This document provides interim guidelines for sharing biological and clinical samples and data related to COVID-19 research in India. It outlines procedures for acquiring, storing, and sharing samples and data while protecting individual privacy. Sample and data sharing can help accelerate COVID-19 research, but must be done safely and ethically in accordance with various regulatory frameworks. The guidelines establish a process for requesting and approving the sharing of samples and data between approved research institutions and stakeholders.
This document discusses biotechnology and its role in addressing the COVID-19 pandemic. It outlines the main branches of biotechnology including blue, green, bioinformatics, red, and white biotechnology. It also lists top biotech companies in India and specializations within biotechnology. The document explains opportunities for biotech companies to develop vaccines, drugs, and medical equipment for COVID-19. Governments are supporting biotech industry efforts to rapidly develop treatments and remedies for the pandemic.
The document outlines India's biosafety guidelines for genetically engineered organisms (GEOs). It discusses the various committees that implement the guidelines: the Institutional Biosafety Committee regulates research, the Review Committee on Genetic Manipulation reviews high-risk research, and the Genetic Engineering Approval Committee approves large-scale use of GEOs. The guidelines establish containment levels and review processes to minimize risks from GEOs and ensure public health and environmental safety.
Although other departments of the government shall look after market completion, polices etc. BMRC is going beyond jurisdiction to create an oligopoly situation of three brands of vaccine and depriving the nation from an own successful research. Bangladesh could be proud of global standard research by a local company.
The document summarizes Bangladesh's biosafety regulatory system and its evolution over time. Some key points:
- Bangladesh started developing its biosafety framework in the 1990s and ratified the Cartagena Protocol on Biosafety in 2004.
- The biosafety regulatory system includes biosafety guidelines, a national biosafety framework, and biosafety rules gazetted in 2012.
- Various committees provide governance, including the National Committee on Biosafety, Biosafety Core Committee, Institutional Biosafety Committees, and Field Level Biosafety Committees
The document provides guidance on biosafety levels and risk group classification. It describes the four biosafety levels and relates them to the four risk groups based on pathogenicity and availability of treatment and prevention measures. Biosafety level designation is based on risk assessment and considers the specific laboratory work being conducted. The summary provides an overview of facility requirements at each biosafety level.
The document outlines India's national biosafety policies and guidelines over time. It begins with the need for biosafety regulation to safeguard biological resources from indiscriminate use of technologies. India's biosafety policy timeline is then described, starting from the 1980s with recombinant DNA technology. Key guidelines are summarized, including the 1990 Recombinant DNA Safety Guidelines, 1998 Guidelines for Research in Transgenic Plants, 1999 Guidelines for Generating Data for rDNA Vaccines and Diagnostics, 2008 Guidelines for Safety Assessment of GE Food and Guidelines for Confined Field Trials of GE Plants. The document provides an overview of India's development of biosafety laws and policies to regulate emerging biotechnologies.
The document summarizes the role and functions of the Institutional Biosafety Committee (IBSC) in India for regulating research involving genetically modified organisms (GMOs). Key points:
1) The IBSC is responsible for reviewing and approving research projects involving GMOs at the institutional level before submitting to the higher Review Committee on Genetic Manipulation (RCGM).
2) The IBSC monitors adherence to biosafety guidelines, assesses research facilities, and reports all GMO activities to the RCGM. It also reviews proposals for field trials and imports/exports.
3) The IBSC is composed of a chairperson, scientists, a biosafety officer, and a nominee from the Department of
rDNA Technology-Biosafety Regulations and GuidelinesRahul Kumar
This document discusses guidelines for biosafety regulations and recombinant DNA (rDNA) technology in India. It outlines the various committees established to develop policies and safety guidelines for rDNA research, oversee projects, and approve large-scale activities. The guidelines cover containment levels, classification of pathogens, research oversight, environmental release of engineered organisms, import/export, and quality control of products developed through rDNA technology.
This document discusses biotechnology and its role in addressing the COVID-19 pandemic. It outlines the main branches of biotechnology including blue, green, bioinformatics, red, and white biotechnology. It also lists top biotech companies in India and specializations within biotechnology. The document explains opportunities for biotech companies to develop vaccines, drugs, and medical equipment for COVID-19. Governments are supporting biotech industry efforts to rapidly develop treatments and remedies for the pandemic.
The document outlines India's biosafety guidelines for genetically engineered organisms (GEOs). It discusses the various committees that implement the guidelines: the Institutional Biosafety Committee regulates research, the Review Committee on Genetic Manipulation reviews high-risk research, and the Genetic Engineering Approval Committee approves large-scale use of GEOs. The guidelines establish containment levels and review processes to minimize risks from GEOs and ensure public health and environmental safety.
Although other departments of the government shall look after market completion, polices etc. BMRC is going beyond jurisdiction to create an oligopoly situation of three brands of vaccine and depriving the nation from an own successful research. Bangladesh could be proud of global standard research by a local company.
