This document discusses ethics guidelines for health and biomedical research. It outlines several key points:
- Ancient Indian texts like Charaka Samhita and Sushruta Samhita established early guidelines for medical ethics. More modern codes developed in response to unethical Nazi experiments in WWII.
- Major guidelines now include the Nuremberg Code, Helsinki Declaration, Belmont Report, and ICMR guidelines. These aim to ensure the highest ethical standards in research involving human subjects.
- Key principles of research ethics are autonomy, beneficence, non-maleficence, justice, and confidentiality. Informed consent and protecting participants are paramount.
- The ICMR
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role in ensuring the ethical conduct of research involving human subjects. These boards are typically established by organizations, institutions, or agencies that conduct or sponsor research activities. The primary purpose of an IRB/IEC is to protect the rights, well-being, and confidentiality of human research participants.
Protocol writing is a critical phase in the planning and execution of clinical research studies. A well-structured and comprehensive protocol serves as the blueprint for the study, guiding researchers, ethics committees, and regulatory authorities.
Institutional review board or Independent ethics committee.pdfdabloosaha
The document discusses the role and responsibilities of an Institutional Review Board or Independent Ethics Committee (IRB/IEC). The IRB/IEC reviews clinical trial protocols and protects the rights, safety, and well-being of study participants. It consists of at least five members with diverse backgrounds and expertise. The IRB/IEC reviews proposed trials, provides guidance to researchers, ensures informed consent, and maintains records for regulatory authorities. Its main purpose is to ethically evaluate clinical trials and safeguard participant protections.
The executive director provided an update on the activities and achievements of the Patient-Centered Outcomes Research Institute (PCORI) over the past few months. Key points included funding 50 pilot projects totaling $30.8 million to engage patients and stakeholders in research, finalizing the national research agenda, and relocating to a new office in Washington, D.C. The methodology committee delivered its first report on methodological standards for patient-centered outcomes research and plans to seek public comment on the report over the next few months before presenting it for board approval.
High quality research requires high ethical standards. Learn about Research Ethics basics in the UK and NewZealand. These guidelines are likely to apply to most European and American institutions with the exception of the Treaty of Waitangi.
Role of IRB and IEC in Safeguarding the Subjects in Clinical TrialsClinosolIndia
In clinical research, the protection of human subjects is of utmost importance to ensure ethical conduct and adherence to regulatory standards. Two key entities responsible for safeguarding the rights, safety, and well-being of subjects in clinical trials are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). They play essential roles in the oversight and ethical review of clinical research protocols. Here's a breakdown of their roles in safeguarding clinical trial subjects:
Institutional Review Boards (IRBs):
Ethical Review: IRBs are responsible for conducting an ethical review of research protocols to ensure that the study is designed and conducted in an ethical and morally sound manner. They assess the study's potential risks, benefits, and the protection of subjects' rights.
Informed Consent: IRBs review and approve the informed consent process to ensure that subjects are provided with comprehensive and understandable information about the study, including its purpose, procedures, risks, and benefits. They assess the adequacy of the informed consent document.
Risk-Benefit Assessment: IRBs assess the risks and potential benefits of the research to determine whether they are balanced and reasonable. They weigh the scientific and societal value of the research against the risks posed to subjects.
Subject Recruitment and Selection: IRBs review the methods and materials used for subject recruitment and selection to ensure that they are non-coercive, fair, and do not discriminate against vulnerable populations.
Continual Oversight: IRBs provide ongoing oversight of approved studies. They monitor the progress of research, ensuring that it adheres to the approved protocol and that any deviations or adverse events are appropriately reported and addressed.
Conflict of Interest: IRBs evaluate potential conflicts of interest among researchers, ensuring that financial or non-financial interests do not compromise the rights or safety of research subjects.
Privacy and Confidentiality: IRBs assess how subjects' privacy and confidentiality will be protected, particularly in studies involving sensitive information or data.
Emergency Use of Investigational Products: In cases of emergency use of investigational products, IRBs may provide authorization, ensuring that the use is in the best interest of the subject.
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is a critical component of the ethical oversight process in clinical research involving human participants. Its primary purpose is to protect the rights, welfare, and well-being of study participants by ensuring that research studies are conducted ethically, following established ethical principles and regulatory guidelines. IRBs/IECs play a crucial role in reviewing, approving, and monitoring research protocols to ensure they meet ethical and regulatory standards.
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role in ensuring the ethical conduct of research involving human subjects. These boards are typically established by organizations, institutions, or agencies that conduct or sponsor research activities. The primary purpose of an IRB/IEC is to protect the rights, well-being, and confidentiality of human research participants.
