CV-REC CENTRAL VISAYAS RESEARCH ETHICS COMMITTEE STANDARD OPERATING PROCEDURES

Transcription

1 CV-REC CENTRAL VISAYAS RESEARCH ETHICS COMMITTEE STANDARD OPERATING PROCEDURES CV-REC SOP 2016 v2 i

2 CENTRAL VISAYAS RESEARCH ETHICS COMMITTEE (CV-REC) I. STANDARD OPERATING PROCEDURES Table of Contents No. Standard Operating Procedure (SOP) Title Page 1 CV-REC Structure and Composition Constituting the Central Visayas Research Ethics Committee 2 Management of Initial Submissions and Resubmissions 27 3 Management of Post Approval Submissions 3.1 Review of Progress, Final, and Early Termination Reports and Protocol Amendments 3.2 Review of SAE-Reportable Negative Events (RNEs) 3.3 Review of Protocol Deviations and Violations 4 Review Procedures 4.1 Full Review 4.2 Expedited Review 4.3 Exempted Review Meeting Procedures 5.1 Agenda Preparation and Conduct of Regular and Special Meetings 83 6 Documentation of REC Actions 6.1 Managing the Meeting Minutes 6.2 Communicating CV-REC Decisions 7 Management and Archiving of Files 7.1 Managing CV-REC Incoming/Outgoing Communications 7.2 Maintenance and Storage of Active Study Files (Administrative and Study Files) 7.3 Archiving and Retrieval of Documents (Inactive, Terminated and Completed Files) 7.4 Maintenance and Confidentiality of Study Files Preparing for Monitoring/Site Visits Managing Queries and Complaints Writing, Reviewing, Distributing and Amending SOPs 128 CV-REC SOP 2016 v2 i

3 II. LIST OF CV-REC SOP FORMS Form No. Form Description Page Form 1A Invitation Letter for Independent Consultant/Observer 12 Form 1B Appointment Letter 13 Form 1C Curriculum Vitae 14 Form 1D Roster of CV-REC Members 15 Form 1E Terms of Reference 16 Form 1F Confidentiality and Conflict of Interest Agreement 22 Form/Financial Disclosure Form 1G Evaluation Form 25 Form 2A Research Protocol Application Form 32 Form 2B Protocol Review Assessment Form 33 Form 2C Informed Consent Form (ICF) Checklist 36 Form 2D Detailed Budget Sheet 38 Form 2E Submission Checklist 39 Form 2F Document Receipt Form 40 Form 2G Log of Protocol Submission 41 Form 2H Acknowledgement Letter of Protocol Submission 42 Form 2I Assessment Form of Resubmitted Protocol/Other submitted 43 documents Form 3A Study Protocol Amendment Submission Form 50 Form 3B Continuing Review Application Form 51 Form 3C Early Termination Report Form 53 Form 3D Final Report Form 54 Form 3E Reminder Letter for Continuing Report 56 Form 3F Serious Adverse Event Report 60 Form 3G Study Protocol Noncompliance (Deviation or Violation) Report 64 Form 4A Primary Reviewer Appointment 72 Form 4B Review Exemption Application Form 82 Form 5A Notice of Meeting/Agenda Template 87 Form 5B Protocol Approval Template 92 Form 5C Letter Template for Clarification or PI Interview 94 Form 5D Approval of Protocol Amendment 95 Form 5E Approval of Final Report Template 96 Form 5F Approval of SAE Deviation Site Visit Continuing Review 97 Form 7A Logbook for Incoming Communication 106 Form 7B Logbook for Outgoing Communication 107 Form 7C Document Request Form 113 CV-REC SOP 2016 v2 ii

4 Form No. Form Description Page Form 7D Borrower s Log 114 Form 8A Notice of Site Visit 122 Form 8B Site Visit Report 123 Form 9A Query/Complaint Form 127 Form 10A Template for CV-REC SOP 133 Form 10B Request for Creation/Revision of an SOP 134 Form 10C Document History of the SOPs 135 Form 10D Log of SOP Distribution 136 CV-REC SOP 2016 v2 iii

