Section 2 - external ethical review guidance
Further guidance
This section provides additional information regarding external tools to help determine whether the proposed project requires external ethical review where you have indicated ‘unsure’ in response to one of the questions in the flowchart above.
If you are able to clarify your understanding to answer yes/no in the flowchart based on information in this section, please return to the relevant question in section 1 and continue with the flowchart. Otherwise, please seek further advice as appropriate.
HRA Research Toolkit
The HRA decision toolkit provides access to five different decision tools to help you understand what approvals are required for your research project:
- Is your study defined as research under the UK Policy Framework for Health and Social Care Research?
- If yes, is your research taking place in the NHS and will need NHS approval?
- If yes, do you need a favourable opinion from an NHS REC via the HRA?
- If yes, do you need Full or Proportionate NHS/Social Care REC review?
- Once the above approvals have been identified, is your student eligible to carry out their research under the student research eligibility criteria (Students and supervisors of students).
The toolkit contains links to existing HRA decision tools as well as some new ones developed especially for students to help students understand what approvals are required and whether they are eligible to carry out their research in the UK. Unless otherwise specified above, the decision tool is relevant for all research projects that fall under the remit of the HRA.
You should go through each decision tool until the final outcome is provided for that decision tool and, as appropriate, move onto the next decision tree. Further guidance is available from the HRA’s website.
If a favourable ethical opinion from an NHS REC is required, then you do not usually need to also seek ethical review from a University REC. If not required, please check with your local ethics review processes whether University ethical review is required.
If further advice is required regarding NHS ethical review, please contact the Clinical School research governance team
MoDREC Guidance (JSP 536)
The Ministry of Defence REC (MoDREC) JSP 536 Part 2: Guidance provides detailed guidance to support researchers to decide whether their research requires ethical review from the MoD.
In the first instance, it is advised you refer to ‘Annex 1A: Does my protocol need to be submitted for Scientific and Ethics Review?’ in the JSP 536 Part 2
If the answer to ALL three questions below (taken from Annex 1A) is yes, MODREC ethical review is required:
- Is your project funded by the MOD, or does it involve MOD-employed staff or participants?
- Is your project ‘research’?
- Are human participants involved?
If yes or unsure, please refer to ‘Annex 1C The process for scientific and ethics review’ in JSP 536 Part 2.
As set out in the MODREC guidance, Annex 1A must be read in conjunction with Parts 1 and 2 of the MODREC documents. Full direction on research that is within scope and needs review may be found in JSP 536 Part 1, Chapter 1 paragraphs 6-14.