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Topic:- IRB, ICMR, Ethical issues & Schedule Y
Subject Name :- Research Methodology, Biostatistics & IPR
Subject Code:- MRM301T
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–Vapi
Presented by:-
Machhi Dhruvi A.
3rd sem. M.Pharm.
Guided by:-
Dr. Neha Desai
Assistant Professor
CONTENTS
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• IRB
• Ethical guidelines by ICMR
• Ethical issues
Informed consent process
Confidentiality
Payments
Conflict of Interest
Vulnerable participants
• Schedule Y
• References
INSTITUTIONAL REVIEW BOARD (IRB)
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• The Institutional Review Board (IRB) is a local administrative body which is
established to protect the rights, safety & well being of human research subjects
recruited to participate in a clinical research.
• has authority to approve, require modification in, or disapprove all research activities
that fall within its jurisdiction.
• provides assurance to research subjects that every reasonable attempt has been made
to protect their rights & safety as subjects.
ETHICAL REVIEW PROCEDURES
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• It is mandatory that all proposals on biomedical research involving human participants
should be cleared by an appropriately constituted Institutional Review Board (IRB)
also referred to as Institutional Ethics Committee (IEC), Ethics Review Board (ERB)
& Research Ethics Board (REB) in other countries, to safeguard the welfare & the
rights of the participants.
• They have the responsibility of regular monitoring of the approved programs to
foresee the compliance of the ethics during the period of the project.
BASIC RESPONSIBILITIES OF IRB
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1. The IRB has the responsibility & the authority to approve or reject or ask for
modification in the trial.
2. The investigator are required to forward to the IRB all serious adverse event reports,
which the IRB should evaluate to check whether subjects are at undue risks.
3. To protect the dignity, rights & well being of the potential research participants.
4. Oversight the safety of the drug under trial.
5. All suspected unexpected serious adverse reaction report should also be forwarded to
the IRB for review.
COMPOSITION OF IRB
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1.Chairperson
2. Two persons from basic medical science area
3.Two clinicians from various institutes
4.One legal expert or retired judge
5.One social scientist
6.One philosopher/ ethicist/ theologian
7.One lay person from the community
8.Member Secretary
REVIEW PROCEDURES
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• The IRB should review every research proposal on human participants before the
research is initiated.
• It should ensure that a scientific evaluation has been completed before ethical review
is taken up.
• The IRB's member-secretary shall screen the proposals for their completeness &
depending on the risk involved categorize them into 3 types, namely;
1. Exemption from review
2. Expedited review
3. Full review
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1. Exemption from review: Proposals which present less than minimal risk fall under
this category
2. Expedited Review: proposals presenting not more than minimal risk to research
participants may be subjected to expedited review.
3.Full Review:
All research presenting with more than minimal risk
Proposals or protocols which do not qualify for exempted or expedited review
projects that involve vulnerable population
IRB MEETINGS
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
should be held periodically
Member secretary convenes the meeting at a suitable location & time as well as
informs all the members
During meeting, free discussion should be allowed
If a member wishes his or her point to be specifically mentioned, the member is
allowed to do so
IRB DECISION
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• The IRB may take a decision on the basis of majority opinion.
• There is a standard format in which the approval has to be conveyed.
• In case the IRB has some suggestion to make regarding any aspect of the trial, they
are free to record them in their letter of approval.
• If the IRB is rejecting the proposal then reasons for rejection should be included in the
letter.
IRB DOCUMENATION
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Must contain an updated list of members serving on the board, which states their;
 Names
Qualifications
Affiliations & even their gender
• IRB must have written SOP regarding its functioning. This would generally include;
Method for invitation of members
Fees of the IRB
Meeting schedule
Documents to be submitted
ICMR
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• The Indian Council of Medical Research (ICMR) is the apex body in India.
• It is for the formulation, coordination & promotion of biomedical research & is one of
the oldest & largest medical research bodies in the world.
• It is funded by the Government of India through the Department of Health Research,
Ministry of Health & Family Welfare
• The Council's research priorities coincide with National health priorities such as
control & management of communicable diseases.
