MRC Good Research Practice Guidelines
All EME-funded research teams are expected to conduct their research in accordance with the Medical Research Council's Good Research Practice Guidelines
Research Governance Documentation and Information Guide
The Research Governance Framework defines the principles of good research governance and is vital for ensuring that health research is conducted to high scientific and ethical standards. EME Programme-funded researchers must work within this framework. The NHS R&D Forum and the Primary Care Working Group have produced an updated version of a guide on Research Governance The guide, available as a downloadable Word document or as an online resource, provides a comprehensive summary of the current regulations, guidance and information relating to Research Governance, plus full reference details of how these documents can be accessed electronically.
Guidance on Professional Legal Representatives
Updated guidance on who can be identified as a Professional Legal Representative (PrLR) and their role in Clinical Trials of Investigational Medicinal Products (CTIMPS) has been produced by the NHS R&D Forum Research Governance Working Group.
The Medicines for Human Use (Clinical Trials) Regulations 2004 profoundly changed the legal basis for consent for vulnerable subjects (minors and incapacitated adults) in CTIMPs. The document defines a Personal and Professional Legal Representative. It then clarifies in a question and answer format issues such as how a PrLR should be nominated, their role, how they should make their decision and their indemnity.
The guidance gives you useful links to regulatory documents and the National Research Ethics Service (NRES) guidance on informed consent in Clinical Trials.
Integrated Research Application System (IRAS)
The National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) came into effect on 18 November 2008 for NIHR Clinical Research Network Portfolio studies in England.
The Integrated Research Application System (IRAS) is the single gateway for NIHR CSP. IRAS can be accessed at www.myresearchproject.org.uk . If you wish to apply to NIHR CSP, you must therefore use IRAS for your ethics and R&D applications.
From 1 September 2009 the online NRES form system will be completely closed. From this date, old REC and SSI applications in the NRES form system may be viewed and printed but it will no longer be possible to create a new application form, duplicate or submit any existing forms in this system.
To add sites or submit amendments to existing studies applicants will need to create a minimal dataset in the Integrated Research Application System. Completion of a small number of fields will provide the appropriate information to create SSI Forms and amendment forms for existing studies.
For details of how to use this function, please see the guidance on the Help page in IRAS.
NIHR CSP will not be available to you if your study is not included in the NIHR Clinical Research Network Portfolio. If your study is not eligible for the Portfolio, you should continue to seek permission directly from the NHS Trusts involved in the study. The eligibility criteria for inclusion of studies on the NIHR Clinical Research Network Portfolio can be found on the UKCRN website
If you are an investigator based in Scotland, Wales or Northern Ireland and you are conducting a study with sites in England, you should contact the NIHR CSP Helpdesk at email@example.com for guidance.
IRAS was updated to version 2.4 on 14 August 2009. This version includes the facility for creating Site-Specific Information Forms and managing amendments for studies that were submitted for REC review outside IRAS. This is in preparation for the closure of the NRES form system on 1 September 2009. For details of how to use this function, please see the guidance on the Help page.
Model Clinical Investigation Agreement (mCIA)
The UK Clinical Research Collaboration (UKCRC) has launched the model Clinical Investigation Agreement (mCIA). This has been designed in collaboration with the Department of Health and the Association of the British Healthcare Industry (ABHI).
Use of the mCIA is not mandatory for either NHS hospitals or member companies of either the ABHI or other medical technology trade associations but it is intended that the model would be widely adopted and carry an authority equivalent to that of the ABHI Form of Indemnity. Its routine use is strongly commended by the UK Departments of Health in England and the devolved administrations of Wales, Northern Ireland and Scotland; and the ABHI. These bodies recommend that no modifications are made to the agreement, other than those necessary to correctly identify the investigation, the contracting parties, and the investigator, and set out the financial terms and clinical investigation subject recruitment arrangements. Its use removes the need for company-by-company, investigation-by-investigation and site-by-site legal review of contract terms.
Copies of the mCIAs for England and each devolved administrations plus the Guidance can be found on the UKCRC website
NIHR Clinical Research Networks (NIHR CRN)
There are a number of useful resources for researchers on the NIHR CRN website, including a costing template.
Website of UKCRC-registered Clinical Trials Units
A website has been developed to help researchers and funders identify Clinical Trials Units (CTUs) in the UK with expertise in centrally coordinating multicentre clinical trials from design and development, through to data management, and final analysis. The CTUs listed on the website have all achieved UK Clinical Research Collaboration (UKCRC) Registration status. It will allow users to find suitable CTUs by disease research areas (e.g. diabetes, mental health), methodological research areas (e.g. economic evaluation, systematic reviews and meta-analysis) or specific types of clinical research study (e.g. surgical trials, trials of investigational medicinal products). See www.ukcrc-ctu.org.uk
Joint Statement by INVOLVE and NRES
INVOLVE and the National Research Ethics Service (NRES) have developed a statement to provide clarity and guidance on patient and public involvement in research and the requirements of research ethics review. The active involvement of members of the public does not generally raise any ethical concerns as they are acting as specialist advisors, therefore ethical approval is not needed for the active involvement element of research e.g. helping to develop a protocol/questionnaire or helping to analyse survey data. The ethics committee will continue to review where there is direct contact with study participants. The statement has been approved by the NRES Advisory Group on NHS Service Users and Ethical Review. http://www.invo.org.uk/pdfs/INVOLVE_NRESfinalStatement310309.pdf
New Declaration of Helsinki
The World Medical Association has published a new version of the Declaration of Helsinki The 2008 version is now the only official one; all previous versions have been replaced and should not be used or cited except for historical purposes.
