Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Not the fault of research governance
- Peter J Allmark (30 July 2004)
-
A question of power?
- Ike Anya (2 August 2004)
-
Participants may benefit from speaking directly to the researcher, as GPs have other priorities
- Philip A Morgan, Peter J. Franks, and Christine J. Moffatt (3 August 2004)
-
Informed consent: the question of direct interaction
- Kelechi E Nnoaham (4 August 2004)
-
Ethics obligations in equal measure
- Umesh T Kadam (5 August 2004)
-
A solution is urgently needed to streamline NHS research governance approval in the context of large-scale epidemiological studies
- A Boshier, SAW Shakir, P Telfer, E Behr, T Pakrashi, AJ Camm (7 August 2004)
|
|
|||
|
Peter J Allmark, Senior Nursing Lecturer School of Nursing, Sheffield University, SFH, Northern General Hospital, Sheffield S5 7AU
Send response to journal:
|
Ward et al state that, “Ethics committees should weigh the benefits to society against costs to the individual when considering studies” (1). This is a utilitarian argument rejected at the Nuremberg trials and out of tune with one of the first principles of the Declaration of Helsinki: “In medical research on human subjects, considerations related to the well- being of the human subject should take precedence over the interests of science and society” (2). As such, where the well-being of individual research participants is threatened for the sake of others, ethics committees are always likely to take the line of defending the former. However, Ward et al might reasonably argue that most people would not find the small violation in confidentiality inherent in their proposal to be a threat to their well-being. The question then becomes one of whether the Data Protection Act is unreasonably protective of confidentiality. If so, this is a fault of law, not of research governance. The authors, and your journal, are shooting at the wrong target. 1. BMJ 2004;329:277-279 2. WMA. Declaration of Helsinki, 5th Amendment. URL http://www.wma.net/e/policy/b3.htm Competing interests: MREC member |
|||
|
|
|||
|
Ike Anya, Specialist Registrar in Public Health Bristol North PCT BS2 8EE
Send response to journal:
|
The BMJ does well to focus on the many incongruities associated with obtaining ethical approval for research in the United Kingdom. Ward et al highlight the fact that people on public databases are routinely contacted by market researchers and salespersons who have no need to obtain ethical approval and wonder why the situation is different for health researchers. Perhaps the answer lies in the varying perceptions of professional power by the individuals concerned. People may feel more at ease saying no to marketers than they would to health professionals. Competing interests: IA has recently had to modify an MSc project proposal because of potential difficulties in obtaining ethical approval |
|||
|
|
|||
|
Philip A Morgan, Post-doctoral Research Fellow CRICP, Thames Valley University, 32-38 Uxbridge Road, London W5 2BS, Peter J. Franks, and Christine J. Moffatt
Send response to journal:
|
Editor, With regard to the article "Obstacles to conducting epidemiological research in the UK general population" BMJ 2004; 329: 277-279, we are currently undertaking a case-control study of patients with lymphoedema and wish to endorse the experiences documented therein. Ours is a smaller study involving 113 patients with lymphoedema and controls originally matched for age, gender and GP. LREC approval was gained after ensuring that the recruitment of controls complied with Caldicott guidelines regarding patient confidentiality [1]. We wrote to 78 GP practices and, over a six month period during which reminders were sent out, we received 17 positive responses and 3 negative responses. 58 GPs did not respond at all. This protracted exercise provided a total of 23 controls willing to be interviewed. In view of this poor response rate we reluctantly changed our methodology and controlled for age and gender only. Our rationale was to recruit a small number of GPs who are willing to participate and use their patient data systems to identify controls. Each GP writes to the identified patient and encloses an information sheet in the normal way and, in addition, a reply slip is included which the patient sends directly to the researchers in a postage paid envelope. The reply slip provides space for the patient to give a contact telephone number so that arrangements for the interview can be made directly between the researcher and the patient over the telephone. This change of approach is now having a positive effect on the recruitment of controls. Our experience supports the premise that current regulations developed to protect patient confidentiality produce a number of additional barriers when attempting to identify and interview suitable controls. First, researchers are dependent on already overburdened GPs playing their part in a process they do not always see as their primary purpose. Second, patients have to make decisions about whether to take part in a study without the benefit of speaking directly with a researcher and, finally the process of control identification has become over complex and expensive in both time and resources. 1. The Caldicott Committee. Report on the review of patient identifiable information. Department of Health, 1997. Competing interests: None declared |
|||
|
|
|||
|
Kelechi E Nnoaham, MSc Student London School of Hygiene and Tropical Medicine, WC1E 7HT
Send response to journal:
|
