Ethical Issues Raised By Epidemiological Research Health Essay
Requires a new physician to swear upon a number of healing gods that he will uphold a number of professional ethical standards. One of the best known prohibitions is, “to do no harm” (History of Medicine Division, National Library of Medicine. Available from: http://www.nlm.nih.gov/hmd/greek/greek oath.html [Accessed 20th October 2009]).
Coughlin and Beauchamp in their 1996 book believed that the Hippocratic Oath does not even come close to covering the obligations placed on health professionals to consider biomedical and public health ethics. In the more recent years a 2007 article by Melo-Martin and Intemann states that many epidemiologists believe that they:
ought not engage in ethical evaluation or endorse any particular ethical,
political, or social values while involved in scientific reasoning (Intemann and Melo-Martin 2007 p.215) .
They state that many epidemiologists believe that considering ethics would lead to bias in the data collection and analysis being done for the research. The authors go on to reason that evaluating ethics in epidemiology is essential for conducting epidemiological research. They state that epidemiologists like any other scientists have ethical obligations to the participants. They believe that scientists/epidemiologists require training in ethical reasoning.
Guidelines produced by the Industrial Epidemiology Forum highlight general ethical principles that can be applied to all research.
The American College of Epidemiology have also produced ethics guidelines, the reasons for producing these guidelines among others include the lack of ethics information given during epidemiological training (Coughlin et al. 1999; Stoto et al. 2003). Updated guidelines have also been produced by The Council for International Organizations of Medical Sciences (CIOMS), entitled, “Special Ethical Considerations for Epidemiological Research” (PHG Foundation, 2009. Available from www.phgfoundation.org/news/2648/ [accessed 28th October]). The authors of these guidelines believe that they are necessary due to the “increased attention” on ethics and the problems that occur when epidemiological studies deal with more than observation. They believe that issues arise in the “disclosure of health related-information and the need to protect the confidentiality of the data”. If epidemiology did not raise new ethical issues would there be any need for these special guidelines? What’s different about epidemiological research and any other type of research? The American College guidelines detail the core values for epidemiologists including:
minimizing risks and protecting the welfare of research participants; providing benefits; ensuring an equitable distribution of risks and benefits; protecting confidentiality and privacy; obtaining informed consent; submitting proposed studies for ethical review; maintaining public trust; avoiding conflicts of interest and partiality; communicating ethical requirements; confronting unacceptable conduct; and obligations to communities (Coughlin 2006 p.4).
Although these are core values within epidemiology they can perhaps all relate to research as a whole, these will be considered below.
Is the study of how disease occurs in different groups of people and why. Epidemiological Information is used to plan and evaluate strategies to prevent illness and as a guide to management of patients in whom disease has already developed (British Medical Journal. Available from http://www.bmj.com/epidem/epid.1.html [Accessed 20th October 2009]).
Epidemiology is widely believed to be the cornerstone of public health (FPH. Available from http://www.fphm.org.uk/careers/ph_consultant/ [accessed 18th Jan 010])., as such perhaps the ethical issues raised by epidemiology research are akin to those for public health research. Coughlin (2006 p.2) believes that the:
Ethical concerns in public health often relate to the dual obligations of public health professionals to acquire and apply scientific knowledge aimed at restoring and protecting the public’s health whilst respecting individual autonomy.
In other words to try and ensure an equitable distribution of risks and benefits epidemiologists must try to balance the rights and welfare of the individual and those of the population. With regards to this Coughlin debates about the moral reasoning behind public health studies stating that in public health two theories have been commonly cited: deontological and utilitarian. Deontological is the theory that the outcome does not justify the action no matter if the action can be considered right or wrong so in public health the end does not always justify the means. As such this means that individuals and populations should be protected even if this impacts on the research that could help the masses. Utilitarian is the theory that the end justifies the means if the end or outcome is good for the majority. In public health this means putting aside the rights of the individual or individual populations to concentrate on the greater good.
Epidemiology therefore lends itself to the ethical debate of how to gain knowledge that promotes public health but respects the rights of the individuals and groups involved. With regards to minimising risks and protecting the welfare of the individuals taking part in epidemiology studies Coughlin (2006) discusses the thoughts that the risks that are confronted in clinical trials and experimental medicine studies can be considered relatively large compared with epidemiological studies. The epidemiological risk can be great in terms of the loss of privacy, time spent and the emotional risk of taking part in such studies.