The document summarizes Bangladesh's biosafety regulatory system and its evolution over time. Some key points:
- Bangladesh started developing its biosafety framework in the 1990s and ratified the Cartagena Protocol on Biosafety in 2004.
- The biosafety regulatory system includes biosafety guidelines, a national biosafety framework, and biosafety rules gazetted in 2012.
- Various committees provide governance, including the National Committee on Biosafety, Biosafety Core Committee, Institutional Biosafety Committees, and Field Level Biosafety Committees
The document provides guidance on biosafety levels and risk group classification. It describes the four biosafety levels and relates them to the four risk groups based on pathogenicity and availability of treatment and prevention measures. Biosafety level designation is based on risk assessment and considers the specific laboratory work being conducted. The summary provides an overview of facility requirements at each biosafety level.
The document outlines India's national biosafety policies and guidelines over time. It begins with the need for biosafety regulation to safeguard biological resources from indiscriminate use of technologies. India's biosafety policy timeline is then described, starting from the 1980s with recombinant DNA technology. Key guidelines are summarized, including the 1990 Recombinant DNA Safety Guidelines, 1998 Guidelines for Research in Transgenic Plants, 1999 Guidelines for Generating Data for rDNA Vaccines and Diagnostics, 2008 Guidelines for Safety Assessment of GE Food and Guidelines for Confined Field Trials of GE Plants. The document provides an overview of India's development of biosafety laws and policies to regulate emerging biotechnologies.
The document summarizes the role and functions of the Institutional Biosafety Committee (IBSC) in India for regulating research involving genetically modified organisms (GMOs). Key points:
1) The IBSC is responsible for reviewing and approving research projects involving GMOs at the institutional level before submitting to the higher Review Committee on Genetic Manipulation (RCGM).
2) The IBSC monitors adherence to biosafety guidelines, assesses research facilities, and reports all GMO activities to the RCGM. It also reviews proposals for field trials and imports/exports.
3) The IBSC is composed of a chairperson, scientists, a biosafety officer, and a nominee from the Department of
rDNA Technology-Biosafety Regulations and GuidelinesRahul Kumar
This document discusses guidelines for biosafety regulations and recombinant DNA (rDNA) technology in India. It outlines the various committees established to develop policies and safety guidelines for rDNA research, oversee projects, and approve large-scale activities. The guidelines cover containment levels, classification of pathogens, research oversight, environmental release of engineered organisms, import/export, and quality control of products developed through rDNA technology.
Biosafety refers to ensuring safety when working with biological organisms. This document discusses biosafety concepts and issues including containment levels, biosafety cabinets, and risk assessment. The four biosafety levels range from level 1 posing minimal risk to level 4 posing high individual risk without vaccines or treatments. Biosafety cabinets are used to protect workers and the environment, with class I protecting environment, class II protecting samples and environment, and class III providing maximum protection in BSL-4 labs. Risk assessment considers an organism's pathogenicity, virulence, proliferation ability, and transmission route. Guidelines for recombinant DNA research emphasize risk-based containment and avoiding unnecessary regulation.
The document discusses biosafety definitions, biological risk assessment, and guidelines for working with genetically modified organisms (GMOs). It defines biosafety as ensuring safety in using, handling, and disposing of biological organisms. Risk assessment of GMOs involves characterizing the agent, identifying hazards, evaluating risks, and applying management strategies. The guidelines classify GMOs based on their history of safe use and specify containment levels and approvals required for field testing.
This document presents guidelines on biosafety from the Government of India. It discusses the history and necessity of biosafety, describing the four biosafety levels established by the Centers for Disease Control and Prevention for handling infectious agents. It also outlines the roles of the Institutional Biosafety Committee, which reviews research using hazardous organisms, and the Genetic Engineering Appraisal Committee, which approves large-scale production of genetically modified organisms. The document emphasizes the importance of containment methods like physical barriers and biological techniques to prevent the spread of microbes in laboratories.
This document provides an overview of events related to exposures to select agents at Texas A&M University's biodefense research laboratories. It discusses the characteristics of select agents and regulations governing their use. It describes safety protocols for BSL-3 laboratories and summarizes inspections that found issues with Texas A&M's brucellosis and Coxiella research resulting in researcher exposures. The document also provides background on the university and its biodefense research programs.
The International Journal of Engineering and Science (The IJES)theijes
This document summarizes a research paper on food safety and quality maintenance through irradiation. It discusses how irradiation is used to kill harmful bacteria in foods like meat and poultry to reduce food-borne illness. The paper describes the irradiation process, where food is exposed to gamma rays or electron beams in a shielded facility. This kills bacteria and pathogens while leaving the food largely unchanged. Proper handling and disposal of radioactive materials used in irradiation is also discussed to prevent environmental contamination. Instrumentation for detecting radiation levels is highlighted.
