Consent and Participant Information Guidance

Accessing ONS, NRS and other registry data

• Information Services Division (ISD) Scotland
• NHS Digital (Formerly HSCIC)
• National Records of Scotland (NRS) - formerly General Register Office for Scotland (GROS).
• NRS - National Health Service Central Register: About the register
• Office for National Statistics (ONS)

Adults who are not able to consent for themselves

UK WIDE

• The British Psychological Society - Conducting research with people not having the capacity to consent to their participation: A practical guide for researchers
• The Medicines for Human Use (Clinical Trials) Regulations 2004

ENGLAND AND WALES

• British Medical Journal - Assessing mental capacity: the Mental Capacity Act
• Mental Capacity Act 2005 and consent for research - Department of Health guidance
• MRC Ethics Guide 2007 - Medical research involving adults who cannot consent
• Office of the Public Guardian - Mental Capacity Act 2005: Code of Practice

NORTHERN IRELAND

• Code of Practice - MCA (NI) 2016 - Money & Valuables and Research
• Mental Capacity Act (Northern Ireland) 2016

SCOTLAND

• Adults with Incapacity (Scotland) Act 2000
• The Scottish Government - Adults with Incapacity: Forms and Guidance

Children and Young People

• Involving children in research: MRC and ESRC joint guidance
• NIHR Clinical Research Network for Children
• NIHR Clinical Research Network for Children Young Person's Advisory Group
• Nuffield Council on Bioethics - Children and clinical research: ethical issues
• Royal College of Paediatrics and Child Health (RCPCH) - Guidelines for the ethical conduct of medical research involving children

Data and Tissues (including Generic Consent)

• Information Commissioner’s Office – Anonymisation Code of Practice
• Information Commissioner’s Office – Key definitions in data protection
• Information Commissioner’s Office – Key definitions in the General Data Protection Regulation (GDPR)
• HRA technical and operational guidance on GDPR
• MRC Regulatory Support Centre – Using data about people in research
• Section 251 and the HRA Confidentiality Advisory Group (CAG)
• EU-US Privacy Shield (Provides adequate protection to allow personal data to be transferred to the US, as confirmed by the European Commission).
• Human Tissue Authority (HTA) Codes of Practice – Consent and Research
• MRC Research and human tissue legislation summaries
• MRC Research and human tissue legislation e-learning

Deceased

• Human Tissue Authority (HTA) Guidance for hospital and mortuary staff on brain and spinal cord donations for research

Deception as part of the research method

• British Psychological Society (BPS) Code of Human Research Ethics

eConsent: seeking consent by electronic methods

• HRA/MHRA joint statement on seeking consent by electronic methods (“eConsent”)

Ethical Principles

• The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research involving Humans
• World Medical Association (WMA) Declaration of Helsinki
• The Belmont Report - produced by the US Department of Health and Human Services

Examples of providing information using different formats

• CRASH 3 trial
• The Interval study

Expenses and Payments

• HRA Guidance on Payments and Incentives in Research

Good Clinical Practice

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Official website
• ICH Topic E 6 (R1) Guideline for Good Clinical Practice
• MHRA Guidance for Good Clinical Practice for Clinical Trials
• The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 – Provides the legal definition of the principles of GCP as applied to Clinical Trials of Investigational Medicinal Products (CTIMPs)

Health Related Findings

• MRC/Wellcome Trust Framework on the feedback of health-related findings in research
• Management of Incidental Findings Detected During Research Imaging

Involving patients and the public

• HRA Guidance on Patient and Public Involvement
• HRA Guidance for Researchers: Information for participants at the end of a study
• INVOLVE - National advisory group that supports greater public involvement in NHS, public health and social care research.
• Medical Research Council PPI resources – includes guidance and a template for writing a participant information sheet for trials in adults
• Testing Treatments – Funded by the James Lind Initiative, aims to inform the public, students, teachers and the media on why research is important, how to recognise reliable science and how to ensure research is relevant.

Ionising Radiation

• HRA Guidance on Ionising Radiation

Pragmatic trials

• Health Research Authority Guidance - Applying a proportionate approach to the process of seeking consent

Risks and benefits

• MRC Experimental Medicine Risk Assessment Tool

Therapeutic studies - what happens when the research study stops

• HRA Care after research: A framework for NHS RECs

UK wide standards for informing participants

• Participant information quality standards
• Participant information design and review principles

Writing in plain English / readability

• INVOLVE Plain English Summaries
• The Cochrane Collaboration (see Standards for the reporting of plain language summaries in new reviews of interventions)
• The Plain English Campaign
• Understanding Patient Data
• The Royal National Institute for the Blind: Advice for professionals
• Free Text Readability Consensus Calculator
• K Gillies, W Huang, Z Skea, J Brehaut, S Cotton. Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials 2014; 15: 62. doi:10.1186/1745-6215-15-62