Research Ethics: General Principles and Statements
'Research Ethics: General Principles and Statements' is the core document underpinning the University's Ethics Policy. It should be read by all University staff and registered students who are conducting, or planning to conduct, research involving human participants, personal data, and human tissue, as well as any others conducting research on University premises. It sets out the fundamental principles governing research ethics at the University, the key objectives of the Policy, its scope and applicability, as well as research governance and responsibilities.
|1. Fundamental principles of research ethics||
The founding motto of the University of Sheffield is ‘To discover the causes of things’. The University’s mission is to uphold the ideals of discovery, to encourage and support research into new ways of acquiring, investigating and developing knowledge for the good of society, and to ensure that all research is conducted in accordance with ethical principles.
The paramount principle governing all University of Sheffield research involving human participants, personal data and human tissue is respect for the participants’ dignity, rights, safety and well-being.
1.1 Participants’ rights
Participants have a right, as a principle of research ethics, to:
1.2 Researchers’ obligations
Researchers have an obligation to ensure that their research is conducted with:
Guidance on the interpretation and application of these principles is detailed in this Policy document.
These principles of research ethics are recognised in international and regional treaties, as well as national laws. Breach of these principles may, in some instances, be a civil or criminal offence. The principles and requirements outlined in this Policy reflect the principles of research ethics but do not displace a researcher's obligation to comply with any relevant legal and regulatory requirements.
Ethical research conduct does not require the avoidance of potentially high-risk research. An ethical approach to research involves, rather, proper recognition of, and preparation for, risks, and their responsible management. Ethical research is therefore a matter of being risk aware, not risk averse.
Finally, if research ethics are to be more than merely formulaic and procedural they must be meaningful and relevant to - and accepted by - researchers. To this end, this Policy specifies an ethics review procedure that is devolved to academic departments in the first instance, and which depends on ethically aware, self-reflective researchers taking responsibility for operationalising the principles and requirements embodied in the Policy.
|2. Introducing research ethics||
The University’s definition of research is taken from the Research Excellence Framework 2014: ‘a process of investigation leading to new insights, effectively shared’. This applies to all research undertaken by, or on behalf of, the University, across the full range of academic disciplines, from the arts and humanities to the natural sciences (whether funded or not), and also encompassing administrative research (undertaken within, or on behalf of, professional services departments or academic faculties/departments), and research undertaken by or within University research centres/institutes, advisory/consultancy services and subsidiary companies. This definition includes:
This definition of research excludes:
The University of Sheffield’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue, applies only to research involving human participants, personal data and human tissue. What is understood by these terms is discussed in Research Ethics Policy Note no. 1. It does not cover broader ethics or integrity issues that may apply to any type of research (e.g. ethical issues surrounding the source of funding for research), or ethical issues surrounding the use of animals in research.
|3. Research ethics at the University of Sheffield||
The University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue recognises that the responsibility for maintaining ethical conduct lies, in the first instance, with researchers themselves. If researchers do not take responsibility for the ethical conduct of their own research, defensible research ethics will be an unrealisable goal. To this end, responsibility for operating the University’s Ethics Review Procedure, informed by the Policy, is devolved to academic departments and funding units.
Within this devolved framework, the University recognises that diversity enriches and strengthens its research culture and performance. Diversity means that research activities involving human participants, personal data and human tissue may differ widely from one department or funding unit to another. Thus the ethical issues relating to human participation in research may also differ considerably from one academic department or funding unit to another.
This means that the formal ethical review of research proposals involving human participants, personal data or human tissue is best carried out within departments, within the broad parameters provided by this Policy and the Research Ethics Approval Procedure.
The key principle underlying the Research Ethics Approval Procedure is that researchers should reflect on the ethical issues that are raised by their research and be able to justify, in ethical terms, the practices and procedures that they intend to adopt during their research. Matters of research ethics are often not ‘black and white’, and there is no ‘one size fits all approach’. This Policy therefore aims to set a clear framework and guiding principles to assist researchers in addressing the ethical issues that may arise in the course of their research.
|4. Research governance and responsibilities||
Heads of departments and funding units are responsible for the conduct of the research that is undertaken in their departments. They are therefore responsible for ensuring that departmental researchers have access to appropriate ethics review procedures for research activities that involve human participants, personal data or human tissue, in line with the University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue. They are also responsible for ensuring that all research-active staff and students are familiar with the content of the Policy and that appropriate training and guidance is made available. In particular, it is compulsory for all staff to undertake the University’s Information Security training, and this training is also recommended for students who undertake research involving personal data. As in all other matters, individual researchers are expected to follow the leadership of their Head of Department.
