Cebu Doctors' University Hospital Research Ethics Committee (CDUHREC) Table of Contents CDUHREC Organizational Chart Page 3 CDUHREC List of Members and Contact Details Page 4 Introduction Institutional Authority, Vision, Mission and Functions Page 5 SOP 1 Structure and Composition Page 6-10 SOP 2 Meetings Page 11-15 SOP 3 The Review Process for New Applications Page 16-22 SOP 4 Post-Approval Review Page 23-26 SOP 5 Review Fees Page 27 SOP 6 Documentation and Archiving Page 28-29 SOP 7 Writing and Revising SOPs Page 30-33 APPENDIX A1 Checklist for the Assessment of Clinical Trial Page 34-40 Protocol APPENDIX A2 Checklist for the Assessment of Informed Consent Page 41-43 Form APPENDIX A3 Risk/Benefit Assessment Form Page 44-45 APPENDIX A4 Scientific Evaluation of a Clinical Trial Protocol Page 46-47 APPENDIX A5 Study Protocol/ICF Amendment Submission Form Page 48-49 APPENDIX A6 Initial Submission Checklist (Sponsor’s Initiated Page 50 Study) APPENDIX A7 Initial Submission Checklist (Researcher Initiated Page 51 Study) APPENDIX A8 Confidentiality Agreement and Conflict of Interest Page 52-54 Disclosure (as Member of CDUHREC) APPENDIX A9 Confidentiality Agreement and Conflict of Interest Page 55-57 Disclosure (as external expert of CDUHREC) APPENDIX A10 Appointment Letter (Chair) Page 58 APPENDIX A11 Appointment Letter (Deputy Chair) Page 59 APPENDIX A12 Appointment Letter (Member) Page 60 APPENDIX A13 GUIDELINES Page 61-64 APPENDIX A14 Curriculum Vitae Page 65 APPENDIX A15 Training Record Page 66 CDUHREC Glossary Page 67-97 CDUHREC References Page 98 CDUHREC List of Acronyms Page 99-100 2 Cebu Doctors' University Hospital Research Ethics Committee (CDUHREC) Organizational Chart BOARD OF DIRECTORS PRESIDENT AND CHAIRMAN OF THE BOARD Dr. Potenciano S.D Larrazabal III MEDICAL DIRECTOR CLINICAL GOVERNANCE BOARD RESEARCH ETHICS COMMITTEE CHAIRPERSON Secretariat Deputy Chairperson Secretary Treasurer Memb ers 3 Cebu Doctors' University Hospital Research Ethics Committee (CDUHREC) List of Members The members of the Cebu Doctors' University Hospital Research Ethics Committee (CDUHREC) effective immediately until 31 December 2017: 1. Dr. Enrico B. Gruet Chair; Medical Doctor Contact no. +63 32 416 9341 2. Dr. Ma. Noemi A. Uy Deputy Chair; Medical Doctor Contact no. +63 32 416 9341 3. Mr. Nimrod N. Quiñones Committee Secretary, Journalist; Not affiliated with the Institution; Non-scientific member 4. Mrs. Lani B. Arcenal Treasurer; Nurse 5. Dr. Lamberto M. Garcia, Jr. Medical Doctor 6. Dr. Helen V. Madamba Medical Doctor 7. Atty. Allan Orvien Geotina Lawyer; Non-scientific member 8. Rev. Fr. Julius D. Pelarion Priest; Non-scientific member 9. Ms. Fabiana G. Sunit Teacher; Lay member; Not affiliated with the Institution; Non-scientific member 10. Ms. Quenie Mae Tiro Pharmacist CDUHREC Office Secretary: Divelyn Grace B. Paulino Office Hours: Mondays to Fridays 8:00am to 12:00 noon; 1:00 pm to 5:00pm Office Address: Ground Floor, CDUH Administrative Offices Building Cebu Doctors’ University Hospital Gov. M. Roa St. corner Don Jose Avila St. 6000 Cebu City, Philippines Office Telefax +63 32 416 9341 Email [email protected] 4 Cebu Doctors' University Hospital Research Ethics Committee (CDUHREC) Institutional Authority, Vision, Mission and Functions I. Institutional Authority The CDUHREC is a part of and operates under the authority of the Cebu Doctors' University Hospital (CDUH) Clinical Governance Board. It is responsible for the review and final approval of the human subject studies that would be conducted at Cebu Doctors' University Hospital, South General Hospital, North General Hospital, Mactan Doctors’ Hospital, San Carlos Doctors’ Hospital and Ormoc Doctors’ Hospital. II. Vision All research projects at CDUH involving human subjects are conducted according to the highest ethical standards. III. Mission To protect the psychological and physical welfare, rights, dignity and safety of participants in research, to facilitate ethical research through efficient and effective review processes, to promote ethical standards of human research and to review research in accordance with the National Ethical Guidelines for Health Research (2011), ICH-GCP, CDUH policies and local regulatory laws. IV. Functions 1. To provide independent, competent and timely review of research projects involving human subjects with respect to their ethical acceptability; 2. To provide ethical oversight, monitoring and advice for research projects involving human subjects; 3. To prescribe the principles and procedures that govern research projects involving human subjects, human tissue and/or personal records. 