04 control of spills and mechanism of implementation of biosafety guidelinesIndranil Bhattacharjee
1. The document outlines procedures for controlling spills of biological materials in laboratories, including spills in biological safety cabinets, open laboratories, centrifuges, and on persons. It describes wearing protective equipment, warning others, and using appropriate disinfectants.
2. It then describes the mechanism for implementing biosafety guidelines in India, including committees that provide oversight of recombinant DNA research. The key committees are the Recombinant DNA Advisory Committee, Institutional Biosafety Committees, and the Review Committee on Genetic Manipulation.
3. The committees provide guidance on biosafety, review research proposals, oversee safety training, and ensure containment facilities and procedures are followed to regulate genetic engineering activities and protect
This presentation is all about Biosafety - Rules & Regulations at both National & International levels.... All you need to know about BIOSAFETY ... The ppt will allow you to access the vast Biological procedures around globe.
This document summarizes a presentation on COVID-19 vaccines given at USC. It lists the moderators and discusses several vaccine candidates in development or approved for emergency use, including those from Oxford/AstraZeneca, Moderna, Pfizer, and others. It also covers regulatory considerations for approving vaccines, including requirements for clinical trial data to support emergency use authorization or full licensure. Community engagement efforts to promote vaccination are also summarized.
Survey to Assess the Attitude of Nursing Students Regarding Prevention of COV...YogeshIJTSRD
The present study has been conducted to know the attitude of nursing students regarding preventive techniques to prevent from COVID 19 during COVID 19 pandemic. In order to achieve the objectives non experimental approach with survey research design was adopted. Setting of the study selected was Dr. Achal Singh Yadav institute of nursing and paramedical sciences, Lucknow. The selection of sample was done by using convenient non probability sampling technique. The sample size was 30. The method of data collection was using demographic variables questions and structured attitude rating scale related to attitude regarding prevention of COVID 19. Result shown that nursing students had neutral attitude regarding prevention of COVID 19 and there is no significant association between demographic variables with attitude of nursing students, hence hypothesis 1 rejected. Saniya Susan Issac | Sarita Bhatt | Bince Varghese "Survey to Assess the Attitude of Nursing Students Regarding Prevention of COVID-19 during COVID19 Pandemic" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-4 , June 2021, URL: https://www.ijtsrd.compapers/ijtsrd41258.pdf Paper URL: https://www.ijtsrd.commedicine/nursing/41258/survey-to-assess-the-attitude-of-nursing-students-regarding-prevention-of-covid19-during-covid19-pandemic/saniya-susan-issac
The document provides information about the coronavirus outbreak in India. It discusses the following key points:
- India has reported 5 confirmed cases of coronavirus so far, with the latest two cases being reported in Delhi and Telangana.
- The Drug Controller General of India has approved using a combination of lopinavir and ritonavir to treat coronavirus if it becomes a public health emergency in India.
- Several labs across India are equipped to test for coronavirus, including 10 under the Indian Council of Medical Research. As of February 6th, 510 samples had been tested in India, with 3 confirmed positive.
- The coronavirus outbreak in China is expected to significantly impact India's trade and imports/exports
- The document discusses biosafety regulations and policies across Asian countries. It notes the diversity in the region and importance of agriculture.
- Many countries have approved GM crops for cultivation or import and have national biosafety frameworks in place. Key countries like China, India, Pakistan have seen success with Bt cotton.
- Risk assessment and monitoring are important aspects of biosafety regulations. Approaches differ across countries but aim to ensure safety and transparency. Regional cooperation can help strengthen regulatory capacity.
The presentation depicts the supply chain management of the Covid-19 vaccination drive in India. It also focuses on the implementation of Industry 4.0 and digitization of the process to make the vaccination drive a success, Asides, it also briefs about the vaccine candidates in use and prospected to be used in India until 6th June '21. SWOT analysis of the vaccination drive in India is also provided in this presentation.
This document describes the experience of a hospital laboratory in Italy producing disinfectants and antiseptics during the COVID-19 pandemic. Due to high demand from hospitals, the laboratory started producing these products when pharmaceutical industries could not meet the need. The laboratory produced WHO-recommended formulations of ethanol and isopropanol-based hand rubs in-house. Quality control measures were implemented to test alcohol concentration, hydrogen peroxide content, and ensure sterility. The experience demonstrated that local production could help address shortages and control the spread of infection during public health emergencies.
The r-DNA Biosafety Guidelines of India classify research activities into three categories based on risk. Category I requires only intimation, Category II requires prior permission, and Category III requires review and approval before starting. The guidelines aim to regulate research safely and minimize accidental release of GMOs. Implementation occurs through four committees - RDAC provides regulatory oversight, IBSC monitors research, RCGM reviews risks and permissions, and GEAC approves large-scale use and environmental release. The guidelines establish containment levels and procedures to safely conduct r-DNA research and ensure biosafety.
