Download RECs in the News #12 Apr 2005 - National Patient Safety Agency

Author: Sandra Tapping
RECs in the News issue 12 (April 05)
Research Ethics Committees in the News
Issue 12, April 2005
Welcome to Research Ethics Committees in the News, which is also archived on
the COREC web site. www.corec.org.uk/recs/recsinthenews.htm
The objective of this publication is to alert REC administrators, REC members
and COREC staff to issues which may be of interest. Please note that all entries
are to inform readers about different views and opinions as part of their ongoing
training and development.
Inclusion does not signify recommendation, nor
endorsement by COREC. Staff in the NHS can obtain access to many journals
electronically via an NHS Athens Account. Your local healthcare library can
provide details, as well as access to hard copy of articles not available
electronically.
To ensure that this publication is relevant to the needs of the REC community I
would particularly welcome being alerted to articles which others readers might
find useful. [email protected].
Sandra Tapping, COREC Information Officer, National Patient Safety Agency
REGULATIONS and GUIDELINES
(R and G 1)
Pharmaceutical Research in the NHS - guidance document
A guidance document on conducting commercial clinical research in the NHS
was launched at a joint conference of the NHS R and D Forum with the Institute
of Clinical Research on 28 February 2005.
http://www.rdforum.nhs.uk/docs/commercial_research_guidance_2005.pdf
(R and G 2)
Paediatrics and Ethics Predominating in 2005
Peter O'Donnell, Applied Clinical Trials, March 2005, 14(3) 32-35
The author questions whether new paediatric and ethics initiatives receive
enough funding to make them truly work.
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=1492
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(R and G 3) Developing a European Framework for Research on
Children’s Medicine
Andrew Smith, Clinical Research Focus, March 2005 16(2) 5-9
A report on a European Forum for Good Clinical Practice (EFGCP) conference in
Brussels in January to discuss the proposed Regulation on medicinal products
for paediatric use.
(R and G 4) Draft Paediatric Regulation: Could do Better
Alan Davies and Viki Wills, Clinical Research Focus, March 2005 16(2) 23-25
The authors share some of the problems they envisage with the new Regulation.
(R and G 5)
Greater openness required by new European laws
Pharmafocus , March 31, 2005
Pharmaceutical companies will be obliged to share safety data more openly from
November with the adoption of new pan-European laws. The MHRA says the
UK pharma industry is already practising many of the European directive
requirements but says the legislation will formalise this responsibility.
Key stakeholders, including patient groups, industry and the DH will take part in a
12-week consultation on how the EU directive should be translated into UK law
by 30 October. http://www.pharmafocus.com/cda/focusH/1,2109,21-0-0MAR_2005-focus_news_detail-0-338156,00.html
(R and G 6)
New Standard NHS R&D Application Form and website
The new standard online NHS R&D Application Form was launched on 31
March. This replaces Part D of the NHS REC application form, which has now
been withdrawn. It can be accessed at http://www.rdform.org.uk/. All NHS
organisations are strongly recommended to accept the form.
MISCELLANEOUS
(Misc 1)
Funding boost for UK biotech industry
Pharmatimes 08/03/2005
Funding for the UK biotechnology industry will rise to more than £1 billion pounds
over the next three years. Funding will be ploughed into stem cell research and
DNA-based medicines. http://www.pharmatimes.com/news/080305c.asp
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(Misc 2)
EU regulatory moves "could curb drug development"
Pharmatimes 14/03/2005
Two top pharmaceutical industry executives have come out fighting against
European regulatory demands that will see investigational compounds being
pitted against existing treatments rather than placebo, saying that the move
would stifle innovation, and curb drug development.
http://www.pharmatimes.com/news/140305d.asp
(Misc 3) Expertise in research ethics: is there any such thing?
Lynn Gillam, Monash Bioethics Review, Jul 2004, 23(3) 58-64, ISSN: 13212753.
In this Australian paper the author argues that ethics expertise is a set of
generic analytic skills and knowledge of ideas and logical processes, and that
research ethics expertise differs from ethics expertise in general. The author
suggests that people with such expertise would be useful members of
Australian RECs, and this may or may not involve adding 'ethicist' to the list of
Australian RECs membership categories.
(Misc 4)
The practice of obtaining approval from medical research
ethics committees: A comparison within 12 European countries for a
descriptive study on acetyl cholinesterase inhibitors in Alzheimer's
dementia.
