Ethics Approval for Projects based overseas

1. Ethics Approval for Projects based overseas George Ellison (Director) Research & Graduate School g.ellison@londonmet.ac.uk

2. Examples of regulations at other UK Universities and research funders Bristol University: “Researchers collecting data overseas must obtain evidence that they have satisfied research ethics approval requirements for that country.” – Where are these in place? What if these are weaker than in UK? Aberdeen University: “For research carried out overseas approval by a local research ethics committee is preferred.” – Where are these in pace? What if they do not exist? Royal Holloway, University of London: “Research conducted overseas will often require local ethical approval. Specific requirements may vary in different countries.” – What if these are weaker than in the UK? Wellcome Trust: “The Council for International Organizations of Medical Sciences (CIOMS) produced guidelines on ethical research in developing countries.” – What about non-medical projects?

3. Key problems – and best practice • 1. Unclear regulations: Where does one find these? 2. Different regulations: What if these are more or less stringent than UK regulations? 3. Absent regulations: What are appropriate regulations to apply in the absence of local guidelines? ---------------- Sheffield University: “The researcher will need to provide the U-REC’s Secretary with certain information about that country’s ethics review procedure, or about the procedure in place at the relevant collaborative institution in that particular country… If the information provided does not reassure the U-REC that the ethics review procedure in that country is not a sufficiently robust mechanism to help protect the dignity, rights, safety and well-being on the human participants in the research then ethics review will be required via the University’s ethics review procedure.”

4. Overseas Ethics Regulations • There are essentially three approaches to research ethics regulation outside the United Kingdom: • Independent regulations – the country does not recognise the research ethics approval granted by UK-based ethics committees • Reciprocal recognition – the country recognises the research ethics approval granted by UK-based research ethics committees1 as sufficient • Absent regulations – the country does not have any clear research ethics approval structures • 1Some countries only recognise ethics approval from select UK research ethics committees and some may require this

5. Independent Regulations • Where the country does not recognise the research ethics approval granted by any UK-based research ethics committees as sufficient, take the following steps: • Obtain written confirmation from a local collaborator detailing the specific ethics arrangements in place • Follow the specific research ethics arrangements as require • Submit a copy of the application and approval letter to a University RERP for final approval

6. Reciprocal Regulations • Where the country concerned recognises the research ethics approval granted by (specific) UK-based research ethics committees as sufficient, take the following steps: • Obtain written confirmation from a local collaborator detailing the specific reciprocal arrangements in place • Apply for the (specific) level of research ethics approval from UK-based research ethics committees: - research involving the temporary storage of human tissues will always require UK NRES approval - research involving experimental trials on human or animal subjects may require UK NRES approval - research involving children or adults with limited competence will always require UK CRB checks • Submit a copy of the application and approval letter to a University RERP for final approval

7. Absent Regulations • Where the country concerned has no formally constituted national research ethics framework the following steps should be taken: • Obtain written confirmation that no such framework exists and written permission for the proposed research from a senior official • Apply for a similar level of research ethics approval as that required for UK-based research: - research involving the temporary storage of human tissues will always require UK NRES approval - research involving experimental trials on human or animal subjects may require UK NRES approval - research involving children or adults with limited competence will always require UK CRB checks • Submit a copy of the application and approval letter to a University RERP for final approval

8. Role of University RERPs • The appropriate University RERP should be informed at two key stages: • Submit a Research Ethics Checklist detailing the potential risks posed by the proposed research • For proposed research in countries with independent regulations, ensure that both a copy of the research ethics application and the formal ethics approval letter are forwarded to the RERP for approval • For proposed research in countries with reciprocal or absent ethics regulations, ensure that either: - a copy of any external research ethics application (such as the UK NRES), associated clearance (such as CRB clearance) and formal ethics approval letter are forwarded to the RERP for approval; or - that an application is submitted directly to the RERP