Government of India

GUIDELINE FOR SHARING OF BIOLOGICAL, CLINICAL SAMPLES AND DATA

FOR RESEARCH RELATED TO COVID-19

I. BACKGROUND

The world is witnessing the pandemic of severe acute respiratory syndrome

coronavirus-2 (SARS-CoV-2), commonly known as 2019 novel coronavirus (COVID-
19). COVID-19 has been declared as pandemic by the World Health Organization.
The scientists and researchers across the global are working towards the
development of prophylactics, therapeutics and rapid diagnostic methods for
treatment and management of COVID-19 situations.

It is imperative to to ensure that biological samples are appropriately managed. The

Government of India is committed to provide an enabling ecosystem research
ecosystem in the country to develop tests, diagnostics, drugs, therapeutics and
vaccines for COVID 19. To address this, there is an urgent need for having a
sharing mechanism for Biological /Clinical Samples and Data between Institutions
and Researchers during unprecedented public health emergency due to COVID-19.

II. SCOPE

The present Guideline provides a basic framework for sharing of Biological/ Clinical
samples and Data amongst all the National and public research Institutions,
healthcare facilities and those private entities which are working in collaboration with
the Government Departments which undertake research activities related to the
COVID-19. These guidelines have been framed in line with the existing International
frameworks such as Biological Weapons Convention to which the Country is a
signatory. The present Guidelines are consistent to the National Guidelines/ Policies
and regulatory frameworks related to conduct of scientific research, Clinical Trials,
medical practice and Data privacy

The present Guidelines specifically has considered the Article X (1) of the Biological
Weapons Convention that provides, “The States Parties to this Convention
undertake to facilitate, and have the right to participate in, the fullest possible
exchange of equipment, materials and scientific and technological information for the
use of bacteriological (biological) agents and toxins for peaceful purposes”.

III. DEFINITIONS

a. Biological Sample- Shall mean Primary isolate consisting of a

pure microbial or viral sample that has been obtained from an infected individual,
, Secondary isolate grown in a laboratory or Repository, isolate including DNA,
RNA and antibodies accessed from institutions

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 b. Clinical Sample- Shall mean blood, plasma, urine, tissue, cells,
cell cultures, naso-oro-pharyngeal swabs or saliva collected from persons
presenting to screening centres with suspected COVID-19 infection, patients
diagnosed with COVID-19 infection being kept under home quarantine or hospital
isolation, patients with moderate and severe COVID-19 being treated in hospitals
or intensive care units and those who are in convalescent stage (beyond 10 days
and 6 weeks of origin of symptoms)

c. IBSC- Institutional Biosafety Committee (IBSC) shall mean the

Committee as defined under the “Rules for the manufacture, use/import/export
and storage of hazardous microorganisms/ genetically engineered organisms or
cells, 1989” notified by the Ministry of Environment Forests and Climate Change
(MoEF&CC), Government of India under the Environment (Protection) Act (1986)

d. RCGM- Review Committee on Genetic Manipulation (RCGM)

shall mean the Committee defined under the “Rules for the manufacture,
use/import/export and storage of hazardous microorganisms/ genetically
engineered organisms or cells, 1989” and functions in the Department of
Biotechnology to monitor the safety related aspects in respect of on-going
research projects and activities involving genetically engineered
organisms/hazardous microorganisms.

e. CDSCO- The Central Drugs Standard Control Organization

(CDSCO shall mean the Regulatory Authority under Directorate General of
Health Services, Ministry of Health & Family Welfare, Government of India

f. IATA- shall mean the International Air Transport Association

(IATA)

g. IEC: Institutional Ethics Committee

h. ISBER: International Society for biological and environmental

repository

IV. SAMPLE ACQUISITION AND STORAGE

Moving biological/clinical samples from one place to another and sharing of

related data can be very critical for addressing the pandemic created by
COVID-19, as progress in science & technology and subsequent medical
research and development of products is driven by such biological samples.
Therefore, rapid and timely movement of samples and sharing of associated
data must be simple and transparent, without compromising the interests of
the sample providers. Also, the identity of the individual(s) who consented to
provide samples must be protected.

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A. SAMPLE ACQUISITION

i. All samples/specimens for conducting research & product development on

COVID-19 shall be collected and handled in accordance with the
Guidelines for Clinical Samples issued by ICMR under the ‘Strategy of
COVID 19 testing in India’ (Updated as on Date) and Interim Guidance
Document on Laboratory Biosafety to Handle COVID-19 Specimens as
issued by Department of Biotechnology ,Ministry of Science &
Technology(ref-BT/BS/17/635/2015 dated 08.04.2020) (ANNEXURE- A)

ii. All facilities, institutions and other entities should collect biological or
clinical samples for research and product development purposes as
approved by institutional or national authorities, as appropriate. The
approvals granted under the frameworks governing research and clinical
trials from respective Institutional Ethics Committees, IBSC, RCGM or
CDSCO as applicable shall be duly obtained before initiating sample
and/or data collection.

iii. Biological Sample acquisition

Viral isolation from Biological samples, viral propagative activities and

technical procedures related to Biological Samples should be performed in
strict adherence to the standard operating protocols, IBSC/RCGM
approval as per the Regulations & Guidelines for Recombinant DNA
Research and Biocontainment, 2017 and Interim Guidelines on
laboratory biosafety to handle COVID 19 specimen for R & D purpose
2020 (Access link to both the Guidelines are provided at ANNEXURE-A).
Interim guidelines also provide for research other than those that involve
handling of live virus. Any sharing of further samples among the
participating research institutions/stakeholders in India will require
execution a suitable MTA and approval of IBSC/RCGM.