This document summarizes a clinical trial of an influenza vaccine. The trial aims to compare the immunogenicity and reactogenicity of a self-administered intradermal influenza vaccine to a nurse-administered intradermal vaccine. It describes the trial design as a randomized, open-label study. The primary objective is to show non-inferior immunogenicity of the self-administered vaccine. Safety and ability of participants to self-administer will also be assessed. The trial involves vaccination, follow-up of adverse events, and measurement of antibody response to evaluate the objectives. Standard clinical trial procedures for informed consent, safety monitoring, and regulatory compliance are discussed.
This document provides a high-level overview of the vaccine development process from research and testing in animals through clinical trials in humans and regulatory approval. It discusses key stages including preclinical research in animal models to test safety and efficacy, phases of human clinical trials, requirements for good manufacturing practices and regulatory compliance, and the role of quality assurance. It also provides examples of DVC's experience developing vaccines for biodefense threats like anthrax, smallpox, and plague.
Current Status and Future Perspective of Rapid Diagnostic Kits Vaccine agains...ijtsrd
Coronavirus disease 2019 COVID 19 , which causes serious respiratory illness such as pneumonia and lung failure, was first reported in Wuhan, the capital of Hubei, China. The etiological agent of COVID 19 has been confirmed as a novel coronavirus, now known as severe acute respiratory syndrome coronavirus 2 SARS CoV 2 , which is most likely originated from zoonotic coronaviruses, like SARS CoV, which emerged in 2002. Rapid diagnostics, vaccines and therapeutics are important interventions for the management of the 2019 novel coronavirus 2019 nCoV outbreak. Currently, various diagnostic kits to test for COVID 19 are available and several repurposing therapeutics for COVID 19 have shown to be clinically effective. In addition, global institutions and companies have begun to develop vaccines for the prevention of COVID 19. Here, we review the current status of, diagnosis, and vaccine development for COVID 19. M A Nandedkar | R A Shinde | S S Bansode "Current Status and Future Perspective of Rapid Diagnostic Kits / Vaccine against COVID-19" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-4 , June 2020, URL: https://www.ijtsrd.com/papers/ijtsrd30977.pdf Paper Url :https://www.ijtsrd.com/pharmacy/analytical-chemistry/30977/current-status-and-future-perspective-of-rapid-diagnostic-kits--vaccine-against-covid19/m-a-nandedkar
This document provides guidance on conducting rapid qualitative research to understand barriers and drivers to COVID-19 vaccination among target groups. The process involves establishing a research team, developing a protocol, obtaining ethics approval, collecting and analyzing data, linking findings to intervention types, developing a monitoring plan, and implementing tailored interventions. The goal is to use behavioral insights to inform the design of effective programs that increase vaccination uptake.
Guidelines for archiving in clinical trials published by Turkish Medicine and...Serkan Kaçar
This document provides guidelines for archiving materials from clinical trials. It outlines responsibilities for storing archive materials, including protecting documents from damage and ensuring confidentiality. The guidelines specify that archive materials must be kept for a defined period, then can be disposed of or transferred abroad. Institutions seeking to archive clinical trial documents must apply for permission from health authorities.
Biosafety refers to ensuring safety when working with biological organisms. This document discusses biosafety concepts and issues including containment levels, biosafety cabinets, and risk assessment. The four biosafety levels range from level 1 posing minimal risk to level 4 posing high individual risk without vaccines or treatments. Biosafety cabinets are used to protect workers and the environment, with class I protecting environment, class II protecting samples and environment, and class III providing maximum protection in BSL-4 labs. Risk assessment considers an organism's pathogenicity, virulence, proliferation ability, and transmission route. Guidelines for recombinant DNA research emphasize risk-based containment and avoiding unnecessary regulation.
The document discusses biosafety definitions, biological risk assessment, and guidelines for working with genetically modified organisms (GMOs). It defines biosafety as ensuring safety in using, handling, and disposing of biological organisms. Risk assessment of GMOs involves characterizing the agent, identifying hazards, evaluating risks, and applying management strategies. The guidelines classify GMOs based on their history of safe use and specify containment levels and approvals required for field testing.
This document presents guidelines on biosafety from the Government of India. It discusses the history and necessity of biosafety, describing the four biosafety levels established by the Centers for Disease Control and Prevention for handling infectious agents. It also outlines the roles of the Institutional Biosafety Committee, which reviews research using hazardous organisms, and the Genetic Engineering Appraisal Committee, which approves large-scale production of genetically modified organisms. The document emphasizes the importance of containment methods like physical barriers and biological techniques to prevent the spread of microbes in laboratories.
This document provides an overview of events related to exposures to select agents at Texas A&M University's biodefense research laboratories. It discusses the characteristics of select agents and regulations governing their use. It describes safety protocols for BSL-3 laboratories and summarizes inspections that found issues with Texas A&M's brucellosis and Coxiella research resulting in researcher exposures. The document also provides background on the university and its biodefense research programs.
