Public Health Concern Trust, Nepal (phect-nepal)

Transcription

1 Public Health Concern Trust, Nepal (phect-nepal) Institutional Review Committee (IRC) GPO Box 6064 Pradarshani Marg, Kathmandu, Nepal Tel. (+977) , Policies A standard protocol on research involving human participants Version 1.6 1

2 Contents 1. Introduction: Roles of the IRC: Main objective Ethical standard Action Guidance Composition of the IRC: Number of members Temporary specialist members Member demographics IRC Members: Appointment method Conditions for appointment Length of term/service Dismissal Resignation Alternate members Responsibilities Conflict of Interest: Office bearers of the IRC: Chairperson Secretary Meetings: Location Frequency Quorum Duration Visitors Research proposal review: Application Submission Schedule Reviewers Review Outcome Appeal Research involving external institutions Voting Expedited review process: Approved research: Monitoring Progress reports Final report Other submissions Processing Fees: References:...17 Version 1.6 2

3 Version 1.6 3

4 1. Introduction: The Institutional Review Committee (IRC) was established in January 2011 by the phect- NEPAL Executive Board to oversee all research activities involving human participants conducted within the organization. The committee follows guidelines set by the National Health Research Council (NHRC) of Nepal, with the goal of promoting scientific study and quality of research in health in Nepal. The policies and guidelines described here have been designed to promote the use of a standard protocol by the IRC when reviewing research proposals and to safeguard the dignity, rights, safety and wellbeing of research participants. GOAL OF THE IRC: The IRC strives for the promotion of quality human health research activities within phect-nepal, in order to reach the standards set by the NHRC as well as to comply with international standards, and is committed to the education of the phect-nepal research community. These goals aim to advance the field of medical research in Nepal. 2. Roles of the IRC: 2.1 Main objective Oversee all research activities involving human participants conducted within phect- NEPAL to ensure the research maintains international ethical standards, in compliance with NHRC guidelines. Version 1.6 4

5 2.2 Ethical standard Systematically review the ethical aspects of research proposals to ensure the dignity, safety, rights and wellbeing of the participants is adequately protected. Compliance to ethical principles is based upon the following criteria: i. Risks to participants are minimized whenever possible. Risks to participants are considered reasonable based on the prospective benefits. iv. Selection of participants is justified. Voluntary informed consent is obtained and documented. v. Scientific methods of data collection and analysis are followed. vi. Participants privacy and confidentiality are protected at all times, with provisions made for the secure retention and/or destruction of data after study completion. v If vulnerable populations are involved, additional measures are in place to ensure their protection. 2.3 Action Maintain high scientific and ethical standards for human medical research, in order to become a leader of the field in Nepal, by taking the appropriate actions on research proposals: i. Approval Conditional approval, to ensure adherence to ethical standards. Suspension or termination in the case of non-compliance to ethical standards and/or the approved research methods. iv. Rejection Version 1.6 5

6 2.4 Guidance Provide guidance to researchers through review of proposal, progress and final reports. The committee will provide researchers with an evaluation of their proposal and may call for modifications to the research design and will assess any amendments. 3. Composition of the IRC: 3.1 Number of members The IRC shall have a minimum of six to a maximum of thirteen regular members. The Chairperson (see section 5.1 below), with consent from other members, can appoint additional temporary members to provide special expertise in relevant areas if required. 3.2 Temporary specialist members In the case of studies involving participants from vulnerable or minority populations, the IRC must make an effort to include a representative of the population under study. For example, the inclusion of an individual who has in-depth knowledge and experience working with children, pregnant women, prisoners or individuals with physical or intellectual disabilities would be recommended if a proposed research study involved any of these groups. 3.3 Member demographics To ensure the committee has sufficient knowledge to represent both the institution and the community, the members shall belong to both scientific and non-scientific professions. They shall also have diverse cultural backgrounds and constitute a fair distribution in terms of age and gender. At least one member shall be a layperson; usually a representative of an interest group, such as those for consumer rights or Version 1.6 6