Protocol writing is a critical phase in the planning and execution of clinical research studies. A well-structured and comprehensive protocol serves as the blueprint for the study, guiding researchers, ethics committees, and regulatory authorities.
Institutional review board or Independent ethics committee.pdfdabloosaha
The document discusses the role and responsibilities of an Institutional Review Board or Independent Ethics Committee (IRB/IEC). The IRB/IEC reviews clinical trial protocols and protects the rights, safety, and well-being of study participants. It consists of at least five members with diverse backgrounds and expertise. The IRB/IEC reviews proposed trials, provides guidance to researchers, ensures informed consent, and maintains records for regulatory authorities. Its main purpose is to ethically evaluate clinical trials and safeguard participant protections.
The executive director provided an update on the activities and achievements of the Patient-Centered Outcomes Research Institute (PCORI) over the past few months. Key points included funding 50 pilot projects totaling $30.8 million to engage patients and stakeholders in research, finalizing the national research agenda, and relocating to a new office in Washington, D.C. The methodology committee delivered its first report on methodological standards for patient-centered outcomes research and plans to seek public comment on the report over the next few months before presenting it for board approval.
High quality research requires high ethical standards. Learn about Research Ethics basics in the UK and NewZealand. These guidelines are likely to apply to most European and American institutions with the exception of the Treaty of Waitangi.
Role of IRB and IEC in Safeguarding the Subjects in Clinical TrialsClinosolIndia
In clinical research, the protection of human subjects is of utmost importance to ensure ethical conduct and adherence to regulatory standards. Two key entities responsible for safeguarding the rights, safety, and well-being of subjects in clinical trials are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). They play essential roles in the oversight and ethical review of clinical research protocols. Here's a breakdown of their roles in safeguarding clinical trial subjects:
Institutional Review Boards (IRBs):
Ethical Review: IRBs are responsible for conducting an ethical review of research protocols to ensure that the study is designed and conducted in an ethical and morally sound manner. They assess the study's potential risks, benefits, and the protection of subjects' rights.
Informed Consent: IRBs review and approve the informed consent process to ensure that subjects are provided with comprehensive and understandable information about the study, including its purpose, procedures, risks, and benefits. They assess the adequacy of the informed consent document.
Risk-Benefit Assessment: IRBs assess the risks and potential benefits of the research to determine whether they are balanced and reasonable. They weigh the scientific and societal value of the research against the risks posed to subjects.
Subject Recruitment and Selection: IRBs review the methods and materials used for subject recruitment and selection to ensure that they are non-coercive, fair, and do not discriminate against vulnerable populations.
Continual Oversight: IRBs provide ongoing oversight of approved studies. They monitor the progress of research, ensuring that it adheres to the approved protocol and that any deviations or adverse events are appropriately reported and addressed.
Conflict of Interest: IRBs evaluate potential conflicts of interest among researchers, ensuring that financial or non-financial interests do not compromise the rights or safety of research subjects.
Privacy and Confidentiality: IRBs assess how subjects' privacy and confidentiality will be protected, particularly in studies involving sensitive information or data.
Emergency Use of Investigational Products: In cases of emergency use of investigational products, IRBs may provide authorization, ensuring that the use is in the best interest of the subject.
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is a critical component of the ethical oversight process in clinical research involving human participants. Its primary purpose is to protect the rights, welfare, and well-being of study participants by ensuring that research studies are conducted ethically, following established ethical principles and regulatory guidelines. IRBs/IECs play a crucial role in reviewing, approving, and monitoring research protocols to ensure they meet ethical and regulatory standards.
The document provides information about research funding opportunities in India. It discusses the objective of research and lists various international and national funding agencies for government and private organizations. It also describes the Science and Engineering Research Board (SERB) and its schemes for basic research funding. One of SERB's schemes discussed in detail is the Teachers Associateship for Research Excellence (TARE) scheme, which provides funding and fellowships for faculty to conduct research in other established institutions. The document concludes with information on how to apply for SERB funding online and get research papers free of cost.
Ou Code Of Practice For Researchers And Those Conducting Researchanesah
This document provides a code of practice for research and researchers at the university. It aims to ensure research meets standards set by bodies like research councils and protects participants. The code covers principles of research like treating people with respect, adhering to ethics, ensuring accuracy, and acknowledging contributions. It discusses leadership responsibilities, seeking advice, training, supporting early career researchers, and addressing allegations of misconduct.
