Policy Document Title: Document ID: Document Name: Human Research Governance Review Policy PY-RSH-300304 Human Research Governance Review Policy Version Number: 2 Revision Date: Key Words 28/10/2014 10:40:00 AM Research Governance, Research, Monitoring, Suspension, Cessation, Conflicts of Interest, Complaints, Collaborative Research Internal Use Only: The Material within this document has been developed solely for the internal business purposes of Mater Research. Disclosure of information of this classification may result in a breach of statutory or regulatory obligations by the Mater. Notice of Currency: If viewing a printed copy of this document, NEVER assume that the printed copy being viewed is current. Always check the online Mater Research Handbook to confirm you are viewing the current version of this framework. Our Mission Our Vision Our Values As Mater Research, together with our partners, we conduct, enable and translate exceptional clinically relevant health research. Achieving better health for all through exceptional research. Mercy Dignity Care Commitment Quality Affirmation This governance document is consistent with the Mater Values and supports the Mater Research Mission and Vision by establishing and mandating appropriate controls to support the delivery of health care services. Copyright Mater Medical Research Institute Limited. All Rights Reserved.
Table of Contents 1 Document Controls... 3 1.1 Document Revision History... 3 1.2 Document Review and Approval... 3 1.3 References... 3 2 Introduction... 5 2.1 Purpose... 5 2.2 Scope and Context... 5 2.3 Definitions... 5 2.4 Legislative Compliance... 7 2.5 Industry Standards... 7 3 Principles... 8 3.1 Principle 1: Commencing Human Research at MHS / MR... 8 3.2 Principle 2: Research Governance Review... 8 3.3 Principle 3: MHS / MR Departmental Approvals... 8 3.4 Principle 4: Conduct of Research at MHS / MR... 8 4 Policy Requirements... 9 4.1 Conduct of Research... 9 4.2 Research Governance Review Process... 9 4.2.1 Biobanks... 10 4.3 Monitoring Research... 10 4.4 Suspension or Cessation of Research... 10 4.4.1 Suspension or Withdrawal of Ethical Approval... 10 4.4.2 Suspension or Withdrawal of Site Authorisation... 10 4.5 Managing Conflicts of Interest... 11 4.6 Handling Complaints... 11 4.7 Collaborative Research with Other Organisations... 11 Copyright Mater Medical Research Institute Limited. All Rights Reserved.
1 Document Controls 1.1 Document Revision History Version Date Description 1 12-Aug-2014 Initial Draft 2 14-Oct-2014 Revisions following Committee review 1.2 Document Review and Approval Person Name / Committee Position (if applicable) Function (Owner Review Approve) Louise Hutley Senior Research Governance Officer Document Owner Kristen Gibbons Manager, Mater Research Office Review Allan Maraj Manager, Risk & Compliance, MHS Review Executive Leadership Team Mater Research Approve Corporate Policy Governance Committee 1.3 References Internal Documents Document Type Document ID Document Title Supporting PY-IID-100016 Information Privacy Policy Approve PY-RSH-300300 PY-RSH-300301 PY-RSH-300302 PY-RSH-300310 Ownership, Storage and Retention of Human Research Materials and Data Policy Collection, Storage, Use and Disposal of Human Biospecimens in Research Policy Responsible Conduct of Research Policy Research Misconduct Policy Related PY-RSH-300305 Human Research Ethics Review Policy External Documents 1 The Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, 2013 2 Hospital and Health Boards Act, 2011 Document Title: Human Research Governance Review Policy Page 3
3 Privacy Act, 1988 Guidelines approved under Section 95 of the Privacy Act, 1988 Guidelines approved under Section 95A of the Privacy Act, 1988 Guidelines approved under Section 95AA of the Privacy Act, 1988 (Cth) Australian Privacy Principles 4 Public Health Act, 2005 5 Australian Code for the Responsible Conduct of Research, 2007 6 National Statement on Ethical Conduct in Human Research, National Health & Medical Research Council (NHMRC), 2007 (Updated in March 2014) (herein referred to as the National Statement) 7 Catholic Health Australia Code of Ethical Standards for Catholic Health and Aged Care Services in Australia, 2001 8 Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA Comments. Therapeutic Goods Administration, 2000 9 Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research, 2003 10 NHMRC Guidance for Multi-centre Research (http://hrep.nhmrc.gov.au/toolbox/guidance-multi-centreresearch) including: NHMRC Framework for Monitoring: Guidance for the national approach to single ethical review of multi-centre research, January 2012 (http://hrep.nhmrc.gov.au/_uploads/files/framework_for_monitoring.pdf) NHMRC Australian Health Ethics Committee (AHEC) Position Statement on the Monitoring and Reporting of Safety in Clinical Trials, 2009 (http://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/hrecs/reference/090609_nhmrc_position_stateme nt.pdf) 11 NHMRC Biobanks Information Paper, 2010 (http://www.nhmrc.gov.au/_files_nhmrc/file/your_health/egenetics/practioners/biobanks_information_paper. pdf) NHMRC Biobanking (https://www.nhmrc.gov.au/research/biobanking) 12 NHMRC Department of Industry. Australian Clinical Trials: Research Governance: http://www.australianclinicaltrials.gov.au/researchers/research-governance Document Title: Human Research Governance Review Policy Page 4