5 III. Appendices Page I Composition of Central Visayas Research Ethics Committee 137 CV-REC SOP 2016 v2 iv

6 INTRODUCTION This shall serve as the Standard Operating Procedures (SOP) of the Central Visayas Research Ethics Committee (CV-REC). This SOP is provides clear, unambiguous instructions for the evaluation and review of research protocols submitted and presented to the Central Visayas Research Ethics Committee (CV-REC). These Standard Operating Policies and Procedures apply to all the day-to-day operations of the CV-REC and to all persons who serve on the CV-REC and all others who must subscribe to its decisions and its requirements. Establishment of and Mandate of the CV-REC The Central Visayas Research Ethics Committee (CV-REC) is one of the committees of the Central Visayas Consortium for Health Research and Development (CVCHRD). CVCHRD is expected to serve as the regional arm of the Philippine National Health Research System (PNHRS) and assist DOST-Philippine Council for Health Research and Development (DOST-PCHRD) in promoting research culture, establishing mechanisms to strengthen health research capabilities, encourage collaboration and resource sharing between institutions, and promote the dissemination of regional/national health research agenda and utilization of health research results in the region. 1 Since its organization, CVCHRD promotes a problem-based and collaborative approach to health R&D and supports health research that conforms to the highest ethical and technical standards. Its structure dovetails effective linkages through its 21 member institutions mainly from government agencies, academic institutions, hospitals and professional societies, namely: Cebu Doctors University, Cebu Institute of Medicine, Cebu Medical Society, Cebu Normal University, Cebu Institute of Technology University, Chong Hua Hospital, Commission on Higher Education, Department of Health-Center for Health Development VII, Department of Science and Technology VII, Foundation University, Holy Name University, National Economic Development Authority VII, Negros Oriental State University, Silliman University, Southwestern University, St. Paul University Dumaguete, University of Bohol, University of Cebu, University of San Carlos, V. Gullas Memorial College of Medicine and Vicente Sotto Memorial Medical Center. The CV-REC, otherwise known as the CVCHRD Committee on Ethics Review, was established in The function of the committee are: (1) review proposals as to compliance to ethical and other standards; monitor compliance of on-going projects to ethical standards; promote the creation of ethical review committees (ERC) in health research in member institutions, conduct continuing updates on bioethics for members of ERC and institution s ERCs, advocate for the adoption of the Philippine Health Research Ethics Board (PHREB) and international guidelines on ethical standards and practices in health; and encourage the 1 DOST-PCHRD Regional Research Fund Initiation Guidelines CV-REC SOP 2016 v2 v

7 establishment of institutional ethics and review committees in health research organizations in Region VII. 2 As a Level 1 Accredited REC, the CV-REC shall only review researches involving human participants and researches with minimal risk to participants. A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed 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 (National Ethical Guidelines for Health Research 2011, p. 150). Only complete submissions directed to the committee and conducted within Central Visayas shall be accepted and reviewed by the CV-REC. The CV-REC shall ensure that all research proposals comply with the ethical and scientific standard of conducting researches involving human participants. It shall only endorse proposals to the Philippine Council for Health Research and Development for funding when the approved proposals meet the technical and ethical merits duly approved by the CVCHRD Technical Review Board (TRB) and CV- Research Ethics Committee (CV-REC). The CV-REC shall monitor the administration of research protocols or programs and evaluates the outputs and outcomes of research projects within the region or in cooperation with other groups or institutions. Principles/Guidelines guiding the CV-REC The ethical principles and procedures established in this SOP are based on local and international guidelines for biomedical research involving human subjects. Specifically, the CV-REC shall function and be guided by the following: a. PNHRS National Ethical Guidelines for Health Research 2011 b. Declaration of Helsinki (2008) c. WHO Operational Guidelines for Ethics Committees the Review Biomedical Research 2000 d. WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011 e. International Conference on the Harmonization of Good Clinical Practice (ICH GCP) f. Council for International Organizations of Medical Science (CIOMS) 2002 and 2008 g. Western Pacific Region (WPRO) Ethics Review Committee Standard Operating Procedure The CV-REC shall ensure that compliance with the above ethical guidelines is necessary to ensure the safety, dignity and well-being of the human subjects involved in research studies. Organizational Structure The Central Visayas Research Ethics Committee shall operate as an independent committee according to the organization structure of the Central Visayas Consortium for Health Research and Development (CVCHRD) as shown below. 2 Cebu City, Philippines (2012). DOST-PCHRD and CVCHRD Memorandum of Agreement (MOA) for the Organization and Structure of the Regional Health Research Development Consortium in Central Visayas. CV-REC SOP 2016 v2 vi

8 CVCHRD Organizational Structure Advisory Council Secretariat Research and Development Committee Research Ethics Committee Capacity Building Committee Research Information and Utilization Committee Technical Review Boards REC Secretariat CV-REC Member CV-REC Member CV-REC Member CV-REC Member CV-REC Member CV-REC Legal Expert Member CV-REC Independent Lay Member CV-REC SOP 2016 v2 vii

9 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee 1. POLICY STATEMENT The constitution of the CV-REC shall be appropriate to ensure the suitable expertise, multi-discipline backgrounds and independence required for competent research ethics review. The membership shall include individuals with varying backgrounds and appropriate professional competence in reviewing diverse types of protocols. The CV-REC shall consist of at least five (5) members, including both men and women. The selection shall ensure the representation of different disciplines (scientist and nonscientists), gender and age. There shall be at least one member who has no affiliation with the institution. Selection of members shall be through nominations from current committee members and other sources identified by CVCHRD and DOST VII. Final appointment shall be approved by the CVCHRD Chair. 2. SCOPE This SOP shall apply to the constitution of the CV-REC and the selection and designation of the members and its Independent Consultants. This SOP describes the composition and appointment of the members of the CV-REC, the duties and responsibilities of the members, including the attendance, training and disclosure of conflict of interest. 3. RESPONSIBILITIES The Chair, members and the Secretariat shall be active participants in the nomination process. All members shall sign the Conforme to the Terms of Reference (Form 1E Terms of Reference and the Confidentiality and Conflict of Interest Agreement Form/Financial Disclosure of CV-REC Members (Form 1F) The CVCHRD Chair shall: Appoint the members of the CV-REC 3.2. The CVREC Chair shall: Call for the nominations of the vacant positions of the CV-REC Shortlist the submitted nominations 3.3. The CV-REC members shall: Ensure the competent review and evaluation of all scientific and ethical aspects of research protocol received in compliance with appropriate laws and welfare of subjects; CV-REC SOP 2016 v2 1

