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The Guidelines & Legislation section brings together compliance guidance, best practice resources and support materials to help you navigate legal, ethical and regulatory requirements. 

To access online training and competency tests, please visit the Online Training section.

Submit a Guidelines Query - If you have a question that is not answered in the BHBIA's guidance materials, you can submit it to our Ethics Advisor and receive a confidential response. Only available to full BHBIA members (you will need to be logged in to access the form. Submit a Guidelines Query

 

Featured Resources

BHBIA/ABPI guidance on reporting adverse events, product complaints and special reporting situations

The Guidance notes on collecting adverse events, product complaints and special reporting situations during market research are produced by the BHBIA in conjunction with the ABPI.

Legal and Ethical Guidelines for Healthcare Data Analytics

BHBIA guidelines are designed to help us all reduce risk, improve performance and make life a little simpler by drawing key information together in one place.

Legal and Ethical Guidelines for Healthcare Market Research - including Practical Examples

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.

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Consents for Market Research - what is required and when

Details the different consents that might be required during the course of a primary market research project and at what stage these consents must be secured, before or during fieldwork.

Legal and Ethical Guidelines for Healthcare Market Research - Pro Formas

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.

Pro-Innovation approach to AI regulation

An Introduction to Data Protection Law

An overview of the main principles and requirements of the GDPR

Industry Event Accessibility Guidelines

The purpose of these guidelines is to provide best practice guidelines and support pharmaceutical clients, market research and fieldwork agencies in delivering accessible events by considering possible access needs.

How to Utilize Lawful Ethical AI Effectively in Healthcare Research with Jessica Santos, Oracle Life Sciences

Keeping Respondents and Fieldworkers Safe When Undertaking Face-to-Face Market Research

This covers some key aspects to consider when undertaking face-to-face market research and is especially relevant to situations where environmental factors or respondent/recruiter vulnerability may pose a risk.

Sharing Personal Data – Quick Guide

This guide summarises the latest guidance and support available when sharing personal data between data controllers. 

AE/PCS/SRS Reporting - FAQs

Our AE/PC/SRS reporting FAQ resource is a selection of real-life queries from members and the responses from our Ethics Advisor. It supplements the Guidance Notes, but does not cover all topics – please always check the main Guidance Notes document first.

Ethics and Compliance Committee Winter Update 2025 - 4th December 2025

Hear our Ethics Experts discuss their view on the impact of legislative changes in 2025, with a specific focus on the impact of AI technologies.

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