MHRN North East- Your Stake in Evidence-Based Mental Health Care by ihd16607

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                                 ub Newslette
                     North East H                                                 Issue 5
                                                                            OCTOBER 2008




MHRN North East–
Your Stake in Evidence-Based Mental Health Care
Welcome to our Autumn Newsletter.
We thank all of you who have helped us so far       Inside this issue:…………...…..Page
this year. We’re now supporting an increasing
                                                    NE Hub Projects………………………                2
range of research studies which are adding to
the evidence we all need to ensure that mental      Dates for Diary // Training…………...      3
health care improves in the future. Our work has
grown to include projects across the age range      LPOP Study…………………………...                 4
(see pages 4 and 9 for articles on older peoples’
mental health research) and across specialty        RIOTT Study // Research News…….         5
areas (see the addiction research article on        A Researcher in a Clinical Team………      6
page 5). There are also many training and
career progression opportunities that we are all    e-Science………………………………..                 7
benefiting from (see page 8).
                                                    Working for the MHRN ……………..….          8
We’re introducing a more frequent email update
                                                    Research with Older Populations…...     9
between newsletters to keep you informed of
new studies as they are set up.                     Mental Capacity Act 2005……………           10

Please pass on our message widely. And if           GCP & EU Directive for Paediatric
you’re new to the MHRN, please tell us your          Research Staff // New Reports…….       11
interests (see page 12) and we’ll keep you up to    NE MHRN Progress Round-Up……..           12
date with opportunities to help.
North East Hub Projects

Current Projects

CaPE: The impact of treatment foster care on     SIPS-CJS Probation: A cluster randomised
the outcomes for young people looked after by    controlled trial of alcohol screening and brief
the local authorities (The Care Placement        interventions in Probation Services
Evaluation).
                                                 VIEWPOINT:      Mental Health Survey of
DOMINO-AD: Donepezil and Memantine in            Experiences of Stigma and Discrimination in
moderate to severe Alzheimer’s disease           England

HTA-SADD: To determine the clinical and          Projects in set up
cost effectiveness of two classes of
antidepressants for depression in dementia
                                                 CEQUEL: Comparative Evaluation of
(compared with placebo)
                                                 QUEtiapine-Lamotrigine combination versus
                                                 quetiapine monotherapy (and folic acid versus
LPOP: (Liaison Psychiatry for Older People       placebo) in patients with bipolar depression
Project)
                                                 Homash 2: A study examining self-harm
PACT: (Pre-school Autism Communication           presentations in Accident and Emergency
Trial) —closed to recruitment                    Departments

PRAGMATIC: Pragmatic randomised trial of         MDS: Descriptive Evaluation of High Security
risperidone long acting injection versus oral    Services for Men with Dangerous and Severe
atypical antipsychotics in poorly adherent       Personality Disorders (DSPD)
subjects with schizophrenia in a routine care
setting—closed to recruitment
                                                 REEACT: The Randomised Evaluation of the
                                                 Effectiveness    and      Acceptability      of
ProCEED: (Pro-active Care and its Evalu-ation    Computerised Therapy trial
for Enduring Depression)

PsyGrid:       E-science to improve the
                                                 Completed projects
understanding and treatment of people in their
first episode of psychosis                       BALANCE
                                                 GAN
RIOTT:    Randomised       Injectable   Opiate   GenPod
Treatment Trial                                  NACHBID
                                                 TAS
RU486: Efficacy of Mifepristone (RU-486) in
the Treatment of Bipolar Depression

SAGE: The Sibling ADHD Gene Study                     For further information please contact
                                                  Chris Lubach, North East Hub Administrator on
SIPS-AED: A randomised controlled trial of                 Telephone: 0191 2824427 or
different methods of alcohol screening and         Email: chris.lubach@ncl.ac.uk or visit the
brief interventions in routine Accident and
                                                           Website at: www.ukmhrn.info
Emergency Department Care




2
Dates For Your Diary


27–28 November                                         MHRN Training
Centre for Female Health and Neuro-                    The MHRN offers free training events to all
development (FHAND) will be holding a                  those working on or associated with the MHRN
workshop entitled “Autism Spectrum Disorder            studies portfolio: This includes MHRN staff,
(ASD) and Attention Deficit Hyperactivity              carer and service user representatives,
Disorder (ADHD) in Adults: Approaches to               members of MHRN Clinical Research Groups,
Diagnosis and Treatment” at the Institute of           members of study teams for MHRN-adopted
Psychiatry, London. Please refer to the website        projects and any other individuals associated
at: www.iop.kcl.ac.uk/fhand for further information.   with MHRN activities.