10 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee Attend continuing education and training programs to ensure that the CV- REC is qualified to perform their specific duties. 4. WORKFLOW Start Report of vacant positions CVCHRD REC Chair Call for nominations CVCHRD Chair Submission of nominations CV-REC members and other agencies Shortlisting of nominees Secretariat Invitation to and confirmation of interest of the nominees CVCHRD REC Chair Preparation of appointment papers of the new member/s Secretariat Appointment of new member/s CVCHRD Chair Signing of conforme and COI and Confidentiality Agreements New CVCHRD REC member End 5. DETAILED DESCRIPTION OF PROCEDURES 5.1. Call for nominations The CV-REC Chairperson identifies the vacant positions with the corresponding disciplinal, sectoral scientific/non-scientific, medical/nonmedical requirements and reports these to the CVCHRD Chair The CVCHRD Chair calls for nominations. Nomination letters shall include a copy of the Curriculum Vitae (Form 1C). A deadline shall be set for the submission of nominees The criteria for selection of members shall be as follows: Members shall be selected based on their interest, ethical and/or scientific knowledge and expertise, and experience in their field The members representing the medical scientist and/or clinicians should have adequate experience in their respective fields. CV-REC SOP 2016 v2 2

11 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee Conflict of interest shall be avoided while making appointments, but where unavoidable, there should be a transparency with regard to such interests Any persons responsible for business development shall not serve as members or ex-officio members The following qualities are sought in CV-REC members: Disciplinal and sectoral representation Interest in research ethics Willingness to volunteer time and effort for the CV-REC activities Respect for divergent opinions Integrity and diplomacy 5.2. Submission of nominations Submissions shall include a copy of the latest Curriculum Vitae (Form 1C) and a justification why the nominee is suitable as a member of the CV-REC as a medical/ non-medical, scientific/non-scientific member Shortlisting of nominees The Secretariat collates the nominations received and forwards it to the CV- REC Chairperson The CV-REC Chairperson submits the shortlist of nominees to the CVCHRD Chair Invitation to and confirmation of interest of the nominees The CVCHRD Chair, in consultation with the CV-REC Chairperson, selects the new members of the CV-REC Committee Preparation of appointment papers of the new member/s The Secretariat prepares the appointment papers of the new members with the Conforme to the Terms of Reference (Form 1E) for signature of the appointed member Appointment of new member/s The CVCHRD Chair appoints the new CV-REC member or Chair The Appointment Letter (Form 1B) with the Terms of Reference (Form 1E) shall be sent to the new member Signing of Conforme, COI and Confidentiality Agreements CV-REC SOP 2016 v2 3

12 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee The new member indicates his/her acceptance of the appointment by signing the following: Conforme to the Terms of Reference (Form 1E) Confidentiality and Conflict of Interest Agreement Form/Financial Disclosure of CV-REC Members (Form 1F) 6. CONSTITUTION AND FUNCTIONS 6.1. Composition of the CV-REC The CV-REC shall be composed of a minimum of 5 members and a maximum of 7 members. The members shall be selected so as to have an equitable representation of scientific and non-scientific members, clinicians and nonclinicians, members of the community, a lawyer, a social worker/layperson/patient representative to represent different points of view The committee shall comprise of a Chairperson, Co-chairperson, a Member Secretary and other active members who represent an appropriate balance of professional, ethical, legal, cultural, educational and community interests The committee should have adequate representation of age, gender, community to safeguard the interests and welfare of all sections of the community/society. Members should be aware of local, social and cultural norms, as this is the most important social control mechanism The composition shall be as follows: Chairperson Co-Chairperson Member Secretary Clinician Legal expert Social scientist/ non-scientific member/ representative of nongovernmental organization/ philosopher / ethicist / theologian One lay person from the community 6.2. Terms of Appointment The members of the CV-REC shall be appointed for duration of 2 years The appointment procedure for membership shall be followed to allow for the continuity, development and maintenance of expertise and the regular input of fresh ideas and approaches There shall be no limit on the number of times the membership is extended. Extension of membership shall be based on the recommendation of the CV- REC Chairperson and Member Secretary. CV-REC SOP 2016 v2 4