iv. Clinical Sample acquisition

Clinical sample acquisition including the scope of further sharing for

research purposes and publication of results shall be made integral to the
Informed Consent Forms (consent by self or legally accepted
Representative; relative) by the facilities, institutions and other entities.
The specific Annexure that provides for Guidelines related to Sample
Collection should be referred for the detailed considerations in this regard.
- Annexure: B

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 B. STORAGE OF SAMPLES

The collecting entity can store samples at authorized

biorepositories/research laboratories, in compliance with relevant
biosafety and biosecurity guidelines stated herein above as Annexure: A
and as per ISBER.

C. DATA ACQUISITION AND STORAGE

i. The facilities, institutions and other entities that collect Data distinctly
or along with Samples should initiate the collection after the grant of
due approval for the research or study Protocol and shall adhere to the
principles of a proper informed consent from the participating human
subjects.

ii. All collected Data should be catalogued and shall be managed to

ensure findability, accessibility, interoperability and reusability.

iii. Misuse or unauthorized access to the Data should be prevented by

suitable protection measures.

IV. BIOLOGICAL SAMPLES SHARING

a. The sharing of the Biological Samples shall be through the process

provided for by the ICMR. The Investigators/organisations/companies
shall place the request accordingly (ANNEXURE- C)

b. Transit of Biological samples including labelling, packaging, shipment or

transport shall be as prescribed by ICMR, DBT (Regulations & Guidelines
for Recombinant DNA Research and Biocontainment, 2017 and Interim
Guidelines on laboratory biosafety to handle COVID 19 specimen for R &
D purpose 2020) and IATA Dangerous Goods Regulations, as applicable.

V. CLINICAL SAMPLES SHARING

a. The sharing of the Clinical Samples shall be undertaken at the level of the
respective Custodian (the designated/ authorised:
biorepository/laboratory). The request can be submitted in the form
appended hereto as ANNEXURE- D.

b. Provision of further access to the Clinical Samples among the

stakeholders and their sharing for undertaking pertinent activities shall be
based on the approved protocol or research scope for which permission
has been granted by the appropriate authority (Designated authorized
biorepository/ laboratory).

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VI. DATA SHARING

The sharing of the Data among the collaborators and the participating entities
can be undertaken by the respective Custodian (the designated/ authorized:
biorepository/laboratory) in strict adherence to the corresponding statutory
requirements related to personal and sensitive data: where such data has
been collected, disclosed, shared or otherwise processed within the territory
of India

VII. INTERNAL GOVERNANCE MECHANISM

a. The request for access to the Data and/or the Clinical samples will be
considered by the Internal Governance Mechanism of the provider entities
such as the designated/ authorized: biorepository/laboratory/Institution,
Such consideration shall be in line with the proposed study or research
protocol, sensitivity of the Data, specific legal and Commercial
requirements that have approved by relevant authority and evinced
through the documents submitted by the requesting entity(ies).

b. If the sharing of the Sample/Data was proposed at a stage later than

protocol submission, then the entities and organizations participating in
research information exchange initiatives can also execute agreements
such as data sharing agreements, Data Use Agreements (DUA),
Collaborative Research Agreements (CoRA), and Participation
Agreements (PA): collectively known as Data Sharing Agreements (DSAs)
for further sharing of Data and/or Samples. The DSA can be considered
by the Internal Governance Mechanism to determine Data/ Clinical
Sample sharing.

c. The timeline for giving approval should not be more than 48 working
hours.

VIII. CONFIDENTIALITY OF DATA AND SAMPLES AND CREDIT

a. Any of the entity accessing the Data and/or the Samples will abide by the
norms of de-identifying them while reporting or publishing the results of
their respective research/study/trial/registry.
b. However, all reports and publications should describe how to access
underlying Data/ Sample through due acknowledgement to the concerned
source and by citing express credit for the contribution.

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 IX. GOVERNANCE OF RESULTS

a. Intellectual Property: The sharing of the interests in the resultant

Intellectual Property shall be based on the organizational Policy or the
mutually agreed upon Clauses among the contributors provided; they
adhere to the prompt public access requirements in national interest

b. Publications: The Institutions, facilities and the entities who access and
share the Samples and/or Data under this Guideline shall strive to publish
the results in a prompt and ethical manner while the authorship can be
determined based on the mutually agreed upon Clauses between
themselves.

X. ANNEXURE

A. ANNEXURE- A
Regulations & Guidelines for Recombinant DNA Research and
Biocontainment, 2017 and the Interim Guidance Document on
Laboratory Biosafety to Handle COVID-19 Specimens as issued by
DBT (ref-BT/BS/17/635/2015 dated 08.04.2020): The guidelines can
be accessed through the link -https://ibkp.dbtindia.gov.in/
Content/Rules.

