3.1 The University Procedure in practice
Sections 3.1.1 to 3.1.12 explain the procedure
|3.1.1 Who conducts the ethical review of research at the University?||
Each academic department administers the University Procedure and grants ethics approval for research undertaken by its own researchers. Each department has a designated Ethics Administrator who is responsible for the administration of the procedure on a day-to-day basis, and a pool of ethics reviewers who conduct the ethical review of research projects submitted to the department.
Any University member of staff may become an ethics reviewer (with the approval of their Head of Department). Departments should ensure that staff appointed as ethics reviewers (including as supervisors of Undergraduate and Postgraduate Taught student research projects) receive appropriate training and/or guidance to help them fulfil this role effectively and that appropriate records of relevant training are maintained (for example via a training log for each reviewer/supervisor, maintained by the Ethics Administrator).
All ethics reviewers (including those who have undertaken ethical review for another organisation but who are new to the University of Sheffield) should have read the University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue. In addition, they should undertake at least one, and ideally more, of the following:
It is strongly recommended that only experienced reviewers are appointed to act as the lead reviewer. Reviewers should be encouraged to undertake refresher training from time to time, using any of the routes described above. They should also ensure they are aware of changes to the University’s Ethics Policy and Ethics Review Procedure by reading email updates and bulletins circulated by their departmental Principal Ethics Contact and by the UREC.
Each department should also have a group of at least three ethics reviewers, constituting an Ethics Review Panel or Research Committee, who will be available to review contentious applications (i.e. where there is a significant, fundamental difference of opinion between the original ethics reviewers about the ethical implications of the proposed research); none of the members of the Ethics Review Panel or Research Committee should have a conflict of interest with the project in question.
Each department also has its own designated Principal Ethics Contact, who will normally communicate any changes in, or information relating to, the University Procedure to staff and students in the department. This person may also be the Ethics Administrator. The names of Ethics Administrators and Principal Ethics Contacts can be found here:
Sometimes, due to the requirements of a funding body or any other external body the cooperation of which is necessary for the research to proceed, lay input into ethical scrutiny will be required. In such cases, ethical scrutiny of research projects will be undertaken by a sub-committee of the University Research Ethics Committee (see section 3.1.5 for more details).
N.B. The arrangements for the ethical review of administrative research are set out in Research Ethics Policy Note no.7: ‘Administrative research within the University’. If a research project requiring ethical review will be carried out by part of the University that does not fall within the designated procedures for either academic or administrative research, the project leader should contact the Secretary of the University Research Ethics Committee for advice on how to seek ethical approval.
|3.1.2 How is a research project submitted for ethical review?||
The researcher completes and submits the online ethics application form (the Ethics Application System is accessed through ‘My Services’, and further details on how to submit an application can be found here).
The application form should be accompanied by any relevant documentation. For example, if it is intended to use an information sheet, covering letter or written script to inform prospective participants about the proposed research, or if a consent form will be used to record participants’ consent to participation in the research, these should form part of the application. Applicants should also provide further information such as the interview schedules, questionnaires or other research tools that they plan to use, if these are available at the time of review; departments are encouraged to adopt this as best practice, with recognition of the fact that it may not always be possible. Ethics reviewers may ask for subsequent sight of these, if they are not available at the time of applying.
An application for ethics approval of a research project may only be submitted via one academic department. If a project involves staff from more than one department, one department must be selected as the channel through which ethics approval will be sought; the application cannot subsequently be submitted for ethics review in another department.
|3.1.3 Undergraduate and postgraduate-taught student research||
Although the quality of ethics reviewing must be maintained for all types of research, some departments deal with very large volumes of research ethics applications from undergraduate and postgraduate-taught students. Since this can be a significant administrative burden, appropriate versions of the basic procedure have been developed for supervised undergraduate and postgraduate-taught student research, in two respects:
220.127.116.11 Distinct research projects: Where an undergraduate or postgraduate-taught student requires ethics approval for an individual research project that is distinct from any other student research, the supervisor is responsible for classifying the research as either ‘low risk’ or ‘potentially high risk’ (on risk assessment, see Section 3.1.4). A reduced number of ethics reviewers is required to review such projects, dependent on the risk level posed (for full details see Section 3.1.5).
