XJTLU Policy on Ethical Conduct in Research
1. Policy Statement
1.1 Xi’an Jiaotong-Liverpool University (hereinafter referred to as ‘XJTLU’) is fully committed to the advancement of high quality academic research and to carrying out its research within a comprehensive ethical framework. This commitment extends to researchers, students and third parties.
1.2 The underpinning principle for any ethical review should be to ensure that, in undertaking any research, the University strives to contribute to knowledge and avoid causing harm. The term ‘Research’ is normally defined as: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”.
1.3 Research which involves human (including human participants (hereinafter referred to as ‘participants’), survey respondent, human genetic resources and personal data) or animals will always require formal ethical consideration.
The term “human genetic resources” includes the materials of human genetic resources and information on human genetic resources. The term “materials of human genetic resources” means genetic materials such as organs, tissues and cells which contain human genomes, genes and other genetic substances. The term “information on human genetic resources” means information materials such as data generated from the utilization of materials of human genetic resources.
1.4 It is the University’s expectation that staff, students, visitors, collaborators and agents who undertake research under the auspices of XJTLU should be aware of ethical considerations, ensure that they act in an ethical manner to the highest possible ethical standards.
2. Overarching Purpose
The purpose of this Policy is to:
2.1 Set out the principles applicable to all research, conducted in the name of or at XJTLU; and
2.2 Provide members of the University with a clear understanding of the ethical review process operated by XJTLU; and
2.3 Support a culture of high academic excellence and standards by providing an ethical review framework which enables research to be scrutinized in terms of ethical risk.
This Policy applies to all staff and students of XJTLU engaged in research as well as to visitors, collaborators, or agents who undertake research in the name of or at XJTLU.
4. Principles of Ethical Research
4.1 The University recognises that ethical issues vary considerably across different research and will necessarily have differing approaches to ethical review and the framing of ethical guidance. What’s set out below are the broad principles that the University generally expects its researchers to abide by.
a) All research must be designed, reviewed and undertaken in compliance with applicable laws, regulations, policies and guidelines.
b) In order to ensure the independence and trustworthiness of research results, any relevant or potential conflict of interest - whether personal, financial, academic or political - should be identified and declared. Conflict of interest should be declared in research proposals, publications or other forms of dissemination of findings, etc.
c) All human and animal research subjects must be treated with care and respect. The safety, health and welfare of the community and of all people relating to the research must be safeguarded.
d) Participants must be fully informed about the research they are invited to participate in and their consent to take part must be made voluntarily, freely and without any coercion. Consents should be recorded, ideally in writing.
In general, informed consent must be obtained from any participants in research at an appropriate point in the research process. Projects in which informed consent is impracticable due to the nature of the research or participants must be declared.
e) The design of the research should aim at maximizing the benefits and reducing the risks to participants of the research. There should be an appropriate balance between benefits and risks, and the well-being of the participants involved, especially those from vulnerable groups (children, frail and vulnerable elderly people, people with learning or communication disabilities, people in custody or people engaged in illegal activities) and those lacking the capacity or opportunity to make their consent, requires specifically considered protection, including appropriate ethical review.
f) Research involving vulnerable participants should only be undertaken when a project cannot reasonably be carried out with non-vulnerable participants or where the research has the potential to benefit that vulnerable group.
g) Rights of participants to make decisions for themselves should be respected, and researchers should not exert undue influence on participants’ decisions. Researchers should avoid conduct that may directly influence or distort research results.
h) Confidentiality of information given by participants and the anonymity of participants must be respected at all times, and documentation protected accordingly except where participants have agreed otherwise or disclosure is required by law.
i) While anonymisation of stored research data is encouraged, and every effort should be made to ensure effective protection of stored data which is private and confidential. Researchers must ensure that the personal data of participants are properly protected, especially in accordance with any laws relating to personal data protection. The methods of data acquisition and the use to which the data will be put must be approved by the appropriate Ethics Review Panel. The researchers must not use such information for their own personal advantage or that of a third party.
j) The Principal Investigator (hereinafter referred to as ‘PI’) must retain research records (including signed consent documents) for three years after completion of the research. Completion of the research is typically evidenced by the PI providing the completion report or equivalent supporting documents.
k) Researchers must respect a participant’s right to withdraw from active participation in research without adverse consequences to the participant. In some circumstances, however, where the participant opts to withdraw after the data has been aggregated and can no longer be related to the individual, retaining the data will be unavoidable.
l) Animals should be used in research only when alternative means have been found to be not viable or adequate. Where possible, the use of animals in research should be replaced by other methods such as computer simulation or cellular or other model systems. If research involving animals is necessary, the research design should aim at reducing the number of animals used to obtain sufficient information, and no more than the minimum number of animals necessary to ensure scientific and statistical validity should be used.
m) The physical and cultural environment should also be respected and treated with care, and measures need to be taken to minimize any unavoidable harmful impact on the environment. Researchers should take the sustainability of environmental resources into consideration in the research design. All resources should be utilized and deployed efficiently, and waste should be minimized.
n) Risks should be managed so that harm and/or damage arising from the research is avoided or minimised wherever possible and measures should be taken to ensure that the benefits of research should outweigh any potential harm or damage caused.
o) The same high ethical standards shall apply wherever in the world the research is undertaken. Research must adhere to local expectations, practices and laws, without compromising University standards.
