Policy statement

POLICY ON THE ETHICAL CONDUCT OF RESEARCH INVOLVING HUMAN PARTICIPANTS AND PERSONAL DATA

The University's aims

The University of Oxford seeks to protect the dignity, rights and welfare of all those involved in research (whether they are participants , researchers or third parties ) and to promote high ethical standards of research. The University achieves this by:

fostering a culture within the University that embraces the principles set down in this policy and the obligations contained in relevant legislation to protect the rights, dignity and welfare of those involved in research;
providing ethical guidance that communicates regulatory requirements and best practice, and offering ongoing support and training to staff and students to maintain high ethical standards;
maintaining a review process that subjects research to a level of scrutiny in proportion to the risk of harm or adverse affect.

This policy should be read in conjunction with the University’s Code of Practice and Procedure on Academic Integrity in Research and reflects the Universal Ethical Code for Scientists published by the Council for Science and Technology.

Scope

In this policy, the term ‘researcher’ refers to staff and students, and to other persons engaged in a University-led research project who, as a condition of their being granted access to the University’s premises or facilities, have agreed in writing that this policy shall apply to them, whether or not the research is conducted on the University’s premises or using the University’s facilities.

The University's commitments

The University of Oxford is committed to ensuring that its research activities involving human participants and personal data are conducted in a way which:

respects the dignity, rights, and welfare of all participants in research;
minimises risk to participants, researchers, and third parties;
appropriately manages personal data; and
maximises the public benefit of research.

The University requires that all those carrying out such research engage with the University’s commitment to conduct research to high ethical standards; understand the reasons for, and participate fully in, the ethical review process (whether under the University’s procedures or those of authorised bodies such as the National Research Ethics Service); and fulfil their moral and legal responsibilities in respect of the rights and welfare of participants.

Rigour

The University is committed to ensuring that research involving human participants and personal data conducted on University premises or using University facilities or by University researchers is carried out to high ethical standards.

The University meets this commitment by:

requiring that research is designed and undertaken in a manner that evinces a commitment to accountability and quality;
setting appropriate standards for the conduct of research involving human participants and personal data that are in line with current legislation and best practice;
identifying and reviewing all research involving human participants and personal data in proportion to the level of risk, except where the ethical standards of that research are more appropriately secured by another recognised approval procedure, for example that of the National Health Service;
ensuring that research complies with current legislative requirements.

Respect

The University is committed to ensuring that all research involving human participants and personal data contributes to the public good, and that the dignity, rights and welfare of researchers, research subjects and third parties (which may include family members, carers or the wider community) are respected.

The University meets this commitment by:

avoiding harm to people involved in, or affected by, the research, through the early identification and considered assessment of risk;
requiring that people are fully informed about the purpose and intended possible uses of the research, what their participation involves and details of any risks (unless the relevant ethics committee explicitly approves otherwise because, for example, the research falls within a recognised and specific research context);
ensuring that consent to participate in research is informed, valid and freely given;
respecting the participant’s right to withdraw from research at any time without adverse consequences;
observing the confidentiality of information provided by participants and, where appropriate, respecting their anonymity.

Responsibility

The University is committed to providing leadership in the area of ethical conduct of research and to participating openly in discussions on the direction of research, and improvements to practice, in this area.

The University meets this commitment by:

contributing, listening and responding to the debate on issues that research involving human participants and personal data may raise for society;
working closely with relevant peer groups and government agencies to remain abreast of developments and inform UK policy;
maintaining open and transparent procedures relating to the conduct and review of research.

Education and training

The University is committed to sustaining and encouraging ethical research conduct among researchers by the provision of training to equip them with the skills to recognise potential risks and by raising awareness of the University’s policy and procedures and the responsibilities of researchers in helping the University to meet its obligations under the relevant legislation.

The University meets this commitment by:

communicating the University’s standards and policies effectively to researchers and staff in research-related roles;
promoting awareness of best practice through education and training;
providing appropriate training for those undertaking research involving human participants and personal data, and for those responsible for ethical review of such research, so that knowledge and skills are up-to-date;
fostering an environment of openness and integrity that encourages collaboration and early communication of potential risks.

Ethical review process

The University is committed to providing a competent, rigorous and independent process of ethical review that is proportionate to the potential risk.

