Ethics Guideline for Biomedical research

and human participant schedule Y

Presented By:-
Mohima Saha
Guided by:-
Prof. Ajay Shelke (M. pharm in Pharmacology)
dept. of Pharmacology R.No.-2202812220004
 Indian Council of Medical Research

 The Indian council of medical research (ICMR) is the apex

body in India for the formulation, coordination and promotion
of biomedical research.
 One of the oldest medical research bodies in the world.
 The ICMR has come a long way from the days when it was
known as the IRFA (Indian Research and Fund Association,
which was redesignated as the Indian council of Medical
Research in 1949.(with Dr. C.G. Pandit as its first Director)
 The ICMR is funded by the government of India through the
department of Health Research, Ministry of Health and Family
welfare. (MoHF)
Principles Based on ….

 Autonomy of participants

 Beneficence and non maleficence

 Justice
Sections of Guidelines
 Statement of general principles
 General ethical issues
 Responsible conduct of research
 Ethical review procedures
 Informed consent
 Vulnerability
 Clinical trials
 Public health research
 Social and behavioral sciences
 Human genetic testing and research
 Biological materials, Biobanking and Datasets
 Research during humanitarian emergencies and disater research
Scope
 These guidelines are applicable to all
biomedical, socio-behavioural and health
research conducted in India involving human
participants, their biological material and data.
 General principles of biomedical
1.research…
Principle of essentiality
2. Principle of voluntariness
3. Principle of social responsibility
4. Principle of ensuring privacy and confidentiality
5. Principle of risk minimization
6. Principle of non-expoliation
7. Principle of professional competence
8. Principle of maximization of benefit
9. Principle of totality of responsibilities
10. Principle of institutional arrangement
11. Principle of transparency and accountability
 Principle of essentiality
• Human participants are considered to be absolutely essential.
• Research has been considered by an appropriate and responsible
body of persons who are external to particular research.
• Necessary for the advancement of knowledge and benefits of all
members of the human species.
 Principle of voluntariness, informed consent and community
agreement
• Research participants are fully informed of the research and the
impact and risk.
• Participants is incapable of giving consent the principle of
voluntariness and informed consent shall continue to apply.
•
 Principle of non-exploitation
• Remunerated for their involvement.
• Participants kept fully informed of all the dangers.
• Human participants should be selected so that the benefits of the
research are distributed.
 Principle of privacy and confidentiality
• Identity and records of participants are kept confidential.
• Cannot be disclosed without consent in writing of the participants
concerned.
 Principle of precaution and risk minimisation
• Due care and caution is taken at all stages.
• Research participants are put to the minimum risk.
• No known irreversible adverse effects, and generally benefit
 Principle of professional competence
• Conducted at all times by competent and qualified persons.
• Act with total integrity and impartiality.
 Principle of accountability and transparency
• experiment will be conducted in a fair, honesty, impartial and
transparent manner.
 Principle of maximisation of benefit
• Benefits all human kind and not just those who are socially better off
but also the least advantaged.
 Principle of institutional arrangements
• All the procedure required to be complied with and all institutional
arrangements required to be made in respect of the research are made
in a bonafide and transparent manner.
 Principle of public domain
• Results are generally made known through scientific and
other publications.
 Principle of totality of responsibility
• Professional and moral responsibility.
 Principle of compliance
• General and positive duty on all persons, conducting,
associated or connected with any research to ensure that
both the letter and the spirit of these guidelines, as well as
any other normal, directions and guidelines
Ethical review procedures
 Terms of reference
 Composition
 Criteria and selection
 Training
 Roles and responsibilities
 Review procedures
 Types of review
 Submission, protocol
 Decision making
 Continuing review
 Site monitoring
 Record keeping and archiving
Schedule Y
 Drugs and cosmetics Act (1940)
 In 1940 Drugs and cosmetic Act was enacted in India to
regulate import manufacture and distribution of drugs in India.
 The main objective of the Act is to ensure that Drugs and
cosmetics sold in India are safe, effective and complied with
quality standards.
 Safe use of the drug is the ultimate aim of health care system.
 This Act has a set of rule which has provision for
classification of drugs under given schedule and there are
guideline for the storage, sale and display of each schedule.
SCHEDULE “Y”

