Market research may be carried out with a broad range of respondent types, including patients - the sample must always be appropriate for the research objectives

Market research (even that involving patients – for example patient diary studies) does not require Research Ethics Committee (REC) approval because it falls outside the remit of the Research Governance Framework (RGF)

• This has been confirmed in discussions with the NHS R&D Forum – market research as defined within the BHBIA’s Guidelines, does not require REC approval

What is the difference between non-interventional research and market research?

EphMRA (European Pharmaceutical Market Research Association) provides a detailed overview of the differences between market research (MR), non-interventional studies (NIS) and patient support programmes (PSP) within its Code of Conduct (section 1.3) available on the EphMRA website www.ephmra.org.

EphMRA point to the following key distinction:
“Non-interventional research is carried out for a clinical purpose i.e. to assess safety, efficacy or tolerability; Market Research is carried out for a commercial purpose i.e. to investigate market behaviour and opportunities to inform business decision-making; clinical endpoints are not needed for Market Research.”

Non-interventional research does require ethics approval.

Market Researchers are advised to be clear and precise in the terminology they use, and when referring to market research to avoid using the abbreviated term ‘research’, as this could appear to imply health research rather than healthcare market research.

Refer to section H3 of the Guidelines for further information on Research Ethics Committee Approval.

• If needed, request a briefing document, briefing on the study or proposal to familiarise yourself with the study objectives
• Research with patients may involve minors or vulnerable respondents. These may need special arrangements (covered in detail later)