GENERAL PRINCIPLE
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1. Principle of essentiality: whereby after due consideration of all alternatives in the
light of existing knowledge, the use of human participants is considered to be essential
for the proposed research.
2. Principle of voluntariness, informed consent & community agreement: whereby
respect for the right of the participant to agree or not to agree to participate in research,
or to withdraw from research at any time, is paramount.
3. Principle of non exploitation: whereby research participants are equitably selected
so that the benefits & burdens of the research are distributed fairly & without
arbitrariness or discrimination.
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
4. Principle of ensuring privacy & confidentiality: where the identity & records of
the human participants of the research or experiment are confidential.
5. Principle of precaution & risk minimization: To ensure that the research
participants & those affected by it including community are put to the minimum risk.
6. Principle of professional competence: The research is conducted by qualified
person who act with total integrity.
7. Principle of accountability & transparency: Whereby the research or experiment
will be conducted in a fair, honest, impartial & transparent manner.
GENERAL ETHICAL ISSUE
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• All research involving human participants should be conducted in accordance with the
basic & general ethical principles.
• The researcher & team are responsible for protecting the dignity, rights, safety & well-
being of the participants enrolled in the study. They should have the appropriate
qualifications & competence in research methodology.
• The Ethical Committees are responsible for ensuring that the research is conducted in
accordance with the aforementioned principles.
INFORMED CONSENT PROCESS
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Informed consent protects the individual's freedom of choice & respect for individual.
• Adequate information about the research is given in a simple & easily understandable
unambiguous language in a document known as the Informed Consent Form .
• Informed consent protects the individual’s autonomy to freely choose whether or not
to participate in the research.
• The process involves three components;
1. providing relevant information to potential participants
2. ensuring the information is comprehended by them &
3. assuring voluntariness of participation
12/19/2022 17
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Informed consent should explain medical terminology in simple terms & be in a
language that the participant understands.
• The informed consent document (ICD), which includes patient or participant
information sheet (PIS) & informed consent form (ICF) should have the required
elements, should be reviewed & approved by the ethical committee before enrolment
of participants.
CONFIDENTIALITY
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Confidentiality is the obligation of the researcher /research team/ organization to the
participant to safeguard the entrusted information.
• It includes the obligation to protect information from unauthorized access, use,
disclosure, modification, loss or theft.
• The researcher should safeguard the confidentiality of research related data of
participants & the community.
• Some information may be sensitive & should be protected to avoid stigmatization
&/or discrimination (for example, HIV status; sexual orientation such as lesbian, gay,
bisexual, & transgender; genetic information; or any other sensitive information).
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Data of individual participants can be disclosed under the following
circumstances:
1. only in a court of law under the orders of the presiding judge
2. there is threat to a person's life or
3. in cases of severe adverse reaction which may be required to communicate to drug
registration authority
PAYMENTS
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• If applicable, participants may be reimbursed for expenses incurred relating to their
participation in research, for ex. travel related expenses.
• Participants may also be paid for inconvenience incurred, time spent & other
incidental expenses in either cash or kind or both as deemed necessary; for ex. loss of
wages & food supplies.
• If there are provisions, participants may also receive additional medical services at no
cost.
• Ethical Committee’s must review & approve;
the payments (in cash or kind or both)
free services & the processes involved
& also determine that this does not amount to undue inducement.
CONFLICT OF INTEREST
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• It is a set of conditions where professional judgement concerning a primary interest
such as participants welfare or the validity of research tends to be unduly influenced
by a secondary interest, financial or non-financial (personal, academic or political).
• It can be at the level of
Researchers
Ethical Committee members
Institutions or
Sponsors
• Research institutions must develop & implement policies & procedures to identify &
mitigate conflicts of interest & educate their staff about such conflicts.
• Conflict of Interest within the Ethical Committee should be declared & managed in
accordance with SOP.
VULNERABLE GROUPS
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Vulnerable groups & individuals may have an increased likelihood of incurring
additional harm as they may be relatively or absolutely incapable of protecting their
own interests.
