Resource index: All categories

All:

Amendments

• IRAS Amendment Guidance for all Review Bodies

  Guidance on submitting amendments to review bodies via IRAS.

• IRAS Amendment Guidance for original NRES form submissions

  Guidance on submitting amendments for studies originally submitted on an NRES form.

• NRES Information on adding a new site

  For all with NHS REC approval adding a new study site.

• NRES Notification of Amendments

  Guidance on requirements for notifying NRES of study amendments.

Approvals

• Department of Health Guidance: NHS permission for R&D involving NHS patients, 2nd edition

  DH notes explaining what is expected of the NHS when considering permission for research that involves patients on a Primary Care Trust's NHS list, many of the points are also relevant to NHS Trusts.

• ESRC Ethics framework

  Framework outlining structure and function for University Research Ethics Committees.

• General Register Office for Scotland: NHSCR - How to apply

  How to apply for data from NHSCR.

• HSC R&D - Health and Social Care Research & Development (Northern Ireland)

  Information regarding research strategy in Northern Ireland.

• IRAS: Integrated Research Application System

  Link to the new Integrated Research Application System for research in the Health Service.

• IRAS: Question Specific Guidance

  Help and guidance on using IRAS and completing IRAS application form for different types of study.

• NHS IC Medical Research Information Service: Data Depot

  MRIS two way electronic file exchange system (login required).

• NHS Information Centre: Medical Research Information Service

  The Medical Research Information Service provides health information to support medical researchers.

• NHS R&D Site-Specific Information form

  For use for application to any NHS organisation, links to IRAS application form.

• NIHR Research Passport - Algorithm of Research Activity and Pre-Engagement Checks

  Guidance on the pre-engagement check requirements for researchers undertaking research activities in the NHS.

• NIHR guidance on the Research Passport

  NIHR guidance on the research passport.

• NISCHR Permissions Co-ordinating Unit (NISCHR PCU)

  The NISCHR PCU launched in July 2011 and is responsible for the coordination of R&D permissions in Wales. It replaces the All Wales Primary Care Research Management and Governance (SPARC) Office and expands the coordination remit to cover both primary and secondary care.

• NRES: Applying for ethical review by an NHS REC

  Information on submitting a proposal for review by an NHS REC.

• NRES: Defining research

  Guidance to help define whether a project is research, audit, service evaluation or public health surveillance.

• NRES: Ethical Review of Databases

  Specific guidance on the ethical review of research databases.

• NRES: Link to old NRES application form

  Old on-line application form for all NHS RECs.

• NRES: Research Databases

  NRES general guidance on applying for ethical review for the establishment of a research database.

• NRES: Standard Operating Procedures

  NRES Standard Operating Procedures.

• NRES: The remit of NHS RECs

  NRES web pages outlining the remit of NHS RECs.

• Nuffield Council on Bioethics publication

  The Ethics of Research Related to Healthcare in Developing Countries.

• Office for National Statistics - How to become an Approved Researcher

  ONS guidance on how to become an approved researcher.

• Privacy Advisory Committee for Scotland

  Web site on PAC remit, application process and Information Statistics Division.

• Privacy Advisory Committee for Scotland application form

  Link to PAC application form.

• UK Stem Cell Tool Kit

  A regulatory tool for those conducting human stem cell research in the UK.

• UKCRC - Streamlining Information Requirements for Permissions and Approvals

  Overview of National Systems for Streamlining R&D Permissions.

Archiving

• Department of Health Guidance: Retention of Records

  Guidance for research in the NHS on data archiving.

• UK Biobank website

  Information on UK Biobank.

Audit

• Information Commissioner's Office Guidance on Data Protection Audits

  For all organisations holding identifiable personal data.

Confidentiality

• BMJ article: Confidentiality of personal health information used for research

  MRC Consent and Confidentiality group BMJ article by Dipak Kalra, Renate Gertz, Peter Singleton, Hazel M Inskip, BMJ 2006;333:196-198 (22 July). BMJ.com Extra: Tips for managing confidentiality.

• Confidentiality: NHS code of practice

  Department of Health guidance on patient information confidentiality issues.

• Confidentiality: NHS code of practice supplementary guidance

  Department of Health supplementary guidance on public interest disclosures.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 30 - Section 5: Safeguarding Confidentiality.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 32 - Section 5.3: Data Security.