18.104.22.168 Generic research projects: Where a number of undergraduate or postgraduate taught students will be conducting research that is of a sufficiently similar nature to be reviewed together, a single generic ethics application can be submitted for review, using one application form. This process is designed to increase the efficiency of the University Procedure where departments may otherwise have to process large numbers of ethics applications for cohorts of students who undertake similar research projects each year. A generic research ethics review covers more than one sufficiently similar research project.
There are two types of generic research ethics review:
Type 1, in which, at a particular stage in their course, a cohort of students undertakes the same research exercise involving human participants. These research projects are training exercises as part of an educational programme. Examples might be learning how to administer a particular psychological test or how to carry out specific laboratory
Type 2, in which students undertake slightly different research projects, which are
An example might be a cohort of students that has to undertake questionnaire-based surveys to find out about adults’ eating preferences or the relationship between smoking and health.
In the above cases, the person with primary responsibility for the research projects in
Despite the above, supervisors, course leaders or research directors responsible for generic research projects may, for educational and training purposes, decide to ask students to complete individual ethics applications, even though such applications do not necessarily require individual ethics approval.
Where a research activity that has been granted generic research ethics approval is repeated with different cohorts of students on a year-on-year basis, the Ethics Administrator and the academic staff member responsible for the activity should review the approval every year, to ensure that the activity in question has not changed sufficiently to render the original approval inapplicable. This annual review process, and the decision reached, should be documented. If there has been significant change, a new generic ethics application should be submitted. If there has not, a generic ethics approval should, anyway, be renewed every five years, i.e. a new generic ethics application should be submitted for review.
|3.1.4 Assessing ethical risk||
The UREC has developed broad definitions of categories of ethical risk. Research that is potentially high risk will involve ‘particularly vulnerable participants’ - whether directly, or in terms of personal data about them - and/or address ‘highly sensitive topics’. Conversely, low risk research will involve neither ‘particularly vulnerable participants’ nor ‘highly sensitive topics’. The third criterion that should be used to assess ethical risk is the nature of the research itself, particularly with respect to the safety and well-being of participants (including researchers); for example, any research that involves active intervention in the lives of research participants is likely to be more risky than a project that does not, and should be assessed accordingly.
The category of ‘potentially particularly vulnerable participants’ includes, but is not restricted to, the following.
(a) People whose competence to exercise informed consent is in doubt, such as:
(b) People who may socially not be in a position to exercise unfettered informed consent, such as:
(c) People whose circumstances may unduly influence their decisions to consent, such as:
Potentially highly sensitive topics include:
A key word qualifying all of the above lists is ‘potentially’. It should never simply be assumed that the above kinds of research participants and topics are under all circumstances ‘vulnerable’ or ‘risky’: an unreflective ‘box ticking’ approach in this respect is strongly discouraged. In the first place, researchers should reflect upon the specificities of each research project, and the risks and vulnerabilities it may, or may not, present or create should be documented and evaluated as part of the ethics review process. In the second, departments are encouraged to develop local definitions of risk and vulnerability that are appropriate to the nature of their particular research activities, providing these definitions are endorsed by the UREC.
Finally, it cannot be emphasised too strongly that conducting research ethically is not a matter of avoiding potentially high-risk research. It is, rather, about preparing for and managing risks; it is a matter of being risk aware, not risk averse.
|3.1.5 How is the ethical review of a project carried out?||
Once an application for the ethical review of a research project has been submitted via the online Ethics Application System, a notification will be sent to the appropriate person asking them to take action:
Where more than one reviewer is required, a lead ethics reviewer will be appointed by the Ethics Administrator, to consider the decision and comments made by each of the reviewers, and to make a final decision regarding the outcome and the comments to be communicated to the applicant.