1 December                                             MHRN In-house training
2nd North East DeNDRoN Conference from                 The MHRN coordinating centre and hubs
10am-3pm at the Centre for Life, Newcastle             provide training opportunities on a continuous
upon Tyne. If you have any queries please              basis for all new MHRN staff and current staff
email: laura.frisby@ntw.nhs.uk. Further inform-        including      carer   and     service    user
ation is available at www.dendron.org.uk.              representatives.

                                                       UKCRN Training & Education Programmes
                                                       These courses are open to all individuals
                                                       working on clinical studies contained within the
                     2009                              UK CRN portfolio, including MHRN-adopted
                                                       studies. The MHRN would encourage all its
                                                       staff, study team members associated with
                                                       MHRN-adopted studies and individuals
March—date to be confirmed                             associated with other MHRN activities to benefit
North East MHRN Annual Conference. More                from attending these generic courses.
information coming soon. Watch this space!
                                                       UKCRN Governance Training
                                                          Information Governance Foundation (new) -
19 March                                                    available online.
UKCRN Annual National Meeting at the
National Exhibition Centre, Birmingham.                UKCRN Research Approaches Training
Further details will be available shortly. Please         Communication Skills for Working in
visit: www.ukcrn.org.uk.                                    Clinical Trials
                                                          Critical Appraisal Skills
                                                          Research in Clinical Trials: Approaches and
20–22 May                                                   Methods.
4th Annual UK MHRN National Scientific
Conference 2009 at the East Midlands                   For further details on the MHRN training
Conference Centre, Nottingham. Please visit            programme please visit: www.ukmhrn.info or
www.ukmhrn.info. Further information coming            contact the MHRN Coordinating Centre at
soon.                                                  email: mhrn@iop.kcl.ac.uk, or call Imogen
                                                       Hood, MHRN Administrator on 020 7848 0699.




                                                                                                          3
Liaison Mental Health Services for
Older People Project (LPOP)
—By Caitlin Jarrett, Clinical Studies Officer

Research shows that older people occupy 66% of             Services and Dr Elizabeta Mukaetova-Ladinska,
UK general hospital beds and among these patients,         Consultant Psychiatrist for Old Age Psychiatry.
mental health problems are common. For example,
rates of 27% for both depression and dementia and          The research is covering all four hospitals within the
29% for delirium were found to be typical – with even      Newcastle upon Tyne Hospitals Trust (NUTH) and
higher prevalence rates found in particular settings       the local researchers are working closely with the
such as orthopaedic wards, where delirium has been         Liaison Psychiatry team, based at Newcastle
reported in 61% of older patients. Moreover,               General Hospital. The MHRN is involved with Phase
experiencing psychiatric co-morbidity has been             III of the project, evaluating the service model being
shown to increase the length of hospital stay,             used in Newcastle. The evaluation period started in
increase rates of institutionalisation and mortality and   late June and will run for 13 weeks (to mid-Sept
contribute to a reduced quality of life for patients and   2008).
their carers.
                                                           The evaluation is carried out across a mix of 16 Care
Across the UK, these demands are managed in                of the Elderly and acute wards and encompassing
different ways. Earlier research indicates that the        the collection of both qualitative and quantitative
majority of these patients are managed by general          data, including activities such as patient
hospital staff and whilst some sites have developed        assessments, note screening and staff and carer
specialist service models to support them, these           questionnaires as well as tracking new admissions
were not consistent across the UK. In Newcastle,           and referral numbers and collating data relating to
mental health services for older people are delivered      length of hospital stay and demographics. These in-
through the ‘Hospital Mental Health Team’ (or              depth evaluations should provide descriptions of
Liaison Psychiatry) model which is recognised as the       services set within their local contexts and provide
preferred operating model in England. This is defined      the detailed knowledge required to appropriately
as a dedicated, multi-professional team that is based      inform the design of the planned randomised-
within the general hospital and provides the               controlled trial (RCT). The project work involves a wide
psychiatric service across all sectors.                    range of collaboration, from almost all general
                                                           hospital staff (clinical and non-clinical), mental health
The purpose of the LPOP study is to take a closer          services and allied health professionals as well as
look at these different specialist services for older      operational services such as IT and we are very
people in general hospital settings and in particular,     grateful for the encouraging support we have
to better understand the mechanics of liaison style        received from everyone so far.
services. Once this study is finished, the research
team hope to design a randomised controlled study          It is planned that an initial report on the study will be
(RCT) to enable comparative analysis of the different      available in December 2008 on the National Institute
elements that define the structure of liaison service      for Health Research Service Development and
models; it is hoped that this information will then be     Organisation website – www.sdo.nihr.ac.uk. In the
used to augment the evidence base for future               meantime, if you would like any further information
development and implementation.                            please visit the study website www.leeds.ac.uk/lpop/
                                                           or contact any of the following:
There are 12 sites in total involved in the LPOP
study of which Newcastle is one. The MHRN                  Dr John Holmes, Chief Investigator and Senior
researchers are working alongside Dr John Holmes,          Lecturer in Liaison Psychiatry of Old Age, University
Chief Investigator and Senior Lecturer in Liaison          of Leeds - j.d.holmes@leeds.ac.uk
Psychiatry of Old Age and his research team based          Carolyn Montana, LPOP Project Manager, Leeds
at Leeds University to undertake the work at the           University - C.Montana@leeds.ac.uk
Newcastle site.    Locally, the research is being          Jess McCloskey, Local Researcher/Clinical Studies
implemented under the local direction of Dr Stephen        Officer, MHRN – jessica.mccloskey@ntw.nhs.uk
Louw, Clinical Director for Care of the Elderly


