The document provides an overview of institutional ethics committees (IECs), including their evolution, composition, responsibilities, and functions. Key points include:
- IECs were established to safeguard human subjects in clinical research following unethical studies in the 1940s-1970s.
- An IEC typically has 7-15 multidisciplinary members including medical, legal, and layperson representatives.
- Responsibilities include reviewing research protocols, providing oversight of ongoing studies, and ensuring participant safety and consent.
- Functions involve initial and continuing review of research, approving protocols, and maintaining documentation of IEC activities.
Institutional ethics committee : Roles and ResponsibilitiesDrSahilKumar
The document discusses the role and responsibilities of an Institutional Ethics Committee (IEC). The main points are:
1. An IEC is an independent body that reviews clinical trials and ensures the ethical treatment of human subjects. It evaluates protocols, informed consent forms, and other aspects of research proposals.
2. The IEC's main responsibilities are to protect participants, ensure universal ethical values are followed, and help develop research that meets local health needs.
3. The IEC reviews documents like protocols, consent forms, recruitment materials, safety information, and investigators' qualifications before research begins and conducts continuing annual reviews. It documents its approval, required modifications, or disapproval of proposed studies in writing.
The document discusses the roles and responsibilities of ethics committees (ECs) or institutional review boards (IRBs). It states that ECs are independent bodies composed of medical, scientific, and non-scientific members who ensure the protection of human subjects in clinical trials. Their key responsibilities include reviewing and approving study protocols and informed consent documents. The document outlines that ECs should have a diverse membership including specialists in different areas like science, medicine, ethics, law, and lay persons. It explains the perspectives and expertise that different member types, such as basic scientists, legal experts, and social workers, provide to the EC. Finally, it states that the primary purpose of EC/IRB review is to assure the protection of subjects' rights
The document discusses ethics committees in clinical research. It explains that ethics committees were established in India in 1980 by the Indian Council of Medical Research to protect the rights and welfare of clinical trial participants. Ethics committees, also called institutional review boards, are composed of medical, scientific and non-medical professionals who review and approve research protocols. Their primary purpose is to ensure the safety and ethical treatment of human subjects. The document outlines the composition, functions, procedures and documentation requirements for ethics committees in India.
This document discusses the role and functions of an Institutional Ethics Committee (IEC). The IEC is responsible for ensuring research involving human subjects is conducted ethically and protects participants' rights, safety, and well-being. The IEC reviews research proposals, consent forms, and other documents to evaluate risks and benefits to participants. It can approve research, approve with modifications, require resubmission with more information, or disapprove projects. The IEC also conducts continuing reviews of approved research. It is mandated by guidelines in India to ethically review all biomedical research involving human subjects.
The document discusses various topics related to medical ethics and research involving human subjects, including:
1. Historical events that shaped ethical guidelines like the Nuremberg Code and Declaration of Helsinki.
2. The structure and functions of Institutional Ethics Committees, including their role in reviewing research proposals and providing oversight.
3. Key principles of ethical research like informed consent, minimizing risks, and protecting participant privacy and welfare.
4. Issues around informed consent processes and the review of research by ethics committees.
Ethical committee-role, Principal InvestigatorGayathri Ravi
This document discusses ethics in research involving human subjects. It summarizes key landmark documents that guide ethical research, including the Nuremberg Code, Helsinki Declaration, and Belmont Report. It also describes the role and responsibilities of Institutional Review Boards (IRBs) in reviewing research proposals, ensuring risks are minimized and subjects' rights are protected, and providing ongoing oversight of approved studies. IRBs are responsible for ethical and scientific review of research and have authority to approve, require modifications to, or disapprove research.
The document discusses ethics in clinical trials and outlines several key principles:
1) Research should be essential and benefit patients, health care, and the environment.
2) Participants must provide informed consent and can withdraw at any time without penalty.
3) Participants should not be exploited and must be compensated for any risks.
4) Privacy and confidentiality of participant data must be maintained.
5) Precautions must be taken to minimize all risks to participants.
Institutional ethics committee : Roles and ResponsibilitiesDrSahilKumar
The document discusses the role and responsibilities of an Institutional Ethics Committee (IEC). The main points are:
1. An IEC is an independent body that reviews clinical trials and ensures the ethical treatment of human subjects. It evaluates protocols, informed consent forms, and other aspects of research proposals.
2. The IEC's main responsibilities are to protect participants, ensure universal ethical values are followed, and help develop research that meets local health needs.
