Resource index: All categories

All:

Amendments

• IRAS Amendment Guidance for all Review Bodies

  Guidance on submitting amendments to review bodies via IRAS.

• 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 (pdf)

  Framework outlining structure and function for university research ethics committees.

• Gene Therapy Advisory Committee website

  Information on remit and application to GTAC.

• Integrated Research Application System (IRAS)

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

• 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

• NRES and NHS R&D Forum joint bulletins

  Information on the transfer of SSA for NHS sites.

• NRES: About the IRAS application form

  Information about the application form for all NHS RECs.

• NRES: Applying for ethical review by an NHS REC

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

• NRES: Contact list

  Contact details for all NHS research ethics committees

• NRES: Defining research

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

• NRES: Link to old NRES application form

  Old on-line application form for all NHS RECs

• NRES: The remit of NRES

  NRES web pages outlining the remit of NHS RECs

• Nuffield Council on Bioethics publication

  The Ethics of Research Related to Healthcare in Developing Countries.

• 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 (pdf)

  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 (pdf)

  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.

• MRC Ethics Series: Personal Information in Medical Research

  Section 5: Safeguarding Confidentiality.

• NHS Code of confidentiality

  Department of Health guidance on disclosure.

• NHS Information Governance Toolkit

  NHS standards, applicable for all organisations holding identifiable data

• NIGB Section 251 security arrangements; access to System Level Security Policy

  Applications to use section 251 powers will need to complete a System Level Security Policy to provide proof of suitable security arrangements (scroll to fifth of page).

• Patient Information Advisory Group System Level Security Policy (doc)

  Template produced by PIAG documenting responsibilities for organisations holding identifiable data. This is a requirement of Section 60 approval, for all others it is good practice.

• 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.

• 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.

• NIHR CRN CC course on taking consent

  Course organised by NIHR Clinical Research Network aimed specifically at clinical research staff who have direct patient contact.

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

  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

  Section 5: Children, ethics and the law.

Consent (Data)

• Academy of Medical Sciences report

  Personal data for public good: using health information in medical research.

• Association of the British Pharmaceutical Industry guidance

  Guidelines for the secondary uses of data for medical research purposes.

• 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).

• British Medical Association guidance

  Guidance on Secondary Uses of Patient Information.

• 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

  Section 3: covers the complex legal environment surrounding consent.

• MRC Ethics Series: Personal Information in Medical Research

  Section 8: Information and consent forms.

• MRC Ethics Series: Personal Information in Medical Research

  Annex 3: The Data Protection Act 1998.

• MRC Guidance: Consent for Consent (pdf)

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

  MRC draft guidance Consent for Consent (54KB)

• Patient Information Advisory Group leaflet (pdf)

  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

  Section 6: Consent.

Consent and Confidentiality (Data)

• Academy of Medical Sciences, University of Cambridge legal symposium (pdf)

  Report of symposium held to discuss the legal issues raised in AMS report, Personal Data for Public Good: Using Health Information in Medical Research.

• 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

  Section 2: Principles for working with identifiable personal information.

• National Information Governance Board (NIGB)

  The National Information Governance Board for Health and Social Care (NIGB) is now 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.

• PIAG Annual Report 2007-8

  The 6th Patient Information Advisory Group annual report has now been published and is available on the Department of Health website.

• Patient Information Advisory Group web pages

  Comprehensive information about Section 60 and PIAG, including application procedures.

Data

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

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

• 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.

Data Sharing

• MRC Ethics Series: Personal Information in Medical Research

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

• MRC Ethics Series: Personal Information in Medical Research

  Section 7: Storage and re-use of data.

• MRC web pages on Data Access

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

• MRC web pages on Data Sharing

  Information outlining MRC policy and aims on data sharing.

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

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

Dissemination

• DASH study newsletter (pdf)

  Example of disseminating research findings and study updates to participants.

  DASH study newsletter (6MB)

• National Health Development Survey website

  Example of disseminating research findings and study updates to participants

• SHARE study newsletter (pdf)

  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

Embryo research

• HFEA Code of Practice 8th edition

  Sections 17 and 22 are relevant to research.

• 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.

