An overview of Institutional Review Board or Independent Ethics Committee
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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.
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An overview of Institutional Review Board or Independent Ethics Committee
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.
Role of IRB and IEC in Safeguarding the Subjects in Clinical Trials
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.
Institutional review board or Independent ethics committee.pdf
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.
Institutional ethics committee : Roles and Responsibilities
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.
Organization of IRBs and SOPs.pptx
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.
ETHICS COMMITEE in Clinical Research I Clinical Trials.pptx
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
For the purpose of the Rule 122DD, an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.
Siro Clinical Research Institute
www.siroinstitute.com
#Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune
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#clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader
#event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm
#clinicalresearchassociate #clinicalresearchcoordinator
#pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers
#Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience
#medicaldevices,#scdmindia,#societyforclinicaldata
#lifesciencemanagement,#pharmaceuticals,#medicalwriting
#clinicalresearchinstitute #CRA #CRC #Databasedesign
#pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilance #clinicalresearch #quality #clinicalresearchassociate #clinicalresearchcoordinator #clinicalresearchjobs #clinicaltrialmanagement #clinicaltrials #clinicaltraining #pharmacy #pharmacylife #pharmacycollege #pharmaceutical #pharmacist #pharmaindustry
IRB Review and Aproval Process and ongoing mointoring of safety data.pptx
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.
Good clinical practice (GCP)
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Recommended
An overview of Institutional Review Board or Independent Ethics Committee
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.
Role of IRB and IEC in Safeguarding the Subjects in Clinical Trials
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.
Institutional review board or Independent ethics committee.pdf
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.
Institutional ethics committee : Roles and Responsibilities
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.
Organization of IRBs and SOPs.pptx
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.
ETHICS COMMITEE in Clinical Research I Clinical Trials.pptx
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
For the purpose of the Rule 122DD, an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.
Siro Clinical Research Institute
www.siroinstitute.com
#Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune
#clinicalresearch #medicaldevices #career #opportunity #oncology
#safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #sas #statistics #biostatistician #biostatistics #statisticalprogramming #Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS
#clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader
#event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm
#clinicalresearchassociate #clinicalresearchcoordinator
#pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers
#Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience
#medicaldevices,#scdmindia,#societyforclinicaldata
#lifesciencemanagement,#pharmaceuticals,#medicalwriting
#clinicalresearchinstitute #CRA #CRC #Databasedesign
#pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilance #clinicalresearch #quality #clinicalresearchassociate #clinicalresearchcoordinator #clinicalresearchjobs #clinicaltrialmanagement #clinicaltrials #clinicaltraining #pharmacy #pharmacylife #pharmacycollege #pharmaceutical #pharmacist #pharmaindustry
IRB Review and Aproval Process and ongoing mointoring of safety data.pptx
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.
Good clinical practice (GCP)
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Institutional review board/Independent ethics Committee
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.
Biosimilar Development - IBSC - Regulatory Affairs
The document summarizes the role and functions of the Institutional Biosafety Committee (IBSC) in India for regulating research involving genetically modified organisms (GMOs). Key points:
1) The IBSC is responsible for reviewing and approving research projects involving GMOs at the institutional level before submitting to the higher Review Committee on Genetic Manipulation (RCGM).
2) The IBSC monitors adherence to biosafety guidelines, assesses research facilities, and reports all GMO activities to the RCGM. It also reviews proposals for field trials and imports/exports.
3) The IBSC is composed of a chairperson, scientists, a biosafety officer, and a nominee from the Department of
ich gcp principles
This document outlines the principles of ICH GCP and the role of institutional review boards (IRBs) and independent ethics committees (IECs) in clinical trials. It discusses that clinical trials should be scientifically sound and protect subject safety, rights, and well-being. IRBs/IECs are responsible for reviewing trials and documents like protocols, consent forms and investigator qualifications to ensure these principles are followed. They must provide approval or disapproval of trials in writing and conduct continuing oversight, while maintaining independence from trial sponsors and investigators. The composition, functions, operations and review procedures of IRBs/IECs are also described.