B. ANNEXURE- B
Guidelines related to Sample Collection

C. ANNEXURE- C
Form issued by ICMR for submitting request to access Biological
Samples

D. ANNEXURE- D
Form for submitting request to access Clinical Samples/ Data

NOTE: Apart from the above guidelines pertaining to sharing of Data and Samples
related to COVID-19, specific activities undertaken by Participating entities shall
comply with appropriate frameworks issued by concerned authorities as on date

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Annexure A

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 Department of Biotechnology
Ministry of Science and Technology
Government of India

Interim Guidance Document on Laboratory Biosafety to Handle COVID-19 Specimens

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), commonly known as 2019

novel coronavirus (COVID-19) has been declared as pandemic by the World Health
Organization. With little scientifically validated information on this novel virus as well as the
absence of vaccine and medications to treat or limit the spread, the laboratories planning for R &
D work on suspected/confirmed positive COVID-19 samples should follow the precautions as
enlisted for the Risk Group 3/4 organisms in the “Regulations and Guidelines for Recombinant
DNA Research and Biocontainment, 2017”.

The purpose of this document is to provide an interim guideline on laboratory biosafety

(in tune with the international norms) to be followed in handling and processing clinical
samples/infectious virus for diagnostic testing and R&D work to develop new diagnostics /
therapeutics for COVID-19. All virus-related manipulations should be performed in a BSL2/3
laboratory depending on the nature of the work and only by laboratory staff trained in the
relevant technical and safety procedures with strict adherence to sample inventory, Personal
Protective Equipments and Waste Management SoPs.

The basic minimal procedures to be followed are:

All Institutional Biosafety Committee’s (IBSCs) must assess the available facilities,
trained manpower in handling high risk group (RG3 and above) hazardous microorganisms,
personal protection equipment (PPE) and waste disposal mechanism to meet all the requirements
prior to initiation of work involving COVID-19. Prior to the initiation of R&D work involving
COVID-19, proposals should be submitted online at IBKP portal along with IBSC
recommendation for the approval by the Review Committee on Genetic Manipulation (RCGM).
All applications for the development of vaccines, diagnostics, prophylactics and therapeutics will
be considered under Rapid Response Regulatory Framework for COVID-19 by RCGM and
CDSCO as per DBT OM No. BT/03/27/2020-PID, dated 20.03.2020.

i. Appropriate personal protective equipment (PPE) as determined by a detailed risk

assessment, should be worn by all laboratory personnel handling these specimens.
ii. All procedures must be performed based on risk assessment and only by personnel
with demonstrated capability in strict observance to any relevant protocols at all
times.
iii. Where the work involves the use of only the viral components and not the live
SARS-CoV-2 virus, patient specimens collected in the COVID treatment ward in
collection tubes, sealed properly and containing virus inactivation reagents that
denature the viral envelope, and inactivate the virus may be transported from the

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 hospital wards to respective Laboratories, similar to transportation of biomedical
samples from the hospital wards to laboratory.
iv. Patient specimens from suspected or confirmed cases should be transported as
UN3373, “Biological Substance Category B”; Viral cultures or isolates should be
transported as Category A, UN2814, “infectious substance, affecting humans”
respectively and transported as per the WHO “Guidance on regulations for the
transport of infectious substances 2017–2018”. As a first step, it is imperative that
periodical recording of inventory of sample collection, storage, authorization of use,
transfer and disposal of all materials are adhered to.
v. Initial processing (before inactivation) of all suspected specimens should take place
in a validated biological safety cabinet (BSC) or primary containment device.
vi. Non-propagative diagnostic laboratory work (e.g. nucleic acids, sequencing, NAAT,
PCR, isolation of antibodies, serum proteins) should be conducted in laboratories
with facilities and procedures equivalent to BSL-2. Further, infective agent should be
inactivated in BSL-2 cabinet under suitable PPE before any laboratory procedure.
Based on the biological material required, if sample collected in inactivation
medium, such procedure could be adopted.
vii. All propagative work (e.g. virus culture, isolation or neutralization assays) should be
performed only by properly trained and competent personnel in laboratories capable
of meeting additional essential containment requirements and practices (BSL-3).
viii. Appropriate disinfectants with proven activity against enveloped viruses should be
used (e.g. hypochlorite (bleach), alcohol, hydrogen peroxide, quaternary ammonium
compounds and phenolic compounds).
ix. All technical procedures should be performed with standard operating protocols that
minimize the generation of aerosols and droplets.
x. IBSC should quarterly update status of such work in the organization along with
details of inventory and biosecurity information.
xi. Periodic reports of the staff handling the work and their medical surveillance reports
duly certified by a medical doctor should be complied with.
xii. For work related to COVID-19, RCGM may constitute an empowered Committee, if
necessary to visit the laboratory to ensure due diligence to protocols and other
requirements
xiii. To prevent spread of disease in animals, if any, tested animals should be properly
isolated and taken care.

Risk assessment and mitigation measures

Risk assessment and mitigation measures are dependent on the procedures performed and
the competency level of the personnel performing the procedures in addition to identification of
the hazards involved in the process and/or procedures, the laboratory equipment and facility, and
the resources available. It is highly recommended to start by performing a local risk assessment
for each of the process step, i.e. starting from sample collection, to the different processes that

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are planned in the laboratory) and for each of the process step the potential hazards (e.g., aerosol
exposure, potential spillage etc.,) have to be considered and assessed with a grade of risk.
Appropriate risk control measures are to be identified and implemented to mitigate the risk
identified to an acceptable level.

