ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.

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ICMR Guidelines.

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ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.

  1. 1. GUIDELINES OF ICMR
  2. 2. Guidelines For:  Ethical guidelines for Biomedical Research on Human.  Good Clinical Lab Practice (GCLP).  Transfer of Human biological material for research Or commercial purposes.  Evaluation of probiotics in food.  National health research (NHR)policy.  Intellectual property rights(IPR).  Management of Cancer.  Management of Type-II Diabetes.  Management of Retinoblastoma.
  3. 3. Guidelines cont….  Guidelines for research in transplantation.  Stem cell research .  Dietary guidelines for Indians.  National guidelines for Accreditation, Supervision,& regulations of ART clinics in India.  Assisted reproductive technology(ART) Bill 2010.  Assisted reproductive technology(ART) Rule2010.  Guidance for International collaboration and partnership.  Consideration of International collaboration Project by Health ministry’s Screening committee (HMSC)
  4. 4. Ethical guidelines for Biomedical Research on Human. In this guideline, the council provide advice to the researcher on all aspects of the welfare and Safety of the research participants. All the research involving human participants should be conducted in accordance with the basic principles i.e. Respect of participants, Beneficence,& Justice.
  5. 5. Good Clinical Lab Practice (GCLP). ICMR give guidelines for GCLP in the regard of …. Levels of Personnel, Reagents & laboratory, training & Material used Infra Development, in GCP, structure, Data ,Safety in Equipments , management Laboratory
  6. 6. Transfer of Human biological material for research Or commercial purposes  As per the guidelines issued by the Ministry of Health Services by Govt.of India.  For the evaluation of cases where infectious biological material/samples are proposed to be transferred from Foreign research center to the Indian diagnostic centre/laboratories for analysis.
  7. 7. Ten set of Copies are submitted by applicants to ICMR are: .Duly filled application form for transfer of sample. • Duly signed material transfer agreement .Copy of IEC clearence,ICF,Import/ex port certificate, Safety report Copy of patient information sheet
  8. 8. Evaluation of probiotics in food. Probiotics are Bacteria that helps to maintain the natural balance of micro flora in the intestine, (e.g. E.coli) which helps in digestion. The present ICMR-DBT guidelines comprehensively address the various concerns regarding safety ,efficacy, and reliability as well as labeling of probiotic products being sold in India
  9. 9. National health research (NHR)policy. To maximize the returns on investment in the health research through creation of a health research system to coordinate,facilitate,conduct of effective & ethical health research. And its translation in to products, polices, and programs aimed at improving health especially of the vulnerable population.
  10. 10. Intellectual property rights(IPR).  To meet its objectives of improving public health through research, the ICMR pursuing an active policy of ensuring the most rapid & effective development of new medical technologies developed by its scientist seeking IPR in India & abroad.
  11. 11. Guidelines for management of: Cancer • Assist oncologist in making major clinical decision in managing their patient’s in term of : Surgery, Radiation therapy, Chemotherapy, Angiogenesis inhibitors Type-II Diabetes • Assist Diabetologist in making major clinical decision in managing their patient’s in term of : Relief from diabetic symptoms and improvement in quality of life. Retinoblastoma • Retinoblastoma is the most common intraocular tumor in child . • The council provide guidelines to the ophthalmologist to treat R.B ,a/c patient conditions.
  12. 12. Guidelines for research in transplantation: Liver-Donor transplantation • The interest of the donor should always take priority, Over those of the recipients. Cadaver-Donor transplantation • If consent for organ donation is given ,prior to death in presence of two /more witness, consent of transplantation of organ should be permissible without seeking further consent from relatives. Recipients of transplant • Council guide transplant research team should have high technical experience.
  13. 13. Stem cell research  ICMR guideline assure the safety & rights of those donating embryonic, fetal or adult stem cell for basic & clinical research.  Safe guard have to be in place to protect research participants receiving stem cell transplant & patients at a large from receiving unproven stem cell therapies.
  14. 14. Dietary guidelines for Indians: Nutrition is a basic human need for a healthy life . The Guidelines are: …………………………………………… Nutritionally adequate diet, Food supplement Additional food for infants, Intake of salts during pregnancy & lactation Food safety ,water & other beverage
  15. 15. National guidelines for Accreditation, Supervision,& regulations of ART clinics in India.  The present guideline are meant to ensure that Assisted Reproductive Technology (ATR)Clinics in India are accreditated, regulated and supervised to assure the patients as well as the public heath services in any where in India.
  16. 16. Assisted Reproductive Technology(ART): ART-Bill (2010) ART-Rule (2010) • An act to provide for a national frame work for the accreditation ,regulation & supervision of ART for safe & ethical practice of ART Services. • Provide Guideline for Minimum requirement of staff in infertility clinics,Infrastructure,ART procedure ,Patient selection etc.
  17. 17. Guidance for International collaboration and partnership.  The ICMR Co-ordinates the processing ,implementing & monitoring of Biomedical research programmes carried out under bilateral ,Multilateral,& regional collaborative framework for facilitating & strengthing interactions among govt, academia, institutions & industries in the research areas of mutual interest.
  18. 18. Consideration of International collaboration Project by Health ministry’s Screening committee (HMSC)  The technical division at ICMR should complete the review process within 3 months ,if peer review meeting are organized by international collaborative project at ICMR, Members of HMSC.  The investigator should submit all the necessary clearances during the submission of project to ICMR.
  19. 19. CONCLUSION:  The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research.  Is one of the oldest medical research bodies in the world.  The Council's research priorities coincide with the National health priorities such as control and management of communicable diseases, fertility control, maternal and child health, control of nutritional disorders, strategies for health care delivery.  Research on major non-communicable diseases like cancer, cardiovascular diseases, blindness, diabetes and other metabolic .
  20. 20. REFERENCES:  American Fertility Society. Guidelines for Gamete Donation. Fertil Steril 1993 ,59  The UFAW book on the care and management of laboratoryanimals. New York: Churchill Livingstone. 1987.  Baker HJ, Lindsey JR, Weisborth SH, editors. The laboratory rat, Volume II:Research application. New York: Academic Press. 1980.  Bhardwaj KR, Purohit DC, Dhawan BN editors. Laboratory animal ethics andtechnology. Lucknow : Central Drug Research Institute ; 1991.  Coats M.E. The germ free animals in research. New York: Academic Press.1968.  Council on Scientific Affairs and Council on Ethical and Judicial Affairs. Medical applications of foetal tissue transplantation. JAMA 1990; 263 (4):565-570.  Council for International Organizations of Medical Sciences (CIOMS).International Guidelines for Ethical Review of Epidemiological Studies. Geneva:1991.  Council for International Organizations of Medical Sciences (CIOMS).  International Guidelines for Biomedical Research involving Human Participants. Geneva : 1993  Council on Ethical and Judicial Affairs. Code of Medical Ethics - Current opinions with annotations. Chicago: American Medical Association ; 1997; 191

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