STANDARD OPERATING PROCEDURES

Transcription

1 Institutional Review Board STANDARD OPERATING PROCEDURES CONSTITUTING THE ETHICS REVIEW COMMITTEE FOR BIOMEDICAL RESEARCH SOP Number 001 Version No. 1.0, September 2012 SOP Status Final Effective by : October 2012 Author Gemiliano D. Aligui, MD, MPH, PhD Page 1 of 9 Name Signature Date Reviewed by: Approved by TMC-IRB en banc, MQIO, PSDO Eugenio Jose F. Ramos, MD, MBAH 1. PURPOSE This standard operating procedure (SOP) intends to describe the Institutional Review Board, its function, composition, membership requirements, and process of recruitment and terms of reference for the committee members who perform the technical and ethical review of the biomedical research in The Medical City. 2. SCOPE This SOP covers the selection and discipline of members of the IRB, the appointment of the independent consultants as well as assignment of support staff vested on the power to appoint of the SVP-MSG. 3. ETHICAL BASIS OF IRB FUNCTIONS It is the responsibility of each member of the IRB to read and understand the provisions of this SOP, apply and adhere to the policies and principles of referred to in the conduct of research ethics review. For each member and of the independent consultant, understanding is required for a thorough technical review which can then extend to the ethical issues. It is also the responsibility of the support staff to understand the mechanics and operational nature of the Institutional Review Board in order to be efficient and methodical in the review of submitted protocols Ethical Basis of IRB Functions: The conduct of review and decisions made by the IRB on each research proposal or protocol are guided by the Declaration of Helsinki (1964 and subsequent revisions, 2008), the International Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 1983 and subsequent revisions, 2002), the International Conference on Harmonization - Good Clinical Practice (ICH-GCP, E6, R1) for clinical research protocols, and the National Ethical Guidelines for Health Research (2011).

2 Page 2 of 9 4. ORGANIZATIONAL SETUP 4.1. The TMC-IRB is a committee under the Office of the Executive Vice President for Medical Services (SVP MSG) and is accountable to the Head of the Medical Services Group. The SVP MSG is responsible for appointing the Chair and the Co-Chair of the IRB, approving the budget of IRB as well as fully implementing the institution-wide policies enacted by the IRB as an independent committee. The power vested on the SVP MSG as an appointing authority does not imply control of the decisions of the IRB. To maintain independence of the IRB, the SVP MSG cannot participate in any decision making or proceedings of the TMC- IRB. However, it is the duty of the SVP MSG to inform the IRB of any reported misconduct among the appointed members of the IRB and disciplinary action that will be taken against any member after due process. Medical Services Group Credentialing Office Institutional Review Board Clinical Department Professional Staff Development Office Medical Quality Improvement Office Medical Management and Services Dept 5. ROLES AND RESPONSIBILITIES OF THE IRB 5.1. The primary role of the IRB is to safeguard the rights, dignity and welfare of the human participants in any biomedical research undertaken in The Medical City. This role essentially establishes public trust and by virtue of this responsibility vested on the IRB, it must undertake the following: Develops policies, procedures, criteria for the review, evaluation, continuation, suspension and termination of biomedical research protocols involving human participants; that all participants in a biomedical research are duly protected of their rights according to the national and international guidelines for research ethics. This is ensured by a thorough review of each proposal in terms of technical soundness and ethically acceptable processes of biomedical research conduct.

3 Page 3 of Develops the Standard Operating Procedures (SOP) to support the process of review, guidelines amendments and SOP amendments as the case maybe Reviews and evaluates protocols within a reasonable time and communicates the decision in writing Imposes modifications to conform to ethical principles to secure approval. To withdraw approval in matters of grave ethical misconduct or when the life of any human research participant is endangered by any biomedical process involving an investigational drug or procedure Ensures acceptability of the research proposals according to community mores, values and needs Ensures that each protocol is conducted by duly qualified and competent researcher who are oriented and certified according to GCP guidelines Ensures that each proposal has a properly written informed consent and/or properly translated Recommend to the VP MSG any disciplinary action for an investigator who deliberately violated ethical standards, after due process Setup system and mechanisms to ensure education of members of the IRB Develops mechanisms for the monitoring research outcomes by requiring proponents to submit a terminal report, reports of adverse events and new information that may impact on the safety and welfare of the research participants Develops a combination of systematic technical and ethical process of review of the protocol and other relevant documents focused on the following: Technical soundness of the protocol which includes the biomedical, methodical and statistical procedures; that the benefits of the research to the participants or to society in general is justified by the risks the participants are exposed to; Recruiting procedures; procedures for obtaining informed consent; persons from whom consent will be obtained;