Olde-Rikkert-M-G-M, Lauque-S, Froelich-L, Vellas-B, Dekkers-W.
European Journal of Neurology 2005, 12/3 (212-217), ISSN: 1351-5101.
This research project compared how in different EU countries one single
descriptive multinational study on dementia treatment strategies was evaluated
by medical ethical committees and how the issues of informed consent and
capacity to consent were dealt with. It was found there were great differences in
valuation of the study, varying from the judgement that the study was 'no
experimental study' to the judgement that it was a phase IV drug trial. The
authors recommend that procedures for the assessment of informed consent in
dementia research should be harmonized by central national or European
bodies.
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(Misc 5)
An exploration of ethical issues in medical education research:
Roles and responsibilities of deaneries?
Pitts-J, Elmer-R, Bell-J.
Education for Primary Care 2005, 16/1 (1-9), ISSN: 1473-9879.
(copyright Radcliffe Publishing Ltd)
The authors explore some of the ethical dilemmas surrounding educational
research in a medical setting. There is a useful appendix listing 52 ethical issues
which all researchers ought to consider before embarking on any research, not
just student projects. The authors intend to stimulate discussion and thought
about how ethical educational research can be conducted, while avoiding stifling
the development of high quality medical education.
(Misc 6)
Research Ethics Committees – time for a change?
John Saunders, Clinical Medicine Nov/Dec 2002, 2(6) 534-8
This paper was published in 2002, but is still topical. The author suggests that
the present large number of volunteer RECs be replaced by a much smaller
number of fully professional bodies in order to increase speed, efficiency and
consistency of working.
http://www.rcplondon.ac.uk/pubs/ClinicalMedicine/0206_nov_pro3.htm
(Misc 7)
Academic medicine: who is it for?: Applications to local
research ethics committees are down by around 40%
Chris Bentley and Pam Enderby BMJ, 12 Feb 2005; 330: 361.
The authors found that across all strategic health authorities the number of
applications to RECs in England fell from a monthly average of 1008 in 2003-4 to
the current monthly average of 703.
http://bmj.bmjjournals.com/cgi/content/full/330/7487/361/DC1 . Although there is
some variation, overall applications are down by around 35% for local
applications. However, applications to MRECs seem to have been sustained.
The authors state that only those who have full-time commitment to research can
afford to embrace these new systems, leading to a greater separation between
academic and clinical staff.
http://bmj.bmjjournals.com/cgi/content/full/330/7487/361
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(Misc 8)
Genetic research & human biological samples: some legal
and ethical considerations.
Medicine and law, 2004, 23 (4) 897-912, ISSN: 0723-1393.
Sheikh-Asim-A.
This Irish paper examines the medico-legal and medico-ethical issues that
ethics committees and researchers will have to consider when
examining proposals pertaining to non-therapeutic genetic research.
The paper concludes with:



a summary of the main points of concern that ethics committees must
consider before the approval of genetic research
the manner in which consent forms must be drafted
a brief look at medico-legal issues that will become important and will
have to be considered in Ireland in the near future in relation to genetic
research.
(Misc 9)
Baseline Balance and Valid Statistical Analyses: Common
Misunderstandings Stephen Senn, Applied Clinical Trials March 2005, vol 14
(3) 36- 40
The author states some researchers from industry, academia, and the public
health sector have serious misunderstandings regarding what randomization can
and cannot do to underwrite the validity of statistical inferences from clinical
trials. In this commentary he uses games of chance to attempt a simple
explanation of the issues.
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=1499
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(Misc 10)
Human genetic testing: what implications?
The European Commission’s Research Group invited a group of experts to make
recommendations on the ethical, legal and social implications of genetic testing,
The Expert Group came up with 25 recommendations. A summary of the
recommendations can also be found in the Bulletin of Medical Ethics January
2005 pg 9-11
http://europa.eu.int/comm/research/conferences/2004/genetic/pdf/recommendati
ons_en.pdf
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(Misc 11)
Insurers to postpone genetic testing until 2010
The Times 10 March 2005 p.46
After consultations with the Department of Health, insurance companies have
agreed to extend the existing moratorium on genetic testing until after 2010,
allaying immediate fears that a "genetic underclass" will be created.
http://www.timesonline.co.uk/
(Misc 12)
Genetic Testing and Implications for Clinical Research
M Cripps, J Latham, F Sanders, M Read, A Messom, P Iredale
Clinical Research Focus, March 200516(2) 29-33
The authors are members of the Institute of Clinical Research’s Genetic Sub
committee and provide informed comment on several aspects of genetic testing.
