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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 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.

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.
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NEW - Using AI Ethically in Business Intelligence

This guidance focuses on the ethical issues specific to AI, rather than the broader legal, compliance, privacy and governance requirements that must be followed.

NEW - AI and Adverse Event Reporting

Artificial Intelligence (AI) can support adverse event (AE), product complaint (PC) and special reporting situation (SRS) processes, but it does not change existing pharmacovigilance (PV) obligations, reporting requirements or accountability.

NEW - General Guidance on AI and Data Governance

Many AI tools retain information through conversation histories, workspaces, uploaded files and memory features. While experience gained from previous work is not itself a conflict of interest, confidential information from one client must never be disclosed or inappropriately used for another. Users should therefore understand and manage how AI tools store and access information.

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.

AE/PC/SRS Data Collection Form

The AE/PC/SRS Data Collection Form as a word document, for your convenience when adapting for specific projects.

AE/PC/SRS Reconciliation Form

The AE/PC/SRS Reconciliation Form as a word document, for your convenience when adapting for specific projects.

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.

AE/PC/SRS Collection from Market Research - Quick Guide

This guide is suitable for anyone who needs an overview of the adverse event, product complaint and special reporting situation reporting requirements that apply to market research conducted in the UK.

FAQ - Privacy & Data Protection

This resource is based on based on queries that members have sent to our ethics advisor or raised at meetings, grouped under a series of headings.

GDPR-ready Market Research Proformas

Updated versions of the forms from the appendix section of the Legal and Ethical Guidelines) in Word format for ease of use.

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