Research index: All research

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.

• 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 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: Link to old NRES application form

  Old on-line application form for all NHS RECs.

• NRES: Standard Operating Procedures

  NRES Standard Operating Procedures.

• NRES: The remit of NHS RECs

  NRES web pages outlining the remit of NHS RECs.

• 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.

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.

• NRES Guidelines for writing Information Sheets and Consent Forms

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

• University of Kent: Consent checklist

  Tool developed to help with considerations for informed consent.

Data

• Data Curation Centre (DCC) Data Management Plan

  Data Curation Centre (DCC) Data Management Plan.

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.

• 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.

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.

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.

Public/Patient Involvement

• 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

• 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

• 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).

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

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