The University meets this commitment by:

using a procedure that distinguishes research that requires review under external procedures, such as that requiring review by the National Research Ethics Service, and separates out low-risk research for ‘light-touch’ expedited review from those research projects requiring further scrutiny by committee;
appointing to its ethical review committees a combination of lay members, those who are no longer involved in research, and also those who are still active in the research areas submitted to the committee for review, that together reflect the interests of researchers, participants and third parties;
keeping under regular review the effectiveness of the ethical review process, including the composition of its review committees.

University staff and students as participants in research

The University extends to its staff and students participating in research the same protection as to all other participants. Staff and students may be invited to participate in research carried out in the University but their participation must be entirely voluntary, they may withdraw at any time, and their participation or decision not to participate will not affect their employment or academic assessment in any way. It is normally acceptable for students to be invited to take part in teaching exercises, one of the main aims of which is to train them to make their own observations.

Status and sanctions

The University regards any breach of this policy or any breach of the approved terms of a project, as a very serious matter, which may result in disciplinary action, the ultimate sanction being dismissal for staff, expulsion for students and withdrawal of access to University premises and facilities for others. In appropriate circumstances, the CUREC subcommittees have the power under the regulations to withhold, suspend or withdraw approval of research, whether as part of disciplinary proceedings or otherwise.

Responsibilities

Council

It is the responsibility of Council to make, and keep under regular review, policy relating to the ethical conduct of research involving human participants and personal data, and to commit sufficient resources to its implementation.

Registrar

The Registrar, reporting to the Vice-Chancellor, is the University’s chief administrative officer and, as such, has overall responsibility for the University’s compliance with its legislation and policies, and for ensuring their conformity with the general law.

Pro-Vice-Chancellor (Research)

The Pro-Vice-Chancellor (Research) is appointed by Council to provide leadership in all matters relating to research. Specific duties include co-ordination of the activities of bodies concerned with research ethics and an audit role in ensuring that compliance is being achieved in this area, reporting to Council. The Pro-Vice-Chancellor chairs the Research Committee (through which the Central University Research Ethics Committee reports to Council) and consults with the Registrar on ethical matters and compliance issues of wider concern to the University.

Heads of Division

Heads of Division provide senior academic leadership within the University, an important element of which is to promote the highest ethical standards in the design, conduct and reporting of research.

Heads of Department

Heads of Department as senior academic leaders within the University should promote the highest ethical standards in the design, conduct and reporting of research.

As one component of this, Heads of Departments are responsible to Heads of Division for ensuring their staff and students, and other researchers with access to the Department’s premises and facilities, observe this policy and for the effective local review and vetting of departmental research applications before submission to one of CUREC’s subcommittees for ethical review.

Research Services

Research Services is responsible for facilitating all aspects of obtaining monetary and non-monetary support for research, whether through grants, contracts or promoting collaborative activities, and for authorising the same where required. It provides direct support through training, systems and the provision of advice to enable compliance on an individual and institutional level with current relevant legislation and Good Clinical Practice. Research Services encourages the development of an environment which values and abides by the Responsible Conduct of Research principles and compliance with other regulatory requirements. Its officers work closely with the Central University Research Ethics Committee.

Ethical review committees

The Central University Research Ethics Committee (CUREC), which reports to Council through the Research Committee, has overall responsibility for the University’s ethical review process and makes recommendations to Council on changes to this policy, its remit as set out in the University’s regulations and the composition of its membership, and that of its subcommittees.

Officers attached to CUREC’s three interdivisional subcommittees consider applications for ethical review and forward applications assessed to be more than minimal risk to their subcommittee for full review.

Researchers

The University expects researchers to take personal responsibility for familiarising themselves with the policy and procedures.

Research involving human participants that requires ethical committee review must not be undertaken unless and until that review has been undertaken and approval provided.

Research higher degree supervisors should assist their students to become familiar with this and other University policies and procedures relevant to the conduct of the student’s project, and provide specific advice and guidance.

Appeals

Researchers may appeal the decision of a University ethical review committee to withhold, suspend or withdraw ethical approval of research involving human participants or personal data by contacting the Chairman of the Central University Research Ethics Committee.

Complaints

Suspected breaches of this policy should be reported to the Chairman of the Chairman of the Central University Research Ethics Committee.

Further information

Details of the ethical review process and contact information for further advice are available on the CUREC website. Further information on data protection, including the University’s policy on data protection, is also available online.