Good Clinical Practice Guideline – a standard for clinical trialsClinosolIndia
The Good Clinical Practice (GCP) Guideline stands as a universally recognized standard for the conduct of clinical trials in the field of medical research. GCP sets forth a comprehensive framework of ethical and quality principles to ensure the safety, rights, and well-being of human research participants and the reliability of trial data. Encompassing all stages of clinical research, from study design to reporting of results, GCP serves as a guiding compass, promoting the highest standards of trial conduct, data integrity, and regulatory compliance. By adhering to GCP, researchers, sponsors, and regulatory authorities collaborate to uphold the trust and integrity of clinical trials, thereby fostering the development of safe and efficacious medical interventions for the benefit of patients and public health.
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.
This document outlines the ethics appraisal procedure for projects funded by the European Union's Horizon 2020 program. It discusses that ethics must be considered in all EU-funded research from beginning to end. The procedure involves applicants completing an ethics issues table to identify any ethical issues, and providing details in the ethics and security section of their proposal. Proposals may undergo ethics screening and possibly assessment to ensure ethical standards are met. Requirements may be imposed and compliance monitored during and after projects. The goal is to ensure all research respects fundamental ethical principles and legal frameworks.
This document discusses ethics in clinical research. It begins by defining clinical research and ethics. There are four cardinal principles of ethical research: autonomy, beneficence, non-maleficence, and justice. There are also four pillars of ethical research: the principal investigator, ethics committee, institution, and regulator. Ethics in research is important to respect participants, ensure safety, and impose common standards. General principles of research ethics include essentiality of research, voluntary participation, non-exploitation of subjects, and minimizing risks while maximizing benefits. Ethics committees were created to protect participants and promote ethical policies.
This document provides information about developing and funding research projects. It discusses the importance of research, defines what a research project is, and outlines the various types of projects. The document also describes the process of research projects from planning to reporting. It provides guidance on criteria for selecting projects and standard proposal formats. Finally, it identifies potential funding sources in India and internationally for projects in science/technology and social sciences/humanities.
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.
IRB Review and Aproval Process and ongoing mointoring of safety data.pptxAartiVats5
The document describes the process for IRB/IEC review and approval of clinical trials. It discusses that the IRB/IEC protects subjects by reviewing protocols, benefits and risks. The review process requires researchers to submit requests and materials for initial and periodic review. The IRB/IEC can approve protocols, require modifications or disapprove based on ethical and scientific standards to ensure safety and welfare of trial subjects.
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.
White paper on Science and Engineering Research Board (SERB) Established through an Act of Parliament: SERB Act 2008 Department of Science &Technology, Government of India
Academic success and promotion in medicine largely depends on the quality and quantity of received grants. Grant money brings prestige and notoriety to the writer and his institution. However, writing a grant proposal can be a challenging task especially for the inexperienced researcher. As research budgets are being reduced by many funding agencies and more researches are competing for it, it is becoming increasingly important to be able to write a grant proposal of high quality.
The purpose of this article is to give the reader guidance on how to organize a research proposal in order maximize chances to obtain the desired funding. Key aspects will be highlighted and practical tips emphasized. This article will primarily focus on writing a grant for a clinical study.
This document summarizes a presentation about the COMREC processes and procedures for research approval at a medical college in Malawi. It outlines the functions of COMREC, which include protecting human and animal subjects in research and promoting ethical research. It describes the submission procedures, requiring proposals to be submitted by the 1st of each month with a processing fee. It also summarizes the review process, categories of review, exemption criteria, elements of review including ethics and methodology, and application materials required. The goal is to demystify the COMREC research approval processes and procedures for faculty and students conducting research.
The Central Council for Research in Ayurvedic Sciences (CCRAS) has initiated the Studentship Program for Ayurveda Research Ken (SPARK) to promote research interest among undergraduate Ayurveda students. SPARK provides a stipend of Rs. 25,000 per month for two months to students to work with a faculty guide on an independent research project. Eligible students are BAMS students from 1st to 4th year enrolled in an Indian Ayurvedic college. Students submit online proposals that are evaluated based on academic performance and research quality. Selected students complete their project between December and April and submit a final report for review and certification. The goal is to expose students to research methodology and techniques
Supplementary Guidelines for Standards Club activities under Engineering & Ot...renoldmemories
This document provides supplementary guidelines for standards club activities in engineering and other colleges. It categorizes standards clubs into those in schools and those in colleges. For colleges, standards clubs can be organized by department or discipline. A variety of activities are suggested, including presentations on standards, standards parliaments to debate topics, treasure hunts involving standards, and mock technical committee meetings. The purpose is to engage student members in higher-level exploration of quality and standards topics through activities like workshops, projects, and competitions. Sample activities and guidelines for implementation are provided for different suggested event types. The overall aim is to promote awareness and understanding of standards among engineering students.