They include reference the June 2003 Department of Health White Paper “Our
Inheritance, Our Future: realising the potential of genetics in the NHS”
http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAn
dGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4006538
&chk=enskFb
(Misc 13)
Science and Technology Select Committee Fifth Report
Hansard 14 March 2005
Science and Technology Committee is appointed by the House of Commons to
examine the expenditure, administration and policy of the Office of Science and
Technology and its associated public bodies. The fifth report is primarily about
human fertilisation issues. The regulation of other medical practices is covered
in paras 322-354, including reference to COREC, RECs and the Association of
Research Ethics Committee (AREC).
http://www.publications.parliament.uk/pa/cm200405/cmselect/cmsctech/7/702.ht
m
(Misc 14)
Meeting the Ethical Needs of Doctors
Daniel K Sokol, BMJ 2 April 2005, 330: 741-742
An editorial in the BMJ recommending that clinical ethicists are employed in UK
hospitals because medical ethics is not solely common sense. About a fifth of
NHS acute trusts currently have a clinical ethics committee. Although these
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provide a valuable service in drafting hospital policies and helping doctors
resolve ethical dilemmas, most are ill suited to respond to the immediate
problems that doctors encounter in their daily work.
http://bmj.com/cgi/content/full/330/7494/741
(Misc 15)
FDA seeks to ease burden on trial review boards
Bob Roehr BMJ 2 April 2005, 330: 748
The US Food and Drug Administration (FDA) was told at a public hearing at its
headquarters on 21 March that the growth in the number and complexity of
clinical trials has put great strain on institutional review boards (IRBs) in the
United States. IRBs were set up to approve and review biomedical research
using humans, but the pressures on them, due in part to the large number of sites
in trials, are growing to such an extent that a new approach is needed, in
particular to recording adverse
events.http://bmj.com/cgi/content/full/330/7494/748-a?ecoll
(Misc 16) Improving protection for research subjects in France: analysis
of regional ethics committees
Fauriel-I, Moutel-G, Duchange-N, Callies-I, Francois-I, Huriet-C,
Herve-C.
Regulatory toxicology & pharmacology, Dec 2004, 40(3) 312-8, ISSN: 02732300.
This is a further paper by those who evaluated decision-making by French RECs
(item Misc 5
http://www.corec.org.uk/recs/docs/RECs_in_the_News09_Jan05.doc.
It is interesting to compare their findings to those of a study of UK RECs by
Sarah Dyer (item 12
http://www.corec.org.uk/recs/docs/RECs_in_the_News08_Dec04.doc). The
French researchers observed:
The representation of a range of professions was not always respected. This was
partly because the administrative authority had accumulated delays in
nominating members. Another explanation could be the absence of
remuneration for the work and attendance of the members.
There was considerable inter-committee variation concerning the way
documents were distributed to the members during sessions and the extent of
investigator and promoter involvement.
Large differences in the number of dossiers handled between committees led
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the authors to investigate the fairness of dossier distribution, as the number of
dossiers dealt with has consequences, particularly for the finality of the
opinions of the committees.
http://www.sciencedirect.com
(Misc 17) Provision of Support for Producing a European Directory of Local
Ethics Committees (LECs)
This draft report, carried out by the Institute of Science and Ethics based in
Bonn, Germany, aims to gather reliable information concerning the research
ethics committees in the 33 countries of the European Research Area (ERA).
This report starts with general remarks on the historical background of the RECs’
establishment, the process of legislation regarding ethical review and the tasks of
the committees. There follows each of the countries’ profiles, where an overview
is provided of the committees system in each of the target country and the
relevant literature is listed. The final chapter summarises the conclusions and
recommendations.
http://europa.eu.int/comm/research/conferences/2005/recs/pdf/lec_finalreport.pdf
(Misc 18) Another milestone in NHS efficiency drive
DoH Press Release 1 April 2005
From 1st April 2005, the National Patient Safety Agency (NPSA) has expanded,
giving it greater scope to improve patient safety in the NHS. The NPSA’s work
also now encompasses: safety aspects of hospital design, cleanliness and food
(transferred from NHS Estates); ensuring research is carried out safely, through
its responsibility for COREC; and is supporting local organizations in addressing
their concerns about the performance of individual doctors and dentists, through
its responsibility for the National Clinical Assessment Service (NCAS), formerly
known as the National Clinical Assessment Authority. It also manages the
contracts with the three confidential enquiries. This responsibility has been
transferred from the National Institute for Clinical Excellence (NICE).
http://www.dh.gov.uk/PublicationsAndStatistics/
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(Misc 19) UK agency to combat research misconduct
Caroline White BMJ, 19 Mar 2005; 330: 616.
An agency to combat biomedical research misconduct in the United Kingdom is
scheduled to start work in October, initially for three years. Plans for the new
body, known as the UK Panel for Health and Biomedical Research Integrity, were
unveiled at the annual meeting of the Committee on Publication Ethics. The
panel will oversee investigations of misconduct relating to biomedical research in
universities and the National Health Service. However, the body will not have the
power to run its own investigations, but will advise institutions on how to run
inquiries. http://bmj.bmjjournals.com/cgi/content/extract/330/7492/616-a
(Misc 20a)
Religious leaders call for science ethics committee
Daily Telegraph Thursday 31st March 2005, page 2
Religious leaders alarmed at rapid developments in medical science are calling
for a national body to debate the ethics of issues thrown up by medical
advances. Some clerics are concerned about the recommendation from MPs that
the regulation of genetics and embryo research should be relaxed. Cardinal
Cormac Murphy O'Connor, who is head of the Roman Catholic Church in
England and Wales, together with Chief Rabbi Dr Jonathan Sacks want a
statutory bioethics committee to scrutinise developments.
http://www.telegraph.co.uk
http://www.axappphealthcare.co.uk
(Misc 20b)
More ethics, less emotion
John Haldane, The Tablet 2 April 2005
Professor John Haldane of the centre for ethics and philosophy at St Andrew's
University states that a national bioethics committee is the only way forward now
that the vital moral issues of abortion, euthanasia, stem-cell research and gender
selection are taking centre stage on the public and political platforms
https://www.thetablet.co.uk/cgi-bin/register.cgi/tablet-00996
BOOKS
Research Methods in Health: Investigating Health and Health Services Ann
Bowling, McGraw Hill, ISBN 0-335-2064-3
This book is primarily written for researchers, but REC members wishing to
expand their knowledge of research methods may be interested in this book.
The topics include sampling for survey research, cross-sectional and longitudinal
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survey design, experimental methods and techniques of group assignment,
questionnaire design, interviewing techniques, coding and analysis of
quantitative data, methods and analysis of qualitative observational studies,
types of unstructured interviewing, cluster randomization, and perception of risk,
There is a short section on RECs, but this section is out of date as the book was
published prior to the EU Directive.
The Good Research Guide: for small scale social research projects Martyn
Densombe, , McGraw Hill, ISBN 0-335-21303
This is a practical and comprehensive guide for those needing to conduct smallscale projects. REC members may find the descriptions of qualitative research
methods helpful in their understanding of applications.
WEBSITES
The UK Clinical Ethics Network site, whilst designed for Clinical Ethics
Committees, may be of interest to REC members http://www.ethicsnetwork.org.uk. It includes a useful guide to the Human Tissue Act 2004 (full
implementation not expected until 2006). http://www.ethicsnetwork.org.uk/comment/kaye.htm .
TOPS
(The Overvolunteering Prevention System)
Type 1 RECs may be interested in this website, as there are scientific, safety,
and ethical reasons why healthy volunteers should not participate too frequently
in studies of potential new medicines. First, the subject might be exposed to
interacting substances in consecutive studies. Second, the results of a study
might be influenced by the subject’s participation in a previous study. Third, an
excessive volume of blood might be removed from the subject. Fourth, it is
unethical for subjects to be exposed too frequently to pharmaceutical products
from which they can derive no benefit.
The need for a system to prevent overvolunteering has been recognised for
many years. TOPS (The Overvolunteering Prevention System) was developed
to prevent healthy volunteers from participating too frequently in clinical studies
of potential new medicines. https://www.tops.org.uk/info.htm
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