 4
Randomised Injectable Opioid Treatment Trial (RIOTT)
—By Saffra Knox, Clinical Studies Officer
Having joined the North East Hub as a Clinical          The Elmfield Centre at Darlington is one of three
Studies Officer in June my first task has been to       sites nationwide taking part in the trial, with two
help recruit service users for the RIOTT study at       further sites based in Brighton and London. We
The Elmfield Centre in Darlington, where I had          began recruiting in Darlington in September 2006
been previously working as a Trial Nurse.               and need to recruit 45 service users if the trial is
                                                        to meet its target of 150 recruits across the three sites.
RIOTT is being coordinated by The National
Addiction Centre at the Institute of Psychiatry,        Eligibility criteria requires that service users are
Kings College London and is evaluating the              aged 18-65, have a 3 year injecting history, have
effectiveness of prescribing injectable heroin          been on an oral methadone treatment programme
(diamorphine) or injectable methadone                   for a minimum of six months and are continuing to
(physeptone) compared to more traditional oral          inject heroin. Referrals do not need to come from
methadone treatment. In research trials con-            a professional, so the majority of service users
ducted abroad it has been shown that the                involved have self referred.
prescribing of injectable medications can be
beneficial in improving the health and social           Recruitment for RIOTT is due to finish at the end
functioning of heroin addicts, as well as reducing      of September 2008, depending on how successful
criminal activity. At present the standard treat-       all three sites are in meeting their recruitment
ment for opioid dependence in this country is oral      targets. At the point of MHRN involvement in
substitution (most commonly oral methadone),            June, Darlington needed to recruit 5 clients. To
however, the success of this approach is                date, however, our input has generated double
questionable with many service users continuing         this from brand new referrals and re-referrals. All
to use illicit heroin ‘on top’. The majority of         being well Darlington now has the potential to
service users will also openly admit that they          recruit over the 45 needed and this would greatly
dislike taking oral methadone as they feel it simply    improve the chances of RIOTT meeting its overall
gives them ‘a double habit’, rather than help solve     recruitment target.
their problems.
                                                        If you would like further information, please
                                                        contact: simon.douglas@ncl.ac.uk.


 RESEARCH NEWS
                                                        Mental Health Care
 Duets                                                  Mental Health Care is an information and research
 Research on the effects of treatments too often        news website developed by the Institute of
 fails to address questions that matter to patients,    Psychiatry, King’s College London, the South
 and to the clinicians to whom they turn for help.      London and Maudsley NHS Foundation Trust and
 For this reason, the Database of Uncertainties         the mental health charity Rethink. The website is
 about the Effects of Treatments (DUETs) gives          aimed at the friends, relatives and carers of
 priority to identifying and publishing unanswered      anyone with a mental illness. Latest research
 questions about the effects of treatments which        findings include:
 have been asked by patients and clinicians, while       Helping parents cope with caring for a child with
 also noting therapeutic uncertainties identified          anorexia nervosa;
 through systematic reviews, clinical guidelines, and    Is DVD training and telephone coaching useful
 other formal mechanisms. Visit: www.duets.nhs.uk.         for carers of people with an eating disorder?
                                                         Cognitive behaviour therapy as a treatment for
 Research Governance Made Simple—a brief                   schizophrenia.
 introduction to the Research Governance                Other research areas include stigma, bipolar
 Framework for Health and Social Care 2001.             disorder, psychosis and much more. Visit:
 Visit: www.rdforum.nhs.uk/toolkit/rgsimple.pdf.        www.mentalhealthcare.org.uk
                                                                                                                     5
A Researcher in a Clinical Team