4 Page 4 of completeness of the elements found in the information sheets; appropriateness and accuracy of translation of the English consent into the dialect by reviewing the back translation document; appropriateness of incentives or payments and how this will be done; measures taken to protect the privacy of the participants and ensure confidentiality; provision of treatment for any adverse or serious adverse events for the duration of the study and the availability of a trial insurance or indemnification fund for the trial participants; in the case of clinical trials in support of licensure, that steps will be taken to ensure that the effective intervention identified from the research will be provided to the study community or any other negotiations to be done Composition of the IRB: The members of the IRB shall be at least eight (8) At least 2 members of the IRB will not be affiliated with The Medical City and will either be from the community or non-medical sector or religious sector The rest of the members of IRB will be affiliated with The Medical City and will have the following background: epidemiology/public health, social science, clinicians, and law Membership Requirements: The SVP MSG or the Director of the MQIO (Medical Quality Improvement Office) may directly invite an individual to become an IRB member Any member may nominate or recommend an individual to be a member of the IRB in case of vacancy or imminent resignation of a member. This nomination shall be communicated to the Chair or to the SVP MSG, through the Chair of the IRB, in a letter of recommendation The Chair of IRB can write a letter of invitation to any individual and subsequently recommend to the SVP MSG.

5 Page 5 of The IRB member shall be selected on the basis of the following: Competencies in their field of interest or specialty or representativeness of sector of society or community; Interest in research ethics and willingness to be educated in research ethics; Willingness to be appointed for at least three (3) years, or for as long as necessary in the interest of The Medical City; A balance of composition to retain old members and invitation for new members Each member must file an updated and signed curriculum vitae, to be filed in a binder, appropriately labeled for this purpose. All training certificates of each member shall be filed in the same folder Resignation, Disqualification and Replacement of Members: An IRB member may resign at any time during his/her term of appointment. This has to be communicated to the Chair in writing, preferably two months notice to give time for a suitable replacement A member of the IRB may be asked to resign on allegations of misconduct or research misconduct after a due process Replacement of a member who signed or who intends to resign (see Item 6.3). This can be done anytime to preserve quorum requirements Chairs of the IRB: The Chair of IRB shall set the agenda and preside all IRB meetings The Co-Chair presides in the absence of the Chair The Chair and Co-Chair are appointed for a term of 3 years and renewed for as long as the Chair is willing. Members can confer among themselves to decide who may agree to be appointment as Chair and Co-Chair The Chair or Co-Chair, performs an initial review and determines if the proposal should be reviewed by the IRB as full review (en banc) or as expedited review (2 members, 1 technical and 1

6 Page 6 of 9 ethical). The Chair or Co-Chair has the prerogative to assign a primary technical reviewer and primary ethics reviewer The Chair presides in all full reviews The Chair/Co-Chair ensures that all members of the IRB are oriented with IRB policies, procedures, and SOPs The Chair/Co-Chair communicates all matters of institutional research policies to the VP MSG in coordination with MQIO, agreed upon by the IRB for consideration and approval The Chair/Co-Chair ensures the IRB s accreditation and recognition by local and international bodies Secretary-Member of the IRB: A Secretary-Member shall be appointed from among the members of the IRB and shall act as the person to attend to all documentations of the IRB Ensures that the SOPs are applied appropriately Ensures a coordinated schedule of IRB meeting and initial count of members for purposes of determining a quorum SAE Monitoring Officer: A member, qualified by pharmacy/pharmacology background will act as person who shall provide analysis of SAEs and SUSARS, to recommend actions which are forwarded to the Secretary for presentation to the IRB Responsibilities of the IRB Members: Attend TMC-IRB meetings regularly, either for the purpose of reviewing research protocols, discussing and deciding on relevant ethical issues or information update Participate in the review and evaluation of research protocols either in its full or expedited review Act or decide on reviewed research protocols (i.e. approves, disapproves, or requires modifications, etc.) based on agreed criteria Participate in the monitoring of approved protocols.

