Jurisdiction(s):
United Kingdom

Key definition

HRA definition

What does HRA mean? HRA is used in legal practice to refer to: 1) The Human Rights Act 1998, the UK statute giving effect to ECHR rights in domestic law. It requires courts to interpret legislation compatibly where possible (section 3), makes it unlawful for public authorities to act incompatibly (section 6), and enables claims and declarations of incompatibility (sections 7 and 4). It applies in England and Wales, Scotland and Northern Ireland; Ireland uses the European Convention on Human Rights Act 2003. 2) Habitats Regulations Assessment, the screening and, where needed, Appropriate Assessment of plans and projects for likely significant effects on European sites (SACs/SPAs)....

Participant Information Sheets in UK clinical research: legal, ethical and UK GDPR compliance checklist for CTIMPs and non-CTIMPs

Published by a LexisNexis Life Sciences expert

Checklists

$imgtext$

Checklist

This Checklist sets out the practical actions for creating, drafting and quality-checking a Participant Information Sheet (PIS) for UK clinical research. It describes what the PIS is for and how it works, and gives hands-on advice on the essential components, addressing content and presentation alongside layout, format and style. The Checklist also explains how the PIS should meet obligations under UK data protection law, including the transparency duties in the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR). It is suitable for any study involving human participants, with particular emphasis on clinical trials of investigational medicinal products (CTIMPs). A clinical trial is a study in human subjects intended to identify or confirm the effects of an adverse reaction to a medicinal product. In the UK, such trials are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (MHU(CT)R 2004), SI 2004/1031, which transposed EU Directive 2001/20/EC, the Clinical Trial Directive (CTD), into domestic law. These rules create a legal framework designed to protect the safety and rights of people taking part in clinical trials. To take part in a clinical trial, an individual must provide their ‘informed consent’...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Web page updated on 20/05/2026

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...