27 June 2007

News from the Forum

Mental Capacity Act 2005

The NHS R&D Forum has produced a brief guide to the Mental Capacity Act for NHS R&D staff. Any NHS R&D staff in England or Wales who have not familiarised themselves with the Act and its implications should do so by 1 July 2007 so that they can ensure that research hosted by their organisation complies with the Act by 1 October 2007. See http://www.rdforum.nhs.uk/docs/mca_guidance.doc. Detailed guidance from NRES on the requirements for ethical review are now available - see below for more details.

The Department of Health has published draft guidance for consultation on how to identify an appropriate "consultee" for the purposes of section 32 of the Mental Capacity Act 2005. The guidance indicates how researchers should go about identifying an appropriate person to consult when they wish to carry out research which involves someone who lacks capacity to consent to take part. Consultation closes 14 September 2007. See http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_076216.

Annual Report 2006-7

The NHS R&D Forum's Annual Report for 2006-7 has been published and is available at http://www.rdforum.nhs.uk/library.htm.

NIHR Update

Keep up with the closing dates on all the new programmes and schemes by downloading the calendar at http://www.rdforum.nhs.uk/docs/nihr%20calendar.doc (updated 26/06/07). See http://www.rdforum.nhs.uk/classifieds.htm#proposals for up to date information on calls for proposals from NIHR and other schemes.

Research for Patient Benefit (RfPB) programme 4th competition

Proposals are now invited for the fourth round of RfPB. The date for submitting a Registration of Intention (ROI) to apply is Friday 10 August 2007 and the application closing date is 21 September 2007.

Comprehensive Research Network Update

Calls for Expressions of Interest - CLRN Senior Managers and CLRN Lead RM&G Managers

The UKCRN Coordinating Centre is inviting expressions of interest for the CLRN Core Team posts of Senior Manager and Lead RM&G Manager in each of the 25 CLRNs. Closing date 12 noon on Friday 29 June 2007. See the UKCRN website (http://www.ukcrn.org.uk/index/jobs/crn.html) for details.

UKCRC update

Advice Service Update

The UKCRC R&G Advice Service provides support for local advice providers, such as NHS R&D departments and university research managers, by providing a route for handling more complex queries such as those involving more than one regulatory issue and on-line resources such as Tool Kits and Question & Answers. The NHS R&D Forum is one of the partners in the advice service. A pilot of the service has been completed and a report is now available on the UKCRC website http://www.ukcrc.org/pdf/UKCRC%20R&G%20AS%20Pilot%20Report_FINAL.pdf. The Advice Service can be accessed at http://www.ukcrc-rgadvice.org.

UKCRC R&D Advisory Group to Connecting for Health

UKCRC has published a report on the use of the NHS Care Records Service in research. The report highlights the technical, regulatory and governance issues related to using the NHS Care Records Service in health research and made a number of recommendations which are now being taken forward by the Department of Health. See the UKCRC website for more information (http://www.ukcrc.org/publications/news/electronicpatientrecords.aspx).

Information from other organisations

Update on the UK Research Integrity Office

Many of you will have seen in the press recently that the UK Panel for Research Integrity in Health and Biomedical Sciences launched the Research Integrity helpline to provide advice and guidance to those involved in issues relating to conduct in research. The helpline - 0844 77 00 6 44 - is available 8am and 8pm, Monday to Friday, with voicemail available at other times or email helpline@ukrio.org. The aim is to ensure that the most appropriate advice is available to those leading or managing investigations, as well as those who have concerns about the conduct of research. The service is confidential and is available to those working in the NHS as well as universities.

Alongside this, the Panel is developing a practical guidance document - The Code of Practice for Research - which is due to be published shortly. This will provide the research community with guidance on the definition and implications of research misconduct, and practical advice for employers on the issues which need to be addressed to manage instances of fraudulent research and other aspects of research misconduct.

Update on Trial Registration from the ICMJE

In 2005, the International Committee of Medical Journal Editors (ICMJE) initiated a policy requiring researchers wishing to publish in their journals to register trials on an accepted clinical trials registry before the onset of patient enrolment. The ICMJE have now evaluated this policy and have made further recommendations about trial registration http://www.icmje.org/clin_trial07.pdf.

Registration in any of the primary registers that participate in WHO's International Clinical Trials Registry Platform (ICTRP) will be accepted www.who.int/trialsearch (see What's New on the R&D Forum website on 24 May 2007 for more information about the platform). From 1 July 2008 the requirement for registration will be expanded to include phase 1 studies, and registration will therefore be required in accordance with the WHO definition of clinical trials - "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes". To support the development of registration of trial results, the ICMJE will consider publication of results that have previously been posted in the form of a brief, structured abstract or table in the same clinical trials registry in which the primary registration is held.

Update on proposed voluntary accreditation scheme for Phase 1 clinical trial units

In response to the recommendations of the Expert Scientific Group, chaired by Sir Gordon Duff, the MHRA GCP Inspectorate is proposing to implement an accreditation scheme for units conducting non-therapeutic studies. The scheme is intended to give assurance to the MHRA and to ethics committees that phase 1 facilities meet satisfactory standards for minimising risk to trial subjects and for handling medical emergencies if they arise. Draft proposals are available on the MHRA website http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031409&ssTargetNodeId=387 and a public consultation will open in the next few months. The NHS R&D Forum is represented on the MHRA consultative committee which has been involved in drafting the proposals.

NRES Update Roadshows

The National Research Ethics Service is holding a series of roadshows to provide an update on the implementation of NRES business plans. NHS R&D staff are welcome to attend, numbers permitting. For more information see http://www.nres.npsa.nhs.uk/docs/events/NRES_Update_Flyer.doc.

NRES guidance on applying for approval under the Mental Capacity Act 2005

The National Research Ethics Service has published detailed guidance and supplementary information forms relating to approval for research under the Mental Capacity Act. See http://www.nres.npsa.nhs.uk/applicants/index.htm#25060.

Updating your membership or R&D office contact details

All members who have not updated their contact details via the online form are reminded to do so. Go to http://www.rdforum.nhs.uk/membership.htm#update

If you have any difficulties with the system (e.g. due to firewall or spam filter systems) please just contact janet.messer@rdforum.vispa.com.

Anyone working in an NHS R&D office can now also sign up to receive occasional emails from the R&D Forum directed specifically at R&D staff. If you are from an NHS R&D office and would like to receive R&D emails direct instead of via one contact in your office, please log in as above and update your subscriptions to include to include Rdoffice emails.

The R&D office contact database on the website is now updated separately from the R&D office mailing list. Please make sure that the contact listed on the website is the most appropriate contact for researchers seeking advice or wishing to apply for R&D approval. Check http://www.rdforum.nhs.uk/links/rdlinks.htm.

If you want to keep up with messages on the discussion board, you don't need to remember to keep checking the website - just subscribe to the weekly digests - log in via http://www.rdforum.nhs.uk/membership.htm#update and update your subscriptions.

Regards

Janet

Dr Janet Messer
Deputy Director
NHS R&D Forum
Tel: 01570 421172
Web: www.rdforum.nhs.uk
Email: janet.messer@rdforum.vispa.com