13 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee 6.3. Conditions of Appointment The members shall accept the appointment in writing and shall submit a Curriculum Vitae (CV) and training certificates in Health Research Ethics The name, gender, profession and affiliation of CV-REC members shall be publicized Members shall be required to sign the Confidentiality and Conflict of Interest Agreement Form/Financial Disclosure of CV-REC Members (Form 1F) at the start of their term. The confidentiality agreement protects the privacy and confidentiality of all parties whose information may be disclosed to the CV- REC in the course of its work. All members shall disclose in writing all conflicts of interest for themselves and their spouses/domestic partners and dependent children Members shall apprise themselves of the National Ethical Guidelines and CV- REC SOPs Renewal The membership shall be renewed after the stated term of 2 years The process of renewal shall be as follows: Selection shall be done at least 3 months and 1 month in advance respectively. New members shall be inducted as an observer during the board meeting before starting their tenure as CV-REC Members Resignation / Replacement Procedure A new member shall be appointed for the remaining term of the regular member who resigned or ceased to be a member due to disqualification or death Members who decide to resign shall provide the CV-REC Chairperson the written notification of their proposed resignation date at least 30 calendar days prior to the next scheduled meeting In case of resignation, the CVCHRD Chairperson, in consultation with the CV-REC Chairperson, shall appoint a new member, falling in the same category of membership (e.g. clinician with clinician) The CV-REC Chairperson shall evaluate the qualifications of the nominees and shall submit the final list of nominees to the CVCHRD Chairperson Disqualification Procedure In case of conduct of unbecoming for a member, inability to participate in the meetings on any grounds and failure to attend more than 3 consecutive meetings, the CV-REC shall decide to terminate the membership. CV-REC SOP 2016 v2 5

14 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee The CV-REC Chairperson shall make a recommendation to the CVCHRD Chairperson for necessary action In all such situations, the CV-REC Chairperson shall serve a letter of termination to the member Documentation of the termination shall be recorded in the minutes of the next duly constituted CV-REC meeting and the CV-REC membership roster and circulars shall be revised General Duties and Responsibilities: The members primary responsibility shall determine the scientific and ethical validity of the research and the protection of the safety, rights and confidentiality of the research subjects The members shall participate in the meetings, review and discuss research proposals assigned for evaluation, review progress reports and monitor ongoing studies, monitor Serious Adverse Events (SAEs) and recommend appropriate actions, and maintain confidentiality of the documents and deliberations of the meetings The members shall participate in continuing education activities in health research ethics and shall provide information and documents related to trainings obtained in health research ethics to the CV-REC Secretariat Specific Duties and Functions: Chairperson The CV-REC Chairperson shall be a highly respected individual from any CVCHRD member institutions, fully capable of managing the committee and the matters brought before it with fairness and impartiality The task of making the CV-REC as a respected institution shall fall primarily on the shoulders of the Chairperson The CV-REC Chairperson shall respect the diverse backgrounds, perspectives, sources of expertise of all members, especially the contributions of non-scientists, and shall foster such respect among the members Co-Chairperson The CV-REC Co-Chairperson shall be a highly respected individual from any CVCHRD member institutions, with the same capabilities of the Chairperson so as to manage the committee and the matters brought before it with fairness and impartiality CV-REC SOP 2016 v2 6

15 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee In the absence of the Chairperson, the Co-Chairperson shall chair the meeting. In the absence of both, a member who is independent of the institution shall chair the meeting as the Acting Chairperson Member Secretary The Member Secretary shall be appointed by the CV-REC Chairperson committed to the task of coordinating and managing the activities of the committee He/she shall be responsible for scheduling the meetings, describing the agenda and ensuring that the function of the committee is conducted as per norms and policies described in this SOPs In the absence of the CV-REC Member Secretary, the Secretariat staff of the CVCHRD shall function as acting Secretary for routine work In the absence of the CV-REC member-secretary for scheduled meeting, another member shall be nominated for that meeting to coordinate and manage the activities for that meeting The Member Secretary shall review disclosures to determine whether a conflict of interest exists and to determine appropriate management for the conflict of interest Secretariat The Secretariat shall be composed of the Member Secretary and the CVCHRD Secretariat/supporting staff The Secretariat shall have the following functions: Organization of an effective and efficient tracking procedure for each proposal received Preparation, maintenance and distribution of study files Organization of regular meetings Preparation of the agenda and the minutes of the meetings Maintenance of the records and archives Communication with the members and Principal Investigators (PIs) Arrangement of training for personnel and CV-REC Members Provision of the necessary administrative support for CV-REC related activities CV-REC SOP 2016 v2 7