• NHS Information Governance Toolkit

  NHS standards, applicable for all organisations holding identifiable data.

• NIGB Section 251 security arrangements: System Level Security Policy template

  Applications to use section 251 must complete a System Level Security Policy to provide proof of suitable security arrangements.

• Templates for confidentiality letters and agreements (doc)

  Three templates developed by the Confidentiality working group of the MRC Consent and Confidentiality project.

  Confidentiality agreements templates (56KB)

Consent (All research)

• BMJ article: Overcoming barriers to recruitment in health research

  MRC Consent and Confidentiality group BMJ article by Jenny Hewison and Andy Haines, BMJ 2006;333:300-302 (5 August).

• Department of Health Reference Guide to consent

  Advice on English law, developed for examination or treatment, many issues are relevant to research.

• GMC Research Guidance

  GMC research guidance on good practice in research and consent to research.

• MRC Ethics Guide: Medical research involving adults who cannot consent

  This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to participation in research. It also discusses participation in research projects when such capacity is lacking.

• NRES Guidance: Research involving adults unable to consent for themselves

  Includes information on Mental Capacity Act 2005 and Adults With Incapacity Act 2000.

• NRES Guidelines for writing Information Sheets and Consent Forms

  These guidelines should be followed for submission to all NHS Research Ethics Committees.

• NRES Questions & Answers to the Mental Capacity Act 2005 (V3)

  NRES guidance in the form of questions and answers.

• NRES web page listing guidance on adults unable to consent for themselves

  NRES web page providing links to guidance produced by NRES and Department of Health; and links to the Mental Capacity Act 2005, Adults with Incapacity (Scotland) Act 2000, and associated Regulations.

• University of Kent: Consent checklist

  Tool developed to help with considerations for informed consent.

Consent (Children)

• MRC Ethics Series: Medical Research Involving Children

  PDF page 20 - Section 5: Children, ethics and the law.

Consent (Data)

• BMA Confidentiality and disclosure of health information tool kit

  Guidance on confidentiality relating to children, adults who lack capacity and the deceased as well as the secondary uses of information.

• BMJ article: Consent for the use of personal medical data in research

  MRC Consent and Confidentiality group BMJ article by Peter Singleton and Michael Wadsworth, BMJ 2006;333:255-258 (29 July).

• Connecting for Health: CRDB secondary uses report

  Report of the Care Record Development Board Working Group on the Secondary Uses of Patient Information.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 16 - Section 3: covers the complex legal environment surrounding consent.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 38 - Section 8: Information and consent forms.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 42 - Annex 3: The Data Protection Act 1998.

• MRC Guidance: Consent for Consent (doc)

  Draft MRC guidance offering recommendations and drawing together existing guidance on accessing identifiable patient information without consent.

  MRC draft guidance Consent for Consent (54KB)

• PIAG leaflet: Information about patients

  Information about patients: An introduction to the Patient Information Advisory Group for health professionals and researchers.

Consent (Tissues)

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 17 - Section 6: Consent.

Consent and Confidentiality (Data)

• BMJ article: Balancing potential risks and benefits of using confidential data

  MRC Consent and Confidentiality group BMJ article by Christina Davies, Rory Collins, et al, BMJ 2006;333:349-351 (12 August).

• Connecting for Health: Contact details

  Initial enquiry point for access to NHS IT networks.

• Information Commissioner’s Office Guidance

  For organisations that hold identifiable data.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 12 - Section 2: Principles for working with identifiable personal information.

• NHS IC Medical Research Information Service: Application flowchart

  Flowchart to help you with the process of applying to MRIS.

• NIGB - Ethics & Confidentiality Committee Applications

  Guidance for applications to the NIGB's Ethics & Confidentiality Committee who are responsible for providing section 251 approval to set aside the common law duty of confidentiality.

• NIGB - National Information Governance Board

  The National Information Governance Board for Health and Social Care (NIGB) is responsible for Section 251 of the NHS Act 2006 in England and Wales; and reviews applications for use of identifiable data where consent is not practicable.

Data

• Academy of Medical Sciences: Personal data for public good: using health information in medical research

  The Academy of Medical Sciences report looking at the use of patient information in medical research.

