Department of Economics’ Ethics Policy for Research Involving Human Participants, Data and Tissue
1. Which Proposals Need to be Reviewed?
2. (a) The Ethics Review Process for Staff Research proposals:general principles
(b) Research Proposals Involving the NHS
(c) Research Proposals to the ESRC
3. Ethics Review of Student Research
1. Which Proposals Need to be Reviewed?
From 1st October 2005, the University´s new ethics policy for research projects means that all relevant proposals for research projects (by members of staff or their students) must be reviewed to check their ethical content.
`Relevant´ in the previous paragraph means an ethics review is required for any research project that:
- Directly involves people in the research
- Indirectly involves people in the research through access to personal data and/or tissue
- Involves people on behalf of others (e.g. parents, guardians etc)
Personal´ data in part b.) above means any data, including archival data, from which living individuals can be identified. Any research project involving the analysis of an anonymous data set that has been provided to you (for example the British Household Panel Survey, many of those supplied by the ESRC Data Archive, and most other nationally and internationally provided data sets) does NOT have to be ethically reviewed.
HOWEVER, if any new research project you are formulating involves the direct participation of individuals (most likely through interviews or questionnaires in our case –i.e. you are devising the sample and doing the interviews or distributing the questionnaires yourself or via a team working for you) then you MUST first get the proposal ethically reviewed. Note that this is the case, even if the questionnaires are returned to you anonymously, since people have been directly involved in your research project (case a.) above).
Similarly, if a data set has been provided to you in which individuals can be identified (most obviously if the data set contains their names, but also if an individual could in principle be identified from the responses they give), then again you MUST first get the proposal ethically reviewed. Examples of the latter could be data sets that include detailed post codes, as well as background characteristics. In that case, there may only be one, say, 35 year old single woman with 1 child living on a particular street, who could then in principle be identified with the postcode data.
What if the research is being conducted in another country?
Research that will take place in another country and will involve human participants from that country should be ethically reviewed via the appropriate ethics review procedure in that country. A review and assessment of how local approval is obtained is an essential part of the ethical review process.
However, any such ethics review procedure must also be assessed by the department in order to ascertain whether it is sufficiently robust in comparison to the University of Sheffield´s own Ethics Review Procedure. If the ethics review procedure in the other country (or countries) is deemed to be insufficiently robust when compared to the University of Sheffield´s Ethics Review Procedure, the University of Sheffield´s procedure applies (although it should be noted that review via the other country´s ethics review procedure may still be mandatory). For example, the robustness of local ethical approval may be doubtful if all it involves is obtaining the signature of a local official. A sufficiently robust mechanism is one that helps protect the dignity, rights, safety and well-being of the human participants in the research.
What if the research is done in collaboration with other institutions?
If the University is collaborating with another United Kingdom university and the other United Kingdom university is the lead partner, then the ethics review procedure in place within the other United Kingdom university should apply, rather than the University of Sheffield´s procedure. However, as with research conducted overseas, this is subject to the condition that the other United Kingdom university´s ethics review procedure is sufficiently robust. To check this, contact the Departmental Ethics Administrator, who will liaise as necessary with the University.
If you are in any doubt about whether your proposal should be ethically reviewed, please contact the Ethics Administrator, Paul Mosley. Further information can also be obtained on the University's central Research Ethics website at:
2. The Ethics Review Process for Staff Research Proposals:
(a) General principles for new applications
On the webpage in the link immediately above, you will see a link to a file describing the University´s Ethics Policy, in the downloads section.
The first of the main links in the middle of the page is for `staff and postgraduate researchers´. Clicking on this leads to a page with all the information you need to make an ethics application. Most of this can be found by clicking on the link `Guidance on ethical issues´. In this guidance section, in the box on the right-hand side labelled `Ethics Principles´ are three fact sheets on:
These fact sheets describe the three principles you should build into your research proposal to ensure it passes the ethics review. To quote the University's new ethics document (draft June 2010) `The paramount principle governing all research involving human participants, personal data and human tissue is respect for the participants´ welfare and rights.´
Summarising the ethics review procedure, if you have decided that your research does directly involve individuals or indirectly their personal data, and so your proposal requires reviewing, you need to go to the Further Information section on the main ethics page for staff and postgraduate researchers mentioned above, and download the approriate forms
These downloads include:
- The application form that needs to be completed to have a project reviewed.
- Information helpful for completing the application form.
- Guidance on how to complete an information sheet, if it is decided that one is needed.
- A model participant consent form, if it is decided that one is needed.
You need to complete the application form and send it to the Ethics Administrator for the Department of Economics, Paul Mosley. Once he has received your form, he will pass it on to 3 `Ethics Reviewers´ , one of whom will typically be outside the department. These three reviewers will decide whether the proposal is ethically acceptable and the lead reviewer will give their opinion to the Ethics Administrator, who will then inform the applicant of the result. This will either be an acceptance, an acceptance subject to some amendments or a rejection. On average, we shall aim to provide a decision within 10 working days. If your proposal is rejected on ethical grounds you can appeal to the Ethics Administrator, in which case the Department of Economics `Ethics Review Panel´ will sit, and if you are also unhappy with their decision you can appeal to the University´s central University Research Ethics Committee. You must obtain ethical approval before starting work: retrospective ethics review is not permissible.