16 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee 7. SELECTION OF INDEPENDENT CONSULTANTS 7.1. When the CV-REC Chairperson or Member Secretary determines that a study will involve procedures or information beyond the area of expertise of the members, the CV-REC shall call upon or establish a standing list of independent consultants to provide special expertise on the proposed research protocols These consultants shall be invited to attend the meeting (Form 1A) and shall sign the Confidentiality Agreement Form (Form 1F) These consultants or subject experts shall not vote for a decision Any persons responsible for business development shall not be appointed as independent consultants. 8. CONFIDENTIALITY AND CONFLICT OF INTERESTS 8.1. The members shall disclose all conflict of interests including their spouse/domestic partner and their dependent children with regard to a research project involving human participants The CV-REC member or independent consultant shall evaluate whether a conflict of interest exists and he/she shall disclose any identified conflicts at the next CV-REC meeting CV-REC members shall cooperate with the committee and other officials in their review of the conflicts of interest issues and shall comply with all requirements of the CV-REC A conflict of interest may be identified as either financial in nature (such as when a member holds an economic interest in the research) or non-financial in nature (such as when a member or consultant participates in the research or will be included as co-author on a publication from the research), either of which could affect or appear to affect the design, conduct, oversight, or reporting of the research project Financial interests that require disclosure include but are not limited to: Ownership interest, stock options, or other economic interest related to the research, CV-REC Committee, scientific officer/principal investigator, or executive relationship related to the research, regardless of compensation for that position Non-financial interests that require disclosure include, but are not limited to: Participation in the research as key personnel (Principal Investigator, Co-PI, sub-investigator); Co-Author on a publication of the research project s results; Other relationships which may influence judgement of the CV-REC member in reviewing the research project An investigator can be a member of the CV-REC. However, the investigator-asmember shall not participate in the review and approval process for any project in CV-REC SOP 2016 v2 8

17 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee which he or she is present as a PI, Co-PI or has any other potential conflict of interest CV-REC members shall be prohibited from participating in the review of a research protocol or plan in which they have a conflict of interest except to provide information requested by the CV-REC. 9. TRAINING OF CV-REC MEMBERS 9.1. CV-REC members shall receive an introductory training material in CV-REC SOPs and health research ethics and shall be exposed to ongoing opportunities for enhancing their capacity for ethical review The CV-REC shall organize workshops to impart training to the members. The training program shall be scheduled and spread over the year The members shall be encouraged to attend workshops at least once every year. 10. ANNUAL ACTIVITY REPORT The Secretariat in consultation with the Chairperson shall prepare an annual activity report of the CV-REC for submission to the CVCHRD Chair, DOST- PCHRD, and Philippine Health Research Ethics Board (PHREB). 11. HONORARIUM All CV-REC members and Independent Consultants shall be given honorarium based on the DOST Memorandum Circular Order on the guidelines on the grant of honoraria to personnel whose services are engaged by the national science and technology system. 12. ANNUAL EVALUATION OF CV-REC CHAIR/ CO-CHAIRPERSON/ MEMBERS/ MEMBER SECRETARY/ STAFF An annual evaluation of the CV-REC personnel shall be done. The evaluation forms (Form 1G) shall be provided by to the members. 13. DISSOLVING THE CV-REC The CV-REC shall be automatically dissolved when the Central Visayas Consortium for Health Research and Development (CVCHRD) ceases to exist. 14. GLOSSARY Ethics Review Committee An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a CV-REC SOP 2016 v2 9

18 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (from ICH-GCP) Lay Person Non-affiliated member Non-scientist Regular members Scientific member A member who is not part of a profession and represents the rest of the community. An individual who represents the general community interests, is not a researcher, is not affiliated with any of the CVCHRD member institutions and is not an immediate family member of a person who is affiliated with the CVCHRD member institution. A member who is an expert in fields other than science. A full member, duly appointed by the CVCHD Chair. A member who is an expert in the field of science. 15. FORMS Form 1A Invitation Letter for Independent Consultant/Observer Form 1B Appointment Letter Form 1C Curriculum Vitae Form 1D Roster of CV-REC Members Form 1E Terms of Reference Form 1F Confidentiality and Conflict of Interest Agreement Form/Financial Disclosure Form 1G Evaluation Form 16. HISTORY of SOP Version Date Authors Main Change No. 1 06/01/15 CV-REC Committee Final version 2 04/28/17 CV-REC Committee SOP 003/v1 was renumbered to SOP 1.1 (and revised adopting The SOP Workbook). CV-REC SOP 2016 v2 10

19 Central Visayas Research Ethics Committee SOP No: 1.1 (CV-REC) Version No.: Constituting the Central Visayas Research Ethics Committee Ethics Committee 17. REFERENCES Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) Development of Standard Operating Procedures for Ethics Committees National Ethical Guidelines for Health Research 2011 Philippine Health Research Ethics Board Workbook on Standard Operating Procedures The SOP Workbook CV-REC SOP 2016 v2 11

20 FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee <Date> Form 1A Invitation Letter for Independent Consultant/Observer Sir/Madam: CENTRAL VISAYAS RESEARCH ETHICS COMMITTEE The CV-REC has nominated you as an independent consultant, in your capacity as a (EXPERTISE), to provide expert review of a research protocol submitted to the CV-REC for approval. The study protocol requires scientific or medical expertise not represented in the current composition of the committee. You are requested to attend the meeting on.at.and to provide written opinion regarding the assigned research proposal (CV-REC code no.. and title of project.). The responsibilities of an Independent Consultant are as follows: 1. Submission or accomplishment of the following documents a. Copy of Curriculum Vitae (Form 1C) b. Signed Confidentiality Agreement and Conflict of Interest Disclosure Form (Form 1F) 2. Provision of the following consultation services a. Completion of the Protocol Review Assessment Form (Form 2B) b. Completion of the Informed Consent Form (ICF) Checklist (Form 2C) c. Attend the CV-REC meeting when invited, where deliberations on said protocols will be made or alternatively, submit results of review to the Secretariat if unable to attend the meeting. d. Return all protocol-related materials to the Secretariat after review. e. Submit an updated and signed CV annually. If you agree to accommodate this request, please sign the conforme and submit the documents indicated in 1.a and 1.b above, to facilitate processing of your appointment. As an independent consultant, you will be entitled to standard honorarium package effective during your appointment period. Thank you. Sincerely yours, CV-REC Chair Signature CV-REC SOP 2016 v2 12