In everyday research practice, however, the first responsibility for considering, respecting and safeguarding the dignity, rights, safety and well-being of human participants involved in research lies with the lead researcher (e.g. the principal investigator or supervisor). However, this practical principle does not absolve more junior, or more senior, staff, or students, from personal responsibility in this respect, or from their responsibility to disclose any failure to meet the principles of conduct required by the Policy.
All researchers at the University of Sheffield, whether staff members or students, are responsible to a range of stakeholders for their conduct during, and delivery of, their research activities involving human participants. These are:
The University Research Ethics Committee (UREC) is responsible to the University’s Senate for:
|5. Scope and applicability of research ethics policy||
The University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue applies to:
This specifically includes research undertaken by non-academic departments of the University of Sheffield, and administrative research undertaken within academic departments or faculties. For further definition and discussion of these activities and the procedures for their ethical review, see Research Ethics Policy Note no. 7, Administrative Research within the University.
The University of Sheffield’s Policy is designed to complement the National Health Service (NHS) ethics review system. The University’s Ethics Review Procedure does not, therefore, duplicate the functions, or overlap with the remit, of the NHS ethics review system. For further detail about ethics review via the NHS ethics review system, and information about which University research requires NHS, rather than University, ethics approval, see Research Ethics Policy Note no. 5.
Other external bodies, such as some public-sector social care providers or the armed forces, also have their own research ethics policies and review procedures. In the case of social care research, see Research Ethics Policy Note no. 5. In all other cases, contact the Secretary of the University Research Ethics Committee for guidance.
Research funding bodies may have their own research ethics policies and/or requirements, which must be met as a condition for receiving research funding. However, this does not obviate the need for observance of the University’s Policy and its associated procedures; in such cases, the external policies and requirements are an extra layer of research ethics governance, not an alternative to the University’s Policy.
Similarly, external research collaborators may be required to follow the ethics policies and procedures of their own organisations. However, the University’s Policy and procedures must still be followed in any collaborative research that involves University of Sheffield staff or students. In some cases, an external organisation’s ethics review procedure may be deemed sufficiently robust that additional ethical approval via the University of Sheffield’s procedure is not required – see section 4 of the Research Ethics Approval Procedure for more details (‘Alternative Ethics Review Procedure’).
The final external stakeholders to be considered are professional bodies and learned societies, which may also have their own research ethics policies, guidelines and requirements. While learned societies’ research ethics guidelines are useful resources that may offer supplementary guidance, the University’s Policy must, in the first instance, take precedence for University staff members and with respect to research conducted on University premises. External bodies that have professional licensing or registration responsibilities are, however, a different matter and their external principles have a different weight. Although it is unlikely that professional ethical codes will conflict with the University’s Policy, in the event of a perceived conflict of this kind, the member of staff concerned should contact the Secretary of the University Research Ethics Committee for guidance.
|6. The objectives of the ethics policy governing research involving human participants, personal data and human tissue||
The Policy is intended to:
|7. Good research practice||
Observing recognised research ethics principles is basic to good research practice in general. The University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue should, therefore, be read alongside:
Upholding ethical standards in the conduct of research means accepting and respecting principles of integrity, honesty and openness. Conducting research with integrity means embracing intellectual honesty and accepting personal responsibility for one’s own actions.
Prior to, during, and following the completion of research activities, researchers are expected to consider the ethical implications of their research and, depending on its nature, the cultural, economic, psychological, physiological, political, religious, spiritual and social consequences of it for the human participants involved.
Researchers should always consider their research from the perspective(s) of the participants and any other people who may possibly be affected by it.
|8. Safety and well-being||
Finally, issues of safety and well-being are at the heart of research ethics. Researchers have a responsibility to protect all participants, as well as they can, from avoidable harm arising from their research. Researchers also have a responsibility to consider their own safety and that of any co-researchers or collaborators.
As a general rule, people participating in research should not be exposed to risks that are greater than, or additional to, those they encounter in their normal lifestyles. If it is expected that harm, unusual discomfort or other negative consequences might occur in prospective participants’ future lives as a result of participation in a research project, the researcher should highlight this during the ethics approval process, and discuss the matter fully with participants during negotiations about informed consent.
However, it should also be noted that it may not be possible for researchers to identify every eventuality that may arise in the course of a research project, and that this Policy is not designed to cover all possible situations. Unexpected incidents affecting the safety or well-being of those involved, and/or presenting a potential reputational risk to the University, may arise even in a project that has been well-considered and thoroughly ethically reviewed. Should such an incident arise, the researcher should take appropriate steps to manage the immediate situation in line with the University’s Health and Safety procedures. At the earliest opportunity they should make their supervisor or line manager aware of the situation. Where there are potential implications relating to research ethics (e.g. if the terms of ethics approval have been breached), the UREC’s Secretary should be contacted for advice.