The International Journal of Engineering and Science (The IJES)theijes
This document summarizes a research paper on food safety and quality maintenance through irradiation. It discusses how irradiation is used to kill harmful bacteria in foods like meat and poultry to reduce food-borne illness. The paper describes the irradiation process, where food is exposed to gamma rays or electron beams in a shielded facility. This kills bacteria and pathogens while leaving the food largely unchanged. Proper handling and disposal of radioactive materials used in irradiation is also discussed to prevent environmental contamination. Instrumentation for detecting radiation levels is highlighted.
04 control of spills and mechanism of implementation of biosafety guidelinesIndranil Bhattacharjee
1. The document outlines procedures for controlling spills of biological materials in laboratories, including spills in biological safety cabinets, open laboratories, centrifuges, and on persons. It describes wearing protective equipment, warning others, and using appropriate disinfectants.
2. It then describes the mechanism for implementing biosafety guidelines in India, including committees that provide oversight of recombinant DNA research. The key committees are the Recombinant DNA Advisory Committee, Institutional Biosafety Committees, and the Review Committee on Genetic Manipulation.
3. The committees provide guidance on biosafety, review research proposals, oversee safety training, and ensure containment facilities and procedures are followed to regulate genetic engineering activities and protect
This presentation is all about Biosafety - Rules & Regulations at both National & International levels.... All you need to know about BIOSAFETY ... The ppt will allow you to access the vast Biological procedures around globe.
This document summarizes a presentation on COVID-19 vaccines given at USC. It lists the moderators and discusses several vaccine candidates in development or approved for emergency use, including those from Oxford/AstraZeneca, Moderna, Pfizer, and others. It also covers regulatory considerations for approving vaccines, including requirements for clinical trial data to support emergency use authorization or full licensure. Community engagement efforts to promote vaccination are also summarized.
Survey to Assess the Attitude of Nursing Students Regarding Prevention of COV...YogeshIJTSRD
The present study has been conducted to know the attitude of nursing students regarding preventive techniques to prevent from COVID 19 during COVID 19 pandemic. In order to achieve the objectives non experimental approach with survey research design was adopted. Setting of the study selected was Dr. Achal Singh Yadav institute of nursing and paramedical sciences, Lucknow. The selection of sample was done by using convenient non probability sampling technique. The sample size was 30. The method of data collection was using demographic variables questions and structured attitude rating scale related to attitude regarding prevention of COVID 19. Result shown that nursing students had neutral attitude regarding prevention of COVID 19 and there is no significant association between demographic variables with attitude of nursing students, hence hypothesis 1 rejected. Saniya Susan Issac | Sarita Bhatt | Bince Varghese "Survey to Assess the Attitude of Nursing Students Regarding Prevention of COVID-19 during COVID19 Pandemic" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-4 , June 2021, URL: https://www.ijtsrd.compapers/ijtsrd41258.pdf Paper URL: https://www.ijtsrd.commedicine/nursing/41258/survey-to-assess-the-attitude-of-nursing-students-regarding-prevention-of-covid19-during-covid19-pandemic/saniya-susan-issac
The document provides information about the coronavirus outbreak in India. It discusses the following key points:
- India has reported 5 confirmed cases of coronavirus so far, with the latest two cases being reported in Delhi and Telangana.
- The Drug Controller General of India has approved using a combination of lopinavir and ritonavir to treat coronavirus if it becomes a public health emergency in India.
- Several labs across India are equipped to test for coronavirus, including 10 under the Indian Council of Medical Research. As of February 6th, 510 samples had been tested in India, with 3 confirmed positive.
- The coronavirus outbreak in China is expected to significantly impact India's trade and imports/exports
- The document discusses biosafety regulations and policies across Asian countries. It notes the diversity in the region and importance of agriculture.
- Many countries have approved GM crops for cultivation or import and have national biosafety frameworks in place. Key countries like China, India, Pakistan have seen success with Bt cotton.
- Risk assessment and monitoring are important aspects of biosafety regulations. Approaches differ across countries but aim to ensure safety and transparency. Regional cooperation can help strengthen regulatory capacity.
The presentation depicts the supply chain management of the Covid-19 vaccination drive in India. It also focuses on the implementation of Industry 4.0 and digitization of the process to make the vaccination drive a success, Asides, it also briefs about the vaccine candidates in use and prospected to be used in India until 6th June '21. SWOT analysis of the vaccination drive in India is also provided in this presentation.
This document describes the experience of a hospital laboratory in Italy producing disinfectants and antiseptics during the COVID-19 pandemic. Due to high demand from hospitals, the laboratory started producing these products when pharmaceutical industries could not meet the need. The laboratory produced WHO-recommended formulations of ethanol and isopropanol-based hand rubs in-house. Quality control measures were implemented to test alcohol concentration, hydrogen peroxide content, and ensure sterility. The experience demonstrated that local production could help address shortages and control the spread of infection during public health emergencies.
