BioRepository Facility

COVID-19 BIORESOURCE ACCESS REQUEST

COVID-19 Biological Sample Access Request Form

SARS CoV2
Handling and culturing of virus requires certified & validated BSL-3 laboratory since, it belongs to risk group III category.

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 WHO.
https://www.who.int/docs/default-source/coronaviruse/laboratory-biosafety-novel-coronavirus-version-1-1.pdf

Other interim guidelines are also available:
https://www.cdc.gov/sars/guidance/f-lab/app5.html

ln the view of the need to rapidly support collateral multi-sectoral research & development activities to further strengthen India’s capacity in dealing with the COVID-19 pandemic, the following SARS-CoV 2 research material: can be shared with the authorized laboratories.

  1. SARS-CoV-2 Live virus strain
  2. SARS-CoV-2 Heat inactivated
  3. SARS-CoV-2 Synthetic molecular standard (genomic RNA)
Obligations of the recipient:
The recipient of the virus and parent organization will have to give an undertaking on compliance issues mentioned at the end of the form. Please note that this is mandatory. All users will be ultimately assigned unique IDs for assuring best services from the repository.

Instructions:
Please read the instructions carefully before filling the COVID-19 Clinical Sample Access Request Form. Please note that requests with incomplete information will be rejected. it is also mandatory to complete the declaration on responsibility/liability clauses with authorization from the office of appropriate authority of the requesting organization.
The information requested needs to be filled, duly signed by the requester and forwarded through the director/ competent authority of the requesting institute.
Please make sure that all information provided is factual and auditable/verifiable under National and International regulatory/ Biosecurity laws and any other guidelines of Govt. of India as amended from time to time. Please note that provision of the information does not make it mandatory for the institute to provide the requested sample. This will be done subject to all necessary approvals following the access policy guidelines.

Note:
The Access Control Committee (ACC)/ Project Coordinator/ Project Investigator will oversee and approve of all data and biospecimen-access that will be prioritized based on sample availability, scientific merit, usefulness in terms of public health importance, translational component, feasibility, appropriate use, ethical appropriateness and novelty of the proposal. Given the national crisis situation, priority will be given to product development for Covid-19. Material Transfer Agreement (MTA) will be executed for all samples leaving the institute.

1. Organization
Name
Address
2. Category of Organization
3. Title of the Research Project
4. Area of Research
5. Principal Investigator
Name
Organization
Address
Telephone
Email
CV
6. Research Team / Co-investigators Name Organization CV
Co-investigator (1)
Co-investigator (2)
Co-investigator (3)
Co-investigator (4)
Co-investigator (5)
Co-investigator (6)
Co-investigator (7)
Co-investigator (8)
Co-investigator (9)
Co-investigator (10)
7. Project Summary
Brief description of the proposal highlighting its strategic importance along with potential outcomes should be provided as a letter of intent
Title
Rationale/Background
Primary Objectives
Methodology
Outcome
8. Multi-Centre Study
9. Study Period Estimated Start Date Estimated End Date
10. Funding
(if you are applying for a grant please provide details about the funding application)
11. Funding Agency
12. Virus Requirement
13. Ethical Approval
(if approved attach copy of approval letters from respective IRBs)
14. Institutional Biosafety Committee (IBSC)
(if approved attach copy of approval letters from respective IBSCs)
15. Review Committee on Genetic Manipulation (RCGM)
(if approved attach copy of RCGM approval)
Undertaking for proper use of live virus and for giving due credit in publications and resultant products (Please sign to confirm all the below mentioned undertakings)
  1. Viral samples/data requested will be used exclusively for purposes of the approved project detailed in the application submitted to the COVID-19 Biorepository.
  2. Due credit/ acknowledgement shall be given to the data contributors (institutions and their investigators who have contributed to collection, processing of biospecimens and the generation of meta data) while reporting, presenting or publishing the results of the research/ project in any manner. Funders should be given appropriate credits.
  3. For all the sample/data access requests coming to biorepository either for development/ testing/ validation due credit/ acknowledgement shall be given as stated below:
    • "The RECIPIENT who receives MATERIAL/ MODIFICATIONS from the BIOREPOSITORY, if results in a successful commercial product must state in their product information sheet that “We acknowledge the significant contribution and expertise of THSTI, NCR Biotech Science Cluster BIOREPOSITORY, DBT India Consortium in development/testing/validation of our product”. The RECIPIENT must agree to list all the members/ collaborating hospitals of the DBT India Consortium**, as annexure documents of the product information sheet/website.
    • ** Name of all the collaborating Institutes/ Hospitals: Translational Health Science Technology Institute, Clinical partners: Maulana Azad Medical College, Lok Nayak Jai Prakash Hospital, and Lady Hardinge Medical College in Delhi, ESI Medical College Hospital, Faridabad, Civil Hospital, Gurugram, Haryana; Civil Hospital, Palwal, Haryana; Al-Falah School of Medical Science & Research Centre and Hospital, Dhauj, Haryana; Medanta Hospital, Gurugram; Shaheed Hasan Khan Mewati Government Medical College, Nalhar, Haryana.
    • "The RECIPIENT agrees to acknowledge the source of the MATERIAL/ MODIFICATIONS in any publication reporting on its use. The acknowledgement note should read as “This research has been conducted with the significant contribution and expertise of THSTI, NCR Biotech Science Cluster BIOREPOSITORY and DBT India Consortium”.
  4. The bioresource shared are for national use only.
  5. All data generated from this project will be returned as part of the “open research” platform sharing. I/we approve THSTI to list us in their database/presentation/reports/website as one of the organizations who had access to the COVID-19 Bioresources.