5 Cebu Doctors' University Hospital Research Ethics Committee (CDUHREC) SOP No. 1 Version No. 5 STRUCTURE AND COMPOSITION Version Date 15 Dec 2015 Effective Date 15 Dec 2015 I. Policy The procedures conducted by CDUHREC are based on the provisions of CDUH, national and international guidelines (WHO Operational Guidelines/CIOMS Guidelines/ICH GCP and the National Ethics Guidelines) II. Purpose The purpose of this section is to define the composition and process of appointment of members of CDUHREC. III. Document History SOP No. 1 (Institutional Authority, Objective & Functions of CDUHREC) Version 1 dated 01 June 2012 SOP No. 1 (Membership) Version 4 dated 9-July-2015, formerly SOP No. 2 version 1 dated 01 June 2012, version 2 dated 01 Apr-2013 and version 3 dated 01- Feb-2014 Final as SOP No. 1 (Structure & Composition) version 5 dated 15-Dec-2015 IV. Scope This Standard Operating Procedure applies to the membership of Cebu Doctors’ University Hospital Research Ethics Committee. V. Appointment of CDUHREC Members 1. Members are appointed as individuals rather than in a representative capacity. 2. The Chair, Deputy Chair and members are appointed by the CDUH Medical Director. 3. The conditions of their appointment include: a) Being compliant with the provisions of the WHO Operational Guidelines/CIOMS Guidelines/ICH GCP and the National Ethical Guidelines for Health Research (2011). Hard and soft copies of above guidelines are kept on file, accessible for use by any member. b) Preparing for and attending scheduled meetings; or if unavailable, providing comments c) Attending continuing education or training in research ethics at least every 2 years. All members are expected to attend introductory and continuing education and training (such as. Proof of training will be 6 kept on file. Reasonable costs associated with attendance of training and educations are met by the CDUHREC. To aide in the monitoring, a checklist will be provided and kept on file for each member on the trainings and continuing education attended and to be attended. d) An assurance of confidentiality on undertaking their appointment (all matters which they become aware of during the course of their work in the CDUHREC will be kept confidential). e) Declaration of any conflicts of interest, which exist at the time or which may arise during their tenure in the CDUHREC. This should be made to the Medical Director or at a CDUHREC meeting if the conflict of interest relates to a specific research project. 4. Members are appointed for a period of two years and may serve consecutive terms at the discretion of the CDUH Medical Director and Board of Directors. Members are advised when his/her term is about to expire. 5. Members may seek a leave of absence from the CDUHREC for extended periods. Steps shall be taken to fill the vacancy when necessary. 6. A member may be removed if he/she fails to attend at least fifty percent (50%) of all scheduled CDUHREC meetings in each year, barring exceptional circumstances. 7. A member may resign from the CDUHREC at any time upon giving notice in writing to the CDUHREC Chair and CDUH Medical Director. Steps shall be taken to fill the vacancy when necessary. VI. Workflow (Appointment) ACTIVITY RESPONSIBILITY Identify possible members including external CDUHREC Members experts ↓ Invite and Confirm CDUHREC Chair ↓ Endorsement CDUHREC Chair ↓ Appoint Medical Director ↓ Announce CDUHREC Chair ↓ File CVs in the membership file CDUHREC Office Secretary Detailed Instructions of the Steps based on the Workflow Step 1 – CDUHREC members will identify and recommend new members including external experts based on their qualifications and the needs of the committee. The qualifications considered are: scientific and medical expertise, for non-scientific members, those related to social, legal or cultural considerations, and gender balance Step 2 – CDUHREC Chair will invite and confirm the availability of possible members and the external expert 7 Step 3- CDUHREC Chair endorses the recruited member and the external expert for appointment by the medical director Step 4 – The Medical Director appoints the new members and the external expert based on the recommendations of the CDUHREC and endorsement of the Chair. The CDUHREC Chair will have the following responsibilities: prepares the agenda for each meeting; assigns a lead reviewer for all new study applications including a lead reviewer for the ICF; presides over the meeting; determines the kind of review that will be done, either full board or expedited; conducts expedited review together with the lead reviewer; assigns the Safety Report Reviewer and signs the