The r-DNA Biosafety Guidelines of India classify research activities into three categories based on risk. Category I requires only intimation, Category II requires prior permission, and Category III requires review and approval before starting. The guidelines aim to regulate research safely and minimize accidental release of GMOs. Implementation occurs through four committees - RDAC provides regulatory oversight, IBSC monitors research, RCGM reviews risks and permissions, and GEAC approves large-scale use and environmental release. The guidelines establish containment levels and procedures to safely conduct r-DNA research and ensure biosafety.
This document summarizes a clinical trial of an influenza vaccine. The trial aims to compare the immunogenicity and reactogenicity of a self-administered intradermal influenza vaccine to a nurse-administered intradermal vaccine. It describes the trial design as a randomized, open-label study. The primary objective is to show non-inferior immunogenicity of the self-administered vaccine. Safety and ability of participants to self-administer will also be assessed. The trial involves vaccination, follow-up of adverse events, and measurement of antibody response to evaluate the objectives. Standard clinical trial procedures for informed consent, safety monitoring, and regulatory compliance are discussed.
This document provides a high-level overview of the vaccine development process from research and testing in animals through clinical trials in humans and regulatory approval. It discusses key stages including preclinical research in animal models to test safety and efficacy, phases of human clinical trials, requirements for good manufacturing practices and regulatory compliance, and the role of quality assurance. It also provides examples of DVC's experience developing vaccines for biodefense threats like anthrax, smallpox, and plague.
Current Status and Future Perspective of Rapid Diagnostic Kits Vaccine agains...ijtsrd
Coronavirus disease 2019 COVID 19 , which causes serious respiratory illness such as pneumonia and lung failure, was first reported in Wuhan, the capital of Hubei, China. The etiological agent of COVID 19 has been confirmed as a novel coronavirus, now known as severe acute respiratory syndrome coronavirus 2 SARS CoV 2 , which is most likely originated from zoonotic coronaviruses, like SARS CoV, which emerged in 2002. Rapid diagnostics, vaccines and therapeutics are important interventions for the management of the 2019 novel coronavirus 2019 nCoV outbreak. Currently, various diagnostic kits to test for COVID 19 are available and several repurposing therapeutics for COVID 19 have shown to be clinically effective. In addition, global institutions and companies have begun to develop vaccines for the prevention of COVID 19. Here, we review the current status of, diagnosis, and vaccine development for COVID 19. M A Nandedkar | R A Shinde | S S Bansode "Current Status and Future Perspective of Rapid Diagnostic Kits / Vaccine against COVID-19" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-4 , June 2020, URL: https://www.ijtsrd.com/papers/ijtsrd30977.pdf Paper Url :https://www.ijtsrd.com/pharmacy/analytical-chemistry/30977/current-status-and-future-perspective-of-rapid-diagnostic-kits--vaccine-against-covid19/m-a-nandedkar
This document provides guidance on conducting rapid qualitative research to understand barriers and drivers to COVID-19 vaccination among target groups. The process involves establishing a research team, developing a protocol, obtaining ethics approval, collecting and analyzing data, linking findings to intervention types, developing a monitoring plan, and implementing tailored interventions. The goal is to use behavioral insights to inform the design of effective programs that increase vaccination uptake.
Guidelines for archiving in clinical trials published by Turkish Medicine and...Serkan Kaçar
This document provides guidelines for archiving materials from clinical trials. It outlines responsibilities for storing archive materials, including protecting documents from damage and ensuring confidentiality. The guidelines specify that archive materials must be kept for a defined period, then can be disposed of or transferred abroad. Institutions seeking to archive clinical trial documents must apply for permission from health authorities.
The document provides an overview of Good Clinical Practice (GCP) guidelines. It discusses the history and principles of GCP, as well as the roles and responsibilities of ethics committees, investigators, and sponsors in ensuring clinical trials are conducted properly and that patient rights and safety are protected. The document also summarizes the different phases of clinical trials and essential documents required for GCP compliance.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety also means safety from exposure to infectious agents.
Necessity
In order to avoid infection/biohazard to the laboratory personnel & the environment, biosafety levels are very important.
Spanish National Biobank Network Strategic PlanEuroBioForum
The Spanish National Biobank Network approved a 2010-2013 Strategic Plan to integrate and harmonize hospital biobanks across Spain in order to better support biomedical research. The network was established by the Spanish Ministry of Science and Innovation and Carlos III Health Institute to meet legal requirements, provide added value through integration and public service, and facilitate researchers' access to quality biological samples and data. The Strategic Plan aims to further develop the network's organizational structure and strengthen its role in supporting translational research.
This document provides guidelines for quarantining healthcare workers (HCWs) exposed to COVID-19 patients in India. It defines quarantine versus isolation and recommends facilities for quarantine. HCWs are categorized as high or low risk based on their exposure level. High risk HCWs should quarantine for 14 days, while low risk can continue working with self-monitoring. Guidelines are provided for active quarantine during work and passive quarantine afterwards, which may take place in institutional housing or at home if criteria are met. Testing is recommended upon start and end of quarantine. The policies aim to reduce virus transmission while accounting for available resources.