The Consolidated Standards of Reporting Trials (CONSORT) Statement aims to alleviate the problems arising from inadequate reporting of randomised controlled trials (RCTs) with a minimum set of recommendations for reporting RCTs. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. See www.consort-statement.org for more details about the statement. You may also find the flow diagram generator of use.
Merrick Zwarenstein et al have published a review of the CONSORT statement entitled ‘Improving the reporting of pragmatic trials: an extension of the CONSORT statement' following two two-day meetings in Toronto. The article is available at www.bmj.com/cgi/content/abstract/337/nov11_2/a2390
They recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented in the article along with illustrative examples of reporting and an explanation of each extension.
The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is a new quality improvement initiative that seeks to enhance reliability of medical research literature by promoting transparent and accurate reporting of health research. In addition to the information on reporting, you may find the templates for flow diagrams useful. See www.equator-network.org
Mental Capacity Act (MCA) 2005
The website www.thinkmca.co.uk distils the main elements of the MCA 2005 and the accompanying Code of Practice and presents these in ways which allow quick familiarisation. This site will be useful for those who treat or care for adults who may lack or have reduced capacity, or if you want to learn more about the MCA 2005. It also has a useful section looking at obligation and the approval process for research under the MCA and practical steps when designing a research study.
Certain categories of people are legally required to have regard to the Code of Practice i.e. being aware of the Code and being able to show regard to it when acting or making decisions on behalf of a person who may lack capacity. These people include healthcare staff, social care staff and people who are being paid for acts for or in relation to a person who may lack capacity (such as care assistants in care homes and care workers providing domiciliary care services).
The information can also be a useful resource for those who are not legally obliged to have regard to the MCA and Code of Practice. The MCA Code of Practice can be found at www.opsi.gov.uk/acts/acts2005/related/ukpgacop_20050009_en.pdf ( 1.25MB)
Human Tissue Authority
The Human Tissue Act 2004 refers to ‘relevant material’ for the purpose of consent requirements and licensing by the Human Tissue Authority. The Human Tissue Authority has now published revised guidance on the definition of relevant material
Following consultation on the revised versions of HTA codes of practice the updated codes have been approved by Parliament and were published in September 2009. The new codes of practice can be download from http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm
Clinical Trials Toolkit
The MRC and the Department of Health have devised a clinical trials toolkit which contains information on trial regulation and governance requirements.
The Importance of Methodological Input to Clinical Trials Tool
On behalf of the EME programme Board, Professor Graham Dunn and Dr Lisa Douet have developed a resource to provide guidance on designing a clinical trial, including randomisation, sample size and recruitment.
Download a PDF of the tool here .
Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Tool
Randomised trials have been broadly categorised as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, ‘‘Does this intervention work under usual conditions?’’ whereas explanatory trials are focused on the question, ‘‘Can this intervention work under ideal conditions?’’ Design decisions make a trial more (or less) pragmatic or explanatory.
To help with this process a tool was developed during the course of two international meetings by participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory.
The tool is called PRECIS and it identifies criteria to help researchers determine how pragmatic or explanatory their trial is, assisting trialists to make design decisions that are consistent with their trial’s stated purpose. The assessment is summarised graphically. It can be viewed here at the Journal of Clinical Epidemiology: http://www.jclinepi.com/article/PIIS0895435609000481/fulltext .
Experimental Medicine Tool Kit
An Experimental Medicine Tool Kit has been launched. It aims to support investigators, research managers and ethics committees in assessing the risks involved in experimental medicine studies, and devising risk proportionate management and monitoring strategies.
The Tool Kit can be accessed at www.em-toolkit.ac.uk
Model agreement for non-commercial research in the Health Service
The model agreement for non-commercial research in the Health Service has been published on the UK Clinical Research Collaboration (UKCRC) Website: www.ukcrc.org/regulationgovernance/modelagreements/mnca.aspx
Research in the NHS: Good HR Practice Resource Pack
A full HR Good Practice guide is available on the NIHR website. The HR Good Practice resource pack sets out the standards, guidance and documentation to be followed by employers and NHS host organisations when implementing the Research Passport scheme to issue Honorary Research Contracts. Some minor points of clarification have been made to the current version of the Resource Pack, and a version control section, specifying the changes made and the reasons why, is now included in the pack. This includes clarification on the NHS to NHS arrangements.
Requirements to support research in the NHS
A letter is provided from Professor Dame Sally Davies, Director General of Research and Development and Chief Scientific Adviser for the Department of Health and NHS, regarding requirements to support research in the NHS. This letter includes information of operational requirements for research within the NHS and policy statements.
The letter is available here: Requirements to support research in the NHS letter
UK Research Integrity Office (UKRIO)
The UKRIO has launched a code of conduct which draws upon existing good practice and the experiences of UKRIO in addressing good conduct and misconduct in research. Particular attention has been paid to areas where UKRIO has most often been approached for guidance, in the hope of passing on lessons to the research community.
Research organisations can use the principles and standards when drafting or revising their own codes of practice. UKRIO 's intention is to assist research organisations in fulfilling the requirements of regulatory, funding and other relevant bodies and ensure that important issues have not been overlooked. The code can be found at http://www.ukrio.org/home/
What issues should I consider to ensure that my application is deemed 'deliverable'?
NETSCC is working closely with the NIHR Clinical Research Networks to ensure that the studies which it funds can be successfully delivered in the NHS, securing maximum benefits to patients and value-for-money of the NETS programmes. The Medicines for Children Research Network and the Association of Medical Research Charities have produced a guide on 'Points to consider when assessing the feasibility of research'. Many of the points discussed in the document apply to all types of clinical research, not just paediatrics. The document can be accessed here