Ethics Approval for

1
Ethics Approval for Projects based overseas
George Ellison (Director) Research Graduate
School g.ellison_at_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.

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-RECs Secretary with certain information
  about that
• countrys 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 Universitys 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