Social media engagement on COVID-19 vaccination during the pandemic: Cross-se...Pugalendhi R
. Social media plays an idealistic part in the present society. It assumes a significant role in expanding public awareness
and gathers perspectives. Thus, social media has taken a huge place among people all over the world. And the ideas shared on
social media reach people instantly. The Covid-19 virus, which is affecting more and more people around the world, It has infected
millions in various countries and caused many thousands of deaths. In India, a country with a large population, the incidence of
this virus is really higher. A Pune-based serum company has won a contract to develop the Covishield, a vaccine developed by the
University of Oxford in the United Kingdom to control the virus. And Bharat Biotech, based in Hyderabad has developed a vaccine
called 'Covaxin' in the national level invention. The two vaccines have been approved by the federal government for use on an
emergency basis. Accordingly, the Ministry of Health and Family Welfare of India has confirmed that these two vaccines are
completely safe. Covid-19 vaccination is currently being implemented across India. This study explains whether the news about
the Covid-19 vaccine that is appearing on social media at the moment is raising awareness or causing fear among the people. For
this study the researcher selected the most Covid-19 affected areas in Chennai, Namely called Royapuram, Thiru Vi Ka Nagar,
Anna Nagar, and Kodambakkam. A total of 320 Respondents participated in the study and responded. This study was conducted
from 10 March 2021 to 10 April 2021.
Scopus Indexed Journal- AIP Conference Proceedings May 2023.pdfPugalendhi R
Social media engagement on COVID-19 vaccination during the pandemic: Cross-sectional survey in Chennai metropolitan
The document summarizes a survey conducted in Chennai, India from March to April 2021 on social media usage and perceptions of COVID-19 vaccines. The survey found that WhatsApp and YouTube were the most widely used and trusted social media platforms. While social media helped increase awareness, it also spread misinformation at times. Most age groups followed social media for vaccine information, with WhatsApp being the predominant source. The study aimed to understand social media's role in shaping views on vaccination.
Ethical guidelines for biomedical research in human participantsgangireddysaisneha
This document provides ethical guidelines for biomedical research involving human participants. It discusses the history of human research ethics beginning with the Nuremberg Code and Declaration of Helsinki. It establishes the role of institutional ethics committees in reviewing all proposed research and provides general ethical principles of respect for persons, beneficence, and justice. It outlines 12 basic principles and specific ethical principles for informed consent, vulnerable populations, privacy/confidentiality, and more. The document aims to ensure the ethical conduct of research and protection of human subjects.
Ethical guidelines for biomedical research in human participantsgangireddysaisneha
This document provides ethical guidelines for biomedical research involving human participants. It discusses the history of human research ethics beginning with the Nuremberg Code and Declaration of Helsinki. It establishes the role of institutional ethics committees in reviewing all proposed research and provides general ethical principles of respect for persons, beneficence, and justice. It outlines 12 basic principles and specific ethical principles for informed consent, vulnerable populations, privacy/confidentiality, and more. The document aims to ensure the ethical conduct of research and protection of human subjects.
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Re-purposing ILRI labs to support national COVID-19 testing in KenyaILRI
Poster prepared by Edward Okoth and Samuel Oyola for the Global Agenda for Sustainable Livestock Africa 1 regional online meeting, 2-3 September 2020. Nairobi, Kenya: ILRI.
The document provides an overview of South Korea's health system response to COVID-19. Key measures included transparent communication, social distancing guidelines, extensive testing and contact tracing, increasing hospital capacity, and maintaining access to healthcare. The country's universal health coverage system supported its efficient mobilization of resources to test, treat, and manage COVID-19 cases.
The document summarizes the key differences between the Indian guidelines for Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) GCP guidelines. Some differences include: the Indian GCP requires investigators to be qualified by the Medical Council of India, while ICH GCP does not; Indian GCP mandates signing standard operating procedures between sponsors and investigators; and Indian GCP gives ethics committees power to discontinue trials, while ICH GCP assigns that role to independent data monitoring committees. Overall, the Indian GCP guidelines include some additional requirements compared to the international ICH standards.
1) Development of dengue vaccines requires addressing regulatory issues like evaluating efficacy against the four virus serotypes and safety regarding antibody-dependent enhancement.
2) Clinical trials are most likely to occur first in developing countries with dengue, where discussions among regulators can define the approval pathway with WHO's guidance.
3) It is important to standardize diagnostic tests and identify a correlate of protection to help evaluate vaccines.
The document discusses the state of the COVID-19 vaccine and therapeutic pipeline. It notes that as of October 23, 2020 there were 4 main vaccine platforms under development, with 10 candidates in Phase 3 trials. These include nucleic acid, viral vector, protein subunit, and virus-based platforms. It also summarizes some of the leading monoclonal antibody and antiviral therapeutic candidates and their stages of development, noting over 100 actionable therapeutic trials expected to readout by the end of 2020. Lastly, it discusses considerations for large-scale manufacturing and deployment of vaccines, including cold chain requirements and monitoring for safety.