21 FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee Form 1B Appointment Letter <Date> To Sir/Madam: We are pleased to appoint you as the of the Central Visayas Research Ethics Committee (CV-REC). The appointment is in accordance with the CV-REC Standard Operating Procedures which stipulates that a requirement for "at least one member who is the." The members of the committee are appointed for a term of two years. The term shall be effective on and shall expire on. As per our Standard Operating Procedures, we shall require you to submit your Curriculum Vitae as well as your training certificates in ethics. Enclosed you will find the Terms of Reference for your perusal. If you have any inquiries, please contact the secretariat through cvrec.secretariat@gmail.com. Sincerely yours, CV-REC Chair Signature Enclosure: Terms of Reference CV-REC SOP 2016 v2 13

22 FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee Form 1C Curriculum Vitae CURRICULUM VITAE First Name: Middle Initial: Last Name: Date of birth (mm/dd/yyyy) Sex Professional Mailing Address (Include institution name): Telephone (Office): Telephone (Residence): Mobile Number: Academic Qualifications (Most current qualification first): Degree/Certificate Year Institution, Country Professional Experience: Month and Year Title Institution/Company, Country A. Experience in Bioethics: Sr. No. 1 Courses/Workshops/Conferences/ Meetings Attended Organized by Place Duratioin 2 B. Membership of the other Ethics Committee/Bioethics Societies with duration: Signature (signature required) Date <MM/DD/YY> CV-REC SOP 2016 v2 14

23 FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee Form 1D Roster of CV-REC Members Roster of CV-REC Members Sr. No. Name Affiliation Gender Roles CV-REC SOP 2016 v2 15

24 READ UNDERSTOOD and IN CONFORME (AUTHORIZED SIGNATURE ABOVE PRINTED NAME) FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee Form 1E Terms of Reference CENTRAL VISAYAS RESEARCH ETHICS COMMITTEE TERMS OF REFERENCE This Term of Reference of has been drawn up to ensure that the CV-REC functions independently to maintain a consistent scientific and ethical framework for health research and to integrate ethical values into practice, policy relationships and organizational activities. The constitution of the CV-REC shall be sufficient to ensure the appropriate expertise, multidiscipline backgrounds, and independence required for competent research ethics review. The membership of the CV-REC shall include individuals with varying backgrounds and appropriate professional competence to review the diverse types of protocols that are received. CONSTITUTION AND FUNCTIONS 1.1. Composition of the CV-REC The CV-REC shall be composed of a minimum of 5 members, and a maximum of 7 members. The members shall be selected so as to have an equitable representation of scientific and non-scientific members, clinicians and nonclinicians, members of the community, a lawyer, a social worker/layperson/patient representative to represent different points of view The committee shall comprise of a Chairperson, Co-chairperson, a Member Secretary and other active members who represent an appropriate balance of professional, ethical, legal, cultural, educational and community interests The committee should have adequate representation of age, gender, community to safeguard the interests and welfare of all sections of the community/society. Members should be aware of local, social and cultural norms, as this is the most important social control mechanism The composition shall be as follows: Chairperson Co-Chairperson Member Secretary Clinician Legal expert Social scientist/ non-scientific member / representative of nongovernmental voluntary agency/ philosopher / ethicist / theologian One lay person from the community 1.2. Terms of Appointment The members of the CV-REC shall be appointed for duration of 2 years The appointment procedure for membership shall be followed to allow for the continuity, development and maintenance of expertise, and the regular input of fresh ideas and approaches. CV-REC SOP 2016 v2 16

