Dr.Pratik Bangi’s Post

🔬 Navigating the World of Clinical Research: The Essential Role of Ethics Committees in Clinical Trials 🛡️ In Clinical Research, Ethics Committees (or Institutional Review Boards or IRBs) play an essential role as the guardians of ethics and safety. These committees stand at the forefront, ensuring that participants' rights, dignity, and well-being are always prioritized, even amidst the complexities of scientific innovation. Before any clinical trial can begin, the Ethics Committee reviews the study's protocol, scrutinizing everything from participant recruitment strategies to the informed consent process. Their goal? To confirm that the study adheres to rigorous ethical guidelines and complies with national and international regulatory standards such as the Declaration of Helsinki and ICH-GCP (Good Clinical Practice). In addition to initial approval, the ECs provide oversight throughout a clinical trial; Ethics Committees continually monitor for deviations from approved protocols, unforeseen risks, or adverse events that could compromise participant safety. They also act as a crucial checkpoint for amendments, ensuring that any proposed changes to the study continue to meet ethical and legal requirements. Ethics committees are the backbone of a responsible clinical research environment. They foster transparency and promote trust between researchers, participants, and the broader public. Without their oversight, the delicate balance between scientific advancement and participant protection would be at risk. These committees are critical in clinical research in keeping patient safety at the heart of every decision. #ClinicalResearch #EthicsCommittee #GCP #ClinicalTrials #ParticipantSafety

Hello Everyone!! I'm excited to share that I've completed Ethics and Review of Interventional Clinical Research course! This certification enhanced my understanding of ethics, Clinical Research techniques, tools, and best practices. I'm eager to apply these insights to real-world projects and continue growing in the field of Clinical Research. #ClinicalResearch #Ethics #WorldHealthOrganization

I recently learning about clinical research through Module 1 of the National Drug Abuse Treatment Clinical Trial Network's course. Here are some key insights, 🔬 Module 1, Institutional Review Boards (IRBs) 🔬 🔍 Part 1, What is an Institutional Review Board (IRB)? An IRB is essential for maintaining ethical standards in research. It ensures that the rights, welfare, and privacy of participants are protected throughout the study. 🎯 Part 2, Purpose of an IRB The main role of IRBs is to protect participants by ensuring that their rights and wellbeing are considered first in all decisions related to clinical trials. 🤝 Part 3, Membership of an IRB Understanding who makes up an IRB highlights the importance of having a variety of expertise and viewpoints. This diversity helps make informed and fair decisions on ethical matters in research. 📋 Part 4, Responsibilities of an IRB The various duties of Institutional Review Boards (IRBs) highlight dedication to maintaining ethical standards in research. Their careful work ensures that studies are conducted ethically. 📝 Part 5, Criteria for IRB Approval of Research Reviewing the criteria for IRB approval highlights how important thorough methods, safety measures, and informed consent are. Each element is crucial for conducting ethical research. ⏱️ Part 6, Expedited Review Analyzing expedited review procedures shows the available quick options for studies with low risk. It is important to keep a balance between speed and ethical thoroughness in these cases. 🤲 Part 7, Investigators' Responsibilities to the IRB Recognizing investigators' responsibilities emphasizes their cooperative relationship with IRBs. Being open and following rules are essential aspects of this partnership. Protocols are essential for conducting research. 🌐 Part 8, IRBs and Multisite Research Studying multisite research shows how important it is to have oversight in different places. IRBs are crucial in aligning ethical standards across various sites. 🔍 Focus on Ethics and Efficiency in Research 🔍 With our expertise in clinical research, we recognize the importance of IRBs in protecting ethics. As I delve deeper into Module 1 of my training, I'm interested in learning about your experiences and perspectives: 🌟 Question: 🌟 Have you come across or implemented any innovative methods or approaches to enhance the IRB approval process while ensuring that ethical standards are upheld? Let's share our ideas and work together to promote research practices that are both efficient and ethically sound. #ClinicalResearch #EthicalStandards #IRB #ResearchEthics #Innovation #Collaboration