3. The IEC reviews documents like protocols, consent forms, recruitment materials, safety information, and investigators' qualifications before research begins and conducts continuing annual reviews. It documents its approval, required modifications, or disapproval of proposed studies in writing.
The document discusses the roles and responsibilities of ethics committees (ECs) or institutional review boards (IRBs). It states that ECs are independent bodies composed of medical, scientific, and non-scientific members who ensure the protection of human subjects in clinical trials. Their key responsibilities include reviewing and approving study protocols and informed consent documents. The document outlines that ECs should have a diverse membership including specialists in different areas like science, medicine, ethics, law, and lay persons. It explains the perspectives and expertise that different member types, such as basic scientists, legal experts, and social workers, provide to the EC. Finally, it states that the primary purpose of EC/IRB review is to assure the protection of subjects' rights
The document discusses ethics committees in clinical research. It explains that ethics committees were established in India in 1980 by the Indian Council of Medical Research to protect the rights and welfare of clinical trial participants. Ethics committees, also called institutional review boards, are composed of medical, scientific and non-medical professionals who review and approve research protocols. Their primary purpose is to ensure the safety and ethical treatment of human subjects. The document outlines the composition, functions, procedures and documentation requirements for ethics committees in India.
This document discusses the role and functions of an Institutional Ethics Committee (IEC). The IEC is responsible for ensuring research involving human subjects is conducted ethically and protects participants' rights, safety, and well-being. The IEC reviews research proposals, consent forms, and other documents to evaluate risks and benefits to participants. It can approve research, approve with modifications, require resubmission with more information, or disapprove projects. The IEC also conducts continuing reviews of approved research. It is mandated by guidelines in India to ethically review all biomedical research involving human subjects.
The document discusses various topics related to medical ethics and research involving human subjects, including:
1. Historical events that shaped ethical guidelines like the Nuremberg Code and Declaration of Helsinki.
2. The structure and functions of Institutional Ethics Committees, including their role in reviewing research proposals and providing oversight.
3. Key principles of ethical research like informed consent, minimizing risks, and protecting participant privacy and welfare.
4. Issues around informed consent processes and the review of research by ethics committees.
Ethical committee-role, Principal InvestigatorGayathri Ravi
This document discusses ethics in research involving human subjects. It summarizes key landmark documents that guide ethical research, including the Nuremberg Code, Helsinki Declaration, and Belmont Report. It also describes the role and responsibilities of Institutional Review Boards (IRBs) in reviewing research proposals, ensuring risks are minimized and subjects' rights are protected, and providing ongoing oversight of approved studies. IRBs are responsible for ethical and scientific review of research and have authority to approve, require modifications to, or disapprove research.
The document discusses ethics in clinical trials and outlines several key principles:
1) Research should be essential and benefit patients, health care, and the environment.
2) Participants must provide informed consent and can withdraw at any time without penalty.
3) Participants should not be exploited and must be compensated for any risks.
4) Privacy and confidentiality of participant data must be maintained.
5) Precautions must be taken to minimize all risks to participants.
Ethics committee’s role and functioning committee formationDrSatyabrataSahoo
The document discusses the role and functioning of ethics committees in reviewing clinical research studies involving human participants. It outlines how ethics committees should be formed, composed of at least 7 but no more than 15 heterogeneous members, and registered. Standard operating procedures provide detailed guidelines for ethics committee procedures. Individual member roles include scientific review of research proposals and protocols, assessment of risks and benefits, review of adverse events and protocol deviations. Proper functioning of ethics committees in accordance with standard operating procedures is important for ethical research oversight.
Institutional ethics committee(IEC): A brief insight, by Rxvichu!!RxVichuZ
This is my 26th powerpoint.....its on INSTITUTIONAL ETHICS COMMITTEE(IEC) ...also known as RESEARCH and ETHICAL COMMITTEE(REC). It focusses on the general principles, that ought to be made, while selecting subjects for study.
Brief points, under specific headings, have been included.
Do go through this, and let me know your feedbacks.
Thank you!
Vishnu.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
The document provides an overview of good clinical practices (GCP) and the historical standards that contributed to its development. It discusses key milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report that established ethical and quality standards for clinical research involving human subjects. The document also outlines the four phases of clinical trials and principles of GCP like prior approval, informed consent, and quality assurance. It notes that GCP provides an international quality standard to ensure the rights, safety, and well-being of clinical trial participants.
Icmr ethical guidelines for biomedical research on human subjectSuraj Pamadi
This document outlines ethical guidelines for biomedical research involving human subjects presented by Suraj P.S. It discusses the ICMR Code established in 1949 and covers several topics including general principles of biomedical research, informed consent, composition and responsibilities of ethics committees, training requirements, and the review process. The key principles are that research must be directed to increasing knowledge, conducted in a way that respects human dignity, and subjected to evaluation at all stages.