Eleanor Barry writes…

I joined the North East Hub MHRN as a
Research Assistant on the PsyGrid project. My
post involves working on the initial phase of the
project: Outlook. This entails recruitment of
patients who have experienced a first episode                        Eleanor Barry
of psychosis. The primary aim of the project is
to build up a large database from a
representative cohort of individuals to further
improve our understanding of first episode          has become the norm for the care coordinators
psychosis. This covers presentation in the          as another part of the referral and assessment
prodromal period, development of the psychotic      procedure. As I’m here, on site, it’s no surprise
episode, triggering events and long term            that meeting patients and arranging
outcomes. PsyGrid is an e-science project           appointments with care coordinators is not
where all of this data collected from patient       necessarily easier but it is accepted as the
interviews is fed into a secure repository which,   norm and this, I feel, has benefited PsyGrid in
in turn, will then be used as a valuable research   the North East.
resource for clinicians and mental health care
researchers.                                        By working in a clinical setting my understand-
                                                    ing of a patient’s needs has increased. I not
My primary concern in this post is recruitment,     only see the patient as a part of PsyGrid but as
and to put me in the best environment in which      a part of EIP’s caseload, taken on for three
to fulfil my role I have been placed in the Early   years. This has given me a wider experience in
Intervention in Psychosis (EIP) Team. Rather        my post whilst I’ve been recruiting for the
different from most researchers based within a      project. Working alongside the care coord-
research network, I am working in a clinical        inators has meant that I have been able to
team alongside care coordinators with nursing       discuss and engage with a newly referred
and social care backgrounds, occupational           patient and, if the patient has consented to the
therapists, cognitive behavioural therapists and    study, the assessments I do are a valued part
a consultant psychiatrist. My routine here          of the patient’s engagement with the team. In
includes attending weekly clinical meetings and     terms of my experience this has been the most
reviews, assisting with EIP day to day              rewarding part of working in EIP. Recruiting to
processes and, most importantly, working            the study is my primary role and it is most
alongside care coordinators and engaging with       satisfying to see the cumulative figures
new patients who may or may not be eligible for     increase, however, by working in a team I have
PsyGrid. Working here not only allows me to         found the patient centred team work to be just
become a part of a multidisciplinary team, it       as rewarding. Reflecting on a patient interview
also brings research closer to the clinical         and incorporating my research into the work
setting. When a new patient is referred to EIP      that EIP carry out has been interesting and
they are assessed for their suitability for the     challenging for me and, I believe, beneficial to
team, then they are discussed in terms of           EIP. Bringing research to the team has made it
eligibility for family therapy, CBT and now         an accepted part of their every day lives, which
PsyGrid. Since every patient that is referred to    can only be a positive thing for engagement in
us is screened in this way, my recruitment role     mental health research.



6
e-Science
—By Amandeep Dhillon, e-Science Officer

e-Science has been described as using computers
and technology to help scientists work together to
solve problems of global relevance. The role of the
e-Science Officer (eSO) within the MHRN is to help
to facilitate the use of IT in mental health research
through the use of networking, secure data storage,
on-line collaboration and access to information.
                                                                         Access Grid in use
Works in Progress:

OpenCDMS                                                 Access Grid
OpenCDMS (formerly PsyGrid) is an e-science              Access Grid (AG) is an advanced video-conferencing
project that uses the valuable pool of knowledge         application that uses audio and video tools allowing
from computer scientists to facilitate the               people in different locations worldwide to meet in a
improvement of mental health care. It has the            virtual venue (virtual meeting room). Participants
potential to address many of the problems that           can see and speak to each other in real-time, use
arise within the healthcare system today.                online chat and share applications simultaneously.
OpenCDMS is a complete system for remote                 As an application, AG is ideal for any size of
clinical data capture for studies and trials adopted     meeting. At its most basic it can run on a laptop
on the Mental Health Research Network and other          with webcam using the laptop's display and
topic specific networks, such as the Diabetes            webcam microphone for a one-to-one meeting or it
Network. e-Science officers based at individual          can be used in a conference room with a server,
hubs provide the first line of support for all the       several high specification cameras and large
portfolio studies using this tool. More information on   display boards to create a group-to-group meeting
OpenCDMS can be found at www.psygrid.org.                with participants from across the globe.