The document provides an overview of the steps involved in conducting a systematic review, including forming a team, developing a search strategy and inclusion/exclusion criteria, searching databases, extracting and analyzing data, and reporting results. Key aspects of systematic reviews discussed include developing a protocol, conducting a comprehensive literature search, assessing risk of bias, and synthesizing evidence both qualitatively and quantitatively through meta-analysis when possible. Challenges of systematic reviews include the time and resources required as well as ensuring methodological rigor.
Codes of ethics for biologist By Anita bibisamiiikhan5264
Codes of ethics for biologists outline ethical principles and standards to guide professional practice. They typically address research integrity, professional conduct, and respect for life and the environment. Key aspects often included are honest research, minimizing harm to living organisms, professional responsibility, environmental responsibility, informed consent, avoiding conflicts of interest, and public education. Institutional review boards ensure research involving humans meets ethical standards and protects participants.
The document discusses IRB, ethical guidelines from ICMR, and Schedule Y requirements for clinical trials in India. It provides information on the roles and responsibilities of IRBs, including reviewing research proposals, ensuring ethics compliance, and approving clinical trials. Key ethical issues like informed consent, confidentiality, payments, and protecting vulnerable groups are explained. Schedule Y guidelines from ICMR for obtaining permission to import or manufacture new drugs and conduct clinical trials are summarized. The document aims to provide guidance on research ethics and regulatory processes in India.
The document provides information about research funding opportunities in India. It discusses the objective of research and lists various international and national funding agencies for government and private organizations. It also describes the Science and Engineering Research Board (SERB) and its schemes for basic research funding. One of SERB's schemes discussed in detail is the Teachers Associateship for Research Excellence (TARE) scheme, which provides funding and fellowships for faculty to conduct research in other established institutions. The document concludes with information on how to apply for SERB funding online and get research papers free of cost.
Ou Code Of Practice For Researchers And Those Conducting Researchanesah
This document provides a code of practice for research and researchers at the university. It aims to ensure research meets standards set by bodies like research councils and protects participants. The code covers principles of research like treating people with respect, adhering to ethics, ensuring accuracy, and acknowledging contributions. It discusses leadership responsibilities, seeking advice, training, supporting early career researchers, and addressing allegations of misconduct.
Good Clinical Practice Guideline – a standard for clinical trialsClinosolIndia
The Good Clinical Practice (GCP) Guideline stands as a universally recognized standard for the conduct of clinical trials in the field of medical research. GCP sets forth a comprehensive framework of ethical and quality principles to ensure the safety, rights, and well-being of human research participants and the reliability of trial data. Encompassing all stages of clinical research, from study design to reporting of results, GCP serves as a guiding compass, promoting the highest standards of trial conduct, data integrity, and regulatory compliance. By adhering to GCP, researchers, sponsors, and regulatory authorities collaborate to uphold the trust and integrity of clinical trials, thereby fostering the development of safe and efficacious medical interventions for the benefit of patients and public health.
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.
This document outlines the ethics appraisal procedure for projects funded by the European Union's Horizon 2020 program. It discusses that ethics must be considered in all EU-funded research from beginning to end. The procedure involves applicants completing an ethics issues table to identify any ethical issues, and providing details in the ethics and security section of their proposal. Proposals may undergo ethics screening and possibly assessment to ensure ethical standards are met. Requirements may be imposed and compliance monitored during and after projects. The goal is to ensure all research respects fundamental ethical principles and legal frameworks.
This document discusses ethics in clinical research. It begins by defining clinical research and ethics. There are four cardinal principles of ethical research: autonomy, beneficence, non-maleficence, and justice. There are also four pillars of ethical research: the principal investigator, ethics committee, institution, and regulator. Ethics in research is important to respect participants, ensure safety, and impose common standards. General principles of research ethics include essentiality of research, voluntary participation, non-exploitation of subjects, and minimizing risks while maximizing benefits. Ethics committees were created to protect participants and promote ethical policies.
This document provides information about developing and funding research projects. It discusses the importance of research, defines what a research project is, and outlines the various types of projects. The document also describes the process of research projects from planning to reporting. It provides guidance on criteria for selecting projects and standard proposal formats. Finally, it identifies potential funding sources in India and internationally for projects in science/technology and social sciences/humanities.
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.