This document discusses conflicts of interest in drug research. It defines conflicts of interest and provides examples of financial and non-financial conflicts. Significant financial interests that must be disclosed include salaries, equity, patents, and intellectual property if they exceed $10,000 or 5% ownership. Conflicts can occur at all stages of research and compromise integrity. Recommendations include adopting disclosure policies, managing conflicts through oversight committees, and restricting industry payments and gifts to researchers and medical institutions. Transparency and accountability are important principles to mitigate conflicts of interest in medical research.
The document summarizes the key differences between the Indian guidelines for Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) GCP guidelines. Some differences include: the Indian GCP requires investigators to be qualified by the Medical Council of India, while ICH GCP does not; Indian GCP mandates signing standard operating procedures between sponsors and investigators; and Indian GCP gives ethics committees power to discontinue trials, while ICH GCP assigns that role to independent data monitoring committees. Overall, the Indian GCP guidelines include some additional requirements compared to the international ICH standards.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
Research Ethics Committees (RECs- IRBs)Tamer Hifnawy
This document discusses the roles and functions of research ethics committees (RECs) and institutional review boards (IRBs). It provides an overview of when REC/IRB approval is required, the review process, and composition of RECs/IRBs. It also discusses interactions between IRBs in different countries and the roles of data safety monitoring boards. The document is authored by Dr. Tamer Hifnawy, an associate professor of public health in Egypt and Saudi Arabia who trains others in international research ethics.
An informed consent form is a document that is provided to prospective participants in a research study. It is a crucial component of the informed consent process and serves to ensure that participants are fully informed about the study and its potential risks and benefits before they decide to participate. Here are the key elements typically included in an informed consent form
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
The document outlines ethical guidelines for biomedical research on human subjects established by the Indian Council of Medical Research (ICMR). It discusses ICMR's role in regulating medical research in India and establishes general principles for ethical research involving human participants, including principles of voluntary and informed consent, privacy/confidentiality, and minimizing risks. It also covers specific ethical considerations for certain types of clinical trials and establishes procedures for ethical review of research by institutional ethics committees.
Dr. Nazuk Sharma will present on placebos, including:
1. Defining placebos and exploring their history and mechanisms of action.
2. Examining factors that influence placebo response and their applications in clinical trials and research.
3. Discussing ethics and guidelines around the use of placebos in human research.
The document discusses conflicts of interest in health research. It defines a conflict of interest as occurring when an individual's interests could compromise their judgment in conducting or reporting research. It outlines different types of conflicts, including those involving researchers, research ethics board members, and institutions. Conflicts can arise at various stages of research. While conflicts are not always problematic, they can risk loss of objectivity and influence research priorities or results. Practical steps to address conflicts include disclosure, stringent conflict analysis, independent monitoring and review. The document also discusses a case study of a researcher whose work was impacted by a conflict with her research's drug company sponsor.
A clinical research coordinator (CRC) is responsible for conducting clinical trials according to regulatory requirements and under the supervision of the principal investigator. The CRC acts as a vital link between all parties involved in the clinical trial. Their responsibilities include completing feasibility assessments, obtaining ethics committee approval, recruiting and retaining subjects, maintaining documentation, ensuring safety of patients, and closing out the trial in accordance with regulations.
The document discusses the roles and responsibilities of investigators in clinical trials. It states that the principal investigator is responsible for leading the clinical trial team at a trial site and ensuring proper conduct of the trial. Key responsibilities include being qualified to conduct the trial, obtaining necessary approvals, following good clinical practice guidelines, properly storing and using investigational products, obtaining informed consent, adhering to the protocol, maintaining accurate records, and communicating with regulatory bodies and the institutional review board. The investigator must ensure patient safety and welfare, medical care for participants, and protection of participant rights and confidentiality.
This document outlines the roles and responsibilities of ethics committee (EC) members in reviewing clinical trial protocols. It describes the composition of ECs, which includes chairs, clinicians, scientists, legal experts, social scientists, philosophers, theologians, and lay people. The roles of EC members include scientifically and ethically reviewing protocols, informed consent documents, risks and benefits, qualifications, and providing ongoing trial oversight. The chair oversees meetings while the member secretary organizes documentation and communication. Together the multidisciplinary EC works to protect research participants.