Institutional ethics committee & informed consent
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.
IRB / IEC
The document discusses institutional review boards (IRBs) and independent ethics committees (IECs), which are groups that review clinical trials to protect participant rights and safety. IRBs/IECs review trial protocols, risks/benefits, informed consent documents, and monitor trials. They must have at least five members with varying backgrounds, including a lay person and independent member. The principal investigator is responsible for ensuring compliance with IRB/IEC requirements. The document also provides information on IRBs/IECs in India and an example IEC in Mumbai.
Good Clinical Practice Guideline – a standard for clinical trials
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.
Protocol Writing in Clinical Research
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.pptx
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.
ICH and GCP by Naveen
The document describes the International Conference on Harmonization (ICH), which was established in 1990 to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan and the United States. It aims to reduce duplication in drug development through international guidelines on Good Clinical Practice (GCP), quality, safety and efficacy. The ICH framework includes guidelines, working groups and a secretariat. Its goal is to make safe and effective new drugs available more quickly and economically worldwide while maintaining high regulatory standards.
Differences between indian gcp and ich-gcp
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.
Addressing ethics in clinical research
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.
IBR, ICMR, Ethical Issues & Sch. Y
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.
Information about Ethics committee
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.
Icmr ethical guidelines for biomedical research on human subject
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.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptx
The document discusses the role and responsibilities of an Institutional Review Board/Independent Ethics Committee (IRB/IEC). It states that an IRB/IEC reviews clinical trial protocols to ensure the ethical treatment of study participants and protection of their rights and well-being. The IRB/IEC is composed of at least five members with diverse qualifications and one member from a non-scientific discipline. It is responsible for approving, monitoring and reviewing research involving humans. The IRB/IEC conducts initial and annual reviews of trial procedures and documentation. All records are maintained for at least three years.
CORE: Ethics from an IRB Perspective
Research Ethics from an IRB Perspective - Presented by Dr. Heidi Sato & Dr. Stefan Hanson
Understanding the IRB requirements before initiating a research study may be a challenging task. Learn about research ethics from an IRB perspective. In this webinar you will learn:
· What is an IRB and its purpose?
· What requires IRB review and approval?
· What are the different types of IRB review?
· What is the process for submitting an IRB application?
· What criteria must be met for IRB approval?
· What are possible outcomes of an IRB review?
About CORE:
The Culture of Research and Education (C.O.R.E.) webinar series is spearheaded by Dr. Bernice B. Rumala, CORE Chair & Program Director of the Ph.D. in Health Sciences program in collaboration with leaders and faculty across all academic programs.
This innovative and wide-ranging series is designed to provide continuing education, skills-building techniques, and tools for academic and professional development. These sessions will provide a unique chance to build your professional development toolkit through presentations, discussions, and workshops with Trident’s world-class faculty.
For further information about CORE or to present, you may contact Dr. Bernice B. Rumala at Bernice.rumala@trident.edu
ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
This presentation will provide the detail of ICH-GCP E6 and their differences to Indian GCP and Shedule Y.
121725101007-IRBs.pptx
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.
IRB (1).pptx
The document discusses the roles and responsibilities of an Institutional Review Board (IRB) in protecting human subjects in clinical research. It outlines that the IRB reviews research protocols, ensures ethical standards are upheld, and provides oversight of informed consent processes. The IRB should have at least seven qualified members and meet quorum requirements. It is responsible for initial and ongoing review of research and for notifying investigators of its decisions. Informed consent forms must provide all key information about research risks, benefits, procedures, and subjects' rights in language they can understand.
Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
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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.
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The document summarizes the role and functions of the Institutional Biosafety Committee (IBSC) in India for regulating research involving genetically modified organisms (GMOs). Key points:
1) The IBSC is responsible for reviewing and approving research projects involving GMOs at the institutional level before submitting to the higher Review Committee on Genetic Manipulation (RCGM).
2) The IBSC monitors adherence to biosafety guidelines, assesses research facilities, and reports all GMO activities to the RCGM. It also reviews proposals for field trials and imports/exports.
