1. News from the Forum
1.1 Skills for Monitoring Non-Commercial Clinical Trials
The R&D Forum with the Association of Clinical Research Professionals (ACRP) run a training course for monitoring clinical trials of medicinal products in the non-commercial sector. The following courses are opened to bookings - Preston (6-7 October 2009) and Bristol (28-29 October 2009).
This two-day course provides an introduction to the skills required for monitoring of clinical research trials of medicinal products in the UK non-commercial sector. The course is designed for all staff involved in monitoring, or supervising monitoring of clinical research e.g. R&D Managers, research governance staff, study coordinators, and investigator site staff. More details can be found at http://www.rdforum.nhs.uk/events.htm
1.2 Preparing Investigator Sites and Research & Development Departments for GCP Inspections (for the UK)
This course run by the NHS R&D Forum with the Association of Clinical Research Professionals (ACRP) is for all non-commercial sector professionals working on trials subject to GCP inspection by the Medicines and Healthcare products Regulatory Agency (MHRA). This one-day introductory/intermediate level course is offered in 2 parts. The morning session concentrates on organisational issues arising within R&D department and therefore all categories of R&D staff are strongly recommended to attend. The afternoon session concentrates on issues specific to investigator sites and all members of the site staff as well as pharmacists and lab staff will find this of benefit. R&D staff should attend the full day as they will need to help and advise site staff prepare for inspections.
The following courses are opened to bookings - London (22nd October 2009), Manchester (6th November 2009) and Bristol (2nd December 2009).
More details can be found at http://www.rdforum.nhs.uk/004c.asp?entryid=188
1.3 Survey of training skills of individuals who have part-time or full-time responsibility for training colleagues in-house
The NHS R&D Forum invite you to participate in a survey of the training skills of ALL individuals involved in training their in-house clinical research colleagues. The survey also looks at attitudes to training within organisations. The survey is organised by the Education Department of the Association of Clinical Research Professionals (ACRP).
This is not limited to officially designated "trainers." This is about ANYBODY whose job involves delivering education, technical skills or soft skills to clinical research staff whether through face-to-face or online courses, or designing/ developing/ writing training materials. Confidentiality will be maintained for all responses. Analyses will be conducted only on pooled data and no names will appear in any report or publication.
ACRP, as a non-profit professional association, have confirmed that they will make the data collected public so that stakeholders may make use of the information.
The survey is available at http://www.zoomerang.com/Survey/?p=WEB2297VAY3QT4 until 30 September 2009.
2. DH/ NIHR Update
2.1 Best Research for Best Health updated implementation plans
The Government's health research strategy: Best Research for Best Health has a range of related objectives that the NIHR must deliver. In July the implementation plans were updated and can be found at www.nihr.ac.uk/about/Pages/about_implementation_plans.aspx grouped under six headings.
2.2 NIHR plan for Research Support Services
The NIHR has issued a new Implementation Plan for NIHR Research Support Services which aims to improve the quality, speed and efficiency of research and research processes in the NHS by facilitating the reconfiguration of NHS Trust R&D Departments within a national framework for the NIHR Research Support Services. See http://www.nihr.ac.uk/news/Lists/News/DispForm.aspx?ID=961
2.3 Improving the Environment for Medical Device Clinical Research, Stakeholder Workshop, 12 October, London
Improving the Environment for Medical Device Clinical Research, Stakeholder Workshop, has been organised by the NIHR to explain the recent improvements in the UK clinical research environment and the implications for the healthcare industries. More details can be found at http://www.nihr.ac.uk/news/lists/news/dispform.aspx?id=957
2.4 Current NIHR calls for proposals
NIHR NHS Physical Environment Research Programme
The NHS Physical Environment Research Programme invites research proposals that will contribute to the built environment and non-clinical services and support emerging National Service Frameworks and ministerial priorities. Proposals are welcome from the NHS, companies, consultancies and academic institutions. The closing date for applications is 18 September 2009. NHS Physical Environment Research Programme
Efficacy and Mechanism Evaluation (EME) programme
The EME programme is funded by the MRC and managed by the NIHR as the lead organisation for clinical trials and evaluation. The EME programme is broadly aimed at supporting 'science driven' studies with an expectation of substantial health gain. The clinical studies are likely to be mostly randomised controlled trials but other forms of evaluation appropriate for the intervention under study will also be supported. The EME programme is an ongoing research funding opportunity.
Applicants are welcome to submit a preliminary application at any time, however there are three submission deadlines each year. The submission deadline for consideration in the next round is Tuesday 24 November 2009 (before 1pm). More details
NIHR SDO Programme - Management Fellowship Evaluation
The intention of this call is to:
- commission an external evaluation of the SDO Management Fellowships initiative
- generate evidence that can be used for learning as the Fellowships grow and develop
- improve patient outcomes by adding to the evidence base on the impact of closer engagement between academic researchers and healthcare managers.