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
Ethics committee’s role and functioning committee formationDrSatyabrataSahoo
The document discusses the role and functioning of ethics committees in reviewing clinical research studies involving human participants. It outlines how ethics committees should be formed, composed of at least 7 but no more than 15 heterogeneous members, and registered. Standard operating procedures provide detailed guidelines for ethics committee procedures. Individual member roles include scientific review of research proposals and protocols, assessment of risks and benefits, review of adverse events and protocol deviations. Proper functioning of ethics committees in accordance with standard operating procedures is important for ethical research oversight.
Institutional ethics committee(IEC): A brief insight, by Rxvichu!!RxVichuZ
This is my 26th powerpoint.....its on INSTITUTIONAL ETHICS COMMITTEE(IEC) ...also known as RESEARCH and ETHICAL COMMITTEE(REC). It focusses on the general principles, that ought to be made, while selecting subjects for study.
Brief points, under specific headings, have been included.
Do go through this, and let me know your feedbacks.
Thank you!
Vishnu.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
The document provides an overview of good clinical practices (GCP) and the historical standards that contributed to its development. It discusses key milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report that established ethical and quality standards for clinical research involving human subjects. The document also outlines the four phases of clinical trials and principles of GCP like prior approval, informed consent, and quality assurance. It notes that GCP provides an international quality standard to ensure the rights, safety, and well-being of clinical trial participants.
Icmr ethical guidelines for biomedical research on human subjectSuraj Pamadi
This document outlines ethical guidelines for biomedical research involving human subjects presented by Suraj P.S. It discusses the ICMR Code established in 1949 and covers several topics including general principles of biomedical research, informed consent, composition and responsibilities of ethics committees, training requirements, and the review process. The key principles are that research must be directed to increasing knowledge, conducted in a way that respects human dignity, and subjected to evaluation at all stages.
This document discusses conflicts of interest in drug research. It defines conflicts of interest and provides examples of financial and non-financial conflicts. Significant financial interests that must be disclosed include salaries, equity, patents, and intellectual property if they exceed $10,000 or 5% ownership. Conflicts can occur at all stages of research and compromise integrity. Recommendations include adopting disclosure policies, managing conflicts through oversight committees, and restricting industry payments and gifts to researchers and medical institutions. Transparency and accountability are important principles to mitigate conflicts of interest in medical research.
The document summarizes the key differences between the Indian guidelines for Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) GCP guidelines. Some differences include: the Indian GCP requires investigators to be qualified by the Medical Council of India, while ICH GCP does not; Indian GCP mandates signing standard operating procedures between sponsors and investigators; and Indian GCP gives ethics committees power to discontinue trials, while ICH GCP assigns that role to independent data monitoring committees. Overall, the Indian GCP guidelines include some additional requirements compared to the international ICH standards.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
Research Ethics Committees (RECs- IRBs)Tamer Hifnawy
This document discusses the roles and functions of research ethics committees (RECs) and institutional review boards (IRBs). It provides an overview of when REC/IRB approval is required, the review process, and composition of RECs/IRBs. It also discusses interactions between IRBs in different countries and the roles of data safety monitoring boards. The document is authored by Dr. Tamer Hifnawy, an associate professor of public health in Egypt and Saudi Arabia who trains others in international research ethics.
An informed consent form is a document that is provided to prospective participants in a research study. It is a crucial component of the informed consent process and serves to ensure that participants are fully informed about the study and its potential risks and benefits before they decide to participate. Here are the key elements typically included in an informed consent form
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
The document outlines ethical guidelines for biomedical research on human subjects established by the Indian Council of Medical Research (ICMR). It discusses ICMR's role in regulating medical research in India and establishes general principles for ethical research involving human participants, including principles of voluntary and informed consent, privacy/confidentiality, and minimizing risks. It also covers specific ethical considerations for certain types of clinical trials and establishes procedures for ethical review of research by institutional ethics committees.
Dr. Nazuk Sharma will present on placebos, including:
1. Defining placebos and exploring their history and mechanisms of action.
2. Examining factors that influence placebo response and their applications in clinical trials and research.
3. Discussing ethics and guidelines around the use of placebos in human research.
The document discusses conflicts of interest in health research. It defines a conflict of interest as occurring when an individual's interests could compromise their judgment in conducting or reporting research. It outlines different types of conflicts, including those involving researchers, research ethics board members, and institutions. Conflicts can arise at various stages of research. While conflicts are not always problematic, they can risk loss of objectivity and influence research priorities or results. Practical steps to address conflicts include disclosure, stringent conflict analysis, independent monitoring and review. The document also discusses a case study of a researcher whose work was impacted by a conflict with her research's drug company sponsor.
