While the intent of this thesis was to investigate the impact of ethical changes on longitudinal health studies, what became apparent during the analysis of the data was the impact that community had on the studies. The concept of community is something that initially was not considered, however it became apparent that in all of the methodologies the utilisation of the community was an influencing factor in recruitment and on-going participation.
The purpose of using the GP and Framingham studies was to provide a varied and broad range of comparative populations and methodologies within the range of 1940 to 2010. This would allow for changes in the ethical framework for longitudinal research to emerge. This allowed for comparisons for the Tasmanian Iodine Studies with regards to ongoing follow- up, loss to follow-up and cohort selection. While the Tasmanian study does not follow a
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single cohort over as long a period of time as the two earlier studies do, it retains the concept of examining a community – be it a changing community – to determine outcomes based on behavioural habits.
In the case of the Doll and Hill studies, the behavioural habit in question was smoking and the outcome was to determine the risk factors for lung cancer. In the Framingham study, it was originally designed to determine potential factors for CHD, but has evolved over the years to determine other factors linked to the risk of heart disease. The concept of a
community being an epidemiologic laboratory (as put forward by Kessler and Levin [399]) may be dependent on the definition of community and whether an individual is using the scientific or popular definition. The Oxford English Dictionary defines community as ―A body of people or things viewed collectively.‖ However, community and population cannot be used interchangeably. While both the Framingham and Doll and Hill studies can be considered to comprise a community, a community has to be populated. There are two types of population which are considered in these studies: one which can be considered a physical population, the other a conceptual population. The physical population is defined by certain physical boundaries (such as the Framingham Study). The conceptual population is where the population is characterised by something other than residence within a defined boundary. These definitions are analogous to Lasts population and sampling population definitions respectively [400]. With respect to these case studies: while the physical population could be considered to be the sampling frame, within that physical population a conceptual population has been established. The establishment of the conceptual population in all three of these studies described in this thesis varied from the primary method of population establishment (GP Study) to a secondary population establishment after the physical population had been defined (Framingham and Tasmanian Iodine). However, all three populations became a community by virtue of the fact that certain results with the study are viewed at a collective level – this is particularly true within the Framingham study, which is constructed of many populations as differing cohorts, yet they are viewed collectively within the studies in question.
The GPs are a community by virtue of them all having a particular degree and membership of a certain society, Framingham is a community by virtue of location and the Iodine study is a community as it looked collectively at a group of young people in a defined area. Even though within the Iodine studies the students under study changed each time the study was
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undertaken, the concept of looking at changes within a defined community is still valid. This concept, based in ethnographical research, may not seem to be relevant to a science based study but is actually pertinent to the perception of study populations and recruitment [3]. It is the concept of community in the Framingham study that allowed for the 2nd and 3rd generation cohorts to be recruited so successfully. The community contributed to the successful recruitment of the 2nd and 3rd generations, as well as the recruitment of the Omni cohorts by participating in the collection of potential participants‘ information [145, 163]. This could be interpreted as strategic use of the people already involved in the study, but could also potentially be seen as a case study for the use of a whole community in public health studies. Studies such as the Busselton Health Study [129] have built on the work that Framingham have done with regards to community involvement in the study. They have done this by involving the community. This has given the community a vested interest in the study itself and its ongoing success.
Within the Tasmanian iodine studies, the concept of community as mentioned earlier is evident in the Gibson studies. The whole school testing concept allowed for community engagement and a feeling of doing good for the greater benefit could be assumed to be established. This use of community is something that does not occur in the Menzies studies. This could not only be primarily due to the methodology, but also to the significantly smaller sample sizes than the earlier studies. In the Broadstreet studies, there is an apparent loss of potential sampling through the layers of permissions. Personal experiences of the author suggest that the smaller schools, while having potentially smaller sampling frames, were much more willing to participate and follow through on completing consent forms and missing samples.
This context of community, and the community getting together to help for the greater good, in public health type studies can be perceived as important. As can be seen from a study such as Framingham, community investment through participation and time can allow for a large representative study with minimal community impact with regard to methodologies can lead to significant outcomes for the wider community. This is also the case in the Iodine studies. The result from the sampling undertaken in all the studies has influenced the supplementation process by either changing the type of supplementation or confirming that supplementation was either needed or the current supplementation regime was working.
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This concept of doing good for the greater community is summed up very well by Ashcroft [350] who stated:
―We want people to act morally, it is not because so acting is in enlightened self interest alone, but because sometimes we need people to make genuine sacrifices of their interests to the benefit of others: to act against their interests, in the certainty or high probability of personal loss.”
However, the sense of community and doing the greater good for the community as a whole is not as prevalent nowadays in Western society as it used to be. This can be seen in the some of the studies undertaken in the mid to late 1900‘s, such as the Framingham Heart Study, The Tecumseh Michigan Community Health Study, the Health and Ways of Living in Alameda County California Population Laboratory and others [399]. While large-scale community studies such as the Busselton Health Study are still undertaken, there is not the proliferation of studies which existed earlier. It is still evident in other countries, such as, for example, Africa. Jegede [70] noted that a Western bioethical construct of individual
autonomy is not necessarily prevalent in Africa; it is more likely to be a communal or social autonomy.
This move from communal or social autonomy to a more individual approach with regards to selection and consent is a concept that can potentially affect human studies in many different ways. While it may seem to be a societal norm to try to protect the individual, this protection appears to be potentially biasing the selection process for many varied longitudinal studies. Various studies have been undertaken to determine if there are differences between known responders and non-responders [372, 375-377, 401-404]. Junghans [372] found that the opt- in arm of their angina study generally had healthier participants and a lower response rate. Kristman [401] noted that a certain type of non-responder in cohort studies can bias the results. They have named this type of non-responder ―Missing Not At Random‖. This type of non-responder generally has a reason for not responding to follow-up after the initial survey, but this reason may be unknown. Kristman [401] has shown that statistically this group can bias the results in a long term study.
This concept of community generally appears to be an underlying theme throughout most of the case studies. To undertake a successful long-term longitudinal study involving
surveillance, the support of the community appears to be paramount. While protection of the individual is required, numerous layers of protection can inhibit the true random nature of
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selection within a community. A balance between protection of the individual and doing research for the greater good needs to be established. It will probably only be found through communication with the potential research participants, ethics committees and researchers. This need for balance has already been highlighted by various researchers. Madhavan et al [405],while approaching the issue from a demographical point of view, highlighted that ―community involvement‖ allows a longitudinal study to be undertaken in a more equitable manner. They found that once lines of communication within the community had been established, information was transmitted between villages within the communities much quicker. The use of locals as field workers also allowed the researchers to gain the trust of the community, as well as an understanding of concepts unique within that community [405]. The NERE, as an entity that has been evolving since the late 1940‘s, is still in a state of flux even today. While studies ethically are encapsulated within the ethical time frame in which they are originally conceived, the evolving environment will affect them if major changes to their methodologies are proposed. The consequences of changes to methodologies within a study can have an impact on the conclusions drawn and the decisions made within the context of the study and the greater good.