NIHR Portal                                              The use of AG will have a positive impact on the
The NIHR portal is an internet-based service for all     MHRN in terms of financial savings, with reduction
NIHR or Department of Health Policy Research             of travel time and expenses. Other benefits include
Programme (PRP) funded organisations and health          facilitation of teaching and participation in national
professionals. The portal is accessible through a        and international meetings/seminars.
web browser and provides secure intranet
capabilities and collaborative working tools for the     Access Grid conference rooms are available at The
health research community. These include docu-           University of Newcastle Upon Tyne and Durham
ment repositories, shared calendars, forums, news        University. Desktop nodes are available for use at
feeds, online workspaces etc. The MHRN, namely           the RVI – Department of Psychiatry and soon to be
eSOs, will be responsible for the administration of      installed at Durham University, Queen’s Campus,
the MHRN site within the portal. The portal will         Wolfson Research Institute. The equipment is avail-
provide a secure collaborative environment to store      able for use by those running MHRN adopted
files, calendars and information of interest to hub or   studies.
study staff, hold discussion forums and build
workflows to support document control and other          If you would like to use PsyGrid for your study or
activities.                                              use the Access Grid equipment, please contact me
                                                         Amandeep Dhillon – eSO (North East Hub) on 0191
Currently, the e-Science team are building the           3340705 or amandeep.dhillon@durham.ac.uk.
appropriate knowledge and documentation for the
portal as well as promoting various aspects to hubs.


                                                                                                              7
Working for the MHRN helps prepare for
Doctorate in Clinical Psychology
Siobhan Currell writes…
As I come to the end of my time working for the
MHRN to take up a place on the Doctorate in Clinical
Psychology at Newcastle University, it seems like a
good time to reflect on the positive experiences I                                 Siobhan Currell
have gained in my time here. I joined the MHRN in
November 2007 and coming from a year’s work as an            need, you will be supported in pursuing this wherever
Assistant Psychologist in a low secure hospital, it was      feasible.
certainly quite a change of environment. Since I left
university I had been pursuing job opportunities that        Another valuable resource I have been able to exploit
would give me relevant experience to help secure a           is the vast opportunity to attend training courses. The
training place on the Doctorate. Given the multi-            UKCRN host a number of training courses relevant
faceted nature of the role of the Clinical Psychologist      for people working in research trials, and local
and the increasing move towards the scientist-               networks also host their own training days. The skills
practitioner model of practice, it is useful to gain         I gained at these events were useful in my doctorate
experience in a number of relevant areas, so having          interviews. Attending national conferences has also
gained some clinical experience, working in a                been enjoyable and insightful, and quite eye-opening
research environment seemed like an ideal next step.         to see the huge amount of research being conducted
                                                             across the UK.
Working for the MHRN has been a very beneficial
experience. I have had the opportunity to work on a          My role has also been beneficial in giving me local
number of different studies and thus gained                  knowledge, for instance, being immersed in an NHS
knowledge and skills in a variety of areas. DOMINO           setting and learning how it is structured; meeting with
gave me more understanding of Alzheimer's disease;           mental health professionals and getting an idea of the
PACT, a childhood autism study, gave me the chance           different teams and services; working with staff who
to visit schools and develop skills in assessing             are highly involved in R&D and teach on the
communication skills between parent and child; being         doctorate; and understanding the various trusts and
trained for PsyGrid familiarised me with the                 PCTs. Whilst this is by no means essential in securing a
assessment of symptoms of Schizophrenia.                     place on the doctorate, I do think it gives me a little bit
                                                             of extra confidence starting out on the course.
LPOP, looking at Mental Health services for Older
People in general hospital, has given me the most            Working on PACT gave me the chance to meet local
varied experience, such as working through the               researchers who are linked to the university and the
practicalities of setting up a study and putting effective   Doctorate. I was able to work alongside third year
systems in place, making relevant contacts with local        trainees and get an insight into how they conduct
staff, giving me insight into local mental health service    research. Newcastle University is increasingly moving
provision by shadowing the Liaison Psychiatry team and       towards a programmatic research model, so meeting
practical experience of working on busy hospital wards.      local researchers was really valuable as it helped me
                                                             to get an idea of the sorts of research interests in the area.
The initial transition from doing direct clinical work
with patients to working at much more of a distance          I think there is some anxiety amongst new graduates
was a little hard to get used to; however, as time has       looking to gain experience to get on the doctorate
gone on I’ve been able to incorporate more clinically-       that working in a research post is somehow not as
based work into my role, for instance, conducting            valuable as a clinical post. However, I feel my time
assessments with young people with autism as part            with the MHRN has given me more of a balance of
of a third year doctoral student’s research project.         knowledge and skills to complement those gained
More recently, working on the LPOP study has given           through my clinical posts, and having been offered a
me the opportunity to engage with elderly patients           place on two of the Doctorate courses, it seems that
admitted to general hospital wards and discover the          universities also recognise that working as a Research
common mental health issues affecting them. A                Assistant provides applicants with relevant experience
definite plus of working for the MHRN is that if you         which will benefit them through their training on the
have a particular interest or professional development       doctorate.