• Human Fertilisation and Embryology Authority Inspections

  Information on HFEA inspections

• Human Fertilisation and Embryology Authority Progress Reports

  Guidance on progress reporting to HFEA

• Human Fertilisation and Embryology Authority Renewal of Licence

  Application form and guidance for changes renewal of, or changes to licences

• Human Fertilisation and Embryology Authority contact details

  Contact details for HFEA

• Human Fertilisation and Embryology Authority licensing pages

  HFEA Human Embryo licensing pages

• Human Fertlisation and Embryology Authority Incident Report Form

  HFEA Incident Report Form

• Human Fertlisation and Embryology Authority Incidents Procedure

  Standard Operating Procedure for incidents and near misses

Ethics Committees

• IRAS brochure March 2009

  Link to the Integrated Research Application System (IRAS) brochure, March 2009

• 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 web pages on applying for a grant

  Information on applying for a grant from the MRC.

• Sources of research funding

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

Good Research Practice

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

  Short checklist 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 Good Research Practice

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

• 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

• Human Tissue Authority Code of Practice 5 (pdf)

  Removal, storage and disposal of human organs and tissue.

• Human Tissue Authority Licence Fees

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

• Human Tissue Authority licensing

  Link to HTA web pages on Licensing

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

  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 (pdf)

  Applicable for England, Wales and Northern Ireland.

Information to participants

• Information Commissioner's Office Checklist (pdf)

  For organisations handling access requests.

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

  Section 8: Feedback of Information.

• MRC Ethics Series: Personal Information in Medical Research

  Section 6.2: Feedback and publication.

Inspections

• HTA Summary Inspection Report - Research 2006-2008

  The HTA summary inspection report on research, summarising the key learning points from a range of information that the HTA holds about the establishments that it regulates.

• Human Tissue Authority Inspections

  HTA web page on Inspections

• MRC Guidance: Tips for HTA Inspections (pdf)

  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 for Public involvement in research grant applications (pdf)

  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.

• Patient Information Advisory Group leaflet: Using patient information and involving service users in research (pdf)

  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

• Human Tissue Authority 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 2nd Edition

  Page 40 for adverse event reporting to NPSA.

Research Governance Framework

• 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 (doc)

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

• NHS R&D Forum Sponsorship Principles (doc)

  NHS R&D Forum document outlining sponsorship principles.

• NHS R&D Forum document on peer review (doc)

  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.

• NIHR guidance on the research passport

  NIHR webpages on the research passport

• Research Governance Framework 2nd Edition, England

  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 Community Care for Scotland (pdf)

  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 for Wales 2nd edition (2009)

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

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

  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.

• Streamlined NHS Permissions Approach to Research - Cymru (SPARC)

  SPARC provides a streamlined and consistent approach for obtaining NHS permission for primary care research studies in Wales.

• 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 (pdf)

  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 (pdf)

  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 (doc)

  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

  Section 4: Use of human material for commercial research.

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

  Section 9: Management of collections of human material. 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 (revised Sept 2009)

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

• HTA Code of Practice on Research

  The HTA Code of Practice on Research came into force on 15 September 2009 and includes consent and licensing requirements relevant to the research community.

• Human Tissue Authority Code of Practice on Import and Export (pdf)

  Detailed guidance from HTA on the import/export requirements.

• Human Tissue Authority web page on ‘relevant material’

  More detailed information from HTA describing relevant material.

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

  Section 10: Established collections.

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

  Page 22: Using established collections in research – a decision tree.

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

  Section 3: Use of human material surplus to clinical requirements for research.

• MRC Guidance: Standards for transfer of human tissues (pdf) (updated July 2009)

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

  MRC Guidance standards for transfer of Human tissue (updated July 2009) (pdf) (26KB)

• MRC Research and Human Tissue Legislation Series: Consent (pdf)

  Applicable for England, Wales and Northern Ireland.

• MRC Research and Human Tissue Legislation Series: Disposal (pdf)

  Applicable for England, Wales and Northern Ireland.

• MRC Research and Human Tissue Legislation Series: Import and Export (pdf)

  Applicable to all of UK.

• MRC Research and Human Tissue Legislation Series: Scotland (pdf)

  Applicable for Scotland.

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

  Detailed information from Scottish Executive.

• onCore UK website

  Information on this national cancer tissue bank, relevant for all tissue banks