In 1964 the World Medical Association drew up the first Declaration of Helsinki (see most up-to-date version at
http://www.wma.net/e/policy/b3.htm), the most widely accepted guidance on biomedical research on humans; its key principles are listed in Table
1. This Declaration was a response to medical experiments conducted on prisoners in Nazi concentration camps across Europe during the Holocaust [
9,
10], as came to light during the Nuremburg trials. It is now generally accepted that research participants have a right to expect that the research is conducted to appropriate standards, and adds something to the body of knowledge as highlighted in the Nuremburg Code of 1947. Although serious research misconduct is relatively rare, the exceptions remind us that vigilance is always required, especially because misconduct can be hard to prove [
11]. One of the textbook examples of serious health services research misconduct is the Tuskegee Syphilis Study [
10]. Between 1932 and 1972 researchers in a long-term study regularly examined a large number of poor African Americans in Alabama (USA), suffering from syphilis, to study the natural course of the disease [
12]. These men were made to believe that they were receiving proper medical treatment when, in fact, either no treatment or inadequate treatment was given.
Table 1
The four key ethical principles
Do good/beneficence |
Justice |
Respect for autonomy |
These extreme cases highlight why we need a public body to protect the general population from unethical research. In the Declaration of Helsinki, the World Medical Association [
13] outlined that a research protocol "should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence." The reply in the USA has been the establishment of IRBs (Institutional Review Boards) at universities and research institutes, whilst the UK originally went down the path of local NHS (National Health Service) research ethics committees (REC), although many British universities have began to establish their own RECs for health research conducted outwith the NHS. For example, the one for our own university was established in 2008.
There have been considerable changes in the past decade in the rules and regulations governing applications for ethical approval to conduct low-risk population-based health research in the UK [
14]. New national research governance frameworks are intended to improve the research process. These changes are supposed to make applying for research ethics permission more transparent, with a greater emphasis on ethical considerations for researchers. In practice, the changes introduced in the past few years have made the process of applying for ethical approval more time-consuming, complex, and bureaucratic [
15‐
17]. The standard application form for MRECs (Multicentre Research Ethics Committees) and/or local RECs is long and fairly complicated. For example, the NHS REC application form in use in the summer of 2007 was 80-odd pages long, and some point in 2005 it was as long as 96 pages.
This paper reports on the process of applying for research ethics approval for a relatively straightforward, unobtrusive, non-interventionist health promotion study. It highlights some of the oddities of the current UK system, and the potential impact on the ability to conduct good quality health promotion and health education research in the future. We suggest some improvements to the current system of gaining research ethical approval for low-risk health and health promotion research, which are based on principles of pragmatism, consistency and efficiency, as well as the four key principles listed in Table
1
Ethics committees in the UK
In the UK health service, clinical, health care, public health, nursing, epidemiological, and health promotion research must be considered under general biomedical research ruling [
18]. Each region has one or more separate research ethics committees which operate independently from the local universities and health-care providers. A national body called COREC (Central Office for Research Ethics Committees), was established by the UK Government to oversee all the area-based research ethics committees. This was replaced in 2008 by the National Research Ethics Service (NRES) run by the NHS National Patient Safety Agency
http://www.nres.npsa.nhs.uk/. Therefore, anybody conducting research in the UK on NHS premises, with NHS patients and/or NHS staff has to apply to such a committee. In theory then all applications nationwide are assessed by the same criteria by a similar committee. It is universally accepted that a team of doctors wishing to conduct a clinical trial of a pharmaceutical drug with potentially dangerous side effects must apply for appropriate ethical approval. However, it is also the case that social or health researchers planning a study, of for example, NHS hospital porters' attitudes towards cycling to work must apply to the same research ethics committee.
There are around 200 local RECs in the UK, each with a mixture of between 10 to 20 (lay and professional) members [
19]. The remit of a research ethics committee is "to protect the rights, safety, dignity and well being of all actual or potential participants" [
20]. The role of each committee is to assess the potential ethical implications of the proposed research as outlined on the application form, the study protocol. In addition the study materials are considered, for example, the participants' information sheets, letters inviting people to participate in a study, posters to recruit interviewees in a clinical setting and any other items submitted. The process of applying for ethical approval is widely considered to be a lengthy, bureaucratic one [
21]. If a research project fails to receive ethical approval the proposed research should not go ahead until a revised proposal which addresses the concerns of the REC is accepted.
Problems have arisen in this system when researchers have looked to conduct a nationwide study or a study involving participants from more than one region. Hence Multi-centre Research Ethics Committees (MRECs) were introduced to avoid researchers having to apply to several local RECs with the same application [
18,
22]. At the time of our study a two tier-system existed, whereby MRECs, as overarching ethics committees, considered the key ethical issues of the proposed research, whilst the second tier, the RECs, considered specific local issues, such as, for example, the number of studies already running locally in the same patient population in order to avoid overburdening these participants.
Over the past two decades there has been much criticism from the research community (and not just in Public Health) on the way RECs operate in the UK [
4,
15‐
17,
23‐
30]. Barker, for example, describes an epidemiological study of a pre-NHS archive of health visitors' records babies living in Hertfordshire (UK) [
31]. Based on these records Barker and his team conducted a long-term epidemiological follow study of 15,000 people some 50 years later. His final comment is highly relevant here:
At the time we had no difficulty in getting permission to trace, interview, and examine large numbers of people. It is unlikely that such permission would be so readily obtained today. Had current data protection laws been in force 15 years ago, they might have prevented thousands of willing Hertfordshire people from taking part in medical research-and the fetal origins hypothesis would not exist [
32].
Of course, the RECs system is not fail-safe; even with active ethics committees there is still going to be unethical research. For example, having undergone an appropriate ethical review did not prevent the UK scandal of body parts of children being kept for research without parents being informed or asked for permission at Alder Hey Hospital in Liverpool [
33]. Whilst the 2006 drug trial at Northwick Park Hospital (London), that caused serious side effects in six healthy male volunteers in a private facility [
34], had been reviewed and approved by the appropriate research ethics committee. As Dingwall reminded us, the relatively regulatory environment in Germany of the 1930s did not prevent the medical experimentations of the Nazi in the 1940s [
34]. So although we are convinced of the importance of having such ethics committees, it is clear that they can not (and will not) police all on-going research to help maintain ethical standards. Therefore, it is ultimately a key role for researchers to consider the ethical elements of their research (and that of their students), and to ensure that research is being conducted ethically.