The SDO programme have provisionally allocated £100,000 to this call and anticipate funding one project, ideally to be completed within six months. The application process will be in one stage, with full proposals being invited. Full applications need to be submitted by 1pm on Thursday 8 October 2009. Call MF261: SDO Management Fellowships - Evaluation
NIHR i4i Future Product Development Funding Stream 3a (FPD3a) - Commercial Viability Study
The NIHR Invention for Innovation (i4i) Programme invites project proposals of up to one year for a collaboration between at least one industry and one research partner (academic or clinical) to determine the commercial viability of a proposed device or technology, with the development of a robust route to market and a strong, appropriate consortium being the main deliverables. Costs can be no more than £100k in total and a maximum of 75% funding is available. The closing date for applications is 18 September 2009. NIHR i4i FPD3a - Commercial Viability Study call
NIHR i4i Future Product Development - Stream 3b (FPD3b) - Collaborative Applied Research
The NIHR Invention for Innovation (i4i) Programme invites outline project proposals which should build upon the results of a completed assessment of feasibility and is a collaboration between at least one industry and one academic research partner (academic or clinical). This will provide further evidence of the capability to deliver improved healthcare outcomes and commercial and intellectual property exploitation. Funding to a maximum of 50% of the total project costs, and £100k-£300k per year, up to three years is available. The closing date for outline proposals is the 18 September 2009. NIHR i4i FFPD3b - Collaborative applied research call
DH PRP - High Quality Care for All - Evaluation of Academic Science Centres
The Department of Health's Policy Research Programme (PRP) invites proposal to evaluate Academic Health Science Centres (AHSCs). AHSCs are partnerships that bring together a small number of health and academic partners to focus on the integration of world-class research, teaching, and patient care. The key aim is to help speed up the process of translating developments in research into benefits for patients and the local community and to promote the uptake of discoveries within the NHS and across the world. The purpose of the evaluation is to identify how effectively these partnerships are working and to inform future designation policy.
The call is for an evaluation in two parts:
an evaluation of the progress of each of the AHSCs as they work to deliver on the vision they set out to the international designation panel;
a comparative study of the AHSCs, including an evaluation of the designation policy itself.
The deadline for receipt of full applications is 5.00pm on Monday 21 September 2009. Link to Page: DH PRP - High Quality Care for All - Evaluation of Academic Health Science Centres call
3. News from other organisations
3.1 News from NRES
New arrangements for studies using the NRES form online system
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 .
Proportionate ethical review - pilot scheme starts
A pilot scheme for proportionate review of applications to Research Ethics Committees (previously known as 'fast track') will begin in London on 1 September 2009 in Wandsworth, London and Surrey Borders and Outer North East London.
This follows wide consultation on the principles of proportionate ethical review and evaluation of the results of a screening pilot carried out by NRES last year.
During the pilot scheme, applications will be considered for proportionate review where:
- The application is booked through the London Local Allocation Service for review by a London-based REC
- The study falls into one of the categories listed in the No Material Ethical Issues Tool
- The applicant considers that the application raises no material ethical issues and requests review under the proportionate review pilot scheme
All applications are subject to the capacity of the proportionate review sub committees established by the four RECs taking part.
A flowchart summarising the operation of the proportionate review pilot scheme is available. Further information about submitting applications under the scheme is available in Applications.
Subject to evaluation of the pilot scheme and to provision for proportionate review being included in the final version of the harmonised GAfREC, NRES plans to extend the scheme to other Research Ethics Committees and incorporate it in the NRES Standard Operating Procedures during 2010.
Joint statement by INVOLVE and NRES on the ethical considerations on patient involvement in research
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
3.2 News from IRAS
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.
3.3 New online Portal for Cancer researchers
The National Cancer Research Institute has launched an online cancer research portal. ONIX (ONcology Information eXchange) enables scientists and clinicians to search through and access international research data held online - to improve the flow of cancer research information between individuals, institutions and organisations. http://www.ncri-onix.org.uk/portal/#S1
3.4 The UK Research Integrity Office (UKRIO) code of conduct for research
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/
3.5 The Human fertilization & Embryology Authority (HFEA) new code of practice
The HFEA has issued the 8th edition of their Code of Practice, updated consent forms and HFEA Directions and these come into force on 1 October 2009.
The 8th Code has been updated to reflect changes in the Human Fertilisation and Embryology Act 2008 and in HFEA policy. The consent forms and Directions have also been updated in line with the amended Act. More details can be found at http://www.hfea.gov.uk/523.html
3.6 News from the Human Tissue Authority
FAQs on serious adverse events and serious adverse reactions
Under the Quality & Safety Regulations, licensed premises are required to record and submit notifications of any serious adverse events / reactions that occur. These notifications then need to be followed up by the submission of a report, documenting the outcomes of local investigations into the incident.
The HTA is required to investigate and register information about serious adverse events and reactions, and communicate information about incidents as necessary. This communication allows appropriate action to be taken if tissues or cells need to be withdrawn, or control measures implemented.
To provide additional guidance for the human application sector, the HTA have recently published frequently asked questions (FAQs) on their website about serious adverse events and serious adverse reactions. http://www.hta.gov.uk/licensingandinspections/faqsonseriousadverseeventsandadversereactions.cfm
Licensing requirements for research tissue banks with generic ethics approval
NHS Research Ethics Committees (RECs) may give generic ethics approval for research tissue banks, providing they are stored on HTA-licensed premises. These banks are then required to operate under the terms and conditions agreed with the REC. This means that a specified remit of work is permitted without the need for further individual project-specific approvals.
