STANDARD OPERATING PROCEDURES

Transcription

1 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURES 2013 Edition

2 INSTITUTIONAL ETHICS REVIEW COMMITTEE Standard Operating Procedures INTRODUCTION to the Second Edition The Research and Biotechnology Division (RBD) of St. Luke s Medical Center (SLMC), from its beginnings in 1995, has recognized the need to uphold the highest standards of ethics in research. This second edition of the Standard Operating Procedures of the Institutional Ethics Review Committee (IERC) is the culmination of several months work to integrate the best practices in the ethical review of clinical research at the St. Luke s. Revisions to the First Edition were made as an offshoot to recommendations made during the survey prior to the recognition given by the Forum for Ethics Review Committees in Asia and Western Pacific (FERCAP) in November Incorporating international standards and regulations on which to base the ethical review process assures that research at St. Luke s maintains a leading edge in upholding integrity and protection of human subject rights at all phases and in any type of clinical research It will be a valuable aid to guide and implement excellence in institutional research, leading us towards becoming an internationally recognized academic medical center by 2020 under the leadership of SLMC President and CEO Dr. Edgardo R. Cortez. In 2012, members of the St. Luke s IERC and RBD support staff, together with the Vice-President of RBD, held a series of writeshops to draft out all the required standard operating procedures employed to date. During this time, the authors of this handbook assiduously reviewed the evolution of research ethics review from its beginnings with the Helsinki protocols to the current global advocacy of informed subject participation and discernment of sociocultural norms. They drew from their vast experience of training and education in Good Clinical Practice courses through the years. Thus, this handbook is the product of a mature assessment and critical appraisal of the best practices in the implementation of ethical review and operations of the review committee and its support offices. This has been made possible through the unstinting support and insightful perspective of the present IERC Chair, Dr. Prospero Ma. C. Tuano, who shared his valuable time and wisdom for the completion of this manual. As SLMC gears up to intensify research throughout its various sectors, we envision the IERC to perform its review function seamlessly, with diligent adherence to the precepts of these SOPs. The goal is to raise the bar of human subject research in SLMC and to serve as the benchmark for Ethics Review Committees in the country to improve clinical outcomes for the benefit of our patients and all Filipinos. FILIPINAS F. NATIVIDAD, PhD Executive Secretary St. Luke s Institutional Ethics Review Committee SL-IERC SOP 2013 V2 2

3 INSTITUTIONAL ETHICS REVIEW COMMITTEE Standard Operating Procedures I hereby submit this Revised Manual (2 nd ed,2013) of the St. Luke s-institutional Ethics Review Committee Standard Operating Procedures (SL-IERC SOPs) to be the official guide of the Institutional Ethics Review Committee of St. Luke s Medical Center. FILIPINAS F. NATIVIDAD, PhD Executive Secretary St. Luke s Institutional Ethics Review Committee I hereby recommend acceptance of this Revised Manual (2 nd ed, 2013) of the St. Luke s- Institutional Ethics Review Committee Standard Operating Procedures (SL-IERC SOPs) to be the official guide of the Institutional Ethics Review Committee of St. Luke s Medical Center. PROSPERO MA. C. TUAŇO, MD Chairman St. Luke s Institutional Ethics Review Committee This Revised Manual (2 nd ed, 2013) of the St. Luke s Institutional Ethics Review Committee Standard Operating Procedures (SL-IERC SOPs) is hereby officially accepted to serve as a guide of the Institutional Ethics Review Committee of St. Luke s Medical Center. EDGARDO R. CORTEZ, MD, FPCS, FACS President and CEO St. Luke s Medical Center SL-IERC SOP 2013 V2 3

4 INSTITUTIONAL ETHICS REVIEW COMMITTEE Sop Table Of Contents I. SL-IERC STANDARD OPERATING PROCEDURES CHAPTER STANDARD OPERATING PROCEDURE (SOP) TITLE PAGE 1. Preparation of SOPs and Guidelines for the Institutional Ethics Review Committee (IERC) 1.1. Preparation and Amendment of SOPs Preparation Guidelines on SOPs 1.3. Documentation Control System of SOPs SOPs of the Institutional Ethics Review Committee (IERC) 2.1. Composition, Duties and Responsibilities of the SLMC QC & GC IERC Confidentiality Agreements and Conflict of Interest Disclosure Training of IERC Members and Staff Resource Persons Honorarium of IERC and Appointment, Duties and Responsibilities of Executive Secretary and IERC Procedures for Initial Protocol Submissions and Ethical Review 3.1. Initial Protocol Submissions 3.2. Initial Submission of Application through the Web portal Preliminary Review By IERC Members Prior to Presentation Full Board Review of Protocols 3.5. Expedited Review. 4. Continuing Review and Monitoring of Protocols 4.1. Review of Protocols That Require Major Revisions after Presentation Review of Protocol Amendments Progress Reports for Continuing Review Assessment of Serious Adverse Events Early Termination of Clinical Trials Due to Protocol Deviations/Violations 4.6. Site Visit.. 5. Administrative Procedures 5.1. Preparation of Notice of Meeting and Agenda 5.2. Preparation and Distribution of Minutes of Meetings 5.3. Emergency/Special Meetings Preparation for a Regular Meeting Conduct of a IERC Meeting Management of Communications Management of Administrative Files, Logbooks and Forms SL-IERC SOP 2013 V2 4

5 II. LIST OF SL-IERC FORMS FORM DESCRIPTION FORM # 1. Agreement on Confidentiality and Conflict of Interest Form SL-IERC FORM#01A 2. Agreement on Confidentiality and Conflict of Interest Form (for Preliminary Reviewer) SL-IERC FORM#01B 3. Initial Protocol Review Submission Form SL-IERC FORM#02 4. Initial Protocol Review Submission Acknowledgment Form SL-IERC FORM#03 5. CT Tracking Form SL-IERC FORM#04 6. Technical Review Form SL-IERC FORM#05A 7. Ethics Review Form SL-IERC FORM#05B 8. Notice of Meeting SL-IERC FORM#06A 9. Notice of Emergency Meeting SL-IERC FORM#06B 10. Invitation to Present SL-IERC FORM # IERC Attendance Sheet SL-IERC FORM #09A 12. Attendance Sheet for Presentors SL-IERC FORM #09B 13. Principal Investigator s Responsibilities SL-IERC FORM # Notice of Action SL-IERC FORM #12A 15. IERC Composition SL-IERC FORM #12B 16. Ethical Clearance SL-IERC FORM#13A 17. Request for Ethical Clearance Renewal SL-IERC FORM#13B 18. Ethical Clearance Renewal Form SL-IERC FORM#13C 19. SAE Form SL-IERC FORM#14A 20. SAE Tracking Form SL-IERC FORM#14B 21. Protocol Deviation/Violation SL-IERC FORM# Continuing Review Report Form SL-IERC FORM# Agenda Template SL-IERC FORM# Minutes of the Meeting Template SL-IERC FORM# Final Report Form SL-IERC FORM#19 III. GLOSSARY.... IV. REFERENCES. SL-IERC SOP 2013 V2 5

6 INSTITUTIONAL ETHICS REVIEW COMMITTEE Preparation of Standard Operating Procedures (SOPs) and Guidelines for the Institutional Ethics Review Committee(IERC) Document History REVIEW REVISION REASON FOR NO. DATE NONE NO. REVISION REVIEWED BY APPROVED BY REVISED EFFECTIVE DATE For compliance with FERCAP surveyors suggestions FILIPINAS F. NATIVIDAD, PhD Executive Secretary IERC Chair April 2013 SL-IERC SOP 2013 V2 6

7 INSTITUTIONAL ETHICS REVIEW COMMITTEE CHAPTER 1 Preparation of Standard Operating Procedures (SOPs) and Guidelines for the Institutional Ethics Review Committee (IERC) 1.1. Preparation and Amendment of SOPs 1.2. Preparation Guidelines on SOPs 1.3. Documentation Control System of SOPs SL-IERC SOP 2013 V2 7

8 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Preparation and Amendment of SOPs SL-IERC SOP # 1.1 Effective Date: April PURPOSE To describe the manner in which an SOP shall be formulated, reviewed, approved, distributed, and amended. 2. SCOPE From identification of the SOP to be formulated or amended, writing of the SOP, to the review and approval process, implementation and archiving. 3. FLOW CHART PROCESS PERSON/S RESPONSIBLE Identification of SOP to be written Executive Secretary/IERC SOP team Formatting of SOP IERC SOP team and Review and Amending of SOP IERC Chair and Members Approval President and CEO Implementation IERC Chair and Members 4. PROCEDURE 4.1. Identification of the SOP to be formulated or amended The Executive Secretary through the IERC shall propose the formulation of a new SOP or the amendment of an existing SOP The proposal shall include the rationale for the new SOP or for the amendment and shall be discussed as part of the Agenda of an IERC regular meeting The decision on the proposal shall be made through a consensus of the IERC Writing, Formulation, Formatting and Approval of the SOP The Executive Secretary and the IERC SOP Team shall be responsible for the writing or amending the SOP The final draft of the new/amended SOP shall be included in the Agenda of the IERC regular meeting and shall be formally approved by a consensus The President and CEO shall sign and date the approved SOP upon recommendation of the IERC Chair and the Executive Secretary SL-IERC SOP 2013 V2 8

9 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Preparation and Amendment of SOPs SL-IERC SOP # 1.1 Effective Date: April ARCHIVING/FILING SYSTEM 5.1. The signed SOP shall be assigned a Control SOP Number and shall be incorporated in the SOP file The shall keep the original signed and dated controlled copy as part of the Updated SOP Manual The shall maintain the revision history for all amended SOPs, including the Revision date and Version Number. 6. EFFECTIVITY and IMPLEMENTATION 6.1. The new or amended SOP shall be effective immediately upon the recommendation of the IERC, Chair and approval of the President and CEO The IERC Chair and Members and shall be responsible for the implementation of the approved new or amended SOP The shall provide uncontrolled copies to IERC members and other authorized personnel. ---Nothing Follows--- SL-IERC SOP 2013 V2 9

10 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Preparation Guidelines on SOPs SL-IERC SOP # 1.2 Effective Date: April PURPOSE To describe the guidelines and procedures in the preparation and writing of the SOP of the St. Luke s Institutional Ethics Review Committee. These guidelines shall serve as reference in the preparation and writing of SOP for the St. Luke s Institutional Ethics Review Committee (SL-IERC). 2. SCOPE From the description of the format and contents to the numbering of the SOP. 3. FLOW CHART PROCESS RESPONSIBILITY Standardization of the SOP format, contents and signatories Executive Secretary Numbering of SOP Implementation Executive Secretary IERC SOP team and IERC Chair and members 4. PROCEDURE 4.1. The IERC shall follow a standard format for a written SOP. Each page shall have the following: Logo of SLMC in the upper left portion INSITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCECURE in bold upper case letters as header at the center Title of the specific SOP below the header SOP number in the upper right portion Effectivity date below the SOP number Pagination and Revision history as Footer 4.2. The standard contents of the main text of the SOP shall have the following parts: Purpose Scope Flow Chart Procedure SL-IERC SOP 2013 V2 10