• Characteristics that make individuals vulnerable are:
legal status (children)
clinical conditions (cognitive impairment, unconsciousness) or
situational conditions (being economically or socially disadvantaged, for ex., certain
ethnic or religious groups, individuals or communities which have language barriers
& cultural differences).
12/19/2022 23
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• On the other hand, vulnerable populations also have an equal right to be included in
research so that benefits accruing from the research apply to them as well. This needs
careful consideration by researchers as well as the ethical committee.
• The ethical committee should determine vulnerability & ensure that additional
safeguards & monitoring mechanisms are established. It should also advise the
researcher in this regard.
SCHEDULE Y
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Requirements & guidelines for permission to import or manufacture of new drugs for
sale or to undertake clinical trials.
Purpose:
• To frame guidelines for conduct of clinical research control & regulation for new
drugs
REQUIREMENTS & GUIDELINES ON CLINICAL TRIALS
FOR IMPORTING & MANUFACTURE OF NEW DRUG
12/19/2022 25
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1.1. Application for Permission
1.2. Clinical Trial
1.3. Studies in specific population
4. Post Marketing Surveillance
5. Special studies: BA/BE studies
1. APPLICATION FOR PERMISSION
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Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• It shall be made in Form 44 accompanied with the following data in accordance
with appendices, namely;
Clinical & pharmaceutical information
Animal Pharmacology data
Animal Toxicology data
Human clinical pharmacology data
Regulatory status in other countries
Prescribing information
2. CLINICAL TRIAL
12/19/2022 27
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1. Approval for Clinical trials
• Clinical Trial on a new drug shall be initiated only after permission by licensing
authority & approval from ethical committee.
2. Responsibilities of Sponsor
• Implementing & maintaining QA
• Submit status report to the licensing authority periodically
• Serious Adverse Event should be reported to the licensing authority within 14
calendar days
3. Responsibilities of Investigator
• Ensure adequate medical care is provided to the subject
• Serious Adverse Event & unexpected Adverse Effect should be reported to the
sponsor within 24 hours & to the ethical committee within 7 working days.
12/19/2022 28
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
4. Informed consent
• Freely given informed written consent
• Provide information about the study verbally
• Non-Technically & understandable language
5. Responsibilities of ethics committee
• Approve trial protocol to safe guard the rights, safety & well being of all trial subject
& to protect rights, safety & well being of all vulnerable subjects
• Conduct ongoing review of trials
6. Human Pharmacology (Phase I)
• Safety & tolerability
12/19/2022 29
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
7. Therapeutic exploratory trials (phase II)
• To evaluate the effectiveness of a drug for a particular indication
• To determine the short term side effects & risk associated with the drug
• To determine the dosage regimen for phase III trials.
8. Therapeutic confirmatory trials (phase III)
• Demonstration of therapeutic benefit
• Drug is safe & effective for use & provide adequate basis for marketing approval
9. Post marketing surveillance
• Performed after drug approval & related to the approved indication
• Includes drug-drug interaction, dosage response & safety studies, mortality or
morbidity studies
3. STUDIES IN SPECIAL POPULATION
12/19/2022 30
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
1. Geriatrics
2. Pediatrics
3. Pregnant or Nursing Women
4. POST MARKETING SURVEILLANCE
12/19/2022 31
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Closely monitored new drugs clinical safety
• Periodic Safety Update Reports: to report all relevant new information.
• It shall be submitted every 6 months for the first 2 years.