Are you involved in research requiring human participation in any way? Then this pivotal Global Health Research Ethics course is for you! Enroll today! #training #competency #healthresearch #global #ethics #confidentiality #integrity #success

EU Clinical Trials / Ethical Review This publication (Open Access) offers a peek into the ethical review process of clinical research studies based on the example of the Medical Research Ethics Committee NedMec in the Netherlands. There are some valuable insights around the reasons for negative decisions issued in the past as well as more recently under the Clinical Trials Regulation: Heinsbroek, S. E. M., Bontrop, V., Chorus, R. P., & Zwaan, C. M. (2024). Issues in Clinical Studies Leading to Medical Research Ethics Committee (MREC) Negative Decisions. Journal of Trial & Error. https://lnkd.in/g3GJTvNM #ClinicalResearch #ClinicalTrials #EthicalReview #ResearchAssessment #MREC #CTR

🎉 Exciting News! 🎉 I am thrilled to announce that our IFCC Task Force on Ethics has published a paper focused on enhancing ethical standards in healthcare and research. Ethical checklists for clinical research projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings We aimed to create two ethical checklists to evaluate (i) the management of ethical concerns in research projects and (ii) the awareness of ethical conduct among healthcare laboratory professionals. The checklist for clinical research projects is designed to evaluate research proposals from an ethical standpoint before they are submitted to an Institutional Review Board (IRB) or equivalent. This tool is expected to reduce rejection rates and enhance the efficiency of research projects. In addition, the checklist for evaluating ethical conduct in laboratory medicine can be used for self-evaluation (internal audits) and during certification/accreditation processes by third parties. Congratulations to the entire team for their hard work and dedication. Let's continue to champion ethical practices in our field! 👏 --- #EthicsInHealthcare #ClinicalResearch #LaboratoryMedicine #EthicalStandards #HealthcareProfessionals #IFCC https://lnkd.in/d6NFGSCh

🌟 Proud to Announce Completion of Ethics Review of Health Research Course!! 🌟 I'm excited to share that I have successfully completed a course on the Ethics Review of Health Research. This training is crucial for medical professionals, especially in the field of Clinical Medicine. Understanding ethical guidelines ensures that our research and clinical practices uphold the highest standards of integrity and patient safety. In Transfusion Medicine, ethical considerations are vital for safeguarding donor and recipient rights, ensuring informed consent, and maintaining public trust in our practices. This course has deepened my commitment to ethical excellence in all aspects of my work. Looking forward to applying these insights to further enhance our research and clinical protocols. #EthicsInMedicine #TransfusionMedicine #MedicalResearch #ProfessionalDevelopment #HealthcareEthics #PatientSafety #InformedConsent #ResearchIntegrity #thebloodblog #bloodawareness #socialcause #ethics

Starting from 1 Aug24, the Health Research Authority (HRA) will implement the following changes to research studies reviewed by Research Ethics Committees (RECs) across the UK: # Removal of the requirement to submit annual progress reports # Changes to the submission process for safety reports These changes apply to anyone conducting research approved by a REC in England, Wales, Scotland, and Northern Ireland. What's Changing is that previously, from 1 June 2024, changes were made to streamline processes for researchers and staff in England and Wales. Study teams were no longer required to submit annual progress reports, and there were updates to how Suspected Unexpected Serious Adverse Reactions (SUSARS) and annual safety reports were acknowledged. Now, Scotland and Northern Ireland will implement these changes from 1 August 2024, aligning RECs throughout the UK. Changes to Annual Progress Reporting: To reduce the burden on researchers, the requirement to submit annual progress reports is being removed across the UK from 1 Aug. However, annual reviews must still be submitted to the Confidentiality Advisory Group (CAG) via IRAS, as per legislative requirements. Researchers must continue to report any changes that materially affect the ethics of an application as amendments. Researchers are still required to submit an end of study declaration and final study report to ensure the REC and the wider community are informed of research outcomes. Changes to SUSARS and Annual Safety Reports: Fatal and life-threatening SUSARS must continue to be reported to the MHRA and REC immediately. SUSARS and safety reports for CTIMPs approved by combined review should only be submitted to the MHRA. Other SUSARS or annual safety reports will be acknowledged by email, with no need for signed cover reports. What Happens Next: The HRA is updating its guidance to reflect these UK-wide changes, effective from 1 August 2024. Together with their Devolved Administration partners, they will monitor the impact to ensure these changes benefit staff, REC members, and applicants, while ensuring efficient resource use.