11 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Preparation Guidelines on SOPs SL-IERC SOP # 1.2 Effective Date: April Description of Contents Purpose- This states the aim of the SOP Scope- This shows the initial activity involved until the entire procedure ends Flow Chart -This illustrates the chronological order of the various steps involved in the procedure, including the person or groups of persons who are responsible for each step Procedure -This is a detailed description of the various steps outlined in the Flow Chart Optional parts -References and attachments shall be included when appropriate Signatories of SOPs The signatories of the SOPs shall include the following: Prepared and Recommended by the Executive Secretary Approved by the IERC Chair 5.3. Numbering of SOPs All SOP shall be identified by a document code that contains letters and numbers, i.e. SL- IERC SOP #XX Only the final version of an SOP shall be given a document code The original version of an SOP shall have the following in the footnote: SL-IERC SOP Year- v When an SOP undergoes revision, it retains the same document code, but the footnote shall indicate the year of revision and version number shall as follows: Year-v A revised SOP shall have a new effectivity date ---Nothing Follows --- SL-IERC SOP 2013 V2 11

12 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Documentation Control System for SOPs SL-IERC SOP # 1.3 Effective Date: April PURPOSE To establish a system to properly maintain and control IERC SOPs 2. SCOPE From stamping of controlled copies to distribution of uncontrolled copies. 3. FLOW CHART PROCESS RESPONSIBILITY Establishment of a system of filing/ retrieving/releasing of SOP copies Executive Secretary /IERC Stamping of original signed copies as CONTROLLED COPIES Assigned Member of the IERC Distribution of UNCONTROLLED COPIES Assigned Member of the IERC 4. PROCEDURE 4.1. The Executive Secretary and members of the shall establish a system of filing, retrieving and releasing of SOP copies The IERC office shall be the central repository of all SL IERC SOPs The IERC shall stamp an original signed SOP as CONTROLLED COPY The IERC shall ensure that any SOP that is reproduced and circulated is stamped as UNCONTROLLED COPY The IERC shall be the control center and repository for all SL IERC SOPs. ---Nothing Follows --- SL-IERC SOP 2013 V2 12

13 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE SOPs of the Institutional Ethics Review Committee (IERC) Document History REVIEW REVISION REASON FOR NO. DATE NONE NO. REVISION Compliance with suggestions of FERCAP surveyors REVIEWED BY APPROVED BY REVISED EFFECTIVE DATE Filipinas F. Natividad, PhD Executive Secretary IERC Chair April 2013 SL-IERC SOP 2013 V2 13

14 INSTITUTIONAL ETHICS REVIEW COMMITTEE CHAPTER 2 SOPs of the Institutional Ethics Review Committee (IERC) 2.1. Composition, Duties and Responsibilities of the IERC 2.2. Confidentiality Agreements and Conflict of Interest Disclosure 2.3. Training of IERC Members and Personnel 2.4. Selection of Resource Persons 2.5. Honorarium of IERC Members and 2.6. Composition, Duties and Responsibilities of IERC Executive Secretary and IERC Attachment: St. Luke s Medical Center Organizational Chart SL-IERC SOP 2013 V2 14

15 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the SLMC QC and GC Institutional Ethics Review Committee SL-IERC SOP # 2.1 Effective Date: April PURPOSE To ensure a standard process of selection of members, the criteria for membership, the organizational structure and the duties and responsibilities of the Chair and members since the Ethics Committee is authorized to review various types of protocols submitted to SLMC-QC/GC. 2. SCOPE From selection of membership to specifying duties and responsibilities of SLMC-QC/GC IERC. 3. FLOW CHART PROCESS Recommendation for constitution of IERC membership PERSON/S RESPONSIBLE VP for RBD Appointments and Terms of appointments and disqualification of the IERC members President and CEO of SLMC Description of the Duties and Responsibilities of the IERC Chair and Executive Secretary and members Executive Secretary Resignation, Disqualification and Replacement of an IERC member IERC Chair, VP of RBD, Executive Secretary and President and CEO 4. PROCEDURE 4.1. Method of Selection and Terms of Reference The VP of RBD shall recommend the constitution for SL-IERC The President and CEO shall officially appoint the Chair, Vice-Chair and Executive Secretary and members of the IERC Members shall be appointed for a term of 2 years There shall be no limit as to the maximum number of terms a member is reappointed. SL-IERC SOP 2013 V2 15

16 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the SLMC QC and GC Institutional Ethics Review Committee SL-IERC SOP # 2.1 Effective Date: April Membership of the IERC shall be multidisciplinary and multi-sectoral with the following minimum composition in accordance with the guidelines set by the Philippine Health Research Ethics Board and the requirements listed on the manual Reviewing Clinical Trials: A Guide for the Ethics Committee Two physicians from the institution with experience in medical research. A member of a religious community A lawyer, who represents concerns of the community A basic medical research scientist A layperson independent from the institution and with no scientific expertise A member independent from the institution with scientific expertise One clinician who is experienced in working with vulnerable participants (e.g. children and those persons incapable of giving consent) 4.3. Both male and female genders shall be represented in the IERC 4.4. The Vice President for RBD shall be a regular member of IERC The President and CEO shall appoint an Executive Secretary to head and oversee the IERC which shall also be a voting member of the committee. Refer to SOP 2.6 for the Duties and Responsibilities of an Executive Secretary The President and CEO may appoint additional members to the IERC in conformity with ICH- GCP regulations. 5. ROLES AND RESPONSIBILITIES OF THE IERC 5.1. The IERC shall review clinical trials/studies on drugs, devices and diagnostics, herbal medicine research, complementary and alternative medicine research as well as other researches that involve human participants including research on identifiable human material or identifiable data The IERC shall review essential documents of clinical trials and researches involving human subjects (i.e. all Phases of Clinical Trials including Investigator-Initiated, Observational, Registry and Post Marketing Surveillance Studies) submitted to IERC to safeguard the rights, dignity and welfare of human participants The IERC shall ensure that clinical trials and researches shall be conducted in accordance with Philippine laws and National Ethical Guidelines for Health Research 2011 by Philippine National Health Research System (PNHRS), International Conference on Harmonization (ICH) for Good Clinical Practice and Association for the Accreditation of Human Research Protection Programs, Inc.(Please see ICH GCP Guidelines and Philippine National Ethical Guidelines for Health Research 2011 handbook and Reviewing Clinical Trials: A guide for Ethics Committees 2010 as reference.) 5.4. The IERC shall recommend the approval of clinical trial/study, investigator-initiated researches, RBD-funded researches if: all ethical issues have been addressed the protocol is compliant with Good Clinical Practice and has no ethical issue after the presentation the Protocol has been revised in accordance with the Notice of Action issued by the IERC to the Principal Investigator and the IERC has made a Continuing Review of the response. Please refer to Quality Procedures on the Ethical Review Clinical Trial Protocols and SL-IERC SOP#4.1 Review of Protocols that Require Major Revisions. SL-IERC SOP 2013 V2 16

17 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the SLMC QC and GC Institutional Ethics Review Committee SL-IERCSOP # 2.1 Effective Date: April The IERC shall assemble for meetings on the following occasions. Regularly every month commonly agreed by the IERC members Emergency meetings convened by the IERC chair Special assignments designated by the PHREB and St. Luke s Medical Center President & CEO It shall issue the Ethical Clearance to indicate IERC approval following the review of the Protocol The Ethical Clearance shall indicate the dates of review, approval, validity and responsibilities of the Principal Investigator The Ethical Clearance shall be valid for 2 years according to trial site (e.g. St. Luke s Medical Center-Quezon City and Global City and other institutions) Extension of the Ethical Clearance shall be granted upon: written request of the Principal Investigator submission of progress report favorable evaluation of the progress report. payment of extension fee 5.7. It shall evaluate reports on serious adverse events/ unexpected adverse events and submit reports to the Medical Director-QC or Medical Director-GC. (Please refer to policy on Monitoring of Clinical Safety of Investigational Drugs) It shall perform continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects or at least once a year (based on the IERC review approval date) using the IERC Continuing Review Report Form issued by the IERC. (Refer to SOP on Continuing Review Procedures) 5.9. It shall identify a resource person or a known expert to provide additional information about a study when necessary. 6. RESPONSIBILITIES OF THE IERC MEMBER Each Member of the IERC shall have the following responsibilities: Attend IERC meetings regularly and participate in the review and evaluation of research protocols and other related requests as part of a full or expedited review. Participate in the evaluation of approved protocols through the continuing review process. Participate in the review of progress and final reports, amendments presented during IERC meetings, and adverse events Make himself familiar with the SOPs of the SL-IERC Attend seminars, workshops and conferences in research ethics to enhance his competencies as member of the IERC Obtain GCP certificate which shall remain valid for 3 years. Submit an updated CV at the start of each new appointment Declare any conflict of Interest on any of the research protocols submitted for review. Maintain confidentiality of the documents and deliberations of the IERC meetings. SL-IERC SOP 2013 V2 17

18 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the SLMC QC and GC Institutional Ethics Review Committee SL-IERC SOP # 2.1 Effective Date: April RESPONSIBLITIES OF THE IERC CHAIR The IERC Chair shall have the following responsibilities: Finalize the agenda and preside in all IERC meetings. Conduct a preliminary review of all protocols and decide on the nature of review Ensure that a final decision on all protocols reviewed is made and break a tie whenever a deadlock in IERC voting occurs Sign the Ethical Clearance Form Sign the following communications: Notice of Meetings, Notice of Action to Principal Investigators and Sponsors Represent St. Luke s Medical Center in ethics-related symposia or meetings that require institutional participation Ensure that appropriate decisions/actions are made by the IERC on issues that include but are not limited to research participants complaints, findings of noncompliance during an FDA audit, loss of records or study drugs, higher than expected occurrences of adverse events, unexpected adverse events that are at least possibly related to the study, drug accountability problems, unanticipated change in Principal Investigator, etc. Submit annual reports on the accomplishments of the IERC to PHREB Communicate decisions of the IERC to research proponents. 8. Responsibilities of the Vice-Chair The Vice-Chair shall have the authority to perform all the duties of the Chair when the latter is unavailable or unable to perform them He shall perform such other tasks as delegated by the Chair 9. Resignation, Disqualification and Replacement of Members 9.1. An IERC member may resign from the committee at any time during his term through an official letter addressed to the Chair An IERC member may be recommended by the Chair for disqualification for any of the following reasons: Failure to attend 3 consecutive meetings of the IERC without any valid reason Failure to disclose Conflict of Interest Violation of the Confidentiality Rule 9.3. Replacement of the resigned ERC member shall be made by the President/CEO, upon recommendation of the VP for RBD (SOP ) ---Nothing Follows --- SL-IERC SOP 2013 V2 18

19 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Confidentiality Agreement and Disclosure of Conflict of Interest SL-IERC SOP # 2.2 Effective Date: April PURPOSE To ensure that the members of the Institutional Ethics Review Committee (IERC) read, understand, accept, sign and date a Confidentiality Form and a Conflict of Interest Disclosure. 2. SCOPE From providing the forms to filing of signed and dated documents 3. FLOW CHART PROCESS PERSON/S RESPONSIBLE Provision of forms for Confidentiality Agreement and Disclosure of Conflict of Interest to IERC members Reading/signing/dating of 2 copies of the forms IERC members Filing of signed documents to Member s Referendum Binder and providing copies to respective member 4. PROCEDURE: 4.1. The shall provide each IERC member a copy of the Agreement on Confidentiality and Conflict of Interest. (Refer to SL-IERC Form # 01A) 4.2. IERC members read the forms and affix their signature, indicating the date of signing The files the signed documents in the respective Reference Binders of each IERC member and the Master File. ---Nothing Follows--- SL-IERC SOP 2013 V2 19

