at ICMR HQs only after the receipt of the
following:

a. Final audited statement of expenditure.


b. Final utilization certificate.
c. List of equipment procured from the project mentioning the cost, date of purchase and
suggestions for disposal of all items purchased under equipment.
d. The unspent grant paid by ICMR shall be refunded by the institution as and
when the investigator discontinues a scheme midway or does not follow the detailed
technical programme laid down and approved.

18. Overhead expenses

a. Will be restricted to 5% of the total cost of the project.


b. Overhead expenditure will not be granted on equipment and travel allowances.

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.

20. Duration of schemes

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

a. PIs are encouraged to have a co-investigator in the project.

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.

22. Intellectual Property Rights

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.

23. Publication of Result/Presentation of Papers

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

Cost details of permanent equipment/assets

(Please use a separate sheet for each equipment)

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

FORMAT FOR ANNUAL PROGRESS REPORT

1. Project title

2. PI (name & address)

3. Co-PI (name & address)

4. Date of start

5. Duration

6. Objectives of the proposal

7. Methodology

8. Interim modification of objectives/methodology (with justifications)

9. Detail progress of the work carried out during the period

10. A summary sheet of not more than two pages under following heads (Title, Introduction,
Rationale, Objectives, Methodology, Results, Translational Potential)

11. Research work which remains to be done under the project

12. Applied value of the project

13. Any publications.

14. Any patents applied for

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)

1. Sanction letter No. :....................... ……………

2. Total Project Cost : Rs…………………………

3. Sanction /Revised Project cost(if applicable) :Rs………….......................

4. Date of Commencement of Project :…………….......................

5. Statement of Expenditure :………….…......................

S.No. Sanctioned/Heads Funds Expenditure Balance Requirement Remarks


Allocated Incurred as on of Funds upto
I II III (Date) 31st March
Year Year Year
1. Salaries
2. Permanent
Equipments
3. Supplies &
Materials
4. Travel
5. Contingencies
6. Overhead Expenses
7. Others (if any)
8. Total

Signature of Principal Investigator Signature of Accounts Officer


with date With date
Annexure-3a

Check list for covering note to accompany Utilization Certificate of grant for the project for the period
ending 31st March, 20 __)

1) Title of the project

2) Name of the Institutions

3) Principal Investigator

4) ICMR letter No. and date sanctioning the project.

5) Head of account as given in the original sanction letter

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).

9) Balance amount available at the end of the financial year.

10) Amount already committed, if any.

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 ............................................

Signature of Signature of Registrar/ Signature of Accounts Officer


Principal Investigator of the Institute with date of the Institute with date
with date
Annexure-4
FORMAT FOR FINAL REPORT

FORMAT FOR FINAL REPORT

1. Title of the Project:

2. Unique ID of the Project (provided by ICMR)

3. Principal Investigator and Co-Investigators with designation and mobile no.

4. Implementing Institution and other collaborating Institutions with address

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.

10. Field/Experimental work giving full details of summary of methods adopted.

11. Supported by necessary tables, charts, diagrams and photographs.

12. Detailed analysis of results

13. Contributions made towards increasing the state of knowledge in the subject.

14. Conclusions summarizing the achievements and indication of scope for future work.

15. Science and Technology benefits accrued:

i) Please provide the information in the following format on identification of potential


lead(s), vaccine candidate(s), Medical devices, biomarkers, diagnostics methods/assays,
Health Care System Processes and preparation of guidelines having translational
potential for public health use.

Sl. Chemical (IUPAC) Target Disease IC 50/equivalent remarks


No. biomarker (Protein/DNA)

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)

iii) Would you be interested in carrying this work forward Yes / No

If yes, do you have infrastructure facilities for further work.

iv) Patent(s)/ copyright*

 Applied with number and date of filing

 Granted with Number and date of approval

 Granting authority : National / International

 Nil /Not applicable

*would you like to have assistance from ICMR in patenting/copyright (Yes / No) :

v) Products developed, if any. (Brief description of the product – 200 words)

vi) List of research publications with complete details:

Authors, Title of paper, Name of Journal, Vol., page, year

vii) Manpower trained in the project:

 Research Scientists or Research Fellows

 No. of Ph.Ds produced

 Other Technical Personnel trained

viii) Any other comments

16. Abstract (300 words for possible publication in ICMR Bulletin).

17. Procurement/usage of Equipment


a.
S.No. Name of Make/ Cost Date of Utilisation Remarks regarding
Equipment Model FE/Rs Installation rate % maintenance/breakdown
b. Suggestions for disposal of equipment(s)

Name and signature with date

1. __________________________
(Principal Investigator)

2. __________________________
(Co-Investigator)

FORMAT FOR FINAL STATEMENT OF EXPENDITURE


(to accompany the Final Report)

1) Sanction letter No.


2) Total project cost
(Sanctioned/revised project cost, if applicable)
3) Date of commencement of project:
4) Date of completion of project:
5) Grant revised in each year (financial):

S. Sanctioned Funds Expenditure Incurred Balance Remarks


No. Heads Allocated Financial year-wise (if any)
Ist yr IIndyr IIIrdyr IVthyr
Total
1 2 3 4 5 6 7 8 9 10
1 Salaries
2 Equipment
3 Consumables
4 Travel
5 Contingencies
6 Overhead
Expenses
7 Others
(if any)
8 Total

Amount to be refunded/reimbursed (whichever is appropriate): Rs.


Name & Signature
Principal Investigator
With date

Signature of Competent
Financial/audit authority
With date
To,
Director General
Indian council of Medical Research
Ansari Nager
New Delhi-110029

Subject: Acceptance the project No---------

Dear Sir/Madam,

We are very happy to accept the project proposal entitled “-------------------------------“having


ICMR No. ----------- from the Division of --------------.

We hereby provide the fallowing undertaking:

1. We accept that the project with its sanctioned budget.

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.

6. We agree to submit the annual and final reports on time.

7. We assure that the project will be completed on time.


Thanking you

Yours sincerely

(Name of PI)

Name and seal of

Head of the Institute.

*****

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