A clinical research coordinator (CRC) is responsible for conducting clinical trials according to regulatory requirements and under the supervision of the principal investigator. The CRC acts as a vital link between all parties involved in the clinical trial. Their responsibilities include completing feasibility assessments, obtaining ethics committee approval, recruiting and retaining subjects, maintaining documentation, ensuring safety of patients, and closing out the trial in accordance with regulations.
The document discusses the roles and responsibilities of investigators in clinical trials. It states that the principal investigator is responsible for leading the clinical trial team at a trial site and ensuring proper conduct of the trial. Key responsibilities include being qualified to conduct the trial, obtaining necessary approvals, following good clinical practice guidelines, properly storing and using investigational products, obtaining informed consent, adhering to the protocol, maintaining accurate records, and communicating with regulatory bodies and the institutional review board. The investigator must ensure patient safety and welfare, medical care for participants, and protection of participant rights and confidentiality.
This document outlines the roles and responsibilities of ethics committee (EC) members in reviewing clinical trial protocols. It describes the composition of ECs, which includes chairs, clinicians, scientists, legal experts, social scientists, philosophers, theologians, and lay people. The roles of EC members include scientifically and ethically reviewing protocols, informed consent documents, risks and benefits, qualifications, and providing ongoing trial oversight. The chair oversees meetings while the member secretary organizes documentation and communication. Together the multidisciplinary EC works to protect research participants.
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
Control resolutions ensure ethical values are applied in hospitals by considering ethics in accreditation processes. Guidelines like the Declaration of Helsinki provide authoritative guidance for human research ethics. Ethics committees review proposed research before it begins to safeguard participants and ensure research quality. Committees have 5-15 diverse members including medical scientists, clinicians, legal experts, and community members. They provide independent review of studies' ethics, design, consent processes, qualifications, infrastructure, risks and benefits, confidentiality, and post-trial access.
Indian Council of Medical Research (ICMR).pptxSamikshaHamane
Introduction
Objective
Organisation structure
Roles & responsibilities of ICMR
Intramural research & Extramural research
General principles
Ethical Review Procedures
Composition
Training & regulation
A well-established hospital is frequently approached by pharmaceutical industry to conduct research on human subjects, for their products and / or for new drug and new formulation.
Even doctors in the hospitals have a keen desire to investigate some of their new ideas by experimenting on the patients.
For all such research involving human subjects in hospital should be routed through an important committee called , 'research and ethics committee' or simply 'independent ethics committee (IEC).
All research involving human subject should be conducted in accordance with ethical principle contained in the current revision of 'declaration of helsinki'.
The declaration is based on three basic considerations namely, justice, respect for persons and to maximize benefits and to minimize harms.
INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRRsarwankumar4524
This document provides an overview of the Indian GCP guideline. It discusses key aspects of GCP including principles, the role of the independent ethics committee, informed consent process, responsibilities of sponsors, investigators and monitors, special considerations for vulnerable populations in clinical trials, and comparisons between Indian GCP and ICH GCP.
This document discusses medical ethics in view of medical research. It begins by noting conflicts between various stakeholders in medical institutions. It then defines what ethics are and are not, establishing that ethics are based on moral principles of right and wrong. It discusses how medical ethics regulate professional conduct and relationships. The document outlines guidelines from organizations like WHO and ICMR for ethical research involving human subjects. It emphasizes informed consent and the role of institutional ethics committees in reviewing research proposals and ensuring ethical standards are followed. Throughout, it stresses applying ethical values with human perception in medical research.
The document discusses the role and functions of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). The IRB protects the rights and welfare of human subjects in research. It reviews research proposals to ensure they are ethical and in compliance with regulations. The IRB upholds principles like respect for persons, beneficence, and justice. It is composed of members from varying backgrounds who review research proposals and can approve, require modifications to, or disapprove research.
Ethics in research are integral to protect participants and ensure research is conducted for legitimate purposes. The summary discusses key ethical standards including informed consent, confidentiality, and treating participants according to principles of autonomy, beneficence and justice. Research ethics committees review proposals to evaluate risks and benefits before research begins. Historical documents like the Nuremberg Code and Declaration of Helsinki established ethical guidelines which research ethics boards now use to review proposed studies.
The document discusses the need for research ethics policies and the role of research ethics committees. It outlines the development of ethical codes starting in 1947 with the Nuremberg Code. Research ethics committees were established to maintain ethical standards, protect subjects, and ensure research complies with recognized standards. The university is responsible for developing policies, providing guidance to researchers, and establishing ethics committees to review proposed research.