20 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Training of IERC Members and Staff SL-IERC SOP # 2.3 Effective Date: April PURPOSE To ensure that members of the IERC and team regularly attend seminars/training/ workshops/conferences to maintain and enhance their competence and skills through an updated knowledge of research ethics and guidelines. 2. SCOPE From identification of to attendance in seminars/training/workshops/conferences on ethics, ethics review committees, and other related topics 3. FLOW CHART PROCESS PERSON/S RESPONSIBLE Identifying availability and schedule of seminars/trainings/workshops/conferences Identifying personnel to attend seminars/training/workshops/conferences IERC Chair/ Executive Secretary No International seminar/training/workshop Yes Approval to provide funding for local training/workshop/conferences Request for financial support VP for RBD Approval to provide funding for international training/workshop/conferences President/CEO Attendance in seminars/training/workshops/ conferences IERC members and Filing of Training Certificates SL-IERC SOP 2013 V2 20

21 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Training of IERC Members and Staff SL-IERC SOP # 2.3 Effective Date: April The shall regularly obtain information on the availability and schedule of training courses, workshops, and conferences on ethics, ethics review committees, and other related topics The IERC Chair and Executive Secretary shall identify members of the IERC and the team who will attend seminars/training/workshops and conferences For attendance in local venues, the Vice President for RBD shall make the official approval For regional and international venues, the Vice President for RBD shall make the appropriate request for financial support and approval by the President/CEO IERC members and Team who attend any seminars/training/workshops and Conferences shall submit their certificate or proof of attendance for filing by the. ---Nothings Follows--- SL-IERC SOP 2013 V2 21

22 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Resource Persons SL-IERC SOP # 2.4 Effective Date: April PURPOSE To describe the procedure for getting the services of an expert to serve as Resource Person on matters outside the expertise of members of the Institutional Ethics Review Committee (IERC) 2. SCOPE From identifying the need and the expert to providing compensation for the Resource Person 3. FLOW CHART PROCESS Determination of need for a Resource Person PERSON/S RESPONSIBLE IERC Identification of expert and invitation to serve as Resource Person IERC Signing of Service Agreement Resource Person/VP for RBD Participation in appropriate Meeting Resource person Payment of honorarium Accounting Dept./ 4. PROCEDURE 4.1. When deemed necessary, the IERC may invite an expert to serve as resource person for the review of a specific protocol The VP of RBD shall have the prerogative to appoint the resource person as an independent consultant upon recommendation of the IERC/IERC Chair The resource person shall sign a Service Agreement upon his/her appointment The resource person shall participate in the review of a specific protocol and give his/her inputs on specific issues related to his expertise The resource person shall not have any voting rights The resource person shall receive an honorarium, the amount of which shall be determined by the VP for RBD, for his/her services rendered shall request Accounting Department to prepare honorarium for Resource Persons gives the honorarium to Resource Person. ---Nothing Follows--- SL-IERC SOP 2013 V2 22

23 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Honorarium of IERC and SL-IERC SOP # 2.5 Effective Date: April PURPOSE To ensure that the members of the Institutional Ethics Review Committee (IERC) and are granted honoraria for their work in the committee. 2. SCOPE From recommendation for grant of honorarium for, to acknowledgment receipt of honorarium by the members of the Institutional Ethics Review Committee (IERC)and. 3. FLOW CHART PROCESS PERSON/S RESPONSIBLE Recommendation for grant of honoraria of IERC members and VP of RBD Approval/Disapproval President and CEO Request for preparation of honorarium Dispensation of honorarium Accounting Department Acknowledgment of honorarium IERC/ 4. PROCEDURE 4.1. The Vice-President for Research and Biotechnology Division shall recommend to the President/CEO the granting of honorarium to the IERC and for their work in the committee. The honorarium shall cover an amount for review of protocols, for attendance and participation in meetings and other IERC activities and a year-end bonus 4.2. The VP for RBD shall recommend increase in the honorarium depending on the workload The shall prepare request for honorarium forwarded to SLMC Accounting Department The IERC members and shall sign a voucher upon receipt of honorarium check from the Accounting Department. ---Nothing Follows--- SL-IERC SOP 2013 V2 23

24 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Appointment, Duties and Responsibilities of the Executive Secretary and IERC SL-IERC SOP # 2.6 Effective Date: April PURPOSE To describe the appointment of the Executive Secretary and IERC and delineate their duties and responsibilities. 2. SCOPE From the appointment and identification of the Executive Secretary and staff of IERC to the delineation of their duties and responsibilities. 3. FLOW CHART PROCESS Executive Secretary Appointed PERSON/S RESPONSIBLE President and CEO Identification of Staff and Administrative Staff for the IERC Executive Secretary Delegation of duties and Executive Secretary 4. PROCEDURE The IERC and Administrative Support Staff 4.1. An Executive Secretary shall be appointed by the President and CEO to head and oversee the IERC The Executive Secretary shall be a member of the IERC and has the following duties: Acts as voting member of the IERC (transfer to SOP 2.1) Generally conducts the business of the IERC i.e. supervises the work of the secretariat. Receives and acknowledges all correspondence with the Principal Investigator Does initial review to determine type of review and submits recommendation to IERC Chair Identifies and assigns an expert reviewer/resource person for a specific protocol Convenes meetings as instructed by Chair when necessary Arranges regular EC meetings and documents the proceedings and resolution of all meetings(transfer to SOP 2.1) Documents the start of each meeting the existence of any conflicts of interest (transfer to SOP 2.1) Clarifies to the Principal Investigators ethical problems that may arise from a clinical trial/research and presents the ethical problem for IERC review Prepares and sends memorandum to all Principal Investigators (whether sponsored-study, investigator-initiated or RBD-funded) to comply with the IERC Continuing Review Report. SL-IERC SOP 2013 V2 24

25 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Appointment, Duties and Responsibilities of the Executive Secretary and IERC SL-IERC SOP # 2.6 Effective Date: April The Research and Biotechnology Division staff assigned to the IERC shall be the administrative support staff of the IERC re-word/re-write Responsibilities of the Receives, documents, and records all applications for protocol review Prepares the tracking form and assigns a tracking number for all complete protocols received/as soon as initial submission is complete Forwards submitted protocol to Executive Secretary for pre-determination of type of Review ERC Chair for initial review in order to determine type of review process Prepares agenda and Notices of Meetings of ERC Collates all essential documents for ERC meetings and distributes these to ERC members Prepares and distributes communications to, and coordinates with, all Principal Investigators regarding schedule of protocol presentation Takes and prepares Minutes of ERC Meetings Keeps and maintains archives of the following: Dossier of each reviewed protocol, minutes of meetings, file of ERC members Answers queries from Clinical Research Organizations (CROs), Sponsors, and Investigators on matters relevant to the functions/activities/schedules etc. of the ERC Maintains confidentiality of all documents of the ERC Prepares reports and other matters to be presented at ERC meetings Requests the use and assures the availability, of venue for ERC meetings Prepares request for food and beverages to be served during ERC meetings Assures functionality of audiovisual equipment for presentors Prepares requests for honorarium of ERC members Arrange transport service for ERC members not affiliated with SLMC Performs other functions as requested by ERC members ---Nothing Follows--- SL-IERC SOP 2013 V2 25

26 INSTITUTIONAL ETHICS REVIEW COMMITTEE Procedures for Initial Protocol Submissions and Ethical Review Document History REVIEW REVISION REASON FOR NO. DATE NONE NO. REVISION Compliance with suggestions of FERCAP surveyors REVIEWED BY APPROVED BY REVISED EFFECTIVE DATE Filipinas F. Natividad, PhD Executive Secretary IERC Chair April 2013 SL-IERC SOP 2013 V2 26

27 INSTITUTIONAL ETHICS REVIEW COMMITTEE CHAPTER 3 Procedures for Initial Protocol Submissions and Ethical Review 3.1. Initial Protocol Submissions 3.2. Initial Submission of Application through the Center for Clinical Trials (CCT) Web portal 3.3. Preliminary Review By IERC Members Prior to Presentation 3.4. Full Board Review of Protocols 3.5. Expedited Review SL-IERC SOP 2013 V2 27

28 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Initial Protocol Submissions SL-IERC SOP # 3.1 Effective Date: April PURPOSE To ensure a standard process of submission of protocols for review, particularly the responsibilities and procedures for initial review. 2. SCOPE From submission of protocol dossier up to the classification of the type of review. 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Receipt of Documents for review with the accomplished CT Initial Protocol Submission Form Evaluation for Completeness of submitted dossier using CT Initial Protocol Review Acknowledgement Form If not complete, information sent to concerned Principal Investigator If complete, acceptance and assignment of a EC Reference Number Initial Review to determine type of review Executive Secretary/IERC Chair No Full Review? Yes Expedited Review will send Protocol to assigned IERC members informed Principal Investigator Protocol that he/she will present to IERC SL-IERC SOP 2013 V2 28

29 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Initial Protocol Submissions SL-IERC SOP # 3.1 Effective Date: April PROCEDURE 1.1. Receipt of documents for review The receives the protocol dossier at the IERC office which includes the following: Accomplished Initial Protocol Submission Form (Refer to SL-IERC Form#02) Letter of intent addressed to IERB Chair 10 copies of the following (if applicable): Protocol with the following attachments - Informed Consent Form (English and Tagalog) - Case Report Forms - Investigator s Brochure 1 copy each of the following (If applicable): Pharmacokinetics Subject Worksheets/Patient Diary/Alert Cards (English and Tagalog versions) Questionnaire (English and Tagalog Versions) Philippine Food and Drug Administration Approval Certificate of Product Registration in the Philippines for Post Marketing Surveillance Studies(PMSS) Curriculum Vitae of Investigators GCP Certificates of Investigators Certificate of Insurance The logs the protocol submission using the CT Tracking Form. (Refer to SL-IERC Form #04) 1.2. Evaluation of completeness of the dossier based on the IERC Initial Protocol Review Acknowledgement Form. (Refer to SL-IERC Form #03) If the dossier is incomplete, communicates with the concerned PI through phone or . This is logged in the appropriate logbook. For protocols only awaiting approval from the FDA, the IERC can conduct a parallel review; however, the issuance of Ethical Clearance shall be withheld until completion of said requirement. If the dossier is complete, the assigns anec Reference Number to the protocol. EC Reference Number is composed of the letters, C T, last 2 digits of the year; running number starting with 1 (eg. CT ) 11is for 2011; 001 is First protocol received for the year, etc Classification of type of review The shall inform the Executive Secretary of the receipt of a new protocol The IERC Chair and the Executive Secretary shall determine if the protocol is for Full Board review or for Expedited Review The shall prepare the appropriate communication as to the type of review If protocol is for full review, the shall inform the Principal Investigator the type of review to be done and schedule the presentation of the protocol in a regular IERC meeting. (Refer to SL-IERC SOP#3.3) If protocol is for expedited review, the shall send a protocol to IERC members assigned to review. ---Nothing Follows--- SL-IERC SOP 2013 V2 29

