British Journal of Medicine & Medical Research
11(4): 1-6, 2016, Article no.BJMMR.21444
ISSN: 2231-0614, NLM ID: 101570965
Published 27th September 2015
DHS Further Analysis Reports No. 100
These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be: i. directed towards enhancing knowledge about the human condition while ...maintaining sensitivity to the Indian cultural, social and natural environment; ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
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The main objective of these guidelines is to provide guidance on up-to-date, uniform, evidence-informed practices for suspecting, diagnosing and managing various forms of extra-pulmonary tuberculosis (EPTB) at all levels of healthcare delivery. They can then contribute to the National Programme to i...mprove detection, care and outcomes in EPTB; to help the programme with initiation of treatment, adherence and completion whilst minimizing drug toxicity and overtreatment; and contribute to practices that minimize the development of drug resistance.
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These Guidelines are intended to provide knowledge to the treating ophthalmologists, pediatricians, ocular oncologists, pediatric oncologists, and general physicians to arrive at an early diagnosis of retinoblastoma in the settings of district hospital, in private clinics and hospitals. The guidelin...es will enable the contact health personnel to refer at the right
time to the tertiary care hospital for management of retinoblastoma.
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These guidelines have been developed specifically to address ethical issues of conducting research in children.
These guidelines will assist the ICMR institutions/ centers/ Hqrs. by providing information on the policies, principles and approaches which should be followed in carrying out procurement of goods and services at their respective institute/ center/ Hqrs.
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Combination file of all the documents related to the national guidelines for accreditation, supervision and regulation of ART clinics in India. Documents included:
National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India | Preliminary Pages | Corrigendum | Chapter 1 ...- Introduction, Brief history of ART and Requirement of ART Clinics | Chapter 2 - Screening of Patients for ART - Selection Criteria and Possible Complications | Chapter 3 - Code of Practice, Ethical Considerations and Legal Issues | Chapter 4 - Sample Consent Forms | Chapter 5 - Training | Chapter 6 - Future Research Prospects | Chapter 7 - Providing ART Services to the Economically Weaker Sections of the Society | Chapter 8 - Establishing a National Database for Human Infertility | Chapter 9 - Composition of the National Accreditation Committee | Bibliography
| Members of the Expert Group for Formulating the National Guidelines for Accredation, Supervision and Regulation of ART Clinics
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SOP number: ICMR-NIV/2019-nCoV/Specimens_01
Prepared by: Dr. Y.K. Gurav Reviewed by: Dr. V. Potdar Approved by: Dr. P. Abraham
Date: 19/01/2020 Date: 20/01/2020 Date: 20/01/2020
COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h...igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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Reliable cause specic mortality statistics are the cornerstone of national health information
systems. They are essential for evidence-based decision making for monitoring health of
populations, health services planning and delivery, programme implementation, policy development
and epidemiolog...ical research.
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