Reseach Ethics committee for Medical and CliniciansManojKumbhare2
This document discusses research ethics committees and their functions. It begins with an introduction by Dr. Kumbhare Manoj Ramesh on microteaching sessions about research ethics committees. It then defines what constitutes a human subject and discusses how ethics committees aim to protect human participants in medical research. The composition of ethics committees is also outlined, requiring at least 7 but not more than 15 members from diverse backgrounds. Finally, the functions of ethics committees are explained, including prior review of research proposals, monitoring approved research, and resolving complaints.
This document provides an overview of medical ethics. It begins with definitions of ethics and discusses how ethics became important in medicine due to crimes against humanity in the 20th century. It then outlines the major developments in medical ethics codes and guidelines over time, including the Nuremberg Code, Declaration of Helsinki, and U.S. regulations. The document also covers ethical principles of beneficence, justice and respect for persons. It discusses types of ethics like professional, medical, bio and clinical ethics. Finally, it emphasizes the importance of ethical norms and codes in promoting responsible research and protecting subjects.
The document summarizes the functions and ethical guidelines of the Indian Council of Medical Research (ICMR). ICMR is the apex body for biomedical research in India. It provides funding for research, has governing bodies like a scientific advisory board, and aims to conduct ethical research that respects participants. The document outlines general ethical principles like voluntary participation, informed consent, and minimizing risks. It also discusses issues like privacy, payment for participation, and managing conflicts of interest. ICMR has various divisions, regional centers, and institutes that conduct and support biomedical research across India.
The document discusses the organization of Institutional Review Boards (IRBs) and standard operating procedures (SOPs) in research ethics. It provides details on the National Research Ethics Review Committee (NRERC) established in Ethiopia, responsibilities of IRBs in reviewing research protocols, requirements for SOPs, and a list of SOPs maintained by EPHI-IRB. IRBs apply research ethics by ensuring research methods are ethical and protect participants, while SOPs clarify decision-making procedures and processes in ethical reviews.
This document discusses Institutional Review Boards/Independent Ethics Committees (IRB/IEC) and their role and responsibilities. It explains that IRB/IECs serve as independent bodies that review clinical trial protocols to evaluate scientific and ethical aspects and protect participant safety and rights. The document outlines the background, composition, responsibilities and procedures of IRB/IECs, including reviewing proposed trials, providing continuing oversight, and maintaining records for regulatory authorities. IRB/IEC membership includes experts from medical, scientific, non-scientific, and layperson backgrounds.
The document discusses institutional review boards (IRBs), which are charged with protecting the rights and safety of clinical trial participants. IRBs review research protocols to ensure they are ethical and risks to participants are minimized. The document outlines the composition, procedures, and functions of IRBs, including that they must have at least five members from diverse backgrounds and one community member. IRBs review research plans, consent forms, and any changes or adverse events during a study. Their goal is to uphold ethical standards for human subjects research set forth in documents like the Belmont Report.
The document discusses ethical guidelines for biomedical research involving human participants as outlined by the Indian Council of Medical Research. It covers the history of ethical codes emerging from inhumane experiments, key principles of informed consent, protecting vulnerable populations, and preventing therapeutic misconception. Guidelines address general research principles, review procedures, clinical trials, and other specialized research areas. The importance of ethics committee oversight and obtaining valid informed consent is emphasized throughout.
This document provides an overview of Good Clinical Practice (GCP) guidelines, including:
- The historical background and development of GCP from codes like the Nuremberg Code to modern guidelines.
- The key principles of GCP including ethics, informed consent, responsibilities of sponsors, investigators, and monitors.
- Requirements for ethics committees and special considerations for trials involving vulnerable groups.
- Guidelines address the design, conduct, monitoring, recording, analysis and reporting of clinical trials involving human subjects.
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Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) Curriculum
Institutional ethics committee.pptx
1. U m a r F a r o o q u e S h a i k h
1 s t Y e a r M . S c C l i n i c a l R e s e a r c h
Institutional Ethics Committee
2. Learning Objective
▪ Introduction of Institutional Ethics committee (IEC)
▪ Composition of IEC
▪ Responsibilities of IEC
▪ Functions of IEC
▪ Maintenance of records IEC
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3. ▪ After the World War II, trial was conducted by 23 Nazi doctors and scientists
at Nuremberg for the murder of concentration camp inmates who were used
as research subjects.
▪ The code highlighted on the need for informed consent, prior animal work,
qualified scientists, risk justification by anticipated benefits, avoidance of
physical and mental suffering, death, or disabling injury.