7 Page 7 of The IRB Secretary: Attend meetings, seminars, workshops and conferences which will upgrade their competencies in the performance of their duties as TMC-IRB member Declare any conflict of interest on any of the research protocols he/she reviews Maintain confidentiality of the documents and deliberations of TMC-IRB meetings Participate in the evaluation of serious adverse events as they are presented to the IRB by the Secretary Review the technical and ethical aspects of the proposal according to accepted guidelines and norms set by the TMC and IRB as well as the relevant laws and regulations of the Philippines This is a Clerical Secretary or Administrative Assistant or a Research Assistant who is knowledgeable with the process of ethical review Prepares all relevant communications and documents of the IRB under the supervision of the Secretary-Member Prepares IRB meeting agenda and minutes Records and summarizes the findings and decisions of the IRB The clerical secretary is designated as the Clinical Research Administrative Assistant with a regular appointment processed by the Human Resource Department of The Medical City. 6. QUORUM REQUIREMENTS OF THE IRB 6.1. The Medical City Institutional Review Board is a combination of technical and ethical reviewers The quorum is established as presence half of the total members plus one member of the currently appointed members of the IRB. 7. VOTING PRIVILEGES 7.1. Each member will constitute one vote A consensus is the default manner of decision making. However, a majority vote is the rule on whether to grant or deny approval for a protocol if a consensus is not reached by the IRB.

8 Page 8 of Independent consultants have no voting privileges for a particular research protocol. 8. INDEPENDENT CONSULTANTS OR RESOURCE PERSONS: 8.1. The IRB shall maintain a pool of consultants for each specialty, relevant to the types of specialties that are reviewed by the TMC-IRB, to be recommended by the Chair or by the Director of the Medical Quality Improvement Office (MQIO) or the VP of the MSG or by the TMC Department Chair. These appointing officers have adequate backgrounds of the consultants for their experience and level of expertise The consultants will review the protocol based on the need to get an independent opinion on specific protocols. These are those involving a specialty or a combination of several specialties in cases of a multi-specialty protocol Independent consultants are also required in case a serious adverse event arise in an approved protocol wherein an expert opinion is required. This is assumed to be required even after the initial review has been done by the independent consultant The independent consultant shall be assigned for specific protocol review. The Medical City consultants pool shall provide the resource persons who will be appointed by the SVP MSG. However, the medical pool member will serve as a non-voting member of the TMC-IRB. The roster of independent consultants will be kept in the TMC-IRB folder together with their updated CVs and appointment papers. 9. DISSOLUTION OF THE IRB 9.1. The IRB may be dissolved by the SVP MSG after due process The IRB is automatically dissolved if The Medical City ceases to exist. 10. RELATIONSHIP OF THE TMC-IRB WITH THE PHILIPPINE HEALTH RESEARCH ETHICS BOARD (PHREB), THE FORUM FOR ETHICAL REVIEW COMMITTEES IN ASIA AND THE WESTERN PACIFIC (FERCAP) The Medical City IRB recognizes the Philippine Health Research Ethics Board (PHREB) as the highest body in the Philippines that governs and establishes the ethical conduct of research in the Philippines and will abide by its policies The Medical City IRB recognizes the FORUM for Ethical Review Committees in Asia and the Western Pacific (FERCAP) as the international body that grants recognition to IRBs in the ASEAN Region The TMC-IRB is independent of other IRBs and proposals already approved in other institutions will have to undergo review by the TMC-IRB even if the protocols/proposals have been approved by those institutions.

9 Page 9 of SUPPORT STAFF (THE IRB SECRETARY) The support staff for the TMC-IRB shall be appointed. A clerical support staff shall have a term of appointment based on the assignment made by the Director of the Medical Quality Improvement Office (MQIO) who will provide the administrative plantilla for the job. This person shall be assigned under the Chair of the TMC-IRB but the day-to-day supervision shall be with a designated MQIO senior staff. The clerical support shall be designated as a position compatible with a research assistant salary grade and designation. The Term of Reference (TOR) of the staff shall be filed with the folder of the TMC-IRB together with the members of the Committee. A valid appointment with the TOR shall be filed in the same folder. 12. FLOWCHART ACTIVITY Constituting the IRB, based on international and local guidelines. Define TMC OPM 17, Chapter 2, TMC Institutional Review Board Assignment of support staff Prepare terms of reference for the IRB Send membership invitations Confirm membership requirements and agreement of selected members Prepare appointment papers of members Appoint members of the IRB. RESPONSIBLE PERSON SVP,MSG/MQIO/Research Office Head Research Office Head IRB Secretary IRB Secretary IRB Secretary IRB Secretary SVP,MSG REFERENCES 1. World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, Philippine National Health Research System, National Ethical Guidelines for Health Research, PCHRD-DOST, 2011