With regards to protecting privacy in epidemiological studies, more than other types of studies, disease/conditions are often linked back to demographics e.g. socio-economic status (based on income, education and occupation). This raises an ethical concern in that these can often be sensitive issues and if these demographics are not sought from the individual then the individual needs to be made well aware of this. If these are sought from the individual then care needs to be taken so not to embarrass or put the individual in an awkward position. A study by Willison et al in 2009 found that when presented with choices regarding the linking of their medical data “people were more willing to link their health information with biological samples than with information about their income, occupation or education” (page 1). The threat of disclosure of medical conditions to companies such as medical insurance companies is a concern, even if the records are anonymised those with a rare condition could be identified. Willison et al (2009) looked at the difference of the willingness to disclose personal health information between people with a stigmatizing health condition and those without. They stated that those with the stigmatizing conditions may have more concern over that disclosure of information due to the affect on the future e.g. if disclosed to future employers or life insurance companies. Whilst this concern is increased with regard to many epidemiological studies it exists in all studies where details of conditions are gathered.
As epidemiological research often relies heavily upon accessing information and participant details from computerised systems the ethical issues regarding confidentiality, access to medical records/data and anonymisation have a profound impact on carrying out this type of research. A case control study into Creutzfeld-Jakob disease (Ward et al. 2004) found that the restrictions placed upon them by the ethics committee due to ethical concerns regarding patient confidentiality led to a very low response rate from those with the disease and controls. They put this down to the ethical concern of the committee that anything other than writing to the participants and receiving a response in writing was unethical. This of course varies from the procedure used during a study conducted from within a clinic by a medical professional directly involved in treating the patient where a discussion could take place and the study explained in person. Confidentiality however is a key issue in any kind of clinical research (Emmanuel, 2000).
Epidemiology relies more and more on large datasets, keeping these confidential with access granted only to those whom it is necessary to do so is a large ethical concern. This may not be different in many cases to other research rather than epidemiology. However in the case of epidemiology you can perhaps argue that the non anonymisation of the data is more common in many cases to allow linkage to data, such as demographics, over the course of a study. This makes security more of an issue than a study where little data is gathered from the individual during the course of a study. Public interest being better served by access to data than the individuals rights can mean a court of law allowing access (International Medical Journal. Available from www.e-imj.com/vol3-no2/vol3-no2-E5.htm [Accessed 20th October 2009]) providing an interesting ethical debate.
With regards to maintaining public trust the American College Guidelines state that
To promote and preserve public trust, epidemiologists should adhere to the highest ethical and scientific standards and follow relevant laws and regulations concerning the conduct of these activities, including the protection of human research participants and confidentiality protections (McKeown et al. 2003 p.5).
This should be applied to all research and not just epidemiological research. Guidelines produced by the Association of American Medical Colleges were produced in 2002 in order to try and increase public trust in all clinical research.
To address epidemiologists meeting their obligations to communities the American guidelines detail this should be undertaken by performing research that addresses health problems including those of the appropriate utilisation of health care resources (McKeown et al. 2003 p.5) All research has to be deemed worthwhile and is presumably working towards a goal of addressing health problems. As such I don’t think this can be considered a new ethical issue with regards to epidemiology compared to other types of research. With regards to undertaking research of utilisation of health care resources although this is a public health/epidemiology ethical value this does not apply to all epidemiology research but to the public health research community as a whole.
Epidemiological studies often involve screening programmes, commonly to assess the benefits/disadvantages of these programmes or to assess the numbers with the disease. Screening programmes often present ethical issues with regards to confidentiality and minimising risk to the participant. They can introduce a difficult ethical dilemma where the disease is inherited or where little can be done for the disease. Miller et al (2009) discuss the effects of screening for infant sickle cell disorder. A disease which is highly treatable but would show up carriers who may not be previously aware that they were carriers for the disease. They state that “whether these incidental results should be routinely disclosed remains controversial” (p.626). The same could presumably be said regarding the introducing of screening for any inherited disease in a population – a large area in epidemiology. False positives and negatives can be a problem with screening, screening can also be an issue once a disease has been detected when nothing or little can be done to improve prognosis (Coughlin 2006). The:
potential harms of screening may include labelling effects and psychological impact of test results or a diagnosis (Coughlin 2006 p.9).
