NRES - Guidance and good practice

NRES guidance on submission of curriculum vitae (CV) for ethical review or site-specific assessment, version 2.0. The template is issued as guidance and is not intended to be prescriptive. Use of the template is not a requirement for a valid application.

Care after researchThere are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here.
GP indemnity Guidance NRES guidance on the ethical review of indemnity for GP researchers.
Guidance on suspension of ethical opinion NRES Guidance on the suspension or termination of ethical opinion 22/03/06
Guiding principles for biobanks A statement of guiding principles for research tissue banks / biobanks, published by the National Cancer Research Institute’s (NCRI) Confederation of Cancer Biobanks (CCB).
Language and Exclusion How should RECs consider and decide about the inclusion or exclusion of participants in research who may have difficulties in adequate understanding of English?
NRES Leaflet: Building on Improvement NRES leaflet Building improvement.
NRES Leaflet: Research Ethics Timeline Research Ethics Timeline
Template policy for access to samples and data A toolkit created by the National Cancer Research Institute (NCRI) to assist organisations in developing a policy for access to collections of samples or data, including a template Material Transfer Agreement.

Communications on medical devices investigations Communications on medical devices investigations final version1
Medical devices - questions and answers Guidance on medical devices in the form of questions and answers.
NIHR CRN MedTech Study Start up Route Map The Medtech study start-up route map is for use by companies intending to sponsor and fund a clinical research study of one or more pieces of medical technology (medtech) involving patients in the NHS in England.
NRES guidance on the approval of medical devices research NRES guidance on the approval of medical devices research, version 2.0
Revisions to the European Medical Device Directives (2007/47/EEC): Clinical evaluation and investigation

Care after researchThere are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here.
Medical Research Council guidance on ethics and best practice (external link) Medical Research Council
Note For Guidance On Good Clinical Practice (External link) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (‘ICH GCP’) 10/06/96
World Medical Association Declaration of Helsinki Oct 2008 version- external link.

Guidance and good practice