If you have not done so already, those working at HTA-licensed establishments need to inform HTA if the establishment also houses a REC-approved research tissue bank storing relevant material. To do this, please email Lucy Atwal: email@example.com with your licence number, tissue bank REC approval reference number and where on the premises the bank resides.
The National Research Ethics Service (NRES) recommends that research tissue banks apply to specific flagged RECs to obtain generic approval, although any REC may consider an application.
More information is available at http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/positionstatementondiagnosticarchivesreleasingtissueforresearch.cfm
Licensing requirements for tissue held with project-specific ethics approval
The HTA has been made aware of some instances where the legal requirements of the Human Tissue Act 2004 (HT Act) as well as the governance arrangements for NHS Research Ethics Committees (GAfREC), have been over-interpreted. Where this is happening, it can lead to unnecessary stringency in the way research on human tissue is governed.
Tissue held for a specific project that has gained REC approval does not need to be stored on HTA-licensed premises. Conversely, tissue held for a project approved by a committee that is not an NHS REC (e.g. a university ethics committee) must be stored on HTA-licensed premises.
Although it is good practice for NHS REC approval to be in place, it is not a legal requirement that a project approved by a university ethics committee also needs to gain NHS REC approval.
More information on licensing and consent requirements of the HT Act is available in the new code of practice on Research. If you would like more information, contact Christiane Niederlaender: firstname.lastname@example.org. If you would like more information about the requirements of GAfREC or the NRES standard operating procedures, email email@example.com.
Human Tissue Authority (HTA) revised code of practice
Following consultation on the revised versions of HTA codes of practice the updated codes have been approved by Parliament and are expected to be published in September 2009. The new codes of practice can be download from www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/draftrevisedcodes.cfm
The existing codes of practice should be used until the revised codes are brought into force in September.
3.7 European News
Update on the Ethical Review of Protocols for Clinical Research Projects in the European Union from EFGCP
The European Forum for Good Clinical Practice (EFGCP) has updated the report on "The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union". The report identifies various aspects of the ethical review process for each member state. The updated report for the UK can be found at www.efgcp.be/Downloads/EFGCPReportFiles/uk.pdf
European Medicines Agency (EMEA) adopts guideline on neonate investigations
The EMEA has formally adopted a guideline on the investigation on medicinal products in term and preterm neonates (up to 27 days). Special aspects of clinical trial design are covered in Section 9 (pages 15 onwards) which gives guidance on particular factors to be taken into account when designing studies amongst neonatal populations. Section 7 discusses dosages. This comes into effect on 1st January 2010. The guidance can be found at http://www.emea.europa.eu/pdfs/human/paediatrics/53681008enfin.pdf
EMEA and FDA launch GCP Initiative
The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. The new initiative will begin with an 18-month pilot phase on 1 September 2009.
Key objectives of the initiative will be:
- To conduct periodic information exchanges on GCP
- To conduct collaborative GCP inspections
- To share information on interpretation of GCP
More detailed information about the EMEA-FDA GCP Initiative can be found here.
Applicants interested in volunteering to participate in a collaborative inspection during the pilot phase can contact Dr. Ana Rodriguez at the European Medicines Agency, GCP@emea.europa.eu.
Further revision to Q&A for EudraLex Clinical Trials guidelines
The European Commission has published a further revised Q&A section for EudraLex (The rules governing medicinal products in the European Union, Volume 10 - guidance on clinical trials) on 28 July. The document indicates the changes that have been made. Version 4 can be accessed at http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_07_28-q%26a_v4.pdf.
Report on Workshop looking at a Single CTA for multinational clinical trial
A report is now available on a one day workshop that took place in Brussels on 7th July looking at a single authorisation progress for Multinational Clinical Trials. The workship was organised by the European Forum for Good Clinical Practice. The report clarifies the issues, the guiding principles and options for progress in the short and long term. The report is available from the EFGCP website at http://www.efgcp.be/Conference_details.asp?id=236&L1=10&L2=2&TimeRef=2
4. Updating your membership or R&D office contact details
Membership contact details
If you change jobs or change your email address, please make sure you update your details for your newsletter subscription. Go to http://web.rdforum.nhs.uk/manage/member_details.php
Emails to R&D offices
NHS R&D office staff are reminded to ensure that at least one person from each office is subscribed to receive R&D office emails. These are an important route of communication directly to R&D staff. You are recommended to ensure that all relevant R&D staff are subscribed. Please log in to the website http://web.rdforum.nhs.uk/manage/member_details.php and update your subscriptions to include R&D office emails. This subscription category is only open to NHS (or joint NHS-university) R&D staff across the UK and to CLRN staff.
R&D office contact details
The NHS R&D Forum maintains the R&D office contact database on the website as a service to researchers. (see Contacting R&D Offices). The R&D Forum website allows you to login and update the contact details we have for your R&D Department. Please ensure that you check the details at regular intervals to ensure the details are up to date, for the benefit of researchers.