The purpose structure and function of institutional ethics

The purpose, structure, and function of institutional ethics committees group 01 week 10

GROUP MEMBERS OF GROUP 01 KIU • KATAZA D HAJJI BMS/0017/143/DU • OBII-UZOMA TOCHUKWU BMS/0022/141/DF • BLESSING JOSGUA BMS/0021/151/DF • SSEBAGGALA ELIJAH BMS/0023/143/DU • MOHAMED S RASHID BMS/0025/152/DF • GYET HENRY INNOCENT BMS/0029/151/DF • ASKAR MOGE BMS/0031/152/DF • WAZIRA S ADAM BMS/0043/151/DF • BUSOBOROZI PATRICK BMS/0044/151/DF • HARUNA YAKASSAI A BMS/0046/151/DF • TUMWINE STEVEN BMS/0071/143/DU • MAMMEN G PRECIOUS BMS/0075/151/DF • ATWINE NACY BMS/0086/143/DU • SALAAMU FRANCIS BMS/0104/151/DU • MUGYEMA DAVID BMS/0151/143/DU • MANIRADUKUNDACHRISTIAN BMS/0217/123/DU • MUSOKE NICHOLAS BMS/0235/143/DU • EDEKET JOHN PAUL BMS/0397/143/DU

Question ? The purpose, structure, and function of institutional ethics committees

INTRODUCTION Institutional Ethics Committee- independent body constituted of medical/scientific professionals and non-medical/non-scientific members to ensure protection of the rights and welfare of human subjects participating in clinical trials and to provide public reassurance, inter alia, by previewing trial protocol and many others as defined by WHO They might have different names at different instiutions e. g v. Independent Ethics Committee v. Institutional Review Board (IRB) v Institutional Ethics Committee(IEC)

PURPOSE • IRBs ensures a competent review of all the ethical aspects of project proposals received by it in an objective manner free from any bias and influence • IRBs provide advice to researchers on all aspects of welfare and safety of research participants after ensuring the scientific soundness • IRBs may take up the dual responsibility of review of both, the scientific content and ethical aspects of the proposal. It is advisable to have separate Committees for each ( scientific review precedes the scrutiny for ethical issues)

Functions of institutional ethics committees Main responsibilities of an IRB can be defined as follows: v To protect the dignity, rights and well being of the potential research participants v. To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs v. To assist in the development and the education of a research community responsive to local health care requirements

Additional functions of institutional ethics committees No Clinical Trial should be initiated with out obtaining a written approval by the IRB. The IRB should obtain the following documents; 1) Trial protocols/amendments 2) Written informed consent forms and consent form updates that the investigator proposes for use in the trial 3) Subject recruitment procedures like advertisements 4) Written information to be provided to subjects 5) Investigator’s Brochure (IB) 6) Available safety information 7) Information about payments and compensation available to subjects 8) The investigator’s current CV and other documentation evidencing qualifications 9) Any other documents that the IRB may need to fulfill its responsibilities

Additional functions of institutional ethics committees The IRB should review a proposed trial within a reasonable time and document its views in writing for the following v. Approval/ favorable opinion v. Modifications required prior to its approval/ favorable opinion v. Disapproval / negative opinion v. Termination / suspension of any prior approval/ favorable opinion

Additional functions of institutional ethics committees v. IRBs should consider qualifications of investigator by a current CV or other relevant documentation v. IRBs should conduct continuing review at intervals appropriate to degree of rick, but at least once per year. The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals v. The IRBs may request more information to be given to subjects when the additional information would add meaningfully

Additional functions of institutional ethics committees v. When Non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable representative, IRB should determine that relevant ethical concerns and applicable regulatory requirements are met v. Where prior consent not possible, the IRB should determine that relevant ethical concerns and applicable requirements are met like in emergency situations v. IRB should review both amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on trial subjects v. IRB should ensure that information regarding payment to subjects is set forth in written informed consent form and any other written information to be provided to subjects, The way payment will be prorated should be specified

Record Keeping All documentation and communication of an IRB are dated. Filed and preserved according to written procedures, strict confidentiality maintained. Records should be maintained for the following i. Constitution and composition of the IRB ii. CV of all the IRB members iii. Standard Operating procedures of the IRB iv. National and International guidelines v. Copies of the protocol, data collection formats, investigational brochures and many others, that are submitted for review vi. All correspondence with IRB members and investigators regarding application, decision and follow up vii. Agenda of all IRB meetings viii. Minutes of all IRB meetings with signature of the Chairperson ix. Copies of decisions communicated to the applicants x. Record of all notification issued for premature termination of a study with a summary of the reasons xi. Final report of the study including micro films, CDs and video-recordings Records must be safely maintained after termination of the study for at least a period of 3 -5 years

STRUCTURE v IRB should be multidisciplinary and multi-sectorial in composition v. The number of persons kept fairly small like 5 -7. But the minimum should be 5, however there is no specific recommendation for maximum number of persons, Noting too large committee will make it difficult in reaching consensus opinion v. The Chair person of the committee should preferably be from outside the institution and not head of the same institution to maintain independence v. The Member Secretary generally belongs to the same institution should conduct the business of the Committees

STRUCTURE The composition may be as follows as per Schedule Y Amendment 2005 a) b) c) d) e) f) g) h) Chairperson 1 -2 basically medical scientists( preferably one pharmacologist) 1 -2 clinicians from various institutes One legal expert or retired judge One social scientist/ representative of non-governmental voluntary agency One philosopher/ethicist/ theologian One lay person from the community Member Secretary

MEMBERSHIP REQUIREMENTS üDuration of appointment is initially for a period of 2 -3 years üAt the end of 2 -3 years committee is reconstituted. And 50% of the members will be replaced by the defined procedure üA member can be replaced in the event of death or long term nonavailability or for any action not commensurate with the responsibilities laid down in the guidelines deemed unfit for a member üA member can tender resignation from the committee with proper reasons üAll members should maintain absolute confidentiality of all discussions

REVIEW PROCESS PERIODIC REVIEW- at regular intervals of six months to one year as may be specified in the Standard operating procedures CONTINUING REVIEW-approved projects for continuation, new information, adverse event monitoring, follow up INTERIM REVIEW- can be resorted to instead of waiting for the scheduled time of the meeting, However decisions taken should be brought to the notice of the main committee.

ADMINISTRATION AND MANAGEMENT ØA full time secretariat and space for keeping records is required ØThe members could be given a reasonable compensation for the time spared for reviewing the proposals ØA reasonable fees can be charged to cover the expenses related to review and administrative processes

References • Healthcare Encyclopedia, Healthcare resources, institutional ethics committees • John M. Freeman, M. D, Tough Decisions: Cases in Medical Ethics, 2 nd Edition, Oxford University Press, 2001 • Pence Gregory E; Classic cases in medical ethics; accounts of cases that have shaped medical ethics, with philosophy, legal and historical backgrounds, third edition, 2000 • Medical Ethics Manual, John. R. Williams, World Medical Association. Inc. 3 rd edition 2015