Routine laboratory procedures

Clinical samples being processed for non-culture-based laboratory diagnostic procedures

and PCR analysis from patients suspected or confirmed to be infected with the novel coronavirus
should adopt procedures and practices routine to a clinical and microbiology laboratory. A
validated biosafety cabinet (BSC) to be strictly used for all manipulations that might potentially
result in droplets or aerosol (e.g. loading and unloading of sealed centrifuge cups, grinding,
blending, vigorous shaking or mixing, sonic disruption, opening of containers of infectious
materials whose internal pressure may be different from the ambient pressure), from infectious
COVID-19 samples.

Specimen and nucleic acid storage

Suspected or confirmed COVID-19 specimens, with appropriate identification labeling,

should be stored at a designated place with controlled access to authorized personnel only at 2-8
C or at -70 C depending on the nature of the experiment(s). Extracted nucleic acid samples
should be stored at -70 C or lower. All diagnostic laboratories should strictly follow the
retention period as per standard guidelines for the samples submitted to them for testing.

Viral isolation

Viral isolation from clinical specimens suspected or confirmed to be infected with the
novel coronavirus (COVID-19) should be performed only in Biosafety level 3 (BSL3) and above
facilities.

Disinfectants and Laboratory waste management

For the selection of appropriate decontamination and disinfection strategies for

biomedical waste treatment and disposal should be in accordance to those mentioned in the
“Revised Guidelines for Common Bio-medical Waste Treatment and Disposal Facilities”
(2016) developed by Central Pollution Control Board (CPCB). In the light of the comparable
genetic characteristics with SARS-CoV and COVID-19, COVID-19 is likely to be susceptible to
disinfectants with proven activity against enveloped viruses, including sodium hypochlorite
(bleach) (e.g. 1,000 ppm (0.1%) for general surface disinfection and 10,000 ppm (1%) for
disinfection of blood spills), 62-71% ethanol, 0.5% hydrogen peroxide, quaternary ammonium
compounds and phenolic compounds and used as per manufacturer’s recommendations. The
contact time for disinfection, dilution/concentration of the active ingredient and its shelf life

4
should also be considered. The waste generated in the laboratory handling live virus be
incinerated. The laboratory waste should be handled like other biohazardous waste as per the
DBT notified “Regulations and Guidelines on Biosafety of Recombinant DNA Research and
Biocontainment, 2017”.

Specimen packaging and shipment

All specimens being transported should have appropriate packaging, labeling and
documentation. For details, follow WHO’s “Guidance on regulations for the transport of
infectious substances 2017–2018”. This document provides practical guidance to facilitate
compliance with applicable international regulations for the transport of infectious substances by
all modes of transport, both nationally and internationally, and include the changes that apply
from 01 January 2017.

i. All materials to be transported should be placed in a leak proof unbreakable primary

container followed by a leak proof, watertight secondary packaging with absorbent
material and a rigid outer packaging to minimize the potential for breakage or
spillage.
ii. Patient specimens from suspected or confirmed cases to be transported for diagnostic
or investigational purposes - as UN3373, “Biological Substance, Category B”
iii. Transporting viral cultures or isolates - as Category A, UN2814, “infectious
substance, affecting humans”.
iv. Transport of specimens within national borders should comply national regulations.
v. For cross boundary transport of novel coronavirus specimens should follow the UN
Model Regulations, Technical Instructions by the International Civil Aviation
Organization and other applicable regulations depending on the mode of transport
being used.

Note: For further information, the IBSCs are advised to refer to the following two Interim
Laboratory Biosafety Guidelines.

1. WHO interim guidelines: Laboratory biosafety guidance related to the novel

coronavirus (COVID-19) (as on 19 March 2020)
2. CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens
Associated with Coronavirus Disease 2019 (COVID-19) (as on March 31, 2020).

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 Annexure B to the Sample/Data Sharing Guidelines

Annexure B

Collection of data and biospecimens for COVID-19 research purposes

While diagnosis and management of the disease is paramount in a pandemic, it is also

essential to empower the healthcare system with the ability to develop novel diagnostic,
preventive and therapeutic tools at an expedited pace to manage the pandemic
effectively. Data and samples collected from patients can be used for measuring and
monitoring disease and to develop and test diagnostics and vaccines.

The following guidelines should be adopted for sample collection, transport and storage.
Institutional ethics approval should be obtained on expedited basis from Institutional
Ethics Committees/Institutional Review Boards on expedited basis for any collection
involving samples that are minimal risk (e.g. blood, naso-/oro-pharyngeal swabs, urine,
saliva). Additional clinical research involving other specimen types may require a
convened meeting, which, if required, should be held rapidly.

Categories of patients from whom samples should be collected:

1. Patients presenting to screening centres with suspected COVID-19 infection
2. Diagnosed cases of COVID-19 infection being kept under home quarantine or
hospital isolation
3. Patients with moderate and severe COVID-19 being treated in high dependency
units or intensive care units
4. Convalescent blood sample beyond 3-4 weeks from diagnosis for authorised
biorepository/research laboratory

Guidelines for data and sample collection of patients presenting to screening centres
with suspected COVID-19 infection:
1. Obtain informed consent before specimen collection, informing patients that if
they test positive they will be asked to provide samples and data during and after
their illness.
2. In addition to the respiratory (nasopharyngeal, nasal and oropharyngeal)
samples collected by the hospital for diagnostic purposes, an additional set of
nasopharyngeal, nasal and/or oropharyngeal samples should be collected for
sending to authorised biorepository/research laboratory.
3. The process of collecting the biospecimens should follow the steps detailed in
theGuidance on specimen collection, processing, transportation, including related
biosafety procedures, that is available on https://mohfw.gov.in/media/disease-
alerts.