30 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Initial Submission of Application through the Web portal SL-IERC SOP # 3.2 Effective Date: April PURPOSE To establish a documented procedure for assessing protocols submitted through the web portal 2. SCOPE From the submission of application for protocol review via the web portal to the classification of type of review 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Daily checking of web portal Automatic reply generated Electronic Reply from web portal Acknowledgment of receipt of Application Submission of hard copies of documents for review Principal Investigator Assessment of completeness of submission using CCT Initial Review Submission Form Assignment of a EC Reference Number Classification of type of review Executive Secretary/IERC Chair SL-IERC SOP 2013 V2 30

31 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Initial Submission of Application through the Web portal SL-IERC SOP # 3.2 Effective Date: April PROCEDURE 4.1. Application through the web portal Principal Investigator logs in to the IERC web portal on the SLMC Website and fills up the Initial Protocol Submission Form. (Refer to SL-IERC Form#02) The completed Initial Protocol Submission Form is submitted electronically An automatic acknowledgement is generated by the web portal upon submission of the on-line application The shall inform the applicant through to submit required documents in order to complete his on-line application. (Refer to SL-IERC SOP #3.1) 4.2. Submission of requirements for application The applicant shall submit hard copies of the required documents to complete his application to the IERC office either by hand carry or courier The applicant may check the status of his application in the webportal The shall assess the completeness of submitted documents using Initial Protocol Submission Form The assigns an EC Reference Number. If submitted protocol is complete/upon completion of protocol and required documents 4.3. Classification of type of review (Refer to SL-IERC SOP# 3.1) ---Nothing Follows--- SL-IERC SOP 2013 V2 31

32 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Preliminary Review By IERC Members Prior To Protocol Presentation SL-IERC SOP # 3.3 Effective Date: April PURPOSE To establish a documented procedure for the preliminary ethical review of clinical trial protocols prior to an IERC meeting. 2. SCOPE From the distribution of protocol dossier to each IERC members ton risk assessment. 3. FLOW CHART PROCESS PERSON/S RESPONSIBLE Distribution of Protocol Dossier to IERC members Individual Review IERC members Risk Assessment IERC members 4. PROCEDURE 4.1. The shall provide each member of the IERC, one week in advance, copies of all clinical trials/research protocols scheduled for presentation in a regular or special meeting of the ERC 4.2. Each member of the IERC shall make his/her own individual review by using the Ethics Review Forms (Refer to SL-IERC Form#05B) Evaluate or Comment of the Technical aspects Evaluate the Informed Consent Form Comment on the Assent Form if the protocol includes children as participants Make a Risk Assessment by checking the appropriate box as follows: High Risk - if study can lead to an unexpected/unplanned loss of life, or permanent impairment of quality of life, or may lead to serious legal action against Principal Investigators and/or institution -The study risk is greater than a moderate risk study due to the increased probability for generating serious adverse events. There is a high probability of an event that is serious and prolonged or permanent occurring as a result of study participation* SL-IERC SOP 2013 V2 32

33 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Preliminary Review By IERC Members Prior To Protocol Presentation SL-IERC SOP # 3.3 Effective Date: April 2013 Medium Risk /Moderate Risk- if the result requires notification to ethics committee Moderate Risk- Risks are recognized as being greater than minimal, but are not considered high. There is a medium to high probability of a moderate-severity event occurring as a result of study participation (e.g., reversible worsening of a non-fatal disease such as seasonal allergy while receiving placebo or pneumonia from a bronchoscopy), but there is adequate surveillance and protections to identify adverse events promptly and to minimize their effects. * Low risk /Minimal Risk - if the consequences can be dealt with by routine operations Minimal risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.( 45 CFR ) Note: University of Kentucky Minimal risk definition ---Nothing Follows--- * Protocol Risk assessment and Monitoring Guidelines of the North Carolina Translational and Clinical Sciences Institute SL-IERC SOP 2013 V2 33

34 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Full-Board Review of Protocols SL-IERC SOP # 3.4 Effective Date: April PURPOSE To describe the procedure for full review of submitted clinical trial protocols/research proposals 2. SCOPE From presentation of the protocol /proposal in a regular IERC meeting to filing of Notice of Action in appropriate folder 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Presentation of Protocol/Proposal Principal Investigator Interpolation IERC Evaluation of Protocol/Proposal IERC Deliberation IERC Decision by consensus IERC Notice of Action /Principal Investigator/Proponent 4. PROCEDURE 4.1. Presentation of Protocol/Proposal The Principal Investigator/Proponent shall present his protocol/proposal before the IERC en banc The Principal Investigator/Proponent shall discuss the 7 basic factors for ethical review as follows: Social or Scientific Value Fair Subject Selection Favorable Risk-Benefit Ratio Independent Review Informed Consent Respect for Potential and Enrolled Subjects At any time during the presentation, the members of the IERC may interrupt and ask a question The interpolation can still proceed after the presentation The IERC Chair or Executive Secretary shall present the issues raised by those who are absent, if these have not been previously resolved SL-IERC SOP 2013 V2 34

35 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Full-Board Review of Protocols SL-IERC SOP # 3.4 Effective Date: April Evaluation of the Protocol The members of the IERC shall make their final evaluation immediately after the interpolation. They shall complete, date and sign the Ethics Review Form (SL-IERC Form#05B) accordingly The IERC Chair shall ask each member to present/recite his/her comments. After a thorough deliberation, a consensus is reached The IERC Chair shall summarize the issues and recommendations on the protocol. These include the following: comments on the evaluation by the IERC members deliberation that ensued after the presentation 4.3. The decision of the committee shall be made by consensus as follows: Approved - protocol is approved since risks to subjects are minimal and reasonable in relation to anticipated benefits. Selection of subjects is equitable, informed consent will be asked from prospective subjects or subject s legal representative and will be appropriately documented. Research plan makes adequate provisions for monitoring data collected to ensure safety of subjects and protect the privacy of subjects and confidentiality of data. Additional safeguards have been included to protect welfare of vulnerable subjects. Minor Revision protocol is found to have some minor issues that need to be addressed as recommended by the committee and upon submission of amendments Executive Secretary will present revisions to the ERC for approval. Major Revision protocol is found to have major issues and there is insufficient information that can help committee to make a decision. Upon completion of issues/documents, protocol will be presented again to the IERC by Principal Investigator. Disapproved - protocol is ethically unacceptable. However an appeal can be made by the Principal Investigator. (Based on WHO- Casebook on Ethical Issues in International Research. Ed. R Cash, D. Wikler, A. Saxena, A. Capron. 2009) 4.4. The shall collect Ethics Review Form (SL-IERC Form#05Bimmediately after the decision Notice of Action The shall prepare the Notice of Action (NOA) stating the decision of the committee for appropriate action of the Principal Investigator and shall ask the IERC Chair to sign The shall deliver the NOA to the appropriate recipient with an Acknowledgement Receipt The shall file the document in the appropriate folder. ---Noting Follows--- SL-IERC SOP 2013 V2 35

36 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Expedited Review SL-IERC SOP # 3.5 Effective Date: April PURPOSE To provide criteria for classifying study protocols for expedited review, as well as instructions for expedited review and approval of study proposals with minimum risk to participants. 2. SCOPE From classifying protocols for review to the process of expedited review and approval. 3. FLOWCHART PROCESS Establishment of criteria for expedited review PERSON/S RESPONSIBLE Executive Secretary/IERC Chair Evaluation of protocols submitted to determine type of review (Expedited or Full review) Executive Secretary Recommendation of protocols for expedited review Executive Secretary Approval of protocols for expedited review and designation of IERC member to conduct Expedited Review IERC Chair Sending Conduct of of protocols expedited to reviewby IERC members referendum who will conduct expedited Review Designated IERC members Submission of results of Expedited Review to Designated IERC members Preparation of summary of recommendations and Notice of Action for PI Reporting of results in a regular IERC meeting to the IERC Executive Secretary 4. PROCEDURE 4.1. The following criteria shall be used as basis for classifying protocols for expedited review: Protocols that entail only a minimal risk to the human participants and to the community Protocols that are retrospective in data collection methodology. SL-IERC SOP 2013 V2 36

37 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Expedited Review SL-IERC SOP # 3.5 Effective Date: April 2013 Protocols previously approved by IERC (for a period of 1 year or less) which have minor changes and need authorized approval ( 21 CFR ) 4.2. Evaluation and classification of protocols for expedited review The Executive Secretary shall evaluate if a submitted protocol is qualified for expedited review based on the above criteria and makes recommendation to the IERC Chair The IERC Chair shall endorse the protocol for expedited review and designate at least 2 IERC members who will conduct the expedited review The shall prepare and send the protocol to the designated members of the IERC Conduct of expedited review The shall send copies of the protocol to designated members of the IERC The IERC members shall be given two weeks to evaluate the protocol using the Ethics Review Form (SL-IERC Form# 05B The recommendations of the reviewers may be any of the following: Approved With revisions Full Board Review The IERC reviewers shall submit to the the results of the expedited review The Executive Secretary shall summarize the results of the expedited review 4.4. The Executive Secretary shall send a Notice of Action to the principal investigator The Executive Secretary shall report the outcome of the expedited review to the IERC during a regular meeting The shall keep the results and document in an active file. ---Nothing Follows--- SL-IERC SOP 2013 V2 37

38 INSTITUTIONAL ETHICS REVIEW COMMITTEE Continuing Review and Monitoring of Protocols Document History REVIEW REVISION REASON FOR NO. DATE NONE NO. REVISION Compliance with suggestions of 2012 FERCAP surveyors REVIEWED BY APPROVED BY REVISED EFFECTIVE DATE Filipinas F. Natividad, PhD Executive Secretary Prospero Ma. C. Tuaňo, MD IERC Chair April 2013 SL-IERC SOP 2013 V2 38

39 INSTITUTIONAL ETHICS REVIEW COMMITTEE CHAPTER 4 Continuing Review and Monitoring of Protocols 4.1. Review of Protocols That Require Major Revisions after Presentation 4.2. Review of Protocol Amendments 4.3. Progress Reports for Continuing Review 4.4. Assessment of Serious Adverse Events 4.5. Early Termination of Clinical Trials Due to Protocol Violations 4.6. Site Visit SL-IERC SOP 2013 V2 39

40 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Review of Protocols that require revisions after presentation SL-IERC SOP # 4.1 Effective Date: April PURPOSE To describe how study protocols that have been evaluated and recommended with minor or major revisions are managed, reviewed and approved by the IERC. 2. SCOPE From preparation of Notice of Action (NOA) and receipt of Response to Notice of Action to second review by the IERC of study protocols that require minor and major revisions 3. FLOWCHART PROCESS Preparation and sending of Notice of Action (NOA) to Principal investigator/proponent RESPONSIBILITY Response to NOA Protocol with Minor Revisions - Expedited Review Designated IERC members Decision presented to the IERC during regular meeting Protocol with Major Revisions- Full-board Review Executive Secretary IERC Communication to Principal Investigator/Proponent re IERC decision SL-IERC SOP 2013 V2 40