• Academy of Medical Sciences: Report of Legal Symposium

  Report of the legal symposium on ‘Personal data for public good: using health information in medical research.’

• Code of Practice to protect service user confidentiality (Northern Ireland)

  Code of Practice to protect service user confidentiality (Northern Ireland).

• Data Curation Centre (DCC) Data Management Plan

  Data Curation Centre (DCC) Data Management Plan.

• General Register Office for Scotland: NHSCR Enquiries

  NHSCR enquiry contact details.

• HESonline

  Hospital Episode Statistics (HES) is the national statistical data warehouse for England of the care provided by NHS hospitals and for NHS hospital patients treated elsewhere. HES is the data source for a wide range of healthcare analysis for the NHS, government and many other organisations and individuals.

• Information Commissioner's Office: ICO register

  ICO public register of Data controllers.

• MRC Information Security Policy

  MRC Information Security Policy.

• NHS Connecting for Health

  Department of Health Informatics Directorate.

• NHS IC Medical Research Information Service: Contact

  Contact details for MRIS.

• NHS IC: Patient Consent Forms

  NHS Information Centre recommended participant information form wording.

• NHS Information Security Management: NHS Code of Practice

  NHS Information Security Management: NHS Code of Practice.

• Statistics and Registration Service Act 2007

  Statistics and Registration Service Act 2007.

Data Sharing

• MRC Data Access webpages

  Principles of access to, and use of, MRC-funded research data.

• MRC Data sharing initiative webpages

  Information outlining MRC policy and aims on data sharing.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 36 - Section 7.2: Re-use of data by third parties.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 36 - Section 7: Storage and re-use of research data.

• Ministry of Justice: Data Sharing Review

  Link to the Data Sharing Report and recommendations by Richard Thomas and Mark Walport.

• NCRI – Samples and data for cancer research: Template for access policy development

  Template to facilitate development of an access policy for sharing data and tissues.

• Organisation for Economic Co-operation and Development (OECD)

  Promoting Access to Public Research Data for Scientific, Economic and Social Development.

Dissemination

• BMC Research Notes

  Open access journal publishing scientifically sound research across all fields of biology and medicine.

• DASH study newsletter (doc)

  Example of disseminating research findings and study updates to participants.

  DASH study newsletter (6MB)

• Journal of negative results in Biomedicine

  Open access, peer-reviewed, online journal that promotes a discussion of unexpected, controversial, provocative and/or negative results in the context of current tenets.

• National Survey for Health and Development website

  Example of disseminating research findings and study updates to participants.

• SHARE study newsletter (doc)

  Example of disseminating research findings and study updates to participants.

  SHARE study newsletter (613KB)

• Southampton Women’s Survey website

  Example of disseminating research findings and study updates to participants.

• UKCRC - The changing regulatory and governance environment for health research across the UK (2009)

  This booklet provides an overview of UKCRC initiatives which were put in place to streamline the regulatory and governance (R&G) environment.

Embryo research

• HFEA After you are licensed

  Guidance on progress reporting to HFEA.

• HFEA Code of Practice 8th edition

  Sections 17 and 22 are relevant to research.

• HFEA Incident Report Form

  HFEA Incident Report Form.

• HFEA Incidents Procedure

  Standard Operating Procedure for incidents and near misses.

• HFEA Inspection reports - research

  Information on HFEA research inspections.

• HFEA Licence renewals

  Guidance on HFEA licence renewals.

• HFEA Research licence

  Human Fertilisation & Embryology Authority Research licence page.

• HFEA Vary your licence

  Guidance on varying your HFEA licence.

• HFEA contact details

  Contact details for HFEA.

• Human Fertilisation and Embryology Act 2008

  The Human Fertilisation & Embryology Act 2008 amends the 1990 Act from the 1st October 2009, providing clarification of the scope of embryo research.

Ethics Committees

• GafREC: Governance arrangements for research ethics committees

  UK Health Departments' policy on what is expected from research ethics committees as well as the principles and standards by which they abide.

• NRES Latest News

  Link to the National Research Ethics Service (NRES) latest news webpage.

• NRES web page After Ethical Review

  Information on what to do following NHS REC review, e.g. reporting, amending protocol.

Funding

• MRC Funding opportunities webpages

  Information on applying for a grant from the MRC.

