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Description : Institutional review board, also known as ethical review board is a group that has been formally designated to review and monitor biomedical research involving human subjects.

Tags : Pharma,ethical review board,IRB Process flow

Published on : Mar 26, 2024 | Views : 341 | Downloads : 0

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1 Institutional Review Board/ Independent Ethics Committee(IRB/IEC) Presented by: Dr. Rashmi Jaiswal (MHA) Enrollment No: A13234023034 Presented to : Dr. Rimpy Pahwa Asst. Professor (Clinical Trials and Healthcare policies) Amity University, Noida
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List of Content Introduction History Composition Responsibilities Working procedures Criteria for IRB approval Maintenance of records Summary 2
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Introduction Institutional review board, also known as ethical review board is a group that has been formally designated to review and monitor biomedical research involving human subjects. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. Main purpose is to protect the rights, safety and well being of the subjects who participate in a trial 3
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History During the 20th century, as research involving human subjects became more common, there were some appalling instances in which the most basic rights of individuals were violated, and serious harm was done to them. The most infamous examples were the Nazi biomedical experiments during World War II, and the Tuskegee Syphilis Experiment from 1932 to 1972. 4
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The National Research Act of 1974, passed in response to growing concern about the ethics violations in research, created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Three foundational principles were: Respect for persons. This principle includes both respect for the autonomy of human subjects and the importance of protecting vulnerable individuals. Beneficence. More than just promotion of well-being, the duty of beneficence requires that research maximize the benefit-to-harm ratio for individual subjects and for the research program as a whole. Justice. Justice in research focuses on the duty to assign the burden and benefits of research fairly. 5
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Composition An IRB is the committee constituted of medical professionals and non medical member of a group who go through research protocol and state whether or not it is ethically acceptable. As per guidelines, IRB should consist of 5 members: One member whose primary concern is scientific area. One member who is not affiliated with institution. One member whose primary concern is non-scientific area All members should not be of same gender 6
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Responsibilities of IRB/IEC It safeguard the rights, safety, and well being of all trial subject. It Reviews a proposed clinical trial within a reasonable time and document its view in writing. Conducts continuing review of each ongoing trial at least once per year. Provide advice to the researchers on all aspects of welfare and safety of research participants. Confirms there are no unreasonable risks Assess suspected or alleged protocol violations. 7
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IRB Process flow 8
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Working procedure The IRB should establish a document in writing Determine composition and source of authority under which it is established Notify members and conduct meeting Conduct initial and continuing review Determine frequency of continuing review 9
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Provide review mechanism for minor changes Specify that no subject may be enrolled and no deviation before approval Specify that the investigator promptly reports protocol or changes or deviation, increased risk to the subject Promptly notify in writing the investigator/ institution about its decision, reasons for its decision, and procedures for appeal 10
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Criteria for IRB approval of research Risks to subjects are minimized Risks to subjects are reasonable in relation to anticipated benefits Selection of subjects is equitable (impartial) Informed consent will be sought from each prospective subject Informed consent will be appropriately documented When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 11
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Maintenance of records IRB/IEC retains all relevant records for at least three years after completion of the trial Written procedures List of occupations, affiliations of members Submitted documents Minutes of meetings IRB/IEC may ask the investigators, sponsors, or regulatory authorities to provide copies of its written procedures and memberships lists. 12
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Summary The main aim to establish IRB is to protect the rights and welfare of human research subjects recruited to participate in research activities/ clinical trials. Over the four decades since IRBs were codified into regulations, IRB review and oversight has developed and matured as part of a robust system that provides “substantial protections for the health, rights, and welfare of research subjects. Independent IRB review ensures that ethical principles are followed and adequate and appropriate safeguards are in place to protect human subjects’ rights and welfare, while they contribute to ethically and scientifically rigorous research. This support progress in clinical research, public trust in the enterprise, and protection of the participants that make research possible. 13
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Reference https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631034/ https://www.youtube.com/watch?v=hwKgIhNg1dU https://journalofethics.ama-assn.org/article/history-and-role-institutional-review-boards-useful-tension/2009-04 https://www.csuci.edu/rsp/committees/irb/irb-history-and-role.htm https://webstor.srmist.edu.in/web_assets/srm_mainsite/files/downloads/Composition_Responsibilities_Procedures_IRBIEC.pdf https://journalofethics.ama-assn.org/article/history-and-role-institutional-review-boards-useful-tension/2009-04 https://en.wikipedia.org/wiki/Institutional_review_board https://research.virginia.edu/sites/vpr/files/2019-08/07-04-Criteria-for-IRB-Approval-of-Research.pdf 14
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Thank You 15