2 Introduction 2.1 Purpose This policy is to guide those involved in the research governance authorisation process to understand their responsibilities and accountabilities for establishing, conducting and monitoring human research. It also emphasises Mater Health Services (MHS) / Mater Research (MR) and researchers responsibilities for the safety, quality, privacy, risk management, financial management and ethical acceptability of research that they conduct, sponsor or permit to be carried out at MHS / MR. 2.2 Scope and Context This policy applies to all MR and MHS employees (permanent, temporary and casual) students, non-mhs research collaborators, MR honorary appointees, sponsors and agents (including Visiting Medical Officers, visiting health professionals, contractors, consultants and volunteers) who propose to undertake human research involving patients, staff and facilities of MHS and MR. 2.3 Definitions Term Biobank Certified HREC Definition Collections of human biological materials (biospecimens) linked to relevant personal and health information (which may include health records, family history, lifestyle and genetic information) and held specifically for use in health and medical research (NHMRC Biobanks Information Paper 2010). For the purpose of this policy the information for databanks in the National Statement also applies for tissue/biobanks. An HREC which has had its processes assessed and certified under the National Health and Medical Research Council (NHMRC) National Certification Scheme. NHMRC certification lasts for three years. The Australian Code for the Responsible conduct of Research (The Code) Co-ordinating Investigator Good Clinical Practice (GCP) To access information on the NHMRC Certification Scheme: http://hrep.nhmrc.gov.au/ To find a certified HREC: http://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/homer/certif ied%20ethical%20review%20process%20v0_11.pdf The Australian Code for the Responsible Conduct of Research (2007) (The Code). This guides institutions and researchers in responsible research practices and promotes integrity in research. It shows how to manage breaches of The Code and allegations of research misconduct, how to manage research data and materials, how to publish and disseminate research findings, including proper attribution of authorship, how to conduct effective peer review and how to manage conflicts of interest. It also explains the responsibilities and rights of researchers if they witness research misconduct. The lead investigator who takes overall responsibility for the conduct of the research project at all study sites. This individual submits the project for ethical and scientific review. They are responsible for ongoing communication with the HREC and passing on any outcomes from this to the Principal Investigators. For single centre research, Coordinating Investigator and Principal Investigator are synonymous. An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. May also be referred to as ICH GCP (International Conference on Harmonisation). http://ichgcp.net/ Document Title: Human Research Governance Review Policy Page 5
Human Research Health and Medical Research Human Research Ethics Committee (HREC) Research conducted with or about people, or their data or tissue as described in the National Statement. Basic, applied, clinical, population health and/or health systems/services research directed at understanding and improving health and wellbeing and its treatment across the population. Human Research Ethics Committees (HRECs) review research proposals that involve humans or their tissue or data research involves humans. HRECs are established by organisations which register their HREC with the NHMRC. It may also be referred to as the Reviewing HREC in multi-centre research studies. Mater Health Services (MHS) MHS means Mater Misericordiae Health Services Brisbane Ltd ACN 096708922 owner and operator of the Mater Hospitals South Brisbane, Redland and other sites notified to the HREC Mater Research (MR) MR means Mater Medical Research Institute Ltd ACN 109834719 owner and operator of Mater Research and Mater Medical Research Institute Mater Site Any site owned by Mater Health Services or Mater Research. The National Statement (NS) National Mutual Acceptance Principal Investigator Project Sponsor Research Research Delegate Research Governance (RG) Research Governance Officer (RGO) Research taking place at MHS Serious Adverse Event (SAE) The National Statement on Ethical Conduct in Human Research (2007) Revised 2014 (and subsequent revisions). A guidance document developed by the NHMRC, the Australian Research Council and the Australian Vice-Chancellors Committee to provide guidelines for researchers, HRECs and others conducting ethical review of research. It also states institutions responsibilities for the quality, safety and ethical acceptability of research that they sponsor or