FREQUENTLY ASKED QUESTIONS
All amendments to applications must be made through the new University Ethics system. To determine which Committee you should apply to, follow the Selecting a REC diagram - Selecting a REC
The CREC criteria intends to capture projects in which the intervention creates those criteria, i.e. the intervention introduces a risk of harm as listed under criteria 4 and had the project not been ongoing the participant wouldn't be exposed to that risk. Where the risk is, in the researchers opinion, increased to a degree that further ethical scrutiny is required. The Applicant should consider the ethical issues and identify the appropriate REC accordingly. If, following consideration of this, you are still uncertain, the applicable FREC Chair can be contacted via the FREC Administrators.
Yes. Where projects have received external ethical approval, the documentation which has been reviewed by the external REC (along with the original approval letter) should be submitted to the applicable FREC in the first instance; there is no requirement to additionally complete and submit the REC Application Form. This helps to avoid additional work, and also ensures that the documents being reviewed by the Keele REC are those which have already been granted ethical approval. The reviewers may then request further information if they feel that the submitted documentation isn’t sufficient to assess any ethical issues requiring consideration by Keele University.
Please note that the Application must be submitted by a member of Keele University as the Applicant (external applicants are not able to submit through the Google system).
Exceptionally, research activity carried out by the University may not fall under a particular Faculty. Under this circumstance, and where the activity does not fall under the CREC Criteria, please contact firstname.lastname@example.org who will work with you to identify the most appropriate FREC to provide an opinion on your application.
Essentially, the research protocol (or proposal) is the document that describes (in detail) the background, rationale, objectives, design, methodology, statistical considerations, and organisation of the project. A good protocol is evidence that you have clarified your research project when you come to collect data and analyse it, you can be confident about the analysis you are going to do and the implications of this analysis on your research questions. A good protocol will also help you in the production of your final report because so much of the thinking and planning of the project will have already been well thought through and documented. The research protocol is distinct from any application forms or other documents which describe the project to reviewing bodies.
The reviewing Ethics Committee must be provided with sufficient documentation to form an opinion. A protocol gives freedom to explore, describe and justify your project’s specific ethical issues in a protocol/proposal rather than being constrained by specific questions within an application form. Protocols / proposals should also describe activities that pose potential legal issues, as well as ethical ones and allow applicants to explore and describe those for other audiences as well as the REC (e.g. Data Protection Office, Insurance, Research Governance, Human Tissue Committee, Health and Safety Committee).
The protocol / proposal might also give greater structure to those delivering the project, including information beyond that which is needed to form an ethical opinion, thereby enhancing research integrity (e.g. data management considerations, publication expectations etc). Ethics committee members should be reassured by a protocol / proposal which allows them to see that legal and general research integrity issues are being thought about, whilst the application form keeps allows REC members to focus on the ethical issues.
All University RECs operate in accordance with their own Standard Operating Procedures (SOPs) which are available under the appropriate web page. Should you have a specific question about your application outside of this, please contact the appropriate REC Administrator in the first instance.
For further support, please contact the Administrator of the relevant REC.