Research Ethics Approval Procedure
4. Alternative Ethics Review Procedures
Wherever possible, the UREC wishes to avoid a situation whereby a researcher needs to apply for ethics review via more than one ethics review procedure (unless the research is taking place in two or more countries in which case this may be unavoidable). However, it is essential that University of Sheffield research involving human participants is subject to a robust ethics review process prior to the involvement of the human participants.
|4.1 Research conducted overseas||
Research that will take place in another country and will involve human participants from that country may require ethics approval via an 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. Where such a procedure exists, it may not be necessary for the researcher to seek ethics approval via the University of Sheffield´s Ethics Review Procedure, providing that the overseas procedure is judged to be sufficiently robust by the UREC (refer to Section 4.2.1, below, for details of the relevant assessment process).
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 ethics 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, safety and well-being of the human participants in the research.
Some departments may prefer to adopt a 'belt-and-braces' approach, in which research ethics review is always undertaken via the University Procedure, regardless of procedures elsewhere. This ensures that departmental, and University, ethical oversight is assured. It is important, therefore, that researchers check the policy of their own department with respect to this issue by contacting their Ethics Administrator or Principal Ethics Contact.
Where a research project involves human participants in more than one country then the expectation is that the appropriate ethics review procedure in each country should apply (for example a project taking place both in the UK and in two other countries would require ethics approval via the University Procedure as well as any ethics approval that is required in the other two countries).
|4.2 Research led by another United Kingdom university||
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 (see Section 4.2.1 for details).
4.2.1 Judging another Ethics Procedure
A list of institutions with ethics review procedures that have already been judged to be sufficiently robust is provided here.
Where ethics approval will be sought via the ethics review procedure of one of the institutions listed, no further information will be required about the robustness of the procedure. However, following the ethics decision, the researcher must create a new ethics application in the online Ethics Application System, selecting the option that confirms that the research is either taking place outside the UK, or is being led by another UK institution, and then follow the process for submitting copies of (1) the research ethics application form and (2) a letter from the institution’s ethics body confirming its ethics decision with respect to the project.
Where ethics approval will be sought via the ethics review procedure of an institution that has not already been judged to be sufficiently robust, the researcher must provide the following information to the UREC's Minute Secretary:
The UREC's Minute Secretary will review the information provided within a short period of time and confirm whether or not the institution´s ethics review procedure is deemed to be sufficiently robust.
If the procedure is deemed to be sufficiently robust, the researcher should then submit the project for ethical review via the approved procedure in the other institution. Following the ethics decision, the researcher must create a new ethics application in the online Ethics Application System, selecting the option that confirms that the research is either taking place outside the UK, or is being led by another UK institution, and then follow the process for submitting copies of (1) the research ethics application form and (2) a letter from the institution’s ethics body confirming its ethics decision with respect to the project.
If the procedure is deemed to be not sufficiently robust then University of Sheffield ethics review proceedure will need to be followed.
A list of organisations who have been through the procedure is available here.