41 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Review of Protocols that require revisions after presentation SL-IERC SOP # 4.1 Effective Date: April PROCEDURE 4.1. Notice of Action and Response The shall prepare the Notice of Action (Refer to SL-IERC Form# 12A) and shall send it to the Principal Investigator/ Proponent Principal Investigator/ Proponent shall acknowledge the Notice of Action by signing the Acknowledgement Receipt Principal Investigator/ Proponent shall be given a time frame of one month to response to the Notice of Action Review of Response to Notice of Action Protocol with minor revision(s) shall pass through expedited review. Refer to SOP 3.5 for expedited review process Protocol with major revision(s) shall pass through another full review The Executive Secretary shall present the protocol and the pertinent major revisions The IERC shall deliberate on the revision and decide by consensus as follows: Approved Disapproved 4.3. Decision/Notice of Action The shall inform the Principal Investigator of the decision. ---Nothing Follows--- SL-IERC SOP 2013 V2 41

42 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Review of Protocol Amendments SL-IERC SOP # 4.2 Effective Date: April PURPOSE To describe how amendments to study protocols are reviewed and approved by the IERC. 2. SCOPE From receipt of letter of request for approval of amendments to the review and approval by the IERC 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Receipt of Letter of Request from Principal Investigator/Proponent Review of Request for Approval of Amendment IERC Communication to Principal Investigator re IERC decision Submission of clean copy of amended protocol Principal Investigator 4. PROCEDURE 4.1. The receives and logs Letter of Request for approval of protocol amendments 4.2. The Executive Secretary classifies the amendments as follows: Minor Amendments: Minor changes to the protocol or other study documentation e.g. correcting errors, minor clarification Changes in the principal investigator s research team Changes in the documentation used by the research team for recording study data Changes in the contact details of the sponsor (or the sponsor s representative), principal investigator or other study staff Major amendments for: Changes in the design or methodology of the study or in the background information that may affect its scientific value Changes in the procedure undertaken by the participant which relates to the safety, physical or mental integrity of the participants. Significant changes in the study documents such as participant information sheets, consent forms, questionnaires Appointment of a new Principal investigator or key collaborator Change in the insurance or indemnity arrangements for the study SL-IERC SOP 2013 V2 42

43 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Review of Protocol Amendments SL-IERC SOP # 4.2 Effective Date: April Presentation of Protocol amendments to the IERC The IERC shall be informed of minor amendments during a regular meeting after they have passed expedited review Major Amendments shall be presented by the IERC Chair/ Executive Secretary during a full board review The Executive Secretary shall prepare Notice of Action to the Principal Investigator regarding the decision of the IERC The amended protocol shall be stamped IERC Approved with date of approval. ---Nothing Follows--- SL-IERC SOP 2013 V2 43

44 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Progress Reports for Continuing Review SL-IERC SOP # 4.3 Effective Date: April PURPOSE To describe the procedure of continuing review of studies involving human participants in order to ensure the continuous protection of their rights and safety and to provide instructions on the preparation of Progress Reports for Continuing Review. 2. SCOPE From submission of progress reports using Continuing Review Report Form (CRRF) and updates on Serious Adverse Events (SAEs) to tracking of reports received. 3. FLOWCHART PROCESS Preparation and distribution of Memorandum re: Submission of Continuing Review Report (Downloadable at IERC web portal) PERSON/S RESPONSIBLE Executive Secretary Review of Progress Reports for Continuing Review Report IERC Communication to Principal Investigator re: Continuing Review Filing of Continuing Review Documents 4. PROCEDURE 4.1. Progress Reports for continuing review The Progress reports for Continuing Review shall include the following: (Refer to SL-IERC Form# 16) Progress of the study Occurrence of Serious Adverse Events Occurrence of Unexpected Adverse Events (UAEs) Rate of accrual of participants Protocol deviations Protocol violations SL-IERC SOP 2013 V2 44

45 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Progress Reports for Continuing Review SL-IERC SOP # 4.3 Effective Date: April The Executive Secretary shall prepare a memorandum to all Principal Investigators to submit a progress report for Continuing Review. The frequency of submission of Progress Reports for Continuing Review shall depend on the level of risks of the study. Low/Minimal Risk Annually based on their approval date Moderate/Medium Risk Semi-annually High Risk Quarterly reporting The shall send the Memorandum to all Principal Investigators The shall compile and include the progress reports of all ongoing Clinical Trials in the agenda of a regular IERC meeting Continuing Review of CTs The shall include the presentation of Progress Reports for Continuing Review in the agenda of IERC regular meetings The IERC Chair shall present the Progress Reports for Continuing Review for discussion The IERC shall make any of the following recommendations on each report: Uphold original approval with no further action Request information Require further action 4.3. Communication to Principal Investigators The shall inform the Principal Investigators of the result of the continuing review of their clinical trials The shall inform Principal Investigators who have not submitted Continuing Review Reports The shall file the continuing review documents in the respective study binders and in the SAE binders. ---Nothing Follows--- SL-IERC SOP 2013 V2 45

46 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Assessment of Serious Adverse Events SL-IERC SOP # 4.4 Effective Date: April PURPOSE To describe the procedure for reporting and assessment of serious adverse events (SAEs) that affect the health, welfare and safety of human participants. 2. SCOPE From the receipt of SAE Report Form (Refer to SL-IERC Form #14A) to evaluation/review of the report by the IERC 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Receipt of SAE Report Logging of SAE Report Notification of IERC Chair Inclusion of Report in the Agenda of IERC Meeting IERC Chair Review and Evaluation of SAE Reports IERC Chair and members Preparation, Signing and Delivery of NOA and IERC Chair Filing of Report and NOA in respective study binder and SAE binder SL-IERC SOP 2013 V2 46

47 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Assessment of Serious Adverse Events SL-IERC SOP # 4.4 Effective Date: April SAE /SUSAR Reporting Oversight Definitions: SAE (Serious Adverse Event/Serious Drug Experiences) as defined under 21 CFR : a) Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death Life-threatening drug experience Inpatient hospitalization or prolongation of existing hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect b) Important medical events that may not result in death, be life-threatening or require hospitalization but when based upon appropriate judgment may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes mentioned above Unexpected Adverse Drug Experience: Any adverse drug experience the specificity or severity of which is not consistent with the current investigator brochure or with the risk information described in the general investigational plan or elsewhere in the current application. Unexpected as used in this definition refers to an adverse drug experience that has not been previously observed or from the perspective of the pharmacological properties of the test product is not anticipated Principal investigators shall follow guidelines on submission of SAE reports in accordance with Monitoring of Clinical Safety of Investigational Drugs The shall receive, acknowledge and date the SAE Report The shall log the SAE Report in a Logbook for SAEs and in the SAE Tracking Form filed in each Study Binder. (Refer to SL-IERC Form # 14B) The SAE report shall indicate if the event is: Unrelated to study Unlikely related to study Possibly related to study Definitely related to study 3.2. The shall forward a copy of the Report to the IERC Chair for immediate action The IERC Chair shall call for an emergency meeting of the IERC if there is an urgent need for early termination of a study because of the SAE reports If the SAE Report indicates Unrelated or Unlikely related to study, the shall include the report in the IERC agenda for information If the SAE Report indicates Possibly or Definitely related to study, the shall include the report in the IERC agenda for review and evaluation Review of SAE Reports The Chair of IERC shall present the SAE reports that are for review and discussion The IERC shall note and discuss the relatedness and expectedness (SUSAR of all onsite/offsite adverse events) The IERC shall make a decision by consensus to: Request an amendment to the protocol or the consent form Request further information Suspend or terminate the study SL-IERC SOP 2013 V2 47

48 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Assessment of Serious Adverse Events SL-IERC SOP # 4.4 Effective Date: April Notification of IERC action If the decision of the IERC is any of the above, the Executive Secretary shall prepare a Notice of Action to the Principal Investigator The shall ask the IERC Chair to sign the NOA The shall deliver the NOA to the Principal Investigator shall file the report and NOA in appropriate study binder and SAE binder. ---Nothing Follows--- SL-IERC SOP 2013 V2 48

49 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Early Termination of Clinical Trials Due To Protocol Deviations/Violations SL-IERC SOP # 4.5 Effective Date: April PURPOSE To describe the procedure and guidelines for termination of clinical trials due to protocol deviations or violations 2. SCOPE From the receipt of the report by the IERC to notice of termination of the protocol by the IERC (Refer to SL-IERC Form #18) 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Receipt of Report Inclusion Report in IERC Meeting Agenda Presentation of Report for Discussion IERC Chair/Executive Secretary Decision by consensus IERC Notice of action Executive Secretary Filing of Report in the appropriate study binder 4. PROCEDURE 4.1. The secretariat shall receive the report on protocol deviations and violations 4.2. The shall include the Protocol Deviation/Violation Report in the IERC agenda The IERC Chair shall present the report for discussion by the committee The IERC shall make a decision to terminate a previously approved clinical trial based on the following considerations: Safety reports that indicate that continuing the study will worsen the condition of, as well as increase the risks to the study participants Recommendation by the Principal Investigator or the sponsor Other considerations that impact on the risk/benefit ratio. SL-IERC SOP 2013 V2 49

50 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Early Termination of Clinical Trials Due To Protocol Deviations/Violations SL-IERC SOP # 4.5 Effective Date: April The IERC shall make a decision by consensus on the recommendation for early termination The shall prepare a Notice of Action to Principal Investigator The shall ask the IERC Chair to sign the NOA The shall deliver the NOA to the Principal Investigator shall file a report in the appropriate study binder. ---Nothing Follows--- SL-IERC SOP 2013 V2 50

51 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Site Visit SL-IERC SOP # 4.6 Effective Date: April PURPOSE To describe the criteria and procedure for site visits. 2. SCOPE From identifying the site to be visited up to the recording and filing of the final report. 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Identification of Principal Investigator (PI) and site to be visited IERC Chair/ Informing IERC Chair /IERC Discussion IERC / Designation of person/s to conduct the site visit(maybe a group already formed and identified to conduct visits) IERC Notification of PI/site of the visit Review of informed consent and other pertinent documents Preparation of report after the site visit Presentation of report/findings to the IERC Designated person/s members of the IERC Designated person/s members of the IERC Designated person/s members of the IERC IERC Deliberation and action on findings IERC Inform PI of findings and actions/sanctions of the IERC Follow-up on action taken by PI after one month File reports on respective protocol file SL-IERC SOP 2013 V2 51

52 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Site Visit SL-IERC SOP # 4.6 Effective Date: April PROCEDURE 4.1. Criteria for selection of Principal Investigator/site to be visited Number of clinical trials/studies handled by the Principal Investigator Receipts of serious adverse events report on a clinical trial Failure to submit progress report or final report New Principal Investigator/site Inquiry/complaint of clinical trial/study participant 4.2. Preparation of the Visit The shall inform the principal investigator of intended site visit of the designated persons/members of IERC shall prepare the Site Checklist and other materials needed for the site visit During the Visit, the designated persons/members of IERC shall: Review the informed consent and make sure that the most recent version is being used Review 25% of the participants files that participants are signing the right informed consent Observe the informed consent process if possible Review the files and documents and ensure that they are being filed properly and with confidentiality 4.4. After the Visit The team shall write a report based on the Site Visit Checklist The shall file a copy of the report on the study file and this shall be forwarded to the IERC for review Presentation of the site visit report to the Institutional Ethics Review Committee The IERC shall deliberate on the findings of the site visit report The shall relay to the Principal Investigator the action of the IERC on the site visit report IERC secretariat shall follow-up the action taken by the Principal Investigator IERC secretariat shall keep record of the report, decisions and action taken on the respective protocol file. ---Nothing Follows--- SL-IERC SOP 2013 V2 52