Editor - Ward et al clearly put in perspective the challenges of conducting medical research in a system inundated with ethical checks and balances on research activities. They note that against a background of a fuzzy definition of confidentiality and an inherently cumbersome procedure for obtaining ethical approval, case- control studies are fraught with a considerable chance of selection bias and low response rates. The veracity of this statement is easily borne out by the fact that diverse factors ranging from domestic circumstances and socio-econonmic status to communication habits could influence on who responds to a letter and who does not. The author also suggest that depending on a letter , rather than early direct interaction with potential participants, was a reason for the low response rate. May I at this point suggest that we also consider that there may be more to high response rates than potential participants' enthusiasm. Taken at surface value, direct interaction may seem to have the virtue of producing good response rates, but we may well consider how it probably achieves this. Informed consent is a well defined end, but the means of achieving it is less well-defined and subject to "innocuous" manipulation. Quite apart from the possibilty that a non-response to an invitation may be an individual's way of declining the invitation, calling non-responders on phone places them at the mercy of the researcher's power of conviction . This power of conviction is conferred on the researcher by the fact that a potential participant will not respond to a doctor seen to be on the course of "public health" in same way as to a salesman on the course of "personal gain". Sadly for the researcher, there is an attrition of this privilege and power in a written medium. This inherent subtle element of coercion is present in all informed consent achieved by verbal direct interaction and is accentuated by the ever-present doctor-patient power gradient. It makes one wonder if obtaining informed consent by direct interaction is ethical in the first place. Competing interests: None declared |
|||
|
|
|||
|
Umesh T Kadam, GP & MRC Fellow Keele University, Staffordshire ST5 5BG
Send response to journal:
|
The series of articles on the role of Ethics and Research Governance is a welcome stimulus to the new challenges facing researchers. As a researcher who can fully empathise with the authors, nevertheless the two articles by Ward (1) and Jones (2) relating their experiences with their respective Research Ethics Committees (REC), I do not believe are a fair challenge to the current ethics process. Ward et al blame poor response in their control population because of their REC’s refusal to directly approach patients. An alternative assessment might have been that their pre-prepared letters were insufficient in detail to recruit patients to a highly sensitive research question - a topic that has often been portrayed alarmingly in the media. Our local experience suggests that good recruitment levels are very possible in the general practice population (3). Furthermore, resorting to an ‘op-out’ clause that some commercial companies operate might not engender public trust, judging by the junk mailing culture we have to endure despite opting-out. Jones and Bamford relate their ‘minor’ problem that they believe was met with a heavy-handed approach. However their ‘simple’ qualitative project in patients with eating disorder would have involved a semi-structured interview covering quality of life areas such as social contacts, relationships, family and employment. This approach might have created critical issues in a vulnerable group of subjects and is the very kind of topic that RECs were meant to address. Where I would wholeheartedly concur with all the authors in this debate, is that we require transparency and clarity in all communications, and efficient procedures that not only protect patients but also promotes good research. These obligations apply in equal measure to both researchers and Governance bodies. 1. Ward HJT, Cousens SN, Smith-Bathgate B, Leitch M, Everington D, Will RG, Smith PG. Obstacles to conducting epidemiological research in the UK general population. BMJ 2004; 329:277-279. 2. Jones AM, Bamford B. The other face of research governance. BMJ 2004; 329:280-281. 3. Dunn KM, Jordan K, Lacey RJ, Shapley M, Jinks C. Patterns of consent in epidemiologic research: evidence from over 25,000 responders. Am J Epidemiol 2004; 159:1087-94. Competing interests: None declared |
|||
|
|
|||
|
A Boshier, Clinical Research Fellow Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, SAW Shakir, P Telfer, E Behr, T Pakrashi, AJ Camm
Send response to journal:
|
Editor, we read with much interest the article by Ward et al. relating to obstacles encountered by epidemiologists in conducting research in the UK.1 As stated, local research ethical approval for studies with ‘no local investigator’ has not been required since 2000. We are currently conducting a case-control study that falls into this category – the Drug Induced Arrhythmia Risk Evaluation study (funded by the British Heart Foundation).2 However, despite MREC approval and ‘no local investigator’ status, we are trying to cope with applying for NHS R&D approval at Trusts throughout England. We have estimated that only 100 cases per year will be recruited, and therefore have no option but to seek approval from as many Trusts as possible. As we are planning to recruit control patients from primary care, the number of Trusts involved will run into hundreds. The R&D approval processes at specific Trusts are, as Dingwall et al. describe, enormously inconsistent.3 As a result, our study has been subject to significant delays, we anticipate it will take years to complete all of the necessary R&D registration forms; and meanwhile there is ongoing expenditure of charitable funds to satisfy NHS bureaucracy. It is surely time for the NHS to develop a central R&D approval process equivalent to MREC in matters ethical. We feel strongly that the survival of large-scale epidemiological research in the UK will depend on streamlining existing NHS approval procedures for this kind of research. As Sir Richard Doll recently pointed out, some types of research may become impossible.4 Such an outcome would clearly not be in the interest of society, whilst being diametrically opposed to the ethos of guidance intended to provoke creativity and innovation in research.5 1. Ward HJT, Cousens SN and Smith-Bathgate B et al. Obstacles to conducting epidemiological research in the UK general population. BMJ, 2004;329:277-279. 2. Davies M, Behr E, Carter N, Jeffery S, Camm AJ, Shakir SAW. Methodology of the Drug-Induced Arrhythmia Risk Evaluation Study (abstract). Pharmacoepidemiology and Drug Safety, 2003;12:S1-S189. 3. Dingwall R and Rowley E. Re: Bureaucracy of ethics applications (letter). http://bmj.com Rapid Responses for Wald, 329(7460) 282-284, accessed 04.08.04. 4. Highfield R. Rules threaten medical research (comments from Sir Richard Doll).http://www.telegraph.co.uk, filed 26/02/04, accessed 02/06/04. 5. Lord Hunt of Kings Heath, Department of Health. Research Governance Framework for Health and Social Care. Department of Health, March 2001. Competing interests: None declared |
|||