IRB Review and Aproval Process and ongoing mointoring of safety data.pptxAartiVats5
The document describes the process for IRB/IEC review and approval of clinical trials. It discusses that the IRB/IEC protects subjects by reviewing protocols, benefits and risks. The review process requires researchers to submit requests and materials for initial and periodic review. The IRB/IEC can approve protocols, require modifications or disapprove based on ethical and scientific standards to ensure safety and welfare of trial subjects.
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.
White paper on Science and Engineering Research Board (SERB) Established through an Act of Parliament: SERB Act 2008 Department of Science &Technology, Government of India
Academic success and promotion in medicine largely depends on the quality and quantity of received grants. Grant money brings prestige and notoriety to the writer and his institution. However, writing a grant proposal can be a challenging task especially for the inexperienced researcher. As research budgets are being reduced by many funding agencies and more researches are competing for it, it is becoming increasingly important to be able to write a grant proposal of high quality.
The purpose of this article is to give the reader guidance on how to organize a research proposal in order maximize chances to obtain the desired funding. Key aspects will be highlighted and practical tips emphasized. This article will primarily focus on writing a grant for a clinical study.
This document summarizes a presentation about the COMREC processes and procedures for research approval at a medical college in Malawi. It outlines the functions of COMREC, which include protecting human and animal subjects in research and promoting ethical research. It describes the submission procedures, requiring proposals to be submitted by the 1st of each month with a processing fee. It also summarizes the review process, categories of review, exemption criteria, elements of review including ethics and methodology, and application materials required. The goal is to demystify the COMREC research approval processes and procedures for faculty and students conducting research.
The Central Council for Research in Ayurvedic Sciences (CCRAS) has initiated the Studentship Program for Ayurveda Research Ken (SPARK) to promote research interest among undergraduate Ayurveda students. SPARK provides a stipend of Rs. 25,000 per month for two months to students to work with a faculty guide on an independent research project. Eligible students are BAMS students from 1st to 4th year enrolled in an Indian Ayurvedic college. Students submit online proposals that are evaluated based on academic performance and research quality. Selected students complete their project between December and April and submit a final report for review and certification. The goal is to expose students to research methodology and techniques
Supplementary Guidelines for Standards Club activities under Engineering & Ot...renoldmemories
This document provides supplementary guidelines for standards club activities in engineering and other colleges. It categorizes standards clubs into those in schools and those in colleges. For colleges, standards clubs can be organized by department or discipline. A variety of activities are suggested, including presentations on standards, standards parliaments to debate topics, treasure hunts involving standards, and mock technical committee meetings. The purpose is to engage student members in higher-level exploration of quality and standards topics through activities like workshops, projects, and competitions. Sample activities and guidelines for implementation are provided for different suggested event types. The overall aim is to promote awareness and understanding of standards among engineering students.
The document provides an overview of the steps involved in conducting a systematic review, including forming a team, developing a search strategy and inclusion/exclusion criteria, searching databases, extracting and analyzing data, and reporting results. Key aspects of systematic reviews discussed include developing a protocol, conducting a comprehensive literature search, assessing risk of bias, and synthesizing evidence both qualitatively and quantitatively through meta-analysis when possible. Challenges of systematic reviews include the time and resources required as well as ensuring methodological rigor.
Codes of ethics for biologist By Anita bibisamiiikhan5264
Codes of ethics for biologists outline ethical principles and standards to guide professional practice. They typically address research integrity, professional conduct, and respect for life and the environment. Key aspects often included are honest research, minimizing harm to living organisms, professional responsibility, environmental responsibility, informed consent, avoiding conflicts of interest, and public education. Institutional review boards ensure research involving humans meets ethical standards and protects participants.
The document discusses IRB, ethical guidelines from ICMR, and Schedule Y requirements for clinical trials in India. It provides information on the roles and responsibilities of IRBs, including reviewing research proposals, ensuring ethics compliance, and approving clinical trials. Key ethical issues like informed consent, confidentiality, payments, and protecting vulnerable groups are explained. Schedule Y guidelines from ICMR for obtaining permission to import or manufacture new drugs and conduct clinical trials are summarized. The document aims to provide guidance on research ethics and regulatory processes in India.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Role of Mukta Pishti in the Management of Hyperthyroidism
Ethics in Research.pptx
1. Ethics in Health & Biomedical Research
Dr.CH.Padmavathy
Senior Resident
Dept. of Community Medicine
9/27/2022 1
2. In Medical profession
oldest prescribed practical guidelines of ethics are in
Charaka samhitha and Susrutha samhitha.
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3. Why this concept?
• Nazi experimentation during World War II was forceful,
without consent of the participants, and collected data that
involved the unnecessary and willful harm of human subjects.