Conflicts of interest are also considered an ethical issue in epidemiology by Coughlin (2006), financial conflicts such as funding, publication conflicts such as contracts limiting when results can be published and what can be said. The same can be said for most other research though so perhaps this does not constitute as a unique epidemiological ethics issue. Hemminki (2001), discusses the effects of commercial interest and competition on the ethics of research into genetic epidemiology, detailing that the effects can lead to:
suppressed openness, delayed publication, reduced collaboration and even attempts to prevent others from obtaining data, material or funding (p.440).
Jennings and Calahan (2002) believe that the collection of data by epidemiologists may put the public health practitioner in a position of vulnerability concerning the information they hold on individuals and the interest that employers and insurance companies may have in this information.
Advances in genetics that can be used in genetic screening, genetic testing and research to provide public health researchers and epidemiologist with a wealth of information. However this genetic information also brings with it new challenges and problems that other types of research do not as well as some of the ethical issues that plague all research.
A specific kind of epidemiology research results in ethical issues similar to those in other types of epidemiology research and presents some of its own issues, Genetic epidemiology. Genetic epidemiology can be used as an example for the need to regard the ethical concern of obtaining informed consent.
As a precursor to the UK Bio Bank project (a collection of DNA samples from 500,000 British men and women aged between 45 and 69) Haimes et al (2004), looked at the legal, ethical and social issues of such a bank. To do this they used as an example a smaller study in Northumbria of a bank of maternal blood samples from women and from new born babies along with accompanying information (via a questionnaire completed by the mothers) to provide a resource for future genetic epidemiology questions. They found that a far greater number (90 versus 60) of the women provided samples than answered the questionnaire. The ethical issues they found cause for concern with included informed consent – did the women really understand what they were donating and how their tissue and information would be used? Other issues for concern included the details of how the people are approached to take part in such studies and what they believed they were taking part in e.g. the research getting mixed up in normal clinical care. These issues regarding genetic epidemiology studies are very similar to the concerns raised over other studies involving samples, such as those of Cancer Genetics (Miller 2008; Hallowell 2009)
Hemminki (2001), believes that the ethical concerns regarding genetic epidemiology focus on the need for the studies to be properly carried out as the results can have implications for clinical decisions. The population the study is carried out in can lead to differences in the results, which can result in a bias. Hemminki (2001) is also concerned with the harmful effects that competition for research in the area of genetic epidemiology leads.
Feedback to individuals and more broadly during epidemiology research can cause an interesting ethical dilemma. Richards et al (2003) found that providing individual feedback during the course of a genetic epidemiology study was difficult. Problems arose if the disease detected had not previously been seen in a family and how to feed this risk back to the family. Also the difficulty when a mutation detected during research can not be confirmed clinically. This seems to be more of a general concern in any study involving samples (Wilfond and Ravitsky, 2006).
As such it would seem that many of the ethical concerns that need to be taken into consideration for epidemiological research are the same as those for many other types of research. Perhaps the ethical concern to concentrate on is the one raised by Coughlin, the difficulty in gaining knowledge that promotes public health but respects the rights of the individuals and groups involved. As epidemiology is commonly claimed to be the backbone of public health perhaps this is the case. Coughlin (2006) page 1:
Public health ethics has a broad scope that includes ethical and social issues arising in health promotion and disease prevention, epidemiologic research, and public health practice.
However a similar moral stance needs to be applied to all research regarding the risk benefit ratio ensuring that the “the potential benefits to individuals and knowledge gained for society must outweigh the risks” (Emanuel et al. 2000 p2701). As such perhaps the ethical considerations for epidemiology relate as in all research to evaluating the type of research being done and weighting the ethical concerns appropriately. An example in the case of epidemiological studies would be taking greater care when assessing the issues of confidentiality when a large dataset with identifying information is collected compared to a drug trial where a small amount of personal information is collected and kept anonymously.
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