GUIDELINES OF ICMR

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.

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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)

Ethical guidelines for Biomedical Research on Human.

In this guideline, the council provide adviceto the researcher on all aspects of the welfare and

Safety of the research participants.

All the research involving human participants shouldbe conducted in accordance with the basic principles i.e.

Respect of participants, Beneficence,& Justice.

Good Clinical Lab Practice (GCLP).

ICMR give guidelines for GCLP in the regard of ….

Levels of laboratory,

Infra structure,

Equipments ,

Personnel, training &

Development, Data

management

Reagents & Material used in

GCP, ,Safety in

Laboratory

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.

.Duly filled application form

for transfer of sample.

• Duly signed material transfer

agreement

.Copy of IEC clearence,ICF,Import/

export certificate, Safety report

Copy of patient information sheet

Ten set of Copies are submitted by applicants to ICMR are:

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

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.

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.

Guidelines for management of:

• Assist oncologist in making major clinical decision in managing their patient’s in term of :

Surgery, Radiation therapy, Chemotherapy, Angiogenesis inhibitors

Cancer

• 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.

Type-II Diabetes

• Retinoblastoma is the most common intraocular tumor in child .

• The council provide guidelines to the ophthalmologist to treat R.B ,a/c patient

conditions.

Retinoblastoma

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.

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.

Dietary guidelines for Indians:

Nutrition is a basic human need for a healthy life .The Guidelines are:

……………………………………………

Nutritionally adequate diet,

Additional food during pregnancy

& lactation

Food supplement for infants, Intake

of salts

Food safety ,water & other beverage

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.

Assisted Reproductive Technology(ART):

ART-Bill(2010)

• An act to provide for a national frame work for the

accreditation ,regulation & supervision of ART for safe &

ethical practice of ART Services.

ART-Rule(2010)

• Provide Guideline for Minimum requirement of staff in infertility

clinics,Infrastructure,ART procedure ,Patient selection etc.

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.

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.

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 .

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