5. SPECIAL STUDIES- BA/BE STUDIES
12/19/2022 32
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
• Conducted according to the guidance for BA & BE studies
• Evaluation of the effect of food on absorption following oral administration
REFERENCES
1. Ethical guidelines for biomedical research on human participants, Published by:
Director-General Indian Council of Medical Research New Delhi 110 029,
October, 2017, 1-10.
https://ethics.ncdirindia.org/ICMR_Ethical_Guidelines.aspx
2. The Drug & Cosmetics Act & Rules
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-
documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
3. http://www.slideshare.net/DeepakKumar2053/regulatory-prespectives-of-
clinical-trials?from_m_app=android
12/19/2022 33
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
Thank you
12/19/2022 34
Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi

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IBR, ICMR, Ethical Issues & Sch. Y

  • 1. Topic:- IRB, ICMR, Ethical issues & Schedule Y Subject Name :- Research Methodology, Biostatistics & IPR Subject Code:- MRM301T Department of Pharmaceutical Quality Assurance Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–Vapi Presented by:- Machhi Dhruvi A. 3rd sem. M.Pharm. Guided by:- Dr. Neha Desai Assistant Professor
  • 2. CONTENTS 12/19/2022 2 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • IRB • Ethical guidelines by ICMR • Ethical issues Informed consent process Confidentiality Payments Conflict of Interest Vulnerable participants • Schedule Y • References
  • 3. INSTITUTIONAL REVIEW BOARD (IRB) 12/19/2022 3 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • The Institutional Review Board (IRB) is a local administrative body which is established to protect the rights, safety & well being of human research subjects recruited to participate in a clinical research. • has authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction. • provides assurance to research subjects that every reasonable attempt has been made to protect their rights & safety as subjects.
  • 4. ETHICAL REVIEW PROCEDURES 12/19/2022 4 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • It is mandatory that all proposals on biomedical research involving human participants should be cleared by an appropriately constituted Institutional Review Board (IRB) also referred to as Institutional Ethics Committee (IEC), Ethics Review Board (ERB) & Research Ethics Board (REB) in other countries, to safeguard the welfare & the rights of the participants. • They have the responsibility of regular monitoring of the approved programs to foresee the compliance of the ethics during the period of the project.
  • 5. BASIC RESPONSIBILITIES OF IRB 12/19/2022 5 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1. The IRB has the responsibility & the authority to approve or reject or ask for modification in the trial. 2. The investigator are required to forward to the IRB all serious adverse event reports, which the IRB should evaluate to check whether subjects are at undue risks. 3. To protect the dignity, rights & well being of the potential research participants. 4. Oversight the safety of the drug under trial. 5. All suspected unexpected serious adverse reaction report should also be forwarded to the IRB for review.
  • 6. COMPOSITION OF IRB 12/19/2022 6 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1.Chairperson 2. Two persons from basic medical science area 3.Two clinicians from various institutes 4.One legal expert or retired judge 5.One social scientist 6.One philosopher/ ethicist/ theologian 7.One lay person from the community 8.Member Secretary
  • 7. REVIEW PROCEDURES 12/19/2022 7 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • The IRB should review every research proposal on human participants before the research is initiated. • It should ensure that a scientific evaluation has been completed before ethical review is taken up. • The IRB's member-secretary shall screen the proposals for their completeness & depending on the risk involved categorize them into 3 types, namely; 1. Exemption from review 2. Expedited review 3. Full review
  • 8. 12/19/2022 8 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1. Exemption from review: Proposals which present less than minimal risk fall under this category 2. Expedited Review: proposals presenting not more than minimal risk to research participants may be subjected to expedited review. 3.Full Review: All research presenting with more than minimal risk Proposals or protocols which do not qualify for exempted or expedited review projects that involve vulnerable population
  • 9. IRB MEETINGS 12/19/2022 9 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi should be held periodically Member secretary convenes the meeting at a suitable location & time as well as informs all the members During meeting, free discussion should be allowed If a member wishes his or her point to be specifically mentioned, the member is allowed to do so
  • 10. IRB DECISION 12/19/2022 10 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • The IRB may take a decision on the basis of majority opinion. • There is a standard format in which the approval has to be conveyed. • In case the IRB has some suggestion to make regarding any aspect of the trial, they are free to record them in their letter of approval. • If the IRB is rejecting the proposal then reasons for rejection should be included in the letter.