  8
Research with Older Populations—Is it worth it?
—By Jess McCloskey, Clinical Studies Officer

Research of any nature can have its trickier               about the study according to their capacity of
aspects—a minefield of ethics boards, recruitment          understanding;
challenges, and complex protocols to follow are all     3. If the participant is capable of forming an
par for the course. So it is unsurprising that             opinion (note that this is different from capacity
people sometimes wonder why researchers would              to give consent) and explicitly wishes to be
make their jobs even more difficult by focusing on         withdrawn from the study, this should be
populations that are thought to present even more          considered by the investigator;
challenges, like working with an older population.      4. “The interests of the patient always prevail
                                                           over those of science and society.”
The answer—surprisingly enough—is that research
with older persons is incredibly valuable to society    The interest of the patient is one of the big
in total and maybe is not as difficult as we tend to    reasons why we do research on this population.
think.                                                  Aging is a process that we will all (hopefully)
                                                        face—and yet we cannot fully understand it until
What do we tend to think of when considering            we are going through it ourselves. Older persons
working with older people? We perhaps worry that        are a large part of society and the “major user
it will be harder to recruit patients who are more      group of health and social care.” Only older
likely to be physically unwell. We have concerns        people are able to talk about their own
about capacity to consent. And for longer-running       understanding of the aging process and what an
studies, we may consider the likelihood of high         older person’s service use is like—which is often
drop out rates.                                         far removed from what service providers think.

According to a study done by Fudge, Wolfe, and          From the Canadian Institutes of Health Research:
McKevitt in 2007, the “barriers to involving older
people were: cultural divisions, language barriers,       The aged constitute one of the most vulnerable
research skills capacity, ill health, time and            groups in society, because a disproportionate
resources.” What is interesting here, though, are         number labour under reduced mobility,
their conclusions:    “…factors hindering the             compromised health and diminished capacity. … It
                                                          is important that the elderly participate in research
involvement of older people in research were
                                                          for the benefit of people in that age group. This is
the same as reported factors hindering                    so because studies done on younger people may
involvement of younger people, suggesting                 or may not be transferable.
that age, per se, is not a barrier.”
                                                        Quite simply, there is no other population like the
The issue of consent is one that can seem               population of aging adults. Any research that is
insurmountable to those who have not yet worked         intended to benefit them cannot be done on other
with vulnerable populations. But just as with           groups in the hopes of applying those findings on
research on children or other vulnerable adults,        the older population. If you want to know about
there are clear guidelines for us to follow regarding   older persons, you must ask older persons. And
consent of older people. The main points from the       that knowledge is worth any extra time we need to
Directive 2001/20/EC is that when working with          spend making sure we do good work throughout
incapacitated adults not able to give informed legal    the consent and assessment process.
consent you must make sure that:
                                                        The network is running other relevant studies. If
1. A legal representative has given consent;            you would like to get involved, please contact:
2. The participant has been given information           simon.douglas@ncl.ac.uk.




