Have legal issues such as privacy impacted on epidemiological research with regards to recruitment and follow-up?
The ability to follow-up on non-responders, recruit participants and develop sampling frames has been affected by legal issues such as privacy. This suggests that legal issues have had an impact on epidemiological research.
The ability of researchers to deal with such ethical dilemmas in a moral way is diminishing due to increasing regulation of the research environment. This is due to the increasingly regulatory needfor privacy and the requirements for data not to be linked to an individual. While this may be societal expectation, data linkage and the thought of Big Brother watching also influences this expectation of privacy. As can be seen specifically in the Broadstreet studies of the iodine surveys, the ability to determine reasons for non-response or to follow- up on non responders individually was not available.
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Within Australia the application of the National Privacy Principles in conjunction with the Privacy Act (1998) and the NHMRC guidelines provides participants with the knowledge that data collected by the researcher will be stored in a manner to protect their right to privacy [406]. This however can cause complications with regards to the use of data for ongoing or associated studies. The privacy principles associated with the act suggest that various modes of collection, use and storage need to be adhered to [406].
While these principles are relevant and best practice, in reality they can cause problems. The relevant section of the privacy principles state that data can be disclosed:
―(d) if the information is health information and the use or disclosure is necessary for research, or the compilation or analysis of statistics, relevant to public health or public safety:
(i) it is impracticable for the organisation to seek the individual‘s consent before the use or disclosure; and
(ii) the use or disclosure is conducted in accordance with guidelines approved by the Commissioner under section 95A for the purposes of this subparagraph; and
(iii) in the case of disclosure—the organisation reasonably believes that the recipient of the health information will not disclose the health information, or personal
information derived from the health information; or
(e) the organisation reasonably believes that the use or disclosure is necessary to lessen or prevent:
(i) a serious and imminent threat to an individual‘s life, health or safety; or (ii) a serious threat to public health or public safety;‖ [406].
These restrictions, if applied ethically, could easily restrict contact data being made available for follow-up of study recipients to partake in similar but methodologically different studies. This construct is not so apparent in either the GP or Framingham studies.
Follow-up methods employed by these studies may not have been permissible under
contemporary ethics frameworks. While the initial recruitment may be similar – utilisation of census and electoral enrolment or of professional databases - follow-up methods would
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have had to have differed. The GP studies method of follow-up was via reminders and notifications of deaths via the Register General of anyone listed as a medical professional [167]. While reminders could still be utilised today, the notifications by the Register General would be subject to privacy laws. This would not allow for cause of death to be determined, thus one of the main objects of the study would not be able to be achieved.
In the Framingham Study, while recruitment could have taken place utilising freely accessible census and voter databases, follow-up would have also proved problematic. Different data sources have been utilised in this study, from records of hospitalizations, death certificates, medical examiner reports, and information from private physicians [146]. Many of these would now have to be given permission individually by the participant to allow the data to be pooled and analysed.
Has research governance has affected research ethics?
Varied influences, dependent on the country of origin, were seen in the three case studies. International codes, while generally providing guidance and suggested actions are not
legislated for in any of the countries under consideration. Thus, even though these codes and events could and have influenced ethical thinking, there is no solid evidence that links ethical events to precise changes in methodology and thinking in the case studies.
Hence, while research governance may have made research ethics more problematic, there is no hard evidence that it has adversely affected the studies under examination. Anecdotal evidence points to instances of change in recruitment methodologies. In particular research governance being seen to have a negative effect with regards to self-selection and response rates [372, 407].
Protection of the individual is part of the remit of an ethics committee. However, ethical requirements are not study dependent. That is, the requirements do not vary depending on how a study is designed, and how its researchers propose to carry it out. Capron [395] confirms this and proposes that non interventional studies may be better managed by the implementation of the ability of a subject to remove themselves post participation after they are made aware of the true nature of the study.
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Do changing ethical environments in longitudinal cohort studies have long- term ethical considerations with regard to various factors within the study?
All of these studies if they were to be undertaken under contemporary research ethics environment would be affected. The differences would be dependent on the country of origin. Epidemiologically, the research methodologies would impact on drawn conclusions. In conclusion, the NERE and the studies it influences can be seen to be a balancing act. For every piece of legislation added to the environment that influences studies, a part of the study may have to be modified to accommodate this. While small adjustments are par for the course with regards to long-term studies, too many may change the results and the comparability of them to earlier results.