The document provides details on agreements made by EU Member States regarding COVID-19 testing strategies. It includes:
1) A common list of rapid antigen tests that meet specified criteria.
2) A selection of rapid antigen tests for which test results will be mutually recognized across EU countries.
3) An agreed upon common standardized set of data to include in COVID-19 test certificates to facilitate recognition of results.
The lists and standards will continue to be reviewed and updated as needed.
Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
🔥🔥🔥🔥🔥🔥🔥🔥🔥
إضغ بين إيديكم من أقوى الملازم التي صممتها
ملزمة تشريح الجهاز الهيكلي (نظري 3)
💀💀💀💀💀💀💀💀💀💀
تتميز هذهِ الملزمة بعِدة مُميزات :
1- مُترجمة ترجمة تُناسب جميع المستويات
2- تحتوي على 78 رسم توضيحي لكل كلمة موجودة بالملزمة (لكل كلمة !!!!)
#فهم_ماكو_درخ
3- دقة الكتابة والصور عالية جداً جداً جداً
4- هُنالك بعض المعلومات تم توضيحها بشكل تفصيلي جداً (تُعتبر لدى الطالب أو الطالبة بإنها معلومات مُبهمة ومع ذلك تم توضيح هذهِ المعلومات المُبهمة بشكل تفصيلي جداً
5- الملزمة تشرح نفسها ب نفسها بس تكلك تعال اقراني
6- تحتوي الملزمة في اول سلايد على خارطة تتضمن جميع تفرُعات معلومات الجهاز الهيكلي المذكورة في هذهِ الملزمة
واخيراً هذهِ الملزمة حلالٌ عليكم وإتمنى منكم إن تدعولي بالخير والصحة والعافية فقط
كل التوفيق زملائي وزميلاتي ، زميلكم محمد الذهبي 💊💊
🔥🔥🔥🔥🔥🔥🔥🔥🔥
This presentation was provided by Racquel Jemison, Ph.D., Christina MacLaughlin, Ph.D., and Paulomi Majumder. Ph.D., all of the American Chemical Society, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
How to Download & Install Module From the Odoo App Store in Odoo 17Celine George
Custom modules offer the flexibility to extend Odoo's capabilities, address unique requirements, and optimize workflows to align seamlessly with your organization's processes. By leveraging custom modules, businesses can unlock greater efficiency, productivity, and innovation, empowering them to stay competitive in today's dynamic market landscape. In this tutorial, we'll guide you step by step on how to easily download and install modules from the Odoo App Store.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
CHUYÊN ĐỀ ÔN TẬP VÀ PHÁT TRIỂN CÂU HỎI TRONG ĐỀ MINH HỌA THI TỐT NGHIỆP THPT ...
Covid guide (3)
1. 1
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
2. 2
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.
3. 3
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
4. 4
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).
5. 5
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.
6. 6
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
8. 2
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
9. 3
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
10. 4
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
11. 5
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).
12. Annexure B to the Sample/Data Sharing Guidelines
Page 1 of 3
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.
13. Annexure B to the Sample/Data Sharing Guidelines
Page 2 of 3
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
14. Annexure B to the Sample/Data Sharing Guidelines
Page 3 of 3
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.
15. 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
16. 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#:==========================
Page 2 of 8
17. Date: Inrouesr FoR sARs cov-2 vrRUs FRoM ICMR-NATToNAL tNsrrurE oF vtRoLoGY, PUNE]
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
User classification
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
Page 3 of 8
18. 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 I idation
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
Page 4 of 8
19. 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
20. 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.
Page 6 of 8
21. 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.
Page 7 of 8
22. 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............
Page 8 of 8
Date:
23. ANNEXURE - D
COVID-19 BIORESOURCE ACCESS REQUEST FORM
Page 1 of 4
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:
24. ANNEXURE - D
COVID-19 BIORESOURCE ACCESS REQUEST FORM
Page 2 of 4
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
(Please describe data particulars that will be
required) Blank case recording forms of the study
will be shared upon request
Yes No
Selection Criteria Inclusion Criteria
Exclusion Criteria
8. STUDY PERIOD
Estimated Start Date Estimated End Date
9. FUNDING (If you are applying for a grant
please provide details about the funding
application. The preference would be for
Biorepository to be a named partner
organization and study team members to be a
collaborator/co- investigator as appropriate
on the grant).
Applied Approved
Yet to be applied
25. ANNEXURE - D
COVID-19 BIORESOURCE ACCESS REQUEST FORM
Page 3 of 4
10. FUNDING AGENCY
11. ETHICAL APPROVAL
(If approved attach copy of the approval letters
from the respective IRBs)
Approved
Applied for
Not applied
12. Institutional Biosafety Committee (IBSC)
(If approved attach copy of the approval letters
from the respective IBSCs)
Approved
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
26. ANNEXURE - D
COVID-19 BIORESOURCE ACCESS REQUEST FORM
Page 4 of 4
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)