Page 1 of 3
 Annexure B to the Sample/Data Sharing Guidelines

4. In addition to the respiratory samples, blood and/or other biological specimens

should be collected from the patients (following approval from institutional ethics
committee of the screening centre if attached to a hospital or of the government
institution linked to the laboratory/centre).
5. Relevant clinical data should be collected from the patients.

Guidelines for data and sample collection of diagnosed cases of COVID-19 infection
being kept under home quarantine or hospital isolation:
1. These are patients admitted to designated COVID-19 hospitals or advised home
quarantine following their diagnosis and clinical assessment.
2. If they are at the hospital, the sample collection process should follow the same
protocol as described above. In addition to the respiratory samples, blood and/or
other biological specimens should be collected from the patients (following
approval from institutional ethics committee of the screening centre if attached to
a hospital or of the government institution linked to the laboratory/centre).
3. If they are not at a hospital, blood should be collected either at home or at a
designated place where the sample collection guidelines of ICMR can be
followed. All measures should be taken to ensure that the participant can be
brought to this place conveniently.
4. Relevant clinical data should be collected from the patients.

Guidelines for data and sample collection of patients with moderate and severe COVID-
19 being treated in high dependency units or intensive care units:
1. These are patients admitted to High Dependency Units or Intensive Care Units
with moderate or severe disease with/ without complications.
2. The medical personnel in the ICUs should administer the consent to the patient
or their attendant if the patient is unable to participate in the consenting process,
reconsenting should be done when the participant regains his ability to
participate.
3. Biological specimens should be collected following the above described
collection process in coordination with the attending clinicians.
4. Lower respiratory tract samples may also be collected when these are readily
available (for example, in mechanically ventilated patients).
5. Relevant clinical data should be collected from the patients/ clinician/ patient’s
attendant.

Guidelines for data and sample collection of patients who are beyond 3-4 weeks of
confirmed COVID-19 for authorized biorepository/research laboratory:

1. With informed consent (taken at the time of acute sample, and with institutional
review board approval of authorised biorepository/research group), additional

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 Annexure B to the Sample/Data Sharing Guidelines

samples will be collected from cases subsequently testing positive for SARS-
CoV2 by the authorised biorepository/research laboratory, based on test results
provided by the testing laboratory.
2. Similar procedures should be followed for obtaining patients’ blood samples at 6
and 12 months wherever required.
3. Biospecimens can be collected either at home or at a designated place where
the sample collection guidelines of ICMR can be followed. All measures should
be taken to ensure that the participant can be brought to this place conveniently.

Any additional samples as approved in the protocol, may include urine, stool, saliva
etc

Principles of Access to the samples and associated data

The basic principles for access are:

● The clinical data and the sample management and quality control data should be
managed by standard operating protocols to include the metadata in machine-
readable formats. This is to ensure rapid retrieval and sharing.
● Data and samples should be made available to all bona fide researchers/product
developers for research and development that is in the public interest. All
applicants will be subject to the same application process and approval criteria.
● Access procedures, ethics and governance framework should be made available
in the public domain.
● Access to the biological samples that are limited and depletable should be
coordinated; judged against potential benefits, with advice from appropriate
experts as required.
● Anonymity and confidentiality of participants’ data and samples should be
maintained.
● The clinical data and biospecimens should be used for developing solutions
which have the highest public health implications.
● Those provided access to data and samples should provide proof of optimal
utilisation of samples through demonstration of product and/or publication of
results based on data or samples obtained through this mechanism.

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Date: Inrquesr ron sans cov-2 vrRUs FRoM tcMR-NATIoNAt tNsrtrurr or vtnorocv, nuur]

tcMR-NATIONAt INSTITUTE OF VIROIOGY, PUNE

lndian Council of Medical Research
SARS CoV2 Virus Request Form

SARS Cov2

Handling and culturing of this virus requires certified & validated BSL-3 laboratory since, it belongs to
risk group lll category. However, if inactive/killed virus is to be used for diagnosis purposes it can be
handled in BSL-2 laboratory. ICMR-National lnstitute of Virology, Pune has recently isolated this virus
from the patients' samples and quality controlled representative high titer isolates are available to
researchers within lndia for both scientific research and industry.

The major goal of DHR/ICMR is to assist and facilitate lndian researchers at various multidisciplinary
levels. The major emphasis has been given on quality assurance of the virus stocks.

The current Biosecurity and lnternational Regulations make it mandatory for ICMR-NlV as a virus holding
entity to evaluate, enforce and have full rights on post-issue compliance by the recipients of the virus
and share information with other National agencies as dictated by regulatory issues of the Govt.

The SARS CoV2 is a coronavirus that is the etiologic agent for human respiratory illness and interim
biosafety guidelines for handling and processing of the specimens and laboratory work associated with
the virus has been laid down by the WHO https://www.who.int/csr/sars/biosafetv2003 04 25len/.