On October 19, 2024, during the 75th WMA General Assembly in Helsinki, Finland, the WMA unveiled the updated #DeclarationofHelsinki2024. As the WMA's most significant #policy statement, the Declaration of Helsinki has been a cornerstone of medical ethics since its initial adoption in 1964. This important document has undergone eight revisions to ensure it reflects contemporary ethical standards in medical research. 𝘏𝘦𝘳𝘦’𝘴 𝘢 𝘣𝘳𝘪𝘦𝘧 𝘰𝘷𝘦𝘳𝘷𝘪𝘦𝘸 𝘰𝘧 𝘪𝘵𝘴 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘵 𝘱𝘰𝘪𝘯𝘵𝘴: 1️⃣ 𝐏𝐮𝐫𝐩𝐨𝐬𝐞: Ethical guidelines for medical research involving human participants, including identifiable human material or data. 2️⃣ 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐏𝐫𝐢𝐨𝐫𝐢𝐭𝐢𝐳𝐚𝐭𝐢𝐨𝐧: Ensures that the rights and well-being of participants take precedence over scientific research goals. 3️⃣ 𝐈𝐧𝐟𝐨𝐫𝐦𝐞𝐝 𝐂𝐨𝐧𝐬𝐞𝐧𝐭: Free, informed consent is required for participation. Researchers must fully inform participants about the study, including risks, benefits, and the right to withdraw. 4️⃣ 𝐑𝐢𝐬𝐤 𝐚𝐧𝐝 𝐁𝐞𝐧𝐞𝐟𝐢𝐭 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭: Medical research can only be conducted if the potential benefits outweigh risks and burdens for participants. 5️⃣ 𝐕𝐮𝐥𝐧𝐞𝐫𝐚𝐛𝐥𝐞 𝐆𝐫𝐨𝐮𝐩𝐬: Special protections are in place for vulnerable populations to prevent exploitation and harm during research. 6️⃣ 𝐄𝐭𝐡𝐢𝐜𝐬 𝐂𝐨𝐦𝐦𝐢𝐭𝐭𝐞𝐞𝐬: Research must be reviewed and approved by independent ethics committees that evaluate the safety and integrity of studies. 7️⃣ 𝐔𝐬𝐞 𝐨𝐟 𝐏𝐥𝐚𝐜𝐞𝐛𝐨𝐬: Use is allowed only when no proven treatment exists or when it's methodologically necessary without risking serious harm to participants. 8️⃣ 𝐏𝐨𝐬𝐭-𝐓𝐫𝐢𝐚𝐥 𝐏𝐫𝐨𝐯𝐢𝐬𝐢𝐨𝐧𝐬: Arrangements must be made for post-trial access to beneficial treatments identified during the research. 9️⃣ 𝐂𝐨𝐧𝐟𝐢𝐝𝐞𝐧𝐭𝐢𝐚𝐥𝐢𝐭𝐲: Strict measures are in place to protect the privacy and confidentiality of participant data. 1️⃣ 0️⃣ 𝐏𝐮𝐛𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧: Results, whether positive or negative, must be publicly accessible, ensuring transparency in research findings. With the release of the #2024update, the WMA continues to uphold its commitment to ethical medical practice and the protection of research participants worldwide. #WMA #DeclarationOfHelsinki #clinicalresearch #clinicaltrial #gcp #safety

I am happy to share that I've completed the WHO certification on "Ethics and Review of Interventional Clinical Research" Understanding of Guidelines, Impact of Ethics on Research Design Awareness of Participant Vulnerability, Continuous Education Modules: 1. Introduction to ethics review of interventional clinical research 2. The product development pathway 3. Considerations in study design Interesting case studies #Clinicaltrails #Research #WHO #Certificate