7 indigenous people s rights. At least one member shall not be affiliated to phect- NEPAL other than his/her membership on the IRC. 4. IRC Members: 4.1 Appointment method i. New member nomination occurs by submission of the relevant name to the Chairperson of the IRC, with justification for their selection. All members of the IRC are appointed by the Executive Board of phect-nepal. 4.2 Conditions for appointment i. Members must make the necessary time commitment. All communications, electronic or otherwise, must be responded to promptly and efficiently at all time. Members must sign a confidentiality agreement. 4.3 Length of term/service i. Members are appointed for a term of three years. Members can serve a maximum of two consecutive terms. If possible, 50% of the members shall be retained at the end of each term to ensure continuity in the functioning of the IRC and to utilize the accumulated knowledge and experience. 4.4 Dismissal i. Any member who fails to attend three consecutive scheduled monthly committee meetings (not including additional special meetings, refer to section 6.2 below) is to be dismissed. Any member who does not abide by the conflict of interest policy (refer to section 4.8 below) is to be dismissed. Version 1.6 7

8 Any member who does not abide by the confidentiality agreement is to be dismissed. iv. Any member may be dismissed from the committee following an internal review process: A signed confidential letter naming the member suggested for disqualification, and stating the reason, is submitted to the Chairperson (or another member if the named individual is the Chairperson) who then meets separately with both parties to verify the details. Should the matter be deemed true, the member suggested for disqualification can elect to either resign or have the matter discussed in an IRC meeting where the membership will vote on the matter. If 50% +1 vote are in favor of the proposal for disqualification, the member will be dismissed. Letters detailing the final verdict will be sent to both parties. 4.5 Resignation A member who can no longer serve on the committee shall resign in writing to the Chairperson of IRC and the letter then be submitted to the Executive Board of phect- NEPAL (if the Chairperson is to resign, the letter shall be given directly to the Executive Board). No reason for the resignation need to be stated. Following the resignation of a committee member, the Chairperson shall promptly recommend a replacement to the Executive Board of phect-nepal. In case of resignation by the Chairperson, appropriate decision will be taken by the EB. 4.6 Alternate members In special cases, such as long-term absence due to unforeseen circumstances or exclusion based on conflict of interest, alternate members may be appointed as voting members for that session. The alternate member(s) will be nominated by the permanent member he/she is representing. Only ex-committee members or individuals Version 1.6 8

9 with adequate knowledge regarding ethical principles and research on human participants (as determined by the Chairperson) are eligible. In case of the Chairperson s absence, the Chairperson shall select committee member to act in his/her place. This member will vote on behalf of the Chairperson and his/her own voting rights will be preserved. 4.7 Responsibilities IRC members are responsible for ensuring the rights and welfare of research participants are protected by reviewing and approving human research in a manner consistent with the Nepal Health Research Council Act 2047 (1991) and the phect- NEPAL guidelines and policies. Committee members must attend scheduled monthly meetings and special meetings where possible. Members may be assigned by the Chairperson as primary, secondary or specialty reviewers for a particular research proposal under review. The primary reviewer will be responsible for managing that research study for all amendments, progress reports, unanticipated problems, deviations and protocol exceptions. The appointment of members as primary or secondary reviewer shall be on a rotational basis. 4.8 Conflict of Interest Members may not participate in the IRC proceedings related to any research study with which they have an active role (principal researcher, responsible supervisor or other researcher) or any other conflict of interest (financial, personal, academic, etc). The member is required to notify the Chairperson of their conflict of interest and shall not be present during any discussion or voting regarding the research study. The presence of a conflict of interest shall be recorded in the minutes. Version 1.6 9

10 5. Office bearers of the IRC: 5.1 Chairperson The IRC Chairperson is to be elected by the members from among themselves and shall serve a term of three years only. He is the presiding officer and overall administrator of the work of the IRC and therefore responsible for: i. Conducting IRC meetings. iv. Selecting primary, secondary and specialist reviewers. Appointing temporary specialist and/or alternate members. Facilitating the dismissal or resignation of members. v. Facilitating the selection of new and/or replacement members. vi. v Signing documents on behalf of the IRC. Ensuring the security and confidentiality of the records and documents of the committee. v Annual reporting to IRC members and to the Executive Board of phect- NEPAL. 5.2 Secretary The IRC secretary is to be appointed by the Chairperson and shall not be a member of the IRC. The secretary shall sign a letter of confidentiality and is responsible for: i. Scheduling IRC meetings. iv. Documenting the proceedings of the committee meetings. Receiving research proposals and scheduling review of the proposals. Managing communications to the IRC members regarding meetings and research proposals under review. v. Managing communications between the IRC and prospective researchers. Version