  • 11. IRB DOCUMENATION 12/19/2022 11 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Must contain an updated list of members serving on the board, which states their;  Names Qualifications Affiliations & even their gender • IRB must have written SOP regarding its functioning. This would generally include; Method for invitation of members Fees of the IRB Meeting schedule Documents to be submitted
  • 12. ICMR 12/19/2022 12 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • The Indian Council of Medical Research (ICMR) is the apex body in India. • It is for the formulation, coordination & promotion of biomedical research & is one of the oldest & largest medical research bodies in the world. • It is funded by the Government of India through the Department of Health Research, Ministry of Health & Family Welfare • The Council's research priorities coincide with National health priorities such as control & management of communicable diseases.
  • 13. GENERAL PRINCIPLE 12/19/2022 13 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1. Principle of essentiality: whereby after due consideration of all alternatives in the light of existing knowledge, the use of human participants is considered to be essential for the proposed research. 2. Principle of voluntariness, informed consent & community agreement: whereby respect for the right of the participant to agree or not to agree to participate in research, or to withdraw from research at any time, is paramount. 3. Principle of non exploitation: whereby research participants are equitably selected so that the benefits & burdens of the research are distributed fairly & without arbitrariness or discrimination.
  • 14. 12/19/2022 14 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 4. Principle of ensuring privacy & confidentiality: where the identity & records of the human participants of the research or experiment are confidential. 5. Principle of precaution & risk minimization: To ensure that the research participants & those affected by it including community are put to the minimum risk. 6. Principle of professional competence: The research is conducted by qualified person who act with total integrity. 7. Principle of accountability & transparency: Whereby the research or experiment will be conducted in a fair, honest, impartial & transparent manner.
  • 15. GENERAL ETHICAL ISSUE 12/19/2022 15 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • All research involving human participants should be conducted in accordance with the basic & general ethical principles. • The researcher & team are responsible for protecting the dignity, rights, safety & well- being of the participants enrolled in the study. They should have the appropriate qualifications & competence in research methodology. • The Ethical Committees are responsible for ensuring that the research is conducted in accordance with the aforementioned principles.
  • 16. INFORMED CONSENT PROCESS 12/19/2022 16 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Informed consent protects the individual's freedom of choice & respect for individual. • Adequate information about the research is given in a simple & easily understandable unambiguous language in a document known as the Informed Consent Form . • Informed consent protects the individual’s autonomy to freely choose whether or not to participate in the research. • The process involves three components; 1. providing relevant information to potential participants 2. ensuring the information is comprehended by them & 3. assuring voluntariness of participation
  • 17. 12/19/2022 17 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Informed consent should explain medical terminology in simple terms & be in a language that the participant understands. • The informed consent document (ICD), which includes patient or participant information sheet (PIS) & informed consent form (ICF) should have the required elements, should be reviewed & approved by the ethical committee before enrolment of participants.
  • 18. CONFIDENTIALITY 12/19/2022 18 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Confidentiality is the obligation of the researcher /research team/ organization to the participant to safeguard the entrusted information. • It includes the obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft. • The researcher should safeguard the confidentiality of research related data of participants & the community. • Some information may be sensitive & should be protected to avoid stigmatization &/or discrimination (for example, HIV status; sexual orientation such as lesbian, gay, bisexual, & transgender; genetic information; or any other sensitive information).
  • 19. 12/19/2022 19 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Data of individual participants can be disclosed under the following circumstances: 1. only in a court of law under the orders of the presiding judge 2. there is threat to a person's life or 3. in cases of severe adverse reaction which may be required to communicate to drug registration authority
  • 20. PAYMENTS 12/19/2022 20 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • If applicable, participants may be reimbursed for expenses incurred relating to their participation in research, for ex. travel related expenses. • Participants may also be paid for inconvenience incurred, time spent & other incidental expenses in either cash or kind or both as deemed necessary; for ex. loss of wages & food supplies. • If there are provisions, participants may also receive additional medical services at no cost. • Ethical Committee’s must review & approve; the payments (in cash or kind or both) free services & the processes involved & also determine that this does not amount to undue inducement.