Once a final decision has been made, the Ethics Administrator will be asked send the response to the applicant. At this stage, Ethics Administrators are encouraged to maintain an overview of the decisions being made by supervisors and reviewers, to ensure that decisions (at both the risk assessment and ethical review stages) are being made in line with University and departmental policy, and to identify any training needs.
Should an Ethics Administrator become aware of a decision that they have concerns about, they should initially discuss the issue with the supervisor or reviewer concerned, at which point the decision may be amended. If the Ethics Administrator continues to have concerns about the decision made following such a discussion, they should refer the situation to the Head of Department or to the UREC.
Should the department prefer to arrange for an application to be reviewed at a minuted face-to-face meeting rather than online, then the Ethics Administrator should use the ‘review by committee’ option within the online Ethics Application System and appoint a lead ethics reviewer to coordinate the meeting and record the outcome in the system.
The following sets out the minimum requirements for the ethical review of research (departments can set more stringent requirements if they so wish):
|3.1.6 What are the possible outcomes of the ethical review of a project?||
On considering the ethical implications of a project, ethics reviewers can recommend one of the following possible outcomes; the final decision rests with the lead reviewer (or the supervisor in the case of low risk undergraduate/postgraduate taught student research):
Ethics reviewers have, with the applicant(s), responsibility for the quality of the ethics application. Where they feel that the applicant has not included sufficient detail for the reviewer to make an informed judgement, they should ask that the applicant clarifies or expands on the information that has been provided before a decision can be made.
|3.1.7 How long will it take to obtain ethics approval for a project?||
A relatively straightforward ethics review should ideally take approximately ten working days (the exact timing will depend on the academic department, and circumstances). However, delays can occur if a research ethics application form is not fully completed, if the ethics reviewers request more information, if an application is judged contentious, or if the applicant appeals against the ethics decision.
|3.1.8 What happens if changes are made to the project after ethics approval has been obtained?||
In this situation, the researcher must consider whether the proposed amendment constitutes a significant change that could have a potential impact on the dignity, rights, safety and well-being of the participants. A ‘significant change’ refers to a new research approach or method that, had it been planned at the time, would have been mentioned on the original research ethics approval application. Examples of this include:
This list is indicative, rather than exhaustive. In such cases, or if there is any other doubt about whether a proposed change is significant, the researcher should contact the departmental Ethics Administrator who will then provide the details to one of the ethics reviewers who originally reviewed the project (ideally the lead reviewer, where relevant). The reviewer should then consider the changes and liaise with the Ethics Administrator to advise the researcher on the appropriate course of action. This could involve re-applying for full ethics approval, if the changes are particularly significant; alternatively, the reviewer may be happy to approve the changes immediately (it is left to the discretion of academic departments to decide departmental procedure in this regard). The Ethics Administrator should make a record of the proposed changes and the actions that were undertaken as a result, and upload a copy of this to the original approved application in the online Ethics Application System.
The requirements of this section do not apply to the routine, everyday adjustments to data gathering plans and activities that researchers must often make in response to the contingencies of research. Nor does it apply to minor corrections in the written information given to participants, such as remedying spelling errors or typos. Discretion, responsibility and common sense are necessary in interpreting this section: researchers are required to reflect upon what they are doing, its relationship to their original ethics approval application, and whether any ongoing adjustments are significant, in the terms outlined above.
|3.1.9 Retrospective Ethics Review||
Research involving human participants, human tissue or personal data should not begin before research ethics review has taken place and ethics approval granted. Retrospective ethics review is, therefore, not permitted. It is the responsibility of the principal investigator or, in the case of a student project, the supervisor, to ensure that ethics review is undertaken in good time. There are no exceptions to this principle.