• Sources of research funding

  Link to RDFunding web pages which provide information on sources of health research funding.

Gene therapy

• Gene Therapy Advisory Committee website

  Information on remit and application to GTAC.

• Gene therapy medicinal product legal definition

  Legal definition of gene therapy medicinal product - legally these trials must go to GTAC.

Good Research Practice

• Checklist for Investigators: Are you ready to start? (doc)

  Short checklist for multicentre studies to ensure that all staff have all the relevant information before starting the study.

  Checklist: Are you ready to start? (24KB)

• Declaration of Helsinki

  Informed consent is fundamental principle.

• MRC Ethics Series: Good Research Practice

  MRC guidance looking at all aspects of research, including general principles, planning research studies and applying the results.

• MRC Reviewers Handbook

  Responsibilities of reviewers when assessing research proposals.

• RD Info Research Process Flow Chart

  Information on how to turn an idea into a research question, reviewing the literature and designing the study.

Human Tissue Authority Licences

• HTA Licence Fees

  Link to Human Tissue Authority web pages on Licence fees and payment.

• HTA List of Licensed Establishments

  HTA List of Licensed Establishments.

• HTA licensing and inspections

  HTA web pages on Licensing and inspections.

• MRC Guidance: Applying for a Human Tissue Authority Licence (doc)

  Guidance developed for MRC research units applying for an HTA Licence, applicable to all.

  MRC Guidance on applying for an HTA licence (248KB)

• MRC Research and Human Tissue Legislation Series: Licensing

  Applicable for England, Wales and Northern Ireland.

Information to participants

• Information Commissioner's Office Checklist

  For organisations handling access requests.

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 20 - Section 8: Feedback of Information.

• MRC Ethics Series: Personal Information in Medical Research

  PDF page 34 - Section 6: Safeguarding other interests of the individual.

Inspections

• HTA Inspections

  HTA web page on Inspections.

• HTA Summary Reports on Inspection Findings

  These reports provide information about the HTA's inspection findings and regulatory activity for the business years 2009/10, 2008-09 and 2007-08.

• MRC Guidance: Tips for HTA Inspections (doc)

  Guidance produced for MRC units on HTA Inspections and the role of the DI, applicable to all.

  Tips for HTA inspections (104KB)

Public/Patient Involvement

• INVOLVE leaflet: Public involvement in research grant applications

  INVOLVE guidelines for researchers interested in public involvement in preparing grant applications.

• INVOLVE website

  INVOLVE promotes public involvement in NHS, public health and social care research, and provide useful advice on how to involve members of the public in research activities.

• PIAG leaflet: User Involvement

  PIAG guide outlining what user involvement in research is, its importance, the methods and what is appropriate for individual studies.

• People in Research website

  People in Research aims to help members of the public make contact with organisations that want to actively involve people in clinical research.

Reporting

• HTA Adverse Event Reporting

  For projects involving human application.

• NRES Guidance on Annual Progress Reports

  Applicable to all with NHS REC approval.

• NRES Guidance on Safety Reports

  Safety reports for research other than clinical trials of investigational medicinal products (CTIMPs).

• NRES Report of Serious Adverse Event Form

  Form to report serious adverse events in research other than CTIMPs.

• Research Governance Framework for Health and Social Care in England, 2nd Edition

  PDF page 44 for adverse event reporting to NPSA.

Research Governance Framework

• Medicines for Human Use (Clinical Trials) Regulations 2004

  Medicines for Human Use (Clinical Trials) Regulations 2004.

• NHS R&D Forum Contacts for R&D Offices

  Contact details for obtaining NHS R&D permission for research.

• NHS R&D Forum Sponsorship FAQs

  NHS R&D Forum document providing answers to frequently asked questions on sponsorship.

• NHS R&D Forum Sponsorship Principles

  NHS R&D Forum document outlining sponsorship principles.

• NHS R&D Forum document on peer review

  Guidance to outline what requires peer review, who should undertake it and how.

• NHS Research Scotland (NRS)

  NRS streamlines the process of obtaining R&D permission for commercial and non-commercial multicentre studies in Scotland.

• NIHR Coordinated System for gaining NHS Permission (CSP)

  The National Institute for Health Research (NIHR) system for standardising and streamlining the process for gaining NHS permission for research in England.