Other interim tuidelines are also available

https://www.cdc.sov/sars/suida nce/f-lab/app5.html

https://www.who. int/d ocs/defa ult-source/coronaviruse/la boratorv- biosafetv-novel-coronaviru s-

version-1-1.pdf?sfursn=912a9847 2

ln the view of the need to rapidly support collateral multi-sectoral research & development activities to
further strengthen lndia's capacity in dealing with the COVIO-19 situation, the lndian Council of Medical
Research can share through the ICMR-NlV the following SARS-CoV 2 research material:

1. SARS-CoV-2 genomic RNA and heat inactivated virus

2. Positive and negative samples fiimited numbers]
3. Live virus

The details have been provided in subsequent sections. ln summary, investigators from all Govt research
organizations, recognized Universities (under UGC/National status), autonomous research/academic
lnstitutions of Govt of lndia and lndian pharma/biotech biological industries are eligible to receive virus
isolates.

The application process is multilayered as per compliance with regulatory issues. ln the first phase the
investigator has to fill up the form in original, sitn every page and forward it with a letter of request

Page 1of 8
Date: InEqUrSr FOR SARS COV-2 VIRUS FROM ;CMR-NATIONAL INSTITUTE Or VtnOlOeV, eUur]

through the Head of the Organization to the Director NIV Pune with a copy to Director General, ICMR.
Confirmation of qualification for receipt of virus will be sent to the indentor directly.

What happens after the requisition form is received at NIV?

The application will be evaluated by ICMR-NlV and intimation of the status of the application for pre-
qualification will be sent. The user's facilitv mav also be inspected bv a team from NlV. ln case of a
completely qualified recipient the intimation details of virus shipment will be sent on completion of the
process.

Evaluation of the application for prequalification status: 5 working days from date of receipt at NlV.

Final notification on virus status: variable depending on case-wise evaluation status.

Obligations of the recipient:

The recipient of the virus and parent organization has to give a legal undertaking on compliance issues
mentioned in detail at the end of the form. Please note that this is mandatory. All users will be
ultimately assigned unique lDs for assuring best services from the repository.

lnstructions:

Please read the instructions carefully before filling the virus indent request form.

Complete information sought under the following fields is mandatory. Please note that requests with
incomplete information will be rejected. lt is also mandatory to complete the SECTION 3 declaration on
responsibility/liability clauses with authorization from office of appropriate authority as mentioned in
detail in SECTION 3.

The information requested needs to be filled, duly signed on each page by the indentor and forwarded
through the appropriate authority with a covering letter to the Director, ICMR-National lnstitute of
Virology, 20A Dr Ambedkar Road Pune 411001, signed and sealed on official stationery. No email or FAX
copies will be accepted.

The indentor is requested to make sure that all information provided is factual and auditable/verifiable
under National and lnternational regulatory/ Biosecurity laws and any application clauses of Govt. of
lndia as amended from time to time. Please note that provision of the information does not make it
mandatory for the lnstitute to provide the requested virus. The decision of the DG, ICMR or Director
ICMR-NIV will be final.

Please note that availability of requested virus stock will be as per availability with inventory position.

For queries and further information please feel free to contact:

Director
ICMR-National lnstitute of Virology 20-A Dr. Ambedkar Road Pune 4L1001

I=]113i!!3l]:_:::.=:2?:,:=,]j-T]]=5i#:==========================

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Date: Inrouesr FoR sARs cov-2 vrRUs FRoM ICMR-NATToNAL tNsrrurE oF vtRoLoGY, PUNE]

User classification

CATEGORY 1: GOVT RESEARCH ORGANIZATIONS

Department of Biotechnology Council of Scientific and lndustrial Research
Indian Council of Medical Research Dept. of Atomic Energy
Department of Science & Technologv DRDO/Defense
ISRO ICAR
Others

CATEGORY 2: RECOGNIZED UIVERSITY UNDER UNIVERSITY GRANTS COMMISSION (P|ease fuTnish details
)
National Universities/Centers of excellence (viz.
llSc. llT, NllT, IISER etc.)
Please furnish details

CATEGORY 3: INDUSTRY
Pha rma/Biotech/others Public/Private/Registration details/Detailed
companv info
Full lndian owned
lndian subsidiarv of multi-national companv
Foreign

sEcTtoN -1
lnformation on primary individual giving indent
Name
Affiliation
Status in project where virus is indented
PI
Co-Pl
I nvestigator(s)
Date of birth
Employee lD number
Affiliation
Ed ucational qualification
Experience in risk group-3 or -4 virus handling and
resea rch
Certified courses and/or practical training obtained if any
Place (b) date(c) details (c) copy of certificate
Date of appointment
Permanent Temporary Project Other

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Date: [neeuesr FoR sARs cov-2 vrRus FRoM rcMR-NATtoNAL lNsrtrurE oF vtRoLoGY, PUNEI

Orga nizational details

Name of organization
Address with contact details
Tel/email/urllemail
Affiliation of orsanization with source of fundine
Name designation and contact of Director/ Project
Co-Ordinator(s)
ln case of CATEGORY-2 user please provide details
on (a) Department
ln which research will be used (b) Details of
Department Head (c) Dean/Director
ln case of CAT-3 organization, please provide
details on:
(a) Division where research will be used
(b) Details of divisional Head
(c) Name, designation and details of person
responsible for the project and virus work

sEcTroN -2
2.1. lnformation on laboratory facilities
Biosafety status of the laboratory where the
indented virus will be handled
Category 1 Category 2
Category 3 Category 4
lnformation on personnel (other than indentor)
who will be handling the virus
Please attach all details of each individual as
outlined in Section L.1
Details on effluent treatment that will be done
Detailed layout of workplace IBSL-3] for live virus
handling
Age ncy/Com m ittee's Ce rtificate of La b va idation
I

for use of RG-3 agents [Names & affiliations of

Committee membersl
Decontamination protocols in place (copy from
LAB certified SOP mandatory)
Safety or Operations Manual to be followed for lab
personnel involved (copy of certifies manual to be
enclosed)
Nos of Biosafety cabinets with compliance data
and calibration sheets for last 6 months