However, there may be circumstances in which there is legitimate uncertainty about when research begins (or has begun). In particular, materials may originally be noted without any explicit intention to undertake research, but subsequently become of research interest (i.e. they could be used as data within research). For more detailed discussion of the kinds of circumstances in which this may happen, and how the ethical approval for such situations may be dealt with, see Research Ethics Policy Note no. 10.
|3.1.10 When is research ethics approval NOT required?||
Ethics approval is not required in the following situations:
Note regarding the Data Controller: according to the Data Protection Act, the Data Controller will usually be the University of Sheffield (i.e. not a particular individual or research team), although collaboration with other institutions may result in joint Data Controllers. In practice, in the case of discrete research projects, it is highly unlikely that members of a research team will come into contact with data from other parts of the University that may result in the re-identification of participants whose data has been anonymised. However, researchers should think carefully about this possibility when seeking to anonymise their data; strictly speaking, if there is any possibility that anonymised data could be traced back to the individual that provided it via any other data held by, or likely to come into the possession of, the Data Controller, then the data has in fact only been ‘pseudonymised’. This means that it would in fact still be classed as personal data. Two examples of situations in which this problem is more likely to arise include:
|3.1.11 Procedure to be followed in the event of concerns arising about whether a research proposal or ongoing research activity complies with the University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue||
Should concerns arise, for whatever reasons, about whether a research proposal or ongoing research activity complies with the University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue, the UREC should be notified as soon as possible. The UREC will contact the Head of the Department concerned, as the person ultimately responsible for the implementation and observance of the Policy within that Department, indicating that the research activity in question, or the approval process with respect to the proposal in question, should be suspended in order to allow an investigation of the case. The UREC and the Department in question should carry out any such investigation collaboratively and as a matter of urgency. The UREC will determine the outcome of the investigation; the University’s Policy on Investigating and Responding to Allegations of Research Misconduct, and/or another appropriate University procedure, may be activated (further details are set out in the University’s Good Research & Innovation Practices policy).
In the case of students who have not obtained the appropriate ethics approval for their project, the Senate-approved ‘Procedure for dealing with students who have not obtained research ethics approval’ should be followed (see section 3.1.12 below).
Should a member of staff or a student have concerns about whether a particular project is being managed ethically they should, in the first instance, report this to their Head of Department and the issue should be investigated informally. If the concerns are substantiated, the Chair of the University Research Ethics Committee should be informed and the matter investigated fully in accordance with the process set out above.
|3.1.12 Procedure for dealing with students who have not obtained research ethics approval||
General University Regulation 10 states that:
"A person seeking to undertake research which would involve human participants, personal data or human tissue must comply with the University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue, and prior to the commencement of the research, must ensure that appropriate ethics approval has been obtained. Any breach of this Regulation may be dealt with under the Regulations as to the Discipline of Students."
Such breaches are relatively rare. Existing procedures require students and supervisors to be aware of the requirements of research ethics and their responsibilities in this area. All first year PGR students take a compulsory faculty-level DDP module on ethics and integrity, and many PGT/UG students in disciplines where research is likely to require ethical review also cover ethics as part of their research methods training. Supervisors, however, are ultimately responsible for ensuring students are aware of the need to obtain ethical approval where appropriate. As a final check in the case of PGR students, the 12-month confirmation review requires supervisory teams to declare whether ethics approval is required and if it has been obtained.
If a breach does however occur, it should be dealt with in line with the principles of natural justice and on a case by case basis, in particular taking into account what was known by the student and at what time. Their potential vulnerability and the role of their supervisor should also be considered. This does not negate the requirement that all researchers are expected to be familiar with the ethics review procedure and that they have received appropriate training. Any action taken against the student by a department should be proportionate to the circumstances, taking account of their explanation of events and any mitigating circumstances.
Where a student has not obtained ethics approval for a research project, the following procedure should be followed: