Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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 72 SKT/81944657 1 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) (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 SKT/81944657 2 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) (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. SKT/81944657 3 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) (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 SKT/81944657 4 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) (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 63 (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 SKT/81944657 5 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) (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 SKT/81944657 6 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) 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 SKT/81944657 7 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) 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/ SKT/81944657 8 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) (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 SKT/81944657 9 of 10 12/08/2017 Author: Sandra Tapping RECs in the News issue 12 (April 05) 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 SKT/81944657 10 of 10 12/08/2017