 9
       Mental Capacity Act 2005 – Implications for Research
                       A summary based on Northumberland Tyne and Wear
                 Comprehensive Local Research Network Training Day—12th June 2008


   The Mental Capacity Act 2005 provides a                         Understand the information relevant to the decision
statutory framework to empower and protect                         Retain the information relevant to the decision
vulnerable people who are not able to make their                   Use or weigh the information, or
own decisions. It makes it clear who can take                      Communicate the decision (by any means)
decisions, in which situations, and how they should
                                                                Should an individual fail one or more parts of this test
go about this.
                                                                then they do not have the relevant capacity.
The whole Act is underpinned by a set of five key               The Act sets out clear parameters for research in
principles stated at Section 1:                                 Sections 30-34.
 A presumption of capacity - every adult has the               Research involving, or in relation to, a person
   right to make his or her own decisions and must                 lacking capacity may be lawfully carried out if an
   be assumed to have capacity to do so unless it is               “appropriate body” (normally a Research Ethics
   proved otherwise;                                               Committee) agrees that the research is safe,
 The right for individuals to be supported to make               relates to the person’s condition and cannot be
   their own decisions – people must be given all                  done as effectively using people who have mental
   appropriate help before anyone concludes that                   capacity. The research must produce a benefit to
   they cannot make their own decisions;                           the person that outweighs any risk or burden.
 That individuals must retain the right to make                  Alternatively, if it is to derive new scientific know-
   what might be seen as eccentric or unwise                       ledge it must be of minimal risk to the person and
   decisions;                                                      be carried out with minimal intrusion or
 Best interests – anything done for or on behalf of              interference with their rights.
   people without capacity must be in their best                 Carers or nominated third parties must be
   interests; and                                                  consulted and agree that the person would want to
 Least restrictive intervention – anything done for              join an approved research project. If the person
   or on behalf of people without capacity should be               shows any signs of resistance or indicates in any
   the least restrictive of their basic rights and freedoms        way that he or she does not wish to take part, the
                                                                   person must be withdrawn from the project
Section 2 of the Act makes it clear that a lack of
                                                                   immediately. Transitional regulations will cover
capacity cannot be established merely by reference
                                                                   research started before the Act where the person
to a person’s age, appearance, or any condition or
                                                                   originally had capacity to consent, but later lost
aspect of a person’s behaviour which might lead
                                                                   capacity before the end of the project.
others to make unjustified assumptions about
capacity.                                                       Excluded from the Act, however, are those clinical
                                                                trials regulated under the Medicines for Human Use
The Act uses a four part ‘functional’ test of capacity
                                                                (Clinical Trials) Regulations. Medicines for Human
which focuses on the decision-making process
                                                                Use (Clinical Trials) Regulations Medicines for
itself. Under the Act, a person is regarded as being
                                                                Human Use (Clinical Trials) Regulations 2004 (SI
unable to make a decision if, at the time the
                                                                2004/1031)
decision needs to be made, he or she is unable to:


     For further information

     Mental Capacity Act 2005
     http://www.opsi.gov.uk/acts/acts2005/20050009.htm
     Mental Capacity Act 2005 Code of Practice, part 3, Chapter 11
     http://www.dca.gov.uk/menincap/legis.htm#codeofpractice
     Mental Capacity Act training materials
     http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_074491
     A simple guide to the Mental Capacity Act 2005 in relation to research, Research and Development Forum
     http://www.rdforum.nhs.uk/docs/mca_guidance.doc
     Making Decisions- A guide for people who work in health and social care, Metal Capacity Implementation Programme
     http://www.dca.gov.uk/legal-policy/mental-capacity/mibooklets/booklet03.pdf

        Disclaimer: This article is for general information only. For detailed or specific guidance seek
            legal advice. For information on applying for ethical approval see the NRES website.
10
Good Clinical Practice and the EU Directive
for Paediatric Research Staff
—By Sue Leach, Clinical Studies Officer

I attended this UKCRN Course held in London on         on human subjects involving medicinal products.
Wednesday 18th June 2008. Topics from the day          This makes GCP a legal requirement for CTs in
related to Good Clinical Practice (GCP) with           member states. It serves to standardise systems
special reference to Paediatric Research. These        and protect trial subjects. The EudraCT database
were then explored through interactive delegate        provides an overview of clinical trials conducted in
participation either during workshops or Q&A           the EU (http://eudract.emea.europa.du and
sessions, initiating general discussions about         information regarding the EU regulation on
issues relevant to practice. A summary of the          paediatric medicines can be viewed at http://
main points is below.                                  tinyurl.com/57skdd.

