ICMR Guidelines.

1. GUIDELINES OF ICMR

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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