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.

1. Welcome
Role of IRB and IEC in Safeguarding the Subjects
in Clinical Trials
A. Hemanth
B. Pharmacy
Student Id- 202/092023
10/18/2022
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2. Contents
• What is IRB & IEC.
• What are the responsibilities of IRB & IEC.
• When did IRB & IEC monitor clinical Trails.
• Other responsibilities of IRB & IRC.
• Team composition of IRB & IRC.
• Clinical trail decision by IRB & IRC.
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3. What is IRB or IEC
• Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
• The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as
a group formally designated to protect the rights, safety and well-being of humans involved in a
clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called
independent ethics committees (IECs).
• An unbiased frame created from medical, clinical, and non-medical members, whose obligation is
to make certain the safety of the rights, protection and properly-being of human subjects
concerned in an ordeal through, among different matters, reviewing, approving, and offering
persevering with assessment of trial protocol and amendments and of the strategies and cloth to be
used in acquiring and documenting informed consent of the trial subjects.
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4. Responsibilities of IRB or IEC
• An IRB/IEC must safeguard the rights, protection and well-being of all trial topics. Unique
attention have to be paid to trials that can encompass inclined subjects.
• The IRB/IEC evaluations the following documents: trial protocol(s)/amendment(s), written
informed consent form(s) and consent shape updates, subject recruitment strategies (e.g.
advertisements), written records to be provided to subjects, investigator’s brochure, safety data,
data approximately bills and reimbursement, investigator’s curriculum vitae, and some other
essential documents.
• The IRB/IEC need to assessment a proposed clinical trial within a affordable time and report its
perspectives in writing, sincerely figuring out the trial, the files reviewed and the dates for its
selection on approval
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5. • The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the
degree of risk to human subjects, but at least once a year.
• The IRB/IEC may request more information to be given to subjects when, in the judgment of the
IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and
well-being of the subjects.
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When did IRB or IEC monitor clinical Trails.

6. Other responsibilities of IRB or IRC.
• Where a non-therapeutic trial is to be carried
out with the consent of the subject’s LAR,
the IRB/IEC should determine that the
proposed protocol and /or other documents
adequately addresses relevant ethical
concerns and meets applicable regulatory
requirements for such trials.
• The IRB/IEC should determine that the
proposed protocol and/or other documents
adequately addresses relevant ethical
concerns and meets applicable regulatory
requirements for such trials.
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7. Team composition of IRB or IRC.
• The IRB/IEC should consist of a reasonable number of members who
collectively have the qualifications and experience to review and evaluate
the science, medical aspects, and ethics of the proposed trial. It is
recommended that the IRB/IEC should include:
1. At least 5 members
2. At least one member whose primary area of interest is in a non-scientific
area
3. At least one member who is independent of the institution/trial site.
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8. Clinical trail decision by IRB or IRC.
• The IRB/IEC should make its decisions at announced meetings at which at
least a quorum, as stipulated in its written SOP, is present.
• Only members who participate in the review and discussion should
vote/provide their opinion and/or advice
• The investigator may provide information on any aspects of the trial, but
should not participate in the deliberations or in the vote/opinion of the
IRB/IEC.
• An IRB/IEC may invite non-members with expertise in special areas for
assistance.
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9. ThankYou!
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