11 vi. Maintaining IRC records and receipts, including a registry of all research proposals reviewed by the IRC. v Executing other tasks assigned by the Chairperson. 6. Meetings: 6.1 Location IRC meetings will be held at phect-nepal meeting room in Kathmandu Model Hospital (Pradarshani Marg), unless otherwise specified. 6.2 Frequency IRC meetings shall be held once per month, with the schedule provided well in advance by the Secretary. Special meetings may be called by the Chairperson when necessary, either as a full committee meeting or in subcommittees. Scheduled meetings can be cancelled or re-scheduled around holidays, if quorum is not achieved or in cases of political disturbances. 6.3 Quorum Quorum must be achieved in order for a meeting to take place. At least fifty percent of the members, with at least one whose concerns are primarily non-scientific, must be present to achieve quorum. 6.4 Duration Sufficient time shall be given for full review of each application scheduled to be discussed at the sitting. 6.5 Visitors Researchers, independent consultants and other individuals may attend an IRC meeting in order to provide their specific expertise, as approved by the chairperson. Version

12 However, at the time of decision-making and/or voting, all visitors must leave the room. 7. Research proposal review: 7.1 Application The IRC Application for ethical approval of a research project involving humans document must be completed for each research proposal. Incomplete proposals will not be reviewed. 7.2 Submission Submission should be electronic, to, with an additional printed and signed copy delivered to the phect-nepal administration office Kathmandu Model Hospital (Pradarshani Marg), or by mail to Public Health Concern Trust (phect- NEPAL), GPO Box: 6064, Pradarshani Marg, Kathmandu, Nepal. The signed copy shall be retained by the IRC in a secure facility. 7.3 Schedule A research proposal should be submitted at least one month prior to a scheduled IRC meeting in order to be scheduled for review at that meeting. In the case of student projects with limited time, additional meetings may be called at the discretion of the Chairperson. 7.4 Reviewers All committee members must review each submitted proposal before the relevant IRC meeting. If a primary reviewer has been assigned, they shall perform a thorough review and submit a report to the Secretary at least 3 days prior to the relevant meeting. A secondary and/or specialist reviewer may be assigned to assist the primary Version

13 reviewer. All other members may then use this report to assist in their review of the proposal and are required to submit a completed assessment form checklist to the Secretary at least 1 day prior to the relevant meeting. 7.5 Review Discussion of the research proposal will take place during the relevant IRC meeting and shall be facilitated by information included on the primary review report and/or assessment form checklist. Only members who participate in the meeting will be allowed to participate in making the final decision or voting. The IRC will attempt to arrive at all decisions through consensus; however a vote may be taken when consensus is not achieved (50%+1 vote). If further information is to be requested from the researcher, the proposal shall be returned for review after resubmission from the researcher. 7.6 Outcome The decision of the IRC shall be communicated to the researcher in writing by the Secretary, at the direction of the Chairperson. If further information is requested, or the research proposal has been declined, a detailed explanation shall be given. There shall be no direct communication between the IRC members and the applicant. 7.7 Appeal If an appeal against rejection of a research proposal is submitted by the researcher, the matter will be discussed at the next IRC meeting with specific review of the reasons for which the research was suspended or terminated. Only one appeal is allowed per research proposal. Version