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Date: InrqUrSr FOR SARS COV-2 VTRUS FROM 1CMR-NATIONAL INSTITUTE Or unOlOeV, eUrue]

Details on virus storage and security control for

such places
Nature of access control security in place to virus
work area
Nature of access of virus workplace and storage to
non-scientific personnel (cleani ng
crew/janitor/security personnel) and level of
restriction
Nature of records kept for virus amplification and
audit
ls the program single/multi-institutional
lf multi-institutional then details on collaborator(s)
Details of any other viruses being handled in the
same lab

2.2. lnformation on lnstitutional Committee

Name and details of IBSC committee members

2.3. lnformation on project for which virus is requested

Title of proiect
Source of funding
Research purpose/ commercial use (please
specify)
Approval by lnstitutional SAC/PRC/IBSC (all
relevant copies certified by lnstitutional head
mandatorv)
Duration of project
Summary and objectives
Place where project will be carried out
lnvolvement of any other human specimens if yes
IHEC committee approval copy to be enclosed
Animal experimentation if any with approval of
AEC of the institute
Cell culture/recombinant molecular studies if any
with undertaking on restricted experimental work
as in SECTION 3
Upscaling proposal if any?
For CATEGORY 3 users
Please provide information if DNA recombinant
work is planned using other commercially
licensed/patented products where indented virus
will be used
The indented virus will be used in broad terms of
usage under
Page 5 of 8
Date: IneqUeSr FOR SARS COV-2 VTRUS FROM ICMR-NATIONAL INSTITUTE Or unOlOCv, nUNe]

(a) Basic research

(b) Recombina nt product development
(c) vaccine
(d) Diagnostics
(e) other areas

2.4. Virus strain requested

L. SARS-CoV-2 Live virus strain
2. SARS-CoV-2 Heat inactivated
3. SARS-CoV-2 Synthetic molecular standard
(genomic RNA)

sEcfloN ilt

OBLIGATORY CLAUSES: MANDATORY UNDERTAKING FOR QUALIFIED RECIPIENTS OF VIRUS STOCK

(To be typed and signed on INR 500 Judicial Bond paper with following matter printed, signed and sealed
by organization Head)

l/we hereby declare that we have read, thoroughly understood and

undertake the following responsibility clauses, which l/we have read in detail, understood completely
and will be obliging with. l/we understand that failure to do so might lead to legal/other consequences
as applicable under applicable framework of international/national law.

l/we also declare that the experimentation carried out using the indented virus will not in any way
violate national security and/or lead to potential products that will pose a severe threat to public health
and safety. All entities, Federal, State, University laboratories, commercial enterprises, non-profit
organizations in possession of the indented virus strain willensure that the facility in which the virus is
handled is secured and access is restricted only to personnel as described in the requisition form.

Further, we have read, understood and agree to the following clauses:

3.1. Responsibility of compliance with authenticity of information.

The indentor and parent organization ensures that all information provided are true and verifiable.

3.2. Responsibility and compliance on laboratory facility inspection and audit.

After prequalification for receiving virus the indentors laboratory/organizational facilities maybe
inspected by a biosecurity/biosafety team deemed suitable by the DG ICMR/Secretary Department of
Health Research Govt of lndia. The final report of the team will be binding.

3.3. Responsibility of compliance with nationaUinternational regulatory issues as applicable.

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Date: Inequtsr ron snns cov-2 vrRUs FRoM rcMR-NATtoNAt tNsnrure or vtnotocl curue]

As explained earlier.ln addition the recipient of the virus gives full compliance of responsibility of
research code-of-conduct as stipulated and within framework of relevant articles of the following UN
conventions

UN Biological and Toxin Weapons Convention

The Organization for Prohibition of Chemical Weapons

The Nagoya Protocol

lnclusive of relevant informal arrangements of international disarmament agreements where lndia is a

party particularly (c) The Australia Group 1 (d) The WassenarArangement2

Any other applicable disarmament arrangement and clauses as relevant thereof #

https://www. un.orgldisarmament/wmd/bio/

https://www.opcw.orelmedia-centre/news/2020/03/opcw-implements-covid-19-related-measures

https://www.cbd.int/abs/

fl httos://www.un.org/disarmament/oublications/more/treaties/

3.4. Responsibility and compliance with restricted person liability.

The facility/personnel involved directly with the virus handling should not have in their staff individuals
having record of psychiatric issues/under substance abuse/undergoing treatment for psychiatric
illness/having any criminal records in their staff.

3.5. Responsibility on the compliance with incidence reporting.

It is mandatory for the P/Organization to report any incidences of biosafety/biosecurity issues or

incidences/situations that might arise involving the virus to NIV authorities for immediate necessary
action.

3.6. Responsibility on the compliance with restricted experiments.

No experiments as described in the UN charter on Biological security will be carried out with the
indented virus and the virus will be used solely for the purpose it has been indented for.

3.7. Responsibility on the compliance with non-transferable material agreement.

The indentor/organization shall not transfer share or dispense the indented virus/nucleic
acids/clones/other recombinant products developed thereof to a third party.

