COVID-19 BIORESOURCE ACCESS REQUEST

COVID-19 Clinical Sample Access Request Form

Clinical Sample: Shall mean blood, plasma, urine, tissue, cells, cell cultures, naso-oro-pharyngeal swabs or saliva collected from persons presenting to screening centers 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)

COVID-19 Resources* ready to use:
Development / Evaluation sera panel (details on website)

  • RBD IgG ELISA data available for all the sera panel samples

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.

*Will be updated as and when new resources are developed.

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
For development of sero-diagnostic kits: Information on the nature and the source of the capture antigens to be provided.
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. Samples and Meta Data Requirements
(i) Sample Size:
A. Cases:
No. of Participants
No. of Samples
B. Control:
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 (ul/ml/Cell count)
Clinical data/Metadata required
(Please describe data particulars that will be required) Blank case recording forms of the study will be shared upon request
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)
Undertaking for proper use of biospecimen/data and for giving due credit in publications and resultant products (Please sign to confirm all the below mentioned undertakings)
  1. Biospecimen/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.