14 8. Research from external institutions Research studies from external institutions which involve participant recruitment and/or data collection to occur within phect-nepal must be reviewed and approved by the IRC. If the research proposal has been approved by another ethics committee, a copy of the approval letter must be attached to the application. 9. Voting When a decision cannot be reached through consensus, a vote may be held. Each member is entitled to one vote. If a member is unable to vote, an alternate member (approved by the Chairperson) may vote in his/her place. A committee member may participate in an IRC meeting via teleconference and may vote during the meeting, at the discretion of the Chairperson. Any member participating via teleconference must have access to the meeting agenda and all documents relating to the proposal under review. Proxy votes (written or telephone) are not valid. 10. Expedited review process: Expedited review may occur for proposals which pose no significant risk and/or require only minor revisions after initial review and conditional approval. Activities considered to have minimal risk include: i. Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth, and permanent teeth if patient care indicates a need for extraction. Collection of excreta and external secretions, including sweat, un-cannulated saliva, placenta removed at delivery and amniotic fluid at the time of rupture of the membrane prior to or during labor. Version

15 Recordings of data from subjects 18 years of age or older, using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance, and do not involve input of matter or significant amounts of energy into the subject, or an invasion of the participants privacy. It also includes such procedures weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, and detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. iv. Voice recordings made for research purposes, such as investigations of speech defects. v. Moderate exercise by healthy volunteers. vi. Use of pre-existing data, documents, records, pathological specimens, or diagnostic specimens. v Research involving an individual or group behavior or characteristics such as studies of perception, cognition, game therapy, or test development where the investigator does not manipulate subjects; behavior and the research will not cause serious stress to participants. v In cases of serious disease outbreaks and similar emergency situations. 11. Approved research: 11.1 Monitoring Approved research studies shall be evaluated by the IRC at regular intervals appropriate to the determined level of risk. The IRC shall have the authority to observe, or have a third party observe, any part of the research process. Version

16 11.2 Progress reports Once the research proposal is accepted, the researcher is responsible for submitting timely progress reports to the IRC. Researchers must submit a progress report at the conclusion of data collection. Annual reports are required for research studies with duration greater than one year Final report Upon completion of the study, the researcher shall submit a final report to the IRC which describes the outcomes of the study and the chosen method(s) of presenting the findings to both the scientific and target communities Other submissions The following reports must be submitted by the researcher to the IRC in writing when necessary: i. Report of any adverse events which occur during the research study, including a detailed description of the event, measures taken to address it and the outcomes. This report must be submitted as soon as possible, but no later than two weeks after the occurrence of the event. Report of any ethical problems encountered including a description of how these were addressed. This report must be submitted as soon as possible, but no later than two weeks after the occurrence of the event. Any changes in the research design, including methodology, must be described in detail and submitted to the IRC for approval before implementation. iv. For long-term research and those that are determined to be high risk, the IRC may require more regular progress reports. The IRC may vote to restrict, suspend or terminate a research study that is not considered to be maintaining ethical standards and/or has caused harm to the Version

17 participants. Any suspension or termination of a research study is to be conveyed to the principal researcher/responsible guide promptly in writing, along with the justification for the action taken by the IRC. The researcher may appeal suspension or termination of their research study by submitting a written application to the chairperson within 30 days. Processing of this appeal will occur as described in section 7.7 above. In case of premature termination of the research by the researcher himself/herself, the IRC shall be notified promptly by letter detailing the reason(s). 12. Processing Fees: The IRC shall charge processing fees for the review of research proposals submitted by researchers not affiliated with phect-nepal. Any research subject to other phect- NEPAL fees related to the conduct of that research will be exempt from IRC processing fees. All other external research will be subject to processing fees at the following rates: i. Research without funding Rs. 1,000 Research with funding less than Rs. 100,000 Rs. 2,000 Research with funding greater than Rs. 100,000 2% of research funding 13. References: 1. National Ethical Guidelines for Health Research in Nepal, Nepal Health Research Council, Kathmandu Operational Guidelines for Ethics Committee that Review Biomedical Research. World Health Organization. Geneva Boston University/ Boston Medical Center IRB Policies and Procedures, Boston University, Boston UNISA Guideline for Ethics Review, University of South Africa, South Africa Guidelines for the conduct of research involving human subjects, National Institute of Health, U.S.A National Ethical Guidelines for Health Research, Philippines National Health Research System, Manila Version