53 INSTITUTIONAL ETHICS REVIEW COMMITTEE CHAPTER 5 Administrative Procedures 5.1. Preparation of Notice of Meeting and Agenda 5.2. Preparation and Distribution of Minutes of Meetings 5.3. Emergency/Special Meetings 5.4. Preparation for a Regular Meeting 5.5. Conduct of a Regular Meeting 5.6. Management of Communication Management of Administrative Files, Logbooks and Forms SL-IERC SOP 2013 V2 53

54 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Preparation of Notice of Meeting and Agenda SL-IERC SOP # 5.1 Effective Date: April PURPOSE To describe the procedures for the preparation of the agenda and notice of a regular IERC meeting 2. SCOPE From the setting of the agenda and date of the meeting, to the distribution of meeting materials to IERC members and filing of essential communication documents 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Setting of Meeting Agenda and Chair Setting date of the IERC Meeting and all IERC members Preparation of venue, dietary request, transport service and honorarium for the meeting Notification and Confirmation of attendance of IERC members, Notification of Presentors Preparation and Distribution of meeting materials Filing of all essential documents 4. ROCEDURE 4.1. Setting of Agenda of Meeting The, in consultation with the IERC Chair, shall prepare the Tentative Agenda (Refer to Agenda Template) for the Regular Meeting of the IERC. SL-IERC SOP 2013 V2 54

55 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Preparation of Notice of Meeting and Agenda SL-IERC SOP # 5.1 Effective Date: April The standard agenda for a regular IERC meeting shall include the following: Invocation Call to Order Verification of Quorum Declaration of Conflict of Interest Approval of Agenda Reading and Approval of Minutes of the Previous Meeting Matters Arising from the Previous Meeting Presentation and Review of Protocols Report on Adverse Events Matters for Approval/Action DSMC Reports Matters for information Protocol Deviations Other Correspondences o Study Updates o Reports o Renewal o Others Safety Reports/CIOMS/SUSARS Investigator s Brochures Study Close-out Notification Other Matters Schedule of next IERC meeting Adjournment 4.2. Schedule and Date of IERC meetings Regular meetings of the IERC shall be held on the 2 nd Wednesday of each month at 8:00 in the morning, RBD conference Room, Annex 3, 5th Floor The schedule and date of IERC Meetings shall be posted at the RBD Bulletin Board on the 2 nd floor bridge way and at the Clinical Trials Web portal 4.3. Notification of IERC members and Notification of Presentors The shall send a Notice of Meeting to all members of the IERC signed by the IERC Chair 2 weeks prior to the scheduled meeting. The shall confirm attendance of IERC members through phone and/or short message service (SMS) The secretariat shall send the Tentative Agenda of the Meeting and other materials to IERC members at least one week before the meeting The shall send a letter of invitation to present to all proponents one week before the scheduled presentation for review by the IERC, with specific instructions to discuss the following ethical issues: Social or scientific value Scientific validity Fair subject selection Favorable risk ratio Independent review Informed consent Respect for Potential and enrolled subjects SL-IERC SOP 2013 V2 55

56 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Preparation of Notice of Meeting and Agenda SL-IERC SOP # 5.1 Effective Date: April Preparation of venue and requests from other concerned Divisions The shall reserve the use of the RBD Conference Room for the IERC meeting The shall prepare the following requests: Dietary Request Form to Food and Nutrition Department Transport Request Form to Transport Services Department Check Preparation Request for IERC honorarium to Accounting Department 4.5. Distribution of meeting materials The shall prepare for each IERC member a binder containing the following documents for the meeting: The Tentative Agenda for the Meeting(refer to Agenda Template) Minutes of the Previous Meeting Copy of all protocols for review The IERC Chair shall receive a copy of the following for discussion Report which contains list of SAEs, Request for Amendments, DSMC Reports Correspondences, Response to Notice of Action Other Matters for Approval The shall distribute the binder to each IERC Member at least 1 week prior to the scheduled meeting Filing of essential documents The shall file the following essential documents: Notice of meeting Invitation to Presentors Approved Agenda Approved Minutes Action for Continuing review of protocols ---Nothing Follows--- SL-IERC SOP 2013 V2 56

57 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Preparation and Distribution of Minutes SL-IERC SOP # 5.2 Effective Date: April PURPOSE To describe the procedures for the preparation of the draft of the minutes and its final approval 2. SCOPE From the preparation of the draft of the minutes to filing of the approved minutes 3. FLOWCHART PROCESS Minutes recorded in an MP3 are copied to a Compact Disc CD) PERSON/S RESPONSIBLE Preparation of draft of the Minutes based on MP3 record Sending of the draft of the Minutes to the IERC Chair for revisions/corrections Revisions/corrections in the Minutes made IERC Chair Printing of final version of the Minutes and distribution to IERC Members /IERC members Filing of Approved Minutes 4. PROCEDURE 4.1. Recording of Minutes The shall record the proceedings of an IERC meeting Minutes of an IERC meeting shall be recorded in an MP3 recorder The shall copy the MP3 record to a compact disc and shall label the compact disc with a sticker indicating the date (year, month, day) The shall place the compact disc in a CD clear sheet as electronic file of the Minutes in the IERC office Preparation of draft copy of the Minutes (refer to template of Minutes of Meeting) The shall prepare the draft copy of the Minutes using the following format: Date and venue of the meeting Attendance/Absences Person presiding Declaration of Quorum Time when the meeting started Items discussed in the final agenda Decision on matters discussed i.e. approval/disapproval of clinical trials Schedule of the next IERC Meeting SL-IERC SOP 2013 V2 57

58 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Preparation and Distribution of Minutes SL-IERC SOP # 5.2 Effective Date: April The shall send the draft of the Minutes to the IERC Chair for revisions/corrections Revisions and corrections in the drafts of the Minutes The IERC Chair shall make corrections in the draft of the Minutes The shall incorporate the corrections and print the final version of the Minutes The IERC Chair and person who prepared the minutes shall sign the final version of the Minutes The shall distribute the printed final version of the Minutes to individual IERC members together with the Tentative Agenda of a regular meeting. ---Nothing Follows--- SL-IERC SOP 2013 V2 58

59 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedure-Emergency/Special Meetings SL-IERC SOP # 5.3 Effective Date: April PURPOSE To describe the procedures in recognizing and evaluating events/situations that will require an emergency/special meeting and the conduct of such meetings. 2. SCOPE From evaluating events or situations, making a decision, giving notice, and conducting emergency meetings, to adjournment and communication of decisions made. 3. FLOWCHART ACTIVITY PERSON/S RESPONSIBLE Evaluating members, Medical events/situations IERC Chair, Executive Secretary, IERC Director, VP for RBD, Quality Officer of SLMC Making a decision to have an Emergency Meeting IERC Chair Sending of Notice of Emergency Meeting Conduct of Meeting Communication of decision and filing of documents IERC Chair 4. PROCEDURE 4.1. Evaluating events/situations and deciding to call for an emergency meeting of the IERC: The following events/situations will require an emergency meeting of the IERC: Occurrence of an unexpected serious adverse event that will be life-threatening to study participants Recall of study drug by regulatory authorities Other urgent issues as identified by IERC team, CCT team, SLMC administration officials After an evaluation of the event/situation, the IERC Chair shall call for an emergency meeting of the IERC The shall send a Notice of Emergency Meeting to IERC members, including resource persons, if needed. SL-IERC SOP 2013 V2 59

60 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedure-Emergency/Special Meetings SL-IERC SOP # 5.3 Effective Date: April The shall prepare the Agenda and relevant materials for the emergency meeting 4.2. Conduct of Meeting The IERC Chair shall determine the presence of a quorum The IERC Chair shall immediately present the relevant issues for discussion and shall ensure that the issues are resolved in the meeting The IERC shall make a decision on the issues by consensus. The shall record and take minutes of the meeting Communication of decision and filing of documents The shall prepare the Notice of Action to be signed by the IERC Chair The shall deliver the NOA to the person concerned The shall file the relevant materials and documents appropriately ---Nothing Follows--- SL-IERC SOP 2013 V2 60

61 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedure- Preparation for a Regular IERC Meeting SL-IERC SOP # 5.4 Effective Date: April PURPOSE To describe the procedures in the preparation for a regular IERC meeting 2. SCOPE From making the room reservation to the start of the meeting 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Reservation of venue, Preparation of requests from Food & Nutrition, Transport service and Accounting Departments Preparation of meeting materials (Agenda, Minutes of previous meetings, Protocols for review) and consolidation in a binder Distribution of binders to IERC Members Follow up reminders to IERC Members/PIs /Food and Nutrition Dept./Transport Services/Accounting Preparation of venue and distribution of individual evaluation sheets to IERC members Arrival of IERC Members and Presenters/PI IERC Members and Presenters/PIs Start of Meeting Chair of IERC 4. PROCEDURE 4.1. Preparation of venue and requests to other concerned Divisions The shall reserve the use of the RBD Conference Room for the IERC meeting The shall prepare the following requests: Dietary Request Form to Food and Nutrition Department Transport Request Form to Transport Services Department Check Preparation Request for IERC honorarium to Accounting Department SL-IERC SOP 2013 V2 61

62 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedure- Preparation for a Regular IERC Meeting SL-IERC SOP # 5.4 Effective Date: April Preparation and distribution of meeting materials The shall prepare a binder containing the following documents for the meeting for each IERC member: The Tentative Agenda for the Meeting Minutes of the Previous Meeting All protocols for review In addition, the IERC Chair shall receive a copy of the following for discussion Report which contains list of SAEs, Amendments, Safety Reports, Correspondences Other Matters for Approval The shall distribute the binder to each IERC Member at least 1 week prior to the scheduled meeting Before the day of the meeting, the shall be responsible for: Determining if there will be a quorum for the meeting Preparing the Tentative Agenda for distribution on the day of the meeting Follow up reminders to the following departments: Food and Nutrition Transport Service Dept. Accounting Dept. Housekeeping Dept Preparation of the following: Individual Evaluation Sheets MP3 recorder Laptop and LCD projector References on Research Ethics 4.4. Day of the Meeting The administrative support staff shall see to it that the venue is ready the pertinent documents are available(i.e. Agenda and protocols for review) are placed on the table breakfast is set on the buffet table The shall usher the IERC members to the meeting room The shall usher the Presentors to the Reception area where they can have breakfast while waiting for their turn The shall give the Ethics Review Forms, if any, to the IERC Chair 4.5. Start of Meeting The shall occupy a seat in the meeting room and shall turn on the MP3 recorder placed beside the IERC Chair The IERC Chair shall ask the if there is a quorum The IERC Chair shall call the meeting to order. (Refer to SL-IERC SOP on Conduct of a Regular IERC Meeting) ---Nothing Follows--- SL-IERC SOP 2013 V2 62

