Tiêu đề 9. COMPOSITION, RESPONSIBILITIES, PROCEDURES OF IRB.pdf ✅

PHARMD GURU Page 1 IRB is a regulatory authority that regulates all researchers, carried on human subjects. Its main objective is "conduction of research should be in accordance with other ethical principles". IRB/IEC RESPONSIBILITIES:  An IRB/IEC should safeguard the rights, safety and well-being of all trail subjects. Special attention should be paid to trials that may include vulnerable subjects.  IRB/IEC should obtain the following documents: 1) Trial protocol(s) 2) written information consent form(s) 3) subject recruitment procedures 4) Written information to be provided to subjects. 5) Investigator`s brochure (IB) 6) Information about payment and compensation available to subjects. 7) Available safety information, investigators current curriculum vitae (or) other documentation evidencing qualifications. 8) The IRB/IEC should review a proposal clinical trial within a reasonable time, and document its views in writing, clearly identifying the trial, the documents reviewing and the dates of the following:  Approval/favorable opinion.  Modifications required prior to its approval (or) favorable opinion.  Disapproval/negative opinion, and  Termination/suspension of any prior approval/favorable opinion.  The IRB or IEC should consider the qualifications of the investigator for the proposed withdrawal as documented by a curriculum vitae.  The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, at least once per year.  The IRB/IEC may request more information that be given to subjects when, in the judgment of IRB or IEC, the additional information would add meaningfully to the protection of the rights, safety and well being of the subjects. COMPOSITION, RESPONSIBILITIES, PROCEDURES OF IRB / IEC
PHARMD GURU Page 2  The IRB/IEC should review both the amount and methods of payment to subjects to assure that neither presents problems of coercion (or) undue influence on the trial subjects.  The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts and schedule of payment to trial subjects, is set forth in the written informed consent form. The way payment will be specified. COMPOSITION, FUNCTIONS AND OPERATIONS:  The IRB/IEC should consist of a reasonable number of members, who collectively have the qualification 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: 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:  Only those IRB/IEC members who are independent of the investigator & the sponsor of the trial should vote/provide opinion on a trial related matter.  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/IEC should make its decisions at announced meetings at which, at least a quorum, as stipulated in its overwritten operating procedures, is present.  Only members who participate in the IRB/IEC review and discussion should vote or provide their opinion or advice.  The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC (or) in the vote/opinion of the IRB/IEC  An IRB/IEC may invite non members with expertise in special areas for assistance.
PHARMD GURU Page 3 PROCEDURES: The IRB/IEC should follow its procedures, which should include: 1) Determining its composition (names and qualifications of the members) and the authority under which it is established. 2) Scheduling, notifying its members and conducting its meeting. 3) Conducting initial & continuing review of trials. 4) Determining the frequency of continuing review as appropriate. 5) Providing (Expedited) reviews, and approval/favorable opinion of minor changes in ongoing trials that have the approval/favorable opinion of the IRB/IEC. 6) Specifying that no subjects should be admitted to a trial before the IRB/IEC issues, its written approval or favorable opinion of the trial. 7) Specifying that no deviations from/changes of the protocol should be initiated without prior written IRB/IEC approval/favorable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects (or) when the changes involves only logistical (or) administrative aspects of the trial (Ex: changes of monitor(s), telephone numbers etc.). 8) Specifying that the investigators should promptly report to the IRB/IEC:  Deviations or changes of the protocol, to eliminate immediate hazards to the trial subjects.  Changes increasing the risk of subjects and/or affecting significantly, the conduct of the trial.  All adverse drug reactions (ADR`s) that are both serious and unexpected.  New information that may affect adversely, the safety of the subjects (or) conduct of the trial. 9) Ensuring that the IRB/IEC promptly notify in writing the investigator (or) institution concerning:  Its trial-related decisions/opinions.  The reasons for its decisions/opinions.  Procedures for appeal of its decisions/opinions.
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