  • 21. CONFLICT OF INTEREST 12/19/2022 21 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • It is a set of conditions where professional judgement concerning a primary interest such as participants welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or non-financial (personal, academic or political). • It can be at the level of Researchers Ethical Committee members Institutions or Sponsors • Research institutions must develop & implement policies & procedures to identify & mitigate conflicts of interest & educate their staff about such conflicts. • Conflict of Interest within the Ethical Committee should be declared & managed in accordance with SOP.
  • 22. VULNERABLE GROUPS 12/19/2022 22 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Vulnerable groups & individuals may have an increased likelihood of incurring additional harm as they may be relatively or absolutely incapable of protecting their own interests. • Characteristics that make individuals vulnerable are: legal status (children) clinical conditions (cognitive impairment, unconsciousness) or situational conditions (being economically or socially disadvantaged, for ex., certain ethnic or religious groups, individuals or communities which have language barriers & cultural differences).
  • 23. 12/19/2022 23 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • On the other hand, vulnerable populations also have an equal right to be included in research so that benefits accruing from the research apply to them as well. This needs careful consideration by researchers as well as the ethical committee. • The ethical committee should determine vulnerability & ensure that additional safeguards & monitoring mechanisms are established. It should also advise the researcher in this regard.
  • 24. SCHEDULE Y 12/19/2022 24 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Requirements & guidelines for permission to import or manufacture of new drugs for sale or to undertake clinical trials. Purpose: • To frame guidelines for conduct of clinical research control & regulation for new drugs
  • 25. REQUIREMENTS & GUIDELINES ON CLINICAL TRIALS FOR IMPORTING & MANUFACTURE OF NEW DRUG 12/19/2022 25 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1.1. Application for Permission 1.2. Clinical Trial 1.3. Studies in specific population 4. Post Marketing Surveillance 5. Special studies: BA/BE studies
  • 26. 1. APPLICATION FOR PERMISSION 12/19/2022 26 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • It shall be made in Form 44 accompanied with the following data in accordance with appendices, namely; Clinical & pharmaceutical information Animal Pharmacology data Animal Toxicology data Human clinical pharmacology data Regulatory status in other countries Prescribing information
  • 27. 2. CLINICAL TRIAL 12/19/2022 27 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1. Approval for Clinical trials • Clinical Trial on a new drug shall be initiated only after permission by licensing authority & approval from ethical committee. 2. Responsibilities of Sponsor • Implementing & maintaining QA • Submit status report to the licensing authority periodically • Serious Adverse Event should be reported to the licensing authority within 14 calendar days 3. Responsibilities of Investigator • Ensure adequate medical care is provided to the subject • Serious Adverse Event & unexpected Adverse Effect should be reported to the sponsor within 24 hours & to the ethical committee within 7 working days.
  • 28. 12/19/2022 28 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 4. Informed consent • Freely given informed written consent • Provide information about the study verbally • Non-Technically & understandable language 5. Responsibilities of ethics committee • Approve trial protocol to safe guard the rights, safety & well being of all trial subject & to protect rights, safety & well being of all vulnerable subjects • Conduct ongoing review of trials 6. Human Pharmacology (Phase I) • Safety & tolerability
  • 29. 12/19/2022 29 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 7. Therapeutic exploratory trials (phase II) • To evaluate the effectiveness of a drug for a particular indication • To determine the short term side effects & risk associated with the drug • To determine the dosage regimen for phase III trials. 8. Therapeutic confirmatory trials (phase III) • Demonstration of therapeutic benefit • Drug is safe & effective for use & provide adequate basis for marketing approval 9. Post marketing surveillance • Performed after drug approval & related to the approved indication • Includes drug-drug interaction, dosage response & safety studies, mortality or morbidity studies
  • 30. 3. STUDIES IN SPECIAL POPULATION 12/19/2022 30 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi 1. Geriatrics 2. Pediatrics 3. Pregnant or Nursing Women
  • 31. 4. POST MARKETING SURVEILLANCE 12/19/2022 31 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Closely monitored new drugs clinical safety • Periodic Safety Update Reports: to report all relevant new information. • It shall be submitted every 6 months for the first 2 years.