63 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedure- Conduct of a Regular IERC Meeting SL-IERC SOP # 5.5 Effective Date: April PURPOSE To describe the procedures in the conduct of a regular IERC meeting 2. SCOPE From start of the meeting to adjournment 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Call to Order IERC Chair Meeting Proper/Recording of minutes/assistance to Principal Investigators for their oral presentation Compilation of Evaluation Sheets Adjournment Distribution of IFF to presenters Collection of IFF from presenters 4. PROCEDURE 4.1. Start of meeting The IERC meeting shall be conducted in accordance with the sequence as prepared in the Agenda After the Invocation, the Chair shall call the meeting to order The Chair shall ask the if there is a quorum. Quorum will be declared if: ( 21 CFR c) majority of the IERC members are present but should not be less than 5. Moreover, at least one member whose primary concerns are not in scientific areas is present If there is a quorum, the Chair shall proceed. If no quorum exists, the Chair shall declare adjournment The Chair shall ask for the approval of the agenda The Chair shall ask if any member of the IERC has a conflict of interest in any of the proposals for review. Conflict of Interest is present when an IERC member has affiliation with a Principal Investigator or institute which will undermine his/her ability to make a free and independent evaluation. If any member of the IERC declares a conflict of interest in any of the protocols for review, the Chair/IERC shall request the concerned member not to participate in the decision-making of the specified protocol. If there is no declaration of any conflict of interest, the Chair shall proceed with the next item in the Agenda. SL-IERC SOP 2013 V2 63

64 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedure- Conduct of a Regular IERC Meeting SL-IERC SOP # 5.5 Effective Date: April The Chair shall present the Tentative Agenda for approval/revision Conduct of meeting The IERC Chair shall present the Minutes of the Previous Meeting for Reading and Approval discuss matters arising from the minutes Presentation of Clinical Trial Protocols/Research Proposals The IERC Chair shall call and introduce the presentor The IERC Chair shall facilitate interpolation Before the presenter leaves, the shall request him to fill up and sign the following: Attendance Sheet an Internal Feedback Form (IFF) to serve as his evaluation of the services provided by the (Refer to HRD-ODD-PAMS ) The IERC Chair shall present other items as listed in the Agenda Items for review and discussion: Protocol Amendments Site Specific Informed Consent Forms Serious Adverse Events Posters/Advertisement for patient recruitment Other administrative matters Items for information Other Matters 4.3. Adjournment The Chair shall adjourn the meeting after confirmation of the date of the next Regular Meeting The shall turn off the MP3 recorder distribute honorarium checks and relevant documents to members of the IERC. call transport service to bring community member to her office/residence. call Housekeeper to clean the meeting venue. collect all binders and keep these on file at the IERC Office. ---Nothing Follows--- SL-IERC SOP 2013 V2 64

65 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Management of Communications SL-IERC SOP # 5.6 Effective Date: April PURPOSE To describe the procedures that will ensure proper logging, distribution and documentation of all communications to and from the IERC, as well as communications related to functions of the Center for Clinical Trials. 2. SCOPE From the distribution and receipt to the recording and filing of communications. 3. FLOWCHART: The is responsible for all the following activities: Classification of communications into protocol-related and nonprotocol-related, incoming and outgoing Recording of all communications in a Logbook For incoming, protocolrelated communications: Filing of communications in appropriate binders For outgoing communications: Distribution to appropriate recipients 4. PROCEDURE 4.1. shall classify all communications as follows: Incoming or outgoing Protocol-related or non-protocol-related 4.2. Incoming/Outgoing Communications The shall record all incoming communications in a Logbook chronologically The shall distribute outgoing communications to appropriate recipients. ---Nothing Follows--- SL-IERC SOP 2013 V2 65

66 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Management of Administrative Files, Logbooks and Forms SL-IERC SOP # 5.7 Effective Date: April PURPOSE To describe the procedures in the management of administrative files, logbooks and forms. These include manuals, references, Tracking Forms and other administrative files. 2. SCOPE From generation to disposal of administrative files, logbooks and forms. 3. FLOWCHART PROCESS PERSON/S RESPONSIBLE Generation of various documents and records IERB Chair and Members Executive Secretary and Sorting of accumulated documents and records Maintenance and storage of documents and records in appropriate files Archiving, destruction and disposal of unnecessary files 4. PROCEDURE 4.1. The IERC shall receive documents that are not Protocol-related such as: reference materials letters to IERB Chair members and investigator profiles logbooks and files forms 4.2. The IERC shall sort out documents to protocol-related, non-protocol-related and administrative in nature. SL-IERC SOP 2013 V2 66

67 INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Administrative Procedures- Management of Administrative Files, Logbooks and Forms SL-IERC SOP # 5.7 Effective Date: April The IERC shall maintain the following Logbook files: Active Study files which include files of on-going researches shall contain: CT Tracking Form SAE Tracking Form Correspondence o Submission Letter o Invitation to present o Notice of Action (NOA) o Response to NOA o Ethical Clearance o Principal Investigator s Responsibilities signed conforme o o IERC Members Composition Submissions o Protocol o Investigator s Brochure o Informed Consent Forms o Sample CRF o Patient Recruitment materials/ads/posters o Principal Investigator s CV o GCP Certificate o Malpractice Insurance o PFDA approval o Amendments o SAE Reports o Line Listing of CIOMS/Safety Reports/SUSARS o Protocol Deviations Archived Files which includes protocol on research that are completed, terminated, withdrawn or closed out shall contain : Files of SAEs, SUSARs and CIOMS Meeting Agenda, Attendance, and Minutes of IERC meetings Progress Report Files Forms and List of Forms IERC SOPs 4.4. Destruction and disposal of documents The shall shred and dispose: unused protocols and related documents archived documents beyond the retention period After shredding, all dry waste are collected in a black bag. (Refer to Waste Management Policy-MED-***-ICS ) ---Nothing Follows--- SL-IERC SOP 2013 V2 67

68 INSTITUTIONAL ETHICS REVIEW COMMITTEE SL-IERC FORMS SL-IERC SOP 2013 V2 68

69 LIST OF SL-IERC FORMS FORM DESCRIPTION FORM # 1. Agreement on Confidentiality and Conflict of Interest Form SL-IERC FORM#01A 2. Agreement on Confidentiality and Conflict of Interest Form (for Preliminary Reviewer) SL-IERC FORM#01B 3. Initial Protocol Review Submission Form SL-IERC FORM#02 4. Initial Protocol Review Submission Acknowledgment Form SL-IERC FORM#03 5. CT Tracking Form SL-IERC FORM#04 6. Technical Review Form SL-IERC FORM#05A 7. Ethics Review Form SL-IERC FORM#05B 8. Notice of Meeting SL-IERC FORM#06A 9. Notice of Emergency Meeting SL-IERC FORM#06B 10. Invitation to Present SL-IERC FORM # IERC Attendance Sheet SL-IERC FORM #09A 12. Attendance Sheet for Presentors SL-IERC FORM #09B 13. Principal Investigator s Responsibilities SL-IERC FORM # Notice of Action SL-IERC FORM #12A 15. IERC Composition SL-IERC FORM #12B 16. Ethical Clearance SL-IERC FORM#13A 17. Request for Ethical Clearance Renewal SL-IERC FORM#13B 18. Ethical Clearance Renewal Form SL-IERC FORM#13C 19. SAE Form SL-IERC FORM#14A 20. SAE Tracking Form SL-IERC FORM#14B 21. Protocol Deviation/Violation SL-IERC FORM# Continuing Review Report Form SL-IERC FORM# Agenda Template SL-IERC FORM# Minutes of the Meeting Template SL-IERC FORM# Final Report SL-IERC FORM#19 SL-IERC SOP 2013 V2 69

70 (SL-IERC FORM#01A) Agreement on Confidentiality and Conflict of Interest Form (For IERC Members) SL-IERC SOP 2013 V2 70

71 (SL-IERC FORM#01B) Agreement on Confidentiality and Conflict of Interest Form (For Preliminary Reviewer) SL-IERC SOP 2013 V2 71

72 (SL-IERC FORM#02) Initial Protocol Review Submission Form SL-IERC SOP 2013 V2 72

73 (SL-IERC FORM#03) Initial Protocol Review Submission Acknowledgment Form SL-IERC SOP 2013 V2 73

74 (SL-IERC FORM#04) CT Tracking Form SL-IERC SOP 2013 V2 74

75 (SL-IERC FORM#05A) Preliminary Technical Review Form Page 1 of 2 SL-IERC SOP 2013 V2 75

76 (SL-IERC FORM#05A) Preliminary Technical Review Form Page 2 of 2 SL-IERC SOP 2013 V2 76

77 (SL-IERC FORM#05B) Ethics Review Form Page 1 of 4 SL-IERC SOP 2013 V2 77

78 (SL-IERC FORM#05B) Preliminary Ethics Review Form Page 2 of 4 SL-IERC SOP 2013 V2 78

79 (SL-IERC FORM#05B) Preliminary Ethics Review Form Page 3 of 4 SL-IERC SOP 2013 V2 79

80 (SL-IERC FORM#05B) Preliminary Ethics Review Form Page 4 of 4 SL-IERC SOP 2013 V2 80

81 (SL-IERC FORM#06A) Notice of Meeting SL-IERC SOP 2013 V2 81

82 (SL-IERC FORM#06B) Notice of Emergency Meeting SL-IERC SOP 2013 V2 82

83 (SL-IERC FORM#08) Invitation to Present (Page 1 of 2) SL-IERC SOP 2013 V2 83

84 (SL-IERC FORM#08) Invitation to Present (Page 2 of 2) SL-IERC SOP 2013 V2 84

85 (SL-IERC FORM#09A) IERC Attendance Sheet SL-IERC SOP 2013 V2 85

86 (SL-IERC FORM#09B) Attendance Sheet for Presentors SL-IERC SOP 2013 V2 86

87 (SL-IERC FORM#10) Investigator s Responsibilities SL-IERC SOP 2013 V2 87

88 (SL-IERC FORM#12A) Notice of Action SL-IERC SOP 2013 V2 88

89 (SL-IERC FORM#12B) IERC Composition as Attachment to Notice of Action SL-IERC SOP 2013 V2 89

90 (SL-IERC FORM#13A) Ethical Clearance SL-IERC SOP 2013 V2 90

91 (SL-IERC FORM#13B) Request for Ethical Clearance Renewal SL-IERC SOP 2013 V2 91

92 (SL-IERC FORM#13C) Ethical Clearance Renewal Form SL-IERC SOP 2013 V2 92

93 (SL-IERC FORM#14A) SAE Form SL-IERC SOP 2013 V2 93

94 (SL-IERC FORM#14B) SAE Tracking Form SL-IERC SOP 2013 V2 94

95 (SL-IERC FORM#15) Protocol Deviation/Violation Form SL-IERC SOP 2013 V2 95

96 (SL-IERC FORM#16) Continuing Review Report Form (Page 1 of 2) SL-IERC SOP 2013 V2 96

97 (SL-IERC FORM#16) Continuing Review Report Form (Page 2 of 2) SL-IERC SOP 2013 V2 97

