Legal and Ethical Guidelines

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

The updated February 2022 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 your view of the practical examples. 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 - February 2022:

The Guidelines are usually updated annually on 1st September. However, we occasionally make interim updates if there have been any important changes to guidance or legislation. You will find details of the February 2022 changes on pages 4 to 6 on the updated Guidelines within the ‘Changes at a glance’ section. They are also marked with coloured arrows throughout the document. 

The online Legal and Ethical Guidelines for Market Researchers and Guidance for reviewing/approving market research materials programmes have been updated in line with the new Guidelines (see links on the right hand side of this page).

A brief summary of what’s changed is outlined below:

Section E – Opening paragraph / Section H – Definitions – Market Research

Additional wording has been added:

Please be clear and precise in the terminology you use, when referring to market research do not use the abbreviated term ‘research’, this could appear to imply health research rather than healthcare market research.

We also point out the availability of a new ‘What is Market Research?’ resource on the BHBIA website – which includes sections for HCPs and the General Public

Section E3.3  Sample source

New guidance:

You must verify the provenance of any sample sources. It is your responsibility to satisfy yourself about the integrity of the data supplied to you. You should make appropriate enquiries and checks e.g. about the data source or usage rights.

Additional wording has been added – as specified below:

Section E4.1 – Key recruitment principles

Tell them exactly what participating will involve including the way in which they can expect to be contacted e.g. email and/or telephone.

Section E4.2  Obtaining agreement

The nature of the service to be provided by respondents must be clear: it must be immediately apparent that the purpose is market research. BHBIA, MRS and ABPI requirements mean the agreement/consent must include:

  • subject and purpose of the MR study
  • methodology and approach, including, the medium for the MR and the means by which they would be contacted for recruitment e.g. telephone and/or email, recruitment means must be clear to panel members too

Whilst the recruitment script will need to be tailored to the project and the medium (e.g. telephone, online), the recruitment ‘conversation’ must be based upon a script that is clear and comprehensive. It must be made immediately clear who is making contact and why. Ideally it should also be agreed by all parties involved and approved by the end client.

Section E4.3  Disclosure requirements 

Disclosure requires pharmaceutical companies to make publicly available the details of MR-related payments IF the identities of individuals (HCPs or non-HCPs, healthcare or patient organisations) are known to the commissioning pharmaceutical company. 

We have now incorporated new ABPI guidance, which encourages ‘legitimate interests’ as the lawful basis for processing individuals’ personal data for the purposes of disclosure. 

We now explain that: 

  • A lawful basis for any disclosure related data processing must be in place. This might be Legitimate interests or Consent 
  • The choice of lawful basis impacts on what you must tell respondents as well as what needs to happen if an individual objects / does not give consent. 

New guidance added regarding Patient organisations and MR related payments - this clarifies that:

Information about healthcare organisations (HCOs) is not considered personal data therefore a lawful basis is not required to publish organisations’ names and addresses on Disclosure UK. 

Proforma 3 (disclosure notification) has also been updated.

Section E4.9 – Reimbursing respondents

The following wording has been revised: 

For patients and members of the public, it’s a token of appreciation (reflecting the criteria detailed above within ‘Principles’) rather than a professional fee.

Section E7.2 – Reporting  Technical detail

Additional wording has been added:

You must include the technical detail necessary to assess the validity of the findings, including sample size, sample design and selection procedure, question source and statistical tests used. In addition, researchers must make available if required, the method of data collection and any instruments used, any data cleaning, weighting or post-field adjustments applied, any substantive limitations affecting the validity of the findings. 

Section F2 – Vulnerable respondents

Several additions have been made to this section, to encourage researchers to consider the many different factors that could make a respondent vulnerable, and to help ensure that their needs are taken into consideration at every stage of planning the MR and conducting the fieldwork: 

  • Extension to the definition of vulnerable 
  • New section on design considerations 
  • Additional points about interviewing 
  • Additional points about special planning 

Details of the new policy have been added. You can also find it on the website: click here

Practical examples incorporated into the Guidelines:

The Guidelines include around 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