  • 32. 5. SPECIAL STUDIES- BA/BE STUDIES 12/19/2022 32 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi • Conducted according to the guidance for BA & BE studies • Evaluation of the effect of food on absorption following oral administration
  • 33. REFERENCES 1. Ethical guidelines for biomedical research on human participants, Published by: Director-General Indian Council of Medical Research New Delhi 110 029, October, 2017, 1-10. https://ethics.ncdirindia.org/ICMR_Ethical_Guidelines.aspx 2. The Drug & Cosmetics Act & Rules https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf- documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf 3. http://www.slideshare.net/DeepakKumar2053/regulatory-prespectives-of- clinical-trials?from_m_app=android 12/19/2022 33 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi
  • 34. Thank you 12/19/2022 34 Dhruvi Machhi Smt. BNB SPC, Salvav-Vapi

Editor's Notes

  1. 1. In short the main function of IRB is to protect the RSW rights, safety & well being of the humans or the participants or the subjects which are involved in the trails. 2. Jurisdiction means they have- legal power or authority to approve or disapprove or modify or change the research activity
  2. Means the above 3 authorities have the responsibility to check weather the ethics / rules are followed throughout the trial or project
  3. undue risks.– more extreme than the reasonable Dignity– persons respect or honor 4. Oversight the safety of the drug under trial.--- weather the drug is safe or not 5. If there are some doubtful adverse reaction then it should be reviewed by IRB
  4. 6. Theologian– the person who is expert in the religion 7. lay person– unprofessional or who does not have specialized knowledge in a particular subject
  5. Exemption– which is free from any obligation or consequences Expedited – quick or fast or accelerated review
  6. Exemption– which is free from any obligation or consequences Expedited – quick or fast or accelerated review 3. The proposals which do not fall under above 2 category comes under full review Vulnerable– ex children , elder patients or those with some medical conditions
  7. 1. Each & every member’s opinion or point of view should be taken into consideration prior to the decision
  8. communicable diseases- like COVID 19, HIV-AIDS
  9. Essential means necessary It is necessary to include or to use the human subjects in clinical trial process 2. Voluntariness – means with the persons free will , with their own choice or without any compulsion 3. Discrimination – means unfair – there should not be discrimination with respect to age, gender or community, caste, religon
  10. 4. Confidential– private / secret 5. There are chances of presenting risks so the care should be taken that the participants are subjected to minimum risks as possible 6. Researcher should be qualified & should have knowledge about the research to be conducted 7. Without any discrimination or partiality
  11. 2. Dignity- honor or respect Competence – they must have ability to efficiently doing work in research methodology 3.Aforementioned– acc. To the previously stated rules or guidelines
  12. 1.Consent – permission 2. Unambiguous- clear & precise 3. Autonomy – choice, willingness 4.2. Comprehended– completely understood 3. voluntariness- the participant should be ready with their own choice without any compulsion
  13. 1. If necessary, the local languages should be used for easy understanding
  14. Heading Confidentiality– the info. of the participant should be kept private or secret by the researcher 1. Obligation – means one type of agreement/ legal action 4. Stigmatization- when someone discriminate or views you in a negative way that is the stigmatization
  15. Only in case of following situation/ circumstances, the information can be disclosed
  16. 1. Reimbursed – means paying the money which they had spent Food expense, accommodation expense 2. Cash or kind –either cash or in the form of goods 6. undue inducement– that does not decrease the interest of participant Inducement– one kind of attraction towards the payment
  17. Conflict– battle ,or clash due to opposite thinking
  18. VULNERABLE– physically weak ex. Children, elderly person incurring - occurring cognitive impairment– trouble in remembering or concentrating or understanding Religion or Caste difference
  19. 5. Regulatory status in other countries- weather drug is approved, unapproved or banned in other country
  20. 4. Medical terminology should be understandable to participants
  21. 7. Weather it is effective against its stated indication 9. After drug reaches to market for sale Mortality rate = death rate morbidity studies = rate of occurrence of disease in population