• Research Governance Framework for Health and Community Care in Scotland, 2nd Edition

  Link to Research Governance Framework for Health and Community Care for Scotland. These guidelines are mandatory for all research involving NHS patients and resources.

• Research Governance Framework for Health and Social Care in England, 2nd Edition

  DH published the 2nd edition of the Research Governance Framework for Health and Social Care. These guidelines are mandatory for all research involving NHS patients and resources.

• Research Governance Framework for Health and Social Care in Northern Ireland (2006)

  Link to Research Governance Framework for Health and Social Care for Northern Ireland. These guidelines are mandatory for all research involving NHS patients and resources.

• Research Governance Framework for Health and Social Care in Wales, 2nd edition

  Link to Research Governance Framework for Health and Social Care for Wales. These guidelines are mandatory for all research involving NHS patients and resources.

• UKCRC - IRAS guidance

  UKCRC webpages on the Integrated Research Application System (IRAS).

• UKCRC - Research Passport guidance

  UKCRC webpages on the Research Passport.

Risk Management and Monitoring

• Greater Manchester Research Alliance Management Tools

  MAJIK Monitoring and Audit; and MIRRA Risk Assessment tools (username: gmrarg; password: tools).

• MRC Guidance: Health and Safety A Practical Guide for Research Involving the Public

  An MRC publication giving advice about how to reduce the potential risks to research staff and the public.

• MRC Guidance: Risk Management in Public Health Research (doc)

  MRC guidance tool, outlining potential risks and strategies for managing and monitoring such risks (developed for MRC units, also applicable to others).

  MRC Guidance Risk management in public health research (114KB)

• NHS R&D Forum: Research Governance Monitoring and Auditing

  NHS R&D Forum document looking at monitoring from an organisational perspective.

Tissue Sharing

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 14 - Section 4: Use of human material for commercial research.

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 23 - Section 9: Management of collections of human material. PDF page 25 - Section 10: Established collections.

Tissues

• HTA / NRES Joint Position Statement on Diagnostic Archives used for Research

  The HTA and NRES have developed a joint position statement that sets out licensing, ethical approval and consent requirements and options.

• HTA Code of Practice on Consent (Sept 2009)

  Detailed guidance from HTA on the consent requirements of the Human Tissue Act 2004.

• HTA Code of Practice on Disposal of human tissue

  Detailed guidance from HTA on the disposal of human tissue.

• HTA Code of Practice on Import and Export (May 2007)

  Detailed guidance from HTA on the import/export requirements.

• HTA Code of Practice on Research (Sept 2009)

  Detailed guidance from HTA on the use of human tissues in research.

• HTA Code of Practice on Research (Sept 2009)

  HTA standards, see Governance and quality systems.

• HTA Code of Practice on Research (Sept 2009)

  HTA standards, see Human tissue and research.

• HTA Post Mortem webpages

  HTA Post Mortem webpages.

• HTA ‘relevant material’ webpage

  More detailed information from HTA describing relevant material.

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 25 - Section 10: Established collections.

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 24: Using established collections in research – a decision tree.

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  PDF page 12 - Section 3: Use of human material surplus to clinical requirements for research.

• MRC Guidance: Standards for transfer of human tissues

  MRC guidance on transfer of human tissue samples, developed for MRC research units but applicable to all.

• MRC RSC e-learning: Research and Human Tissue legislation

  Research and Human Tissue legislation e-learning.

• MRC Research and Human Tissue Legislation Series: Consent

  Applicable for England, Wales and Northern Ireland.

• MRC Research and Human Tissue Legislation Series: DNA Analysis

  Applicable for all of the UK.

• MRC Research and Human Tissue Legislation Series: Disposal

  Applicable for England, Wales and Northern Ireland.

• MRC Research and Human Tissue Legislation Series: Import and Export

  Applicable for all of UK.

• MRC Research and Human Tissue Legislation Series: Scotland

  Applicable for Scotland.

• NCRI Oncology Information Exchange

  Link to the NCRI ONcology Information eXchange (ONIX). A free-to-use portal that connects many of the main public sources of cancer research data.

• Scottish Executive Web page on Human Tissue (Scotland) Act 2006

  Detailed information from Scottish Executive.