Legal and Ethical Guidelines

BHBIA Legal and Ethical Guidelines for Healthcare Market Research: Your essential guide

The latest BHBIA Legal and Ethical Guidelines are now available.

Click on the DOWNLOADS link on the right hand side of this web page to view/download your copy.

You should find that the document opens in Adobe Reader, which is needed to optimise the new functionality. If this does not happen automatically, you may need to save the document and then open it with Adobe.

(If you don't have Adobe Reader you can click here to install it, or visit the App store if on a mobile device)

Key changes to the Guidelines - August 2020:

Some additional small updates have been made in June 2021 in line with the 2021 ABPI Code, which comes into operation on 1 July 2021. The main change is the extension of disclosure requirements to cover non HCPs, which takes effect in 2022.

We've listed some of the key changes below. (These are in addition to the practical examples which had already been added in June to bring the guidance to life.) The online Legal and Ethical Guidelines for Market Researchers training programme has been updated in line with the new Guidelines - see link on the right hand side of this page.

Extended guidance:

We have added a little more detail to clarify the guidance we provide on:

  • Principles 3 and 6 of the Guidelines
  • The definition of a sensitive topic

And although the basic principles all remain the same, we’ve added quite a lot more detail to our:

  • Definition of market research (MR) 

New guidance:

  • The need for a contract or agreement detailing data protection responsibilities
  • Added June 2021: Disclosure requirements extended to non-HCPs (from 2022 payments)
  • Making sure that when lists are shared for MR this is legal
  • Keeping clients informed of changes to incentives payments
  • The type of person that should examine MR material
  • Respondents must be trained and supervised when handling a potentially harmful device
  • Respondent personal data cannot be available to observers without consent
  • All parties involved in a MR project must be aware of their data processing obligations
  • Considerations when further processing personal data for a secondary purpose
  • Additional guidance on working with vulnerable individuals
  • Additional guidance on working with children
Practical examples incorporated into the Guidelines:

The Guidelines now include almost 60 practical examples in the form of questions and answers (Q&As) – these are marked by a question mark within an orange circle – look out for this symbol and click to open the examples.

  • By combining these examples within the Guidelines, we hope we have made it easier for you to understand the practical impact of the laws and regulations;
  • You’ll find the examples alongside the relevant section of the Guidelines; 
  • They are quick to access and easy to read;
  • The questions are based on real-life members’ enquiries and issues;
  • The content reflects commissioning client, market research and fieldwork agency perspectives;
  • There is no longer the need for a separate FAQ resource – so you have a ‘one stop shop’ for your legal and ethical guidelines needs (Appendix N provides a full list of all the questions that are now covered by the practical examples).

Thanks to all members of the Ethics & Compliance Committee for contributing to the new format (introduced in June 2020).

About the Guidelines generally:

The BHBIA Legal and Ethical Guidelines include everything you need, in one place, to keep your market research project running smoothly from a legal and ethical point of view - saving you time and trouble.

  • Legal do’s and don’ts
  • Data protection unravelled (GDPR / UK Data Protection Act 2018 requirements are built in throughout)
  • Best practice recommendations
  • Step-by-step through a project (This makes the Guidelines easy to navigate, and you can also search on key words for the information you need)
  • Terms made easy
  • Ready-to-use forms

The Guidelines are updated every year, and changes since the previous version are clearly indicated so that you can see what’s new.  

Other useful resources:

For your convenience the pro formas (found in the appendix section of the Legal and Ethical Guidelines) are also available in word format for ease of use.

View details / Download Pro Formas

If you have a query about the Guidelines - or any legal or ethical query about UK healthcare market research that's not answered in the Guidelines - please use the guidelines Online Enquiries service (full BHBIA members only) - you will need to be logged in to access the form.  

Submit a Guidelines Query

This is covered separately within the specific ABPI/ BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research. We cross reference this in the Guidelines rather than repeating information from it. 

View the AE/PC/SRS Guidance

The BHBIA provides a separate Data Analytics Guidelines series. These guides provide clear guidance on the legal and ethical implications of using secondary data for market research and associated business intelligence purposes such as database building or customer relationship management.

View the Data Analytics guides