▪ In Willowbrook Hepatitis Study (1956), children were deliberately infected
with mild form of hepatitis, and consent was obtained from parents without
informing about the risk invlove and giving the opportunity of school
admission on participation in the study
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Introduction : Evolution of Ethics Guidelines
4. ▪ In 1963, Jewish Chronic Disease Study was conducted where cancer cells
were inoculated in senile subject without proper explanation on risk.
▪ in view of the emerging situation, World Medical Association (WMA)
General Assembly (Helsinki, Finland, 1964) developed a set of guidelines
to safeguard the rights and well-being of subjects participating in clinical
research.
▪ This is referred to as the Declaration of Helsinki and is revised from time
to time, the last amendment in 64 WMA general assembly in Brazil, 2013.
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Introduction : Evolution of Ethics Guidelines
5. ▪ The declaration of WMA binds the physician with the words, “The
health of my patient will be my first consideration,” and the
International Code of Medical Ethics declares that, “A physician
shall act in the patient's best interest when providing medical care.”
▪ The declaration specifically defines that the duty of the physician
who are involved in medical research is to promote and safeguard
the health, well-being, and rights of patients
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Introduction : Evolution of Ethics Guidelines
6. ▪ In a very shocking turn of events, unethical research conducted by the United
States Public Health Service (Tuskegee Syphilis Study) surfaced in 1972.
▪ The sheer misconduct led the US government to set up ‘International Ethical
Guidelines for Biomedical Research Involving Human Subjects’ that submitted
the report (Belmont report) in 1979, which stressed on three basic ethical
principles: autonomy, beneficence, and justice, and recently, two more pillars
are added which includes confidentiality and honesty.
▪ In India Indian Council of Medical Research (ICMR) introduced “Ethical
Guidelines for Biomedical Research on Human Subjects” last amendment on
2017.
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Introduction : Evolution of Ethics Guidelines
7. 7
Introduction : ICMR guidelines on IEC
▪ “It is mandatory that all proposals on biomedical research involving human participants to
safeguard the welfare and the rights of the participants….” should be cleared by an
appropriately constituted Institutional Ethics Committee (IEC) in India.
▪ The ethics committees are based at clinical or academic institutions and hospitals.
▪ Ethics committee ensures a competent review of all the ethical aspects of the project
proposal submitted and does it free from any bias or external influence.
In other country EC also knowns as
▪ Institutional Review Board (IRB) United States,
▪ Research Ethics Board (REB) Canada.
▪ Human Research Ethics Committee (HREC) in Australia
8. ▪ Ethics Committees (EC) are multidisciplinary, independent groups of individuals
appointed to review biomedical research protocols involving human beings to help
ensuring the dignity, fundamental rights, safety, and well-being of research participants
are protected.
▪ Number of persons: 7 -15 (Maximum of 15 members recommended)
▪ Quorum –minimum of 7
▪ Chairperson. Out Side the Institution
▪ Member secretary. Associate of Institution
▪ One to two basic medical scientists (preferably one pharmacologist)
▪ One to two clinicians from various institutions
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Composition of IEC
9. ▪ One legal expert or retired judge
▪ One social scientist/representative of nongovernmental voluntary agency
▪ One philosopher/ethicist/theologian
▪ One lay person from the community .
▪ at least one member whose primary area of interest / specialization is
nonscientific
▪ at least one member who is independent of the institution / trial site
Besides, there should be appropriate gender representation on the IEC.
If required, Subject experts may be invited to offer their views.
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Composition of IEC
10. Responsibilities of IEC
Safeguard the rights, safety, and well-being of all trial subjects
Reviews a proposed clinical trial within a reasonable time and document its views in
writing
conducts continuing review of each ongoing trial at least once per year
Provide advice to the researchers on all aspects of welfare and safety of research
participants
Ensures that information regarding payment to subjects(including the methods,
amounts, schedule of payment) is set forth in the written informed consent form and
any other written information is provided to the subjects
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11. Responsibility of IEC Members : Chairman
▪ A well-respected person from any background with prior experience of having served/serving in an EC.
▪ Conduct IEC meetings and accountable for functioning of the committee.
▪ Ensure active participation of all members (particularly non-affiliated, nonmedical) in all discussions
and review.
▪ Handling of complaints against Investigators, IEC members, conflict of interest.
▪ Ratify minutes of mitting of the previous meetings.
▪ Review SAE reports with causality assessment and report accordingly.