3.8. Responsibility on the compliance with lntellectual Property Rights (lPR) issues.

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Date: Inrquesr ron snns cov-2 vtRus FRoM tcMR-NATIoNAL tNsrtrurr or vtnoLoev, cut'tr]

The indentor shall abide by the IPR rules of GOI in relation to potential product development of
commercial interest with the indented virus. Discussion and MoU with NIV/DHR/lcMR maybe developed
as an interface before commercial venture.

3.9. Responsibility on the compliance with lnstitutional biosafety/biosecurity compliance approvals

(IBSC) bioethics and ICMR regulations and ICMR Guidelines for biomedical research

https://www.icmr.nic.inlsites/default/files/suidelines/lCM R Ethical Guidelines 2017.pdf

s# With mandatory certified compliance with relevant sections specially section (1.2) of the guideline
and to be certified by Head of lnstitute receiving SARS-CoV-2 related material from lcMR-NlV.

All lcM R/international bioethical compliances as relevant shall be followed.

3.10 The above undertaking shall be applicable for the said purpose and cannot be transferred/assigned
to any other Age ncy/lnstitution.

4.0. Declaration of responsibility complying with relevant national legislation

The indentor and recipient of the material fully understands the responsibilities as read and
comprehended with full understanding from sections 3.1 to 4.0 and accepts full responsibility of code-
of-conducts. Any violation, misuse and willful mala-fide intention/violation of the same will be fully
prosecutable under the relevant acts/laws of Government of lndia as applicable.

Si9nature...........................

Name

Designation................

P1ace............

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 ANNEXURE - D

COVID-19 BIORESOURCE ACCESS REQUEST FORM

1. TITLE OF THE RESEARCH PROJECT

2. AREA OF RESEARCH

3. PRINCIPAL INVESTIGATOR
Name:
Organization
Address
Telephone
Email
4. RESEARCH TEAM /CO-INVESTIGATORS (NAME AND ORGANIZATION)
Please add more co-investigators if required
Co-investigator (1)

Co-investigator (2)

Co-investigator (3)

5. A. PROJECT SUMMARY:
Brief description of the proposal highlighting its strategic importance along with its
potential outcomes. (max 500 word count).

i) Title
ii) Scientific Hypothesis
iii) Key/Research questions (100 words):
iv) Rationale:
v) Primary Objectives:
vi) Methodology:

6. MULTI-CENTRIC STUDY Yes

No
7. SAMPLES AND META DATA REQUIREMENTS

(i) Sample size

A. Cases:

Page 1 of 4
 ANNEXURE - D

COVID-19 BIORESOURCE ACCESS REQUEST FORM

No of Participants:
No of Samples(please describe if serial longitudinally collected samples arebeing
requested):

B. Control:

Matching Criteria:
No of Participants:
No of Samples:

Please give the justification for the use of volume and number of biospecimen to
ensure proper utilization and minimal wastage of sample:
Biospecimen type

Biospecimen volume (µl/ml)

Clinical data/Metadata required Yes No

(Please describe data particulars that will be
required) Blank case recording forms of the study
will be shared upon request

Selection Criteria Inclusion Criteria

Exclusion Criteria

8. STUDY PERIOD

Estimated Start Date Estimated End Date

9. FUNDING (If you are applying for a grant Applied Approved

please provide details about the funding
application. The preference would be for Yet to be applied
Biorepository to be a named partner
organization and study team members to be a
collaborator/co- investigator as appropriate
on the grant).

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 ANNEXURE - D

COVID-19 BIORESOURCE ACCESS REQUEST FORM

10. FUNDING AGENCY

11. ETHICAL APPROVAL

(If approved attach copy of the approval letters Approved
from the respective IRBs) Applied for
Not applied

12. Institutional Biosafety Committee (IBSC)

(If approved attach copy of the approval letters Approved
from the respective IBSCs) Applied for
Not applied

13. Particulars of other Agreements on Material

Transfer or Data Sharing
14. Intellectual Property Status:
A. Describe the different types of
intellectual property anticipated from the
current proposal.

B. Details on any relevant patent

information or background IP issues
15. UNDERTAKING FOR PROPER USE AND FOR GIVING DUE CREDIT IN
PUBLICATIONS AND WHILE REPORTING THE RESELUTS OF THE
RESEARCH:

I/we undertake that:

a. the biospecimen/data/ requested will be used exclusively for
the purposes of the ethically approved project detailed in this
proposal; and
b. due credit shall be given to the sample/data provider(s) while
reporting, presenting or publishing the results of the research/
project in any manner (please sign below to confirm)

Place: Name of Principal Investigator

Date: Signature of the Principal Investigator

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 ANNEXURE - D

COVID-19 BIORESOURCE ACCESS REQUEST FORM

List of attachments to be submitted along with the Form:

1. Proposal submitted to the funding body that has been approved/pending
approval
2. CV of the investigators/ Co-Investigators.
3. Scanned copies of the Material Transfer or Data sharing Agreements, Ethics and
Biosafety Approvals.

Foruse of the Sample/Data Provider only:

REQUEST FORM ID:

Additional information to be completed before consideration by the Internal

Governance Mechanism

A. Availability of requested biospecimen and its associated data

B. Volume of sample remaining if project approved

C. Any Other comments:

(Authorized signatory)

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