Review Notification Letter. The Deputy Chair will take over the responsibilities of the Chair in his/her absence. The CDUHREC Secretary will be responsible for the keeping of record of attendance and taking the minutes of the meeting. When required, the CDUHREC may seek advice and assistance from an external expert to help review a clinical study. Such external expert shall have no conflict of interest. Such person(s) is required to provide an undertaking of confidentiality and is not entitled to vote on any matter. A standing list of external expert, as appointed by the Medical Director, is identified to provide special expertise to the EC on proposed research protocols. The external expert is required to attend the deliberation in the full board meeting. Their appointment is for a period of two years. Step 5 - The CDUHREC Chair announces to the committee the newly appointed member(s) and the external expert during the next monthly meeting Step 6 - The office secretary files the CV of the newly appointed member(s) and the external expert VII. Removal of Member (Workflow) ACTIVITY RESPONSIBILITY Identify none compliant member CDUHREC Secretary ↓ Confirm and Reports CDUHREC Chair ↓ Deliberates and Decides CDUHREC Members ↓ Furnish and Files Decision in the membership CDUHREC Office Secretary file Detailed Instructions of the Steps based on the Workflow Step 1 – CDUHREC Secretary will inform the Chair of the attendance of each member taking note of the absences. Step 2 – CDUHREC Chair will determine whether the said member has failed to attend at least 50% of the total meetings from his date of appointment. The Chair will then report to the body of said circumstance. Step 3 – The CDUHREC members will then deliberate on the matter afterwhich a resolution will be passed removing the said member. Step 4 - The office secretary will furnish the affected member the resolution and files the same in the membership files 8 VIII. Framework 1. There shall be a minimum of seven (7) members, with both genders represented, as follows: 1.1 a Chair; 1.2 a Deputy Chair; 1.3 a Secretary; 1.4 at least one member who is a lay person, who has no affiliation with the institution or organization, and who is not currently involved in medical, scientific, or legal work; 1.5 at least one member with knowledge of, and current experience in, the professional care, counseling or treatment of people; 1.6 at least one member who performs a pastoral care role in the community; 1.7 at least one member who is a lawyer; 1.8 at least one member with knowledge of, and current experience in, the areas of research that are regularly considered by the CDUHREC. 2. To ensure the membership equips the CDUHREC to address all the relevant considerations arising from the categories of research likely to be submitted, some or all of the above categories may be represented by more than one person. 3. Additional members may be appointed to ensure the CDUHREC has the expertise required to assess the applications submitted for review. If additional members are appointed, the composition of the CDUHREC shall continue to reflect the diversity and balance of its members, including gender and the relative proportion of institutional and non-institutional members, where possible. 4. The CDUHREC Office Secretary 1. The CDUHREC will hire a fulltime secretary. 2. The responsibilities of the CDUHREC office secretary are as follows: a. Preparing and issuing the schedule of CDUHREC meetings b. Preparing the draft agenda (with the CDUHREC Chair) for review/approval by the committee c. Ensuring completeness of documents for application prior to the committee review d. Informing the lead reviewers as assigned by the Chair e. Distributing the agenda and documents for review f. Notifying the principal investigator of the scheduled review g. Preparing the venue h. Recording apologies for absence prior to the meeting i. Recording attendance j. Ensuring that members have declared an interest in advance of the meeting and mentioning this interest at the beginning of the discussion of that item k. Making a written record of the meeting l. Preparing the minutes of the meeting for review and approval at the following meeting 9 m. Notifying applicants of decisions taken at the meeting and taking other follow-up action as necessary n. Filing and archiving records VIII. Compensation All members shall receive the following honorarium: 1. Five hundred pesos (Php500) for every committee meeting attended; 2. Two thousand five hundred pesos (Php2500) for every new protocol review; 3. One thousand pesos (Php1000) for every substantial/major amendment review. 10