 Definition
• Requirement and guidelines for permission to import and
manufacture of new drugs for sale or to undertake clinical
trials.
• This is a kind of a rule book which provides a specific
instruction and requirements which need to be followed
for conducting clinical trials in India.
• In 1988 Government of India (Ministry of Health and
Family Welfare) introduced Schedule Y.
 1988- Sch y was introduced, established regulatory guidelines for clinical trial
permission; growth of a predominantly generic Indian pharmaceutical Industry;
conduct phase III clinical trials for registration of a new drugs; requirements and
guidelines for import, manufacture of new drugs under rule
122A,122B,122D,122E and Sch Y.
 2005- GLP for toxicity studies has made mandatory; realistic definition for phase
I to IV were presented; Appendices VII to XI were added to the Sch while the
new revised sch allowed the number of patients according to the protocol
requirements.
 2013- Appendix XII was introduced; addition of rule 122DAB (compensation in
case of injury or death during clinical trials); rule 122DD (registration of Ethics
committee made mandatory).
 2014- formula for compensation was devised; SAE reporting timeline was
redefined.
 2015- Audio video recording for vulnerable subjects made mandatory; rule
122AA omitted.
 2016- Post marketing surveillance was added
 Major content of Sch Y
 Preclinical details such as toxicology studies and
pharmacology study
 Clinical study details
 Regulatory requirements or status in other countries
 Details of protocol reports approvals
 Responsibilities of ethics committee investigators sponsor
Features of Sch Y

 For new medicinal product discovered in India Clinical Trial need to

be conducted from phase 1 to phase 4.
 For new medicinal product discovered outside India phase 1 data
from that country where it has been discovered is required
 Concurrent phase global clinical trials permitted
 Set forth responsibilities of ethics committee investigator and
sponsor
 Contains structure contents and formats for clinical trials protocols
reports Ethics committee approvals ICF SAE reporting .
Requirement and guidelines on clinical trials
for importing and manufacture of new drug..

Application for permission

Clinical trials
Studies in specific population

Post marketing surveillance

Application for permission

 It shall made in Form 44 accompanied with the following

data in accordance with appendices, namely …
• Clinical and pharmaceutical information
• Animal pharmacology data
• Animal toxicology data
• Human clinical pharmacology data
• Regulatory status in other countries
• Prescribing information
 Clinical trials …
 Approval for clinical trials
• Clinical trials on a new drugs shall be initiated only after permission by licensing authority and
approval from ethical committee.
 Responsibilities of sponsor
• Implementing and maintaining QA.
• Submit status report to the licensing authority periodically.
 Responsibilities of investigator
• Ensure adequate medical care is provided to the subject
 Informed consent
• Freely given informed written consent
• Provide information about the study verbally.
• Non-technically and understandable language.
 Responsibilities for ethics committee
• Approval trial protocol to safe guard of all trial subject and to protect of all vulnerable subjects .
• Conduct ongoing review of trials.
 Human pharmacology (phase 1)
• Safety and tolerability.
 Therapeutic exploratory trials (phase2)
• To evaluate the effectiveness of a drugs for a particular indication.
• To determine the short term side effects and risk associated with the drugs.
• To determine the dosage regimen for phase 3 trials.
 Therapeutic confirmatory trials (phase 3)
• Demonstration of therapeutic benefit
• Drug is safe and effective for use and provide and adequate basis for marketing approval
 Post marketing surveillance
• Performed after drug approval and related to the approved indication include drug –drug interaction,
dosage response and safety studies, mortality studies.
 Reference

 1. Ethical Guidelines for Biomedical Research on Human Participants. 2006. [Last

accessed on 2018 Jun 26]. Available from: https://www.icmr.nic.in/ethical_guidelines.pdf .

 2. National Ethical Guidelines for Biomedical and Health Research Involving Human
Participants. 2017. [Last accessed on 2018 Jun 26]. Available from:
https://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf .

 https://youtu.be/Urr2wVRSJKM
 https://youtu.be/M2o1M4GB9Sg