(b) Changes in scope of the project
Although ethical approval is required before any data collection involving human participants begins, applicants are expected to consider the ethical implications of their research at all stages of the project. Even the most well thought-out project may come across unexpected ethical challenges after approval has been obtained. Re-approval needs to be obtained if, in the course of the project, there is:
- A change in the nature of the human participation. This could mean a different method of interaction with participants, involvement of a different group of participants, a different method of recruiting participants, or a different method of obtaining consent
- A significant change in the content of the information that will be presented to participants, such as a revised information sheet, covering letter, written script or consent form (minor corrections such as typos are not considered significant changes in this sense)
- A change in the nature of the researcher’s involvement. This could mean, for example, interviewing participants directly rather than using a postal/email survey, or conducting the research in a public place rather than on University premises
In such cases, or if there is any other doubt about whether a proposed change signifies a significant change that could have an impact on the rights, safety or well-being of the participants, 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. The reviewer will then consider the changes and, in consultation with the Ethics Administrator, will advise the researcher on the right course of action. This could involve reapplying for full ethics approval, if the changes are particularly significant; alternatively, the reviewer may be happy to approve the changes immediately.
(c) Research Proposals Involving the NHS
Note that research projects that involve the NHS should be ethically reviewed via the NHS´s own ethics review system, administered by COREC, and such projects should NOT be additionally ethically reviewed via the Department.
(d)Research Proposals to the ESRC
Special arrangements apply for ethically reviewing proposals being submitted to the ESRC for funding. In your grant application to the ESRC you should explain the main ethical issues that may arise in your research, say whether your project provides a high risk or a low risk ethically, and explain how the project will be ethically reviewed by the university (as described below).
The actual ethics review takes place AFTER the grant is awarded (if successful of course). The University´s central Research Ethics Committee (U-REC) will ethically review all projects awarded an ESRC grant (rather than them being reviewed within the Department of Economics as described above for all other projects), so the usual completed University research ethics application form together with related documents where relevant (e.g. completed consent form) needs to be sent to Richard Hudson on U-REC.
The ESRC are willing to meet the cost of universities ethically reviewing projects that are awarded grants. The University has calculated that the additional cost incurred with respect to ethically reviewing a single successful ESRC application is: £640. Therefore, you should include this £640 in your URMS record (and subsequently in your ESRC application), when first applying for the grant. In the URMS record you should state, as a note, that this is a `directly allocated cost´.
The combined Research Councils, including the ESRC, have recently issued a policy document on the governance of good research conduct, available from the following link:
This defines the ESRC's expectations regarding ethical research practice, and further information on ethics and the ESRC can be found at:
3. Ethics Review of Student Research
There are further issues concerned with the ethics of research by students, and what members of staff need to do.
(i) Postgraduate Research Students
If you supervise PGRs, your responsibilities for ethics are laid out in the guidance sheet:
Summarising its contents, you are to make your research student aware of ethical responsibilities in their research, as described with respect to your own research above.
You should help them decide whether their research proposals require ethical reviewing, according to the criteria described above for staff member's own research. If reviewing is required, the student should fill in the application form, as above, and then the supervisor should check it, sign it themselves, and pass it on to the ethics administrator, Paul Mosley, for reviewing as normal.
(ii) Postgraduate Taught Students
Students on the taught postgraduate programmes in the Department of Economics (excluding those on the MSc Economics and Health Economics, see below) are required to complete a Dissertation Proposal form which includes a description of the data being used and the question: `Referring to the Ethics Checklist document (on MOLE) consider whether ethics approval is, or is not, required for your research. If ethics approval is not required please explain why. If ethics approval is required please complete the Ethics Approval form on MOLE and submit alongside this proposal.´ Part of the process of approving the Dissertation Proposal involves the Director of PGT assessing the claim of the student regarding the need for ethics approval against the data and other details about the research provided in the Dissertation Proposal. No Dissertation Proposal will be approved unless the form is complete and ethics-compliant. No dissertation will be accepted for marking unless it has an approved Dissertation Proposal.
Students on the M Sc Economics and Health Economics programme, which is shared with ScHARR, are required to ensure that they follow the research ethics procedures for ScHARR.
(iii) Undergraduate Taught Students
Undergraduate students who are undertaking a piece of research as part of their course must also have their proposals ethically reviewed, if they directly involve individuals, or indirectly via the use of personal data.
If students are undertaking individual projects, they must discuss their research plans with their module leader (coursework) or supervisor (dissertation), and then complete the ethics application form for UG/PGT student
If the ML/supervisor considers the application to be `low risk´, he/she should ethically review the proposed project themselves, and inform the student and the Ethics Administrator of their decision. If they consider the application to be `high risk´, it should be submitted to the Ethics Administrator for consideration.
However, as long as the projects being developed by the students are sufficiently similar, (i.e. addressing the same questions and using the same methodology) then they can be ethically reviewed en bloc, as a generic research proposal.
If this situation applies to your students, then a member of staff (usually the module leader) should fill in the application form for ethics reviewing, as above, indicate on the form that it is a generic research project, sign the form and return it to the Ethics Administrator for reviewing, in this case by 2 of the department's `Ethics Reviewers´.
For further information see: http://www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy
(Note: new guidelines are being prepared for undergraduates embarking on dissertations in 2010/11, and these will be available in August-September 2010.)
If anyone has any questions about any of the issues raised here, please don't hesitate to get in touch.
29 June 2010