permit to be carried out under their auspices. http://www.nhmrc.gov.au/guidelines/publications/e72 A system for single ethical and scientific review of multi-centre clinical trials across participating jurisdictions. The individual who takes responsibility for the overall conduct, management, monitoring and reporting of research conducted at a site. They are responsible for submission of the research project for site authorisation and for study-specific communication with the Research Governance Office. An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a research study. Original investigation undertaken to gain knowledge, understanding and insight as described in the Australian Code for the Responsible Conduct for Research (2007). Person to whom the MHS CEO has delegated the authority to authorise the conduct of research at Mater Health Services Brisbane Those matters concerning the quality, safety, privacy, risk management, financial management and ethical acceptability of research. The individual appointed within the institution who is responsible for assessment and management of applications for site authorisation and oversight of authorised research projects. Research conducted at sites under the control of MHS/MR and/or involving participants, their tissue or data accessed through MHS/MR systems. The definition of a Serious Adverse Event (SAE) will be defined by the Sponsor and included in the Protocol. Generally, an SAE in human drug trials is defined as any untoward medical occurrence that at any dose, results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Document Title: Human Research Governance Review Policy Page 6
Site Site Authorisation Site-specific assessment Therapeutic Goods Administration (TGA) Unanticipated problems Suspected Unexpected Serious Adverse Reactions (SUSARs) are considered a subset of SAEs. A facility, location or service where the research is being conducted. The authorisation granted by the Chief Executive Officer (CEO) or Research Delegate of the Organisation for the commencement of a research project. A mechanism used by MHS/MR to ensure that the proposed research project complies with research governance requirements, and to consider whether the research should be conducted and supported at the proposed site. The Therapeutic Goods Administration is the agency responsible for regulating therapeutic goods: Follow this link for further information: http://www.tga.gov.au/about/about.htm Problems or outcomes which occur during the conduct of clinical research which are: (a) unexpected in terms of nature, severity, or frequency given the research procedures being undertaken (as described in the HREC-approved protocol and related documents), and/or unexpected in the participant population taking part in the study; (b) which may be related to participation in the research; (c) which might place participants or others at greater risk of harm than was previously known or recognised; and/or (d) which result in a breach of confidentiality (regarding participant information and/or research data) 2.4 Legislative Compliance This policy mandates compliance with laws, regulations, guidelines and codes of practice governing a) the conduct of research in Australia; and b) privacy, including the Privacy Act (1988) (including the Australian Privacy Principles), Hospital & Health Boards Act (2011) and Public Health Act (2005). Common law obligations also arise from the relationships between institutions, researchers and participants, while contractual arrangements may impose further obligations. 2.5 Industry Standards The Australian Council on Healthcare Standards (ACHS) EQuIP National Guidelines Standard 15. Sydney Australia; ACHS; 2012 Document Title: Human Research Governance Review Policy Page 7
3 Principles The following set of principles describes the objectives and outcomes of the policy: 3.1 Principle 1: Commencing Human Research at MHS / MR Prior to commencing a human research project at MHS/MR, all researchers are required to obtain both: approval from an HREC (which is constituted in accordance with the National Statement and, in the case of multi-centre studies with single-ethical review, an HREC that holds NHMRC certification for the specific category of research to be undertaken); and authorisation from the MHS CEO or Research Delegate (via the Mater Research Governance Office). 3.2 Principle 2: Research Governance Review and Authorisation Research Governance site assessment review includes determination at the MHS/MR site/s of: whether the use of resources (such as facilities, staff and equipment) are appropriate; whether the project adheres to its site-specific policies. whether the researchers involved in the project have the relevant training, expertise and experience; and whether the project adheres to any other necessary administrative requirements (such as evidence of adequate insurance, indemnity, budget and relevant contracts). The Research Governance Review is to be completed before the conduct of research can be authorised. The ethical review by the HREC and the site-specific assessment by the Research Governance Officer may occur concurrently. The Research Governance Officer reviews all governance site-specific assessment applications to assess and provide outcome recommendations to the MHS CEO or Research Delegate. The MHS CEO or Research Delegate retains responsibility for authorising the conduct of all research at a Mater site. The MHS CEO may delegate the responsibility for authorisation of research that involves no more than low risk to participants to the Research Governance Officer. 3.3 Principle 3: MHS / MR Departmental Approvals For any research project, researchers must obtain written approval from appropriate Heads of Department for each project and for the associated MHS/MR departmental resources to be used for research purposes. Head of Department approval is required from all departments involved in the research and must be submitted to the Research Governance Office as part of the application process. 3.4 Principle 4: Conduct of Research at MHS / MR Mater Health Services will retain its right to determine whether or not to participate in a specific research project as well as when research will commence. Document Title: Human Research Governance Review Policy Page 8
4 Policy Requirements The following are the specific requirements of this policy. 4.1 Conduct of Research Research must be conducted in compliance with the PY-RSH-300305 Human Research Ethics Review Policy. In addition, Conduct of human research must be consistent with all relevant guidance documentation and legislation as described in Section 1.3 Individuals conducting human research are required to be either adequately experienced and qualified, or supervised. They must understand the need to assess risks to their own safety and that of participants and have the freedom to withdraw from research on conscientious grounds; and All researchers must comply with all provisions relating to the confidentiality of health information (see PY-IID-100016 Information Privacy Policy). 4.2 Research Governance Review Process The Research Governance review is the process by which the organisation determines that a proposed research project meets appropriate standards of quality, safety, privacy, risk management, financial management and ethical acceptability for conduct within Mater Health Services. This review process is undertaken by a Research Governance Officer (RGO) using the site-specific assessment framework developed by the organisation for this purpose. This framework ensures that all involved in conduct of human research at Mater (including researchers, department heads and executive directors) are aware of the shared responsibility and accountability for the conduct of research at the Mater site. The RGO is responsible for ensuring an application meets all organisational requirements and is compliant with all relevant local, state and federal legislation. On completion of a review the RGO provides advice and recommendations to the MHS CEO or Research Delegate regarding authorisation of conduct of a project at the Mater site. It is the MHS CEO or Research Delegate who holds the final responsibility for authorisation of human research projects at Mater. Research Governance review can be undertaken at various levels, according to the degree of risk involved in the research (see the Mater Health Services Human Research Ethics and Governance website for further detail (http://www.mater.org.au/home/research/human-research-governance). In some instances, projects may be exempt from Research Governance review. Additionally, there may be exceptional circumstances where as a matter of public policy, and in the national interest, it is essential that an application is reviewed urgently to allow a health-related research study to commence as quickly as possible. In these situations, the MHS Chief Executive Officer (or Research Delegate) may grant authorisation, under an exceptional circumstances category, for a study to commence where: the study holds approval from an NHMRC registered HREC the study appears to conform to the requirements of the organisation; or a clinical need necessitates urgent authorisation of the application. Human research projects must not commence at a Mater site until the Principal Investigator has received written notification of authorisation by the MHS CEO or their Research Delegate. Document Title: Human Research Governance Review Policy Page 9
4.2.1 Biobanks At MHS, the Research Governance Office is responsible for maintaining a register of all human biobanks established within Mater sites. 4.3 Monitoring Research Mater Health Services has ultimate responsibility for ensuring that all human research authorised by the MHS Chief Executive Officer (or Research Delegate) which involves MHS / MR staff, MHS patients and/or MHS / MR facilities is monitored. The frequency and type of monitoring should reflect the degree of risk to research participants. Researchers also have a responsibility for monitoring their research and should report any serious adverse events or unanticipated problems to the reviewing HREC and the MHS Research Governance Officer, taking prompt steps to deal with any unexpected risks. Researchers must also adhere to all conditions of authorisation, as imposed by the MHS CEO or Research Delegate (via the Research Governance Office) at the time of site authorisation of a study. 4.4 Suspension or Cessation of Research If reports of serious adverse events or unanticipated problems (as per Section 4.3) are received, HRECs and/or institutions may require researchers to amend research procedures to protect participants. If such an amendment cannot achieve this the research may be suspended or stopped. If a research project is to be discontinued before the expected date of completion, researchers must inform the following of this decision and provide information regarding the reason for premature closure of the project: Relevant institution/s The Drug Regulatory Authority (for drug- or device-related clinical trial) The review body/bodies that approved the research, and, wherever possible, The research participants For research at more than one site it must be clearly established, before the research begins, how this information will be communicated (National Statement Section 5.5.6). 4.4.1 Suspension or Withdrawal of Ethical Approval Where the reviewing HREC finds reason to believe that continuance of a research project will compromise a participant s welfare, it will immediately seek to establish whether ethical approval for the project should be withdrawn. Where ethical approval for a research project is withdrawn: The reviewing HREC and/or institution should advise the institution of its recommendation; The institution must instruct the researcher to immediately suspend the research; The participants must be informed of the decision to withdraw ethical approval and the institution makes arrangements to meet the needs of the participants; 4.4.2 Suspension or Withdrawal of Site Authorisation If the MHS Chief Executive Officer (or Research Delegate) considers that urgent suspension of research is necessary, due to a risk to participants welfare, or that the site cannot continue to conduct the research project (e.g. due to loss of project funding or resources), site authorisation must be suspended or withdrawn. In such circumstances the instruction to stop should come via the management of the institution. Document Title: Human Research Governance Review Policy Page 10
The institution (via the Research Governance Officer) must immediately notify the site Principal Investigator and the reviewing HREC of the site requirement to suspend or withdraw authorisation; The institution (via the Research Governance Officer) must consult with the reviewing HREC to ensure the safety and welfare of research participants that may be involved in the research; and The research must not be resumed unless the institution is satisfied that the issues relating to suspension have been adequately addressed by the researcher and any modifications to the research have been ethically reviewed and approved by the reviewing HREC and site authorisation re-issued. If reports of serious adverse events or unanticipated problems are received, HRECs and/or institutions may require researchers to amend research procedures to protect participants. If such an amendment cannot achieve this the research may be suspended or stopped. 4.5 Managing Conflicts of Interest If a conflict of interest arises which has, or potentially could have, a bearing on the research, the Research Governance Officer should be informed about the conflict as described in the PY-RSH-300302 Responsible Conduct of Research Policy. The PY-RSH-300302 Responsible Conduct of Research Policy defines, identifies and outlines the procedures for managing actual and potential conflicts of interest involving the MHS, the researchers and the HREC, their members or advisors. The Research Governance process may also identify relevant conflicts of interest during the Research Governance Review. 4.6 Handling Complaints Complaints may be made by research participants, researchers, staff or others about the conduct of research or about the conduct of the HREC or the Research Governance Office in reviewing research proposals. Complaints concerning the conduct of a research project must be reported to the institution s Designated Person for handling research complaints (as described in the PY-RSH-300310 Research Misconduct Policy). Complaints concerning the HREC s review process should be directed to the attention of the Chairperson of the reviewing HREC. If a complaint concerning the HREC cannot be resolved by the HREC Chairperson it should be referred to the institution s CEO. Complaints concerning the research governance review process should be directed to the attention of the Senior Research Governance Officer and the Manager of the Mater Research Office. 4.7 Collaborative Research with Other Organisations PY-RSH-300302 Responsible Conduct of Research Policy describes arrangements to be agreed between researchers before a project begins. As a minimum, these arrangements should cover financial management, intellectual property, authorship and publication, consultancies, secondments, ethics approval, and ownership of equipment and data. Document Title: Human Research Governance Review Policy Page 11