25 READ UNDERSTOOD and IN CONFORME (AUTHORIZED SIGNATURE ABOVE PRINTED NAME) FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee There shall be no limit on the number of times the membership is extended. Extension of membership shall be based on the recommendation of the CV-REC Chairperson and Member Secretary Conditions of Appointment The members shall accept the appointment in writing and shall submit a Curriculum Vitae (CV) and training certificates in Health Research Ethics The name, gender, profession and affiliation of CV-REC members shall be publicized Members shall be required to sign the Confidentiality and Conflict of Interest Agreement Form/Financial Disclosure of CV-REC Members at the start of their term. The confidentiality agreement protects the privacy and confidentiality of all parties whose information may be disclosed to the CV-REC in the course of its work. All members shall disclose in writing all conflicts of interest for themselves and their spouses/domestic partners and dependent children Members shall apprise themselves of the National Ethical Guidelines and CV-REC SOPs Renewal The membership shall be renewed after the stated term of 2 years The process of renewal shall be as follows: Selection shall be done at least 3 months and 1 month in advance respectively. New members shall be inducted as an observer during the board meeting before starting their tenure as CV-REC Members Resignation / Replacement Procedure A new member shall be appointed for the remaining term of the regular member who resigned or ceased to be a member due to disqualification or death Members who decide to resign shall provide the CV-REC Chairperson the written notification of their proposed resignation date at least 30 calendar days prior to the next scheduled meeting In case of resignation, the CVCHRD Chairperson, in consultation with the CV-REC Chairperson, shall appoint a new member, falling in the same category of membership (e.g. NGO representative with NGO representative) The CV-REC Chairperson shall evaluate the qualifications of the nominees and shall submit the final list of nominees to the CVCHRD Chairperson Disqualification Procedure In case of conduct of unbecoming for a member, inability to participate in the meetings on any grounds and failure to attend more than 3 consecutive meetings, the CV-REC shall decide to terminate the membership The CV-REC Chairperson shall make a recommendation to the CVCHRD Chairperson for necessary action. CV-REC SOP 2016 v2 17

26 READ UNDERSTOOD and IN CONFORME (AUTHORIZED SIGNATURE ABOVE PRINTED NAME) FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee In all such situations, the CV-REC Chairperson shall serve a letter of termination to the member Documentation of the termination shall be recorded in the minutes of the next duly constituted CV-REC meeting and the CV-REC membership roster and circulars shall be revised General Duties and Responsibilities: The members primary responsibility shall determine the scientific and ethical validity of the research and the protection of the safety, rights and confidentiality of the research subjects The members shall participate in the meetings, review and discuss research proposals assigned for evaluation, review progress reports and monitor ongoing studies, monitor Serious Adverse Events (SAEs) and recommend appropriate actions, and maintain confidentiality of the documents and deliberations of the meetings The members shall participate in continuing education activities in health research ethics and shall provide information and documents related to trainings obtained in health research ethics to the CV-REC Secretariat 1.8. Specific Duties and Functions: Chairperson The CV-REC Chairperson shall be a highly respected individual from any CVCHRD current member institutions, fully capable of managing the committee and the matters brought before it with fairness and impartiality The task of making the CV-REC as a respected institution shall fall primarily on the shoulders of the Chairperson The CV-REC Chairperson shall respect the diverse backgrounds, perspectives, sources of expertise of all members, especially the contributions of non-scientists, and shall foster such respect among the members Co-Chairperson The CV-REC Co-Chairperson shall be a highly respected individual from any CVCHRD current member institutions, with the same capabilities of the Chairperson so as to manage the committee and the matters brought before it with fairness and impartiality In the absence of the Chairperson, the Co-Chairperson shall chair the meeting. In the absence of both, a member who is independent of the institution shall chair the meeting as the Acting Chairperson Member Secretary CV-REC SOP 2016 v2 18

27 READ UNDERSTOOD and IN CONFORME (AUTHORIZED SIGNATURE ABOVE PRINTED NAME) FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee The Member Secretary shall be appointed by the CV-REC Chairperson committed to the task of coordinating and managing the activities of the committee He/she shall be responsible for scheduling the meetings, describing the agenda and ensuring that the function of the committee is conducted as per norms and policies described in this SOPs In the absence of the CV-REC Member Secretary, the Secretariat staff of the CVCHRD shall function as acting Secretary for routine work In the absence of the CV-REC member-secretary for scheduled meeting, another member shall be nominated for that meeting to coordinate and manage the activities for that meeting The Member Secretary shall review disclosures to determine whether a conflict of interest exists and to determine appropriate management for the conflict of interest Secretariat The Secretariat shall be composed of the Member Secretary and the CVCHRD Secretariat/supporting staff The Secretariat shall have the following functions: Organization of an effective and efficient tracking procedure for each proposal received Preparation, maintenance and distribution of study files Organization of regular meetings Preparation of the agenda and the minutes of the meetings Maintenance of the records and archives Communication with the members and Principal Investigators (PIs) Arrangement of training for personnel and CV-REC Members Provision of the necessary administrative support for CV-REC related activities 2. SELECTION OF INDEPENDENT CONSULTANTS 2.1. When the CV-REC Chairperson or Member Secretary determines that a study will involve procedures or information beyond the area of expertise of the members, the CV-REC shall call upon or establish a standing list of independent consultants to provide special expertise on the proposed research protocols These consultants shall be invited to attend the meeting and shall sign the Confidentiality Agreement Form These consultants or subject experts shall not vote for a decision Any persons who are responsible for business development shall not be appointed as independent consultants. CV-REC SOP 2016 v2 19