4.2 The University meets these principles by communicating its standards and policies to staff through training, publication of this policy and other related policies, and through the process of the ethical review of research.
5. Ethical Review at XJTLU
5.1 XJTLU is committed to undertaking a rigorous and independent ethical review process that is proportionate to the potential risk.
5.2 This process includes a range of procedures for specific application types. The relevant level and type of ethical review may vary, with the principal determinant for the type of review being the risks associated with the research (see appendix 1). In compliance with governmental regulations/policies, and based on characteristics of research activities, the XJTLU currently undertakes the ethical review of Standard Risk Research (hereinafter referred to as ‘SRR’) and Low Risk Research (hereinafter referred to as ‘LRR’).
5.3 The University Ethics Review Panel has overall responsibility for monitoring the ethical review process, and providing the advice and suggestions from an academic perspective on ethics related matters.
5.4 University and school Ethics Review Panels are responsible for ensuring that proposals referred to them receive valid, sufficiently comprehensive, independent and timely ethical review.
A relatively straightforward ethics review for LRR should ideally take approximately ten working days.
A relatively straightforward ethics review for SRR should ideally take approximately fifteen working days.
5.5 School Ethics Review Panels should ensure that their arrangements for ethical review are adequate to cover all relevant aspects of the research undertaken by staff, students, visitors, collaborators in the name of or at XJTLU. These arrangements will be reviewed annually by University Ethics Review Panel.
6. Roles and Responsibilities
6.1 University Ethics Review Panel
6.1.1 University Ethics Review Panel is responsible for keeping under review and monitoring the implementation of the University Ethics Policy.
6.1.2 University Ethics Review Panel is responsible for providing advice and suggestions from an academic perspective on newly emerging and/or high risk ethics related matters, as well as special cases raised within the university.
6.1.3 University Ethics Review Panel will also ensure delivering appropriate training on ethical issues across the whole university to sustain a university-wide awareness of research ethical and related issues.
6.1.4 University Ethics Review Panel will also conduct preliminary ethical review on applications to governmental funding during the application stage, when required.
6.1.5 University Ethics Review Panel expects School Ethics Review Panels to provide reports on a semester basis and to regularly monitor approvals given to ensure the quality of the ethical review undertaken.
6.2 School Ethics Review Panels
6.2.1 Each School will normally be expected to have an Ethics Review Panel but, with the agreement of the Chair of University Ethics Review Panel, School Deans may agree to establish joint Ethics Review Panel across different Schools. This Panel normally consists of the one School Ethics Coordinator and a pool of reviewers within the school.
6.2.2 School Ethics Coordinators act as the main liaison between the university and their respective schools. School Ethics Coordinators are also tasked with relaying information related to the University Procedure to staff and students within their school.
6.2.3 For disputed cases or cases beyond the school review expertise, School Ethics Review Panels should report to and seek academic advice from University Ethics Review Panel.
6.3.1 Individual researchers are responsible for the ethical obligations when conducting research and should take the ultimate responsibility for the overall ethical conduct of their research. The University expects all researchers to take personal responsibility for familiarising themselves with XJTLU Policy on Ethical conduct in Research and the accompanying guidance, as well as any subject specific materials.
6.3.2 Researchers undertaking a project that involves human participants, survey respondent, human genetic resources, personal data or animals which requires ethical review must not commence research until the PI has obtained the XJTLU ethical approval letter and all other required approvals.
6.3.3 Research involving human genetic resources will also come under National Regulations on the Management of Human Genetic Resources and will require the review of Ministry of Science and Technology before the research commences. Research that requires review by an external body should be identified and referred to that body as early as possible in the University ethics review process.
6.3.4 Research involving animals will also come under the relevant governmental regulations scope and may be required to obtain specific license/qualification certificates before the research commences. Research that is required to obtain specific license/qualification certificates from an external body should be identified and referred to that external body as early as possible in the University ethics review process.
6.3.5 It is the responsibility of the PI for any research to ensure that all members involved in that research are aware of and comply with XJTLU Policy on Ethical conduct in Research, the accompanying guidance and the contents of the approved ethics application for the research.
6.3.6 The PI must ensure that research staff are qualified in the aspects including, but not limited to, appropriate human and animal subjects training, education, expertise, credentials, protocol requirements and privileges, to perform the procedures and duties assigned to them during the research.
6.3.7 Notwithstanding any ethical approval that may be obtained, researchers are required to ensure that their research is conducted in accordance with the ethical requirements of their funding body and/or any professional bodies or associations relevant to their discipline, and in compliance with health and safety requirements.
6.3.8 Serious cases of failing to apply for ethical approval or deviating from the approved project will be subjected to the University’s established misconduct procedures.
6.4 Students and Supervisors
Should a project include students in its research team, in addition to all points listed under 6.5, proper supervisory arrangements should also be assured. This includes:
6.4.1 Academic supervisors of undergraduate and postgraduate students shall ensure that their students become familiar with the XJTLU Policy on Ethical conduct in Research and endorse their students' application prior to the submission of ethics applications.
6.4.2 Students should normally be engaged in research projects which are within their field of study and do so under the supervision of a faculty member/academic staff.
1. Appendix 1 Flowchart of Research Ethics Application and Review Process
2. Appendix 2 Ethics in Research Provisional Guidelines on Best Practice
3. Appendix 3 Informed Consent Form
4. Appendix 4 Participant Information Sheet Guidelines
(Last review date: 17-Aug-2023)