HOSPITAL ADMINISTRATIVE POLICY

Transcription

1 HOSPITAL ADMINISTRATIVE POLICY INSTITUTIONAL REVIEW BOARD GOVERNANCE POLICY Document No.: Revision: Original Date: Effective Date: NUH-HAP-ROF Apr Apr-2013 : Description of Content/Change: : New Document Major Content Change Minor Content Change Non-content Change Deletions Only Any hardcopy, printed or photocopied, is considered an uncontrolled copy, unless it is the original, signed-off version. 1.0 Objectives 1.1 The Objective of this policy is to govern the function of the Institutional Review Board of NUH (herein after known as IRB ). 2.0 Scope 2.1 This policy applies to the Institutional Review Board of NUH regardless of the name it is given and whether it is in-house or out-sourced. 3.0 Definition 3.1 Institutional Review Board: 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 research study by, among other things, reviewing, approving, and providing continuing review of research studies, of protocols and amendments, and of the methods and materials to be used in obtaining and documenting informed consent of the research subjects. 3.2 Serious Adverse Event: Adverse reaction to administered drug as defined by local laws and regulations e.g. Singapore Good Clinical Practice. 3.3 Human Research: Any research on human subjects that requires IRB approval as defined by local laws, regulations and guidelines. Print Date: Page 1 of 7

2 4.0 Reference 4.1 This IRB Policy references the Ministry of Health Institutional Review Board Operational Guide. 5.0 Policy 5.1 The functions of NUH Institutional Review Board (IRB) are (1) (a) (b) (c) To carry out review of any proposed human research on ethical grounds; thereafter, (i) To grant its approval for the human research to be conducted or; (ii) To communicate with Researchers and require modifications to be made to the research protocol before granting its approval; (iii) To disallow the conduct or continuation of the research protocol, with written justifications; or (iv) Grant exemption for the requirement for the research to be reviewed by IRB, if the risk is deemed to be minimal. To carry out a review of the progress of human research on ethical grounds at least annually. 5.2 Every proposed research protocol shall undergo one of the following 3 types of ethics review corresponding to its risk of harm to research subjects (2,8): (a) Full Review: All research protocol involving interventions that pose a more than minimal risk to research subjects shall be subjected to a full review. Minimal risk refers to the probability and magnitude of harm and discomfort anticipated in the research that are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. Research projects with special ethics concern e.g. that involve the creation of human embryonic stem cell lines also require full ethics review. (b)expedited Review: Research protocol involving minimal or remote risk to research subjects may be reviewed via an expedited track by IRB, where appropriate. The Chairperson alone or at least one IRB members may make decisions on research protocol that qualify for expedited review. Decisions made by the members must be unanimous. Operational procedures on the expedited review of research protocol, e.g. authority of IRB Chairperson, delegation of tasks to IRB members and the method of reporting and ratification of decisions to the full board, should be clearly documented. Print Date: Page 2 of 7

3 (c)exempt Review: (i) Decision on endorsement of exempted status for exempt reviews may be made by the Chairman alone or at least one IRB member. (ii)researchers shall be required to submit all research protocols to the IRB for endorsement of their status of exemption. (iii)researchers who are aware that research protocols eligible for exempt review have a likelihood of harm to the research subject, should highlight the likelihood of harm to the IRB when submitting for review. 5.3 The following elements of review shall be considered when an IRB reviews a research protocol, where applicable (9): (a) Scientific design and conduct of the clinical study (b) Recruitment of research subjects (c) Care and protection of research subjects (d) Protection of research subject privacy and confidentiality (e) Informed consent process (f) Community/subject considerations (g) Conflict of interest issues (h) Reimbursement and compensation (i) Adequacy of a data and safety monitoring plan 5.4 IRB shall have formal meetings regularly to review and decide on the research protocols submitted to IRB (7). 5.5 IRB shall provide Researcher(s) with an initial outcome of its review of the proposed research protocol in a timely manner (10). 5.6 IRB shall perform regular continuing review, such as the evaluation of progress updates of research protocols, adverse event reports provided by Researchers, to ensure the continued validity of ethics approval of research protocols approved by them. (10, 11, 12, 15) This evaluation may include feedback/complaints received on the respective research protocol Continuing review shall be performed at least once per year for each project, until the termination of the project Final reports should be submitted to IRB within three months of completion of project The frequency and type of monitoring determined by an IRB shall reflect the degree of risk to the research subjects IRB shall require the Researcher to submit written summaries of the progress of the research to the IRB at least annually. Print Date: Page 3 of 7

4 5.6.6 All unexpected serious adverse events (SAEs) related to the research need to be reported immediately to the IRB Expected SAEs shall be submitted as regular summary reports as required by IRB Researchers shall be required by IRB to report all unexpected deaths arising from the research immediately to MOH, followed by detailed, written reports IRB shall require the Researcher to inform them and seek their written approval for any deviations from the terms of approval of the project before they can be implemented, except when they are necessary to mitigate immediate hazards to subjects, or when the changes involve only logistical or administrative aspects of the project, in which case, IRB shall be informed within seven (7) calendar days. 5.7 IRB shall clearly communicate the monitoring and reporting requirements to Researchers. IRB shall also maintain a dialogue, and provide feedback, on application standards with their constituent Researchers and NUH (3, 14). 5.8 IRB has rights to suspend and discontinue human research. (4,13) Where an IRB is satisfied that circumstances have arisen such that a human research project is not being, or cannot be, conducted in accordance with the approved protocol and that, as a result, the safety and well-being of the research subjects are not, or will not, be protected, the IRB shall withdraw its approval and inform the Researcher and NUH of such withdrawal. from the IRB shall remain withheld till such time when adequate, appropriate changes have been made to satisfy the IRB s requirements Any withdrawal of approval shall be accompanied by a statement, expressing the reasons for the IRB s action, and relayed promptly to the Researcher, appropriate institutional officials and the relevant regulatory authority Researchers shall not continue any research project whereby ethics approval has been withdrawn, and shall comply with conditions imposed by the IRB required for reapproval of the project In the case of premature suspension/termination of a research project by a Researcher or sponsor, the Researcher shall promptly inform the IRB of, and provide a detailed written explanation for, the suspension/termination. The IRB may require a summary of the results of the project that have been collected to be communicated to the IRB. 5.9 IRB s documentation and record keeping shall be kept in order.(6,7) All documentation, whether in paper or electronic form, shall be kept in accordance with existing legislation and requirements, as well as institutional standards. Print Date: Page 4 of 7

5 5.9.2 All documentation and communication of an IRB shall be dated, filed, and archived. The IRB shall also maintain and update information on its list of IRB Chair and members IRB shall maintain a record of all research protocols received, with dates and actions taken by the IRB for its continuing ethics review Clear operating procedures shall be established, documented and made widely and easily available for important processes In the review of a research protocol, the views of the IRB shall be documented in writing, clearly identifying the study, the documents reviewed, and the dates for the following: (a) ; (b) Modifications required prior to its approval; (c) Non-approval; (d) Withdrawal of any prior approval All communications in relation to the review of the research protocol, activities and other proceedings of the IRB, shall be fully documented in writing, including: (a) Documents reviewed by members, including correspondence with other parties, and whether the opinion of another IRB was considered; (b) Whether approval was by expedited review; (c) Minority views that were discussed; (d) Outcome of discussion; (e) Terms and conditions, if any, of approval of any project; (f) A record of all concerns and feedback received regarding the conduct of approved research protocols; (g) Action taken by the IRB to monitor the conduct of the research The procedure for accessing and retrieving documents of the IRB shall be clearly documented to safeguard against unauthorized access to the documents of the IRB IRB shall also keep a list of essential documents for an appropriate number of years in accordance with existing standards of the institution and regulatory requirements, following the discontinuation or completion of a study The duration of archiving shall be in accordance with applicable regulatory requirements. It shall be clearly established in the standard operating procedures of the IRB, with modifications made for each protocol in consideration of inputs from the researcher, if deemed necessary, and be proportionate to the risk, and likelihood of appearance, of adverse events which may take a longer time to surface Research protocols that went through full ethics review should be archived for 20 years. Research protocols that went through expedited ethics review should be archived for 10 years. Research protocols that went through exempted ethics review should be archived for 6 years. Print Date: Page 5 of 7

6 5.10 During ethics review of human research that involves more than one institution, Researchers shall identify to their respective IRBs, the designated lead IRB, if any, that is responsible for the primary ethics review. Researchers, NUH and IRB shall: (a) Coordinate the review of multi-centre research projects, and communicate any concerns that they may have, with other IRBs reviewing the research protocol; and (b) Determine how the conduct of multi-centre research should be supervised and define the respective roles of each institution/organization and its respective IRB IRB is to put in place procedures for managing conflicts of interest with respect to IRB members.(5) A member of an IRB shall declare to the board the nature and extent of all conflicts of interest or potential conflicts of interest in relation to a matter under consideration by the board, including those arising from (a) His familial or other relationship with a director, partner or employee of the research institution which appointed the institutional review board; (b) His familial or other relationship with any of the researchers involved in the conduct of the human biomedical research being reviewed by the board; (c) His connection or association with any body or person funding the human biomedical research being reviewed by the board Where the IRB is satisfied that the member (referred to in this section as a conflicted member ) is unable to carry out his duties properly and effectively because of any conflicts of interest or potential conflicts of interest referred to in subsection (1), the conflicted member (a) (b) Shall not take part in any deliberation or decision of the board with respect to that matter; and Shall be disregarded for the purpose of constituting a quorum of the board for such deliberation or decision Notwithstanding , a conflicted member may, with the permission of the IRB, provide such information as the IRB may require, but he shall not participate in its deliberation of a matter, and shall not vote on any decision with respect to that matter A disclosure under and the decision of the IRB in regard to the participation of the member in the deliberations and decisions of the IRB under and shall be recorded in the minutes of the meeting of the board For the purposes of this section, the fact that a member of an IRB is an employee of the NUH, the IRB shall not, by that reason alone, be regarded as a situation where his interest is in conflict with his duty as a member of the IRB. Print Date: Page 6 of 7

7 5.12 Every application to an IRB for the review of human research shall be made by Researchers responsible for the conduct and supervision of the human research (16), and shall include (a) (b) (c) A statement on whether the same or a materially similar research protocol has been submitted before to another IRB; The research institution under whose supervision and control the research would be; and Any other information or other matter which is material for the board s decision on whether to approve the human research. 6.0 Guidelines 6.1 This IRB Policy references the Ministry of Health IRB Operational Guide. 7.0 Annexes Number References Reference Document 1 Investigator Manual, Section Investigator Manual, Section 5 3 Investigator Manual, Section A02 DSRB Members Duties and Responsibilities A04 Conflict of Interest - DSRB Members and Independent Consultants B03 DSRB Communications B04 Document Management C03 Expedited Review C04 Initial Review Criteria for C06 Outcome of Review C05 Continuing Review C07 Study Closure D01 Handling Non-Compliance D04 DSRB Audits E04 Conflict of Interest - Investigators Conflict of interest declaration form NHG+Investigator+ Manual+-+1st+Editio DSRB SOPs version 14 Sept 2009.pdf 201-C03 Expedited Review - 05 Dec 11 (F 201-C04 Initial Review - Criteria for A 201-E04 Conflict of Interest - Investigato Annex+B+ -+COI+Declaration+F Print Date: Page 7 of 7