28 READ UNDERSTOOD and IN CONFORME (AUTHORIZED SIGNATURE ABOVE PRINTED NAME) FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee 3. CONFIDENTIALITY AND CONFLICT OF INTERESTS 3.1. The members shall disclose all conflict of interests including their spouse/domestic partner and their dependent children with regard to a research project involving human participants The CV-REC member or independent consultant shall evaluate whether a conflict of interest exists and he/she shall disclose any identified conflicts at the next CV-REC meeting CV-REC members shall cooperate with the committee and other officials in their review of the conflicts of interest issues and shall comply with all requirements of the CV-REC A conflict of interest may be identified as either financial in nature (such as when a member holds an economic interest in the research) or non-financial in nature (such as when a member or consultant participates in the research or will be included as coauthor on a publication from the research), either of which could affect or appear to affect the design, conduct, oversight, or reporting of the research project Financial interests that require disclosure include but are not limited to: Ownership interest, stock options, or other economic interest related to the research, CV-REC Committee, scientific officer/principal investigator, or executive relationship related to the research, regardless of compensation for that position Non-financial interests that require disclosure include but are not limited to: Participation in the research as key personnel (Principal Investigator, Co-PI, sub-investigator; Co-Author on a publication of the research project s results; Other relationships which may influence judgement of the CV- REC member in reviewing the research project An investigator can be a member of the CV-REC. However, the investigatoras-member shall not participate in the review and approval process for any project in which he or she is present as a PI, Co-PI or has any other potential conflict of interest CV-REC members shall be prohibited from participating in the review of a research protocol or plan in which they have a conflict of interest except to provide information requested by the CV-REC. 4. TRAINING OF CV-REC MEMBERS 4.1. CV-REC members shall receive an introductory training material in CV-REC SOPs and health research ethics and shall be exposed to ongoing opportunities for enhancing their capacity for ethical review The CV-REC shall organize workshops to impart training to the members. The training program shall be scheduled and spread over the year The members shall be encouraged to attend workshops at least once every year. CV-REC SOP 2016 v2 20

29 FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee 5. ANNUAL ACTIVITY REPORT 5.1. The Secretariat in consultation with the Chairperson shall prepare an annual activity report of the CV-REC for submission to the CVCHRD Chair, DOST- PCHRD Executive Director and Philippine Health Research Ethics Board (PHREB). 6. HONORARIUM All members and independent consultants shall be given honorarium based on the DOST Memorandum Circular Order on the guidelines on the grant of honoraria to personnel whose services are engaged by the national science and technology system. 7. ANNUAL EVALUATION OF CV-REC CHAIR/ CO-CHAIRPERSON/ MEMBERS/ MEMBER SECRETARY/ STAFF 7.1. An annual evaluation of the CV-REC personnel shall be done. The individual feedback shall be provided by to the members. 8. DISSOLVING THE CV-REC 8.1. The CV-REC shall be automatically dissolved when the Central Visayas Consortium for Health Research and Development (CVCHRD) ceases to exist. READ UNDERSTOOD and IN CONFORME (AUTHORIZED SIGNATURE ABOVE PRINTED NAME) (DATE) CV-REC SOP 2016 v2 21

30 FORMS SOP 1.1 Constituting the Central Visayas Research Ethics Committee Ethics Committee Form 1F Confidentiality and Conflict of Interest Agreement Form/Financial Disclosure CENTRAL VISAYAS RESEARCH ETHICS COMMITTEE (CV-REC) Confidentiality and Conflict of Interest Agreement Form/ Financial Disclosure of CV-REC Members In recognition of the fact that I,, herein referred to as the "Undersigned", have been appointed as a member of the Central Visayas Research Ethics Committee (CV-REC) and would be asked to assess research studies involving human subjects in order to ensure that they are conducted in a humane, scientific, and ethical manner with the highest standards of care according to the applied national and local regulations, institutional policies and guidelines; WHEREAS, the appointment of the undersigned as a member of the CV-REC is based on individual merits and not as an advocate or representative of a home province/ territory/ community nor as the delegate of any organization or private interest; WHEREAS, the fundamental duty of a CV-REC member is to independently review research protocols involving human subjects and make a determination and the best possible objective recommendations, based on the merits of the submissions under review; WHEREAS, the CV-REC must meet the highest ethical standards in order to merit the trust and confidence of the communities with respect to the protection of the rights and well-being of human subjects; The undersigned, as a member of the CV-REC is expected to meet the same high standards of ethical behavior to carry out its mandate. This Agreement thus encompasses any information deemed Confidential or Proprietary provided to the Undersigned in conjunction with the duties as a member of the CV-REC. Any written information provided to the Undersigned that is of a Confidential, Proprietary, or Privileged nature shall be identified accordingly. As such, the Undersigned agrees to hold all Confidential or Proprietary trade secrets ("information") in trust or confidence and agrees that it shall be used only for contemplated purposes, shall not be used for any other purpose or disclosed to any third party. Written Confidential information provided for review shall not be copied or retained. All Confidential information (and any copies and notes thereof) shall remain the sole property of the CV-REC. The Undersigned agrees not to disclose or utilize, directly or indirectly, any Confidential or Proprietary information belonging to a third party in fulfilling this agreement. Undersigned SIGNATURE Date CV-REC SOP 2016 v2 22