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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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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.

GDPR training resources from the ICO

New 2022 - The ICO (Information Commissioner's Office) have made available the training modules on GDPR that they provide for ICO staff as part of their internal training. This could be a useful resource when training your staff on GDPR. 

MRS and ESOMAR Statement on Client Data and AI

Practical guidance from MRS and ESOMAR on the responsible use of client and research data in AI, including considerations around consent, confidentiality, contracts and data use.

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.

Guidelines for Inclusive Recruitment for Market Research Studies

The BHBIA’s Diversity, Equity & Inclusion (DE&I) Committee has created these guidelines for pharmaceutical clients, market research and fieldwork agencies to conduct inclusive market research and ensure the final insights accurately reflect the targeted population.

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.

Guidelines for Patient Research

A summary of the key sections of the BHBIA's Legal and Ethical Guidelines that pertain specifically to conducting market research with patients.

ICO AI & Data Protection Risk Toolkit

This toolkit is designed to provide practical support to organisations to reduce the risks to individuals' rights and freedoms cause by ther own AI systems.

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