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4. Code of conduct in research
Development of the Nuremberg Code in 1947
Helsinki Declaration in 1964.
Belmont report .
CIOMS-The Council of International Organizations of
Medical Sciences.
International Council on Harmonization- ICH.
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5. Purpose of these guidelines
To ensure highest professional and ethical standards
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6. • Any research involving human subjects should follow
international standards of ethics.
• Indian national standards were developed by ICMR
ICMR guide lines are the gold standard ethical guidelines for
India which were based on international standards.
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7. ICMR POLICY
Applies to All
• ICMR scientific/technical staff and students involved in
research at ICMR Headquarters or at ICMR Research
Institutions,
• Centers or field units across the country.
• (irrespective of source of funding).
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8. All stakeholders
• Researchers,
• Institutions,
• Scientific review committees
• and Ethics committees
involved in the conduct, review or reporting of research..
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9. Research Integrity Unit (RIU)
RIU at ICMR Headquarters, New Delhi would facilitate and guide
research integrity.
Through a designated Research Integrity Officer (RIO) at
Institutional/ Divisional level.
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10. ICMR Bioethics Unit (IBU)
• Unit will be responsible for development and timely updation
of policy on research integrity, misconduct and publication
ethics.
• Research Integrity Officer (RIO)-- facilitate implementation of
this policy.
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11. Before initiating research.
Applicable guidelines and regulations must be followed and
required approvals be obtained .
Institutional Animal Ethics Committee (IAEC), Institutional
Committee for Stem Cell Research (IC-SCR),
Genetic Engineering Approval Committee (GEAC),
Review Committee on Genetic Manipulation (RCGM),
Health Ministry’s Screening Committee (HMSC),
Central Drug Standard Control Organization (CDSCO),
Institutional Biosafety Committee (IBSC),
Atomic Energy Regulatory Board (AERB) etc.
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12. • Research should be undertaken by persons who are
competent with qualifications, having relevant
experience/training to collect reliable data, undertake
accurate analysis, interpretation and publication.
• All raw data should be available and securely kept by the lead
investigator for at least 3-5 years after study completion.
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13. • Completed research irrespective of results must be published
and shared on public databases such as CTRI, institute
websites or other available relevant platforms.
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15. Authorship
• should be duly given to all those who have substantially
scientifically contributed to the research .
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16. Before publication
The researcher/corresponding author should submit- The final
draft along with details of authorship,
1. undertaking (Annexure I)
2. plagiarism check report.
3.Researcher is also required to submit continuing review/
(Common form for EC review - Annexure 3).
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17. Approved only if
• The research documents with acceptable level of plagiarism
(<10%)
• without identified misconduct
shall be forwarded by RIO to Director/ Head for approval before
publication/dissemination.
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18. In case of research misconduct
• Respondent who will be given an opportunity to provide
explanation within a limited time period (15 days).
• enquiry committee to evaluate misconduct and explanation
by respondent to investigate credibility of evidence,
extent/nature of misconduct, personnel involved and
intentions to suggest further course of action, including
punitive/ disciplinary action will be taken by Director.
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19. Guidelines for avoiding Plagiarism
“Acknowledgment” is the ethically right manner of crediting
someone else’s work.
In case of verbatim text is being taken from another source, it
must be enclosed in quotation marks and by providing citation
to indicate its origin.
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20. Types of Plagiarism – by ICMR
• Direct copying or word by word copying of a someone’s work
without acknowledging the original author- Direct Plagiarism
• A situation where the person duplicates his previous works--
Self-Plagiarism.
• Copying of idea- Mosaic Plagiarism
• Accidental Plagiarism
• 'salami' publications/ Redundant publications.
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21. Don’t publish in
In India, ICMR, UGC and other agencies have recommended
the academic as well as scientific community to avoid
publication in predatory journals and conferences.
Any publication in predatory/dubious journals or presentations
in predatory/dubious conferences shall not be considered for
academic credit for selection, confirmation, promotion,
performance appraisal, award of scholarship or academic
degrees or credits in any form.
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22. Reference List of Quality Journals
The Consortium for Academic and Research Ethics (UGC-CARE)
reference List of Quality Journals across various disciplines was
posted at https://ugccare.unipune.ac.in/site/website/index.aspx.
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23. International level
• Office of Research Integrity (ORI)- to tackle scientific
misconduct.
• Committee on Publication Ethics (COPE)- COPE developed
Guidelines on Good Publication Practice.
• International Committee for Medical Journal Editors (ICMJE)--
ethical standards in the conduct and reporting of research and
other material published in medical journals.