▪ In case of anticipated absence of Chairperson and Vice Chairperson (optional) at a planned meeting, the
Chairperson should nominate a committee member as acting Chairperson, or the members present may
elect an acting Chairperson on the day of the meeting.
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12. ▪ Should be a staff member of the institution, have knowledge and experience in
clinical research and ethics, be motivated and have good communication skills.
▪ Should be able to devote adequate time to this activity which should be protected
by the institution.
▪ Organize an effective and efficient procedure for receiving, preparing circulating,
and maintaining each proposal for review.
▪ Schedule IEC meetings .
▪ Organize IEC documentation, communication and archival.
▪ Arrange for training/refresher training of IEC members.
▪ Ensure SOPs are updated as and when required.
▪ Prepare for and respond to audits and inspections
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Responsibility of IEC Members : Member Secretory
13. ▪ Non-medical or medical person with qualifications in basic medical sciences.
▪ In case of EC reviewing clinical trials with drugs, the basic medical scientist
should preferably be a pharmacologist.
▪ Scientific and ethical review on the intervention, benefit-risk analysis,
research design, methodology and statistics, continuing review process,
SAE, protocol deviation, progress, and completion report.
▪ For clinical trials, pharmacologist to review the drug safety and
pharmacodynamics.
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Responsibility of IEC Members : Basic Medical Scientist
14. ▪ Should have a basic degree in Law from a recognized university, with
experience. Desirable: Training in medical law.
▪ Ethical review of the proposal, ICD along with translations, MoU, Clinical
Trial Agreement (CTA), regulatory approval, insurance document, other
site approvals, researcher’s undertaking, protocol specific other
permissions.
▪ Interpret and inform EC members about new regulations if any.
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Responsibility of IEC Members : Legal Expert
15. Responsibility of IEC Members : Social scientist/ /social worker/
Philosopher/ethicist/theologian
▪ Ethical review of the proposal, ICD along with the translations.
▪ Assess impact on community involvement, socio–cultural context,
religious or philosophical context, if any Serve as a
patient/participant/ societal / community representative and bring
in ethical and societal concerns.
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16. Responsibility of IEC Members : Lay person
▪ Representative of the community and aware of the local language, cultural
and moral values of the community. Desirable: involved in social and
community welfare activities.
▪ Assess on societal aspects if any
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17. Functions
Only members who participate in the IEC review and discussion should
vote/provide their opinion or advise.
The IEC should perform its functions according to written standard operating
procedures, should maintain written records of its activities and minutes of its
meetings, and should comply with GCP and with the applicable regulatory
requirement Maintaining current knowledge of application regulation, laws and
institutional policies
▪ Conducting initial and continuing review of trials
▪ Determining the frequency of continuing review, as appropriate
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18. Functions
▪ Specifying that no deviations from, or changes of, the protocol should be initiated
without prior written IEC
▪ Specifying that no subject should be admitted to a trial before the IEC issues its
written approval / favorable opinion of the trial.
▪ Specifying that the investigator should promptly report to the IEC. Deviations
from, or changes of, the protocol to eliminate immediate hazards to the trial
subjects.
▪ Changes increasing the risk to subjects and/or affecting significantly the conduct of
the trial.
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19. Maintenance and recorded of IEC
▪ IEC retains all relevant records (e.g., written procedures, lists of
occupations/affiliations of members, submitted documents, minutes
of meetings, IEC Communication etc.) for a period of at least 5
years after completion of the trial and makes them available upon
request from the regulatory authority
▪ IEC may be asked by investigators, sponsors, or regulatory
authorities to provide copies of its written procedures and
membership lists
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20. Mandatory Documents EC Should Review
▪ Protocol (for scientific rationale)
▪ Informed consent document (for the safety and welfare of research
participants)
▪ Informed consent document’s vernacular translation
▪ Investigator brochure for information regarding clinical and nonclinical
data of the investigational product
▪ Study advertisement for participant recruitment or any other written
information to the patient
▪ Grants, payments, insurance documents.
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21. IEC changes as per new CT rules 2019
▪ EC Application - Form CT-01, approval granted in Form CT-02
▪ Constitution of EC :
1. One woman out of seven members
2. Preferably 50% external members - adequate age and gender
3. Any change - informed to CLA within 30 days
4. Any member not successfully completed training disqualified as
member
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22. IEC changes as per new CT rules 2019
5. EC registration validity increased from 3 to 5 years.
6. EC approval - informed to CLA within 15 working days.
7. Site does not have its own Ethics Committee : obtain
approval from independent EC or another site EC, locked
with in same city or within radius of 50kms
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