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1. Historical events that shaped ethical guidelines like the Nuremberg Code and Declaration of Helsinki.
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3. Key principles of ethical research like informed consent, minimizing risks, and protecting participant privacy and welfare.
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The document discusses institutional review boards (IRBs) and independent ethics committees (IECs), which are groups that review clinical trials to protect participant rights and safety. IRBs/IECs review trial protocols, risks/benefits, informed consent documents, and monitor trials. They must have at least five members with varying backgrounds, including a lay person and independent member. The principal investigator is responsible for ensuring compliance with IRB/IEC requirements. The document also provides information on IRBs/IECs in India and an example IEC in Mumbai.
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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.
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The document describes the International Conference on Harmonization (ICH), which was established in 1990 to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan and the United States. It aims to reduce duplication in drug development through international guidelines on Good Clinical Practice (GCP), quality, safety and efficacy. The ICH framework includes guidelines, working groups and a secretariat. Its goal is to make safe and effective new drugs available more quickly and economically worldwide while maintaining high regulatory standards.
Differences between indian gcp and ich-gcp
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.
Addressing ethics in clinical research
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.
IBR, ICMR, Ethical Issues & Sch. Y
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.
Information about Ethics committee
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.
Icmr ethical guidelines for biomedical research on human subject
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.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptx
The document discusses the role and responsibilities of an Institutional Review Board/Independent Ethics Committee (IRB/IEC). It states that an IRB/IEC reviews clinical trial protocols to ensure the ethical treatment of study participants and protection of their rights and well-being. The IRB/IEC is composed of at least five members with diverse qualifications and one member from a non-scientific discipline. It is responsible for approving, monitoring and reviewing research involving humans. The IRB/IEC conducts initial and annual reviews of trial procedures and documentation. All records are maintained for at least three years.
CORE: Ethics from an IRB Perspective
Research Ethics from an IRB Perspective - Presented by Dr. Heidi Sato & Dr. Stefan Hanson
Understanding the IRB requirements before initiating a research study may be a challenging task. Learn about research ethics from an IRB perspective. In this webinar you will learn:
· What is an IRB and its purpose?
· What requires IRB review and approval?
· What are the different types of IRB review?
· What is the process for submitting an IRB application?
· What criteria must be met for IRB approval?
· What are possible outcomes of an IRB review?
About CORE:
The Culture of Research and Education (C.O.R.E.) webinar series is spearheaded by Dr. Bernice B. Rumala, CORE Chair & Program Director of the Ph.D. in Health Sciences program in collaboration with leaders and faculty across all academic programs.
This innovative and wide-ranging series is designed to provide continuing education, skills-building techniques, and tools for academic and professional development. These sessions will provide a unique chance to build your professional development toolkit through presentations, discussions, and workshops with Trident’s world-class faculty.
For further information about CORE or to present, you may contact Dr. Bernice B. Rumala at Bernice.rumala@trident.edu
ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
This presentation will provide the detail of ICH-GCP E6 and their differences to Indian GCP and Shedule Y.
121725101007-IRBs.pptx
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.
IRB (1).pptx
The document discusses the roles and responsibilities of an Institutional Review Board (IRB) in protecting human subjects in clinical research. It outlines that the IRB reviews research protocols, ensures ethical standards are upheld, and provides oversight of informed consent processes. The IRB should have at least seven qualified members and meet quorum requirements. It is responsible for initial and ongoing review of research and for notifying investigators of its decisions. Informed consent forms must provide all key information about research risks, benefits, procedures, and subjects' rights in language they can understand.
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Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
Clinical data security and Integrity in Clinical Research
Clinical data security and integrity are paramount in maintaining patient confidentiality, protecting sensitive medical information, and ensuring the reliability of healthcare data. Security measures encompass various strategies and technologies aimed at safeguarding clinical data from unauthorized access, breaches, or manipulation.
Encryption techniques, access controls, and secure authentication mechanisms are commonly employed to restrict access to patient records and prevent unauthorized individuals from viewing or altering sensitive data. Additionally, robust network security protocols, such as firewalls and intrusion detection systems, help safeguard against external threats and cyberattacks targeting healthcare systems.