• CONSORT-- to alleviate the problems arising from inadequate
reporting of randomized controlled trials (RCTs).
• National Institutes of Health (NIH)- A Guide to the handling of
research misconduct Allegations
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24. National level
• Department of Biotechnology (DBT).
• ICMR National Ethical Guidelines for Biomedical and Health
Research involving Human Participants 2017.
• University Grants Commission (UGC) Regulations for
promotion of academic integrity and prevention of plagiarism
in Research.
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25. Establishing and Constituting the Institutional Ethics
Committee (IEC)
INSTITUTIONAL Ethics committee is an is independent reviewing
body.
The Dean will select and nominate.
He will ensure that the IEC is established in accordance with the
applicable laws and regulations of the state, country and in
accordance with the value and Principles of communities they
serve .
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26. • The IEC meetings are held once in every three months or in
accordance with the need of the work load.
• All the proposals will be received at least three weeks before
the meeting,
• checked for completeness as per the check list initially by the
office clerk(Form II),
• subsequently by the member secretary (through a nominated
person) using the evaluation form (Form III).
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27. Procedure for submission of research project for review
by Ethics Committee
Applicable to Principal Investigators from institute.
• Every protocol submitted for review to IEC must contain
number, version and date.
• All the research proposals prescribed application form, duly
filled, along with all necessary documents for the review.
• All the members will evaluate the possible risks
• A decision of the IEC will be communicated to the applicant in
writing, within 10 days of the meeting.
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28. A certificate of approval
• At the end of each meeting, every member must return all
the research proposals and documents to IEC office staff.
It will be sent to the applicant within 2 weeks and all the
approvals will be valid for only three years.
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29. Format for submission of Research proposal to IEC
1.Serial No (IEC Office),
2.Date of submission ,
3.Title of the research project,
4.Brief Bio data of the principal investigator name, designation,
department, Educational Qualification, Research experience ,
Address & Tel.no. Email and same for co-investigator also.
5.Departments involved
6. Expected duration of the project.
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30. Format for submission of Research proposal to IEC
1.Attach typed copy of Research Protocol
which need not exceed 5 pages,
2.You must clearly define your role in your project
3. sufficient detail to permit review .
Please also submit a soft copy of the Research Protocol.
Title of the Research Project: - Objectives: (please enumerate) -
Review of Literature (with references) pertaining to the project
(in less than 100 words).
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31. Research Protocol
Rationale of the study (in less than 100 words) Research design
& methodology .
Please include
number of subjects,
Research methods to calculate sample size.
Attach all relevant enclosures like proforma, questionnaires etc
Informed consent process, including patient information sheet
and informed consent form in local language, if applicable.
For any drug / device trial, mention all relevant pre-clinical
animal data and clinical trial data from other centers within the
country /other countries, if available-.
If applicable - Name and signature of Principal Investigator and
co-investigator/s on
research protocol with date.
Signatures of HOD and principal of institute.
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32. Checklist for attached documents
1.Project proposal – 10 Copies
2.Curriculum Vitae of Investigators
3.Brief description of proposal
4.Patient information sheet
5.Informed Consent form
6.Investigator’s brochure for recruiting subject
7.Copy of advertisements/Information brochures 8.Copy of
questionnaire / data collection sheet .
Place ,date and finally the
HOD’s remark with Name & Signature.
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36. • All research proposals must be submitted in English language
only.
• Must be submitted at least three weeks in advance from the
scheduled date of IEC meeting .
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37. Receipt of the application will be acknowledged by the IEC
office.
Every application will be allotted an IEC registration number to
be used for all future correspondence and reference .
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38. Organization of the IEC
1.Chairman – from outside the institution
2.one-two persons from basic medical science area
3.One –two clinicians from various institutions
4.One legal expert or retired judge
5.One social scientist /representative of NGO
6.One philosopher/ethicist
7.One lay person from the community
8.Member secretary
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39. When should we apply to IEC?
It is Before initiation of your research
For all research activities you must take approval from EC.
NOTE :
Even when we are using available data where we say that there
is no risk involved to human participants, ethics review is
required.
Even in these situations ethics review is considered important
and mandatory.
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40. General principles of research are
• Autonomy
• Beneficence
• non maleficence
• Justice
• Confidentiality.
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41. Autonomy
It represents a patient's right to determine his or her own
health-care decisions.
Patient autonomy is the most fundamental principle underlying
all health-care ethics.
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42. For example,
• patients have the right to refuse undesired therapy, and they
have the right to choose whether or not they will participate
in experimentation.
• Each patient has the right to have his wishes carried out even
in the event that he loses consciousness or the capacity to
make decisions for himself.