Introduction to GCP underlined the principles of       Ethical and Legal Considerations in Paediatric
Good Clinical Practice consistent with standards       research looked at the history of research involving
set in the Declaration of Helsinki. The Thirteen       children and then addressed the reasons behind
Principles can be viewed at www.evidencias.com/        why research involving children is so important.
gcp_02.pdf and the full Declaration at                 The issues of consent and assent in paediatrics
www.wma.net/e/policy/b3.htm.                           were discussed at this session, and also in the
                                                       final session of the day which raised issues of
A Clinical Trial (CT) was defined as an inter-         conflict in consent and related legal issues. The
ventional study – the intervention could be any-       ethical principles of beneficence, respect for
thing from a device, a drug, food supplement to        autonomy and justice to treat fairly or equally
behavioural support. Where the intervention is a       were looked at throughout. Further information
medicine and the trial is investigating its safety     can be found in the MRC Ethics Guide for re-
and efficacy then it is termed a clinical trial of a   search involving children http://tinyurl.com/5j2qv3.
medicinal product (CTIMP). For further inform-
ation regarding the Clinical Trials toolkit, see       Further sessions focused on the          roles and
www.ct-toolkit.ac.uk.                                  responsibi lity     of the  trial         sponso r,
                                                       pharmacovigilance and the role of        Pharmacy.
The EU Directive applies to all 27 member states       Online information available            at http://
of the European Union and is applicable to all CTs     tinyurl.com/6nokjq.



NEW REPORTS
Paying the Price: The cost of mental health
care in England to 2026                                wasted resources but also in wasted lives. To
Recognising the significance of mental health in       read the report, visit www.kingsfund.org.uk/
terms of both expenditure and the overall health       publications/kings_fund_publications/
of the population, the King’s Fund commissioned        paying_the_price.html.
a review. This report presents current and pro-
jected needs for mental health services and their      Attitudes to mental illness research report
related costs. It gives details on a number of spe-    Shift's national survey into attitudes towards men-
cific disorders, including depression, schizo-         tal illness has been published. The full report can
phrenic disorders and dementia. Paying the Price       be downloaded from www.dh.gov.uk/en/
suggests that without the right level and type of      Publicationsandstatistics/Publications/
investment we will all pay the price – not just in     PublicationsStatistics/DH_084478.



                                                                                                              11
NE MHRN Progress Round-up
The last six months have seen exciting times in         Clinical Psychology) – we thank them for all of
the research community in the north east, and           their hard work over the past year.
particularly in developments in the research net-
works. The launch of the Comprehensive Re-              The North East Hub is currently running 14 pro-
search Networks (CLRNs) have provided a base            jects with a further six in set up across all areas of
for research support where there are no existing        mental health. New studies mentioned elsewhere
topic-specific networks, which has impacted on          in this edition of the newsletter are RIOTT (trial of
the MHRN NE particularly in the North and East          injectable opiates) and Viewpoint which we are
Yorkshire and Northern Lincolnshire area. Along         particularly excited about because of the involve-
with our more local CLRNs, Northumberland Tyne          ment of service users both in the development
and Wear and Durham and Tees Valley, they               and running of the trial. Also new to the North
have agreed to provide funding for research sup-        East are CEQUEL, a medication trial for bipolar
port posts to increase accrual to portfolio studies     depression and REEACT, a trial of computerised
in the NE MHRN area, which we anticipate will be        Cognitive Behavioural Therapy for depression in
a great success.                                        primary care.

The North East Hub has recently increased its           If anyone is interested in finding out more about
complement of staff with the addition of two new        these developments, or in subscribing to MHRN
Clinical Studies Officers, Michael Johnson and          NE’s regular email updates, please email:
Saffra Knox, who will both be supporting studies        chris.lubach@ncl.ac.uk or telephone 0191 2824427.
in the Tees Esk and Wear Valleys NHS Trust
area, while sadly leaving us are Caitlin Jarrett                                        Simon Douglas
(maternity) and Siobhan Currell (Doctorate in                                   North East Hub Manager



                                                      About Us
                                                      The UK Mental Health Research Network (MHRN)
                                                      is part of and funded by the National Institute for
                                                      Health Research (NIHR). The Network provides the
                                                      NHS infrastructure to support commercial and non-
                                                      commercial large scale research in mental health,
                                                      including clinical trials. It is one of the topic specific
                                                      networks under the umbrella of the UK Clinical
                                                      Research Network (UKCRN) and is managed by a
                                                      partnership between the Institute of Psychiatry,
                                                      King's College London and the University of
                                                      Manchester.

                                                      Aims
                                                       To coordinate and facilitate the delivery of large-
                                                         scale research projects that will inform policy and
                                                         practice as it develops.
                                                       To broaden the scope and capacity of research in
                                                         mental health, including full involvement of
                                                         service users and carers as well as frontline staff.
                                                       To help identify the mental health research needs
                                                         (particularly in health and social care)
                                                       To develop research capacity through a range of
                                                         initiatives at a local, regional and national level.


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