Pharmacovigilance in Patriatics and Geriatrics
Pharmacovigilance in pediatrics and geriatrics is of paramount importance due to the unique physiological and pharmacokinetic characteristics of these populations. In pediatrics, factors such as rapid growth, organ maturation, and differences in drug metabolism can influence the safety and efficacy of medications. Therefore, monitoring for adverse drug reactions (ADRs), including both known and unexpected effects, is crucial in ensuring the safe use of drugs in children. Additionally, since pediatric patients often receive off-label or unlicensed medications due to limited clinical trials in this population, pharmacovigilance efforts play a critical role in gathering real-world data to inform pediatric drug use.
Presenting- Signal mining in Pharmacovigilance
Signal mining in pharmacovigilance involves the systematic analysis of large datasets to identify potential safety signals associated with medications. It encompasses a variety of computational and statistical methods aimed at detecting patterns or trends that may indicate previously unrecognized adverse drug reactions (ADRs). Signal mining relies on data from sources such as spontaneous reporting systems, electronic health records, clinical trials, and medical literature. Advanced algorithms and data mining techniques, including disproportionality analysis, Bayesian data mining, and machine learning, are employed to sift through vast amounts of data to uncover potential signals of concern. These signals are then subjected to further evaluation to determine their clinical relevance and potential impact on patient safety. By leveraging the power of big data and analytics, signal mining plays a crucial role in enhancing pharmacovigilance efforts, enabling proactive identification and mitigation of medication-related risks, and ultimately contributing to improved patient care and drug safety.
Patient centered Pharmacovigilance .. .
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Introduction to Blogs, Presentations and Review Articles- Noorush Shifa Nizami
Blogs, presentations, and review articles stand as dynamic mediums, each with its unique power to engage, inform, and influence. Blogs, the conversational storytellers; presentations, the visual orchestrators; and review articles, the comprehensive knowledge curators, collectively play pivotal roles in shaping how we share, learn, and explore diverse subjects. This exploration delves into the distinct characteristics and purposes of these forms of communication, unveiling the art of effective expression and knowledge sharing in the digital age.
Patient-Centric Approaches in Precision Medicine Trials: Strategies for Success
Precision medicine, with its focus on tailoring medical treatment to the individual characteristics of each patient, has ushered in a new era in healthcare. Within this paradigm, clinical trials play a pivotal role in testing and validating targeted therapies. This article explores the importance of adopting patient-centric approaches in precision medicine trials and outlines strategies to enhance their success. By prioritizing patient engagement, leveraging digital technologies, and fostering collaborative partnerships, precision medicine trials can not only advance scientific understanding but also ensure that patient perspectives and experiences are integral to the research process.
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...
Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
They advocate for affordable and equitable access to innovative therapies, ensuring that the benefits of precision medicine are accessible to a broader population.
In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...
The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
Regulatory Considerations in Precision Medicine: Navigating the Approval Process
Precision medicine, with its focus on tailoring medical treatments to individual characteristics, presents unique regulatory challenges in the drug development and approval process. This ppt delves into the regulatory considerations associated with precision medicine, exploring the key aspects that pharmaceutical and biotechnology companies need to navigate
Emerging Technologies and Tools in Precision Medicine Research
Precision medicine has witnessed significant advancements with the integration of emerging technologies and innovative tools. This abstract explores the current landscape of precision medicine research, focusing on the role of cutting-edge technologies and tools in revolutionizing healthcare approaches.
Precision Medicine in Action: Case Studies and Success Stories
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Harnessing Big Data and Artificial Intelligence for Pharmacovigilance in Prec...
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Integration of Clinical Trial Systems: Enhancing Collaboration and Efficiency
Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...
Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.
Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine
Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
Artificial Intelligence In Clinical Trial
Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
Emerging Technologies Shaping the Future of Precision Medicine
Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
Innovations in Liquid Biopsies for Precision Cancer Diagnosis
Precision medicine, with its focus on tailoring medical interventions to individual characteristics, benefits significantly from the integration of machine learning (ML) algorithms for predictive analytics. These algorithms analyze complex datasets, identify patterns, and generate predictions that inform personalized treatment strategies. This article explores the diverse applications of ML in precision medicine, highlighting the key algorithms driving predictive analytics in this transformative field.
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An overview of Institutional Review Board or Independent Ethics Committee
- 1. Welcome An overview on Institutional Review Board (IRB)/ Independent Ethics committee (IEC) Mohammed Junaid Pasha Pharm.D CSRPL_STD_IND_HYD_ONL/CLS_164/082023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1
- 2. Definition • It is a regulatory body that regulates all researches which are carried out on human subjects. • The main objective of Institutional Review Board (IRB)/ Independent Ethics committee (IEC) is to ensure that the research should be conducted in accordance with the ethical principals • Ensuring the safety, rights and well being of the human subjects 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. Institutional Review Board (IRB) 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3 Safeguard Obtaining Documents Review Evaluates Approves Decision
- 4. Roles and Responsibilities 1. It helps in safeguarding the rights, safety and well being of all the subjects in the trial. 2. IRB/IEC Should obtain the following documents: - Trial Protocol - Informed Consent Form - Written information is being provided to the subjects - Investigator’s brochures (IB) - Information about the compensation or any reward being given to the subjects - Safety information for the subjects and the Curriculum vitae of the investigator 3. IRB/IEC should timely review the clinical trial and propose a written document which should consist of: - Approval/favorable opinion - If any modification is required - Any negative opinion - Termination of the opinion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4
- 5. Roles and Responsibilities 4. The IRB or IEC should consider the investigators qualification and should be documented by a curriculum vitae. 5. They should conduct a continuing review of the ongoing trial at least once a year. 6. The IRB or IEC can request more information about the trial, and should be furnished to the subject when ever required. It should be meaningful and protect the rights, safety and well being of the subjects. 7. The IRB or IEC should ensure that there is no undue influence on the subjects by anyone in the trial and the amount and method of payment to the them are carried out accordingly and should be mentioned in the written informed consent form. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5
- 6. Members of the IRB/IEC 1. Chair Person 2. 1-2 Medical Scientist 3. 1-2 Clinicians 4. One Legal Expert 5. One Philosopher 6. Lay Person 7. Member Secretary 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6
- 7. Composition, Function and Operations: • It is recommended that the IRB/IC should include: (a) At least five members. (b) At least one member whose primary area of interest is in a non scientific area . (c) At least one member who is independent of the institution/trial site: • 1. Only those IRB/IC members who are independent of the investigator & the sponsor of the trial should vote/provide opinion on a trial related matter. • 2. A list of IRB/IEC members and their qualifications should be maintained. • • The IRB/IEC should perform its functions accordingly to written operating procedures, should maintain written records of its activities and minutes of its meeting, and should comply with GCP. and with the applicable regulatory requirements. An IRB/IC should make its decisions at announced meetings at which, at least a quorum, as stipulated in its overwritten operating procedures, is present. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7
- 8. Procedure • The IRB/IEC should follow its procedures, which should include: • 1. Determining its composition (names and qualifications of the members) • 2. Plan and notify its members and conducting its meeting. • 3. Conducting a continuing review of trials. • 4. Maintaining a frequency of continuing review. • 5. Providing approval/favorable opinion of minor changes in ongoing trials • 6. Specifying that no subjects should be admitted to a trial before the IRB/IEC approval/favorable opinion. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8
- 9. • 7. Mentioning that no deviations from the protocol should be initiated without consulting IRB/IC approval/favorable opinion • 8. The investigators should report to the IRB/IC: (a) If there is any deviation or changes of the protocol, to eliminate immediate hazards to the trial subjects. (b) Any changes that put the subject at risk (c) Serious and unexpected adverse drug reactions(ADR's). 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9
- 10. Records • The IRB/IEC should maintain relevant records even after 3 years of completion of the trial of the following documents: • SOP's • Membership files • Submitted documents of meetings • Correspondence 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10
- 11. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11