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43. Autonomy is similar to
Freedom of religion,
Freedom of speech,
Freedom of assembly.
The concept of patient autonomy is similar to that of voting.
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44. Minor(< 18 years)
Minors are generally not considered competent to make their
own decisions.
• Only a parent or a legal guardian can give consent for a
minor.
• Neighbors, aunts, uncles, and grandparents cannot give
consent for treatment of a minor.
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45. • All adult patients are considered competent unless specifically
proven otherwise
A patient with mental illness or mental retardation that might
be considered incompetent for other areas of life may still retain
the right to refuse medical procedures.
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46. Beneficence
Doing what is good for people is a high aim and ethical principle,
autonomy is considered more important and takes precedence.
You cannot treat him or her against his or her will even if the
treatment is for her benefit.
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47. confidentiality
You cannot release medical information to anyone about a
patient unless the patient gives you permission to do so.
confidentiality is breached in case of HIV, tuberculosis, or a
sexually transmitted disease because these are legally notifiable
to public health authority and also these conditions can harm an
innocent third party.
The patient has an absolute right to freely access the
information it contains.
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49. Let us know some of the ethical issues in health
biomedical research
1.Can you do?
• Automatic HIV testing of patients without their specific
informed consent that you will be testing for HIV.
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50. You cannot do.
When a patient enters the hospital there is general consent
given that allows the routine testing of blood for chemistry and
hematology and so on.
• An additional HIV-related consent required to test for HIV.
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51. A psychiatric patient who told you he was going to harm
someone.
Do you keep this confidential?
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52. 2
You have to disclose.
• Although you have a duty to maintain the confidentiality of
the patient, you also have a duty to inform the person at risk.
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53. • Is it a duty for a health care professional to inform about his
HIV status to patient?
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54. 3
No
But he must follow Universal precautions that are supposed to
be maintained.
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55. Will you breach his confidentiality of a STD patient with
syphillis/HIV?
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56. 4
No
“Encourage him to disclose:' "offer counseling for partner.“
If the patient refuses then you must directly notify his pregnant
wife immediately.
Ask if he has already told his contacts that should be the first
thing to do.
The Department of Health can compile a list of contacts of
patients with STDs and notify the contacts that they are at risk.
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57. 5
• A young husband and wife visit your office to discuss methods
of contraception. The wife decides that she wants a tubal
ligation for sterilization.
Her husband is shocked and strongly objects stating that they
have no children. His wife is clear that she wants the sterilization
and that she wishes to be referred for the procedure.
What should you do?
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58. Refer for the tubal ligation as requested by the wife.
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59. 6
A 35-year-old married woman with four children is in your office
seeking a termination of an unwanted pregnancy in the first
trimester. Later in the day after you give the patient the referral,
her husband calls and is very distressed because he does not want
the abortion to occur. He very much wants to keep the baby.
What should you tell him?
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60. you have an absolute duty to the mother to honor her wishes
no matter what his personal feelings are.
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61. 7
• Is there any legal obligation if a doctor won’t aid a injured
person?
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62. • No.
You may feel a moral obligation to help everyone, but there is no
legal obligation for a doctor. Even laws, which protects
caregivers from liability .
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63. 8
All reproductive issues, including abortion, contraception, and
sterilization can be performed over the objection of the spouse.
Is it correct?
• .
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64. Of course
• Each person has autonomy over his or her own body.
• For any question concerning reproductive rights, decisions are
based entirely on maternal wishes. The father has no legal
right.
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65. 9
• Parental consent is not necessary to obtain contraception for
minors.
• Is it true?
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67. 10
• For example, an elderly man with COPD progresses to the
point of needing mechanical ventilation on a chronic basis.
• He tells you, after long consideration, that he just does not
want to live on a ventilator. What should you tell him.?
•
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68. • You must honor his wishes.
• This patient is an adult with the capacity to understand his
medical problems, so he has the right to choose whether or
not he wishes to be on a ventilator.
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69. 11
• It is ethically unacceptable for a physician/nurse of any kind
to have other relationship with a current patient.
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70. Professionalism
• It is the behavior displayed in being a professional.
• Fundamentally, these include
• their ethics,
• values,
• behaviors,
• expertise
• and service to the profession as a good doctor/nurse.
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71. Acknowledgements
• The Research Ethics Review Committee of WHO Regional
Office for South-East Asia (SEARO-ERC).
• National ethical guidelines for biomedical and health research
involving human participants –ICMR.
• ICMR Policy on research integrity and publication.
• Medical ethics by Dr.conrad.
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