98 (SL-IERC FORM#17) Agenda Template SL-IERC SOP 2013 V2 98

99 (SL-IERC FORM#18) Minutes of the Meeting Template SL-IERC SOP 2013 V2 99

100 (SL-IERC FORM#19) SL-IERC SOP 2013 V2 Final Report Form 100

101 INSTITUTIONAL ETHICS REVIEW COMMITTEE GLOSSARY SL-IERC SOP 2013 V2 101

102 INSTITUTIONAL ETHICS REVIEW COMMITTEE GLOSSARY Adverse events - any untoward or undesirable medical occurrence in a patient or participant in clinical investigation after use or administration of an investigational product. This is not necessarily caused by the treatment. See also adverse drug reaction, serious adverse event and unexpected adverse event. Amendment to the protocol - A written description of a change(s) to, or formal clarification of a protocol and changes on any other supporting documentation made from the originally approved protocol by the research ethics review body after the study has began. See protocol amendment. Approval - favorable or affirmative decision of the Research Ethics Committee following a review of the protocol and other required documents and thus research may already be started and undertaken as set forth by the ethics committee, CPG, the institution, and relevant regulatory terms. Assent - authorization for one s own participation in research given by a minor or another subject who lacks the capability to give informed consent. The assent is a requirement for research in addition to consent given by a parent or legal guardian; It is agreement by an individual not competent to give legally valid informed consent like a child or cognitively impaired person to participate in research. See also child s assent and surrogate assent. Center for Clinical Trials This is one of the Centers of the Research and Biotechnology Division of St. Luke s Medical Center- Quezon City that has the mandate for the administration and management of clinical trials at St. Luke s. The budget of the IERC is channeled through this Center Clinical research - is a study undertaken involving a particular person or group of people with the purpose of increasing knowledge and determining how well treatment or diagnostic test works in a particular patient population. The NIH-USA defines clinical research as: Patient-oriented research involves a particular person or group of people or uses materials from humans. This research can include: Studies of mechanisms of human disease; Studies of therapies or interventions for disease; Clinical trials and Studies to develop new technology related to disease. Epidemiological and behavioral studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions. Outcomes and health services research seeks to identify the most effective and most efficient interventions, treatments, and services. Clinical trials - is a planned scientific research or study among human volunteers to determine the effects of treatment or diagnostic test on their safety, efficacy, and its effect on quality of life. It is also a systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study the absorption, distribution, metabolism, and excretion of the products with the object of ascertaining their efficacy and safety (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products) It is also defined as investigative work to evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings. Clinical trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. See also clinical research. Dossier - a file containing detailed records on a particular person or subject. (Merriam-Webster Dictionary) Ethical clearance - a certification that a research proposal has complied with ethical requirements; action of an ethics review committee on a research protocol that signifies approval and permission to proceed with the research. See approval Ethics review - the evaluation of a research protocol by an ethics review committee to promote the safety and protection of the dignity of human participants. This a systematic process by which this independent committee evaluates a study protocol to determine if it follows ethical and scientific standards for carrying out biomedical research on human participants. It checks if the protocol complies with the guidelines to ensure that the dignity, rights, safety and well-being of research participants are promoted. Ethics review committee - also called research ethics committee (REC), institutional ethics review board - (IERB), independent ethics committee (IEC) or institutional review board (IRB) - committee constituted to review the ethical aspects of a research proposal and its possible implementation. This is an independent body whose responsibility is to ensure the protection of the rights, safety and well-being of human participants involved in a trial and to provide public assurance of that protection. See also research ethics committee SL-IERC SOP 2013 V2 102

103 Expedited review Full board review Good clinical practice guidelines (GCP) Guidelines Health research High-risk group Human subjects Resource Person Informed consent INSTITUTIONAL ETHICS REVIEW COMMITTEE GLOSSARY - is an ethics review of research protocol by the IRB chair or a designated voting member or subgroup of voting members rather than by the entire IRB. This is done for some research involving no more than minimal risk and maybe for minor changes in approved research, annual renewals of approved projects, approval of protocol amendments, research conducting health record review, and for confirming changes required by the ethics committee for approval of the protocol. - review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting - an international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with these standards provide public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the International Declaration of Helsinki, and that the clinical trial data are credible. These are standards and procedures for clinical trials that encompass the design, protocol approval, monitoring, termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and activities of the sponsor, principal investigators and monitor involved in the clinical trials. The GCP ensures that the studies are scientifically and ethically sound, and all the clinical properties of the product under investigation are properly documented. For complete information, reference is made to the published WHO and International Conference on Harmonization Code of Good Clinical Practice. (Department of Health Administrative Order No. 47-A series of 2001, [August 30, 2001); It is a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical products (diagnostic, therapeutic or prophylactic) under investigation are properly documented (World Health Organization, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products). - a set of rules or recommendations intended to effect a course of action. - generation of new knowledge (biomedical, clinical, social) to identify and deal with health problems, health systems and policies as well as those that impact on health such as socioeconomic, environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004). This is composed of investigational activities that aim to generate data that shall contribute to improvement in the diagnosis, prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of life of individuals and health conditions in communities. See also clinical research. - social group known to have a high prevalence of a health problem because of shared environmental, occupational, nutritional or genetic factors including practices that contribute to ill-health. - See research participants and respondent - an expert who gives advice(s), comment(s) and suggestion(s) upon review of the study protocols; with no affiliation to the institute(s) or investigator(s) proposing the research proposal. - the process of obtaining approval to participate in an investigative study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making; It is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation (CIOMS, 2002). SL-IERC SOP 2013 V2 103

104 INSTITUTIONAL ETHICS REVIEW COMMITTEE GLOSSARY Informed Consent Document Investigator Investigator s Brochure Minimal risk Monitor Monitoring Philippine Health Research Ethics Board Principal investigator Privacy Protocol - A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. - a person responsible for the conduct of the critical trial at a trial site. If trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and be called the principal investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1); It is a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of, medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products); The investigator must be a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites See principal investigator - compilation of all relevant clinical and non-clinical information and data on the investigational product. the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR ) - - a person appointed by and responsible to the sponsor or contract research organization for monitoring and reporting progress of the trial and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products) - is the process of checking or scrutinizing research participants health status during a clinical trial, and/or to oversee the progress of a trial or research and/or to check researcher's compliance with the protocol and regulatory requirements with in which the protocol is given ethical approval - was created on March 1, 2006 through DOST Special Order No. 091 series of 2006 as a policymaking body for research ethics in the Philippines - the chief or person primarily responsible for the implementation of a research project See also investigator - is the right or claim or state or ability or condition of an individual or group or institution to conceal or seclude or hide themselves or information about themselves and thus reveal or expose themselves selectively; It is a conceptual space defining the individual s boundary as a person, intrusion of which is limited by human rights and by law. It is right to determine when, how, and to what extent information about someone is communicated to others - a document that provides the background, rationale, and objective(s) of a biomedical research project and describes its design, methodology, and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22); a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. (International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.44). SL-IERC SOP 2013 V2 104

105 INSTITUTIONAL ETHICS REVIEW COMMITTEE GLOSSARY Protocol amendment Regulatory requirements Research ethics committee Research participants or subjects Research protocol Risk Risk-benefit ratio Risk factors Serious adverse event - a written description of a change(s) to, or formal clarification of a protocol. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22) See amendment to protocol - necessary prerequisites for the approval and conduct of clinical trial by a national regulatory authority. For example, for pharmaceutical and biologic products it means obtaining a permit for clinical investigational use which is a registration document issued by the FDA for the purpose of allowing the conduct of Phase I, Phase II, and Phase III clinical trials of investigational biologic products in the country DOH Administrative Order No. 47-A series of 2001 Rules and Regulations on the registration including approval and conduct of clinical trials, and lot or batch release certification of vaccines and biologic products. See Permit for clinical investigational use. - is an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.27) See also Institutional Ethics Review Committee, Cluster research ethics committee, ethics review committee - An individual who participates in a biomedical research project, either as the direct recipient of an intervention (e.g., study product or invasive procedure), as a control, or through observation. The individual may be a healthy person who volunteers to participate in the research, or a person with a condition unrelated to the research carried out who volunteers to participate, or a person (usually a patient) whose condition is relevant to the use of the study product or questions being investigated. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22) - a document that provides the background rationale and objective(s) of a biomedical research project and describes its design, methodology and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. See also protocol - the probability of discomfort or harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Risks to research participants must be justified by the anticipated benefits to the subjects or to society. The investigator(s) and IRB must assess the risks and benefits of proposed research. See also minimal risk. - The risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated. (clinicaltrial.gov/ct2/info/glossary) - are variables or conditions that increase the risk or chances of disease or infection; determinants of disease development. Also see risk. - or serious adverse drug reaction is an adverse event that results to death, lifethreatening incident or causes immediate risk of death from the event; results to inpatient or prolongation of hospitalization, causes significant disability, incapacity, and congenital anomaly or another episode which is considered a significant hazard to the participant. See also adverse event or unexpected adverse event. Also, any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, -results in persistent or significant disability/incapacity, or - is a congenital anomaly/birth defect (International Conference on Harmonisation (ICH) - Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.50) See adverse event, adverse drug reaction SL-IERC SOP 2013 V2 105

106 INSTITUTIONAL ETHICS REVIEW COMMITTEE GLOSSARY Risk factors Study Document Unexpected adverse event Voluntary Vulnerability Vulnerable persons/groups Web portal - are variables or conditions that increase the risk or chances of disease or infection; determinants of disease development. Also see risk. - means all records, accounts, notes, report, data and ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Study, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as CRFs and all other reports and records necessary for the evaluation and construction of the Study. - is an adverse reaction that has not been anticipated, nor previously experienced, or observed, and is not consistent with the informed consent, information sheets or applicable product information in the investigator s protocol or brochure, product or package insert or summary of product characteristic. See also adverse event and serious adverse event - free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity. (IRB Guidebook, US DHHS in downloaded on June 19, 2010) - refers to a substantial incapacity to protect one's own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group. (CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General Ethical Principles) - are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.61) Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. (CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 9) These are also classes of individuals who have characteristics that lessen their capacity to protect their own interests or promote their own welfare; These are persons whose situation or characteristics may make them unable to provide free and informed consent to participate in research. This group includes children, institutionalized persons, those who have cognitive impairments, and those in a position of inferiority ( down loaded on July 9, 2010) - is a web site that brings together information from diverse sources in a unified way. (Wikepedia) SL-IERC SOP 2013 V2 106

107 INSTITUTIONAL ETHICS REVIEW COMMITTEE REFERENCES SL-IERC SOP 2013 V2 107

108 INSTITUTIONAL ETHICS REVIEW COMMITTEE REFERENCES 1. Philippine National Ethical Guidelines for Health Research 2011 handbook 2. International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6 3. International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E10 4. Protocol Risk assessment and Monitoring Guidelines of the North Carolina Translational and Clinical Sciences Institute; University of Kentucky Minimal risk definition 5. WHO- Casebook on Ethical Issues in International Research. Ed. R Cash, D. Wikler, A. Saxena, A. Capron WHO-Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants CFR CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects Revised draft, January WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22St. Luke s Policy on Monitoring of Clinical Safety of Investigational Drugs 11. St. Luke s Quality Procedures on the Ethical Review Clinical Trial Protocols 12. Reviewing Clinical Trials: A guide for Ethics Committees St. Luke s Hospital Policy on Waste Management 14. St. Luke s Hospital IFF Form HRD-ODD-PAMS Merriam-Webster Dictionary SL-IERC SOP 2013 V2 108

109 St. Luke s Medical Center INSTITUTIONAL ETHICS REVIEW COMMITTEE For more information, please contact: IERC SECRETARIAT Direct Line: (632) Trunkline: (632) Locals: 7391/5562 Fax: (632) ethicsreview@stluke.com.ph Visit our website at: Annex III, 5th Floor 279 E. Rodriguez Sr. Boulevard Quezon City 1102 Philippines